Original instructions

Operation Manual
MV5 H00[ Multiple mode (Hemoglobin / Calprotectin) ]Be sure to read “Safety Precautions” before use.
Safely use this product after reading this Operation Manual carefully.
Store this Operation Manual in a safe place so that it can be referred to whennecessary.

◆ Manufacturer: EIKEN CHEMICAL CO., LTD.
4-19-9, TAITO, TAITO-KU, TOKYO◆ Authorized Representative: Advena Ltd.

110-8408, JAPANTower Business Centre, 2nd Flr., Tower Street,
Swatar, BKR 4013 MaltaImportant・Copyright for this Operation Manual belongs to Eiken Chemical Co., Ltd. and Hitachi, Ltd.
Use, reprinting, duplication, and modification of its contents in part or in whole without
permission is strictly prohibited.

・The content in this Operation Manual and system specifications may be changed without
notice in order to make improvements.

・We are not responsible for any damages or the like if the system is not used in accordancewith this Operation Manual.

・In vitro Diagnostic Medical Device Regulation (EU)2017/746

・EN 61010-1:

Safety requirements for electrical equipment for measurement,		

control, and laboratory use Part 1: General requirements.

・

Safety requirements for electrical equipment for measurement,

IEC 61010-2-101 :		control, and laboratory use - Part 2-101: Particular requirements for		in vitro diagnostic (IVD) medical equipment.

・ EN 61326-1

Electrical equipment for measurement, control, and laboratory use.

:		

EMC requirements. General requirements.

・ EN 61326-2-6Electrical equipment for measurement, control, and laboratory use.

:		

EMC requirements. Particular requirements. In vitro diagnostic (IVD)		

medical equipment.

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Introduction
Prior to reading this Operation Manual
OC-SENSOR PLEDIA is a fully automated fecal occult blood analyzer—that is, it is a movable anddiscrete clinical chemistry automatic analysis system (below, “system”).
The system and its Operation Manual is meant for doctors, clinical laboratory technicians, and those whohave received specialized education or training in test procedures that use diagnosis systems outside thebody.
Read this Operation Manual carefully prior to use, in order to use the system properly.
Note that using the system in a manner not described in this Operation Manual or in conditions outside
the system specifications could negatively impact the system’s safety and performance.
Be sure to use the system according to the instructions in this Operation Manual.

Operation Manual organization
This Operation Manual consists of the following chapters:

Introduction： Describes the organization and notation of this Operation
Manual, as well as “Safety Precautions” when using the system

Chapter 1 Overview： Gives an overview of the system, including measurement
principles, analysis flow, as well as the names and functions ofeach part.

Chapter 2 Operation (Basic)： Gives an overview of initial settings prior to use, and describes
basic operation of the system, such as daily operation.

Chapter 3 Operation (Applied) ： Describes applied operation of the system, such as searchingmeasured data, recalculation, output, and deletion of test data,
as well as quality control.

Chapter 4 Support Functions： Describes support functions run prior to analysis, such aspriming and cell blanking.

Chapter 5 Maintenance： Describes inspection and maintenance methods users should
follow in order to safely use the system, maintain performance,and discover malfunctions and the like as early as possible.

Chapter 6 Settings： Describes details on initial settings for operating the system.

Chapter 7 Help

： Describes analysis flow, as well as inspection and maintenancemethods after use.

Chapter 8 Error Handling： Describes how to read the error screen.

Chapter 9 Operator/Latex： Describes how to Login/Logout, and managing Latex/QC Lots
Management Function(Option)Appendix： Describes data processing, analysis operations, printing
examples, and errors.

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Prior to reading this Operation Manual

Operation Manual notation
This Operation Manual describes matters that must be followed in order to safely use the system,
prevent danger to the user and others, and prevent damage to property.

■“Warnings,” “Cautions,” and “Requests”

Warning
CautionRequest

Indicates a possibility that improper use of the system will cause deathor severe personal injury to the user.
Indicates a possibility that improper use of the system will cause
personal injury to the user or damage to property.
Indicates something the user should do to prevent damage or degradation
to the product and to use the system efficiently.
Severe injuries:

Personal injuries:■

Injuries that result in permanent damage or which require longterm hospitalization or outpatient treatment.
Examples include loss of eyesight, injury, burns, electric shock,fractures, poisoning, and infection.
Injuries that do not require long-term hospitalization or
outpatient treatment.

Symbols
Caution symbols:

Indicate that users should use caution.

Attention

Prohibition symbols:

Biohazard

Electrical shock

Pinching hazard

Indicate prohibited actions.

Prohibited

Disassembly
prohibited

Instructional symbol:

Indicates instructions users must follow.

Required■

Other notations
Explanatory note：

Describes related supplementary notes.

【】：

Indicates something that can be operated, such as a tab or a button on the screen.

［］：

Indicates the name of a screen, or settings that require selection or input.

：

Indicates reference locations.

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Safety Precautions
Be sure to read this section before using the system.

Installation precautions
Power supplies and cords
Warning
・Do not connect the power cord to an extension cord or an adaptor plug.
Prohibited・Do not insert or remove the power plug with wet hands.
・Do not damage or alter the power cord.
・Do not apply excessive force to the power cord.
・Do not fasten the power cord using metal fixtures or the like.
・Do not use power cords other than that provided.
Failure to observe this precaution may lead to electric shock or fire.

Warning・Make sure that the system is grounded.
Required

Failure to observe this precaution may lead to electric shock.

・Connect to the appropriate power supply.
RequiredPower supply voltage:~100-240 V

Frequency:

50/60 HzPower consumption:

500 VA

Socket:

The power plug uses a protective earth terminal.
Use a fixed power socket (electrical outlet for medical use) that iscorrectly grounded.

Failure to observe this precaution may lead to electric shock or fire.

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Installation precautions

Installation conditions
Caution・Use indoors.
Required・Avoid exposure to water.
・Avoid harmful effects that can result from barometric pressure, atmospherictemperature, humidity, poor ventilation, sunlight, dust, saline matter, or air
including sulfur.
・Install in a location that is flat and free of vibration or impact.
・Install in a chemical storage area or in a location free from gas emission.

Caution・Do not move the system.
RequiredThis system should only be installed or moved by a maintenance person who has been certified
by Eiken Chemical.

・Use a platform that can support the weight of the system. Make sure that theplatform is stable.
If the system falls, it could cause unexpected injury.

・ Install the system in a location with plenty of space, so as to not hinder operation or
maintenance.
(Refer to the following diagram.)

30cm or more

63cm

30cm or
more

63cm

30cm ormore

・ Size(cm) and weight (kg) of system
Width 63 x Length 63 x Height 56 Weight : approx. 60
・Do not place the system near the exhaust ports of heating and cooling equipment.
Doing so could result in incorrect analytical results.

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Installation precautions

Environmental conditions
Caution・Adhere to the following environmental conditions:
Usage conditions

RequiredTemperature: 15°C to 30°C
Humidity: 20% to 80% (no condensation)
Height of 2,000 m or less*
Pollution degree 2*
Overvoltage category II*

Explanatory note

Storage conditions

Temperature: 0°C to 55°C
Humidity: 20% to 90% (no condensation)

Transport conditions

Temperature: -20°C to 60°C
Humidity: No more than 95%
when the temperature is 25°C to 55°C
(no condensation)* Standardized conditions are based on EN61010-1:2010 “Safety requirements for electricalequipment for measurement, control, and laboratory use-Part 1: General requirements.”

EMC (Electromagnetic Compatibility)
Caution・This equipment is not intended for use in residential environments and may not
Requiredprovide adequate protection to radio reception in such environments.
・TThis equipment is designed for use in a PROFESSIONAL HEALTHCAREFACILITY ENVIRONMENT. It is likely to perform incorrectly if used in a
HOME HEALTHCARE ENVIRONMENT. If it is suspected that performanceis affected by electromagnetic interface, correct operation may be restored byincreasing the distance between the equipment and the source of the interface
・The electromagnetic environment must be evaluated before operating thedevice.
・Do not use this device in proximity to sources if strong electromagnetic
radiation (e.g. unshielded intentional RF sources), as these can interfere withproper operation.

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Installation precautions

Security
CautionObserve the following to prevent leakage or falsification of data.
Required・To avoid unauthorized access, restrict the operation of the system to authorized
personnel only.
・Make sure that only verified computers are connected to the system network.
・Conduct cybersecurity assessments regularly to ensure an appropriate level ofdata security.
・Do not use personally identifiable information for sample IDs and patient IDs.
Instead, use anonymized IDs for management.
・For network security, address the security of IT infrastructure in your facility
to ensure that IT security is not compromised by malicious software or hacker
attacks.
- Protect all devices and services used in your facility from malicious softwareand unauthorized access.
- Connect the system only to the internal network of your facility that is notconnected to the external network.
・Regularly protect your data by strong it on external media. There is a possibilityof data corruption due to cyber attacks, disasters, etc.
・Please review your users and passwords regularly.
・Check the USB flash drive in advance for viruses and make sure that no viruseshave been detected.
Failure to observe this precaution may lead to infection by computer viruses.
Failure to observe this precaution may lead to leakage or falsification of information.

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Usage precautions
Work and operation precautions
Warning・Wear protective equipment when handling samples.
Biohazard

・Wash your hands well after using the system.
Failure to observe this precaution may lead to infection from samples.

・Dispose of drainage after using the system.
Biohazard

・Make sure that drainage does not leak into the area surrounding the device when
detaching the drain tank hose.
・Make sure the drain tank is empty prior to using the system.
Failure to observe this precaution may lead to infection from samples.

・Be careful not to let the sample container fall over when attaching / detaching
the sample rack or tray.

Biohazard

Failure to observe this precaution may lead to infection/contamination from samples.
Failure to observe this precaution may lead to loss samples.

・Be careful of sample splattering when removing the sampling bottle from therack.

Biohazard

Failure to observe this precaution may lead to infection from samples.

・Do not disassemble the system.
Disassembly
prohibited・Do not remove any of the system’s exterior parts.
Failure to observe this precaution may lead to electric shock.

Electrical shock

・Do not spill any samples or reagents inside the system.
Failure to observe this precaution may lead to electric shock.

Prohibited・Do not mix the washing solution with acid washing solution.
Failure to observe this precaution may damage the operator’s health.

Prohibited

Caution・Do not open the cover of the analysis chamber during operation.
Pinching hazard

・Keep out of the operational range of the system during operation.
Failure to observe this precaution may lead to injury or damage.

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Usage precautions

Caution・ Do not move the rack while it is conveying.
If the rack is accidentally moved, remeasure (retest) all samples in the rack.
RequiredIf the rack is misaligned, it could result in incorrect measurements.

CautionRequired・Connect each tank (purified water, wash solution, and drainage) correctly witheach hose.
・Monitor the quality control function and positive rate change periodically.
Failure to observe this precaution may lead to a false diagnosis.

Caution・Be careful of static electricity when operating the reaction processing section,such as when replacing cells
Electronic components may be damaged by static electricity.

RequiredFor example, you can discharge static electricity by touching a grounded metal part around thedevice.

Caution・Use only recommended external media (such as USB memory).
Contact us for details on recommended products.

Required・Manage external media appropriately. Check for viruses periodically.
Failure to observe this precaution may lead to infection by a computer virus.

Caution・Use only reagents that have not expired.
Failure to observe this precaution may lead to a false diagnosis.
RequiredCaution・If the reagent compartment or buffer compartment becomes abnormally hot,dispose of the reagent or buffer that was set.
Failure to observe this precaution may lead to a false diagnosis.

RequiredCaution・Do not turn off the primary power switch until the system shut downs
completely.
Required

The hard disk(SSD) inside the system could be damaged and data could be lost.

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Usage precautions

Maintenance and inspections
Warning・Wear protective equipment when maintaining and inspecting the system.
Biohazard

・The tip of the nozzle is sharp. Use caution when handling it.
・The tip of the puncture needle is sharp. Use caution when handling it.
Failure to observe this precaution may lead to infection from samples.

Request・Inspect the system before starting operations each time.
- Check that there is no water leakage.
- No devices other than the designated ones should be connected.
- The environmental conditions are satisfied.
・Be sure to maintain and inspect the system daily, and keep it clean.

Request・If the system has not been used for some time, check that the system is operating
properly prior to use.

Request・ If system failure is suspected, do not touch the system, and do not attach afailure notice or other notification. Immediately contact the manufacturer or alegal representative.

Disposing of drainage and waste
Warning
・Dispose of drainage and waste (reagent containers, reaction containers,
Biohazard

sampling bottles, and sample cups) appropriately in accordance with facility
safety management procedures and the instructions of the person in charge of
infectious medical waste management.
(Some examples of infectious medical waste include reagent containers, reaction containers,
sampling bottles, and sample cups.)

・Refer to the usage instructions attached to the reagent for information on how todispose of reagent containers and drainage.
・Contact your dealer for information on disposing of the system.
・Wear protective equipment during disposal.
Failure to observe this precaution may lead to environmental contamination.

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Caution labels and where they are affixed
The following caution labels are affixed to the system.
Understand where the caution labels are and what they mean before using the system.

Tank (for drain)

Caution Label

Meaning
Keep out of operational range during system operation.
Failure to observe this precaution may lead to injury.
Do not handle drainage with bare hands.
Failure to observe this precaution may lead to infection or contamination.

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Identification plate and where affixed

A two-dimensional code (GS1-DataMatrix) is printed in the " ☒ " area.

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MEMO

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Table of Contents
Introduction
Prior to reading this Operation Manual･･･････････････････････････････ ii
		Operation Manual organization ･･･････････････････････････････････････ ii

		Operation Manual notation･･･････････････････････････････････････････ iii

Safety Precautions
Installation precautions･････････････････････････････････････････････････ iv
Usage precautions･･･････････････････････････････････････････････････････ viii
Caution labels and where they are affixed････････････････････････････ xi
Identification plate and where affixed ･ ･･･････････････････････････････ xii

Chapter 1

Overview

1.1

OC-SENSOR PLEDIA Features････････････････････････････････････ 2

1.2

Use････････････････････････････････････････････････････････････････････ 2

1.3

Measurement Principles･････････････････････････････････････････････ 2

1.4

System Configuration････････････････････････････････････････････････ 3

1.5

Analysis Flow････････････････････････････････････････････････････････ 5

1.6

System Specifications･ ･･････････････････････････････････････････････ 6

1.7

Reagents Used by System･･･････････････････････････････････････････ 8

1.8

System Dimensions･･････････････････････････････････････････････････ 9

1.9

Names and Functions of Parts
1.9.1

Exterior parts･ ･････････････････････････････････････････････････ 10

		

1.9.2

Internal parts･･･････････････････････････････････････････････････ 12

		

1.9.3

Accessories/other･ ･････････････････････････････････････････････ 14

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Table of Contents

Chapter 2
2.1

		Operation (Basic)

Basic Screen Operation
2.1.1[MENU] screen and functions･ ･････････････････････････････････ 18

2.1.2

Screen composition and button operation････････････････････････ 19

2.1.3[Monitor] screen and functions･･････････････････････････････････ 24

2.2

Starting the System
2.2.1

Shut down normally (with all settings configured to “NO”)･･･････ 27

2.2.2“Exchange buffer and wash sol to p. water” set to “YES” in Closemode, or Long suspense mode selected･･････････････････････････ 28

		

2.2.3

“Cell blank” checked under “Settings of auto start up” in Closemode･････････････････････････････････････････････････････････････････････ 30

		

2.2.4

“Test” checked under “Settings of auto start up” in Close mode･･･････････････････････････････････････ 31

		

		

		

2.3

2.4

Initial Settings
2.3.1

System settings･ ･･･････････････････････････････････････････････ 32

2.3.2

Protocol settings･ ･･････････････････････････････････････････････ 34

Daily Operation
2.4.1

Daily operation flow･ ･･････････････････････････････････････････ 36

2.4.2

Setting printer paper････････････････････････････････････････････ 38

2.4.3

Check the drain tank (connected to system by maintenance person)･･･････････････････････････････････ 39

2.4.4

Setting purified water･･･････････････････････････････････････40

2.4.5

Setting wash solution･･･････････････････････････････････････････ 41

2.4.6

Setting buffer･ ･････････････････････････････････････････････････ 42

2.4.7

Priming (normal prime, pipe line activation)･････････････････････ 44

2.4.8

Measure cell blanks････････････････････････････････････････････ 48

2.4.9

Setting reagents (Pos.-1/Pos.-2/Pos.-3)･ ･････････････････････････ 50

2.4.10Installing samples･････････････････････････････････････････････ 52

2.4.11

Starting tests･･････････････････････････････････････････････59
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2.5

2.6

2.7

2.4.12

Adding samples (continue testing)･････････････････････････････ 72

2.4.13

Additional tests (changing test conditions while testing)･････････ 74

2.4.14Cut-in analysis････････････････････････････････････････････････ 79

2.4.15Completing testing (normal close)･ ････････････････････････････ 82

Inspection/Maintenance after Use
2.5.1

Cleaning parts･ ････････････････････････････････････････････････ 85

2.5.2

Opening the parts check list･････････････････････････････････････ 87

2.5.3

Opening the error log･･･････････････････････････････････････････ 89

System shutdown (Close mode/Long suspense mode)
2.6.1

Close mode････････････････････････････････････････････････････ 90

2.6.2

Long suspense･････････････････････････････････････････････････ 94

Drain Tank Processing･･････････････････････････････････････････････ 96

Chapter 3		

3.1

Operation (Applied)

Measured Data Processing
3.1.1

Opening the [Process data] screen･･･････････････････････････････ 98

3.1.2

Displaying the [Test data] screen･･･････････････････････････････ 100

3.1.3

Specifying measured data by measurement date･････････････････ 104

3.1.4

Specifying measured data by range･････････････････････････････ 106

3.1.5

Reading “measured data” not in the list (reading again)･ ････････ 108

3.1.6

Reading “measured data” from external media(switching external media)･････････ 109

3.1.7

Sorting measured data･････････････････････････････････････････ 110

3.1.8

Searching for measured data･･･････････････････････････････････ 112

3.1.9

Recalculating measured data･･･････････････････････････････････ 116

3.1.10

Outputting measured data･ ･･･････････････････････････････････ 120

3.1.11

Deleting measured data･･･････････････････････････････････････ 124

3.1.12

Copying measured data･ ･････････････････････････････････････ 126

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3.2

Editing Sample IDs････････････････････････････････････････････････ 128

3.3

List of Positive Samples

3.4

3.5

3.6

3.3.1

Displaying the positive sample list･･･････････････････････････130

3.3.2

Sorting positive sample data･････････････････････････････････････ 134

3.3.3

Specifying positive sample data by range････････････････････････ 136

3.3.4

Searching positive sample data･･･････････････････････････････････ 138

3.3.5

Recalculating positive sample data･･･････････････････････････････ 140

3.3.6

Calculating cut-off values from positive rates････････････････････ 142

3.3.7

Outputting positive sample data･･････････････････････････････････ 146

3.3.8

Deleting positive sample data････････････････････････････････････ 148

List of Error Samples
3.4.1

Displaying the list of error samples･･････････････････････････150

3.4.2

Sorting error sample data･･･････････････････････････････････152

3.4.3

Specifying error sample data by range････････････････････････154

3.4.4

Searching error sample data･ ･･･････････････････････････････156

3.4.5

Outputting error sample data････････････････････････････････158

3.4.6

Deleting error sample data･･････････････････････････････････160

Histogram
3.5.1

Displaying histograms･････････････････････････････････････････ 162

3.5.2

Changing the histogram range･ ･･････････････････････････････････ 166

3.5.3

Outputting histograms･ ･･････････････････････････････････････････ 168

Positive Rate Change
3.6.1

Displaying positive rate changes･ ･･･････････････････････････170

3.6.2

Configuring calculation conditions for positive rates･ ･･････････172

3.6.3

Changing the range of positive rate change･ ･･････････････････174

3.6.4

Outputting positive rate changes･････････････････････････････176

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3.7

Replicate
3.7.1

Displaying the replicate list (samples/STAT samples)･ ･･････････ 178

3.7.2

Displaying the [Replicate (STD)] screen････････････････････････ 182

3.7.3

Saving replicate data (STD) to external media･ ･････････････････ 184

3.7.4

Displaying the [Replicate (QC)] screen･････････････････････････ 186

3.7.5

Sorting replicate data (samples/STAT samples)･ ････････････････ 188

3.7.6

Specifying replicate data by range･･････････････････････････････ 190

3.7.7

Searching replicate data･ ･･････････････････････････････････････ 192

3.7.8

Recalculating replicate data････････････････････････････････････ 194

3.7.9

Editing/recalculating calibration curves (samples/STAT samples)････････････････････････････････････ 197

3.7.10

Editing/recalculating calibration curves (STD)･････････････････ 200

3.7.11

Reading/registering calibration curves (samples/STAT samples)････････････････････････････････････ 202

3.7.12

Displaying/printing time courses (samples/STAT samples)･ ････ 204

3.7.13

Displaying/printing time courses (STD)･･･････････････････････ 205

3.7.14

Changing the range of the time course (samples/STAT samples)････････････････････････････････････ 206

3.7.15

3.8

Changing the range of the time course (STD)･･････････････････ 208

Quality Control
3.8.1

Displaying the QC lot list ([QC lot select] screen)･･･････････････ 210

3.8.2

Selecting QC lots･ ････････････････････････････････････････････ 214

3.8.3

Deleting QC lots･･････････････････････････････････････････････ 215

3.8.4

Changing STD/QC measurement process settings from the[QC lot select] screen････････････････････････････････････････ 216

3.8.5

Opening the [Intra-day/Inter-day] screen･ ･･････････････････････ 218

3.8.6

Editing (recalculating) inter/intra-day data･･････････････････････ 222

3.8.7

Deleting inter/intra-day data･･･････････････････････････････････ 224

3.8.8

Specifying inter/intra-day data by range････････････････････････ 226

3.8.9

Displaying the X-R control graph･･･････････････････････････････ 228

3.8.10Changing the range of the X-R control graph･･･････････････････ 232

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3.9

Rack info

		

3.9.1

Displaying the [Rack info] screen･･････････････････････････････ 234

		

3.9.2

Replacing trays (optional)･ ････････････････････････････････････ 238

3.10

Measuring Using Sample Cups･･････････････････････････ 239

Chapter 4 Support Function
4.1

Initialization････････････････････････････････････････････････････････ 242

4.2

Priming･････････････････････････････････････････････････････････････ 244

4.3

Cell Blanking･ ･････････････････････････････････････････････････････ 245

4.4

Washing･･･････････････････････････････････････････････････････246

Chapter 5 Maintenance
		

5.1

		

Inspection/maintenance
5.1.1

Opening the [Maintenance] screen･ ････････････････････････････ 250

5.1.2

Clean touch panel (daily)･･････････････････････････････････････ 251

5.1.3

Clean conveyance line (daily)･･････････････････････････････････ 252

5.1.4

Clean washing nozzle (weekly)････････････････････････････････ 253

5.1.5

Clean sample & reagent nozzles (weekly)･ ･････････････････････ 254

5.1.6

Clean tray (weekly)･ ･･････････････････････････････････････････ 255

5.1.7

Clean racks (weekly)･･････････････････････････････････････････ 256

5.1.8

Clean tank (monthly)･･････････････････････････････････････････ 257

5.1.9

Replacing measurement cells (when cell blank value is abnormal)･ ･････････････････････････････････258

		

		

5.2

List of Parts to Check and Exchange
5.2.1

Opening the [Parts check list] screen･･･････････････････････････ 262

5.2.2

Changing parts････････････････････････････････････････････････ 263

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Chapter 6 Settings
		

		
		

6.1

6.2

System settings
6.1.1

Sample barcode settings (common)･ ･･･････････････････････････ 266

6.1.2

Sample barcode settings (detailed settings by barcode type)･ ････ 268

6.1.3

Rack No./QC No.･････････････････････････････････････････････ 272

6.1.4

Environment settings･･････････････････････････････････････････ 276

6.1.5

Data output settings - [Destination]･ ･･･････････････････････････ 280

6.1.6

Data output settings - [Online settings]･････････････････････････ 284

6.1.7

Data output settings - [Test setting]･････････････････････････････ 288

6.1.8

Output format･････････････････････････････････････････････････････････290

6.1.9

Alarm･･････････････････････････････････････････････････････････････････292

6.1.10Screen saver･････････････････････････････････････････････････ 296

6.1.11

STD/QC analysis process settings･････････････････････････････ 298

6.1.12

Sample cup･･････････････････････････････････････････････････ 302

6.1.13

Printing information on system settings･ ･･････････････････････ 305

6.1.14

Backing up information on system settings/protocol settings･ ･･ 306

6.1.15

Restoring information on system settings/protocol settings･････ 307

Protocol settings
6.2.1

Samp/QC protocol settings･ ･･･････････････････････････････････ 308

6.2.2

CC No. 1 to CC No. 6 protocol settings･ ･･･････････････････････ 314

Chapter 7 Help
7.1

Opening the [Help] Screen from the [MENU] Screen･･･････････ 318

7.2

Opening the [Help] Screen from the [Monitor] Screen･･････････ 320xx
NN1-1703 Rev.3

Table of Contents

Chapter 8 Error Handling
8.1

How to Read [Error] Screens･ ････････････････････････････････････ 324

8.2

Error Cancellation Buttons････････････････････････････････････････ 325

8.3

Clearing Errors･････････････････････････････････････････････････････ 326

Chapter 9 Operator/Latex Management Function（Option）
9.1

LOGIN/LOGOUT･･････････････････････････････････････ 330

9.2

Registering,Mondifying,and Deleting Operators(ID Information)･･････････････････････････････････････ 334

9.3

Managing Latex/QC Lots････････････････････････････････････････････ 340

Appendix		1

Calculation Processing
1.1

STD/QC Sample Measured Data Check･･･････････････････ 343

1.2

Calibration curve calculation･･･････････････････････････････ 344

1.3

DA value calculation････････････････････････････････････････ 350

1.4

Measured Data (Concentration) Calculation andQualitative Assessment･････････････････････････････････････ 351

1.5

Prozone check･･･････････････････････････････････････････････ 352

1.6

Reagent Blank Check (A1 Check)･････････････････････････ 354

1.7

Calculate Cell Blank････････････････････････････････････354

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Test Operations
2.1

Operation when first measuring a sample using
a “sample rack” (first test)･ ･･･････････････････････････････ 356

2.2

Operation when retesting a sample using a “retest rack”(retest)･ ････････････････････････････････････････････････････ 358

2.3

Operation when remeasuring a sample using a“sample rack” (remeasure)････････････････････････････････ 360

2.4

Operation when measuring a sample again it using
a “dilute test rack” (dilute remeasure)･････････････････････ 362

		

3

2.5

Operation when measuring STD/QC samples･････････････ 364

2.6

Operation when performing cut-in analysis･･･････････････ 368

Printing examples
3.1

Positive sample printing････････････････････････････････････ 373

3.2

Final result printing when using a dilute test rack orwhen analyzing 15-times dilution simultaneously･･･････ 374

		

4

3.3

1 day, 2 day, 3 day printing･････････････････････････････････ 376

3.4

Printing when measuring STD/QC samples･･･････････････ 377

3.5

Error message printing･･････････････････････････････････････ 379

Handling the Printer4.1

Setting printer paper･ ･･･････････････････････････････････････ 380

4.2

LED lamp display･･･････････････････････････････････････････ 381

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5

6

Error List
5.1

ERR# 0-1001～･ ････････････････････ 382
0-2005（Main）

5.2

ERR# 1-000～･････････････････････････ 389
1-200（SS1）

5.3

MES# 1-001～

1-007（SS1）･ ････････････････････････ 407

5.4

ERR# 2-001～･････････････････････････ 409
2-200（SS2）

5.5

MES# 2-001～

2-007（SS2）･ ････････････････････････ 416

Save to External Media
6.1

Sample Measured Data Information･ ･･････････････････ 418

6.2

Sample Replicate Information･ ････････････････････････････ 420

6.3

QC Measured Data Information････････････････････････････ 423

6.4

QC Replicate Information･･････････････････････････････････ 425

6.5

STD Measured Data Information･･････････････････････････ 427

6.6

STD Replicate Information･････････････････････････････････ 429

6.7Time Course Data Information･････････････････････････････ 431

6.8

Histogram Information･ ････････････････････････････････････ 433

6.9

Positive Rate Change Information･････････････････････････ 435

6.10 List of Error for Output to External Media････････････････ 437

		7Management USB Stick Setting
7.1

How to Set a Management USB Stick･ ････････････････ 440

Index/Glossaryxxiii
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xxiv
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Chapter 1 Overview

		

1.1

OC-SENSOR PLEDIA Features

		

1.2

Use

		

1.3

Measurement Principles

		

1.4

System Configuration

		

1.5

Analysis Flow

		

1.6

System Specifications

		

1.7

Reagents Used by System

		

1.8

System Dimensions

		

1.9

Names and Functions of Parts

1
NN1-1703 Rev.3

Chapter 1 Overview
This section gives a general outline of the system and describes the configuration of OC-SENSOR
PLEDIA, a fully automated fecal occult blood analyzer (movable and discrete clinical chemistry
automatic analysis system).

1.1 OC-SENSOR PLEDIA Features• OC-SENSOR PLEDIA (below, “system”) is equipped with functions required for
immunoanalytical equipment, such as automatic sample dilution, a wide range ofmeasurements, carryover countermeasures, and prozone checking.
• The system is always in standby. Reagents and buffers are managed by the thermal insulation
system allowing for 24-hour sample measurement.

1.2 UseThe system determines the quantity of hemoglobin etc. in feces by detecting changes in transmitted
light caused by latex agglutination reactions.

1.3 Measurement Principles
Latex turbidimetry
An antigen-antibody reaction is a specific reaction that occurs between an antigenic determinant
and the active group of an antibody. The amount of bonding depends on the concentrations of theantigen and antibody.
A latex agglutination reaction is the clumping of antigen- or antibody-sensitized polystyrene latex
particles caused by an antigen-antibody reaction. A light beam is passed through the reaction liquid
to measure changes in the intensity of the transmitted light beam. This method is called “latex
turbidimetry.” This system makes use of this “latex turbidimetry.”2
NN1-1703 Rev.3

1.4 System Configuration
Check the configuration prior to using the system.
Name
Model
Fully
automatedfecal
occultBody
OC-320blood analyzer(movable and discrete clinicalchemistry automatic analysis
system)
OC-SENSOR PLEDIA
Accessories (1) Software package･Software program

Number Remark
11Preinstalled in harddisk(SSD)(2) Racks･Sample racks

OC-RK-41A

2boxes10 units/box･STD/QC racks

OC-RK-42A

1

2 units/box･Retest rack

OC-RK-33C

1

1 units/box･Dilute test rack

OC-RK-34C

1

1 units/box･Tank(for purified water)

NBU-4033-W1

1

10 L tankw/ zero-level sensor･Tank(for wash solution)･Tank(for drain)

NBU-4033-W2

1

NBU-4033-W3

1

･Tank
(for wash solution preparation)

NBU-4033-W4

1

5 L tank･Auxiliary tank

5BL

1

5 L tank･Empty bottle (for buffer)

PB-11

1

･Beaker

PP200ML1(3) Tanks/bottles･Tank nozzles

2

5 L tank
w/ zero-level sensor
10 L tankw/ maximum-level sensor

Attached to tank (for wash
solution preparation) andauxiliary tank(4) Others･End ring

OC-RING-2･Cap spacer1

For 10 L tank･Cap spacer1

For 5 L tank･Cap spacer

1

For buffer bottle･Sample cups

DSP-SC-20B･Power cable

CP-114 or K-CP-700

1 bag

Consumable supplies

1･Measurement cells

LX-CELL-1B5

1 box“001-010” , “011-020” ,“091-099”
Consumable supplies･Thermal roll paper

P-58-40

1 rollConsumable supplies･Operation Manual

NN1-1703

1･Barcode labels for rack

Papers1

3 sheets･Certificate of compliance

1･Tank label

1

Affixed to tank3

NN1-1703 Rev.3
Rev.5

1.4 System Configuration■

Options
Name
Rack trays

Model
OC-TR-20

Number1

Remark2/box

Two-dimension code reader

OC-320-OP1

1

1/box

Temperature change driver board OCP-NBP4033-502DU

1

1/Box
(Buffer Temperature control system
25°C-30°C)

4
NN1-1703 Rev.3

1.5

Analysis Flow
The analysis flow for this system is as follows:1

Sample dispensing

2

Reagent/buffer dispensing

The sample nozzle dispenses samples to cells.

The reagent nozzle dispenses reagents from the reagent
compartment’s reagent bottle to cells.

Number of cycles (T)It then dispenses buffer.

3

Mix

4

Measure5

he mixer mixes the sample, reagent, and buffer.

Measures transmitted light over 4 to 38 cycles, from mixing
to cell washing.

･･･
･･･
38
Wash cells

39(flushing wash solution)

First wash･･

The washing nozzle absorbs the finished reaction liquid and･･then dispenses the wash solution.

Wash cells

43(flushing of purified water)

Second wash･･

The washing nozzle absorbs the wash solution, and dispenses･･

the purified water.
Wash cells

47(flushing of purified water)

Third wash
The washing nozzle absorbs and dispenses the purified water.

･･

During this time, the cell blank value is measured.

･･
51

Wash cells(absorption of purified water)

Fourth wash
The washing nozzle absorbs purified water.

Explanatory note

: 11.3 seconds are required for a single cycle.。

5
NN1-1703 Rev.3

1.6■

System Specifications
Basic specifications
Name

Specification

Measurement Principles

Latex turbidimetry

MethodDiscrete method, random access method （Maximum of 2 items）

Test mode

1-Step rate

Samples

Feces

Processing capacity

160 tests/hour (including 1 measurement using sample cup)

Measurement method

1-day, 2-day, or 3-day

Sample setting

200 samples: 20 special 10-sample racks

Sample container

S sampling bottle (Eiken Chemical special bottle)
Sample cup (DSP-SC-20B)

Calibration curve generation

Automatic generation of calibration curves

Stat sample setting

Up to 10 samples

Dilute test

15- or 250-times dilution

Measurement cells

Semi-disposable, 11-cell plastic holder (up to five loadable),
automatic washing with wash solution and purified water

Sample dispensing

Non-disposable sampling (with a nozzle washing function)

Sample dispensing range

0 μL, 5-80 μL (1 μL unit)

Reagent dispensing

Non-disposable reagent sampling (with a nozzle washing function)

Reagent dispensing range

Latex reagent: 0 μL, 5-300 μL (1 μL unit)
Buffer: 0 μL, 5-350 μL (1 μL unit)

Mix

Mixer (with washing function)

Barcode reading

Rack barcodes, sample barcodes, reagent barcodes

Prozone check

PRC method, RBC method

Check reagent blank

Detection using A1 value check

Number of analysis items

Hemoglobin, Calprotectin
Latex reagent (24-hour control) 25°C-30°C heat block method

Temperature control system

Buffer (24-hour control) 35°C-41°C heat block method*25-30°C (The upper limit is room temperature) when using option(OCP-NBP-4033-502DU)
Reaction table 40±0.5°C air bath method

Light source

LED (Wavelength: 660 nm)

Detector

Photo diode

Operation control/dataprocessing

Multi-CPU system on internal LAN

6
NN1-1703 Rev.3

1.6

System Specifications

Name

Specification

External online

RS-232C, Ethernet

Sample dispensing accuracy

20 μL ±2 μL, C.V. 1.0% or lessReagent dispensing accuracy

220 μL ±2 μL, C.V. 1.0% or lessBuffer dispensing accuracy

300 μL ±10 μL, C.V. 1.0% or lessSecurity

Whitelist

Input method

Color LCD screen (10.5-inch), touch panel, barcode reader

Output method

Thermal printer (thermal paper width: 58 mm)
Internal hard disk(SSD)
External media over USB connection

Dimensions

Approx. 630 mm × approx. 630 mm × approx. 560 mm (W × D × H)

WeightApprox. 58 kg

Power~100-240 V 50/60 Hz 500 VA or lessSound leve

65 dBA or less

Explanatory note

: The acceptable range of dimensions is within ±5%; The acceptable range of weight iswithin ±10%.

■

Sample barcode specifications
Type■

No. of Digits

Check Digit

NW-7

5-17 digits(including start/stop character)

Modulus 10/3 weight
Modulus 16
Modulus 11
Modulus 10/2 weight
7 check DR
Weighing modulus 11
Loons

ITF

6-15 digits

Modulus 10/3 weight

IND 2 of 5

6-15 digits

None

COOP 2 of 5

6-15 digits

None

CODE395-15 digits(including start/stop character)

Modulus 43

JAN

5-15 digits

Modulus 10/3 weight

CODE128

5-15 digits

None

RemarkUsable life
5 years (self-certified [based on manufacturer data]) from start of use (installation)* Assuming periodic inspection/maintenance, part replacement, and repairs/overhaul(when required after inspection) are conducting as described in this Operation Manual.
7

NN1-1703 Rev.5
Rev.3

1.7

Reagents Used by System
Refer to the reagent’s attached document for reagents used with this system.

■

Reagents for hemoglobin measurement

Product nameProduct code

Package

OC-SENSOR DIANA Latex Reagent

V-PZ01

15 mL x 5

OC-SENSOR DIANA Buffer

V-PZ03500 mL x 1

OC-Calibrator 2 kit

V-PH52

3 mL x 1

OC-Control LV1

V-PH535 mL x 2

OC-Control LV2

V-PH545 mL x 2

OC-Control LV3

V-PH595 mL x 2■

Reagents for Calprotectin measurement

Product nameProduct code

Package

OC-FCa Reagent (For OC-SENSOR PLEDIA)

V-PH11

Latex 8mL x 2
Buffer 15mL x 2

OC-FCa Calibrator

V-PH12

1 mL x 6

OC-FCa Control LV1

V-PH135 mL x 2

OC-FCa Control LV2

V-PH145 mL x 2

Product nameProduct code

Package

OC-SENSOR Sample Diluent

V-PH1945 mL x 3■

Common8
NN1-1703 Rev.3

1.8

System Dimensions

63cm

63cm

Top view

63cm

56cm

Front view9
NN1-1703 Rev.3

1.9

Names and Functions of Parts
1.9.1 Exterior parts(4) Thermal printer(3) Cover of theanalysis chamber(5) Control panel(9) Power cord

(6) Port to external
media(7) Ethernet(2) Standby switch(8) RS-232C(1) Primary power switch(10) Installation location
for tanks(left side of system)

ONOFF(9) Power cord10
NN1-1703 Rev.3

1.9

Names and Functions of Parts(11) Wash solution tank(12) Purified water tank(13) Drain tank

Zero-level sensor

Zero-level sensor

Maximum-level sensor

Name(1) Primary power switch

FunctionIf the primary power switch is turned on, the system controls thetemperature of the reagent compartment and buffer compartment.
The primary power switch should normally be left on.

(2) Standby switch

If the standby switch is turned on, the system starts and controls
the temperature of the reaction table.

(3) Cover of the analysis chamber

Safety feature to prevent accidents during system operation.

(4) Thermal printerPrints setup conditions, measurement results, error messages, or otherdata.
Page380 “Handling the Printer”(5) Control panel

Shows operation screens and analytical results.
The screen can be touched directly to operate.

(6) Port to external media

Allows connection to external media for storage of measureddata.

(7) Ethernet

Connects to the host computer.

(8) RS-232C

Connects to the host computer.

(9) Power cord

The power cord for this system.

(10) Installation location for tanks

Connects piping and wiring to the tanks (for wash solution,
purified water, and drainage).

(11) Wash solution tank
(Wash Solution)

Filled with wash solution.

(12) Purified water tank(Purified Water)

Filled with purified water.

(13) Drain tank
(Drain)Stores liquid disposed by washing the sample nozzle, reagent nozzle,
mixer, and cells.
11

NN1-1703 Rev.3

1.9

Names and Functions of Parts

1.9.2

Internal parts(14) Sample dispensing pump(13) Reagent dispensing pump(inside the cover)(inside the cover)(15) Washing nozzle(16) Sample nozzle(17) Squeezing system(12) Mixer(20) Sample ID
barcode reader(11) Reaction table(18) Conveyanceline(10) Reagent
nozzle(9) Reagent
compartment(1) Rack supply unit

(8) Overflow cell(7) Discharge bar(19) Supply bar(2) Conveyance bar(6) STAT rack position(4) Puncturing system(3) Buffer compartment(5) Rack discharge unit

(6) STAT rack position (enlarged)(17) Squeezing system (enlarged)

12
NN1-1703 Rev.3

1.9

Names and Functions of Parts(4) Puncturing system (enlarged)

Name(1) Rack supply unit

Function
Location where racks are placed.
Up to 20 racks can be placed.

(2) Conveyance bar

Conveys a rack along the conveyance line.

(3) Buffer compartment

Location for setting the special 500 mL bottle for buffer. Constantly
maintained at 35°C-41°C.

(4) Puncturing system

Punctures the double-layered aluminum seal attached to sampling bottles.

(5) Rack discharge unit

Location where racks are discharged from.

(6) STAT rack position

Location where rack is placed for cut-in analysis.

(7) Discharge bar

Feeds a rack to the rack discharge unit at the end of analysis.

(8) Overflow cell (OF)For sample nozzles
Washes the inner and outer wall of sample nozzles using purified water andwash solution.
Drainage is sent to the drain tank.
For reagent nozzles
Washes the inner and outer wall of reagent nozzles using purified water.
Drainage is sent to the drain tank.
For mixer
Washes mixer blades using purified water and wash solution.
Drainage is sent to the drain tank.

(9) Reagent compartment

Location to set hemoglobin reagents, calprotectin reagents and calprotectin
dilutions. Simultaneous installation is not possible.
Constantly maintained at 25°C-30°C.

(10) Reagent nozzle

Dispenses reagents.

(11) Reaction table

Performs antigen-antibody reaction and photometry.

(12) Mixer

Mixes samples and reagents.

(13) Reagent dispensing pumpAbsorbs and flushes reagents and buffers.

(14) Sample dispensing pumpAbsorbs and flushes samples.

(15) Washing nozzle

Washes measurement cells.

(16) Sample nozzle

Dispenses samples. Also creates calibrator dilution series and dilutes during
dilute tests.

(17) Squeezing system

Raises the sample’s level of liquid in the sampling bottle.

(18) Conveyance line

Conveys racks from the rack supply unit to the rack discharge unit.

(19) Supply bar

Feeds racks placed in the rack supply unit to the conveyance line.

(20) Sample ID barcode reader Reads barcodes on reagent bottles and racks.
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1.9

Names and Functions of Parts

1.9.3

Accessories/other(2) Reagent bottle(1) Buffer bottle(3) Sample rack (light blue)(4) Retest rack (green)(6) STD/QC rack (blue)(5) Dilute test rack (orange)(7) Tray (optional)
Tray lever
Pull forward to release
the lock on the set racks.

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1.9

Names and Functions of Parts

Name

Function(1) Buffer bottle

Hemoglobin Buffer (OC-SENSOR DIANA Buffer).

(2) Reagent bottle

Latex reagents and diluents for calprotectin(3) Sample racks(4) Retest rack(5) Dilute test rack

Holds sampling bottles and sample cups.

(6) STD/QC racks(7) Tray (optional)

Used to place each rack.

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MEMO

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Chapter 2 Operation (Basic)

		

2.1

Basic Screen Operation

		

2.2

Starting the System

		

2.3

Initial Settings

		

2.4

Daily Operation

		

2.5

Inspection/Maintenance after Use

		

2.6

System shutdown (Close mode/Long				suspense mode)
2.7

Drain Tank Processing

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Chapter 2 Operation (Basic)
2.1

Basic Screen Operation
This section describes functions that can be run from the [MENU] screen, as well as buttons
displayed on the screen and their basic operation.

2.1.1[MENU] screen and functions

When the system is started, the [MENU] screen is displayed.
The following functions (froma - h ) can be run from the [MENU] screen.

a

b

c

d

e

f

g

h

[MENU] screen

a

Test

Sets conditions for running tests (such as Test mode, Latex/CC settings, Set
reagents, and Test setting).

bb

Set latex

Set latex after reading the latex barcode.
Touching the {Close} button completes reagent setting.

cc

Prep functions

Display the [Prep functions] screen.
Initialize, Prime, Cell blank, and Wash can be run from “Prep functions.”

dd

Data processing

Run “Process data” or “Process QC.”
A password must be entered to open the “Select measured data” screen (if apassword is set).

ee

Help

Display the [Help] screen. Used to confirm how to operate the system.

ff

Settings

Perform “System settings” and “Protocol settings” for the system.

gg

MaintenanceConfirm parts to check and exchange, or perform maintenance.

hh

Close

Shut off the system. Running “Close mode” or “Long suspense” willautomatically turn the standby switch off.

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2.1.2

Basic Screen Operation

Screen composition and button operation

This section describes the {Buttons} and {tabs} displayed on the screen, and how to input settings.

■

Screen composition

a
↓

a→
←e
b
↓
←d

[Monitor] screen

←c

a

Tabs

Buttons to select functions in the same hierarchical directory at the top of
the screen.
They are located on the top and left side of the screen.

b{Information} button

Touching the button displays the [Information] screen.
Page 24 “2.1.3 [Monitor] screen and functions”

c

Status bar

Displays messages and the date.

dButtons

Buttons for running processes.
Buttons are displayed according to the screen. ({Start/Cancel}, {Register/Cancel},{abort}, etc.)
Page 20 ■ “{Start/Cancel} button and {Register/Cancel} button”e

Next page button

Switches the page up and down on the screen.

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2.1

Basic Screen Operation■{Start/Cancel} button and {Register/Cancel} button
There is a {Start/Cancel} button on the processing screen, and a {Register/Cancel} button on thesetting screen. The description will now continue with the [Histogram Range change] and [Latex/
CC settings] screens as examples.
[Histogram Range change] screen
Touching the {Continue} button opens the dialog box.

Dialog box{Start}:Start processing (in this case, change the histogram range).

{Close}:Cancel processing and return to the previous screen (in this case, the[Histogram] screen).

{Cancel}:The dialog box closes.

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2.1

Explanatory note

Basic Screen Operation: The {Del} button appears on screens such as Process data and Process QC.
Touching the {Del} button deletes the data in memory, but does not delete data from the harddisk(SSD). To update data, touch the {Register} button.

[Latex settings] screen

Touching the {Continue} button opens the dialog box.

Dialog box{Register}:

Register settings (in this case, register Latex settings).

{Close}:Cancel setting registration and return to the previous screen (in this case, the [Test]
screen).

{Cancel}:The dialog box closes.
21

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Rev.3

2.1

Basic Screen Operation■

Setting inputThis section describes how to input, insert, and delete numerical values.
([MENU] - [Settings] - [Protocol settings] - [CC1 protocol])

a
↓

d
b→
c

←e

[CC No. 1 protocol] screen

Numerical input① Touch the input field (a).
②Touch the numeric keypad (b) and input the numerical value.

③

Touch {enter} (e) (confirm the numerical value).

Single character insertion① Touch the input field (a).
② Move the cursor to the left of the character to insert using the {←} and {→} buttons (c).

Single character deletion①

Touch the input field (a).

②Move the cursor to the left of the character to delete using the {←} and {→} buttons (c).

③

Touch the {del} key (d).
Explanatory note

: Item settings can be skipped by inputting an asterisk (*).
“*” cannot be input for some settings. See the message displayed in the status bar at thebottom of the screen to confirm what can be input.

Explanatory note

: Input using the keypad is the same as input using the numeric keypad. (right page)
Touch the {A/a} button to switch between uppercase and lowercase letters; touch the{Sign} button to input symbols.

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2.1

■

Basic Screen Operation

Radio buttons and check buttons
Radio buttons and check buttons are for selecting one or several items when configuring conditions.

←g

↑
f

[Output format] screenfRadio button●

Allow selection of a single item.

gCheck buttons■

Allow selection of several items.

Switches between
uppercase and lowercase
letters.

Keypad →Switches input to symbols.

[Search word settings] screen

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2.1

Basic Screen Operation

2.1.3[Monitor] screen and functions

Touching the {Start} button on the [Test] screen starts the self check function.
After the self check is complete, the [Test] screen is displayed.
The following functions can be run from the [Test] screen.

a
↓

b
↓

c
↓

d
↓

e
↓

f→

g
↓

[Test] screenaAdditional test

Test conditions such as “Test mode” and “Latex/CC settings” can bechanged while testing.
Page 74 “2.4.13 Additional tests (changing test conditions while
testing)”b

STAT

Cut-in analysis for test racks and STD/QC racks can be run during testing.
Page 79 “2.4.14 Cut-in analysis”c

Set reagents

Reagents 1 through 3 and the buffer can be set to the system during testing.
Page 42 “2.4.6 Setting buffer”
Page 50 “2.4.9 Setting reagents (Pos.-2/Pos.-3)”d

Set samp

Racks can placed on the rack supply unit during testing.
Page 52 “2.4.10 Placing samples”

eSettings

Open the “System settings” screen. The system settings and protocol settings
can be confirmed.
Page 266 “Chapter 6 Settings”

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2.1

f

Basic Screen Operation

MonitorRack

The rack number and position in the rack of the sample (stat samples, STD
samples, and QC samples) being tested is displayed.

Samp No.

The number of the sample (stat samples, STD samples, and QC samples)
being tested is displayed.
Symbols shown after the sample number have the following meanings:
A: Retest
A*: 15-times dilution retest
A**: 250-times dilution retest

Item name

The analysis items are displayed.
F-Hb、 FCa、

State of process

The current state of processing is displayed.
The following is displayed:
Dispensing sample
Dispensing latex
MixingReacting [# min]
Data
Err*
Explanatory note

The time until analytical results are output is shownin the brackets ([ ]).
(when the measurement has completed normally)(when the measurement has not completed normally): *Main errors
No Tube, Puncture Err, Sample Short, L. Dispense Err, S.
Dispense Err, No Cal. Curve, Mixing error, Latex Blank Err, B/C
Duplication, B/C Read NG
B/C Read NG are displayed in the comment field.

gComment

The sample ID that was read is displayed.
“Barcode read err” is displayed if the sample barcode could not be read.

Expected end
time
(min)

Display the expected time that washing will complete for all reaction cells andthe system will stop.
Explanatory note This time will not change while sample dispensing continues.

{Information}

Touching the {Information} button opens the [Information] screen anddisplays Latex information, Test condition, and Latex settings information.
Touching the {Close} button returns to the [Monitor] screen.
Page 69 “ ■ Viewing information”

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2.1

Basic Screen Operation

h→
←j
i→

[Monitor] screenh.

Rack info

The [Rack info] screen is displayed.
The condition of the rack in the rack discharge unit can be confirmed here.
Page 234 “3.9 Rack Information”i.

QC screen

Opens the [QC lot select] screen, and displays the QC lot list.
－
Switch the tab to display the inter-day/intra-day data and X-R control
diagram.
Page 210 “3.8 Quality Control”jButtons{Connect}

If an abnormality communicating with an outside computer is detected andthe communication is disconnected, the {Connect} button is displayed.
Resume communication using the following method.
① Resolve the communication error.
② 【Touch the {Connect} button.
* Communication resumes and remaining data is output.
Explanatory note

If you stop the testing with the {Close} button,communication finishes even if there is data that has notbeen output. In this case, specify the range of measured
data on the [Test data] screen and then output it.

{Help}The [Help] screen opens.
Page 318 “Chapter 7 Help”{Completed}

Finish testing.

{Pause}Pause testing.

{Prime}Functions when testing of the sample placed on the rack supply unit isfinished, and the system is waiting.
Prime purified water and wash solution.

{Process data}

Functions when testing of the sample placed on the rack supply unit isfinished, and the system is waiting.
Output measured data to a printer, external media, or online.

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2.2 Starting the System
When the system is started, the [MENU] screen is displayed. Operation once the system starts varies
according to how the system was shut down. There are three patterns:• Shut down normally (with all settings configured to “NO”)•“Exchange buffer and wash solution to purified water” set to “YES” in Close mode, orLong close mode selected• “Cell blank settings” or “Test” checked under “Settings of auto start up” in Close mode

2.2.1

Shut down normally (with all settings configured to “NO”)
1

Check that the primary power switch is on.
If the system is not on, turn the switch on.

2Turn the standby switch on.

		 * The startup screen is displayed.

[Startup] screen
		 * The [MENU] screen is displayed.。

[MENU] screen
27
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2.2 Starting the System

2.2.2“Exchange buffer and wash solution to purified water” set to “YES” in
Close mode, or Long suspense mode selected1

Check that the primary power switch is on.
If the system is not on, turn the switch on.

2Turn the standby switch on.

		 * The startup screen is displayed.
		[Startup] screen3

Set the buffer bottle and wash solution tankaccording to the operation guide.

① Remove the bottle filled with purified water and		
the wash solution.

		
		
		

② Set a buffer bottle filled with buffer.
③ Fill the wash solution tank with wash solution.
④ Touch the {Start} button.

		 * Pipe line activation begins.

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2.2 Starting the System

Caution・Do not open the cover of the analysis chamber during operation.
・Keep out of the operational range of the system during operation.
Pinching hazard

Failure to observe this precaution may lead to injury or damage.

4

Activate prime* When pipe line activation is complete the dialog box closes.。

{Pause}:Processing pauses.

{Start}:Resume processing.
If the Pause button is touched, it will change to
the Start button.

{Abort}:5

Abort processing.

Touch the {MENU} button.
* The system returns to the [MENU] screen.

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2.2 Starting the System

2.2.3 “Cell blank” checked under “Settings of auto start up” in Close mode
1

Check that the primary power switch is on.
If the system is not on, turn the switch on

2Turn the standby switch on.

		 * The startup screen is displayed.

3

Cell blank measurement is run.

When cell blank measurement is complete, touch the{Close} button.

4

Touch the {MENU} button.
			

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2.2 Starting the System

2.2.4 “Test” checked under “Settings of auto start up” in Close mode

1

Turn the standby switch on.

		 * The startup screen is displayed.

2

Self check begins.

3

The [Monitor] screen opens and testing begins.

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2.3

Initial Settings
Initial settings must be configured to use the system for the first time.
Initial settings are broadly classified into two categories: “system settings” and “protocol
settings.”
Touching the {Settings} button on the [MENU] screen displays a screen from which settings
can be selected for both.
This section will give an overview of system settings and protocol settings.
See page 266 “Chapter 6 Settings” for details on operation.

2.3.1

System settings
1

Touch the {Settings} button.

		

2

Touch the {Button} for the item to configure.

		 * The settings screen for each is displayed. (See the		following page.)						

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2.3

a→

←c

b

d→

←f

e

g→

←i

h
↑
j

↑
k

Initial Settings

↑
l

←m

[System settings] screenaBarcodeSet conditions for reading sample barcodes.

bRack No./QC No.

Register STD/QC racks, retest racks, and dilute test racks. Configure the
QC sequence number.

c

ConfigConfigure the date.
Register a password for data processing.
Select the supply method for purified water and the drainage method fordrainage.
Select automatic rack supply.
Set the automatic logout time when using the operator/latex management
function.

dData Output

Select the output destination for the data.
Select the format of data output to a printer, external media, or online.
Configure settings for online communication control.
Configure test items.

e

Output format

Select the output format.
Select items for output to a printer, external media, or online.

f

Alarm

Configure the type of alarm and how long it sounds.

g

Screen saver

Configure the screen saver activated on the [MENU] screen.

h

STD/QC Process

Configure conditions for checking measured data for STD samples/QC
samples.

i

Sample cup

Register the shape of the sample cup.

jBack up

Save system setting/protocol setting information to external media.

k

RestoreRead system setting and protocol setting information saved to external
media, and restore it to the system.

l

Print

Print system setting information.

m

Menu

The system returns to the [MENU] screen.

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2.3

Initial Settings

2.3.2

Protocol settings
1

Touch the {Settings} button.

		

2

Touch the {Protocol settings} tab.

		

3Touch the {Button} for the item to configure.
* The settings screen for each is displayed. (See thefollowing page.)34
NN1-1703 Rev.3

2.3

Initial Settings

a→
b→

←d

c→

←e
Protocol settings screenaAnalysis items

Select the analysis items for [SAMP QC protocol settings], "CC No.#
protocol settings", and "Manufacturer settings" (for service personnel).
[F-Hb],[FCa], [Common] Check any of the radio boutons. If [Common] ischecked, you can set [SAMP replicate count] and [QC replicate count].

b

Samp/QC protocol

Set test conditions when measuring samples and QC samples.

c

CC1 to CC6 protocol

Allows for registration of calibration curves for protocols No. 1 throughNo. 6.
CC No.1 to CC No.3 are [F-Hb], and CC No.4 to CC No.6 are [FCa].

dManufacturer use
only

Configure common conditions required for measuring samples, statsamples, QC samples, and STD samples (for maintenance people only).

e

Menu(Close)The system returns to the [MENU] screen.
(The {Close} button is displayed during testing. The system returns to the[Monitor] screen. )35
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2.4

Daily Operation
This section describes daily operation processes and procedures.

2.4.1

Daily operation flow
Explanatory note

装置の起動

Test start: This section assumes that initial configuration of the system has been completed.

Check that the “primary power switch” is on.
(The primary power switch should normally be left on.)Turn the “standby switch” onConfirm initial settings

Page 27

Page 32

分析前の準備Preparations prior to testing(Confirm when settings have changed.)Set printer paper

Page 38

Set the drain tank

Page 39

Set purified water, wash solution, and buffer

Page 40

Introduce purified water, wash solution, and buffer topiping (priming)

Page 46

Measure cell blanks

Page 48

Set reagent

Page 50

Place sample

Page 52

To next page
36

Explanatory note: If “Cell blank” is checked in “Auto start” in close mode, cell blank measurement will be
automatically run when the system starts.
NN1-1703 Rev.3

System
shutdown

nspection/
maintenance

Testingcompleted

Testing

Test start

2.4

Daily Operation

Open the [Test] screen

Page 59

Configure “Test mode & Measure mode”

Page 59

Configure “Latex/CC settings”

Page 64

Confirm calibration curves

Page 66

Start test

Page 68<When required>

Add samples

Page 72

Additional test

Page 74

Cut-in analysis

Page 79

Rack info

Page 234
Page 82

Finish testing
Normal close
Pause
Abort

Page 85 ,,250

Clean parts
Daily
WeeklyMonthly
Turn the system off(close/long suspense mode)

Page 90*The standby switch shuts off automatically.

Place sample

Page 9637
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2.4 Daily Operation

2.4.2

Setting printerpaper

This section describes printer paper setting.

Paper cover

CautionPaper coveropen lever・Be careful of the blade of the manual
Failure to observe this precaution may lead to
Required

LLED lamp

FEED button

Manual cutter①

Preparations prior to testing

injury.

Raise the paper cover open lever and open the
cover.

Paper cover②

Set the paper as shown in the diagram to the left.
(If this is set with the opposite facing, the system
will be unable to print.)

Paper output

Manual cutter③

Set the paper so that its edge sticks out of thepaper output.

④

Press both edges of the paper cover to close it.
Confirm that the paper cover is locked.

FEED button⑤

Touch the FEED button.

⑥

Cut the paper using the manual cutter.

38
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2.4

2.4.3

Daily Operation

Check the drain tank (connected to system by maintenance person)

Confirm that the maximum level sensor and hose attached to the drain tank are connected to thesystem.

Warning・Wear protective equipment when handling the drain tank.
Failure to observe this precaution may lead to contamination.

Biohazard

Caution・Empty the drain tank prior to using the system.
If the system detects that the drain tank is full, dispensing will stop.
Required・Install the waste liquid tank below the equipment.

Preparations prior to testing

If the waste tank is above the equipment, it may not be able to drain properly.

1

Attach a maximum-level sensor (a) and hose (b)to each drain tank port (two).

a

b

2

a

Confirm that the maximum-level sensor (a) andhose (b) are connected to “Drain” at the“installation location for tanks” on the left side of
the system.

b

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2.4 Daily Operation

22.4.4

Setting purified water

Add purified water to the purified water tank.

Request・After setting the purified water tank (including adding purified water), be sure toprime it.

・Be sure to use the included purified water tank.

Preparations prior to testing

Explanatory note

: Purified water tank dpe size: 10 L tank1

Add purified water to the purified water tank.

2

Attach a zero-level sensor (a) and hose (b) toeach purified water tank port (two).

ab
3

Confirm that the zero-level sensor (a) and hose (b)are connected to “Purified Water” at the“installation location for tanks” on the left sideof the system.

a

b

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2.4

2.4.5

Daily Operation

Setting wash solution

Fill the wash solution tank with 3% distilled wash solution.

Request・After setting the wash solution tank (including adding wash solution), be sure toprime it.

・Make sure there is enough wash solution prior to using the system.
・Be sure to use the included wash solution tank.
1

Dilute the wash solution 3%.
① Fill the tank (for wash solution preparation) with150 mL of washing solution (undiluted).
② Add purified water to the tank in ① so that it
contains 5 L of total liquid.

Preparations prior to testing2

Fill the wash solution tank with the 3% wash
solutions.

a3

Attach a zero-level sensor (a) and hose (b) toeach wash solution tank port (two).

b
4

Confirm that the zero-level sensor (a) and hose(b) are connected to “Wash Solution” at the“installation location for tanks” on the left sideof the system.

ab
Explanatory note

: Wash solutions not indicated with “(undiluted)” refer to 3% wash solutions.

41
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2.4 Daily Operation

2.4.6

Setting buffer

Set the buffer bottle for hemglobin analysis to the “buffer compartment.”
Set the buffer for calprotectin in the reagent compartment.
Page 50“2.4.9 Setting Reagents (Pos.-1/Pos.-2/Pos.-3)”

Request・After setting the buffer bottle (including adding purified water), be sure to prime it.

Explanatory note

: After touching the {Reset} button on the [Set reagents] screen, priming automaticallybegins once the buffer bottle has been set.

Explanatory note: If the buffer is reset, the number of remaining tests stored by the system will bedeleted, and a new number of remaining tests will be stored (that is, the number ofremaining tests will be overwritten).

1

Set the buffer bottle (a) to the buffer

Preparations prior to testing

compartment (b).

ab2Remove the cap of the buffer bottle, and insert
the hose (c).

Make a flat surface of the connector to the front.

cFlat surface

3

Touch the {Set latex} button on the [MENU]
screen.

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2.4

4

Daily Operation

Touch the {Reset} button.

		 * The buffer is reset, and the number of remaining tests
		is displayed.

Explanatory note

: Touch the “Remaining tests” field forthe buffer and use the numeric keypad
to modify the value.

Preparations prior to testing5

Explanatory note

Touch the {Close} button.

		* Pipe line activation begins.

		* The system returns to the [MENU] screen.

: If the remaining volume in [Information] - [Buffer bottle] is 50 mL or less, the number of remaining
tests will be “0,” and the user will be asked to change the buffer bottle via alarm and message.

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2.4 Daily Operation

2.4.7

Priming (normal prime, pipe line activation)

There are two kinds of priming. “Normal prime” removes air bubbles in the piping, while “pipe line
activation” introduces buffer to the piping.

Caution・Do not open the cover of the analysis chamber or reach into the range of motion
Pinching hazard■

during operation.
Failure to observe this precaution may lead to injury or damage.

Normal priming
Used to remove air bubbles in the piping

Preparations prior to testing“Normal prime” is also used when the system has been left off for some time.

1

Touch the {Prep functions} button.

2

Touch the {Prime} tab.

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2.4

3

Daily Operation

Select normal priming.
① Check Normal prime.

1② Select items to prime.
○ YES: Prime.
○ NO: Do not prime.

2

Select whether or not to reset the buffer volume([YES] or [NO]).
③ Touch the {Start} button.

3		 * Normal priming begins.

4

Priming

Preparations prior to testing		 * When priming is complete, the dialog box closes.

{Pause}:Processing pauses.

{Start}:Resume processing.
If the {Pause} button is touched, it will change
to the {Start} button.

{Abort}:Explanatory note

Abort processing.

: If the cover of the analysis chamber is opened during normal priming, “Cover open” is displayed at
the bottom right of the screen.

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2.4

Daily Operation

Pipe line activation■

Preparations prior to testing

Used to introduce buffer into the piping.

1

1

Touch the {Prep functions} button.

2

Touch the {Prime} tab.

3

Select pipe line activation.
① Check “Pipe line activation.”② Select “Volume reset.”。
③ Touch the {Start} button.

		 * Pipe line activation begins.
2

3

46
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2.4

4

Daily Operation

Activate prime

		 * When priming is complete, the dialog closes.

{Pause}:Processing pauses.

{Start}:Resume processing.
If the {Pause} button is touched, it will change
to the {Start} button.

{Abort}:Explanatory note

Abort processing.

: If the cover of the analysis chamber is opened during pipe line activation, “Cover open”

Preparations prior to testingis displayed at the bottom right of the screen.

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2.4 Daily Operation

2.4.8

Measure cell blanks

Run cell blanking to wash cells and evaluate them on a pass/fail basis.
If “Cell blank” is checked in “Auto start” in close mode, cell blank measurement will be
automatically run when the system starts.

Caution・Do not open the cover of the analysis chamber or reach into the range of motion
during operation.

Preparations prior to testing

Pinching hazard

Failure to observe this precaution may lead to injury or damage.

1

Touch the {Prep functions} button.

2

Touch the {Cell blank} tab.

3

Select measurement cell washing.
① Check “YES.”② Touch the {Start} button.

1* Cell blank measurement begins.

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2.4

4

Daily Operation

Cell blank measure		 * When measurement is complete, the {Abort} button
will change to {Close}.

Preparations prior to testing			

Explanatory note

: Cells that cannot be used are displayed in red.

Explanatory note

: When 10 or more cells can no longer be used “There are more than 10 unclean

measurement cells. [COMMENT_RANGE]Please exchange cells.”[/COMMENT_RANGE VALUE::This
could reduce processing performance. Replace the measurement cells
Page 258 “5.1.9 Replacing measurement cells (when cell blank value is abnormal)”5

Touch the {Print} button to print the measurement
results.

* The results of the measured cells are printed.
		Touch the {Close} button.
* The system returns to the [Cell blank] screen.

{Pause}:Processing pauses.

{Start}:Resume processing.
If the {Pause} button is touched, it will change tothe {Start} button.

{Print}:Print the measurement results.

{Close}:Displayed when processing completes.
The system returns to the measurement cellwashing selection screen.

{Abort}:Abort processing.

{MENU}: The system returns to the [MENU] screen.

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2.4.9

Setting reagents (Pos.-1/Pos.-2/Pos.-3)

Read the reagent barcode for Pos-1 (the latex reagent for hemoglobin) and Pos-3 (the latex reaget
for calprotectin), and then set the reagent bottle in the reagent compartment. Set the buffer for
calprotectin into Pos-2.The positioning of the reagent bottles is Pos.-1, Pos.-2, and Pos.-3 in order,
from the left of the reagent compartment.
There are two ways to enter barcodes: “input using barcode reader” and “keypad input.”

RequestReagent barcode information

・Barcodes on reagent bottle labels are of the CODE 39 type, consisting mainly ofeight characters (excluding the initial and terminal characters).

・When entering barcodes, follow the format below.

Preparations prior to testing

AACMXXXD (barcode)
AA:

Item code, two digits (numeric, 0 to 99; 90: feces Hb)

C:

Last digit of the year (numeric, 0 to 9)

M:

Month (alphanumeric, 1 to 9, or X, Y, or Z)

XXX:

Serial number for the year (numeric, 0 to 999)

D:

Check digit (alphanumeric)Explanatory note1

: Reagents can be set from the [Test] screen or the [Monitor] screen.

1

Touch the {Set latex} button.

2

Enter the reagent barcode.
There is no barcode entry when setting the buffer
fof calprotectin. Touch Pos-2□.

* The check box turns blue.
2<Keypad input>① Touch the barcode field for the appropriate reagent.
* The check box turns blue.

② Use the numeric keypad to enter the seven digitsof the eight-digit barcode affixed to the reagent
bottle, excluding the last digit (check digit).

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Explanatory note

Daily Operation: If there is no calibration curve in the reagent lot, the “No CC” message isdisplayed.Create a calibration curve.

Caution・After setting the reagent bottle, close the lid of the reagent compartment.
If the cover is left open, the reagent nozzle could make contact with the cover.

Required

Request・Close the lid of the reagent bottle when reading the reagent barcode.
Failure to observe this precaution could result in the reagent being spilled.

<Barcode reader input>① Touch the barcode field for the appropriate reagent.
* The check box turns blue

② Lower the barcode reader lever.

③ Place the reagent bottle into the barcode reading port

Preparations prior to testing

Barcode reading portwith the barcode surface facing to the front.
* The seven-digit barcode (excluding the check

Barcode reader leverdigit) is displayed.

3

When the barcode reader has finished reading,move the barcode reader lever to its original
position.

4

4 Set the Pos.-1, Pos.-2, and Pos.-3 (in order fromleft to right) bottles to the reagent compartment.
① Open the lid of the reagent compartment.

Reagent bottle② Remove the cap of the reagent bottle.
③ Insert the reagent bottles into the reagent insertion

Reagent compartment

port, with the barcode surface facing to the front.
④ After setting all reagents, close the lid of the reagent
compartment.

5

Touch the {Reset} button to reset the number ofremaining tests for buffer.
Touch the {Set complete} button.
* When the reagent bottle has been set, confirm thevolume of the reagent bottle with the reagent
nozzle.
* The system returns to the [MENU] screen.

{Set complete}: Finish setting reagent.
{Reset}:Update the buffer information. Pipe line
activation automatically begins when thereagent is set.

Explanatory note: If the number of remaining tests is “0” on the [Information] reagent bottle display, theuser will be asked to change the reagent bottle via alarm and message.

NN1-1703 Rev.3

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Daily Operation

2.4.10Installing samples

Place the rack to which samples have been set in the rack supply unit. If you are using a tray
(optional), place the tray to which the sample rack has been set in the rack supply unit.

1

Set the sample (sampling bottle) to the rack.

Explanatory note

: Use a measurement mode and rack that suit the sample to be measured.

・When measuring a sample, specify the test mode and use a “sample rack.”・

When remeasuring a sample, specify the remeasure/retest mode and use a “sample rack.”・

When retesting a sample, use a “retest rack” (there is no need to specify a mode).
Page 52 “Setting samples using measurement method (1 day/2 day/3 day)”		When measuring an STD or QC sample, use an “STD/QC rack.”・Preparations prior to testing(There is no need to specify the mode.)				Page 55 “Setting STD/QC samples (Hemoglobin)”		Page 57 “Setting STD/QC samples (Calprotectin)”
When running a dilute test on a sample, use a “dilute test rack” (there is no need to specify a mode).

・		Explanatory note

Page 54 “Setting samples when running a dilute test”： Install a sampling bottle vertically.
When the installation of a sampling bottle at an angle, there is a possibility that the puncture is・		

not performed normally.

Setting samples using measurement method (1 day/2 day/3 day)
Sample arrangement on racks varies according to the measurement method (1 day/2 day/3 day).
Samples are arranged on the rack as follows.
Page 59 “Setting test modes, measurement methods, and measurement modes”<1 day>Sampling bottles can also be installed alone
Sampling bottles for up to ten people
can be set to a single rack.

1

2

3

4

5

6

7

8

9

10

Explanatory note

: Set the sampling bottle to the rack, so that the barcode is facing to the front.

Explanatory note

: The numbers in the diagram indicate the rack position number. They are numbered from left (No. 1) to right.

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2.4<2 day>Daily Operation

Arrange two sampling bottles (twoFirst sampling bottle of test subject A

day’s worth) for a single person.

Second sampling bottle of test subject A

Sampling bottles for up to fivepeople can be set to a single rack.

1

2

3

4

5

6

7

8

9

10

<3 day>Arrange three sampling bottles (threeFirst sampling bottle of test subject A

day’s worth) for a single person.

Preparations prior to testing

Second sampling bottle of test subject A
Third sampling bottle of test subject A

Sampling bottles for up to threepeople can be set to a single rack.

1

2

Explanatory note

3

4

5

6

7

8

9

10

: For 3 day measurement, a container is not tested even if the sample is set to rack position
number 10 (right edge).

Explanatory note

: Set the sample to the rack, so that the barcode is facing to the front.

Explanatory note

: The numbers in the diagram indicate the rack position number. They are numbered from left
(No. 1) to right.

Explanatory note

: For 2 day/3 day, if the samples are not gathered for the number of days, leave a space with nosamples (do not set the samples all together).

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Setting samples when running a dilute test
Request・Confirm that there are no bubbles mixed in when filling the sample cups withretest diluent and samples.
・When measuring at 15-times dilution, set an empty sample cup only at the “× 15”
position.
・When measuring at both 15-times dilution and 250-times dilution, or whenmeasuring at 250-times dilution, set empty sample cups at the “× 15” and “×250” positions. Do not set sampling bottles at rack positions No. 3, 4, 6, 7, 9,
and 10.
In this case, it is necessary to set the manufacturer setting [× 15 simultaneous test] to “YES.”
Explanatory note

: When running a dilute test, use the “dilute test rack.”

Explanatory note

: Customers cannot modify manufacturer settings.

Explanatory note

: Set containers filled with diluted sample at rack positions No. 2, 5, and 8.
Either sampling bottles or sample cups may be used.

X15 X250

X15 X250

Empty
sample cup

Sampling bottle

Empty
sample cup

Sampling bottle

Empty
sample cup

Sampling bottle

Preparations prior to testingSpecified retest diluent*<Measuring at both 15-times dilution and 250-times dilution, or at 250-times dilution>

X15 X250* Approximately 2 mL of retest

1

2

3

4

5

6

7

8

9

10

diluent is required.

X15

X15

Empty
sample cup

Sampling bottle

Empty
sample cup

Sampling bottle

Empty
sample cup

Sampling bottle

Specified retest diluent*<Measuring at 15-times dilution>

X15* Approximately 2 mL of retest

1

2

3

4

5

6

7

8

9

10

diluent is required.

Explanatory note

: Set the sample to the rack, so that the barcode is facing to the front.

Explanatory note

: The numbers in the diagram indicate the rack position number. They are numbered from left
(No. 1) to right.

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Daily Operation

Setting STD/QC samples (Hemoglobin)
Request・Confirm that there are no bubbles mixed in when filling the sample cups withcalibrator, calibrator buffer, and QC samples.

・When measuring only QC samples, set them to rack holes No. 9 and No. 10.
Explanatory note

: When measuring STD samples and QC samples, use the “STD/QC rack.”

Explanatory note

: It is possible to set only STD samples or only QC samples to the rack.

Explanatory note

Calibrator buffer*

Calibrator

Preparations prior to testing<When creating dilution series>

1

2

Empty sample cup

QC1 QC2QC3 QC4

3

4

5

6

7

8

9

10

: In the case of the hemoglobin, QC samples can be ID-managed by erection of containers with
QCID (bar code for QC) attached to positions No. 7 and No. 8 in the rack.

* Approximately 2 mL of calibrator buffer is required.

Calibration curve creation method (Hemoglobin:if a dilution series has not been created)）(1) Set calibrator, calibrator buffer, and empty sample cups to the STD/QC rack according to thetests to run.
(2) Enter the concentration listed in the INSTRUCTIONS FOR USE for the calibrator into
“Conc.” in [Protocol settings] - [CC No. # protocol settings].
Page 314 “6.2.2 CC No. 1 to CC No. 6 protocol settings”(3) Place the STD/QC rack in the rack supply unit.
(4) Touch the {Start} button on the [Test] screen.
* Start testing.
* When placing a QC sample, measure along with the QC sample.
* A calibration curve is created.

(5) Confirm that the calibration curve has been properly created.
(6) Touch the {Register} or {Cancel} button.

55
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2.4

Daily Operation<When dilution series have been prepared>
Sample cups for which a dilution series has been created

1

2

3

Calibrator

Calibrator buffer*(In order of concentration weakness, from left to right.)

4

5

6

7

8

9

10

Preparations prior to testing

Explanatory note : The numbers in the diagram indicate the rack position number. They are numbered from left (No. 1)		to right.

Explanatory note

: Do not set sample cups to rack positions No. 1 and No. 2.

Calibration curve creation method (Hemoglobin:if a dilution series has been created)(1) Set the calibrator to rack position No. 8.
(2) Set the sample cups in order of concentration weakness in rack positions No. 4 through No. 7.
(3) Set the calibrator buffer to rack position No. 3.
(4) Place the STD/QC rack in the rack supply unit.
(5) Touch the {Start} button on the [Test] screen.
* Start testing.
* When placing QC samples in rack positions No. 9 and No. 10, measure along with the
QC samples.
* A calibration curve is created without creating a dilution series.

(6) Confirm that the calibration curve has been properly created.
(7) Touch the {Register} or {Cancel} button.

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Daily Operation

Setting STD/QC samples (Calprotectin)
Request・Confirm that there are no bubbles mixed in when filling the sample cups withcalibrator, calibrator buffer, and QC samples.

・When measuring only QC samples, set them to rack holes No. 9 and No. 10.
Explanatory note

: When measuring STD samples and QC samples, use the “STD/QC rack.”

calibrator

In order of concentration weakness, from left to right.
QC1 QC2

Preparations prior to testing

QC3 QC4

1

2

3

4

5

6

7

8

9

10

Explanatory note : The numbers in the diagram indicate the rack position number. They are numbered from left (No. 1)

to right.
Explanatory note

: It is possible to set only STD samples or only QC samples to the rack.

Placing a rack as is in the supply unit (standard specification)

2

Placing racks in the system
Caution・Set racks to the system with the rack barcode facing to the front.
If the barcode is facing the system, a barcode read error could occur.

Required

Set the rack to the rack supply unit with rack position
No. 1 on the left side.
Set it so that the metal claws fit into the depressions
on the lower left of the rack.
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2.4 Daily Operation

Placing a rack in the rack supply unit using a tray (optional)

2'-1 Setting the rack to a tray
Caution・Set racks to the tray with the rack barcode facing to the front.
RequiredIf the barcode is facing the system, a barcode read error could occur.

Front of systemb

Preparations prior to testing

Tray lever

Pull

Front of system

b

1

Push

Pull the tray lever (b) to the front.
* The guide lock releases.

2

Set the rack to the tray.
① Insert the groove on the left edge of the rack into
the guide (a).

c② Align the groove on the right edge of the rackawith the guide (c).
③ Push the tray lever (b) and lock it.

2'-2 Placing the tray in the rack supply unit
Place the tray from the front of the rack supply unit.

Front of system

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2.4

2.4.11

Daily Operation

Starting tests

Open the [Test] screen, and configure the test conditions displayed on the screen after selectingthe {Test} tab. Test conditions are broadly categorized into “Test mode” and “Latex/CC settings.”
Touching the {Start} button starts testing after the self check is run.

Test Start

1

2

Opening the [Test] screen
1

Touch the {Test} button.

2

Touch the {Test mode} button.

Setting test modes, measurement methods, and measurement modes
1

Configure items (see the following page).

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Daily Operation

Item
Sample No.

Range/SelectionG  - SEQ 

Details
Configure the number of the head sample.
A sample number consists of a group numberGroup No. (G)*, 1-9Sequence No. (SEQ)

1 - 99999(Maintained in memory until the(G) and a sequence number (SEQ).
Enter “*” to skip configuring a group number.

system power is turned off.)

NumberingIf there is a rack position in which a sample has(Maintained in memory even if

not been set, configure how to allocate sequence

the system power is turned off.)

numbers.
YES:

Allocate sequence numbers only to set samples.

Test Start

1

2

3

4

5

6

7

8

9

Even if there are empty positions, a “No tube”
error will not occur.

NO:

Allocate sequence numbers even to positions
in which samples are not set.

1 2 3 4 5 6 7 8 9 10
A “No tube” error will occur if there are any

empty positions.

Continued on next page
Explanatory note

: Configuring group numbers allows for the positive rate change to be calculated per group.

Explanatory note

: Serial numbers starting from the configured sequence number will be allocated to samples.

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2.4

Explanatory note

Daily Operation: Sequence numbers are managed for each measure mode (test mode, remeasure/retest mode, dilute test).

Item
Sample barcode

Range/Selection

Details
Configure whether or not to use sample barcodes.
・ Settings are also applied to [Settings] - [Systemsettings] - [Samp barcode settings].

(Configuration maintained inmemory even if the system poweris turned off.)

YES:

Use sample barcodes.

NO:

Do not use sample barcodes.

Measurement method(Configuration maintained inmemory even if the system poweris turned off.)

Select the measurement method.
1 day:

Measure using 1 day method.

2 day:

Measure using 2 day method.

3 day:

Measure using 3 day method.

Measure mode

Select the measurement mode.

(Configuration maintained in･ Measured data when remeasuring a sample inmemory until the system power isremeasure/retest mode is applied to the positive

Test Start

turned off.)rate.
･ Measured data when using a retest rack or dilute

Test:
Test/remeasure test
start position(position in rack)(Not applied when starting new
test.)

test rack is not applied to the positive rate.

Select when first making a measurement.

Retest:Select when remeasuring or retesting a sample.

1 - 10Configure the head rack test start position.
･ Sequence numbers are allocated from the test start
position configured here.
･ This setting does not apply to retest or dilute test
racks.

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Daily Operation

2

Touch the {Continue} button.

3

Touch the {Register} button.
* The settings were registered.

			

Test Start→

Page 64
3

Explanatory note

Configuring [Latex/CC settings]: Touch the {MENU} button to return to the [MENU] screen after registration.

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■

How to use the

Daily Operation(padlock) button to avoid operation errors

There is a button that looks like a padlock on the right side of the [Test mode & Measure mode] screen.
Touching this button locks the applicable settings so that they cannot be operated.
Touching the button once more releases the lock and allows operation again.
When locked it is orange; when unlocked it is gray.

← Lock (orange)

Test Start← Lock release (gray)

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2.4 Daily Operation

3 Configuring [Latex/CC settings]
Touching the {Test} button on the [MENU] screen opens the [Test] screen.
This section will explain operation from the [Test] screen.

Request・Check that the lot number of the reagent to use is the same as that of the reagent forthe calibration curve (CC No.).

・If a calibration curve has not been prepared, do so prior to starting the test.
If testing is started with mismatched reagent lots, a “No CC” error message will be
displayed.

Touch the {Latex/CC settings} button.

2

Configure the reagent and calibration curve.

Test Start

1(See the following page.)

Explanatory note

: [Latex/CC settings] can also be configured during testing on the [Additional test] screen.

Explanatory note

: Touch the {CC setting} button to open the [Protocol settings] screen. CC No. # protocol
setting can be performed here.
Page 314 “6.2.2 CC No. 1 to CC No. 6 protocol settings”

Explanatory note

: Touch the {CC} button to open the [Check CC] screen.
The measurement date and time, reagent lot information, and graph can be checked for eachcalibration curve.
Page 66 “ ■Calibration curve confirmation”

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2.4

Item

Range/Selection

Daily Operation

Details
Setting the calibration curve number used forsample measurement when using the stool
hemoglobin reagent.

1～3［FCa］ ←CC No.□

4～6

Establish the calibration curve number used in themeasurement of samples when using the reagent
for fecal calprotectin.

Latex for CC ［F-Hb］
Pos.-  → Save as CC
No. 

1～3

The reagent used (stool hemoglobin) is fixed.
Registered CC No of the generated calibration
curve. Setting.

Latex for CC ［FCa］
Pos.-  → Save as CC
No. 

4～6

The reagent used (fecal calprotectin) is fixed.
Registered CC No of the generated calibration
curve. Setting.

Test Start［F-Hb］ ←CC No.□A list showing “Date” and “Latex lot” for theregistered CC number is displayed. If no calibration
curve is registered, nothing is displayed.

3

Touch the {Continue} button.

CC No.

Date

Latex lot

CC No.

Date

Latex lot1

20/03/31 17:41

97003

4

20/03/31 17:20

97003

2

5

3

6

4

Touch the {Register} button.

* The settings were registered.
		→Page 68
4

Starting tests

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Daily Operation■

Calibration curve confirmation
Touch the {CC} button on the [Latex/CC settings] screen to display calibration curve information (suchas date and time, and reagent lot) and the calibration curve graph.
Use the tabs on the top of the screen to switch between calibration curves CC No. 1 through CC No. 6.
1Touch the {CC} button.

2

Confirm the calibration curve information andgraph.。

Test Start

Touch the {CC#} tab, and switch the calibration
curve information.
To edit or remeasure the calibration curve,
Page 67 “ ■ Edit and recalculate
calibration curves”

Turns red when outside of specification
3

Touch the {Continue} button.

4

Touch the {Close} button.
* The system returns to the [Latex/CC settings] screen.
(Pressing the {Continue} - {Close} buttons on the[Latex/CC settings] screen in order returns to the [Test]
screen.)Explanatory note

: The origin and DA values can be changed from the [Edit and Recal CC] screen.
Page 67 “■ Edit and recalculate calibration curves”

Explanatory note: If STD sample measurement results fall outside standards, the box to the left of STD-# will turn red.
Page 298 “6.1.11 STD/QC analysis process settings”

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■

Daily Operation

Edit and recalculate calibration curves
Touch the {CC info} button on the [Check CC] screen to open the [Edit and Recal CC] screen. Origins
and DA values are edited using the keypad, and calibration curves can be recalculated.
1

Touch the {CC info} button.。

2

Edit the origin or DA value.
		① Touch the “Origin” or “DA value” field to edit.

		② Input the value.

Test Start

1

3

Touch the {Recal} button ③ .
* The results of recalculating the calibration curve and2

QC are displayed on the [Check CC] screen.
3

Explanatory note

: The DA values of STD-1 through STD-5 are all input using DA1.
The upper DA value for STD-6 is input using DA1, while the lower value input using DA2.

Explanatory note

: DA-2 of STD-6 is used for the PRC check.
Page 352 “Appendix: 1.5 Prozone Check”

4

Touch the {Continue} button.

5

Touch the {Register} button.
* The result of recalculating the calibration curve and
QC were registered.
* The system returns to the [Latex/CC settings] screen.
(Pressing the {Continue} - {Register} buttons on the[Latex/CC settings] screen in order returns to the [Test]
screen.)67
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2.4

Daily Operation

4

Starting tests

This section will explain the procedure from the [Test] screen.
1

Touch the {Start} button.
* Self check begins.

2

Confirm the following diagnostic results

Test Start

1.
2.
3.
4.
5.
6.
7.

Optical unit (Detector)
Cell
Latex temp high (Reagent abnormal
temperature)
Buffer temp high (Buffer abnormal
temperature)
Reaction table (Reaction table abnormal
temperature)
Latex (25°C or higher)
Buffer temperature

If self check results in “Fail”,
Page 71 “■ Self check failed”
3 Begin testing (sample dispensing automaticallystarts once priming and cell blank measurement
preparation is complete prior to the test starting).
* The cell blank value is calculated.

Explanatory note: If a calibration curve has not been created,“There is no calibration curve for~. Measure
STD.” is displayed.
{Cancel}: Cancel testing.
{Continue}: Continue testing without acalibration curve. Or, begin measuring thecalibration curve.

Explanatory note: If pipe line activation is aborted during operation using {Abort}, pipe line activation is performed
when testing begins.。

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■

Daily Operation

Viewing information
There is an {Information} button on the [Monitor] screen. The lot number, remaining tests for thereagent, and the remaining tests for the buffer are displayed in the button.

The images of the reagent bottle and buffer bottle show
how much reagent is left in the bottles.
Light blue:

11% or more

Yellow:

10% or lessRed:

5% or lessTesting

Reagent Lot No.: Reagent lot number (five digits)
Remaining tests: D i s p l a y s h o w m a n y t e s t s(approximate) can be processed based on the amountof reagent and buffer in the bottles.

1

Touch the {Information} button.

2

Confirm the information.
Touching the {Close} button returns to the[Monitor] screen.

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Daily Operation■

Confirming settings on the {Settings} tab.
Touch the {Settings} tab when the [Monitor] screen or [Additional test] screen is displayed to confirm
system settings and protocol settings.
Switching to the settings screen from the [Additional test] screen allows for the modification of “cut-off
value,” “QC LOT,” and “Max/min QC control value” settings.
Switching to the settings screen from the [Monitor] screen allows for checking settings only.

Touch the {Settings} button.

2

Touch the button of the setting to confirm.

Testing

1* The setting screen is displayed.

To confirm protocol settings, touch the {Protocol
settings} tab to switch to the appropriate screen.

3

Touch the button of the protocol setting toconfirm.
* The protocol settings screen is displayed.

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2.4

4

Daily Operation

Touch the {Close} button.
* The system returns to the [Monitor] screen.

■

Self check failed
The method for handling a “Fail” result varies according to the diagnostic item.

Testing

Refer to the following chart.
Diagnostic Item
Optical unit

Handling Method(1) Touch the {Abort} button.
→ The previous and current values are shown, and “Register thecurrent detector maximum output value?” is displayed.

(2) Touch the {Register} button. (The current value is registered)
Cell

Touch the {Abort} button.
Set the cell.

Latex temp highAn error in the reagent compartment was detected when the standby
switch was turned on. Touch the {Abort} button.
Contact the “Customer Support Technical Center.” Dispose of thereagent.

Buffer temp highAn error in the reagent compartment was detected when the standby
switch was turned on. Touch the {Abort} button.
Contact the “Customer Support Technical Center.” Dispose of the buffer.

Reaction table

Wait until the system reaches the set temperature.
When the system has reached the set temperature, the diagnostic resultchanges to “OK” and operation continues.

Latex (25°C or more)
Buffer temperature
Explanatory note

The {Continue} button can also be pressed to start testing without
waiting until the temperature is reached.
: “Under/Over” is displayed if the self check shows that the reaction table temperature has notreached the set temperature; “Under” is displayed if the reagent or buffer has not reached theset temperature.

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2.4.12

Adding samples (continue testing)This section describes the procedure for adding samples to the rack supply unit during testing.
Auto supply of the rack begins once the rack or tray is placed in the rack supply unit.
Page 276 “6.1.4 Environment settings”(If [Config] - [Rack auto start] is set to “YES”
Explanatory note

: When the last rack in the supply unit (tray) is sent to the conveyance line, the supply bar
automatically moves to the front.

1

If [Rack auto start] is set to “NO”, or if using a
tray (optional), touch the {Set samp} tab.。
* The supply bar of the supply unit moves to the front.
* If there is one rack on the tray, the supply bar moves

Testing

to the front after the rack is supplied.

2

Place the rack in the supply unit.
Trays (optional) can also be individually placed in racks.

Request・When placing a tray in the supply unit, hold it by hand so that the head rack does
not jump to the conveyance line or fall.

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Caution・Do not forcibly change the tray while the supply bar has not returned to the front.
Failure to observe this precaution may damage the supply bar.

Prohibited

Request・When setting racks to trays, face the rack barcode to the front.
Required

Explanatory note

Failure to observe this precaution could cause a barcode reading error.
: Trays cannot be placed in the supply unit while the supply bar has not returned to the front.
In this case, place racks individually in the supply unit tray.

<Placing racks at the tray level>(1) Remove the empty tray.
(2) Place the tray to which the rack has been set in the

Testing

supply unit.

3

Touch the {Continue} button.
* The system returns to the [Monitor] screen.
* Rack supply begins.

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Daily Operation

2.4.13

Additional tests (changing test conditions while testing)

Perform an “additional test” when changing test conditions and testing a sample, during testing.
During additional testing, configure the “Rack No.” and “Rack” to start testing with the modified
conditions.
When testing of the number of specified racks is finished, the system returns the test conditions totheir previous values. However, the sample number does not revert.
Select the {Additional test} tab.

2

Touch the {Test mode} button.

3

Change the test conditions.

Testing

1(See the chart on the following page.)

Explanatory note

: When the last rack in the rack supply unit (tray) is sent to the conveyance line, the supply bar
automatically moves to the front.

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Item
Rack No. 

Range/Selection*(default)
1-99

Daily Operation

Details
Configure the [Rack No.] to start testing with themodified conditions.
If the value is not changed from “*”, an error will
occur when the {Continue} button is touched.

Rack 

*(default)
1-99

Configure the [Rack] to test with the modified
conditions.
If “*” is input, all racks from the configured
rack number will be tested with the modified
conditions.
Configure the number of the head sample.

Sample No.
G  - SEQ 

A sample number consists of a group number(G) and a sequence number (SEQ).

Group No. (G)*, 1-9Enter “*” to skip configuring a group number.

Sequence No. (SEQ)

1 - 99999

If “*” is input for the sequence number,sequence numbers will be assigned in sequence

Testingfrom the previous sample number.
NumberingIf there is a position in which a sample has notbeen set, configure how to allocate sequencenumbers.
YES:

Allocate sequence numbers only to set samples.

1

2

3

4

5

6

7

8

9

Even if there are empty positions, a “Notube” error will not occur.
Continued on next page
Explanatory note

: Sequence numbers are allocated in serial order for each measure mode (test mode, remeasure/
retest mode, dilute test).

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Daily Operation

Item
Numbering

Range/Selection
NO:

Details
Allocate sequence numbers even to positions
in which samples are not set.

1

2

3

4

5

6

7

8

9

10

A “No tube” error will occur if there areany empty positions.
Sample barcode

Configure whether or not to use sample barcodes.
･

Settings are also applied to [Settings] - [System

Testingsettings] - [Samp barcode settings].

YES:

Use sample barcodes.

NO:

Do not use sample barcodes.

Measurement method

Select the measurement method.
1 day:

Measure using 1 day method.

2 day:

Measure using 2 day method.

3 day:

Measure using 3 day method.
Select the measurement mode.

Measure mode･ Measured data when remeasuring a sample
in remeasure/retest mode is applied to thepositive rate.
･ Measured data when using a retest rack or
dilute test rack is not applied to the positive
Test:
Retest:Test/remeasure test

1-10

rate.
Select when first making a measurement.
Select when remeasuring a sample.
Configure the head rack dispensing start position.

start position･(position in rack)

dilute test racks.
･

This setting does not apply to retest or
Sequence numbers are allocated from thetest start position.

76

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2.4

Item
Test item of Retes・Dil
test

Range/Selection[F-Hb][FCa]

Daily Operation

Details
Select the assay item.
Selection is possible if two analysis items are
selected in the data output settings.
Page 288 「6.1.7 Data output settings 		 [Test settings]」
Item settings cannot be made if order request
settings have been made.

Touch the {Continue} button.

5

Touch the {Register} button.

Testing

4{Register}:

Register configured settings.

{Close}:Cancel test mode and measure mode selection,		and return to the [Additional test] screen.

{Cancel}:The dialog box closes.

6

Touch the {Continue} button.
* The system returns to the [Monitor] screen.
* Rack supply begins.

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Explanatory note

: When an additional test has been received, “Additional Testing” is displayed on the [Monitor]
screen.

Explanatory note

: When the number of racks has been configured and the applicable rack is supplied, the“Additional Twating” message changes to “Running additional test.”
Once testing is complete for all configured racks, the “Running additional test” message disappears.

Explanatory note: If the number of racks has not been configured (“*” input), the “Running additional test” message is
not displayed.

Explanatory note

: Additional tests cannot be made while the “Additional Testing” or “Running additional test”
messages are displayed.

Testing■

Canceling additional tests
Use the following procedure to cancel additional tests when the “Additional Testing” message isdisplayed.

1

Select the {Additional test} tab.

2

Cancel the additional test.
① Touch the {Continue} button.
* The dialog box is displayed.

② Touch the {Cancel} button.。
* The additional test is canceled.

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2.4.14

Daily Operation

Cut-in analysis

Cut-in analysis for sample racks and STD/QC racks can be run during testing. (Cut-in analysis)
The measurement mode and method for cut-in analysis are “Test mode” and “1 day,” respectively.
Cut-in analysis cannot be performed on retest racks and dilute test racks.

Request・Wait for the “Please wait, a rack is still being tested” message to disappear, thenRequiredplace the rack at the STAT rack position.
If a rack is left on the conveyance line, the system will misidentify it and testing cannot begin.

Request・Do not stop cut-in analysis when measuring an STD sample.
Prohibited

Explanatory note

The data being measured will be deleted.
: If a retest rack or dilute test rack is cut-in during cut-in analysis, the system will display “Rack

Testingbarcode Unavailable” and the rack will be discharged to the STAT rack position.

1

Select the {STAT} tab.
* Rack supply stops.
* The conveyance line rack is discharged.

2

Wait until the “There are racks still in analysis.
Please wait.” message disappears.

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2.4 Daily Operation3

To cut-in an STD/QC rack, configure Latex for
CC and registration destination CC number.

Item
Latex for CC

Range/Selection
Pos.-1 ［F-Hb］
Pos.-3 ［FCa］

Details
Select the reagent to use.
Pos-1: Fecal hemoglobin
Pos-3: Fecal calprotectin
Except for setting analysis items
If reagent is selected, "not applicable to rackbarcoding"The product is unloaded to the position
where the interrupt rack is installed.
Explanatory notePage286

Testing

Save CC No.

CC 1 ～ CC 3

Set the registration target CC No for the createdcalibration curve of fecal hemoglobin.

CC 4 ～ CC 6

Registration destinations of the calibration curves forthe fecal calprotectin createdSetting CC No.
4

Latch the “STAT rack position” conveyance bar
into the groove in the middle of the rack, andplace the rack.

5

Touch the {Start} button.
* The rack is conveyed to the right.

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Daily Operation

6 Check the rack supply unit and the rack on the

tray.
<Cut-in STD/QC rack>① Return the rack supply unit or the rack on the
tray to the front. (See the figure to the left.)
Explanatory note

: When returning the rack to thefront, lift the rack up temporarily.
Failure to observe this precaution may
result in the pin catching and the rackfalling over.

② Touch the {Continue} button.
<Cut-in sample rack>
Touch the {Continue} button.

7 Begin testing the STAT rack.

Testing{STAT stop}: Stop cut-in analysis.
The STAT rack is discharged to the STAT rack
position.

Explanatory note

: Follow operations 4 and 5 to run cut-in analysis again on a rack for which cut-in analysis
was stopped.

Explanatory note

: When cut-in analysis is stopped during calibration curve creation, the current measurement data is
lost.

8

Finish cut-in analysis.
* Racks for which testing has completed are discharged
to the STAT rack position.。

① Remove the STAT rack.
② Touch the {Cancel} button.
* Normal testing resumes.
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Daily Operation

2.4.15Completing testing (normal close)

To complete testing, touch the {Completed} button on the [Monitor] screen, and select {Normal
close}. When testing is complete for all samples on the reaction table, the system returns to the[MENU] screen.

		To pause or abort testing, see the sections explaining each operation.
To “pause” testing, see page 83 “■Pausing testing.”

To “abort” testing, see page 84 “ ■Aborting testing.”。
1

Touch the {CLOSE} button.

		
To continue testing, place the sample rack in therack supply unit.
		 Page 72“2.4.12 Adding samples

Testing completed(continue testing)”

2

Touch the {Completed} button.

3

Touch the {Close} button.
* The system returns to the [MENU] screen.
* The results of the measured samples are printed.

{Close}:Finish testing.

{Cancel}: The dialog box closes.
{Abort}:Finish testing during processing.

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■

Daily Operation

Pausing testing
Touching the {Pause} button on the [Monitor] screen pauses sample dispensing. (Reagent dispensing,mixing, detection, and washing operations are not stopped.)

1

Touch the {Pause} button.
* The {Pause} button changes to the {Restart} button.
* Sample dispensing pauses.

Testing completed

2

Touch the {Restart} button.
* Operation is resumed.

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Daily Operation■

Aborting testing
Touching the {Abort} button on the [Monitor] screen stops all operations and returns to the [MENU]
screen.

1

Touch the {Completed} button.

				

Testing completed

2

Touch the {Abort} button.
* The system returns to the [MENU] screen.
* The result of the sample being measured is discarded.

{Close}:Finish testing.

{Cancel}: The dialog box closes.
{Abort}:Finish testing during processing.

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2.5

Inspection/Maintenance after Use
Run daily inspection and maintenance before turning the system off.
Touch the {Maintenance} button from the [MENU] screen to open the [Maintenance] screen.
“Inspection/maintenance” items are displayed on the screen. Follow the instructions on screen to clean
each part periodically.
The “Parts check list” and “Error list” can also be displayed from the [Maintenance] screen.
Check these as needed.

2.5.1

Cleaning parts
1

Touch the {Maintenance} button.

Inspection/maintenance

				

2

Clean each part.
The parts to clean are as follows.
1.

Clean panel (daily) : Clean touch panel

2.

Clean conveyance (daily): Clean conveyance line

3.

Clean W-nozzle (weekly): Clean washing nozzle

4.

S-nozzle, R-nozzle (weekly): Clean sample & reagent nozzles

Explanatory note5.

Clean trays (weekly)

6.

Clean racks (weekly)

7.

Clean tanks (monthly): If there are parts for which the exchange period has been exceeded, “Some parts should be exchanged.
Please check list of parts to check and exchange.” is displayed.

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Inspection/Maintenance after Use

3

To view procedures touch the {Procedure} button.
Cleaning procedures are displayed.

4

When cleaning is complete, touch the {Close}
button.

{Parts check list}:

Display a list of parts that need to be inspected or exchanged.

					{Error log}:

The error log is displayed. Up to 1000 error log entries can be viewed.

					[MENU]:

Page 87 “2.5.2 Opening the parts check list”
Page 89 “2.5.3 Opening the error log”

Return to the [MENU] screen.

Inspection/maintenance{Maintenance}: Adjust the system and check operation. (This is for maintenance people.)86
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2.5

2.5.2

Inspection/Maintenance after Use

Opening the parts check list

The [Parts check list] screen displays parts, when they were last changed, the number of months
they were used (maximum months used), and how many times they have been used (maximum
times used).
1

Touch the {Maintenance} button.

Inspection/maintenance

				

2

Touch the {Parts check list} button.

3

Check whether there are any parts that need to beexchanged.
Displayed content is shown in the chart on thefollowing page.

If there are parts that have exceeded the maximum
values for number of months used and number oftimes used, the background of the part turns yellow.

				

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Inspection/Maintenance after Use

No.
(1)

Item
Parts

Details
Name of the part to exchange(2)

Changed at

Date the part was exchanged

RemarkUp to 15 (full-width alphanumericcharacters) or 7 (full-widthcharacters) digits can be displayed.

(YY/MM/DD)(3)④

The number of months
used

The number of months used sincelast exchange（

Maximum months used

）

Test
（

The number of times used sincelast exchange）

Maximum times used
4

Exchange the part.
① Select the part to exchange (in yellow).

Inspection/maintenance1② Exchange the part.
③ Touch the {Exchange} button.
* A confirmation dialog box asking “Exchange parts?”
is displayed.

3{Exchange}:

Touch after the part has been exchanged.

{Print}:Print the parts check list.

{MENU}:

Return to the [MENU] screen.

{Close}:Return to the [Maintenance] screen.

④ Touch the {Start} button.
* “Changed at” is updated to the current day.
* “Using month” and “Test” are reset to “0.”* The dialog box closes.
4

Explanatory note

{Start}:Part exchange information is updated.

{Cancel}:The dialog box closes.

: Part can be exchanged even if a part that is not yellow is selected.

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2.5.3

Inspection/Maintenance after Use

Opening the error log

The [Error log] screen displays the date the error occurred, the error code, and the name of the error(details).
Up to 20 errors can be displayed on a single screen, and up to 1,000 errors can be displayed on asingle list. If there are 21 or more errors, use the scroll bar to scroll the list.
1

Touch the {Maintenance} button.

Inspection/maintenance

				

2

Touch the {Error log} button.

3

Confirm the error details.

{MENU}:

Return to the [MENU] screen.

{Close}:Return to the [Maintenance] screen.

				

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2.6

System shutdown (Close mode/Long suspense mode)
There are two methods to shut the system down: “Close mode” and “Long suspense.”
Select “Close mode” to shut the system down normally. Select “Long suspense” when the system
will not be used for a long time. Both modes will automatically turn the standby switch off. (Theprimary power switch is not turned off.)

Close mode

System shutdown

2.6.1

1

Touch the {Close} button.

2

If there are parts for which the exchange period

has been exceeded, “Some parts should be exchanged.
Please check list of parts to check and exchange.” isdisplayed.
Touch the {Close} button and then the {MENU}
button in order to return to the [MENU] screen.
Page 87 “2.5.2 Opening the parts check list”{Long suspense}: Transition to the [Long suspense] screen.
Explanatory note

: It is also possible to close without exchanging parts. To do so, touch the {Close mode} button, then select theprocess to run when complete. However, the same message will be displayed the next time the [Close mode]
screen is opened.

3

If there are no parts for which the exchange
period has been exceeded, select the process to
run when complete.
(See the chart on the following page.)90
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2.6

System shutdown

Item
Cell wash

1

System shutdown (Close mode/Long suspense mode)

Range/Selection
YES:

Details
Wash measurement cells when complete.

NO:

Do not wash measurement cells when complete.

Exchange buffer and wash
sol to p. water

YES:

Exchange with purified water.

NO:

Do not exchange with purified water.

Nozzle/cell soak wash

YES:

Run soaking preservation.

NO:

Do not run soaking preservation.

2

4

Touch the {Settings of auto start up} button.

5

Configure the day of the week and time to3

automatically start the system next (see thefollowing chart).
① Check the day of the week.
② Input the time.

Configure the operation to run automaticallyafter start up, for each day of the week (see thefollowing chart).
③ Check either “Nothing,” “Cell blank,” or “Test.”

6

Register configured settings.
① Touch the {Continue} button.
* The dialog box opens.

② Touch the {Register} button.
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System shutdown (Close mode/Long suspense mode)

Item
None

Cell blank

Test

Range/Selection● Check:

Details
Display the [MENU] screen after starting.

● Do not check:

Run the selected operation after starting.

● Check:

Run [Prep functions] - [Cell blank] after starting, thendisplay the results.

● Do not check:

Do not run cell blank measurement after starting.

● Check:

Automatically start testing after starting.
If a rack is not placed in the rack supply unit, the system
operates for a short while, then enters standby mode.

● Do not check:

Testing does not start automatically after starting.

7

Touch the {Continue} button.

System shutdown

				

8

Run close mode.
① Confirm that the “purified water tank” and “washsolution tank” are not empty.
② Confirm that the “drain tank” is not full.
③ Touch the {Start} button.

3{Start}:Run close mode.

{Close}:Cancel close mode and return to the [MENU]		

screen.

{Cancel}:The dialog box closes.

9

Start washing cells (when “Cell wash” is set to“YES”).

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System shutdown (Close mode/Long suspense mode)

10 Exchange buffer and wash solution in the pipingwith purified water (when “Exchange buffer andwash solution to purified water” is set to “YES”).
① Remove the piping connected to the buffer bottle.
② Connect a container filled with purified water tothe piping in ① .
③ Remove the piping connected to the wash
solution tank.
④ Connect a container filled with purified water tothe piping in ③ .
⑤ Touch the {Continue} button.

Request・If buffer and wash solution have been exchanged with purified water, be sure to

Systemshutdown

run pipe line activation the next time the system is started.

11 Soak wash the nozzle and cell (when “Nozzle/cellsoak wash” is set to “YES”).
* The standby switch shuts off.
* Settings made in close mode are saved.

12 The system turns off.

Explanatory note: If power is forced off when the system is processing in close mode, the process is disabled even if “Cellblank” and “Test” are set to run ( ● check) in the automatic start settings.

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System shutdown (Close mode/Long suspense mode)Long suspense

System shutdown

2.6.2

1

Touch the {Close} button.

2

Touch the {Long suspense} button.

3

Select the process to run when complete.
(See the chart below){Close mode}: The [Close mode] screen is displayed.

Item
Cell wash

Range/Selection
YES:

Details
Wash cells when complete.

NO:

Do not wash cells when complete.

Exchange buffer and wash
sol to p. water

YES:

Exchange with purified water.

NO:

Do not exchange with purified water.

Nozzle/cell soak wash

YES:
NO:

Cannot be selected.

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System shutdown (Close mode/Long suspense mode)4

Touch the {Continue} button.

5

Run close mode.
① Confirm that the “purified water tank” and “wash		solution tank” are not empty.

② Confirm that the “drain tank” is not full.

System shutdown③ Touch the {Start} button.
{Start}:Run close mode.

{Close}:Cancel close mode and return to the [MENU]		

screen.

{Cancel}:The dialog box closes.

6

Begin washing the cell.
(When “Cell wash” is set to YES.)→ to 8			

7

Exchange buffer and wash solution in the pipingwith purified water (when “Exchange buffer andwash solution to purified water” is set to “YES”).
① Remove the piping connected to the buffer bottle.
② Connect a container filled with purified water tothe piping in ① .
③ Remove the piping connected to the wash solutiontank.
④ Connect a container filled with purified water tothe piping in ③ .
⑤ Touch the {Continue} button.

Explanatory note: If buffer and wash solution have been exchanged with purified water, be sure to run pipe line activation the nexttime the system is started

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8

Remove the purified water/wash solution/buffer
piping.

2.7

Drain Tank Processing
Remove the maximum-level sensor and hose attached to the drain tank, then dispose of the drainage
in the tank.
Run through the procedure listed on page 39 “2.4.3 Setting the drain tank” in reverse to remove themaximum-level sensor and hose.

Warning

Systemshutdown・Wear protective equipment when handling the drain tank.
Biohazard

Failure to observe this precaution may lead to contamination.

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Chapter 3 Operation (Applied)

3.1

Measured Data Processing

3.2

Editing Sample IDs

3.3

List of Positive Samples

3.4

List of Error Samples

3.5

Histogram

3.6

Positive Rate Change

3.7

Replicate

3.8

Quality Control

3.9

Rack info

3.10 Measuring Using Sample Cups

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Chapter 3 Operation (Applied)
3.1 Measured Data Processing
Select the measured data from the [Process data] screen, and then edit, delete, change the positive rate, or
display the histogram.
Explanatory note

: ･Measured data is saved for each item.
･ Up to 100,000 sample and STAT sample tests can be saved to the hard disk(SSD).
Once 100,000 tests have been reached the system will begin overwriting the oldest data.
･ Up to 5,000 QC sample tests can be saved to the hard disk(SSD). Once 5,000 tests havebeen reached the system will begin overwriting the oldest data.

3.1.1

Opening the [Process data] screen

Open the [Process data] screen by touching the {Data processing} - {Process data} buttons on the[MENU] screen, or by touching the {Process data} button on the [Monitor] screen. A password willneed to be entered if one was set in the environment settings.

1 <Opening from the menu screen>① Touch the {Data processing} button.

② Touch the {Process data} button.
				98
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3.1

Measured Data Processing<Opening from the monitor screen>		Touch the {Process data} button.

2

Enter a password (displayed when a password
was registered in [System settings] -[Config]).

1① Enter a password.
② Touch the {enter} key.

2

3

Select the analysis items.

○［F-Hb］
				○［FCa］

		 ① Check the item (●).
		② [OK] Touch the button.
[Cancel] : The dialog box closes.

4

The [Process data] screen was displayed.

		* The {Samp} tab is selected.

		* The measurement date and time list is displayed.

		
Explanatory note

: The measurement date and time is the time
the system started up.
If there is no data to process, the time is
not displayed.

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Measured Data Processing

3.1.2

Displaying the [Test data] screen

Select measured data by switching between the {Samp}, {STAT samp},{STD}, and {QC} tabs on
the [Process data] screen. Press the {Test data} button after selecting measured data and specifying ameasurement date to display the specified data (the [Test data] screen varies according to whether the{Samp} or {STAT samp} tabs were selected, or the {QC} tab was selected).
Explanatory note

: The displayed date and time is the date and time the standby switch was turned on. (That is,
the system startup time.) Data measured until the standby switch is turned off is saved to thehard disk(SSD) as data from that day.

Explanatory note

: See page 98 “3.1.1 Opening the [Process data] screen” for information on displaying the[Process data] screen.

1

Touch the tab of the measured data to display.
{Samp} tab{STAT samp} tab{STD} tabPage 182 “3.7.2 Displaying the [Replicate(STD)] screen”{QC} tabPage 186 “3.7.4 Displaying the [Replicate(QC)] screen”

2

Specify the measured data by date and time or
range.
<Specifying by measurement date and time>
Touch the {Date} button, and specify themeasurement date.
Page 104 “3.1.3 Specifying measured data bymeasurement date” 2<Specifying by range>
Touch the {Select-s} button, and specify themeasurement date range.
Page 106 “3.1.4 Specifying measured data by
range” 2

Explanatory note: If {Date} or {Select-s} are not used, all displayed measured data (a max of 5,000 samples of data)
will be processed.

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3.1

3

Measured Data Processing

Touch the {Test data} button.

{Close}:Return to the [Data process selection] screen.

		Or, return to the [Monitor] screen.

		(If {Test data} button on [Monitor] screen as		touched.){MENU}: Return to the [MENU] screen.

4

The measured data was displayed.

{Samp} or {STAT samp} tabs were selected
Explanatory note

: During a dilute test, if no dilution and 15-times dilution are both tested, the final result row isdisplayed in blue text.

{QC} tab was selected101
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Measured Data Processing

Content displayed on [Test data] screen (Samp/STAT samp)
Display

Details

RemarkDate

Date and time sample was measured

RACK

Rack No. - Position number in rack

SEQ.

Group No. - Sequence No.

Data [ng/mL] or [ug/g]

Measurement results(concentration value)Flag-, +, 1 +, 2 +, 3 +Error information (excluding reading errors)

Comment

UR: Under range

Blank output for measured
data and judgment result

OR: Over range

Output only judgment
result

PRC: Prozone

Output only judgment
resultSample ID

Barcode information on sampling bottles

CC

Calibration curve used to calculate measureddata(CC No.)Dilution formation

Dil

Space

: No dilution(test mode, remeasure mode)A: No dilution(Retest mode)

A15: 15-times dilution(Dilution test mode)

A250: 250-times dilution(Dilution test mode)

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Measured Data Processing

Content displayed on [Test data] screen (QC)
Display

Details

RemarkDate

Date and time QC sample was measured

RACK

Rack No. - Position number in rack

QC No.

QC No.1 - 4

QC LOT

QC lot (five digits)

SEQ.

QC sequence number

Data [ng/mL] or [ug/g]

Measurement results(concentration value)

The rack position number
of QC samples is 9 or 10.

Error information (excluding reading errors)
Comment

UR: Under range

OR: Over range

PRC: ProzoneCC

Calibration curve used to calculate measureddata(CC number)

QC ID

QC ID of QC sample at cursor position

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3.1.3

Specifying measured data by measurement dateSpecify the measurement date of the measured data to display from the [Process data] screen.

Explanatory note

: When entering the measurement date, if part of the year, month, or day is omitted, the system
will begin a search from the latest measurement date to find the measured data with the latest
date that matches the entered conditions.
3 on the following page (example)

Explanatory note

: See page 98 “3.1.1 Opening the [Process data] screen” for information on displaying the[Process data] screen.

Explanatory note

: A measurement date is not specified for STD measured data.

1

Touch the tab of the measured data to display.
{Samp} tab{STAT samp} tab{QC} tab2

Touch the {Date} button.

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Specify the measurement date.
① Touch the input field and enter the year, month, andday.
If part of the year, month, or day is omitted, the system
will begin a search from the latest measurement dateto find the data with the latest date that matches theentered conditions.

2(Example) If October 5 is entered and the year is omitted,
the search will display only data for the current year.
For example, if the current year is 2013:2013/10/05 10:10 (displayed)
2013/10/05 10:15 (displayed)
2013/10/05 10:20 (displayed)

・
・
・
3

2012/10/05 14:25 (not displayed
2012/10/05 14:30 (not displayed
2012/10/05 14:35 (not displayed② Touch the {Continue} button.
③ Touch the {Start} button.
{Start}:Search for data using the specified measurement

		date.
{Close}:Cancel measurement date specification, and return		to the [Data process selection] screen.

{Cancel}: The dialog box closes.

4

The data for the specified measurement date isdisplayed.

Explanatory note

: To specify a new measurement date, touch the {Clear} button.
All measured data is displayed, and the system returns to the state it was in before the range
was specified.

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3.1.4

Specifying measured data by range

Specify the measured data to display using a measurement date and time range (start point/end
point).
Specify the range by touching the measurement date and time on the [Process data] screen, or byusing the cursor buttons.
Specify the start point and touch the {Select-s} button to confirm the measured data at the startpoint.
Then, specify the end point and touch the {Select} button to confirm the measured data at the end
point.
After confirming the start and end points, the measured data between the start and end points is
specified as the range.
Explanatory note

: See page 98 “3.1.1 Opening the [Process data] screen” for information on displaying the[Process data] screen.

Explanatory note: If a range is not specified, all data (up to 5,000 samples’ worth) displayed on screen will beprocessed.

1

Touch the tab of the measured data to display.
{Samp} tab{STAT samp} tab{STD} tab
{QC} tab2
1Specify the measurement date and time at the startpoint.
* The measurement date and time at the start point was		 confirmed. (The text turns blue)* When the start point is confirmed, the {Select-s}

2Explanatory note		 button changes to the {Select} button.

: The date and time of the start and end points can also be specified using the cursor buttons.

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Specify the measurement date and time at the end
point.
① Touch the measurement date and time that will be		

1

the end point.

② Touch the {Select} button.
2		* The measurement date at the end point is confirmed.

		* When the end point is confirmed, the {Select} button

			 changes to the {Clear} button.

{Clear}:4

Clear the range specification.

The measured data for the specified range isdisplayed.

Explanatory note

: ･If the dates and times specified for the start and end points are the same, the system willhandle it as though only a single sample of measured data was specified.
･To specify a new range, touch the {Clear} button. All measured data

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3.1.5

Reading “measured data” not in the list (reading again)

Up to 5,000 samples’ worth of measured data can be displayed in the list and edited. (Up to 100,000
samples’ worth of measured data can be saved to each test item.) Data must be read in order to editmeasured data not displayed in the list. Specify the date and time that will be the start point fromthe list, select whether to display data before or after that point, then read the data to edit.
Explanatory note

: See page 98 “3.1.1 Opening the [Process data] screen” for information on displaying the[Process data] screen.

1

Touch the tab of the measured data to read.
{Samp} tab{STAT samp} tab
{STD}
{QC}

2

Specify the start point and read the measured data.
① Touch the measurement date and time that will be		the start point.

		(The cursor buttons at the bottom right of the1		screen can also be used to select this.)② Touch the {Read again} button.

2③ Select the reading method. (See the chart below.)④ Touch the {Start} button.
		* Begin reading measured data.

{Cancel}:Close the dialog box.

{Close}:Return to the [Data process selection] screen.

		Or, return to the [Monitor] screen.
(When the {Test data} button has been touchedon the monitor screen.){MENU}:

Return to the [MENU] screen.

Selection● Get data before the date on the cursor.

Details
Read data from before the date and time at the
cursor position. (This does not include the date
and time at the cursor position.)● Get new data after the date on the cursor.

Read data from after the date and time at the
cursor position. (This does not include the date
and time at the cursor position.)

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3.1.6

Measured Data Processing

Reading “measured data” from external media(switching external media)

Read measured data saved to external media and display it on the screen.
This function is not available for STD and QC sample measured data.
Explanatory note

: See page 98 “3.1.1 Opening the [Process data] screen” for information on displaying the[Process data] screen.

1

Touch the tab of the measured data to read.
{Samp} tab{STAT samp} tab

2Touch the {Media} button.

			* Read the data from the hard disk(SSD).
* Measured data (up to 5,000 samples’ worth) saved to the		 external media is displayed.
* Data is displayed in order of date, with data having the latest
		 measurement date and time displayed first.

3

Touch the {HD change} or {SSD change}button.

			

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3.1.7

Sorting measured data

Sort the measured data by measurement date and time or group, and narrow down measured data toprocess.
When sorting by measurement date and time, measured data is displayed in ascending order by “date.”
When sorting by group, measured data is displayed in ascending order by “sample number group.
Explanatory note

: See page 98 “3.1.1 Opening the [Process data] screen” for information on displaying the[Process data] screen.

1

Touch the tab of the measured data to display.
{Samp} tab{STAT samp} tab
{STD}
{QC}
		

		

2

Specify the measured data by date and time or
range.
<Specifying by measurement date and time>
Touch the {Date} button, and specify themeasurement date.

		Page 104 “3.1.3 Specifying measured data			by measurement date and time” 2<Specifying by range>
Touch the {Select-s} button, and specify themeasurement date range.

3		Page 106 “3.1.4 Specifying measured data			by range” 2Touch the {Test data} button.

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4

Touch the {Sort} button.

5

Touch the {Date sort} button or the {Groupsort} button.

* The sorted measured data is displayed.
			{Date sort}:

Sort measured data in ascending order by		measurement date and time.

{Group Sort}: Sort measured data in ascending order by sample		

number group.

{Cancel}:Cancel sorting measured data.

6

Specify a range to further narrow down themeasured data being displayed.

The procedure is the same as in the [Process data]				screen.

		Page 106 “3.1.4 Specifying measured data by
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3.1.8

Searching for measured data

Search measured data based on sample ID, sample number, rack number, and measurement date
and time.
Explanatory note

: Measured data cannot be searched for using the rack position number.

Explanatory note

: See page 98 “3.1.1 Opening the [Process data] screen” for information on displaying the[Process data] screen.

1

Touch the tab of the measured data to display.
{Samp} tab{STAT samp} tab
{STD}
{QC}

			

		

2

Specify the measured data by date and time or
range.
<Specifying by measurement date and time>
Touch the {Date} button, and specify themeasurement date.
Page 104 “3.1.3 Specifying measured databy measurement date and time” 2<Specifying by range>
Touch the {Select-s} button, and specify themeasurement date range.
Page 106 “3.1.4 Specifying measured databy range” 2

3

Touch the {Test data} button.

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1

4

Measured Data Processing

Search for target samples.
① Touch the target tab.
② Touch the {Search} button.

2

5

Select the type of keyword to search.
□ Sample ID□ Sample No.
□ Rack No.
□ Date16Enter a keyword.
① Touch the “input field” next to the name of the		keyword.

2② Enter a keyword using the keypad.
③ Touch the {enter} key.
Explanatory note3

: The {A/a} and {Sign} buttons areavailable when the cursor is in the
input field.

Explanatory note

: Entry of the group number and measurement date and time can be omitted. However, if ameasurement date and time box is checked, it is necessary to input at least one of thefollowing: year, month, date, hour, and minute.
{A/a}:

Switch input between uppercase and lowercase.

{Sign}:

Allows for input of symbols.

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7

Touch the {Continue} button.

			

8Touch the {Start} button.

* Start searching.
			

9Search results are displayed.

			{Search}: Allows search to continue.

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MEMO

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3.1.9

Recalculating measured data

Recalculate measured data using modified cut-off values, as well as factors A and B.
Explanatory note

: The values used for judging measured data for which a range has been specified are shown in
Cut off 1, Cut off 2, and Cut off 3.
If the cut-off value differs according to the measured data, “0” will be displayed for Cut off 1,
Cut off 2, and Cut off 3.

Explanatory note: If the factor value differs according to the measured data, factor A and factor B are displayed
as 1.00 and 0.00, respectively.

Explanatory note

: Values configured in the [Recalculation condition settings] screen are not applied to protocol
settings. Recalculation is a form of calculation for the purpose of correction using values
configured in condition settings. It is not fitting calculation to a calibration curve.

1

Touch the tab of the measured data to recalculate.
{Samp} tab{STAT samp} tab

2Specify the measured data by date and time or
range<Specifying by measurement date and time>
Touch the {Date} button, and specify themeasurement date.
Page 104 “3.1.3 Specifying measured databy measurement date and time” 2<Specifying by range>
Touch the {Select-s} button, and specify themeasurement date range.
Page 106 “3.1.4 Specifying measured databy range” 2

3

Touch the {Test data} button.

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4

Touch the {Recal} button.

5

Configure the recalculation conditions.
① Touch the “input field” next to the setting.
・ Cut off 1
・ Cut off 2・ Cut off 3

2・ FACTOR A
・ FACTOR B② Enter numbers using the numeric keypad.

Setting

Input Range

Cut off 1

0-9,999,999

Cut off 2

0 to 9,999,999; * (input omitted)

Cut off 3

0 to 9,999,999; * (input omitted)

FACTOR A

0.001-99,999.999

FACTOR B-999.99-999.99

6

Touch the {Recal} button.

{Cancel}:Cancel recalculation and return to the [Test		data] screen

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7

The recalculated measured data was displayed.

To update the recalculated data:① Touch the {Continue} button.
② Touch the {Register} button in the dialog box.

1

2

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Recalculation results when the Samp/QC protocol settings have changed
Request・When changing the Samp/QC protocol settings and recalculating, touch the {Memory}
button on the [Check CC] screen first, and then recalculate.
RequiredPage 197 “3.7.9 Editing/recalculating calibration curves (samples/STAT samples)”・ If the maximum measurement value [ng/mL or ug/g] is set to “*” and recalculation is run, datathat resulted in OR will have a result other than OR.
・ If the maximum measurement value [ng/mL or ug/g] is configured and recalculated so that theresult will be OR, the result will be OR.
・ If the minimum measurement value [ng/mL or ug/g] is configured and recalculated so that thedilute recalculation data will not result in UR, data that resulted in UR will have a result otherthan UR.
・ If the minimum measurement value [ng/mL or ug/g] is configured and recalculated so that thedilute recalculation data will result in UR, the result will be UR.

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3.1.10

Outputting measured data

Specified measured data is output to the selected output destination.
・ Printing measured data
・ Saving measured data to external media
・ Outputting measured data to a host computer online
Explanatory note

: When there is both 15-times dilution and 250-times dilution measured data, the final results
are judged.
If testing was stopped for either 15-times dilution or 250-times dilution, or if the measured
data for either was deleted by the operator, the final results are not judged.

1

Touch the tab of the measured data to output(print).
{Samp} tab{STAT samp} tab

2Specify the measured data by date and time or
range.
<Specifying by measurement date and time>
Touch the {Date} button, and specify themeasurement date.
Page 104 “3.1.3 Specifying measured databy measurement date and time” 2<Specifying by range>
Touch the {Select-s} button, and specify themeasurement date range.
Page 106 “3.1.4 Specifying measured databy range” 2

3

Touch the {Test data} button.

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Request・If the external media runs out of space during output, exchange it with a new device
Requiredand touch the {Retry} button.

4

Specify the output range.
The procedure is the same as in the [Measured
data selection] screen.
Page 106 “3.1.4 Specifying measured databy range” 2

5Touch the {Output} button.

6

Output the measured data.
① Select the output destination.
○ Printer○ External media○ Online② Touch the {Start} button.

2
1{Cancel}: The dialog box closes.

Explanatory note: If an error has occurred in communicating the measurement results, “Online” cannot be
selected in the [Output destination selection] dialog box.

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Measured Data Processing				* The following information is output to				the selected output destination.

				* When output is complete the				[Outputting] dialog closes.

。

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3.1.11

Deleting measured data

Delete measured data for the specified measurement date and time.
If a range is not specified, all displayed data (up to 5,000 samples’ worth) will be deleted.

Explanatory note

: See page 98 “3.1.1 Opening the [Process data] screen” for information on displaying the[Process data] screen.

1

Touch the tab of the measured data to display.

		 {Samp} tab
		 {STAT samp} tab
		 {QC} tab

Explanatory note

: STD measured data cannot be deleted.

2Specify the data to delete using a measurement
date and time range (start point/end point).
(It is not necessary to specify the range whendeleting all data.)
Page 106 “3.1.4 Specifying measured
data by range” 2

3

Touch the {Del} button.

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Request・When deleting measured data, be sure to confirm the specified range.
Required

All measured data (up to 5,000 samples’ worth) displayed on the screen will be deleted.

4

Confirm the specified date and time, and touchthe {OK} button.

{Cancel}: The dialog box closes.

5

Measured data for the specified date and time wasdeleted.

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3.1.12

Copying measured data

Copy specified measured data to other measured data.
Copied information includes sample IDs, measured data, judgment results, and comments.

Explanatory note

: See page 98 “3.1.1 Opening the [Process data] screen” for information on displaying the[Process data] screen.

1

Touch the tab of the measured data to display.

		 {Samp} tab
		 {STAT samp} tab
		 {QC} tab

2Specify the measured data by date and time or
range.
<Specifying by measurement date and time>
Touch the {Date} button, and specify themeasurement date.
Page 104 “3.1.3 Specifying measured databy measurement date and time” 2<Specifying by range>
Touch the {Select-s} button, and specify themeasurement date range.

Page 106 “3.1.4 Specifying measured
data by range”

3

2

Touch the {Test data} button.

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Explanatory note

Measured Data Processing: When copying measured data to other data, individual data obtained through replicate testing
will not be copied.

4

Specify the measured data to copy.
① Touch the measured data to copy (the cursor
		1buttons on the bottom right of the screen can also		be used).
② Touch the {Copy} button.

2

5Specify the measured data to copy to.
① Touch the measured data to copy to (the cursor
		buttons on the bottom right of the screen can also		be used).

1② Touch the {Copy} button.

2

6

Touch the {Start} button.

				* Copying is performed.

{Cancel}:Cancel copying, and return to the [Test data]		screen.

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3.2

Editing Sample IDs
Edit sample IDs for data selected on the [Test data] screen.
Explanatory note: If [Duplicated check] is set to “YES” in [Samp barcode settings] on the [Systemsettings] ･ [Samp barcode settings] screen, a duplication check is run for sample IDs.
However, a duplication check is not run when editing sample IDs for “retest data” or “dilutetest data.”

1

Touch the tab of the measured data to display.

		 {Samp} tab
		 {STAT samp} tab

2Specify the measured data by date and time or
range.
<Specifying by measurement date and time>
Touch the {Date} button, and specify themeasurement date.
Page 104 “3.1.3 Specifying measured databy measurement date and time” 2<Specifying by range>
Touch the {Select-s} button, and specify themeasurement date range.
Page 106 “3.1.4 Specifying measured databy range” 2

3

Touch the {Test data} button.

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4

Select the sample ID.
① Touch the sample ID to edit (sample IDs can also1

be selected by using the {Cursor} buttons tomove the cursor).
② Touch the {ID edit} button.

2

5

Input the sample ID.

1① Touch the “input field” of the sample ID.
② Enter the sample ID using the keypad.

2{A/a}:

Switch input between uppercase and lowercase.

{Sign}:

Allows for input of symbols.

6

Update the sample ID.
① Touch the {Continue} button.
② Touch the {OK} button in the dialog box.

* The edited sample ID is stored.
			

1

2

{Cancel}:Cancel editing the sample ID, and return to the		[Test data] screen.

{Cancel}:The dialog box closes.

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3.3

List of Positive Samples
Display the samples that were measured in test mode or remeasure mode and received “positive
judgment” in a list.
Positive samples displayed in the list can be sorted, searched, recalculated, output, cut-off backcalculated, and deleted.

Explanatory note

: ･ Error samples do not have judgment results, and thus are not displayed on the list.
･ OR, RBC, and PRC samples are positive samples.
･ Samples that were measured in test mode or remeasure mode are displayed on the list.

3.3.1

Displaying the positive sample list

Two display modes are available for the positive sample list: sample mode and testee mode. The
positive rate is shown in either mode. Calculation is performed as follows.
		Sample mode: Positive rate (%) = Number of positive samples ÷ Number of all samples × 100(“Number of all samples” is the number of samples within the range specified on
the [Test data] screen.)
Testee Mode: Positive rate (%) = Number of positive testees ÷ Number of all testees × 100(“Number of all testees” is the number of testees within the range specified on the[Test data] screen.
Explanatory note

: ･ Only positive measured data is displayed in sample mode.
･ For testee mode, if even a single sample is positive in the 2 day or 3 day measured data, allmeasured data for that patient is displayed.
･ For testee mode, positive samples are displayed reversed.

Explanatory note

: All data will be displayed if no range is specified.

1

Touch the tab of the measured data to display.

		 {Samp} tab
		 {STAT samp} tab

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2

Specify the measured data by date and time or
range.
<Specifying by measurement date and time>
Touch the {Date} button, and specify themeasurement date.
Page 104 “3.1.3 Specifying measured databy measurement date” 2<Specifying by range>
Touch the {Select-s} button, and specify themeasurement date range.
Page 106 “3.1.4 Specifying measured databy range” 2

1

3

Touch the {Test data} button.

4

Specify the measured data by range ofmeasurement date and time.
① Touch the measurement date and time at the startpoint (the cursor buttons at the bottom right of thescreen can also be used to select this).
② Touch the {Select-s} button.

2* The text in the row of the specified date and timeturns blue. (Start point)* The {Select-s} button changes to the {Select}button.

③ Touch the measurement date and time at the end
point (the cursor buttons at the bottom right ofthe screen can also be used to select this).
④ Touch the {Select} button.
* The text in the row of the specified range turns
blue. (End point)

3
4{Sort}:

Sort the displayed measured data.

{Select-s}:

Confirm start point data for the specified range.

{Select}:

Confirm end point data for the specified range.

{Clear}:Clear the specified range.

Page 110 “3.1.7 Sorting measured data”
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5

Touch the {Positive data} tab.
* The specified list of positive samples is displayed.

6

Positive samples are displayed by sample or bytestee.
<When selecting sample mode>		Touch the {Sample} button.

<When selecting testee mode>		Touch the {Testee} button.
When the positive sample has been updated throughrecalculation, deletion, etc.:① Touch the {Continue} button.
②  Touch the {Register} button in the dialog box.
			 * Updated positive sample data is registered.

{Del}:

Delete specified positive sample data.
Page 148 “3.3.8 Deleting positive sample data”{Reverse}:

Calculate the cut-off value using the input positive rate.
Page 142 “3.3.6 Calculating cut-off values from positive rates”{Output}:

Output specified positive sample data.
Page 146 “3.3.7 Outputting positive sample data”{Recal}:Recalculate measured data using modified cut-off values, as well as factors A and B.
Page 140 “3.3.5 Recalculating positive sample data”{Search}:Search positive samples based on sample ID, sample number, rack number, and		measurement date and time.
Page 138“3.3.4 Searching positive sample data”

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Content displayed on the [Positive data] screen
Display

Details

RemarkDate

Date and time sample was measured

RACK

Rack No. - Position number in rack.

SEQ.

Group No. - Sequence No.

Data [ng/mL] or [ug/g]

Measurement results(concentration value)Flag-. +, 1 +, 2 +, 3 +Error information (excluding reading
errors)UR: Under range

Blank output formeasured data andjudgment result

OR: Over range

Output only judgment
result

PRC: Prozone

Output only judgment
resultComment

Sample ID

Barcode information on sampling bottles

CC

Calibration curve used to calculate
measured data (CC No.)
Dilution information

Dil

Explanatory noteSpace

: No dilution(test mode, remeasure mode)A: No dilution(Retest mode)

A15: 15-times dilution(Dilution test mode)

A250: 250-times dilution(Dilution test mode): During a dilute test, if no dilution and 15-times dilution are both tested, the final result row isdisplayed in blue text.

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3.3.2

Sorting positive sample data

Positive samples specified on the [Test data] screen can be sorted by measurement date and time,and by group. When sorting by measurement date and time, positive samples are displayed inascending order by “date.”
When sorting by group, positive samples are displayed in ascending order by “sample number
group.”
This section describes the procedure from the [Positive data] screen.
Page 130 “3.3.1 Displaying the positive sample list”

Explanatory note1

through5: If a range is not specified, all positive samples displayed on the [Positive data] screen will besorted.

Explanatory note

: The range of positive samples can also be specified using the {Select-s} button on the [Positivedata] screen.
The method is the same as on page 136 “3.3.3 Specifying positive sample data by range.”

1

Select the display mode for positive samples tosort (by sample/testee).
① Touch the {Sample} or {Testee} buttons.
② Touch the {Sort} button.

1

2

2

Touch the {Date sort} button or the {Group sort}button.

* The sorted measured data is displayed.
			{Date sort}:

Sort measured data in ascending order by		measurement date and time.

{Group Sort}: Sort measured data in ascending order by		sample number group.

{Cancel}:Cancel sorting.

		The dialog box closes.

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3

Positive sample data was sorted.

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3.3.3

Specifying positive sample data by range

Touch the measurement date and time on the [Positive data] screen or operate the cursor buttons to
specify positive sample data by range of measurement date and time (start point/end point).
Specify the date and time at the start point and touch the {Select-s} button to confirm the positive
sample data at the start point. Next, specify the date and time at the end point and touch the {Select}button to confirm the positive sample data at the end point. After the start and end points are
confirmed, the positive sample data between the start and end points is specified.
This section describes the procedure from the [Positive data] screen.
		Page 130 “3.3.1 Displaying the positive sample list”

1

1

through

5

Specify the measured data at the start point.
① Touch the date and time that will be the start point.

1② Touch the {Select-s} button.
* The measured data at the start point was confirmed.
* When the start point is confirmed, the {Select-s}
button changes to the {Select} button.

2

2

Specify the measured data at the end point.
① Touch the date and time that will be the end point.
② Touch the {Select} button.
* The measured data at the end point was confirmed.

1* When the end point is confirmed, the {Select}2

button changes to the {Clear} button.

{Select-s}:

Confirm the measured data at the start point.

{Select}:

Confirm the measured data at the end point.

{Clear}:Clear the specified range.

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Explanatory note: If the measured data specified for the start and end points is the same, the system will handle
it as though only a single sample of measured data was specified.

Explanatory note

: To specify a new range of measured data, touch the {Clear} button. All measured data isdisplayed, and the system returns to the state it was in before the range was specified.

3

Positive sample data was specified.
* The specified measured data is displayed.

Explanatory note

: The display mode for positive samples can be switched with the {Sample} or {Testee} buttons.

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3.3.4

Searching positive sample data

Search positive samples based on sample ID, sample number, rack number, and measurement date
and time.
This section describes the procedure from the [Positive data] screen.
		Page 130 “3.3.1 Displaying the positive sample list”
Explanatory note1

through5: If a range is not specified, all positive samples displayed on the [Positive data] screen will besearched. Measured data cannot be searched for using the rack position number.

Explanatory note

: The range of positive sample data can also be specified using the {Select-s} button on the [Positivedata] screen. The method is the same as on page 136 “3.3.3 Specifying positive sample data by
range.”

Explanatory note

: Sort positive sample data using the {Sort} button on the [Positive data] screen. The method is thesame as on page 134 “3.3.2 Sorting positive sample data.”

1

Touch the {Search} button.

2

Select the type of keyword to search.
□ Sample ID□ Sample No.
□ Rack No.
□ Date31Enter a keyword.
① Touch the “input field” next to the name of the		keyword.

2② Enter a keyword using the keypad.
③ Touch the {enter} key.

3{A/a}:

Switch input between uppercase and lowercase.

{Sign}:

Allows for input of symbols.

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Explanatory note

: Entry of the group number and measurement date and time can be omitted. However, if ameasurement date and time box is checked, it is necessary to input at least one of the following:
year, month, date, hour, and minute.
Explanatory note

: The {A/a} and {Sign} buttons are available
when the cursor is in the input field.

4

Touch the {Continue} button.

5

Touch the {Start} button.
* Searching begins.

{Cancel}:Cancel searching, and return to the [Positive

		data] screen.

{Cancel}:The dialog box closes.

6 Search results were displayed.

Explanatory note

: The display mode for positive samples can be switched with the {Sample} or {Testee} buttons.

Explanatory note

: The search range is the range specified on the [Test data] screen.

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3.3.5

Recalculating positive sample data

Recalculate measured data using modified cut-off values, as well as factors A and B.
This section describes the procedure from the [Positive data] screen.
		Explanatory note

Page 130 “3.3.1 Displaying the positive sample list”

1

through5: ･ The values used for judging measured data for which a range has been specified are shown in
Cut off 1, Cut off 2, and Cut off 3.
･ If the cut-off value differs according to the measured data, “0” will be displayed for Cut off 1, Cut off
2, and Cut off 3.
･ If the factor value differs according to the measured data, factor A and factor B are displayed as
1.00 and 0.00, respectively.

Explanatory note

: Values configured in the [Recalculation condition settings] screen are not applied to protocol settings.
Recalculation is a form of calculation for the purpose of correction using values configured in
condition settings. It is not fitting calculation to a calibration curve

Explanatory note

: Recalculation applies not only to data displayed on the [Positive data] screen, but to all data specified
on the [Test data] screen.

Explanatory note

: The range of positive samples can also be specified using the {Select-s} button on the [Positive data]
screen.
The method is the same as on page 136 “3.3.3 Specifying positive sample data by range.”

1

1

Touch the {Recal} button.

2

Configure the recalculation conditions.
① Touch the “input field” next to the setting.
② Enter numbers using the numeric keypad.
③ Touch the {enter} key.

2･

Cut off 1･

Cut off 2･

Cut off 3･

FACTOR A･

FACTOR B

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Setting

Input Range

Cut off 1

0 to 9,999,999

Cut off 2

0 to 9,999,999; * (input omitted)

Cut off 3

0 to 9,999,999; * (input omitted)

FACTOR A

0.001 to 99,999.999

FACTOR B-999.99 to 999.99
3

Touch the {Recal} button.

{Cancel}:Cancel recalculation, and return to the [Positivedata] screen.

4

The recalculated positive sample data wasdisplayed.

To update the recalculated data:① Touch the {Continue} button.
② Touch the {Register} button in the dialog box.
1

2

Explanatory note

: The display mode for positive samples can be switched with the {Sample} or {Testee} buttons.

Request・When changing the Samp/QC protocol settings and recalculating, touch theRequired{Memory} button on the [Check CC] screen first, and then recalculate.
Page 197 “3.7.9 Editing/recalculating calibration curves (samples/STAT samples)”141
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3.3.6

Calculating cut-off values from positive rates

The cut-off value is back calculated using the measured data of the displayed positive sample andthe input positive rate. Cut-off values are calculated differently in sample mode and testee mode.
Page 145 “ ■ Calculation methods for cut-off values according to display mode”
This section describes the procedure from the [Positive data] screen.
Page 130 “3.3.1 Displaying the positive sample list”
Explanatory note1

through5: ･ If no range is specified, cut-off values are calculated with “all measured data” and with “input
positive rate.”･ The range of positive samples is specified using the {Select-s} button on the [Positive data] screen.

Page 136 “3.3.3 Specifying positive sample data by range”
1

Select the display mode for positive samples (bysample/testee).
Touch the {Sample} or {Testee} buttons.

1

2

Touch the {Reverse} button.

3Enter the positive rate.
① Touch the input field for the positive rate.
② Enter the positive rate using the numeric keypad.
				Input range: 0.0 to 100.0③ Touch the {enter} key.
2

				* Calculate the cut-off value.

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4

The calculated cut-off value is displayed in the
Cut off 1 field.
Cut-off value range: 0 to 9,999,999

5Touch the {Continue} button.

6

Touch the {Memory} button.
		* Applied to Cut off 1 on the [Recal settings] screen.

{Memory}:

Save calculation results to memory.

{Close}:Cancel calculation, and return to the [Process		data] screen.

{Cancel}:The dialog box closes.

7

Touch {Continue}.

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8

Explanatory note

Touch {Register}.

{Register}:

Register the cut-off value.

{Close}:Cancel registration, and return to the [Reverse]		screen.

{Cancel}:The dialog box closes.

: Pressing the {Continue} button will apply the calculated cut-off value to cut-off value 1 on the [Recal
settings] screen.

Page 140 “3.3.5 Recalculating positive sample data”

When changes have been applied to cut-off value 1 on the [Recal settings] screen, cut-off values 2 and3 change to “*.” Use cut-off values 1, 2, and 3 to calculate when recalculating.
Explanatory note: If the measured data for the Nth positive sample is PRC or OR, the cut-off value is not calculated.

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Calculation methods for cut-off values according to display modeTwo display modes are available: sample mode and testee mode.
Cut-off value calculation for each mode is as follows.

Sample mode: N = Input positive rate ÷ Number of all samples × 100 (fractional portions
rounded down to nearest integer)(N = the number of samples that should be positive)

Explanatory note:

1. Decimal points are rounded down for the number of samples.
2. For cut-off values, the measured data of the Nth sample becomes an integer shown when less than the		number. (Integer between 0 and 9,999,999)
Example 1: Nth sample measured data: 100.1 → 100.
Example 2: Nth sample measured data: 100 → 99.

3. When N = 0 in the examples in 2 above, the cut-off value is an integer that exceeds the first measured
		data.
Example: First sample measured data: 100.1 → 101.
4. When there are multiple measured data identical to the Nth sample, they may not follow the specifications
		

listed in 2 and 3 above.
Example: There are 29 samples with measured data of 200 and 71 samples with measured data of
100, for a total of 100 samples. Calculating the cut-off value at a positive rate of 30% results in a
cut-off value of 99.
However, if recalculated with a cut-off value of 99, the positive rate will be 100%.

Testee mode: N = Positive rate ÷ Number of all testees × 100(N = number of testees that should be positive)

Explanatory note:

1. Decimal points are rounded down for the number of testees.
2. For cut-off values, the measured data of the Nth testee becomes an integer shown when less than the		number (an integer between 0 and 9,999,999).
Example 1: Nth testee measured data: 100.1 → 100.
Example 2: Nth testee measured data: 100 → 99.

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3.3.7

Outputting positive sample data

Output positive sample data specified on the “list of positive samples” to the selected output
destination.
･ Printing positive sample data
･ Saving positive sample data to external media･ Outputting positive sample data to a host computer online
This section describes the procedure from the [Positive data] screen.
Page 130 “3.3.1 Displaying the positive sample list”
Explanatory note1

through5: If an error has occurred in communicating the measurement results, “Online” cannot be selected inthe [Output destination selection] dialog box.

Explanatory note

: When there is both 15-times dilution and 250-times dilution measured data, a qualitative
assessment is performed.
If testing was stopped for either 15-times dilution or 250-times dilution, or if the measured data foreither was deleted by the operator, a qualitative assessment is not performed.

Explanatory note

: When outputting time code course data, set “Time course to Ext. media” to YES in [Settings] [System settings] - [Output settings].

1

Select the display mode for positive samples (bysample/testee).
Touch the {Sample} or {Testee} buttons.

2Touch the {Output} button.

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3

Output the positive sample data.
① Select the output destination.
○ Printer○ Ext. media (External media)○ Online② Touch the {Start} button.

				
1

2

* Specified positive sample data is output to theselected output destination.
* When output has completed, the system returns to
the [Positive data] screen.

Explanatory note

{Cancel}:Cancel output, and return to the [Positive data]		screen.

: When “Ext. media” has been selected for the output destination and no external media isconnected, “Not connected with external media.” is displayed. Connect the external media andtouch the {Retry} button.

Explanatory note: If the external media runs out of space during output, “There is not enough space on the external
media. Replace it with new media.” is displayed. Replace with new media and touch the {Retry}button. Resume data output.

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3.3.8

Deleting positive sample data

Delete positive sample data for the selected measurement date and time.
This section describes the procedure from the [Positive data] screen.
		Page 130 “3.3.1 Displaying the positive sample list”

1

1

through5

Select the display mode for positive samples (bysample/testee).
Touch the {Sample} or {Testee} buttons.

2

Specify the measurement date and time range(start point/end point) of the data to delete.
(It is not necessary to specify the range whendeleting all data.)
Page 136 “3.3.3 Specifying positive
sample data by range” 2

Explanatory note: If a range is not specified, all positive samples displayed on the [Positive data] screen will be deleted.

3

Touch the {Del} button.

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4

Confirm the specified date and time, and touchthe {OK} button.

{OK}:

Delete data for the specified date and time.

{Close}:The dialog box closes.

5

Positive sample data for the specified date andtime was deleted.
To update positive sample data:① Touch the {Continue} button.
② Touch the {Register} button in the dialog box.

1

2

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List of Error Samples
Display a list of error samples.
Error samples displayed in the list can be sorted, searched, output, and deleted.

3.4.1

Displaying the list of error samples
1

Touch the tab of the measured data to display.

{Samp} tab				 {STAT samp} tab

23Specify the measurement date and time.
		Page 136 “3.1.3 Specifying measured data			by measurement date and time” 2 Specify			

the range.

		Page 106 “3.1.4 Specifying measured data			by range” 2Touch the {Test data} button.

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4

List of Error Samples

Touch the {Err sample} button.
* The list of error samples is displayed.

Content displayed on the [Err sample] screen
Display

Details

RemarkDate

Date and time sample was measured

RACK

Rack No. - Position number in rack

SEQ.

Group No. - Sequence No.

Data [ng/mL] or [ug/g]

Measurement results

Flag-, +, 1 +, 2 +, 3 +Error information (excluding reading errors)

Comment

UR: Under range

Blank output for measured
data and judgment result

OR: Over range

Output only judgment
result

PRC: Prozone

Output only judgment
resultSample ID

Barcode information on sampling bottles

CC

Calibration curve used to calculate measured
data (CC No.)
Dilution information

Dil

Explanatory noteSpace

: No dilution(test mode, remeasure mode)A: No dilution(Retest mode)

A15: 15-times dilution(Dilution test mode)

A250: 250-times dilution(Dilution test mode): During a dilute test, if no dilution and 15-times dilution are both tested, the final result row isdisplayed in blue text.

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List of Error Samples

3.4.2

Sorting error sample data

Error samples specified from measured data can be sorted by measurement date and time, and bygroup.
When sorting by measurement date and time, error samples are displayed in ascending order by“date.”
When sorting by group, error samples are displayed in ascending order by “sample number group.”This section describes the procedure from the [Err sample] screen.
		Page 150 “3.4.1 Displaying the list of error samples”

1through4

Explanatory note: If a range is not specified, all error samples displayed on the [Err sample] screen will be sorted.

Explanatory note

: The range of error samples can also be specified using the {Select-s} button on the [Err sample]
screen.
The method is the same as on page 154 “3.4.3 Specifying error sample data by range.”

1

Touch the {Sort} button.

2

Touch the {Date sort} button or the {Group sort}button.
* Sorted results are displayed.

{Date sort}:

Sort measured data in ascending order by		measurement date and time.

{Group Sort}: Sort measured data in ascending order by		sample number group.

{Cancel}:The dialog box closes.

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3

List of Error Samples

Register the sorted results.

① Touch the {Continue} button.
		② Touch the {Register} button.
		* Sorted results were registered.
* The system returns to the [Process data] screen.

{Register}:* Sorted data is registered.

{Close}:Cancel registration, and return to the [Process		data] screen.

{Cancel}:The dialog box closes.

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List of Error Samples

3.4.3

Specifying error sample data by range

Touch the measurement date and time on the [Err sample] screen or operate the cursor buttons to
specify positive sample data by range of measurement date and time (start point/end point).
Specify the start point and touch the {Select-s} button to confirm the error sample data at the startpoint.
Specify the end point and touch the {Select} button to confirm the error sample data at the end
point.
After the start and end points are confirmed, the error sample data between the start and end points
is specified.
This section describes the procedure from the [Err sample] screen.
		Page 150 “3.4.1 Displaying the list of error samples”

11

through

5

Specify the error sample data at the start point.
① Touch the date and time that will be the start point.

1② Touch the {Select-s} button.
* The data at the start point was confirmed.
(The text in the row of the specified date andtime turns blue.)* When the start point is confirmed, the {Select-s}
button changes to the {Select} button.

2

2

Specify the error sample data at the end point.
① Touch the data row that will be the end point.

1(The text in the row of the specified range
turns blue.)② Touch the {Select} button.
* The data for the specified range is displayed.
* When the end point is confirmed, the {Select}button changes to the {Clear} button.

2{Select-s}:

Confirm start point data for the specified range.

{Select}:

Confirm end point data for the specified range.

{Clear}:Clear the specified range.

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Explanatory note

List of Error Samples: If the data specified for the start and end points is the same, the system will handle it as though onlya single sample of data was specified.

Explanatory note

: To specify a new range of data, touch the {Clear} button.
All data is displayed, and the system returns to the state it was in before the range was specified.

3

Error sample data was specified.

		To clear the specified range, touch the {Clear}button.

4

Register the error sample data.

① Touch the {Continue} button.
		② Touch the {Register} button.
		* Specified data was registered.

{Register}: Specified data is registered.
{Close}:Cancel registration, and return to the [Process		data] screen.

{Cancel}:The dialog box closes.

		Touch the {Clear} button to specify a new range.

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List of Error Samples

3.4.4

Searching error sample data

Search error samples based on sample ID, sample number, rack number, and measurement date andtime.
This section describes the procedure from when the [Err sample] screen is displayed.
		Page 150 “3.4.1 Displaying the list of error samples”

1through5

Explanatory note: If a range is not specified, all error samples displayed on the [Err sample] screen will be searched.

Explanatory note

: Measured data cannot be searched for using the rack position number.

Explanatory note

: The range of error sample data can also be specified using the {Select-s} button on the [Err sample]
screen.
The method is the same as on page 154 “3.4.3 Specifying error sample data by range.”

Explanatory note

: Sort error sample data using the {Sort} button on the [Err sample] screen.
The method is the same as on page 152 “3.4.2 Sorting error sample data.”

1

Touch the {Search} button.

		2

Select the type of keyword to search.
□ Sample ID□ Sample No.
□ Rack No.
□ Date31Enter a keyword.
   ① Touch the “input field” next to the name of			2

the keyword.

② Enter a keyword using the keypad.
③ Touch the {enter} key.

3{A/a}:

Switch input between uppercase and lowercase.

{Sign}:

Allows for input of symbols.

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Explanatory note

List of Error Samples: Entry of the group number and measurement date and time can be omitted. However, if ameasurement date and time box is checked, it is necessary to input at least one of the following: year,
month, date, hour, and minute.

Explanatory note

: The measured data specified on the [Test data] screen will be searched.

Explanatory note

: The {A/a} and {Sign} buttons areavailable when the cursor is in the
input field.

4

Touch the {Continue} button.

			

5Touch the {Start} button.
* Searching begins.
* Search results are displayed.

6

Register the search results.
①

Touch the {Continue} button.

②

Touch the {Register} button in the dialog box.

{Register}:

Search data is registered.

{Close}:Cancel registration, and return to the [Process		data] screen.

{Cancel}:The dialog box closes.

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List of Error Samples

3.4.5

Outputting error sample data

Output error sample data specified on the “list of error samples” to the selected output destination.
・ Printing error sample data
・ Saving error sample data to external media
・ Outputting error sample data to a host computer online

This section describes the procedure from when the [Err sample] screen is displayed.
		
Explanatory note

Page 150 “3.4.1 Displaying the list of error samples”

1through5: If an error has occurred in communicating the measurement results, “Online” cannot be
selected in the [Output destination selection] dialog.

Explanatory note

: When there is both 15-times dilution and 250-times dilution measured data, a qualitative
assessment is performed.
If testing was stopped for either 15-times dilution or 250-times dilution, or if the measured
data for either was deleted by the operator, a qualitative assessment is not performed.

1

Touch the {Output} button.

		2

Output the error sample data.
① Select the output destination.

○ Printer○ Ext. media (External media)○ Online② Touch the {Start} button.
1

2

				

{Start}:Data is output.

{Cancel}:The dialog box closes.

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List of Error Samples

Error sample data is output to the selected output
destination.

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List of Error Samples

3.4.6

Deleting error sample data

Delete error sample data for the specified measurement date and time.
This section describes the procedure from the [Err sample] screen.
		Page 150 “3.4.1 Displaying the list of error samples”

11

through

5

Specify the data to delete using a measurement
date and time range (start point/end point). (It is
not necessary to specify the range when deleting
all data displayed on the screen.)
Page 154 “3.4.3 Specifying error sample
data by range” 2

2

Touch the {Del} button.

3

Confirm the specified date and time, and touchthe {OK} button.

Explanatory note

{OK}:

Data for the specified date and time is deleted.

{Close}:The dialog box closes.

: If a range is not specified, all samples displayed on the [Err sample] screen will be deleted.

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4

List of Error Samples

The error sample data for the specified date andtime was deleted.

To update error sample data:
1①

Touch the {Continue} button.

②

Touch the {Register} button in the dialog box.

2

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Histogram
Display a histogram for the specified measured data.
Histograms can be output to the selected output destination and their ranges can be changed.

3.5.1

Displaying histograms

Display a histogram for the specified measured data.

1 		 Touch the tab of the measured data to display.
{Samp} tab{STAT samp} tab
{STD}
{QC}

2

Specify the measured data by date and time or
range.
<Specifying by measurement date and time>
Touch the {Date} button, and specify themeasurement date.

		Page 104 “3.1.3 Specifying measured databy measurement date and time” 2<Specifying by range>
Touch the {Select-s} button, and specify themeasurement date range.

		Page 106 “3.1.4 Specifying measured databy range” 2

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Histogram

Explanatory note

: Measured data calculated in the test or remeasure modes will be displayed on the histogram.

Explanatory note

: A histogram for all data will be displayed if no range is specified.

3

Touch the {Test data} button.

4

Specify the measured data by range of1

measurement date and time.
① Touch the measurement date and time at the startpoint (the cursor buttons at the bottom right of thescreen can be used to select this).
2② Touch the {Select-s} button.
* The text in the row of the specified date and timeturns blue (start point).
* The {Select-s} button changes to the {Select}button.

③ Touch the measurement date and time at the end
point (the cursor buttons at the bottom right of thescreen can be used to select this).
④ Touch the {Select} button.

3* The text in the row of the specified range turns blue

4

(end point).

{Select-s}:

Confirm start point data for the specified range.

{Select}:

Confirm end point data for the specified range.

{Clear}:Clear the specified range.

5

Touch the {Histogram} tab.

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Histogram

6 The histogram was displayed.

{Close}:Explanatory note

Return to the [Test data] screen.

: The “ ▼ ” symbol displayed on the histogram can be moved with the cursor buttons.
The cursor’s numeric information is displayed in ★ .
The meaning of the display is as shown in a, b, and c below.

#.# - #.#↑a↑b

# samplea:Measured data minimum

↑
c

b

:

Measured data maximumc:Number of samples within the range between the measured		data maximum and minimum

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Histogram

MEMO

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Histogram

3.5.2

Changing the histogram range

Input “Max sample,” “Min Conc.,” “Max Conc.,” or “Class” to modify the histogram range.
This section describes the procedure from the [Histogram] screen.
		Page 162 “3.5.1 Displaying histograms”

1through5

Explanatory note

: Measured data calculated in the test or remeasure modes will be displayed on the histogram.

Explanatory note

: All data will be subject to range modification if no range is specified.

1

Modify the range.
① Touch the {Range change} button.

1② Touch the input field for the condition to change.

2・ Max sample

2・ Min Conc.
・ Max Conc.
・ Class22③ Modify the setting with the numeric keypad.

3

Setting

Input Range

Max sample

0 - 9,999

Min Conc.

0 - 999,999,999.9

Max Conc.

0 - 999,999,999.9

Class

1 - 99Explanatory note

: “Class” is the number of segments the histogram is divided into

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2

Touch the {Continue} button.

3

Touch the {Start} button.

Histogram			 * The histogram is displayed again.

Explanatory note

{Start}:Modify the range.

{Close}:Cancel range modification, and return to the		[Histogram] screen.

{Cancel}:The dialog box closes.

: Range modification is not saved to the hard disk(SSD).

4

Touch the {Close} button.

			* The system returns to the [Test data] screen.

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3.5.3

Outputting histograms

Output histograms (data) to external media or a printer.
・ Printing histograms
・ Saving histograms to external media
This section describes the procedure from the [Histogram] screen.
		Page 162 “3.5.1 Displaying histograms”

1through5

1

Touch the {Output} button.

2

Output the measured data.
① Select the output destination.
○ Printer○ Ext. media (External media)

1

2② Touch the {Start} button.

* The histogram is output.
* When output has completed, the system
returns to the [Histogram] screen.

{Start}:

The histogram is output.

{Cancel}:The dialog box closes.

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MEMO

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Positive Rate Change
Display the positive rate change of measured data.
Modify maximum/minimum positive rates, or output positive rate changes to external media or a printer.

Explanatory note

: The system can store up to ten years of positive rate changes. A single year’s worth of data
can be displayed at once.

3.6.1

Displaying positive rate changes

Two display modes are available: sample mode and testee mode.
		Explanatory note

Page 130 “3.3.1 Displaying the positive sample list”: This applies to samples that were measured in test or remeasure mode and found to be“positive.”

1

Touch the tab of the measured data to display.
{Samp} tab{STAT samp} tab		

2Specify the measured data by date and time or
range.
<Specifying by measurement date and time>
Touch the {Date} button, and specify themeasurement date.
Page 104 “3.1.3 Specifying measured data by		measurement date and time” 2<Specifying by range>
Touch the {Select-s} button, and specify themeasurement date range.
Page 106 “3.1.4 Specifying measured data by
		 range” 2

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3

Positive Rate Change

Touch the {Pos. rate} button.

			

Explanatory note

: Selecting “Testee” displays the values forthe number of positive testees/number of
all testees.

4

The positive rate change graph was displayed.

{Output}:

Output positive rate changes to the selected
location.

{Range change}: Change the maximum/minimum positive
rates.

Explanatory note

[MENU]:

Return to the [MENU] screen.

{Close}:Return to the [Process data] screen.

: The “ ▼ ” symbol displayed on the positive rate change graph can be moved with the cursor buttons.
The cursor’s numeric information is displayed in ★ (a through d). (Refer to the following diagram.)

Explanatory note

: The cursor’s numeric information is managed in units of measurement date. If the date is changed
during testing, the data that was output after the date changed is managed separately from the datafrom the previous date.

Positive rate change graph

★

a：

a

b
c

← Cursor buttonsdMeasurement dates, positive rates, numbers of positive samples, and all samples (sample mode)
Measurement dates, positive rates, number of positive testees, number of all testees (testee mode)b：

Positive rates for all samples (positive rates for all data displayed)c：

Button to switch between sample mode and testee moded：Calculation condition settings for {Date settings} button positive rates

		Page 172 “3.6.2 Configuring calculation conditions for positive rates”

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3.6.2

Configuring calculation conditions for positive rates

Configure the measurement start date, measurement close date, and positive rate calculation unit
(day, week, month), then calculate the positive rate. Positive rate changes can also be displayed bygroup number of the sample number (if “All” is selected for group selection, positive rate changes
are displayed for all data).
This section describes the procedure from the [Positive rate change] screen.
		Explanatory note

Page 170 “3.6.1 Displaying positive rate changes”: The range from the start date until the close date may be a maximum of one year long. Touchthe input field to enter a date.

1

Select the display mode for positive samples (bysample/testee).
Touch the {Sample} or {Testee} buttons.

			2Touch the {Date settings} button.

3

Configure the calculation conditions.

1① Enter a start date (year/month/day).

2② Enter a close date (year/month/day).

3③ Select a calculation unit (day/week/month).

4④ To display by group number, select a number (“*”
displays the positive rate changes for samples forwhich a group has not been specified).

		

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4

Positive Rate Change

Touch the {Continue} button.

			

5Touch the {Register} button.
			 * The positive rates are calculated.

Explanatory note

{Start}:Calculate positive rates.

{Close}:Cancel calculation, and return to the [Positive		rate change] screen.

{Cancel}:The dialog box closes.

: For “Week,” seven consecutive days’ worth of positive rates will be calculated.

6

Touch the {Close} button.
			 * The system returns to the [Process data] screen.

[MENU]:

Return to the [MENU] screen.

<Month calculation example>
Start date is December 29, 2012, close date is February 15, 2013→

Calculate “December positive rate” using data measured from December 29 until December 31,
2012→

Calculate “January positive rate” using data measured in January 2013→

Calculate “February positive rate” using data measured from February 1 until February 15, 2013
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3.6.3

Changing the range of positive rate changeEnter the “Max Value” and “Min Value,” then change the range of positive rate change.
This section describes the procedure from the [Positive rate change] screen.
Page 170 “3.6.1 Displaying positive rate changes”

		Explanatory note

: This applies to samples that were measured in test or remeasure mode and found to be“positive.”

1

Touch the {Range change} button.

2

Change the positive rate.

1① Touch the [Max Value] field.
② Enter numbers using the numeric keypad.
③ Touch the {enter} key.

4

④ Touch the [Min Value] field.
⑤ Enter numbers using the numeric keypad.
32⑥ Touch the {enter} key.

6

5

3

Touch the {Continue} button.

				

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4

Positive Rate Change

Touch the {Start} button.

						 * The positive rate change is displayed again.

{Start}:Calculate positive rates.

{Close}:Cancel calculation, and return to the [Positive		rate change] screen.

{Cancel}:The dialog box closes.

5

Touch the {Close} button.
			 * The system returns to the [Measured data select]			

screen.

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3.6.4

Outputting positive rate changes

Output positive rate changes to external media or a printer.
・ Printing positive rate changes
・ Saving positive rate changes to external media
This section describes the procedure from the [Positive rate change] screen.
		Explanatory note

Page 170 “3.6.1 Displaying positive rate changes”: This applies to samples that were measured in test or remeasure mode and found to be“positive.”1

Select the display mode for positive samples (byTotal/Testee).
Touch the {Total} or {Testee} buttons.

2Touch the {Output} button.

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3

Positive Rate Change

Output positive rate changes.
① Select the output destination.
○ Printer○ Ext. media (External media)② Touch the {Start} button.

1

2

		

* Positive rate changes are output.

		* When output has completed, the system returns to the		[Positive rate change] screen.

{Start}:Output positive rate changes.

{Cancel}:The dialog box closes.

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Replicate
Display the replicate data of the measured data specified on the [Test data] screen.

3.7.1

Displaying the replicate list (samples/STAT samples)

Display the replicate data for samples and STAT samples.

Explanatory note

: All data will be displayed if no range is specified.

1

Touch the tab of the measured data to display.
{Samp} tab{STAT samp} tab		

2Specify the measured data by date and time or
range.
<Specifying by measurement date and time>
Touch the {Date} button, and specify themeasurement date.
Page 104 “3.1.3 Specifying measured data bymeasurement date and time” 2<Specifying by range>
Touch the {Select-s} button, and specify themeasurement date range.
Page 106 “3.1.4 Specifying measured data by
range” 2178
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Replicate3

Touch the {Test data} button.

4

Specify the measured data by range of1

measurement date and time.
① Touch the measurement date and time at the startpoint (the cursor buttons at the bottom right of thescreen can also be used to select this).
② Touch the {Select-s} button.

2* The text in the row of the specified date and timeturns blue (start point).
* The {Select-s} button changes to the {Select}button.

③ Touch the measurement date and time at the end
point (the cursor buttons at the bottom right of thescreen can also be used to select this).

④ 【Touch the {Select} button.

3* The text in the row of the specified range turns blue
(end point).
4{Select-s}:

Confirm start point data for the specified range.

{Select}:

Confirm end point data for the specified range.

{Clear}:Clear the specified range.

5

Touch the {Replicate} tab.

* The replicate list is displayed.
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Replicate6

The replicate list (samples/STAT samples) was
displayed.

{CC }:

Edit and recalculate the calibration curve of the specified replicate data.

		Page 197 “3.7.9 Editing/recalculating calibration curves”{Time course} : Display time course data.
		Page 204 “3.7.12 Displaying/printing time courses			(samples/STAT samples)”{Recal} :Recalculate replicate data using modified cut-off values, as well as factors
A and B.
Page 194 “3.7.8 Recalculating replicate data”

		{Search} :Search samples based on sample ID, sample number, rack number,and measurement date and time.

		Page 192 “3.7.7 Searching replicate data”

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ReplicateContent displayed on the [Replicate] screen
Display

Details

RemarkDate

Date and time sample was measured

RACK

Rack No. - Position number in rack.

SEQ.

Group No. - Sequence No.

Data [ng/mL] or [ug/g]

Measurement results(concentration value)Flag-, +, 1 +, 2 +, 3 +Error information (excluding reading errors)UR: Under range

Blank output formeasured data andjudgment result(displayed during dilute
test)

OR

: Over range

Output only judgment
result

PRC: Prozone

Output only judgment
resultComment

Sample ID

Barcode information on sampling bottles

CC

Calibration curve used to calculate measured
data (CC No.)
Dilution information

Dil

Explanatory noteSpace

: No dilution(test mode, remeasure mode)A: No dilution(Retest mode)

A15: 15-times dilution(Dilution test mode)

A250: 250-times dilution(Dilution test mode): During a dilute test, if no dilution and 15-times dilution are both tested, the final result row isdisplayed in blue text.

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Replicate

3.7.2

Displaying the [Replicate (STD)] screen

Display STD replicate data.

1

Touch the {STD} tab.

				

2

Touch the {CC#} tab.

3

Data for each selected calibration curve (CC#)
was displayed.

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ReplicateContent displayed on the [Replicate (STD)] screen
Display

Details

Date

Date and time STD was measured

RACK

Rack No. - Position number in rack

DA1

Amount of change for ABS (A#)
A3-A1

DA2

Amount of change for ABS (A#)
A2-A1

DA1comment

Comment for DA1

DA2comment

Comment for DA2{Save data}:“Appendix: 1.3 DA
value calculation”

Page 184 “3.7.3 Saving replicate data (STD) to external media”

Edit and recalculate the calibration curve of the specified replicate data.

				{Time course}:

Page 350

Save replicate data to external media.

				{CC}:		

RemarkPage 197 “3.7.9 Editing/recalculating calibration curves”

Display the [Time course data] screen.

				Page 205 “3.7.13 Displaying/printing time courses (STD)”				Page 208 “3.7.15 Changing the range of the time course (STD)”{Close}: 		

Return to the [Measured data select] screen.

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Replicate

3.7.3

Saving replicate data (STD) to external media

Open the [Replicate (STD)] screen, then save the replicate data displayed on the screen to external
media.

1

Touch the {STD} tab.

				

2

Touch the {Save data} button.
			 * STD replicate data is saved to external media.

Explanatory note: If no external media is connected, “Not connected with external media.” is displayed.
Connect the external media and touch the {Retry} button.

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MEMO

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Replicate

3.7.4

Displaying the [Replicate (QC)] screen

Display QC replicate data.
Explanatory note

: All data will be displayed on the screen if no range is specified.

1

Touch the {QC} tab.

				

2

Specify the measured data by date and time or
range.
<Specifying by measurement date and time>
Touch the {Date} button, and specify themeasurement date.

		Page 104 “3.1.3 Specifying measured databy measurement date and time” 2<Specifying by range>
Touch the {Select-s} button, and specify themeasurement date range.

		Page 106 “3.1.4 Specifying measured databy range” 2

3

Touch the {Test data} button.

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Replicate

4

Touch the {Replicate} tab.

5

The [Replicate (QC)] screen was displayed.

			* Test items and QC IDs are displayed.

Content displayed on the [Replicate (QC)] screen
Display

Details

Date

Date and time STD was measured

RACK

Rack No. - Position number in rack

QC No.

QC sample number

QC LOT

QC sample lot number

Seq.

QC sample sequential number

Data [ng/mL] or [ug/g]

QC sample measured data

Comment

QC IDs and barcode reading errors

CC

Calibration curve numbers (numbers 1
through 6){CC}:

Edit and recalculate the calibration curve of the specified replicate data.

			{Time course}:

Page 197 “3.7.9 Editing/recalculating calibration curves (samples/STAT samples)”Display time course data.

			{Recal}:RemarkPage 204 “3.7.12 Displaying/printing time courses (samples/STAT samples)”Recalculate replicate data using modified cut-off values, as well as factors A and B.

			Page 194 “3.7.8 Recalculating replicate data”{Search}:Search samples based on sample ID, sample number, rack number, and measurement date and

		

time.

			

Page 192 “3.7.7 Searching replicate data”
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Replicate

3.7.5

Sorting replicate data (samples/STAT samples)

Sort sample and STAT sample replicate data by measurement date and time or by group, and narrow
down measured data to process.
When sorting by measurement date and time, replicate data is displayed in ascending order by “date.”
When sorting by group, replicate data is displayed in ascending order by “sample number group.”This section describes the procedure from the [Replicate] screen.
Page 178 “3.7.1 Displaying the replicate list (samples/STAT samples)”1

through5

Explanatory note: If a range is not specified, all samples displayed on the [Replicate] screen will be sorted.

Explanatory note

: The range of samples can also be specified using the {Select-s} button on the [Replicate]screen.

The method is the same as on page 190 “3.7.6 Specifying replicate data by range.
1

Touch the {Sort} button.

2

Touch the {Date sort} button or the {Group sort}button.

{Date sort}:

Sort measured data in ascending order by		measurement date and time.

{Group Sort}: Sort measured data in ascending order by		sample number group.

{Cancel}:The dialog box closes.

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3

Replicate

Replicate data was sorted.

				

4

Touch the {Continue} button.

5

Touch the {Register} button.

{Register}:

Register sorted replicate data.

{Close}:Cancel sorting, and return to the [Measured		data select] screen.

{Cancel}:The dialog box closes.

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3.7.6 Specifying replicate data by range
Touch the measurement date and time on the [Replicate] screen or operate the cursor buttons to
specify replicate data by range of measurement date and time (start and end points).
Specify the start point and touch the {Select-s} button to confirm the replicate data at the start point.
Specify the end point and touch the {Select} button to confirm the replicate data at the end point.
After the start and end points are confirmed, the replicate data between the start and end points is
specified.
This section describes the procedure from the [Replicate] screen.
Page 178 “3.7.1 Displaying the replicate list (samples/STAT samples)”1

1through

5

Specify replicate data at the start point.
① Touch the date and time that will be the start point.

1② Touch the {Select-s} button.
* Data at the start point is confirmed (the text in therow of the specified date and time turns blue).
* When the start point is confirmed, the {Select-s}

2

button changes to the {Select} button.

2

Specify replicate data at the end point.
① Touch the date and time that will be the end point.
* The text in the row of the specified range turns
blue.

1

② Touch the {Select} button.
* The data for the specified range is displayed.

2* When the end point is confirmed, the {Select}button changes to the {Clear} button.

{Select-s}:

Confirm start point data for the specified range.

{Select}:

Confirm end point data for the specified range.

{Clear}:Clear the specified range.

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Explanatory note

Replicate: If the replicate data selected for the start and end points is the same, the system will handle itas though only a single sample of replicate data was specified.

Explanatory note

: To specify a new range of replicate data, touch the {Clear} button.
All replicate data is displayed, and the system returns to the state it was in before the range
was specified.

3

Replicate data was specified.
* The specified replicate data is displayed.

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Replicate

3.7.7

Searching replicate data

Search replicate data based on sample ID, sample number, rack number, and measurement date andtime.
This section describes the procedure from the [Replicate] screen.
Page 178 “3.7.1 Displaying the replicate list (samples/STAT samples)” 1 through 5
Explanatory note: If a range is not specified, all error samples will be searched.
Replicate data cannot be searched for using the rack position number.

Explanatory note

: The range of replicate data can also be specified using the {Select-s} button on the [Replicate]screen.

The method is the same as on page 190 “3.7.6 Specifying replicate data by range.”
Explanatory note

: The replicate data can also be sorted using the {Sort} button on the [Replicate] screen.

The method is the same as on page 188 “3.7.5 Sorting replicate data (samples/STAT
samples).”

1

Touch the {Search} button.

2

Select the type of keyword to search.
□ Sample ID□ Sample No.
□ Rack No.
□ Date31Enter a keyword.
① Touch the “input field” next to the name of the		2

keyword.

② Enter a keyword using the keypad.
③ Touch the {enter} key.

3{A/a}:

Switch input between uppercase and lowercase.

{Sign}:

Allows for input of symbols.

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Explanatory note

Replicate: Entry of the group number and measurement date and time can be omitted. However, if ameasurement date and time box is checked, it is necessary to input at least one of thefollowing: year, month, date, hour, and minute.

Explanatory note

: The search range is the range specified on the [Test data] screen.

Explanatory note

: The {A/a} and {Sign} buttons areavailable when the cursor is in the
input field.

4

Touch the {Continue} button.

5

Touch the {Start} button* Searching begins.
* Search results are displayed.

6

Register the search results.
① Touch the {Continue} button.
② Touch the {Register} button in the dialog box.

		

1

2

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3.7.8

Recalculating replicate data

Recalculate replicate data using modified cut-off values, as well as factors A and B.
Edited calibration curves can also be used for recalculation.
This section describes the procedure from the [Replicate] screen.
Page 178 “3.7.1 Displaying the replicate list (samples/STAT samples)”Explanatory note1

through5: ･The values used for judging replicates for which a range has been specified are shown in Cut
off 1, Cut off 2, and Cut off 3.
･If the cut-off value differs according to the measured data, “0” will be displayed for Cut off 1,
Cut off 2, and Cut off 3.

Explanatory note: If the factor value differs according to the replicate data, factor A and factor B are displayed as
1.00 and 0.00, respectively.

Explanatory note

: Values configured in the [Recalculation condition settings] screen are not applied to protocol
settings.

Explanatory note: If the {Memory} button on the [Check CC] screen is touched before touching the {Recal}
button, recalculation will be performed using the calibration curve in memory.

Example 1:{Recal} run on CC1 and CC2 after saving with {Memory}→

Data that references CC1 and CC2 is fit to the calibration curve in memory, thenrecalculation is performed.

→

Data that does not reference CC1 and CC2 is not fit to the calibration curve, thencorrective calculation (factor A/factor B/dilution ratio calculation) is performed.

Example 2:{Recal} run after saving CC2 to CC1 with {Memory}→

Data that references CC1 is fit to the calibration curve in memory, then recalculation is
performed.

→

Data that does not reference CC1 is not fit to the calibration curve in memory, thencorrective calibration (factor A/factor B/dilution ratio calculation) is performed.

Example 3:{Recal} is run without saving using {Memory} on the [Check CC] screen→

Cut-off, factor A, and factor B recalculation is performed, then calibration curve fitting
calculation is not performed.

Explanatory note

: Recalculation results are applied to measured data, positive sample data, error sample data,and histograms.
After registering recalculation results, they are also applied to values on the [Positive change]
screen.

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Explanatory note

Replicate: If a range is not specified, all replicate data displayed on the [Replicate] screen will berecalculated.

Explanatory note

: The range of replicate data can also be specified using the {Select-s} button on the [Replicate]screen.
The method is the same as on page 190 “3.7.6 Specifying replicate data by range.”

1

Explanatory note

Touch the {Recal} button.

: If recalculating using an edited calibration curve, first save the edited calibration curve tomemory prior to recalculation.

Page 197 “3.7.9 Editing/recalculating calibration curves”

7

through82

Configure the recalculation conditions.
① Touch the “input field” next to the setting.

1② Enter numbers using the numeric keypad.

・ Cut off 1
・ Cut off 2

2・ Cut off 3
・ FACTOR A
・ FACTOR B{Cancel}:Cancel recalculation, and return to the		[Replicate] screen.

Setting

Input Range

Cut off 1

0 - 9,999,999

Cut off 1

0 to 9,999,999; * (input omitted)

Cut off 3

0 to 9,999,999; * (input omitted)

FACTOR A

0.001 - 99,999.999

FACTOR B-999.99 - 999.99
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Replicate3

Touch the {Recal} button.
* Recalculation performed with the conditions thatwere input.

Explanatory note: If the calibration curve was not saved to memory (if the {Memory} button was not touched),
recalculation is performed with cut-off, factor A, and factor B, then calibration curve fitting
calculation is not performed.

4

Touch the {Continue} button.

5

Touch the {Register} button.

{Register}:

Register the recalculation results.

{Close}:Cancel registration, and return to the [Replicate]		screen.

{Cancel}:The dialog box closes.

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Replicate

3.7.9 Editing/recalculating calibration curves (samples/STAT samples)
Edit the origin and DA values of the calibration curve, then recalculate or save the recalculated
calibration curve to memory.
Calibration curves displayed on the screen can also be (memory) saved to other calibration curves(CC numbers), and calibration curve fitting calculation can be redone.
This section describes the procedure from the [Replicate] screen.
Page 178 “3.7.1 Displaying the replicate list (samples/STAT samples)”Explanatory note1

through3: The following DA values can be input through calibration curve editing.
STD-1 through STD-5: DA1
STD-6: DA1, DA2

Explanatory note

: DA-2 of STD-6 is used for the PRC check.
Page 352 “Appendix: 1.5 Prozone Check”

		Explanatory note: If a range is not specified, all replicate data displayed on the [Replicate] screen will berecalculated.

Explanatory note

: The range of replicate data can also be specified using the {Select-s} button on the [Replicate]screen.
The method is the same as on page 190 “3.7.6 Specifying replicate data by range”

1

Display the calibration curve.
		① Touch the row of the applicable data.

1		② Touch the {CC} button.
* The calibration curve of the specified
replicate data is displayed.

2

2

Touch the {CC info} button.

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Replicate3

Edit the data.
① Touch the input field for the item to edit.

1② Enter a value.

Explanatory note

: The following items can be input
through calibration curve editing.

2

STD-1 - STD-5 : DA1
STD-6 : DA1, DA2

4

Touch the {Recal} button.
* The result of recalculating the calibration
curve and QC is displayed.

5

Touch the {Continue} button.

6

Touch the {Memory} button.
* The calibration curve data is saved tomemory (it is not registered to the system).

{Memory}:

Save calibration curve data to memory.

{Close}:Cancel saving to memory, and return to the		[Replicate] screen.

{Cancel}:The dialog box closes.

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7

Touch the {Continue} button.

8

Touch the {Register} button.

Replicate{Register}:

Register the recalculation results.

{Close}:Cancel registration, and return to the [Replicate]		screen.

{Cancel}:The dialog box closes.

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Replicate

3.7.10

Editing/recalculating calibration curves (STD)

Edit the origin and DA values of the calibration curve, then recalculate or save the recalculated
calibration curve to the hard disk(SSD).

1

Touch the {STD} tab.

				

2
1

Select the calibration curve.
① Touch the {CC#} tab.

2

② Select the measurement date and time.
③ Touch the {CC} button.
* The calibration curve is displayed.
3

3

Touch the {CC info} button.

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4

Replicate

Edit the calibration curve.
① Touch the input field for the item to edit.

1② Enter a value.

		Explanatory note

: The following items can be input
through calibration curve editing.

2

STD-1 - STD-5 : DA1
STD-6 : DA1, DA2		
5Touch the {Recal} button.
* The result of recalculating the calibration
curve is displayed.

6

Touch the {Continue} button.

7

Touch the {Register} button.
		* The calibration curve was registered.

{Register}:

Register the calibration curve data.

{Close}:Cancel registration, and return to the [Replicate

		(STD)] screen.

{Cancel}:The dialog box closes.

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3.7.11

Reading/registering calibration curves (samples/STAT samples)

Read calibration curves and display them on the screen, or register displayed calibration curves toother calibration curves (calibration curves are registered to the hard disk(SSD)).
This section describes the procedure from the [Check CC] screen.
Page 197 “3.7.9 Editing/recalculating calibration curves (samples/STAT samples)”1

1

Read the calibration curve.
(Calibration curve CC1 is displayed.)① Touch the {CC1} ~ {CC6} buttons.

			 F-Hb ： CC1 ～ CC3
			 FCa ： CC4 ～ CC6

1		② Select the calibration curve (CC2 through CC3).
③ Check “Reading.”④ Touch the {Start} button.
		 * The calibration curve is read.

2
3
4{Cancel}:The dialog box closes.

Explanatory note

: “Reading” causes the specified
calibration curve to be read anddisplayed on the screen.

Explanatory note: If the reagent lot of the displayedcalibration curve differs from that of thecalibration curve selected for reading,the calibration curve is not read.

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2

Replicate

Register the calibration curve shown on thescreen.
① Touch the {CC1} ~ {CC6} buttons.

		

		

1

② Select the calibration curve of the registration
		destination.
③ Check “Register.”④ Touch the {Start} button.
		 * The calibration curve is registered to the hard		

disk(SSD).

{Cancel}:The dialog box closes.

2
3
4

3

Touch the {Continue} button.

{Print}:4

Print the calibration curve.

Touch the {Memory} button.

			* The system returns to the [Replicate] screen.

{Memory}:

Save the calibration curve to memory.

{Close}:Cancel saving to memory, and return to the		[Replicate] screen.

{Cancel}:The dialog box closes.

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3.7.12

Displaying/printing time courses (samples/STAT samples)

Display the time course of the replicate data (samples/STAT samples).
The time course (graph), number of cycles (cycles), and absorbance (ABS) are displayed on thescreen.
This section describes the procedure from the [Replicate] screen.
Page 178 “3.7.1 Displaying the replicate list (samples/STAT samples)”1

through1

3

Display the time course.
① Touch the date and time field.

1		 * The specified data is enclosed in a blue box.

② Touch the {Time course} button.
		 * The time course of the specified data is displayed.

2

2

The time course was displayed.
Touch the {Print} button to print the time course.

Explanatory note{Print}:Print the time course.

{Range change}:

Change the range of the time course.

{Close}:Return to the [Replicate] screen.

: The “ ▼ ” symbol displayed on the screen can be moved with the cursor buttons.
The cursor’s numeric information is displayed in．

The meaning of the display is shown below.

#Cycle
↑
a

#ABS
↑
b

a

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3.7.13

Replicate

Displaying/printing time courses (STD)

Display the time course of the replicate data.
The time course (graph), number of cycles (cycles), and absorbance (ABS) are displayed on thescreen.
This section describes the procedure from the [Replicate (STD)] screen.
Page 182 “3.7.2 Displaying the [Replicate (STD)] screen”

		1

Touch the {Time course} button.

		 * The time course of the specified data is displayed.

2

The time course was displayed.
Touch the {Print} button to print the time course.

{Print}:Print the time course.

{Range change}: Change the range of the time course.
{Close}:Explanatory note

Return to the [Replicate] screen.

: The “ ▼” symbol displayed on the screen can be moved with the cursor buttons.
The cursor’s numeric information is displayed in.

The meaning of the display is shown below.

#Cycle
↑
a

#ABS
↑
b

a

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3.7.14

Changing the range of the time course (samples/STAT samples)Enter the “Max Value” and “Min Value” and change the range on the [Time course data Rangechange] screen.
This section describes the procedure from the [Replicate] screen.
Page 178 “3.7.1 Displaying the replicate list (samples/STAT samples)” 1 through 3

Explanatory note

: Time course data for which the range has been changed is not saved to the hard disk(SSD).

1

Display the time course.
① Touch the date and time field.

1		 * The specified data is enclosed in a blue box.

② Touch the {Time course} button.
		 * The time course of the specified data is displayed.
2

2

Touch the {Range change} button.

{Print}:Print the time course.

{Range change}: Change the range of the time course.
{Close}:Return to the [Replicate] screen.

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3
1

ReplicateEnter the absorbance.
(input range: 0 to 10,000)① Touch the [Max Value] input field.
② Enter numbers using the numeric keypad.

3③ Touch the [Min Value] input field.
2

4④ Enter numbers using the numeric keypad.

4

Touch the {Continue} button.

				

5

Touch the {Start} button.

		 * The range is modified.

{Cancel}:The dialog box closes.

{Start}:Modify the range.

{Cancel}:Cancel range modification, and return to the		[Time course data] screen.

6

The time course with modified range wasdisplayed.

		{Print}:Print the time course.
To cancel printing, touch the {Cancel} button
during printing.

{Close}:Return to the [Replicate] screen.

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Replicate

3.7.15

Changing the range of the time course (STD)

Enter the “Max Value” and “Min Value” and change the range on the [Time course data Rangechange] screen.
This section describes the procedure from the [Replicate (STD)] screen.
Page 182 “3.7.2 Displaying the [Replicate (STD)] screen”

		Explanatory note

: Time course data for which the range has been changed is not saved to the hard disk(SSD).

1

Display the time course.
① Touch the date and time field.

		 * The specified data is enclosed in a blue box.

② Touch the {Time course} button.
		 * The time course of the specified data is displayed.

1

2

Touch the {Range change} button.

3Enter the absorbance.
(input range: 0 to 10,000)① Touch the [Max Value] input field.

3② Enter numbers using the numeric keypad.
③ Touch the [Min Value] input field.
2

4④ Enter numbers using the numeric keypad.

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4

Replicate

Touch the {Continue} button.

				

5

Touch the {Start} button.

{Start}:Modify the range.

{Close}:Cancel range modification, and return to the		[Time course data] screen.

{Cancel}:The dialog box closes.

6

The time course with modified range wasdisplayed.

{Print}:Print the time course.
To cancel printing, touch the {Cancel} button
during printing.

{Close}:Return to the [Replicate (STD)] screen.

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Quality Control－

The QC lot list, inter/intra-day data, and X-R control graph are displayed in quality control.
－
Quality control also allows for editing inter/intra-day data, and changing the range of the X-R
control graph.

3.8.1

Displaying the QC lot list ([QC lot select] screen)

Touch the {Data processing} - {Process QC} buttons from the [MENU] screen, or touch the {Quality
control} tab on the [Monitor] screen to display the QC lot list ([QC lot select] screen).
(Test items must be selected and the {Start} button must be operated.)－

In addition to the {QC lot select} tab, this screen also has {Intra-day/Inter-day} and {X-R control
graph} tabs.
Page 210 “3.8.1 Displaying the QC lot list ([QC lot select] screen)”
Explanatory note: If there is no measured data, other tabs cannot be switched to from the {QC lot select} tab
screen.

1<Opening from the menu screen>① Touch the {Data processing} button.

② Touch the {Process QC} button.
				

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Quality Control<Opening from the monitor screen>
Touch the {QC screen} tab.

2

Select the analysis items.

○［F-Hb］
				○［FCa］

		 ① Check the item (●).
		② [OK] Touch the button.
[Cancel] : The dialog box closes.

3

The [QC lot select] screen opened.

・ {QC lot select} tab		
・ {Intra-day/Inter-day} tab－

・ {X-R control graph} tab* The recently used QC lots are displayed in order.
(Displayed from left to right, up to down.)

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a
↓

b
↓

c
↓

d→
e→
f→

g→

↑
h

←i

[Screen]: QC lot select screena

QC lot selectThe “QC lot list” saved to QC1 through QC4 is displayed.

bIntra-day/Inter-day

Intra-day and inter-day data for the specified QC# and QC lots are
displayed.

c

X-R control graph

Displays X-R control graphs of intra-day/inter-day data.

d

QC

Select the QC# of the QC lot to display.

e

QC lotThe QC lot of the selected QC# is displayed.
Select the QC lot to use.

f

□ Mon

Specify the QC lot to use by in month units.
Enter the number of months for data processing.

g

Del

Delete the selected QC lot.

h

Lot setting

The [STD/QC process settings] screen is displayed.
Page 298 “6.1.11 STD/QC analysis process settings”

iContinue

Register the modified data.

－

－

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3.8.2

Selecting QC lots

Open the [QC lot select] screen to display the QC lot list. The
QC number and QC lot selected from－this list will be processed on the {Intra-day/Inter-day} and X-R control graph} tabs.
		Page 218 “3.8.5 Opening the [Intra-day/Inter-day] screen”

		Page 228 “3.8.9 Displaying the X-R control graph”－

This section describes the procedure from the [QC lot select] screen.
Page 210 “3.8.1 Displaying the QC lot list ([QC lot select] screen)”		

1

Touch the QC number. (QC1 to QC4)		
* Recently used QC lots are displayed in order on
the list.
(Displayed from left to right, up to down.)

2

Touch the QC lot (can also be selected using the
cursor keys).

3Enter the amount of data to process in months.
(See theExplanatory notefor an example.)① Touch the input field.
② Enter numbers using the numeric keypad.

1

2③ Touch the {enter} key button.

3

Explanatory note

: The QC lot list shows data from the month of the latest data to the specified number ofmonths back (from 1 to 36 months, entered in single month units).
Example 1: “1 mon” entered with June 15 as current date: June 1 to June 15
Example 2: “3 mon” entered with June 15 as current date: April 1 to June 15

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3.8.3

Quality Control

Deleting QC lots

Delete QC number-QC lot selected in “3.8.2 Selecting QC lots.”
After selecting the QC lot to delete, touch the {Continue} button, then touch the {OK} button in the
dialog box.
Data for which QC number-QC lot has been deleted is updated in the hard disk(SSD).

			* If the {OK} button is not touched, the updated data is only in memory, and is not updated in the hard disk(SSD).

This section will explain from the point where the procedure in “3.8.2 Selecting QC lots”
completed.
		2has been

Page 214 “3.8.2 Selecting QC lots”
1

Touch the {Del} button.

2

Touch the {OK} button.

		 * Data in memory was updated.
				
			

{Cancel}:3

Cancel deletion of QC lot.

Save updated data.
① Touch the {Continue} button.
② Touch the {Register} button.

		* The updated data was saved to the hard disk(SSD).

{Close}:Return to the [Data process selection] screen.

{Cancel}:The dialog box closes.

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3.8.4
		

Changing STD/QC measurement process settings fromthe [QC lot select] screen

Pressing the {Lot setting} button on the [QC lot select] screen opens the [STD/QC process settings]
screen. From here settings can be changed.
This is the same screen that opens when the {STD/QC process settings} button is touched on the[MENU] - [Settings] - [System settings] screen. However, settings cannot be modified during
testing.
This section describes the procedure from the [QC lot select] screen.
		Page 210 “3.8.1 Displaying the QC lot list ([QC lot select] screen)”
1

Touch the {Lot setting} button.

2

Change the data.
Touch the {Page 2} tab.

Explanatory note

: For details on settings, see page 298 “6.1.11 STD/QC analysis process settings”

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Quality Control

3.8.5

Opening the [Intra-day/Inter-day] screen

Touching the {Intra-day/Inter-day} tab on the [QC lot select] screen opens the {Intra-day/Inter-day}screen. The inter/intra-day data of the QC number-QC lot specified on the [QC lot select] screen isdisplayed.
Explanatory note

: See page 98 “3.1.1 Opening the [Process data] screen” for information on displaying the[Process data] screen.

1<Opening from the menu screen>① Touch the {Data processing} button.

② Touch the {Process QC} button.
				<Opening from the monitor screen>
Touch the {QC screen} tab.

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2

Quality Control

Select the analysis items.

○［F-Hb］
				○［FCa］

		 ① Check the item (●).
		② [OK] Touch the button.
[Cancel] : Moves to the previous screen.

3

The [QC lot select] screen opened.
* The recently used QC lots are displayed in order.
(Displayed from left to right, up to down.)

4

Select the QC and QC lot.

Page 214 “3.8.2 Selecting QC lots”

5

Touch the {Intra-day/Inter-day} tab.
* The [Intra-day/Inter-day] screen is displayed.
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Quality Control

b
a

c

d
g

j
e

f

h

i

[Screen]: Intra-day/inter-day dataa

QC

The QC (QC1 to QC4) that was specified on the [QC lot select] screen isdisplayed.

b.

QC lotThe QC lot specified on the [QC lot select] screen is displayed.

cQuality control data
(The measurement dateand mean value.)Inter-day data selected
The measurement date and mean value of the specified QC/QC lot isdisplayed.
Intra-day data selected
The measurement time and mean value of the specified QC/QC lot isdisplayed.

dInter-day

Display the inter-day data (measurement date/mean value).

eIntra-day

Display the intra-day data (measurement date and time/mean value).

f{Select-s}

Specify the range of inter-day or intra-day data. The range of data can also
be specified using the cursor buttons.

g

{Del}

Delete the specified inter-day or intra-day data.

h{Edit}

Edit inter-day or intra-day data.

i{Output}

Output inter-day or intra-day data (printer, external media).

j{Continue}

Register edited inter-day or intra-day data to the hard disk(SSD). The data
[Registration confirmation] screen is displayed; touch the {Register} button.

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3.8.6

Editing (recalculating) inter/intra-day data

Touching the {Intra-day/Inter-day} tab on the [QC lot select] screen opens the {Intra-day/Inter-day}screen. The inter-day or intra-day data of the specified QC number-QC lot is displayed.
Select a radio button to switch between inter-day and intra-day data.
				Inter-day: Edit each item of intra-day data.
Intra-day: Edit each item of replicate data.

This section will explain from the procedure, having switched from the [QC lot select] screen to the[Intra-day/Inter-day] screen.

						* This assumes that the QC lot has already been selected on the [QC lot select] screen.

Page 218 “3.8.5 Opening the [Intra-day/Inter-day] screen”
Explanatory note: If there is no measured data, other tabs cannot be switched to from the {QC lot select} tab
screen.

Explanatory note

: Up to ten measurements may be made per day for a single QC lot and QC number.
Results of the 11th or later measurement for the day will not be stored.

1

Select the data to edit.
○ Inter-day○ Intra-day		

2 Touch the {Edit} button.

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3

Quality Control

Edit inter-day data (or intra-day data).

① Touch the input field for the data.
		② Enter numbers using the numeric keypad.

1③ Touch the {enter} key button.

3
2

4

Touch the {Recal} button.

			{Cancel}:Cancel editing inter-day or intra-day data. The
system returns to the [Intra-day/Inter-day]screen.

5

Touch the {Continue} button.
* The new mean value is displayed.

6

Touch the {Register} button.
* Recalculated results were registered.

{Close}:Return to the [Data process selection] screen.

{Cancel}:The dialog box closes.

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Quality Control

3.8.7

Deleting inter/intra-day data

Specify a range of data on the [Intra-day/Inter-day] screen, then delete inter-day or intra-day data.
When deleted, specified data will no longer appear on the screen. However, data is not updated untilthe {Register} button is touched (hard disk(SSD) data is not updated).
This section will explain from the procedure, having switched from the [QC lot select] screen to the[Intra-day/Inter-day] screen.

						* This assumes that the QC lot has already been selected on the [QC lot select] screen.

Page 218 “3.8.5 Opening the [Intra-day/Inter-day] screen”

Explanatory note: If there is no measured data, other tabs cannot be switched to from the {QC lot select} tab
screen.

1

Select the data to edit.
○ Inter-day○ Intra-day		

2 Specify the range of data to delete.
* Only the selected data is displayed.
			Page 226 “3.8.8 Specifying inter/intraday data by range”

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3

Quality Control

Touch the {Del} button.

				

4

Touch the {OK} button.

				* Data in memory is updated.
				 * Data specified on the screen is deleted.

{Cancel}:5

Cancel the deletion of inter/intra-day data.

Touch the {Continue} button.

				

6

Touch the {Register} button.

{Close}:Return to the [Data process selection] screen.

{Cancel}:The dialog box closes.

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3.8.8

Specifying inter/intra-day data by range

Specify the data using a measurement date and time range on the [Intra-day/Inter-day] screen (startpoint/end point).
－

Use this to delete inter/intra-day data in bulk, or when displaying the X-R control graph.
This section will explain from the procedure, having switched from the [QC lot select] screen to the[Intra-day/Inter-day] screen.

						* This assumes that the QC lot has already been selected on the [QC lot select] screen.

Page 218 “3.8.5 Opening the [Intra-day/Inter-day] screen”

1

Select the data to specify.

○ Inter-day		○ Intra-day		2Specify the measurement date at the start point.
① Touch the measurement date that will be the start1

		point.
② Touch the {Select-s} button.
* The data at the start point was confirmed.
			
2

			

* When the start point is confirmed, the {Select-s}

			button changes to the {Select} button.

3

Specify the measurement date at the end point.
① Touch the measurement date that will be the end
		point.

1② Touch the {Select} button.
* The data at the end point was confirmed.
* When the end point is confirmed, the {Select}2

button changes to the {Clear} button.

{Select-s}:

Confirm start point data for the specified range.

{Select}:

Confirm end point data for the specified range.

{Clear}:Cancel the range specification.

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Explanatory note

Quality Control: If the data selected for the start and end points is the same, the system will handle it as though
only a single sample of data was specified.

Explanatory note

: To specify a new range of data, touch the {Clear} button. All data is displayed, and the system
returns to the state it was in before the range was specified.

Explanatory note－: If the [X-R control graph] screen is opened without opening the [Intra-day/Inter-day] screen
from the [QC lot select] screen first, all data will be specified.

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3.8.9

－

Displaying the X-R control graph－

Displays X-R control graphs of intra-day/inter-day data.
－
If inter-day data is selected on the [QC lot select] screen, the X-R control graph for inter-day data isdisplayed.
－
If intra-day data is selected on the [QC lot select] screen, the X-R control graph for intra-day data isdisplayed.
Explanatory note: If there is no measured data, other tabs cannot be switched to from the {QC lot select} tab
screen.

1<Opening from the menu screen>① Touch the {Data processing} button.

② Touch the {Process QC} button.
				<Opening from the monitor screen>
Touch the {QC screen} tab.

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2

Quality Control

Select the analysis items.

○［F-Hb］
				○［FCa］

		 ① Check the item (●).
		② [OK] Touch the button.
[Cancel] : Moves to the previous screen.

3

The [QC lot select] screen opened.
* The recently used QC lots are displayed in order.
(Displayed from left to right, up to down.)

4

Select the QC and QC lot.

Page 214 “3.8.2 Selecting QC lots”

5

Touch the {Intra-day/Inter-day} tab.

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Quality Control

6－

Select the data to display an X-R control graphfor.

		 Page 226 “3.8.8 Specifying inter/intra-day
data by range”

Explanatory note－

7

Touch the {X-R control graph} tab.

8

The X-R control graph was displayed.

－: An R graph’s maximum control limit value is calculated based on the total measurement
determined across multiple repeated measurements. If the number of repeated measurements
varies, it is calculated based on the total measurement of the smallest number ofmeasurements.

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c→

Quality Control

←e

a→

d→

b→
f→
－

[Screen] : X-R control graph
a

b.

c

d
e
f

X graph(upper graph)

・ Data is displayed for the measurement date and measurement time.
・ The overall mean and ± #SD are displayed.
・ The maximum control limit value (UCL) and minimum control limit
value (LCL) set on the [System settings] - [STD/QC process settings]
screen are displayed in blue.
・ Data that meets the criteria of less than LCL value + 1 or not less than
ULC value + 1 is plotted in red.

R graph(lower graph)

・ A range of data is displayed for the measurement date and measurement
time.
・ The R upper limit value is displayed.

Max limit

・ The maximum control limit value (UCL) set on the [System settings] [STD/QC process settings] screen is displayed.

Min limit

・ The minimum control limit value (LCL) set on the [System settings] [STD/QC process settings] screen is displayed.

+ #SD

・ Calculated + # SD value
・ The standard deviation coefficient (# = 1 to 9) set on the [Systemsettings] - [STD/QC process settings] screen is displayed.

- #SD

・ Calculated - # SD value
・ The standard deviation coefficient (# = 1 to 9) set on the [Systemsettings] - [STD/QC process settings] screen is displayed.

Mean

・ Calculated mean value▼ (in graph)・ Shows that a calibration curve that was used has changed.
・ The reagent lot is displayed next to the ▼ symbol.

{

・ Move the cursor (vertical line) displayed in the graph.

－

},{

}

{Range change}

・ Change the range (maximum concentration, minimum concentration, R－

maximum) of the X-R control graph.

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3.8.10－Changing the range of the X-R control graph－

Change the range of the X-R control graph.
－

This section will begin explaining from the [X-R control graph] screen.
－

Page 228 “3.8.9 Displaying the X-R control graph”

1

Touch the {Range change} button.

2

Modify the range.

① Touch the input field for the setting.
		② Enter numbers using the numeric keypad.

1・ Max Conc.
		 ・ Min Conc.
・ R max

2③ Touch the {enter} key.
3

3

Touch the {Continue} button.

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4

Quality Control

Touch the {Start} button.
－* The X-R control graph with modified range is displayed.
		{Close}:Cancel range modification, and return to the		[X-R control graph] screen.

{Cancel}:The dialog box closes.

－

5

Touch the {Continue} button.

6

Touch the {Register} button.
－* The X-R control graph is registered.
* The system returns to the [Data process selection] screen.

－{Close}:Cancel X-R control graph registration, and		

return to the [Data process selection] screen.

{Cancel}:The dialog box closes.

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Rack info
Touch the {Rack info} button on the [Test] screen or [Monitor] screen to confirm rack information,change trays, and more.
<Available functions on the rack information screen>・ Analytical information about the rack on the rack discharge unit
・ Type of measured rack (STD/QC rack, retest rack, dilute test rack, sample rack)
・ Rack position number
・ Sample status display (error, OR/PRC, positive, normal, unfinished, unset)
・ Rack information printing
・ Tray (optional) replacement
Explanatory note

: Rack information for up to 500 racks can be stored after the system is started (up to 25 racks
can be displayed). This rack information is deleted if the power is turned off (rackinformation remains if power is lost due to a power outage or the like).

3.9.1

Displaying the [Rack info] screen

Touch the {Rack info} tab and display rack information.
This section will explain from the [Test] screen and [Monitor] screen.

1<From the [Test] screen>
Touch the {Rack info} tab.

		
<From the [Monitor] screen>

Touch the {Rack info} tab.

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2

Rack info

The [Rack info] screen was displayed.
* Information about the rack that was lastdischarged is displayed at the top of the screen.

Explanatory note

: Touch the {Close} button to return to the [Test] screen.

Explanatory note

: Touch the {Monitor} tab to return to the [Monitor] screen.

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Rack info

b
↓

a
↓

b
↓

a
↓

←c

↑
d

↑
e

↑
f

↑
d

↑
e

[Screen]: Rack informationa Rack info

Analytical information about the rack on the rack discharge unit

White × in a red
background－

Error (including sample barcode reading errors and order errors)×－Yellow－

Yellowish orange－

Light green
－

White
－

Black

b RACK No.

OR/PRC
Positive sample
Normal sample
Unfinished
Unset
Rack number and measurement rack (displayed to left of rack number)

－

Gray
Blue
Green
Orange－－Sample rack (normal)
STD/QC rack
Retest rack－

Dilute test rackc {Stop unloading racks.} Change the tray.
Or, {Restart unloading <Procedure>(1) Touch the {Stop unloading racks.} button.
racks.}
When touched it changes to {Restart unloading racks.}.
(2) Remove the rack discharge unit tray.
(3) Place an empty tray in the rack discharge unit.
(4) Touch the {Restart unloading racks.} button.

d {Clear}

Delete rack information.
<Procedure>(1) Touch the {Clear} button.
(2) Touch the {OK} button in the confirmation dialog box.
(Touching the {Cancel} button cancels rack information deletion.)e {Print}

Print rack information.

fReturn to the [Test] screen.

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Explanatory note

Rack info: If “Numbering” is set to “NO” in [Test] - [Request test/select operation], Unset (white) isdisplayed as an error (× in red).

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Rack info

3.9.2

Replacing trays (optional)

When a tested rack has been discharged to the rack discharge unit, replace it with an empty tray andclear the “rack information.”
This section will begin explaining from the [Rack info] screen.
Page 234 “3.9.1 Displaying the [Rack info] screen”

1

1

Touch the {Stop unloading racks.} button.

2

Exchange the rack.

		① Remove the tray from the rack discharge unit.
		② Place an empty tray.

2

3

Touch the {Restart unloading racks.} button.

				

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Measuring Using Sample Cups
The following settings must be changed when measuring samples using sample cups.

Caution・When using sample cups, make sure to set them in the correct order.
Failure to observe this precaution may lead to jumbled samples.
Required■

Modification of rack number settings
Cups will stick out of a normal sample rack, so a wide rack (STD rack or dilute test rack) must
be used.
Some rack number settings will need to be changed on the [Rack/QC sequence No. settings]
screen to use STD racks or dilute test racks.
Page 272 “6.1.3 Rack No./QC No.”■

Modification of sample barcode settings
Sample barcode labels cannot be affixed to sample cups.
Set “Sample barcode” to “NO” on [Samp barcode settings] - [Common].
Page 266 “6.1.1 Sample barcode settings (common)”239
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Chapter 4 Support Functions

		

4.1

Initialization

		

4.2

Priming		

4.3

Cell Blanking

		

4.4

Washing241
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Chapter 4 Support Functions
4.1

Initialization
Initialize (move to standby position) each system component. The following components are
initialized:
・ Sample nozzle

・ Reagent nozzle

・ Cell washing nozzle

・ Mixer・ Reaction table

・ Puncturing system

・ Squeezing system

・ Supply bar

・ Conveyance bar

・ Discharge bar

Touch the {Prep functions} button on the [Menu] screen to display the [Initialize] screen.

Caution・Do not open the cover of the analysis chamber or reach into the range of motion

during operation.
Pinching hazard

Failure to observe this precaution may lead to injury or could damage the system.

1

Touch the {Prep functions} button.

2

Touch the {Start} button.

[MENU]:

Return to the [MENU] screen.

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3

Initialization was run.

{Pause}:Pause initialization.

{Start}:Resume initialization.

{Abort}:Cancel initialization.

4

Initialization

Initialization completed.

			

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Priming
There are two kinds of priming. “Normal prime” removes air bubbles in the piping, while “pipe line
activation” introduces buffer, wash solution, and purified water into piping.
					 Normal prime:			 Used to remove air bubbles in the piping.
										 Also used when the system has been left unused for a while.
			 Pipe line activation:		 Used to introduce buffer, wash solution, and purified water into										piping.
				Page 44 “2.4.7 Priming (normal prime/pipe line activation)”244
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Cell Blanking
Run cell blanking to wash cells and evaluate them on a pass/fail basis.
If “Cell blank” is checked in “Auto start” in close mode, cell blank measurement will be
automatically run when the system starts.
		Page 48 “2.4.8 Measuring cell blanks”

		Page 90 “2.6.1 Close mode”

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Washing
Touch the {Wash} tab on the [MENU]-[Prep functions] screen to display the [Wash] screen.
Select the wash part and preservation processing (soaking preservation), then touch the {Start}
button. Washing of each part begins.

Caution・Do not open the cover of the analysis chamber or reach into the range of motion

during operation.
Pinching hazard

Failure to observe this precaution may lead to injury or could damage the system.

Request・Run preservation processing (soaking preservation) in close mode.
Soaking preservation can also be run from support functions, but is normally run from close
mode.

			

Page 90 “2.6.1 Close mode”

1

Touch the {Prep functions} button.

2

Touch the {Wash} tab.

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3

Washing

Select whether or not to wash each part (“YES”
or “NO”).

Wash Part● Washing

Range/Selection

Details

S-nozzle (Sample nozzle)

YES:
NO:

Wash sample nozzle.
Do not wash sample nozzle.

R-nozzle (Reagent nozzle)

YES:
NO:

Wash reagent nozzle.
Do not wash reagent nozzle.

Mixer

YES:
NO:

Wash mixer.
Do not wash mixer.

W-nozzles(Cell washing nozzle)

YES:
NO:

Wash cell washing nozzle.
Do not wash cell washing nozzle.

Wash cells

YES:
NO:

Washes measurement cells.
Do not wash measurement cells.

Nozzles

YES:NO:Run soaking preservation for nozzles and mixer.
Do not run soaking preservation for nozzles andmixer.

Cells

YES:
NO:

Run soaking preservation for measurement cells.
Do not run soaking preservation for measurement
cells.

● Preservation processing

4

Touch the {Start} button.

[MENU]:

Explanatory note

Return to the [MENU] screen.

: Soaking preservation of measurement cells is a process where residual liquid in cells isabsorbed using the washing nozzle, then the cell is filled with purified water using the sample nozzle.

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Washing5

Washing was run.

{Pause}:Pause washing.

{Start}:Resume washing.

{Abort}:Cancel washing.

6

Washing completed.

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5.1

Inspection/maintenance

		

5.2

List of Parts to Check and Exchange249
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Chapter 5 Maintenance
5.1

Inspection/maintenance
The [Maintenance] screen displays inspection and maintenance items to run at each frequency (daily,
weekly, monthly).
Touch the {Procedure} button to reference inspection and maintenance procedures.

5.1.1

Opening the [Maintenance] screen

Touch the {Maintenance} button on the [MENU] screen to open the [Maintenance] screen.

1

Touch the {Maintenance} button.

2

The [Maintenance] screen opens.		

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5.1.2

Inspection/maintenance

Clean touch panel (daily)

Touch the {Procedure} button to the right of [1. Clean panel (daily)] on the [Maintenance] screen todisplay the cleaning procedure.

■ Procedure
Use “LCD panel cleaner” to wipe the touch panel clean.
If “LCD panel cleaner” is not available, use a cloth thathas been soaked in mild detergent to wipe the panel
clean.
Caution: Wring the cloth out thoroughly.

{Close}:Return to the [Maintenance] screen.

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Inspection/maintenance

5.1.3

Clean conveyance line (daily)

Touch the {Procedure} button to the right of [2. Clean conveyance (daily)] on the [Maintenance]screen to display the cleaning procedure.

■ Procedure① Soak a soft cloth in mild detergent.
② Use the cloth from ① to wipe the conveyance line
clean (the area enclosed in the red box in the
diagram to the left).
Caution: Wring the cloth out thoroughly.
{Close}:Return to the [Maintenance] screen.

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5.1.4

Inspection/maintenance

Clean washing nozzle (weekly)

Touch the {Procedure} button to the right of [3. Clean W-nozzle (weekly)] on the [Maintenance]screen to display the cleaning procedure.

■ Procedure① Soak a soft cloth in ethanol.
② Use the cloth from ① to wipe the area around 20mm from the tip of the washing nozzle clean.
Caution: Wring the cloth out thoroughly.
Caution: Be especially careful when handling thewashing nozzle.
The tip of the nozzle is sharp and could cause injury.
		{Close}:Return to the [Maintenance] screen.

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Inspection/maintenance

5.1.5

Clean sample & reagent nozzles (weekly)

Touch the {Procedure} button to the right of [4. S-nozzle, R-nozzles] on the [Maintenance] screen
to display the cleaning procedure.

■ Procedure① Soak a soft cloth in ethanol.
② Use the cloth from ① to wipe the area around 20mm from the tip of the sample nozzle and reagent
nozzle clean.
Caution: Wring the cloth out thoroughly.
Caution: Be especially careful when handling thesample nozzle and reagent nozzle.
		 The tip of the nozzle is sharp and could cause injury.
Sample nozzle{Close}:Return to the [Maintenance] screen.

Reagent nozzle

20mm

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5.1.6

Inspection/maintenance

Clean tray (weekly)

Touch the {Procedure} button to the right of [5. Clean trays] on the [Maintenance] screen to display
the cleaning procedure.

■ Procedure① Soak a soft cloth in mild detergent.
② Use the cloth from ① to wipe the rack supply/
discharge unit and tray surface clean.
Caution: Wring the cloth out thoroughly.

<Without tray><With tray (optional)>
Rack supply unit

Rack discharge unit

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Inspection/maintenance

5.1.7

Clean racks (weekly)

Touch the {Procedure} button to the right of [6. Clean racks] on the [Maintenance] screen todisplay the cleaning procedure.

■ Procedure① Check that there are no foreign objects in the rackholes.
② If there are any foreign objects, remove them (forexample, by turning the rack over and shaking it).
Caution: Do not wash the rack.
Doing so could cause the barcode affixed to the rack topeel off.

Rack hole

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5.1.8

Inspection/maintenance

Clean tank (monthly)

Touch the {Procedure} button to the right of [7. Clean tanks] on the [Maintenance] screen todisplay the cleaning procedure. Clean the tank once per month.

■ Procedure<Normal cleaning>
After thoroughly cleaning the tank with tap water, rinse
it lightly with distilled water.
<If tank is extremely dirty>① Clean the tank thoroughly with tap water.
② Fill the tank with tap water and LX wash
solution. Tap water: 2 L, LX wash solution:
20 mL③ Close the tank lid tightly and shake the tank(if very dirty, set it aside for around onehour).
④ Rinse the tank thoroughly with tap water, sothat no wash solution remains.
⑤ Rinse the tank lightly with distilled water.

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Inspection/maintenance

5.1.9

Replacing measurement cells (when cell blank value is abnormal)

When 10 or more measurement cells can no longer be used during cell blank measurement, “There
are more than 10 unclean measurement cells. This could reduce processing performance. Replace
the measurement cells” is displayed. Follow the procedure below to replace the measurement cells.

Caution・Turn the system power off when replacing measurement cells.
Finger pinchinghazardFailure to observe this precaution may lead to injury.

1

Measurement cells that cannot be used are shownin red.
Touch the {Close} button.

2

Touch the {MENU} button.		

3

Shut off the system.

① Touch the {Close} button.
		

1

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Inspection/maintenance② Select “NO” for “Cell wash,” “Exchange buffer		2and wash sol to p. water” and “Nozzle/cell soak
wash.”
		 ③ Touch the {Continue} button.
		

3

		 ④ Touch the {Start} button.		

4

4

If the sample nozzle and reagent nozzle are on
the reaction table, move them by hand so as to
not hinder work.

Reaction table
Sample nozzle

Reagent nozzle

5

Remove the light blocking cover.

Light blocking
cover

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Inspection/maintenance

6

Remove the cell holder.

		① Loosen the screw.
		 ② Remove the cell holder.
		Cell holder

7

Replace the measurement cells.

① Remove the dirty measurement cells.
				 ② Set the new measurement cells.
				* Replace all five.

Measurement cells

8Install the cell holder and light blocking cover inorder to their original locations.
Follow the removal procedure in reverse to install
the parts.

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Inspection/maintenanceCaution・When setting measurement cells, make sure they are fully attached.
Failure to observe this precaution may impact measurement results.
RequiredCaution・When setting the cell holder, install so that the cover is pinched by the reaction

table fixing screw.
RequiredIf the fixing screw is covered by the cover the system will be unable to measure properly.

<Example: acceptable installation>

Protuberance○ “Protuberance” and “hole” are lined up<Example: poor installation>

Protuberance

× “Protuberance” and “hole” are notlined up261
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5.2

List of Parts to Check and Exchange
The [Parts check list] screen displays registered parts, when they were last changed, the number ofmonths they were used, and how many times they have been used.

5.2.1

Opening the [Parts check list] screen

Touch {Parts check list} on the [Maintenance] screen to open the [Parts check list] screen. The line
for parts that need to be changed (that have exceeded the set number of usage months or number ofuses) are displayed in yellow.

Explanatory note1

Touch the {Maintenance} button.

2

Touch the {Parts check list} button.		

3

The [Parts check list] screen was displayed.

: The rows of parts that need to be changed turn yellow.

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5.2.2

List of Parts to Check and Exchange

Changing parts

Change parts that need to be replaced.
This section describes the procedure from the [Parts check list] screen.

11Change parts displayed in yellow.

2

Reset the months used and number of uses
counters to replace parts.
① Touch the row of the part that was changed.
② Touch the {Exchange} button.

2③ Touch the {Start} button.
		 * The months used and number of uses are reset to “0.”		

* The dialog box closes.

{Cancel}:Cancel resetting the months used and number		of uses counters.

3

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Chapter 6 Settings

		

6.1

System settings

		

6.2

Protocol settings

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Chapter 6 Settings
6.1

System settings
In order to use the system for the first time, the system settings must be configured. Once set,settings will not need to be touched during everyday analysis unless changes are made.
See page 32 “2.3.1 System settings” for an overview of “system settings” items.

6.1.1

Sample barcode settings (common)

Set common setting items for reading sample barcodes.

1

Explanatory note

Touch the {Settings} button.

: The [System settings] screen can also be displayed by touching the {Settings} button on the[Test] screen.

2

Touch the {Barcode} button.		

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3

Setting
Sample barcode

System settings

Configure the settings in the {Common} tab.

Choice/Setting
Details
YES: Barcodes are affixed to samples.
NO: 			Barcodes are not affixed to samples.

Duplicated check

From when the system starts up to when the power isturned off:
Check whether a sample with the same barcode has
already been read.
Do not check whether a sample with the same
barcode has already been read.

YES:
NO:

However, even if this is set to “YES” duplicatedcheck is not performed when the measure mode is“retest” or “dilute test.”
Decode accord times
Explanatory note

Numerical input

The recommended value is around ten times.

: Decode accord times
When reading a sample barcode, the sample ID barcode reader scans the barcode amaximum of 500 times. The number of times the barcode was read correctly is called thenumber of decode times.
“Decode accord times” is the number of times a barcode must be read for the system todetermine that the barcode has been read correctly.
Increasing the number of decode accord times can prevent misreading barcodes, but
increases the frequency of “barcode reading errors.”

4

Configure detailed settings for each barcode type.
Page 268 “6.1.2 Sample barcode settings(detailed settings by barcode type)”267
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System settings

6.1.2

Sample barcode settings (detailed settings by barcode type)

In addition to common settings, [Samp barcode settings] includes settings for each type of barcode.
Usable barcodes include CODE39, ITF, JAN, NW-7, IND2of5m CODE128, and COOP2of5.
Barcodes are selected by switching the {Barcode names } tab.
This section will begins explaining from the {Samp barcode settings} screen.
		Page 266 “6.1.1 Sample barcode settings (common)”1

Touch the tab of the type of barcode to configure.
Example:Touch the {NW-7} tab.
(This explanation assumes that NW-7 has been selected.)

2

Configure each item.
(See Charts 6.1.1 through 6.1.4.)

Explanatory note

: The check digit calculation method cannot be changed for Code39, JAN, or ITF barcodes.

3

Touch the {Continue} button.

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4

System settings

Touch the {Register} button.

{Register}: Register configured settings.

{Close}: Cancel registration of sample barcode settings,
and return to the [System settings] screen.

{Cancel}: The dialog box closes.

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System settings
Explanatory note: If “YES” is selected for “Check digit inspection,” the system will perform a check digit
inspection using the last character of the barcode (the digit before the start/stop character) as
the check digit.

Chart 6.1.1 Samp barcode settings
Setting■ Use this type (4 types
available at once)

Choice/Setting

Digit
Sample □ digits

Details
Check the barcode to use.
Up to four types of barcodes can be selected at thesame time.
Configure the number of digits for sample barcodes.
Enter “*” to skip checking the barcode digit.
(Used when sample barcodes have multiple digits.)
The input range varies according to whether “Start/stop
character delete” is set to “YES” or “NO.”For details, see Chart 6.1.2.

Start/stop
Character delSet whether or not to delete the start/stop character.
(Available when NW-7 is selected.)

YES:

Delete start/stop character.

NO:

Do not delete start/stop character.

Check digit inspection

Decide whether or not to perform check digit
inspection.

Check digit calculation
methodExplanatory note

YES:

Perform check digit inspection.

NO:

Do not perform check digit inspection.

See Chart 6.1.3

Configure the check digit calculation method.

: See Chart 6.1.3 for information on input numbers and calculation methods for check digits.

Chart 6.1.2 Barcode digit input range
Barcode TypeStart/Stop Character

Input Range
Upper Limit

DeleteLower Limit

NW-7

YES

17

NW-7 （2）None

15Disabled

15

6

Disabled

15

5

5

ITF
IND2of5
COOP2of5
CODE39JAN
CODE128270
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6.1

Chart 6.1.3 Input No. and Calculation
methodSystem settings

Chart 6.1.4 Barcode Type and Calculation
MethodInput No.

Calculation Method

1

Modulus 10/3 weight

CODE39Barcode TypeCalculation Method
Modulus 43 (fixed)

2

Modulus 16

JAN

Modulus 10/3 weight (fixed)

3

Modulus 11

ITF

Modulus 10/3 weight (fixed)

4

Modulus 10/2 weight

NW-7

Modulus 10/3 weight5

Modulus 10/3 weight

Modulus 16

6

7 check DR

Modulus 11

7

Weighing modulus

Modulus 10/2 weight

8

Loons

7 check DR
Weighing modulus
Loons
IND2of5

No check digit

CODE128

No check digit

COOP2of5

No check digit271
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System settings

6.1.3 Rack No./QC No.
Configure the STD/QC rack number, retest rack number, dilute test rack number, and QC sequencenumber. The system identifies the type of rack from the rack number. During testing, racks withnumbers other than STD/QC rack numbers, retest rack numbers, dilute test rack numbers configured
here are treated as “sample racks.”
This section describes the procedure from the [System settings] screen.
		Page 266 “6.1.1 Sample barcode settings (common)”1

Touch the {Rack No./QC No.} button.

2

Select the analysis items.
Check the item ( ● ).

・ ［F-Hb］
		・ ［FCa］				・ ［Common］

3

Configure each item.
（See page 274）

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4

System settings

Touch the {Continue} button.

* A dialog box appears to confirm changes/registration

5

Confirm the changes and touch the {Register}
button.

{Register}:

Register configured settings.

{Close}:Cancel rack/QC sequence number configuration, and		

return to the [System settings] screen.

{Cancel}:The dialog box closes.

Explanatory note: If no changes were made, the range for each test item/rack number is not displayed.

Explanatory note: If there are duplicate rack numbers, the values of the duplicate locations will be red.

Explanatory note: If the maximum and minimum rack number values are reversed, the values will be red.

Explanatory note: If only one value of the rack number range setting is “*” that location will be red (if the value
input changes after entering “*”).

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System settings

Chart 6.1.5 Rack/QC Sequence Settings
Setting

Choice/Details

Setting
Selection of analysis items［F-Hb］

Select the analysis items.

STD/QC Rack No. (QC1･QC2)［FCa］[Common]1 - 999

Configure a range of STD/QC rack numbers (QC1/

Min:

QC2).

Max:

Enter “*” to disable range specification.
Example 1: If entering rack number 094:
Enter 94.
Example 2: If registering only one rack:
Enter the same rack number for the minimum

STD/QC Rack No. (QC3･QC4)

1 - 999

Min:Max:
1 - 99999

QC sequence No.
QC1:
QC2:
QC3:
QC4:

and maximum (maximum = minimum).
Configure a range of STD/QC rack numbers(QC3/QC4).
Enter “*” to disable range specification.
Configure the QC sequence number.
Enter “*” to disable range specification.
There are two ways to set QC sequence numbers.
(1) Allocate numbers individually to each QC
sequence number(2) Set QC1 as the initial value, and assign
numbers in sequence for QC2 though QC4from QC1
For (2), if a value in entered for QC1 and“*” is set for other QC values, sequencenumbers will be allocated in sequence from
QC1 for QC2 on.
Explanatory note: If set by serial number, values
are retained in the system
until its power is turned off.

Retest Rack No

1 - 999

Configure a range of retest rack numbers.
Enter “*” to disable range specification.

1 - 999

Configure a range of dilute test rack numbers.
Enter “*” to disable range specification.

Min:
Max:

Dil. Rack No

Min:
Max:
Explanatory note

: Enter “*” to disable rack number configuration.
If “*” is entered for either the minimum or maximum, the other value (maximum or minimum)
is automatically set as “*,” and rack number configuration is disabled.

Explanatory note

: STD/QC rack numbers (QC1/QC2) and STD/QC rack numbers (QC3/QC4) cannot both bedisabled.

Explanatory note

: See chart 6.1.6 for details on enabling and disabling setting items by selecting analysis items.

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System settings

Chart 6.1.6 Disabling and Enabling Setting Items Based on Assay Item Selection
Selection of analysis items
Setting
STD/QC Rack No. (QC1･QC2)［F-Hb］［FCa］[Common]EnableEnableDisableSTD/QC Rack No. (QC3･QC4)

EnableEnableDisableQC sequence No.
Retest Rack No

EnableEnableDisableDisableDisableEnableDil. Rack No

DisableDisableEnable275
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System settings

6.1.4 Environment settings
The following settings are configured in the environment settings.
･ Date and time settings･ Water supply and water drainage methods･ Automatic rack supply (sample setting wait time)･ Automatic logout･ Password registration
This section describes the procedure from the [System settings] screen.
		Page 266 “6.1.1 Sample barcode settings (common)”1

Touch the {Config} button.

2

Set the configuration.
(See the following page.)

Explanatory note

: The screen varies based on whether
a password is registered or not.

Password not registered

Password registered276
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6.1

Setting
Date
20YY, MM, DD, HH, MM

Choice/Setting
YY: 0 to 99,
MM: 1 to 12,
DD: 1 to 31,
HH: 1 to 24,
MM: 0 to 59

Water connection

System settings

Details
Configure the year, month, day, and time.

Select the water supply/drainage methods.
Supply:Tank
Auto watersupply(opt)

Drain:

Automatically supply water (optional).

Tank

Drain water to tank.

Sink

Drain water using drain hose.

YES:

Select automatic rack supply.
Supply rack automatically.

NO:

Do not supply rack automatically.

Rack auto startSensor response time (SEC)

Supply water from tank.

0 to 60

When “Rack auto start” is set to “YES,”
configure the time from when the rack isplaced in the supply unit, to when all racks
are completely placed (sensor response time).
Rack supply will begin once the sensor
response time has elapsed.

Automatic logout time
(Minute)0 to 99

When the Operator mode is set, if theautomatic logout time passes while the[MENU] screen is still displayed after
logging in, automatic logout occurs.
The automatic logout function is disabled
setting 0 minutes.
Page 330 “Chapter 9 Operator/Latex
Management Function (Option)”

Save
YES:

Select whether to register a password or not
for data processing.
Register a password.

NO:

Do not register a password.

Password:

5 to 30 characters(0 to 9, -, X, Y, Z, ., /)Enter a password.

Old password

5 to 30 characters(0 to 9, -, X, Y, Z, ., /)(When a password has been set)
Change the password.

New password
Explanatory note

: To use no password, do not input a password, then touch the {Continue} button to complete
registration.

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System settings

4

Touch the {Continue} button.

5

Touch the {Register} button.

{Register}:

Register configured settings.

{Close}:Cancel environment configuration and return to		

the [System settings] screen.

{Cancel}:The dialog box closes.

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6.1.5

Data output settings - [Destination]

The following settings are configured in “Destination.”･ Measured data printer output (print)･ Measured data external media output･ Time course external media output･ Measured data online output･ STAT online output
This section describes the procedure from the [System settings] screen.
		Page 266 “6.1.1 Sample barcode settings (common)”1

Touch the {Data output} button.

2

Touch the {Destination} button.

3

Select the output destination for the data (see thefollowing page).

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Setting
Output to printerChoice/Setting

YES

System settings

Details
Select whether to print measured data or not.
Print measured data in real time during testing.
If you would like to "Print Saving mode" inwhich only the "STD/ QC" measurement result
and the error is printed, please contact us.

NO
Output to Ext. media

Select whether to automatically send measured
data to external media when testing is complete.
YES

Output to external media.

NO

Do not output to external media.

YES

Select whether to output time course to external
media or not.
Output to external media.

NO

Do not output to external media.

Time course to Ext. media

Output data online

Select whether to output measured data online
or not.
Detailed online output settings are made on the[Online settings] screen.
YES

Output online.

NO

Do not output online.

STAT online output

Explanatory note

Do not print measured data.

Select whether to output sample data measured
during cut-in analysis online or not.
Online output of measured data is available if
set to “YES.”
YES

Output cut-in analysis measured data online.

NO

Do not output cut-in analysis measured data
online.

: If all [Destination] settings are set to “NO,” nothing will be output to external media.

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System settings

4

Touch the {Continue} button.

5

Touch the {Register} button.

{Register}:

Register configured settings.

{Close}:Cancel data output selection, and return to the		[Data output destination settings] screen.

{Cancel}:The dialog box closes.

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System settings

6.1.6

Data output settings - [Online settings]

Configure the following conditions to control online communication.
・ Order request		

・ Communication mode・ Baud rate

・ Data length			・ Parity			 ・ Stop bit

・ Transmission procedure・ Delimiter			

・ Check character・ Separator
For details, see “OC-PLEDIA Computer Interface Specifications.”
This section describes the procedure from the [System settings] screen.
		Page 266 “6.1.1 Sample barcode settings (common)”1

Touch the {Data output} button.

2

Touch the {Online settings} button.

3

Select online communication conditions (see thefollowing page).

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Setting
Order requirement

Choice/Setting

YESNO
Com mode

System settings

Details
In online communication, select whether toplace an order request to a higher-level system
or not.The order
Request an order.
Do not request the order.
Select the communication mode.

OC sensor io
OC sensor DIANALANASTMBaud rate

OC sensor io compatibility mode.
OC sensor DIANA compatibility mode.
LAN communication mode.
ASTM communication mode.
Select the communication speed.

2400
4800
9600
19200
38400

2400 baud rate
4800 baud rate
9600 baud rate
19200 baud rate
38400 baud rate
Select the data length.

Length7 （bit）
8 （bit）

Select when sending two-byte characters.

NONE
EVEN
ODD

Select parity checking.
Do not check parity.
Run even number parity checking.
Run odd number parity checking.

ParityStop bit
1
2
Trans.
NONE
ACK/NAKSelect the stop bit.
One bit.
Two bits.
Select the transmission control procedure.
Do not use a transmission control procedure. (Noprocedure)
Use ACK/NAK method.
Select the delimiter

Delimiter
STX/ETX
CR/LF
CF

Select the error detection method.

Chk. char
BCC
SUM
None

Do not use check character.

YESNO

Select whether or not to insert a separator
comma (,) in between data items.
Separate using a comma.
Do not separate.

Separator

NN1-1703 Rev.3

Explanatory note

: Delimiter, check character, and separator are all set to “NO” for LAN communication.

Explanatory note

: The delimiter is set to “STX/ETX” for ASTM communication. This cannot be controlled on
the screen.

Explanatory note

: The check character for ASTM communication is “SUM1, SUM2.” This cannot be
controlled on the screen.

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4

Touch the {Continue} button.

5

Touch the {Register} button.

{Register}:

Register configured settings.

{Close}:Cancel online configuration, and return to the		[Output settings] screen.

{Cancel}:The dialog box closes.

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6.1.7 Data output settings - [Test settings]
Setting the analysis items to be handled by the device.
Test Items
			○ Fecal□ ［F-Hb］ Hemoglobin□ ［FCa］ Calprotectin

This section describes the procedure from the [System settings] screen.
		Page 266 “6.1.1 Sample barcode settings (common)”1[Data output] Touch the button.

2[Test setting] Touch the button.

3

Select the assay item (see next page).

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Setting
Test Items

System settings

Choice/Setting

Details
Select the assay item.
［F-Hb］ Fecal hemoglobin［FCa］ Fecal calprotectin

4[Continue] Touch the button.

5[Register] Touch the button.

[Register] : You can register the settings.
[Cancel] : Aborts Test settings and returns to the screen.
[Close] : The dialog box closes.

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6.1.8

Output format

Configure the output formats for data (such as rack, sample number, and sample ID), for each
output destination (printer, external media, online).
Rack, sample number, and sample ID settings cannot be changed for printer output.
This section describes the procedure from the [System settings] screen.
		Page 266 “6.1.1 Sample barcode settings (common)”1

Touch the {Output format} button.

2

Select the output item (see the following page).

				

3

Touch the {Continue} button.

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4

Explanatory note

System settings

Touch the {Register} button.

{Register}:

Register configured settings.

{Close}:Cancel output format configuration, and return		to the [System settings] screen.

{Cancel}:The dialog box closes.

: Checked items will be output.

Output Items
1. Small space (narrow)Details
PrinterLine spacing when printing to a printer is narrowed.

Printer

A new line is inserted in the following locations when printing toa printer.
･ Between measured data
･ Between items when multiple items were tested(This applies to printing during real time printing and measured
data processi

2. New line

3. Rack No.

4. Sample No.

5. Sample ID

6. DA value

7. Flag(+-)

8. Date9. Value format

Explanatory note

External media
OnlineThe rack number and rack position number are output.
The rack number and rack position number are output.

External media
OnlineOutput the sample number.
Output the sample number.

External media
OnlineOutput the sample ID.
Output the sample ID.

Printer
External media

Print the DA value to a printer.
Output the DA value.

External media
OnlineOutput the judgment results.
Output the judgment results.

Online############.#

Output the measurement date and time.
Select the output format of measured data.
Output as an integer.
Output up to the first decimal place (all measured data is roundedup).

:All information applies when outputting to a hard disk(SSD), regardless of the output format
settings.

Explanatory note: If ASTM communication is set as the communication mode on the [Online settings] screen,
only the [Value format] setting is applied. Other settings are ignored.

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System settings

6.1.9

Alarm

Configure the time and pattern for alarms to sound when testing is completed, the system is waiting
for a new rack to be placed, when there is an operation error, or other situations.
The [Alarm] screen is composed of two pages. Switch pages by touching the {Page 1} and {Page 2}
tabs.
This section describes the procedure from the [System settings] screen.
		Page 266 “6.1.1 Sample barcode settings (common)”1

Touch the {Alarm} button.

2

Configure the alarm time and pattern.
1 Finished
2 Waiting
3 Judging CC
4 No reagent/Tank full		 (See page 294.)

				

3

Touch the {Page 2} tab.

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4

System settings

Configure the alarm time and pattern.
5 Cover open
6 Error
7 Key input error
8 Output error
		 (See page 295.)

5

Touch the {Continue} button.

6

Touch the {Register} button.

{Register}:

Register configured settings.

{Close}:Cancel alarm configuration and return to the		[System settings] screen.

{Cancel}:The dialog box closes.

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System settings{Page 1} tab
Output Items
1. Finished

Details
Sounds when testing of the sample placed in the rack supply unit
is finished, and the system is waiting.
Endlessmin
TimesType aType bType cContinues to sound until the error is cleared.
Configure the time (minutes) for the alarm to sound. (1 to 99)
Configure the number of times for the alarm to sound. (1 to 99)
The alarm will stop once it has sounded the specified number oftimes
Alarm sounds with type a.
Alarm sounds with type b.
Alarm sounds with type c.
Sounds to notify the user when the rack supply is fed from therack supply unit.

2. Waiting

Endlessmin
TimesType aType bType cContinues to sound until the error is cleared.
Configure the time (minutes) for the alarm to sound. (1 to 99)
Configure the number of times for the alarm to sound. (1 to 99)
The alarm will stop once it has sounded the specified number oftimes
Alarm sounds with type a.
Alarm sounds with type b.
Alarm sounds with type c.
Sounds when the system is waiting for the operator ’s
determination following calibration curve judgment.

3. Judging CC

Endlessmin
TimesType aType bType c
4. No reagent
Tank fullContinues to sound until the error is cleared.
Configure the time (minutes) for the alarm to sound. (1 to 99)
Configure the number of times for the alarm to sound. (1 to 99)
The alarm will stop once it has sounded the specified number oftimes
Alarm sounds with type a.
Alarm sounds with type b.
Alarm sounds with type c.
Sounds when the system detects insufficient reagent, buffer, wash
solution, or purified water, or when the drain tank is full.

Endlessmin
TimesType aType bType cContinues to sound until the error is cleared.
Configure the time (minutes) for the alarm to sound. (1 to 99)
Configure the number of times for the alarm to sound. (1 to 99)
The alarm will stop once it has sounded the specified number oftimes
Alarm sounds with type a.
Alarm sounds with type b.
Alarm sounds with type c.

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System settings{Page 2} tab
Output Items
5. Cover open

Details
Sounds when the protective cover is opened during operation.
Endlessmin
TimesType aType bType cContinues to sound until the error is cleared.
Configure the time (minutes) for the alarm to sound. (1 to 99)
Configure the number of times for the alarm to sound. (1 to 99)
The alarm will stop once it has sounded the specified number oftimes
Alarm sounds with type a.
Alarm sounds with type b.
Alarm sounds with type c.
Sounds when an operational error has occurred.

6. ErrorEndlessmin
TimesType aType bType c7. Key input error

Continues to sound until the error is cleared.
Configure the time (minutes) for the alarm to sound. (1 to 99)
Configure the number of times for the alarm to sound. (1 to 99)
The alarm will stop once it has sounded the specified number oftimes
Alarm sounds with type a.
Alarm sounds with type b.
Alarm sounds with type c.
Sounds when an incorrect entry is made using the keypad.

Times

Type aType bType cConfigure the number of times for the alarm to sound. (1 to 99)
The alarm will stop once it has sounded the specified number oftimes
Alarm sounds with type a.
Alarm sounds with type b.
Alarm sounds with type c.
Sounds when there is an error with the output destination when
outputting to a printer or online.

8. Output error

TimesType aType bType cConfigure the number of times for the alarm to sound. (1 to 99)
The alarm will stop once it has sounded the specified number oftimes
Alarm sounds with type a.
Alarm sounds with type b.
Alarm sounds with type c.

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6.1.10Screen saver

The screen saver starts up when there is no keypad activity on the [MENU] screen.
The time required until the screen saver starts is configured in the screen saver settings
This section describes the procedure from the [System settings] screen.
		Page 266 “6.1.1 Sample barcode settings (common)”1

Touch the {Screen saver} button.

2

Configure settings for the screen saver (see thefollowing page).

		
				

3

Touch the {Continue} button.

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4

Setting
Screen saver

Touch the {Register} button.

{Register}:

Register configured settings.

{Close}:Cancel screen saver configuration and return to		

the [System settings] screen.

{Cancel}:The dialog box closes.

Choice/Setting

ON
OFF
Waiting time

System settings

1 to 99 minutes

Character

Details
Select whether or not to start the screen saver
when the configured wait time has elapsed.
Starts.
Does not start.
Input the waiting time.
Select the character.

Character 1
Character 2
Character 3

Character 1 starts.
Character 2 starts.
Character 3 starts.

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6.1.11 STD/QC analysis process settings
Configure the conditions for checking measured data for STD/QC samples.
The [STD/QC process settings] screen is composed of two pages.
STD specifications are set in {Page 1}, while limit values for each QC# are set in {Page 2}.
Touch the tabs to switch pages.
This section describes the procedure from the [System settings] screen.
		Page 266 “6.1.1 Sample barcode settings (common)”1

Touch the {STD/QC Process} button.

2

Configure STD specifications (see page 300).

				
		

3

Touch the {Page 2} tab.

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4

System settings

Configure QC control limit values (page 301).

		

5

Touch the {Continue} button.

6

Touch the {Register} button.

{Register}:

Register configured settings.

{Close}:Cancel [STD/QC process] and return to the		[System settings] screen.

{Cancel}:The dialog box closes.

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System settings{Page 1} tab
Setting(Analysis Items)

Choice/Setting

Details
Select the assay item.
［F-Hb］ Fecal hemoglobin［FCa］ Fecal calprotectin

Operator judgment

Select whether or not the operator makes ajudgment following STD/QC measurement.
YES

Operator makes a judgment.
The system will wait for the operator ’s
judgment following STD/QC measurement,
so it will enter standby.

NO

Operator does not make judgment.
If the measured data is normal, measurement
continues. If there is an error, the systementers standby and waits for the operator’s
judgment.

STD Spec

Configure specifications for each STD point.
The system will determine STD pass/failusing the configured specifications.

STD-6 Min DA-9999 - 99999

STD-6 Max DA-9999 - 99999

STD-6 to 3 back fit±(%)

0 - 100

STD-1 Min DA-9999 - 99999

STD-1 Max DA-9999 - 99999

STD-2 DA back fit±(%)

0 - 100

Explanatory note

Check using DA1 value.
Configure so that minimum < maximum.
Check using the deviation from origin.
Check using DA1 value.
Configure so that minimum < maximum.
Check using the deviation from origin.

:When measuring a QC sample only, the system will not wait for operator judgment even if themeasured data is outside the limit value. Processing continues.

Explanatory note

:See page 343 “Appendix: 1.1 STD/QC Sample Measured Data Check” for information on
how to check STD/QC measured data.

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System settings{Page 2} tab
Setting

Choice/Setting

Details
Configure the maximum/minimum control
limit values for QC1 through 4.
QC pass/fail is determined using the
maximum/minimum values set for each QC#.

QC1 to QC4
Min limit［ng/mL］ or [µg/g]
Max limit［ng/mL］ or [µg/g]

QC LOT

SD coefficient □ SD

0.0 - 9999999.9

Configure so that minimum < maximum.

A string of characterscomposed from 0
through 9, X, Y, and Z.
(Up to five half-widthcharacters.)）

1-9

The standard deviation coefficient can be set
from 1 to 9 SD (initial setting is 3 SD).
The standard deviation coefficient is used－
when calculating the X-R control graph on
Process QC.

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6.1.12

Sample cup

Configure the shape of the sample cup. Two types of containers can be registered: {Cup 1} and{Cup 2}.
Touch the appropriate tab to switch between containers 1 and 2.
Explanatory note

: Only one type of container can be used during testing. Two types of containers cannot be
used at the same time.

This section describes the procedure from the [System settings] screen.
Page 266 “6.1.1 Sample barcode settings (common)”

Caution・Confirm the correct size of the sample cup.
If an incorrect size is configured, the nozzle may be inserted into the liquid too deeply when
Requiredabsorbing the sample, or it may absorb air, leading to incorrect analysis.

1

Touch the {Sample cup} button.

2

Configure the information for sample cup{Cup 1} (see page 304).

3

Touch the {Cup 2} tab, and switch to the settings
screen.

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4

System settings

Configure the information for sample cup{Cup 2} （see page 304） .

5

Check “Use this type of sample cup.”
To select container 1, touch the {Cup 1} tab, andswitch to the settings screen.

6

Touch the {Continue} button.

7

Touch the {Register} button.

{Register}:

Register configured settings.

{Close}:Cancel [Sample cup info settings] and return to		

the [System settings] screen.

{Cancel}:The dialog box closes.

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System settings{Cup 1}/{Cup 2} tabsgf

← Upper most part of container

a

c

e
b

d
← Container bottom

Setting

Setting Rangeab

Details

Inside diameter of straight part8.0 - 12.7 （mm）

Inside diameter of tapered partc

Length of straight partdLength of tapered parte

0.0 - 29.0 （mm）

Length from container bottom to top faceof rackf

0.0 - 10.0 （mm）

Length of straight part at the uppermost
part of the containerg

8.0 - 22.0 （mm）

Inside diameter of straight part at theuppermost part of the container

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6.1.13

System settings

Printing information on system settings

Print information registered to system settings.

1

Explanatory note

Touch the {Settings} button.

: The [System settings] screen can also be displayed by touching the {Settings} button on the [Test]
screen.

2

Touch the {Print} button.
* All setting information registered to [System settings]
will be printed.

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System settings

6.1.14

Backing up information on system settings/protocol settings

Back up information on system settings and protocol settings.

1

Explanatory note

Touch the {Settings} button.

: The [System settings] screen can also be displayed by touching the {Settings} button on the [Test]
screen.

2

Touch the {Back up} button.
* Information on [System settings] and [Protocol
settings] will be backed up to the external media.

{Cancel}:Cancel the backup.

{Start}:Start the backup.

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6.1.15

System settings

Restoring information on system settings/protocol settings

Read information on system settings and protocol settings from external media, and restore to thesystem.
1

Explanatory note

Touch the {Settings} button.

: The [System settings] screen can also be displayed by touching the {Settings} button on the [Test]
screen.

2

Touch the {Restore} button.
* The settings in [System settings] and [Protocol
settings] will be restored from the external media to
the system.

{Cancel}:Cancel restore.

{Start}:Start restore.

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Protocol settings
Protocol settings are largely split into three condition settings.
･ Conditions when measuring samples and QC samples (sample/QC protocol settings)･ Calibration curve settings used by protocols (CC No. 1 to CC No. 6 protocol settings)･ Common conditions when measuring samples, STD samples, and QC samples (manufacturer
		 settings)
Protocol settings will not need to be touched during everyday analysis flow unless changes are
made.
Manufacturer settings are configured at the factory and cannot be changed by the user.

6.2.1

Samp/QC protocol settings

Configure conditions when measuring samples (including STAT samples) and QC samples.
The setting screen is composed of two pages. Pages can be switched using the tabs.

1

Explanatory note

Touch the {Settings} button.

: The [System settings] screen can also be displayed by touching the {Settings} button on the [Test]
screen.、2

Touch the {Protocol settings} tab.		

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3

Protocol settings

Select the assay item.

・ [F-Hb]		・ [FCa]				・ [Common] (Common setting of two analysis items)
Explanatory note

:The items that can be set vary depending on
the selected assay item.

4

Touch the {Samp/QC protocol} button.

5

Configure items (see page 311 ).

6

Touch the {Page 2} tab.

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Protocol settings

7

Configure items (see page 312 ).

{Print}:Print [Sample/QC protocol] settings.

8

Touch the {Continue} button.

9

Touch the {Register} button.

{Register}:

Register configured settings.

{Close}:Cancel [Sample/QC protocol] settings, and		

return to the [Protocol settings] screen.

{Cancel}:The dialog box closes.

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Protocol settings{Page 1} tab
1

Setting
Sample Replicate

2

QC Replicate

3

Cut off 1

Settings
1 to 10 times
1 to 10 times

Cut off 2

1+

Measured data is “above Cut off 1 value” or“Cut off 2 or lower”-

Measured data is “setting value or lower”

Configure the judgment criteria for Cut off 2.
*,
0 - 9999999(integer)5

Configure the number of times to measure QC samples.

Configure the judgment criteria for Cut off 1.
0 - 9999999(integer)4

Details
Configure the number of times to measure samples.

Cut off 3

2+

Measured data is “above setting value,”“larger than Cut off 1,” or “Cut off 3 orless”
If set to “*,” Cut off 2 judgment will not be
performed.
Cut off 1 < Cut off 2

Configure the judgment criteria for Cut off 3.
*,
0 - 9999999(integer)3+

Measured data is “above setting value”
If set to “*,” Cut off 3 judgment will not be
performed.
Cut off 2 < Cut off 3

6

Min Value

0.0 9999999.9

UR

Displayed when measured data is “Min
Value” or lower during dilute testing.

7

Max Value

0.0 9999999.9

OR

Displayed when measured data is larger
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Protocol settings{Page 2} tab
8

Setting
RBC checkSettings

Details
Set whether or not to run RBC checking. Check tohave it run.
Page 352 “ ■ RBC method”

9

RBC coefficient10

PRC check

1.0 - 2.0

Samples with an absorbance larger than theabsorbance × “RBC coefficient” of STD-6 at the
RBC detection point are determined to be prozone
samples.
Page 352 “ ■ RBC method”
Set whether or not to run PRC checking. Check tohave it run.
Page 353 “ ■ PRC metod”

11

PRC coefficient

0.01 - 2.00

Samples with a DA2 value larger than the DA2 value× “PRC coefficient” of STD-6 at the second detection
point (T2) are determined to be prozone samples.
Page 353 “ ■ PRC metod”

12

Factor A

0.001 9999.999

13

Factor B-999.999 999.999

Measured data = A × concentration value + B

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Protocol settings

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Protocol settings

6.2.2 CC No. 1 to CC No. 6 protocol settings
Configure conditions required for measurement of STD samples.
Up to six calibration curves can be registered (CC numbers 1 through 6).
The setting screen is composed of two pages. Pages can be switched using the tabs.

This section describes the procedure from the [Protocol settings] screen.
		Page 308 “6.2.1 Sample/QC protocol settings”

1

Touch the {CC No. # protocol settings} button (#is the protocol number).
[F-Hb] ： CC No.1 ～ 3[FCa] ： CC No.4 ～ 6

		Explanatory note

: When [Common] is selected, the [CC No. # Protocol Setting] button does not work.

2

Configure items (see page 316).

		

3Touch the {Page 2} tab.

{Print}:Print [CC No. # protocol] settings.

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6.2

4

Protocol settings

Configure items (see page 316 ){Print}:Print registered [CC No. # protocol] settings.

5

Touch the {Continue} button.

6

Touch the {Register} button.

{Register}:

Register configured settings.

{Close}:Cancel [CC No. # protocol] settings, and return		to the [Protocol settings] screen.

{Cancel}:The dialog box closes.

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6.2

Protocol settings{Page 1} tab
1

Setting
Replicate

Settings
1 to 10 times

Details
Configure the number of times to measure STD
samples.

2Conc.

0- 99999.9

Configure the concentration listed in the
INSTRUCTIONS FOR USE for calibrator.
Configuring the calibrator concentration willautomatically calculate and configure the STD
concentration for STD-1 through 6 on the second
page.
* This item cannot be entered in [FCa].

{Page 2} tab
3

Setting
STD-6

Settings
0.1 9999999.9

Details
Configure the STD concentration of STD-6.

4

STD-5

0.1 9999999.9

Configure the STD concentration of STD-5.

5

STD-4

0.1 9999999.9

Configure the STD concentration of STD-4.

6

STD-3

0.1 9999999.9

Configure the STD concentration of STD-3.

7

STD-2

0.1 9999999.9

Configure the STD concentration of STD-2.

Explanatory note

:STD-2 through STD-6 are automatically configured when “calibrator concentration” on thefirst page is set.
Settings for STD-2 through STD-6 can be changed using the keypad.

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Chapter 7 Help

7.1

Opening the [Help] Screen from the [MENU]		

Screen7.2

Opening the [Help] Screen from the [Monitor]

		

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Chapter 7 Help
The [Help] screen is used to confirm the analysis flow, input methods on settings screens, and how
to operate the system including sample placement.
Touch the {Help} button on the [MENU] screen or the {Help} button on the [Monitor] screen to
open the [Help] screen table of contents. Then, select the button of the item to check.

7.1

Opening the [Help] Screen from the [MENU] Screen
1

Touch the {Help} button.

2

Touch the button of the item to check.
1.

Test flow

2.

How to input

3.

Setting reagents
Purified water, Wash sol.
Buffer, Latex

4.

Set samples

5.

Test
Change test mode
Change measure mode
Change Latex settings
Create CC

6.

DisposeExample: Touch the {5. Test} button.

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Opening the [Help] Screen from the [MENU] Screen

3

The page (1/#) is displayed at the top right of thescreen.
Use the {Next} and {Back} buttons to check
content.

{Next}:

Display the next page.

{Back}:

Display the previous page.

{CLOSE}:

Return to the [HELP] screen.

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Opening the [Help] Screen from the [Monitor] Screen
1

Touch the {Help} button.

2

Touch the button of the item to check.
1.

Test flow

2.

How to input

3.

Setting reagents
Purified water, Wash sol.
Buffer, Latex

4.

Set samples

5.

Test
Change test mode
Change measure mode
Change Latex settings
Create CC

6.

DisposeExample: Touch the {5. Test} button.

3

The page (1/#) is displayed at the top right of thescreen.
Use the {Next} and {Back} buttons to check
content.

{Next}:

Display the next page.

{Back}:

Display the previous page.

{CLOSE}:

Return to the [Help] screen.

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Opening the [Help] Screen from the [Monitor] Screen

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Chapter 8 Error Handling

		

8.1

How to Read [Error] Screens

		

8.2

Error Cancellation Buttons

		

8.3

Clearing Errors

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Chapter 8 Error HandlingIn the event of an error, the [Error] screen is displayed. If several errors have occurred, thefollowing page is displayed. Touch {Next err}to display errors.

8.1

How to Read [Error] Screens
f
↓
←e

a→

←c

b→

←d
[Error] screenabcdError status
Error location
Error cause andcancellation method
Page buttons

Displays the error number and name.
Displays the location of the error using a graphic.
Displays the cause of the error and how to clear it.
Switch pages when the handling method for a single error spans
multiple pages.

{Back}

Display the previous page.

{Next}

Display the next page.

e

Error cancellation buttons

Buttons to recover from errors.

fError switching buttons

Switch the error display when multiple errors have occurred.

{Last err}

Display the previous error.

{Next}

Display the next error.

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8.2

Error Cancellation Buttons

Error Cancellation Buttons
Buttons for clearing errors are displayed at the top of the [Error] screen.
The following are operations after a cancellation button has been touched:
Button Name

Function{RETRY}

Retry processing on the sample for which an error had occurred.

{PASS}

Cancel processing for the sample that is being tested, and process thenext sample.

{ABORT}

Terminate processing.
If selected during testing, terminates processing for the sample being
tested.

{CONTINUE}

Restart the operation of the working part that was halted due to error
detection{CLOSE}

Close the screen{MUTE}

Mute the alarm.

Explanatory note

: The cancellation buttons that are displayed depend on what error has occurred.

		

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Clearing Errors
Clear errors using the following procedure:

1

Confirm the error.
① Confirm the error and its location.
② Select the cancellation button from the error
		cancellation methods and touch it.

		2Page 325 “8.2 Error Cancellation Buttons”

For all cancellation buttons other than the{ABORT} button, the error is cleared andoperation continues.

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8.3

2

Clearing Errors(continued)<If the {ABORT} button was selected>① Touch the {ABORT} button.

② Touch the {Abort} button.
* Reaction table processing is aborted, and the system
returns to the [MENU] screen.
The result of the sample being measured is canceled.

Explanatory note

{Cancel}:Abort is canceled and the system returns to the		[Error] screen.

{Close}:Reaction table processing is terminated and the		system returns to the [MENU] screen.

: If an error occurs in the following situations, the process is aborted without the Abort confirmation
dialog box being displayed even if the {ABORT} button is touched.
- Errors occurring during maintenance or support functions (errors outside of testing)- Errors occurring on the reaction table (errors that cannot be normally closed)

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Chapter 9

Operator/Latex Management Function(Option)		

9.1

LOGIN/LOGOUT

		

9.2

Registering, Modifying, and Deleting			

Operators (ID Information)

		Managing Latex/QC Lots

9.3

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Chapter 9 Operator/Latex
Management Function（Option）
This function is used to manage the operators that are using the system and expiration dates for latex
being used with the system, in conformance with ISO15189 ｢Medical laboratories — Requirementsfor quality and competence.｣
In order to use this function, operator information (ID information) must be registered and lot numbers
must be entered when setting latex.
Explanatory note: "Analysis" cannot be set in [Auto Startup/Auto Start Settings] for the completion mode whenusing the operator/latex management function.

9.1

LOGIN/LOGOUT
You must login to use all functions on the [MENU] screen. Enter the ID information on the [LOGIN]
screen to login. The ID of the user who is logged in is shown on the [MENU] screen.
After logging in, if there is no operation on the [MENU] screen for a certain period of time, youwill be automatically logged out.
Page 276 "6.1.4 Environment settings"

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9.1

9.1.1

LOGIN/LOGOUT

LOGINStart the system and run either introduction priming or cell blank measurement to open the [LOGIN]
screen.
1Enter the ID and then touch[enter].Confirm thename of the operator that is displayed.

2Enter the PASSWORD and then touch [enter].

3

Touch [LOGIN/LOGOUT].

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9.1 LOGIN/LOGOUT
4

A confirmation message {OK} is displayed.
Touch [LOGIN].

5

The [MENU] screen is displayed, with the ID of
the logged in user shown next to the [key]icon on
the bottom of the screen.

Explanatory note

: Touching 【enter】 without entering ID information will display that [MENU] screen without logging
in.

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9.1.2

LOGIN/LOGOUTLOGOUT
1

Touch the[key] icon (the ID of the logged inuser is shown next to it) at the bottom of the[MENU] screen.

2

Touch [LOGIN/LOGOUT].

3

Touch [LOGIN].

4

The system returns to the [MENU] screen, andthe ID display area switches to a message {Pleaselogin.}. You are now logged out.

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Registering, Modifying, and Deleting Operators(ID Information)
Up to 11 operators (including one administrator) can be registered. The remaining numbers ofregistration are shown on the top-left of the [LOGIN] screen. The first ID that is registered (the ID
registered when the remaining numbers of registration are 11) will be the administrator.

9.2.1

Registering ID Information

This method is used to register new ID information.

1

Open the [LOGIN] screen.If another operator islogged in, touch the [Key] icon on the [MENU]
screen to logout. Once you return to the [MENU]
screen, touch the [Key] icon again.

2

Touch [Register].Confirm the name of theoperator that is displayed.

3Enter the password and then touch [enter].

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9.2

Registering, Modifying, and Deleting Operators (ID Information)
4

Touch [Update].A confirmation message{ Register the entered information.} is displayed.

Explanatory note: If you touch [enter] without entering the ID information,the "One or more required fields are empty" message is displayed.

5

Touch [Update]

ID information registration is complete.
ID information will not be registered if you touch[Cancel].

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9.2 Registering, Modifying, and Deleting Operators (ID Information)

9.2.2

Change ID

This method is used to change ID information that has already been registered.

1Enter the ID and then touch [enter]. Confirm thename of the operator that is displayed.

2Enter the PASSWORD and then touch [enter].

3

Touch [Change Info].The PASSWORD field iscleared.

Explanatory note

: Entering an ID and password that have already been registered will activate the 【Change
Info】 button.

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9.2

Registering, Modifying, and Deleting Operators (ID Information)
4Enter the new ID information and then touch[enter].

5

Touch [Update].

6

A confirmation message { Register the enteredinformation?} is displayed.
ID information registration is complete.
ID information will not be registered if you touch[Cancel].

7

The ID information is updated with the new
information.

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9.2 Registering, Modifying, and Deleting Operators (ID Information)

9.2.3

Deleting ID Information

ID information for individual operators can be deleted by the administrator or the individual operator.
The administrator can also delete all ID information that has been registered.
1Enter the ID and then touch [enter]. Confirm thename of the operator that is displayed.

2Enter the PASSWORD and then touch [enter].

3

Touch [Delete].
A "Delete displayed operator information"
confirmation message appears.

If you are an administrator,
a "Delete all imformation except administrator
in the registration list" confirmation message
is displayed.

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9.2

Registering, Modifying, and Deleting Operators (ID Information)
4

A confirmation message { Delete the operator
information in the registration list whichdisplayed.} is displayed.
Touch [OK].

5

The system returns to the [LOGIN] screen.
To delete ID information for all operators, theadministrator must touch [Delete all] during Step.

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9.3

Managing Latex/QC Lots
When a lot number is entered when setting latex, the expiration date is calculated from the lot
number information.
When sample or QC measurement is performed, the lot number and expiration date are recorded in
the analysis results.
Explanatory note

: Analysis can be performed even if the latex is past its expiration date, so always check the
expiration date.

Lot management information

Details

Operator ID

The ID of the operator that is logged in.

Latex lot(*1)

The lot of the latex that was used.

Latex expiration date(*1)

The expiration date of the latex, calculated from the lot number
entered when setting latex.

Buffer lot(*1)(*2)

The lot of the buffer that was used.

Buffer expiration date(*1)

The expiration date of the buffer, calculated from the lot number
entered when setting buffer.

QC lot(*1)

The lot of the QC that was used.

QCexpiration date(*1)

The expiration date of the QC, calculated from the lot number
entered when setting QC.

*1 If the dispensing operation is not performed, "" is output for the lot and expiration date.
*2 Enter the lot of the buffer on the reagent set screen.

Enter the lot of the buffer
for CalprotectinEnter the lot of thebuffer for Hemoglobin

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Appendix

1

Calculation Processing

2

Test Operations

3

Printing examples

4

Handling the Printer5

Error List

6

Save to External Media

7

Management USB Stick Setting

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1

Calculation Processing
The following calculations are processed during testing:

1.1 STD/QC Sample Measured Data Check
1.2 Calibration curve calculation
1.3 DA value calculation
1.4 Measured Data (Concentration) Calculation and Qualitative
		Assessment
1.5 Prozone check1.6 Reagent Blank Check (A1 Check)
1.7 Calculate Cell Blank

			

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1.1

Calculation Processing

STD/QC Sample Measured Data Check
Check whether the measurement results for STD or QC samples are correct.

1.

STD sample measured data check① Check that the calibration curve is rising from bottom left to top right fromthe magnitudes of the DA1 values at each point.
② Check whether the magnitudes of DA1 values at adjoining points are not
the same. If they are the same, the result is judged as “abnormal.”③ Check the deviation (%) between the origin and back fit.
The specifications for each STD are as follows:
・ STD-1“Abnormal” if outside DA upper/lower range

・ STD-2-“Abnormal” if deviation is not within ±10% of the origin

・ STD-5
・ STD-62.

“Abnormal” if outside DA upper/lower range

QC sample measured data check
Check based on the control limit values set in the [STD/QC process settings]
screen.
The result is judged as “abnormal” in the following cases:

・ The minimum control limit value is less than 1
・ The maximum control limit value is +1 or more343
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Calculation Processing

1.2

Calibration curve calculation
There are three curve types: Aloka curve, linear and cubic curve, and Cubic spline curve.

■

Aloka curve
Fits an Aloka curve to plotted DA1 value to obtain a calibration curve.
Aloka curves are composed of a linear fit portion and a cubic fit portion.

・ Linear fit → between STD-1 and STD-2 (Figure 1-a)・ Cubic fit → between STD-2 and STD-6 (Figure 1-b)

Calibration curve created fromDA1 values
DA ValueYba0

STD-1 STD-2 STD-3 STD-4 STD-5 STD-6

STD concentration X
Figure 1

STD concentration (X):

Converted logarithmically, and a cubic-polynomial fitting is performed.
X = log10 (STD concentration)

DA value (Y):R converted logarithmically, and a cubic-polynomial fitting is performed.
Y = loge {R ÷ (1–R)}

R:

Converted value for Aloka curve
R = (DA value - NSB) ÷ (B0 - NSB)		NSB = Cmin – KL (Cmax – Cmin)		

B0 = Cmax + KH (Cmax – Cmin)		KL = 0.2, KH = 0.2

Cmax:

DA value maximum

Cmin:

DA value minimum

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Calculation Processing<Zero concentration point measured>
A linear line is fitted to the DA values of STD-1 and STD-2.

Calibration curve created fromDA1 values
DA ValueY

0 STD-1 STD-2 STD-3 STD-4 STD-5 STD-6

STD concentration X

Figure 2

DA values used by calibration curve

Replicate n ≧ 3: The mean DA value excluding the maximum and minimum values
Replicate n ＜ 3: The mean DA value345
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1

Calculation Processing<DA value at zero concentration point larger than DA value at STD-2 concentration point>
Regression analysis is not performed between STD-1 and STD-2.
With this kind of calibration curve, measured data cannot be calculated from a DA value lower thanthe DA value of STD-2.

Calibration curve created fromDA1 values

DA Value

Y

↑

Zero
concentration
DA value0

STD-1 STD-2 STD-3 STD-4 STD-5 STD-6

Explanatory note

STD concentration X

Figure 3: In cubic regression calculation, calculation is performed with X and Y reversed.
(X: DA value, Y: concentration value)
In Aloka curve calculation, X and Y are not reversed.
DA value normalization is not performed(normalized DA value = DA value ÷ DA value of maximum concentration point).

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Calculation Processing

Incalculable range of measured data
The range outside maximum DA value, minimum DA value, and B0 cannot be calculated.
The range outside the maximum and minimum concentration values also cannot be calculated (theshaded regions in Figure 5).

DA ValueY

0

STD concentration X↑↑

Minimum
concentration point

Maximum
concentration point

Figure 4347
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1 Calculation Processing■

Linear and cubic curves
A linear line and cubic line are fitted to the DA1 values.

・ Linear fit → between STD-1 and STD-2 (Figure 1-a)・ Cubic fit → between STD-2 and STD-6 (Figure 1-b)

The DA value of the linear STD-2 point is calculated using Newton’s method from the cubic line.
Page 345 “ ■ Aloka curve <Zero concentration point measured>“■

Cubic spline curve
Regress DA1 with a cubic spline curve to create a calibration curve.
A cubic polynomial approximation of each interval from STD-1 to STD-6.

Y ＝ F3i ・ X3 ＋ F2i ・ X2 ＋ F1i ・ X ＋ F0i （ i ： 0 ～ 4）
STD-1 ～ STD-2 interval ： F30 F20 F10 F00
STD-2 ～ STD-3 interval ： F31 F21 F11 F01
STD-3 ～ STD-4 interval ： F32 F22 F12 F02
STD-4 ～ STD-5 interval ： F33 F23 F13 F03
STD-5 ～ STD-6 interval ： F34 F24 F14 F04

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Calculation Processing<DA value at zero concentration point larger than DA value at STD-2 point>
Page 346 “ ■ Aloka curve <DA value at zero concentration point larger than DA value at
STD-2 concentration point>349
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Calculation Processing

1.3

DA value calculation
DA values are final measurement results. Measured data (concentration value: X) is calculated
from DA values and calibration curves. When a reagent is dispensed to a cell that has dispensed asample, latex agglutination proceeds and absorbance (ABS) changes.
The time course shows changes in absorbance.
The time course is monitored once a sample is dispensed into a cell (see Figure 5).

Time course
［ABS］
A3
A2
DA1

DA2
A1

0

T1

T2

T3

[Cycle]T1: 1st detection point

A1: T1 absorbanceT2: 2nd detection point

A2: T2 absorbanceT3: 3rd detection point

A3: T3 absorbanceFigure 5

A1, A2 and A3 are the mean values of absorbance of two consecutive cycles.
Example: T1 = 6, T2 = 8, T3 = 33 [Cycle]
		

A1 = (Absorbance of the 6th cycle + absorbance of the 5th cycle) ÷ 2

		A2 = (Absorbance of the 8th cycle + absorbance of the 7th cycle) ÷ 2

		A3 = (Absorbance of the 33rd cycle + absorbance of the 32nd cycle) ÷ 2

DA values are the amount of change for A1, A2, and A3.
DA1: A3 - A1
DA2: A2 - A1

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1.4

Calculation Processing

Measured Data (Concentration) Calculation and Qualitative
Assessment
Measured data (concentration values) is calculated from DA values and the calibration curve,
normalized measured data and cut-off values are compared, and a qualitative assessment isperformed.

1.

Calculate measured data (concentration values)
using DA values and calibration curves.
Page 350 “1.3 DA Value Calculation”

2.

Range check by minimum/maximum
measurement value*
OR：

Displayed when measured data has exceeded		

maximum measurement value.

Concentration value

Displayed when measured data is at or below：

		maximum measurement value.

UR

Displayed when measured data is lower than：		

minimum measurement value during a dilute test.

Page 308 “6.2.1 Sample/QC protocol settings”* Measured data is the value prior to correction (such as correction by factor A/B
or by applying a dilution ratio).

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Calculation Processing

1.5

Prozone check
Prozone checking is conducted using two methods: RBC method and PRC method.
RBC method: Compare the absorbance of the RBC points in STD-6 (maximum concentration point)
and the sample.
PRC method: Compare the DA2 values in STD-6 (maximum concentration point) and the sample.

■

RBC method
Compare the RBC point sample absorbance (a) and STD-6 absorbance (b), if the following
relationship is formed, designate the sample as “prozone samples.”(b) × RBC method coefficient < (a)Time course［ABS］
Prozone sample

a

STD-6

b

0

RBC point(maximum measurement value)

Explanatory note

[Cycle]Figure 6: The RBC method coefficient is set in “9RBC method coefficient” on {Page 2} of the [Protocol
settings] ･ [Samp/QC protocol] screen.

Explanatory note

: The sample absorbance (a) and STD-6 absorbance (b) are the mean values of each RBC point
and its previous point.
Example:When the RBC point is 5, (a) and (b) are each the value of (5th cycle
absorbance + 4th cycle absorbance) ÷ 2.

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Calculation Processing

PRC method
Compare the DA2 values of the sample and STD-6, forming the following relationship. Standing
samples are designated as “prozone samples.”DA2STD-6 × PRC method coefficient < DA2sample

Time course［ABS］

Prozone sample

STD-6

DA2 sample
DA2STD-6

0

T1

T2

[Cycle]DA2sample :DA2 value of prozone sample

DA2STD-6 :DA2 value of STD-6

Figure 7353
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1

Calculation Processing

1.6

Reagent Blank Check (A1 Check)
Checks whether or not a reagent was dispensed normally using the absorbance of the T1 cycle.
ADC values of the T1 cycle and the T1-1 cycle are averaged to obtain absorbance, which is comparedwith the maximum and minimum values of the A1 check.

If either of the following conditions is met, an error message appears displaying “Latex blankerror.”

Mean absorbance < A1 check minimum valueorMean absorbance > A1 check maximum value
Explanatory note

: Absorbance = log10 (reference value ÷ ADC value) × 10,000 – cell-blank value

Explanatory note

: The A1 check maximum and minimum values are set by the manufacturer.
They cannot be modified by the customer.

1.7

Calculate Cell Blank
Perform detection for each cycle for each of the 55 cells after the start analysis.
• For the 55th cell, the ADC mean value is calculated using ADC values measured during theperiod of time between dispensing of purified water with the 3rd nozzle and absorbing of purified
water with the 4th nozzle (four cycles), and this ADC mean value is used as the reference value.

Reference value = (ADC mean value)= Four-cycle Accumulation of ADC values ÷ 4 (Cycles)• For each of the 1st to 54th cells, calculate the mean value of ADC values in the same way aswith the 55th cell, and calculate a cell-blank value according to the following equation.

Cell-blank value= Log10 (Reference value ÷ ADC average) × 10,000354
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2

Test Operations
This section describes test operations according to the rack or measure mode being used.

2.1

Operation when first measuring a sample using a “sample rack” (first test)

2.2

Operation when retesting a sample using a “retest rack” (retest)

2.3

Operation when remeasuring a sample using a “sample rack” (remeasure)

2.4

Operation when diluting a sample again and measuring it using a “dilute		 test rack” (dilute test)

2.1

2.5

Operation when measuring STD/QC samples

2.6

Operation when performing cut-in analysis

Operation when first measuring a sample using a “sample rack”(first test)

This section describes the “first test” operation.
The sample is set as in the following figure.

1

2

Explanatory note

3

4

5

6

7

8

9

10

: The numbers in the diagram indicate the rack position number. They are numbered from left (No. 1)
to right.

Explanatory note: If the accessory end ring is attached to a rack, racks from the one with the ring will not beanalyzed.

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2

Test OperationsFirst test
Read rack and sample barcodes

Confirm that the sample is set to the rack
(check for container)

Puncture the sampling bottle (when using a sampling bottle)

Squeeze the sampling bottle (when using a sampling bottle)

Confirm that the sample is set to the rack
(check for container)

Dispense reagent/buffer to measurement cells
After dispensing, wash the reagent nozzle

Mix sample and reagent
After mixing, wash the mixer

Measure transmitted light

After calculating measured data/performing a qualitative
assessment, output the data

Wash measurement cells

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Test Operations

2.2

Operation when retesting a sample using a “retest rack” (retest)
This section describes the “retest” operation.
Analyzed samples will be reanalyzed, so do not puncture the sampling bottle.
Otherwise, the procedure is the same as that for “first test.”

RetestRead rack and sample barcodes

Confirm that the sample is set to the rack
(check for container)

Absorb the sample and dispense to measurement cells
After dispensing, wash the sample nozzle

Dispense reagent/buffer to measurement cells
After dispensing, wash the reagent nozzle

Mix sample and reagent
After mixing, wash the mixer

Measure transmitted light

After calculating measured data/performing a qualitative
assessment, output the data

Wash measurement cells

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Explanatory note

Test Operations: Retest results have no impact on the positive rate.
“Duplicated sample barcode checking” is not performed during retests.

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2

Test Operations

2.3

Operation when remeasuring a sample using a “sample rack”(remeasure)This section describes the “remeasure” operation.
Measured samples will be remeasured, so do not puncture the sampling bottle.
Otherwise, the procedure is the same as that for “first test.”

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Remeasure

Test Operations

Read rack and sample barcodes

Confirm that the sample is set to the rack
(check for container)

Dispense the sample to measurement cells
After dispensing, wash the sample nozzle

Dispense reagent/buffer to measurement cells
After dispensing, wash the reagent nozzle

Mix sample and reagent
After mixing, wash the mixer

Measure transmitted light

After calculating measured data/performing a qualitative
assessment, output the data

Wash measurement cells

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Test Operations

2.4

Operation when measuring a sample again it using a “dilute test rack”(dilute remeasure)This section describes the “dilute test” operation.
Analyzed samples will be reanalyzed, so do not puncture the sampling bottle.
If the dilute test rack is used, automatic dilution will be performed. There are two dilution
operations: 15-times dilution and 250-times dilution. The system determines which to use based on
the arrangement of sample cups in the rack.

Request・Use the dilute test rack when remeasuring a sample that had a dilute test

performed on it. Do not use the retest rack.
Explanatory note

: See page 272 “6.1.3 Rack No./QC No.” for information on how to set the retest rack
or dilute test rack numbers.

Explanatory note

: There are two dilution operations: 15-times dilution and 250-times dilution. The system

1

X15 X250

2

3

4

X15 X250567

Empty sample
cup

SamplingbottleEmpty sample
cup

SamplingbottleEmpty sample
cup

SamplingbottleSpecified retest diluent

determines which to use based on the containers arranged on the rack.

X15 X250891015-times dilute test : Creates a 15-times dilution sample in a
×15 empty sample cup, then measures.
250-times dilute test : Uses a 15-times dilution sample to createa 250-times dilution sample in a ×250
empty sample cup, then measures.
Explanatory note

: ×15 simultaneous analysis involves creating 15-times dilution and 250-times dilution samples,
and then measuring them (same as with 250-times dilute test).

Explanatory note

: The numbers in the diagram indicate the rack position number. They are numbered from left
(No. 1) to right.

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Dilute test

Test Operations

Read rack and sample barcodes

Confirm that sampling bottles or sample cups are set
to the rack (check for containers)

Dispense specified retest diluent to sample cups for dilution

Dispense samples from sampling bottles or sample cups tosample cups for dilution.

Mix the retest diluent and sample

Absorb the sample and dispense to measurement cells
After dispensing, wash the reagent nozzle

Dispense reagent/buffer to measurement cells
After dispensing, wash the reagent nozzle

Mix sample and reagent
After mixing, wash the mixer

Measure transmitted light

After calculating measured data/performing a qualitative
assessment, output the data

Wash measurement cells

Explanatory note

: “Duplicated sample barcode check” is not performed during dilute tests.

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Test Operations

2.5

Operation when measuring STD/QC samples
This section describes the operation when measuring STD/QC samples.
When STD/QC racks are placed in the rack supply unit, a calibration curve is created and the samples
set to the rack are measured.
Calibration curves are created using “Latex/CC settings” specified on the [Test] screen. Createdcalibration curves are registered to “Registration CC No.” on the [Test] screen.
Page 64 “3 Configuring [Latex/CC settings]”
				Calibrator buffer

Calibrator

2.5.1

1

2

Measurement of STD and QC in the case of hemoglobin

Empty sample cup

3

4

5

6

7

8

QC1 QC2

Set the sample cups to the STD/QC rack as

QC3 QC4

shown in the diagram to the left.

910

1 Dispense No. 1 calibrator buffer to thesample cups in rack position numbers 3
through 6.
1

2

3

4

5

6

7

8

9

10

2 Create dilution series

1

2

3

4

5

6

7

8

9

10

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STD/QC sample(Hemoglobin)

Test Operations

Confirm that the No. 1 through No. 6 sample cups are set
to the rack (check for containers)
Dispense No. 1 calibrator buffer to the No. 3 through No. 6
sample cups

1

Dispense No. 2 calibrator to the No. 6 sample cup

Mix the No. 6 liquid

Dispense the mixed No. 6 liquid to the No. 5 sample cup

Mix the No. 5 liquid2

Dispense the mixed No. 5 liquid to the No. 4 sample cup

Mix the No. 4 liquid

Dispense the mixed No. 4 liquid to the No. 3 sample cup

Mix the No. 3 liquid

Dispense the No. 1 through No. 6 liquids to the measurement cells

Perform nozzle cleaning after each dispensing
Dispense the No. 9 and No. 10 QC samples to the measurement cells

Perform nozzle cleaning after each dispensing
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2

Test Operations

From previous page

Dispense reagent/buffer to measurement cells
After dispensing, wash the reagent nozzle
Mix sample and reagent
After mixing, wash the mixer
Measure transmitted light

After calculating measured data/performing a qualitative
assessment, output the data

Wash measurement cells

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2.5.2

Test Operations

Measurement of STD and QC in the case of calprotectincalibrator

In order of concentration weakness, from left to right.

Set the sample cups to the STD/QC rack as

QC1 QC2QC3 QC4

1

2

3

4

5

6

7

STD/QC sample(Calprotectin)

8

9shown in the diagram to the left.

10

Confirm that the No. 3 through No. 8 sample cups are set
to the rack (check for containers)
Dispense the No. 3 through No. 8 liquids to the measurement cells

Perform nozzle cleaning after each dispensing
Dispense the No. 9 and No. 10 QC samples to the measurement cells

Perform nozzle cleaning after each dispensing
Dispense reagent/buffer to measurement cells
After dispensing, wash the reagent nozzle
Mix sample and reagent
After mixing, wash the mixer
Measure transmitted light
After calculating measured data/performing a qualitative
assessment, output the data
Wash measurement cells

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Test Operations

2.6

Operation when performing cut-in analysis
This section describes the “cut-in analysis” operation.
Cut-in analysis uses sample racks and STD/QC racks.
Retest racks and dilute test racks can not be used.
Set samples to sample racks and STD/QC racks as follows:
Sampling bottles can also be installed alone

Sample racks

2

3

4

5

6

7

8

Empty sample cup

910

QC1 QC2QC3 QC4

Calibrator

STD/QC racks

Calibrator buffer

1(Hemoglobin)

calibrator

In order of concentration weakness, from left to right.

QC1 QC2QC3 QC4STD/QC racks(Calprotectin)
1

2

3

4

5

6

7

8

9

10

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Test Operations

Cut-in analysis
Begin testing from the cut-in installation position

Read rack and sample barcodes<For STD/QC racks><For sample racks><For Hemoglobin><For Calprotectin>

Confirm the position andConfirm the position andquantityquantityof sample cups set to the rackof sample cups set to the rack

Create the dilution series

Confirm that the containers are
set

Puncture the sampling bottles

Squeeze the sampling bottles

Dispense the dilution series sample/QC sample
to the measurement cells

Dispense the sample tomeasurement cells

Wash the sample nozzle

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2

Test Operations

From previous page

Dispense reagent/buffer to measurement cells
Wash the reagent nozzle

Mix liquid in measurement cells
Wash the mixer nozzle

Measure transmitted light

After calculating sample measured data/performing a qualitative assessment,
output the data

Wash measurement cells

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3 Printing examples
This section describes various printing examples.

3.1

Negative sample printing

3.2

Final result printing when using a dilute test rack or when analyzing

		 15-times dilution simultaneously
3.3

1 day, 2 day, 3 day printing

3.4

Printing when measuring STD/QC samples

3.5

Error message printing

Test item

Rack No.Rack position No.
Qualitative
assessment resultDA********************************
POWER ON
14/02/03 09:00****************************************************************
START
14/02/03 10:00********************************
F-Hb CC No.1
14/01/24 15:25
FCa CC No.4
14/01/24 15:45********************************
005-01 1-00001 123456789012345
F-Hb
89
63 ng/mL
*
FCa
-

114

005-02 1-00002

53 ug/g
NO TUBE005-03 1-00003
Sample No.
Group No.-Sequence No.

7788

Reag.Pippet Err********************************
END		
14/02/03 10:30********************************

Time and data ofsystem power on
Test start data and Time
Calibration curve
number and measurement
date and time
Sample ID
DATA

Messageindicating
Error message (Reagent
dispensing error)
Page 379“3.5 Error message
printing”
OR,UR,PRC is printed
in * area.

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3.1

Printing examples

Positive sample printing<When replicate number = 1>
“Sample information” and positive “analytical results” are printed in bold.

005-01 1-00001
F-Hb
50

123456789012345

005-02 1-00002
F-Hb
+
200

234567890123451

50 ng/mL

200 ng/mL<When replicate number > 1 and mean value is a positive sample>
The mean value row only is printed in bold.
( Example : replicate = 2 )005-01 1-00001
123456789012345
F-Hb
95
95 ng/mL+
110
110 ng/mL----------------------------------+
103 ng/mL

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Printing examples

3.2

Final result printing when using a dilute test rack or when analyzing
15-times dilution simultaneously<When replicate number = 1>********************************
094-03 1-00001
123456789012345
F-Hb+
700 A*
10000 ng/mL
094-04 1-00001
F-Hb+
35 A**

123456789012345
10500 ng/mL================================
094-03 1-00001
123456789012345+
700 A*
10000 ng/mL~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~*********************************

Result of 15-times dilution isprinted.

Result of 250-times dilution isprinted.

Final results are printed.

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Printing examples<When replicate number > 1>********************************
094-03 1-00001
123456789012345
F-Hb+
700 A*
10000 ng/mL+
700 A*
10000 ng/mL--------------------------------+
700 A*
10000 ng/mL
0.00
0.0
094-04 1-00001
123456789012345
F-Hb+
35 A**
10500 ng/mL+
35 A**
10500 ng/mL--------------------------------+
35 A**
10500 ng/mL
0.00
0.0================================
094-03 1-00001
123456789012345+
700 A*
10000 ng/mL~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~********************************

Result of 15-times dilution isprinted.

Result of 250-times dilution
is printed.

Final results are printed.

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Printing examples

3.3

1 day, 2 day, 3 day printing
Sample number 1

1-day

005-01 1-00001
F-Hb
+
200

123456789012345

005-02 1-00002
F-Hb
+
210

234567890123456

200 ng/mL

Sample number 2

210 ng/mL
Sample number 1

006-01 1-00001/1 111111111111111
F-Hb
+
210
210 ng/mL

2-day

First day sample
Second day sample

006-02 1-00001/2 222222222222222
F-Hb
+
220
220 ng/mL
Sample number 2006-03 1-00002/1 333333333333333
F-Hb
+
200
200 ng/mLFirst day sample
Second day sample

006-04 1-00002/2 444444444444444
F-Hb
+
220
220 ng/mL
Sample number 1

007-01 1-00001/1 111111111111111
F-Hb
+
200
200 ng/mL

3-day

First day sample
Second day sample

007-02 1-00001/2 222222222222222
F-Hb
+
210
210 ng/mL
Third day sample

007-03 1-00001/3 333333333333333
F-Hb
+
220
220 ng/mL
Sample number 2

007-04 1-00002/1 444444444444444
F-Hb
+
220
220 ng/mLFirst day sample

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3.4

Printing examples

Printing when measuring STD/QC samples

DA1 value********************************F-Hb
STD･QC START********************************
91-01 STD1

CV value of DA1

91-02 STD6
Replicate number 1

0
0
0

6
0.0

0

DA2 value used bycalibration curve

0.0

CV value of DA2

2621
2580
2655

172
168
173

Replicate number 2

The result and meanvalues are printed foreach STD point.

2621
172
0.0 0.0

Replicate number 3

CC No.

DA2 value

6
5
6

Point number of STD
DA1 value used bycalibration curve

STD/QC sample
test start********************************F-Hb
CAL.CURVE********************************### CC No.1 ###
STD1
DA1(
STD2
DA1(

0.0 ng/mL
0 ng/mL
62.5 ng/mL
64 ng/mL

6
0
+0.0)
74
8
+2.4)

STD6
DA1(

1000.0 ng/mL
1002 ng/mL2621 172+0.2)

OriginBack fit value
Regression

CAL CURVE TYPE = LNR-LNR
DIMENSION= ALOKACAL CURVE EQUATIONDA1 F(0)=-2.743169e+001
F(1)=3.708265e+001
F(2)=-1.804965e+000
F(3)=2.978363e+000********************************DX（%）
Calibration curve type

Dimensions ofcalibration curve*Cubic spline: SPLINE
Aloka curve : ALOKA

Continued on next page377
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3

Printing examples

Continued on next page

QC sample number

SD value of
measured data

Measurement date andtime of calibration curve********************************F-Hb
QC C1/C2********************************
91-09 C-00001
183
133 ng/mL
185
135 ng/mL
183
133 ng/mL
184
0.97
91-10 C-00002
940
952
935

133 ng/mL
0.7

942
7.35

453 ng/mL
1.6

451 ng/mL
447 ng/mL
461 ng/mL*********************************
14/10/14 17:32
47017

STD/QC sample
measurement start
Data

Mean value of
measured data
CV value of
measured data
The result and mean values
are printed for each QC

Reagent lot

DA

・

2621

Calibration curve
graph

・
・
・
0

・
1000.0CONC.

*********************************STD･QC END
CAL.CURVE･QC REGISTER*********************************CANCEL is printed if
the calibration curve wascanceled.

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3.5

Printing examples

Error message printing
The meanings of error messages are shown in the chart below.

********************************
POWER ON
14/02/03 09:00****************************************************************
START
14/02/03 10:00********************************
F-Hb CC No.1
14/01/24 15:25********************************
005-01 1-0001
123456789012345
F-Hb
+ 200
200 ng/mL
005-02 1-0002

NO TUBE005-03 1-0003
F-Hb
7788

Reag.Pippet Err

Error message********************************

Error Message Text

Meaning

Sample Short

Sample insufficientNo Latex

No reagent

Latex Short

Reagent insufficient

Mixing Error

Mixing error

Latex Blank Error

Reagent blank error

No Cal. Curve

No calibration curve

Cal.Curve1 Error

STD error (DA1)

Cal.Curve2 Error

STD error (DA2)

S. Dispense Err

Sample dispensing error

L. Dispense Err

Reagent dispensing error

Puncture Error

Puncture error

None Result

No final results

Order Error

Order error

No TubeSample not placed

B/C Duplication

Double barcode

B/C Read NG

Barcode reading error

No OrderNo OrderPrinter Offline

Printer connection error and re-connection

Explanatory note

: There are cases where before and after the printing of the "Printer Offline" is overlapping.

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4

Handling the PrinterThis section describes printer paper setting and LED lamp displays.

Paper cover

CautionPaper coveropen lever・Be careful of the blade of the manual
Failure to observe this precaution may lead to
Required

FEED button

LED lamp

4.1

injury.

Manual cutter

Setting printer paper①

Raise the paper cover open lever and open the
cover.

Paper cover②

Set the paper as shown in the diagram to the left.
(If this is set with the opposite facing, the system
will be unable to print.)

Paper output③

Set the paper so that its edge sticks out of thepaper output.

Manual cutter④

Press both edges of the paper cover to close it.
Confirm that the paper cover is locked.

FEED button⑤

Touch the FEED button.

⑥

Cut the paper using the manual cutter.

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4.2

Handling the Printer

LED lamp display
If the LED lamp is lit or blinking, there is a printer error.

<Normal status>
LED lamp

Printer Status

Lit green

Waiting to print

Blinking green

Initializing<When an auto carriage return error has occurred>
LED lamp

Printer Status

Blinking red

Abnormal temperature (when it has been detected thatthe temperature is around 70°C or higher)

Lit redOut of paper<When a carriage return error has occurred >LED lamp

Printer Status

Blinking red, green

Voltage upper limit error (when it has been detected thatthe voltage is around 9.2 V or higher)

Blinking red, green

Voltage lower limit error (when it has been detected thatthe voltage is around 4.0 V or lower)

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Error List
This section describes error messages that are displayed on the screen, as well as error messages
printed to a printer.

5.1
Error No.
ERR#0-

ERR# 0-1001 - 0-2005 (Main)
On-screen Message (Upper)
Printed Message (Lower)

Errors and Clearing Method Displayed On-screen

G communication error

1001
1003
1005
1006
1007

1008

(Not displayed on screen)
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERRORG Communication error[SHUT DOWN]: Turn off the system power.
[CLOSE]: CLOSE ERROR DISPLAY
Unexpected command received (Not displayed on screen)
Unexpected command received Operation will continue automatically.
No reply from GLIFE command(Not displayed on screen)
No Reply from GLIFE
Touch the [SHUT DOWN] button to turn off the system power.
CommandFinish the sample process currently being tested.
No reply from G command(Not displayed on screen)
Touch the [SHUT DOWN] button to turn off the system power.
No Reply from G Command
Finish the sample process currently being tested.
Abort failed(Not displayed on screen)
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR
Abort failed[SHUT DOWN]: Turn off the system power.
[CLOSE]: CLOSE ERROR DISPLAY
Multiple absorbance data were Result Data is not affected.
received in the same cycle.
However, if this occurs repeatedly, please contact us.
<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR
Multiple absorbance[CLOSE]: CLOSE ERROR DISPLAYERR# 0-1100 ～
1101
1102
1103
1111

Online ACK timeout error
Online ACK timeout
Online NAK count error
Online NAK countOnline data reception error
Online data reception error
Online connection error
Online connection error(Not displayed on screen)
There was a fault in communication with an external computer.
Operation will continue automatically.
(Not displayed on screen)
There was a fault in communication with an external computer.
Operation will continue automatically.
(Not displayed on screen)
There was a fault in communication with an external computer.
Operation will continue automatically.
(Not displayed on screen)
There was a fault in communication with an external computer.
Operation will continue automatically.

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Error No.
ERR#0-

1112

1113
1114

On-screen Message (Upper)
Printed Message (Lower)
Online transmission error[Reception failed]
Online transmission error[Reception failed]
Online transmission error[Faulty data received]
Online transmission error[Faulty data received]

Errors and Clearing Method Displayed On-screen(Not displayed on screen)
There was a fault in communication with an external computer.
Operation will continue automatically.
(Not displayed on screen)
There was a fault in communication with an external computer.
Operation will continue automatically.

Online transmission error[Timeout error]
Online transmission error[Timeout error](Not displayed on screen)
There was a fault in communication with an external computer.
Operation will continue automatically.

Detector error(Not displayed on screen)
Touch the [ABORT] button to display the detector maximum output
registration screen. Select either [REGISTER] or [CANCEL], andrestart the system. Finish the sample process currently being tested.

ERR# 0-1400 ～1404

Error List

Detector error
Insufficient test reagents

1409
Insufficient test reagents
Insufficient test buffer

1410
Insufficient test buffer

Reagent low volume. Analysis stopped. Reagents need to be set on
the reagent setting screen, so press the [CLOSE] button to clear thewarning message.
Caution: Do not restart analysis until you have set the reagents andcleared the low reagent condition.
<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[CLOSE]: Close the warning message.
Buffer low volume. Analysis stopped. Buffer needs to be set on thereagent setting screen, so press the [CLOSE] button to clear thewarning message.
Caution: Do not restart analysis until you have set the buffer andcleared the low buffer condition.
<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[CLOSE]: Close the warning message.

No buffer left

1412

1415

(Not displayed on screen)(1) Open the [Set reagents] screen.
(2) Add buffer.
No buffer left
(3) (If you will update buffer information and run normal priming once
reagents have been set). Touch the [RESET] button.
(4) Touch the [Set complete] button.
Reference cell acquisition failed Reference data Value of cell blank measurement is out of Standard.
<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR
Reference cell acquisition failed[ABORT]: Finish cell blank measurement without updating thereference value.
[COERCE]: Update the reference value and continue cell blankmeasurement.

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5 Error List

Error No.
ERR#0-

1416

On-screen Message (Upper)
Printed Message (Lower)
Double sample barcode
Double sample barcode
Sample barcode reading error

1417
Sample barcode reading error
Sample barcode digit error

1418
Sample barcode digit error

1419
1420

Reagent barcode reading error
Reagent barcode reading error
Reagent barcode check digit
error
Reagent barcode check digit
error
Insufficient purified water
Warning1423

Insufficient purified water
Insufficient wash solution
Warning

1424

Insufficient wash solution
Drain tank full Warning
Drain tank full

1425

Errors and Clearing Method Displayed On-screen(Not displayed on screen)
A sample barcode is duplicated. This sample will not be tested.
Operation will continue automatically.
(Not displayed on screen)
A sample barcode couldn’t be read. This sample will be tested.
Operation will continue automatically.
(Not displayed on screen)
In sample barcode reading, a sample with a number of barcode digits
exceeding the limit was found. This sample will be tested.
Operation will continue automatically.
(Not displayed on screen)
A reagent barcode couldn’t be read. Try reading again. Operation willcontinue automatically.
(Not displayed on screen)
An error is detected in a reagent barcode check digit inspection.
Try reading again. Operation will continue automatically.
Insufficient purified water Warning: Due to insufficient purified waterin the tank (for purified water), sample dispensing is halted.
During operation of the system, you cannot exchange tanks or add
purified water.
Press the [CLOSE] button to clear the warning message at this point.
Notification will be provided later again when it is safe to change thetank or to add purified water.
<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[CLOSE]: Close the warning message.
Due to insufficient wash solution in the tank (for wash solution),sample dispensing is halted.
During operation of the system, you cannot exchange tanks or add thewash solution.
Press the [CLOSE] button to clear the warning message at this point.
Notification will be provided later again when it is safe to change thetank or to add purified water.
<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[CLOSE]: Close the warning message.
Due to the drain tank being full, sample dispensing is halted.
During operation of the system, you cannot exchange tanks.
Press the [CLOSE] button to clear the warning message at this point.
Notification will be provided later again when it is safe to change thetank or to add purified water.
<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[CLOSE]: Close the warning message.

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Error No.
ERR#0-

1430

On-screen Message (Upper)
Printed Message (Lower)
Cell check error
Cell check error
All cell blank error

1431
All cell blank error
Reagent blank error

1435

Error List

Errors and Clearing Method Displayed On-screen(Not displayed on screen)
No cell has been set. Touch the [Abort] button and set the cells.
(Not displayed on screen)
Cell blank status is abnormal for all cells. Touch the [Abort] buttonand change the cells.
(Not displayed on screen)
Latex blank is abnormal.
Operation will continue automatically.

Reagent blank error

1436
1437

Cell Blank Error
Cell Blank Error
Transportation Result Data
Error
Transportation Result Data
Error
Container check results error(Not displayed on screen)
Cell blank status is abnormal. Operation will continue automatically.
To replace the cells, touch the [Abort] button.
(Not displayed on screen)
An error is detected in a reagent barcode check digit inspection.
Try reading again. Operation will continue automatically.
(Not displayed on screen)
SAMPLE CHECK FAIL
This sample will not be tested. Operation will continue automatically.

1438

Container check results error
Maximum number of samples
reached Warning

1439

1440

Maximum number of samples
reached
Program error
Program Error

Rack loading stopped due to reaching maximum number of sample
analysis after a system start up.
Close error display. If testing, close the instrument under main analysis
screen of [Completed].
After system restart, new analysis can be started.
<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[CLOSE]: CLOSE ERROR DISPLAY

Close error display. Close the instrument under main analysis screenof [Completed]<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[CLOSE]: CLOSE ERROR DISPLAY385
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5 Error List

Error No.
ERR#0-

On-screen Message (Upper)
Printed Message (Lower)

Errors and Clearing Method Displayed On-screen

ERR# 0-1500 ～Startup failed

1501
1502
1503

1504

1505
1506
1509

Startup failed
Analysis end processing failed
Analysis end processing failed
Program end processing failed(Not displayed on screen)
Unable to start system.
Touch the [SHUT DOWN] button to turn off the system power.
(Not displayed on screen)
Unable to complete testing.
Touch the [SHUT DOWN] button to turn off the system power.
(Not displayed on screen)
Unable to shut system down.
Touch the [SHUT DOWN] button to turn off the system power.

Program end processing failed
A required file cannot be found. FILE MISSING
INF1: Missing file No.
1 = Config.ini
2 = Support.ini<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[SHUT DOWN] Shut down the system.
No filefunc.ini is abnormal or cannot(Not displayed on screen)
be found.
A file cannot be found.
Touch the [SHUT DOWN] button to turn off the system power.
func.ini is abnormal or cannot
be found.
kinou.dat is abnormal or cannot (Not displayed on screen)
be found.
A file cannot be found.
Touch the [SHUT DOWN] button to turn off the system power.
Kinou.dat Abnormal
Necessary common memory(Not displayed on screen)cannot be found.
Memory cannot be found.
Touch the [SHUT DOWN] button to turn off the system power.
No common memory386
NN1-1703 Rev.3

5

Error No.
ERR#0-

On-screen Message (Upper)
Printed Message (Lower)
Common memory initialization
failed1511(Message not printed)

Error List

Errors and Clearing Method Displayed On-screen
PROGRAM ERROR (MEMORY) due to file setting failure INF1: Common memory
No. 1-46
No. 01: Sample barcode(SysTBcr.txt)
No. 02: Rack information(SysRack.txt)
No. 03: Environment setting(SysEnv.txt)
No. 04: Data output(SysDtOut.txt )No. 05: Output format(SysForm.txt)
No. 06: RS232C setting(SysRS.txt)
No. 07: Analysis method(SysSoku.txt)
No. 08: Alarm setting(SysAlm.txt)
No. 09: Screensaver(SysScrn.txt)
No. 10: STD･QC run(SysStdQc.txt)
No. 11: Sample cup(SysTube.txt)
No. 12: Order･Test(SysOdrAna.txt)
No. 13: SAMP･QC protocol (PrtSmpQc.txt)
No. 14: CC1-CC6 protocol(PrtCC.txt)
No. 15: Common protocol 1 (PrtCom1.txt)
No. 16: Common protocol 2 (PrtCom2.txt)
No. 17: Analysis(AnaInf.dat)
No. 18: Test mode
(SokuMode.dat)
No. 19: Reagent･CC (SiyakuCC.dat)
No. 20: Remaining volume (SiyakuZan.dat)<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[SHUT DOWN] Shut down the system.
PROGRAM ERROR (MEMORY) due to file setting failure
INF1: MEMORY No.1 ～ 46
No.21:Buffer volume(KBufZan.dat )No.22:Shift register(-------------)
No.23:Supply unit
(KUnitInf.dat )No.24:Unload unit
(HUnitInf.dat )No.25:Rack･Sample(RackInf.dat )No.26:Analysis data
(AnaRslt.dat )No.27:STD result data
(StdRslt.dat )No.28: cell blank analysis(CellBlnk.dat )No.29:Temperature information (-------------)
No.30:Protocol DWLD(-------------)
No.31:System status(-------------)
No.32:Error information(-------------)
No.33:Subsystem(-------------)
No.34:Additional analysis(-------------)
No.35:Test result(-------------)
No.36:STD･QC result(-------------)
No.37:Instrument informat(-------------)
No.38:CC Information(-------------)
No.39:Printer(-------------)
No.40:Spare parts(U_Parts.dat )<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR【 SHUTDOWN 】 :Shut down the system.
PROGRAM ERROR (MEMORY) due to file setting failure
INF1: MEMORY No.1 ～ 46
No.41:spare parts(S_Parts.dat )No.42:Additional analysis recovery (-------------)
No.43:Reagnets･CC W(-------------)
No.44:Auto Start(AutoStart.txt)
No.45:CC1-CC6 Protocol(PrtCC_1.txt )No.46:CC1-CC6 Protocol(PrtCC_2.txt )<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR【 SHUTDOWN 】 :Shut down the system.

387
NN1-1703 Rev.3

5

Error List

Error No.
ERR#0-

On-screen Message (Upper)
Printed Message (Lower)

Errors and Clearing Method Displayed On-screen

ERR# 0-1600 ～COM port is not properly
connected

1601
COM port error

PRINT ERRORCOM PORT CONNECTION FAILCHECK CONNECTION<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[CLOSE]: CLOSE ERROR DISPLAYERR# 0-2000 ～
2001
2002

2003

Waiting(Message not printed)
Supply unit Exchange trays(Message not printed)

The analysis is completed.
(You can continue testing)
The supply unit tray can be exchanged.

Prepare for pipe line activation. Prepare for pipe line activation.
<Buffer bottle>
Exchange the purified water with buffer.
<Tank (for wash solution)>
Exchange the purified water with wash solution.
After exchanging, touch the [START] button.
Touch one of the following buttons to select a process.
[START]: Start pipe line activation.
(Message not printed)
Shutdown error Warning

2004
Shutdown error Warning

2005

Hard disk damaged Warningor
SSD damaged Warning
Hard disk damaged Warningor
SSD damaged Warning

The system was shut down abnormally last time.
The hard disk(SSD) may be damaged.
If there is something wrong with the hard disk(SSD) after systemstartup, please contact our company.
<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[CLOSE]: Start up the system.
A check found that the hard disk(SSD) is damaged.
* Self-restoration was performed; however, the disk cannot be fully
restored. Replace the hard disk(SSD).

388
NN1-1703 Rev.5
Rev.3

5

5.2
Error No.
ERR#1-

Error List

ERR# 1-000 - 1-200(SS1)
On-screen Message (Upper)
Printed Message (Lower)

Errors and Clearing Method Displayed On-screen

Unknown error

000

001

004

A fault occurred in communication within the system.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[ABORT]: Finish processing. If analysis is underway, it will also
Unknown error
terminate.
Sample nozzle Jam (liquid level The sample nozzle jammed during detection of the liquid level of adetection)
sample. If the rack is misaligned, dispensed samples on the conveyanceline may become jumbled. In this case, a retest is recommended.
<ERROR CANCELLATION>
If misalignment of the rack is not the cause of the jamming of thenozzle, remove the cause.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[Pass]: Skip the sample.
[ABORT]: Finish analysis.
SAMP Jam (LSU)
Sample nozzle Jam (liquid level The sample nozzle jammed during detection of the liquid level of adetection)
sample. If the rack is misaligned, dispensed samples on the conveyanceline may become jumbled. In this case, a retest is recommended.
<ERROR CANCELLATION>
If misalignment of the rack is not the cause of the jamming of thenozzle, remove the cause.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Detect the liquid level of the same sample again.
[ABORT]: Finish processing.
SAMP Jam (LSU)
Sample nozzle Jam (STD)

005

SAMP Jam (STD)

The sample nozzle jammed during detection of the liquid level of asample. Creation of a dilution series failed<ERROR CANCELLATION>
Check for sufficient storage of buffer and standard and place new
sample cups in the rack before a retry.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Restart measurement.
[Pass]: Finish processing of the rack.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.

389
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5

Error List

Error No.
ERR#1-

On-screen Message (Upper)
Printed Message (Lower)

Errors and Clearing Method Displayed On-screen

Sample nozzle Jam

007

008

010

011

The sample nozzle jammed during sample absorption.
If the rack is misaligned, dispensed samples on the conveyance line
may become jumbled. In this case, a retest is recommended.
<ERROR CANCELLATION>
If misalignment of the rack is not the cause of the jamming of thenozzle, remove the cause.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR
SAMP Jam (SSIP)[Pass]: Skip the sample.
[ABORT]: Finish analysis.
Sample nozzle Jam
The sample nozzle jammed during sample absorption.
If the rack is misaligned, dispensed samples on the conveyance line
may become jumbled. In this case, a retest is recommended.
<ERROR CANCELLATION>
If misalignment of the rack is not the cause of the jamming of thenozzle, remove the cause.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR
SAMP Jam (SSIP)[CONTINUE]: Continue the process.
[ABORT]: Finish processing.
Sample nozzle Jam (Dispensing The sample nozzle jammed when it was dispensing to a cell.
to cells)
The nozzle may be in improper alignment with the reaction table.
<ERROR CANCELLATION>
If misalignment of the reaction table is the cause of the jamming of thenozzle, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[Pass]: Skip dispensing of the sample.
SAMP Jam (Cell)[ABORT]: Finish analysis. If analysis is underway, it will also
terminate.
Sample nozzle Jam (STD)
The sample nozzle jammed while dispensing a sample to a sample cup
in the creation of an STD dilution series.
Unable to run dilution series.
<ERROR CANCELLATION>
Check for sufficient storage of buffer and standard, and place sample
cups in the rack before a retry.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Restart measurement.
[Pass]: Discharge the rack in process.
[ABORT]: Finish processing. If analysis is underway, it will also
SAMP Jam (STD)
terminate.

390
NN1-1703 Rev.3

5

Error No.
ERR#1-

On-screen Message (Upper)
Printed Message (Lower)
Sample nozzle Jam (OF)012
SAMP Jam (OF)Sample nozzle Jam (OF)013
SAMP Jam (OF)Sample nozzle Jam (OF)014
SAMP Jam (OF)Sample nozzle Jam (dilute test)

015

SAMP Jam (DIL)016

No sample
No sample
No sample (STAT STD)

017
No sample (INT STD)

Error List

Errors and Clearing Method Displayed On-screen
The sample nozzle jammed in the OF position.
The nozzle may be misaligned.
<ERROR CANCELLATION>
If the sample nozzle is in an incorrect OF position, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[Pass]: Wash the nozzle and start normal operations.
[ABORT]: Finish analysis.
The sample nozzle jammed in the OF position.
The nozzle may be misaligned.
<ERROR CANCELLATION>
If the sample nozzle is in an incorrect OF position, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[CONTINUE]: Continue the process.
[ABORT]: Finish analysis.
The sample nozzle jammed in the OF position.
The nozzle may be misaligned.
<ERROR CANCELLATION>
If the same error occurs after another attempt, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Move the nozzle down again.
[ABORT]: Finish processing.
In the creation of a dilution series for a dilution test, the sample nozzle
jammed while dispensing to a sample cup on the rack.
The nozzle or rack may be misaligned.
<ERROR CANCELLATION>
If misalignment of the rack is not the cause of the jamming of thenozzle, remove the cause.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[Pass]: Skip the sample.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
(Not displayed on screen)
No sample was detected.
Operation will continue automatically.
No sample was detected.
<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[Pass]: Finish processing of the rack.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.

391
NN1-1703 Rev.3

5 Error List

Error No.
ERR#1-

018
019

On-screen Message (Upper)
Printed Message (Lower)
Sample dispensing error
Sample dispensing error
Sample nozzle Liquid level error
SAMP Liquid level error

Errors and Clearing Method Displayed On-screen
No sample was detected
Operation will continue automatically.
(Not displayed on screen)
Detected liquid level is abnormal.
Operation will continue automatically.

Sample nozzle Liquid level
error (STAT STD)

020

021
022

023

024

032

Detected liquid level is abnormal.
The metallic portion at the tip of the sample nozzle may be conducting
electrically through the remaining drops.
<ERROR CANCELLATION>
Use cloth, such as gauze, to remove water or other liquid droplets fromthe tip of the sample nozzle, if any.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR
SAMP Liquid level error (INT [Pass]: Finish processing of the rack.
[ABORT]: Finish processing. If analysis is underway, it will also
STD)
terminate.
Sample nozzle Absorption error (Not displayed on screen)
Absorption by the sample nozzle was not performed normally.
SAMP Absorption error
Operation will continue automatically.
Insufficient sample(Not displayed on screen)
Sample amount is insufficient.
Operation will continue automatically.

Insufficient sample
Insufficient sample (STAT STD) Sample amount is insufficient.
<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[Pass]: Finish processing of the rack.
[ABORT]: Finish processing. If analysis is underway, it will also
Insufficient sample (INT STD) terminate.
Absorption error by sample
Absorption by the sample nozzle was not performed normally.
nozzle (STAT STD)<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[Pass]: Finish processing of the rack.
SAMP Absorption error (INT[ABORT]: Finish processing. If analysis is underway, it will also
STD)
terminate.
Detection error Purified water No purified water was detected in OF on the sample nozzle side.
level in OF
Purified water may have not been supplied due to a reason such as
broken piping.
<ERROR CANCELLATION>
Perform another attempt after checking that the piping is not broken.
If the same error occurs, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Restart purified water supply.
Purified water Pump trouble[ABORT]: Finish processing. If analysis is underway, it will also(OF)terminate.

392
NN1-1703 Rev.3

5

Error No.
ERR#1-

On-screen Message (Upper)
Printed Message (Lower)
Detection error Purified waterlevel in OF

033
Purified water Pump trouble(OF)
Detection error Wash solution
level in OF

034
Wash solution Pump trouble(OF)
Detection error Wash solution
level in OF

035
Wash solution Pump trouble(OF)
Rack on conveyance line

040
Rack online
Supply unit 1 No tray

042
Supply unit 1 No tray

Error List

Errors and Clearing Method Displayed On-screen
No purified water was detected in OF on the sample nozzle side.
Purified water may have not been supplied due to a reason such as
broken piping.
<ERROR CANCELLATION>
Perform another attempt after checking that the piping is not broken.
If the same error occurs, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Detect the liquid level of purified water again.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
No wash solution was detected in OF on the sample nozzle side.
The wash solution may have not been supplied due to pipe breakage orother reason.
<ERROR CANCELLATION>
Perform another attempt after checking that the piping is not broken.
If the same error occurs, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Restart supply of the wash solution and clean the nozzle.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
No wash solution was detected in OF on the sample nozzle side.
The wash solution may have not been supplied due to pipe breakage orother reason.
<ERROR CANCELLATION>
Perform another attempt after checking that the piping is not broken.
If the same error occurs, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Detect the liquid level of wash solution again.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
A rack is placed on the conveyance line.
<ERROR CANCELLATION>
Perform another attempt after manually removing the rack from theconveyance line.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Check for racks on the conveyance line again.
[ABORT]: Finish processing.
The tray is flowing over the supply unit, or no tray is in place.
<ERROR CANCELLATION>
Place trays on the supply unit.
Ensure that the trays are placed directly on the unit. PRESS THE
FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Check for racks again.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.

393
NN1-1703 Rev.3

5 Error List

Error No.

On-screen Message (Upper)

ERR#1-

Printed Message (Lower)
Supply unit 1 Rack supply error A rack was not supplied normally from the supply unit to theconveyance line.
<ERROR CANCELLATION>
Arrange the racks on the tray in an orderly manner.
Correctly place racks if they are not perpendicular.
Remove any obstacles.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR
Supply unit 1 Rack supply error [RETRY]: Restart rack supply.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
Supply unit 1 Supply bar return The supply bar of the supply unit was not returned to the front
error
normally.
<ERROR CANCELLATION>
Remove any obstacles.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Retry returning the supply bar to the front.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
Supply unit 1 Return error

043

044

Discharge unit 1 No tray

045
Discharge unit 1 No tray
Discharge unit 1 Abnormal
discharge

046

Discharge unit 1 Abnormal
discharge

Discharge unit 1 Rack full047
Discharge unit 1 Rack fullErrors and Clearing Method Displayed On-screen

The tray is flowing over the discharge unit, or no tray is in place.
<ERROR CANCELLATION>
Place trays on the discharge unit.
Ensure that the trays are placed directly on the unit.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Check for racks again.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
A rack could not be discharged to the discharge unit.
<ERROR CANCELLATION>
Remove the rack on the discharge tray, make sure the discharge tray isfixed properly. and execute "RETRY".
Execute "ABORT" where rack is unable to discharge for Rack would
not be at discharge position due to Rack Transfer is not working
properly.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Attempt discharge again.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
Rack discharge is halted because the discharge unit is full.
<ERROR CANCELLATION>
Close the error message. Exchange trays using the rack information
screen. After exchanging, touching the button to complete theexchange will discharge the rack on the conveyance line to thedischarge unit.
Touch the following button.
[CLOSE]: Close the alarm message.

394
NN1-1703 Rev.3

5

Error No.
ERR#1-

On-screen Message (Upper)
Printed Message (Lower)
Conveyance bar in system
Working error

048
Conveyance bar Error

050

Error List

Errors and Clearing Method Displayed On-screen
The conveyance bar in the system did not work correctly.
A fault may have occurred in the conveyance bar component.
<ERROR CANCELLATION>
If the same error occurs after another attempt, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Attempt to move the conveyance bar again.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.

Puncturing component Working The puncturing component did not work correctly.
error
A fault occurred in the puncturing component.
<ERROR CANCELLATION>
If the same error occurs after another attempt, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Attempt puncturing again.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
Puncturing Error
Puncturing component Jam

052
Puncturing Jam
Barcode Reader Error

053
Barcode Reader Error
Squeezing Error

054
Squeezing Error

The puncturing component jammed.
The component may be caught on a sampling bottle.
<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Attempt puncturing again.
[Pass]: Skip processing of sample.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
There is a hardware-related error with the barcode reader.
Unable to read barcode.
<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
The squeezing component did not work correctly.
<ERROR CANCELLATION>
Remove any obstacles.
If the same error occurs after another attempt, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Retry squeezing.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.

395
NN1-1703 Rev.3

5 Error List

Error No.

On-screen Message (Upper)

ERR#1-

Printed Message (Lower)
Squeezing Error

055
Squeezing Error
Container position Incorrect
(FCa)

057
Container position Incorrect(FCa)
Purified water/buffer tankSensor error

059
Purified water/buffer Sensor
error
Purified water/buffer tank
Insufficient purified water060
Purified water Insufficient(buffer)
Purified water/buffer tank
Insufficient purified water061
Purified water Insufficient(buffer)Errors and Clearing Method Displayed On-screen
The squeezing component did not work correctly.
The status of the squeezing component is unknown, so the rack cannot
be conveyed.
<ERROR CANCELLATION>
Abort processing after the reaction table is at rest.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
Containers are set in the incorrect positions for STD measurement or adilute test.
<ERROR CANCELLATION>
Place containers in the rack correctly. Return the rack to the STAT rack
position.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Check whether the containers are set correctly.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
The sensor of the buffer tank did not switch to OFF.
Possible causes are as follows:- Malfunctioning of sensor- Sample nozzle clogging- Malfunctioning of syringe pump or electromagnetic valve- Dirty buffer tank
<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
Purified water is not stored in the purified water/buffer tank (that is,
not the purified water tank) in the system.
Purified water may have not been supplied due to a reason such as
broken piping.
<ERROR CANCELLATION>
Continue processing after checking that the piping is not broken.
If the same error occurs, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[CONTINUE]: Pump purified water and restart sampling.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
Purified water is not stored in the purified water/buffer tank (that is,
not the purified water tank) in the system.
Purified water may have not been supplied due to a reason such as
broken piping.
<ERROR CANCELLATION>
Perform another attempt after checking that the piping is not broken.
If the same error occurs, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Pump purified water again.
[ABORT]: Finish processing.

396
NN1-1703 Rev.3

5

Error No.
ERR#1-

On-screen Message (Upper)
Printed Message (Lower)
Discharge unit 1 Rack
conveyance error

065
Discharge 1 Discharge error
Container position Incorrect

066
Container position Incorrect
No buffer

067

Error List

Errors and Clearing Method Displayed On-screen
Rack discharge was not completed correctly.
Because dispensed samples on the discharge line may become
jumbled, a retest is recommended in this case.
<ERROR CANCELLATION>
Abort processing after the reaction table is at rest.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
Containers are set in the incorrect positions for STD measurement or adilute test.
<ERROR CANCELLATION>
Place containers in the rack correctly. Return the rack to the STAT rack
position.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Check whether the containers are set correctly.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
No buffer remains in the rack for STD measurement or a dilute test.
<ERROR CANCELLATION>
Check for sufficient storage of buffer and standard, and place sample
cups in the rack before a retry.
[RETRY]: Restart STD measurement or dilute test.
[Pass]: Finish processing of the rack.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.

No buf.
Insufficient buffer

068

Insufficient buf.

The buffer at the top position of a rack is insufficient for STD
measurement or a dilute test.
<ERROR CANCELLATION>
Check for sufficient storage of buffer and standard, and place sample
cups in the rack before a retry.
Touch one of the following buttons to cancel the error.
[RETRY]: Restart STD measurement or dilute test.
[Pass]: Finish processing of the rack.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.

397
NN1-1703 Rev.3

5

Error List

Error No.
ERR#1-

On-screen Message (Upper)
Printed Message (Lower)
Rack barcode Reading error

095

Rack barcode Reading error
Rack conveyance error

096
Supply 1 Rack conveyanceerror
Rack barcode Unavailable

098

Rack barcode Unavailable

Errors and Clearing Method Displayed On-screen
A rack barcode could not be read.
<ERROR CANCELLATION>
Check the following.
- Is a barcode labeled on the rack?
- Is the orientation of the rack correct?
- Is the barcode reader lever not tilted forward?
If the same error occurs after another attempt, exchange the rack witha new one or the label with a new one before another attempt.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Reread the label.
[Pass]: Finish processing of the rack.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
The supplied rack was not conveyed normally.
The conveyance bar in the system may be detached.
<ERROR CANCELLATION>
Abort processing after the reaction table is at rest.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
The retest and dilution test racks are unavailable in a cut-in analysis.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Reread the label.
[Pass]: Finish processing of the rack.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
Explanatory note

: By setting the analysis items at the time ofinterrupt analysis request
If other reagents are selected, this error will also be issued.

Page 79 “Cut-in analysis”

ERR# 1-100 ～Discharge unit 1 Rack full

100
Discharge unit 1 Rack full

Rack discharge is halted because the discharge unit is full.
<ERROR CANCELLATION>
Perform another attempt after exchanging trays.
There is no need to use the rack info. screen to exchange trays.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Discharge the rack.
[ABORT]: Finish processing.

398
NN1-1703 Rev.3

5

Error No.
ERR#1-

On-screen Message (Upper)
Printed Message (Lower)
No buffer103

No buf.
Insufficient buffer

104

Insufficient buf.
STAT Rack Detected

105
Stat Rack Detected
Sample nozzle Jam (STD)

110

SAMP Jam (STD)

Error List

Errors and Clearing Method Displayed On-screen(Not displayed on screen)
Buffer was used up during a dilute test.
Operation will continue automatically.
(Not displayed on screen)
The volume of buffer became insufficient during a dilute test.
Operation will continue automatically.
A rack was detected at the STAT Rack position.
<ERROR CANCELLATION>
Perform another attempt after manually removing the rack from the
STAT rack position.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Recheck for a rack at the STAT Rack position.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
The sample nozzle jammed in the OF position.
The nozzle may be misaligned.
<ERROR CANCELLATION>
Check for sufficient storage of buffer and standard, and place sample
cups in the rack before a retry.
If the same error occurs after another attempt, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Restart measurement.
[Pass]: Finish processing of the rack.
[ABORT]: Finish processing.

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5

Error List

Error No.
ERR#1-

On-screen Message (Upper)
Printed Message (Lower)

Errors and Clearing Method Displayed On-screen

Sample nozzle Liquid level
error (STD)

112

113

114

115

116

Detected liquid level is abnormal.
The metallic portion at the tip of the sample nozzle may be conducting
electrically through the remaining drops.
<ERROR CANCELLATION>
Use cloth, such as gauze, to remove water or other liquid droplets fromthe tip of the sample nozzle, if any.
Check for sufficient storage of buffer and standard and place new
sample cups in the rack before a retry.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Restart measurement.
[Pass]: Finish processing of the rack.
[ABORT]: Finish processing. If analysis is underway, it will also
SAMP Liquid level error (STD)
terminate.
No sample (STD)
No sample was detected.
<ERROR CANCELLATION>
Check for sufficient storage of buffer and standard, and place sample
cups in the rack before a retry.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Restart measurement.
[Pass]: Finish processing of the rack.
No sample (STD)[ABORT]: Finish processing.
Insufficient sample (STD)
Sample amount is insufficient.
<ERROR CANCELLATION>
Check for sufficient storage of buffer and standard, and place sample
cups in the rack before a retry.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Restart measurement.
[Pass]: Finish processing of the rack.
Insufficient sample (STD)[ABORT]: Finish processing.
Sample nozzle Jam (STD)
In the creation of an STD dilution series, the sample nozzle jammed
during absorption from a sample cup on a rack.
Creation of a dilution series failed<ERROR CANCELLATION>
Check for sufficient storage of buffer and standard, and place sample
cups in the rack before a retry.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR
SAMP Jam (STD)[RETRY]: Restart measurement.
[Pass]: Finish processing of the rack.
[ABORT]: Finish processing.
Sample nozzle Absorption error Absorption by the sample nozzle was not performed normally.
(STD)<ERROR CANCELLATION>
Check for sufficient storage of buffer and standard, and place sample
cups in the rack before a retry.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Restart measurement.
[Pass]: Finish processing of the rack.
[ABORT]: Finish processing. If analysis is underway, it will also
SAMP Absorption error (STD) terminate.

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5

Error No.
ERR#1-

On-screen Message (Upper)
Printed Message (Lower)
Rack conveyance bar origin
error

119
Rack Bar ORC error
Sample nozzle Jam (STAT
STD)

120
SAMP Jam (INT STD)
Sample nozzle Jam (STAT
STD)

123
SAMP Jam (INT STD)
Sample nozzle Jam (STAT
STD)

124
SAMP Jam (INT STD)
No buffer (STAT STD)

125
No buf. (INT STD)
Insufficient buffer (STAT STD)

126

Error List

Errors and Clearing Method Displayed On-screen
Unable to detect the origin of the conveyance line rack conveyancebar.
Because dispensed samples on the discharge line may become
jumbled, a retest is recommended in this case.
<ERROR CANCELLATION>
Abort processing after the reaction table is at rest.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
The sample nozzle jammed in the OF position. The nozzle may bemisaligned.
<ERROR CANCELLATION>
If the same error occurs after another attempt, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[Pass]: Finish processing of the rack.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
The sample nozzle jammed during detection of the liquid level of asample. Creation of a dilution series failed<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[Pass]: Finish processing of the rack.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
The sample nozzle jammed while dispensing a sample to a sample cup
in the creation of an STD dilution series.
Creation of a dilution series failed<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[Pass]: Finish processing of the rack.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
No buffer remains in the top position of a rack for STD measurement
or a dilute test.
<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[Pass]: Finish processing of the rack.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
The volume of buffer at the top position of a rack is insufficient for
STD measurement or a dilute test.
<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[Pass]: Finish processing of the rack.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.

Insufficient buf. (INT STD)

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5 Error List

Error No.

On-screen Message (Upper)

ERR#1-

Printed Message (Lower)
Sample nozzle Jam (STAT
STD)

127
SAMP Jam (INT STD)

128

Sample nozzle Liquid level
error
SAMP Liquid level error
Sample nozzle Liquid level
error (STAT STD)

129
SAMP Liquid level error (INT
STD)
Sample nozzle Liquid level
error (STD)

130

135

Errors and Clearing Method Displayed On-screen
In the creation of an STD dilution series, the sample nozzle jammed
during absorption from a sample cup on a rack.
Creation of a dilution series failed<ERROR CANCELLATION>
Check for sufficient storage of buffer and standard, and place sample
cups in the rack before a retry.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[Pass]: Finish processing of the rack.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
Liquid level was detected as abnormal.
Operation will continue automatically.
Liquid level was detected as abnormal.
<ERROR CANCELLATION>
Use cloth, such as gauze, to remove water or other liquid droplets fromthe tip of the sample nozzle, if any.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[Pass]: Finish processing of the rack.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.

Liquid level was detected as abnormal.
<ERROR CANCELLATION>
Use cloth, such as gauze, to remove water or other liquid droplets fromthe tip of the sample nozzle, if any.
Check for sufficient storage of buffer and standard, and place sample
cups in the rack before a retry.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR
SAMP Liquid level error (STD) [RETRY]: Restart measurement.
[Pass]: Finish processing of the rack.
[ABORT]: Finish processing.
Barcode reading Timeout
No reply was received from the barcode reader.
Check system status, which is output to INF1, INF2, and INF3. Please
let our company know of this status.
In the event of this error, you need to turn off the system.
When the Menu screen appears after aborting, turn off the system in
Close mode. Then turn on the system.
If analysis is being performed, abort processing when the reaction
table is at rest.
Barcode reading Timeout
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[ABORT]: Finish processing. If analysis is underway, it will also
terminate.

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5

Error No.
ERR#1-

On-screen Message (Upper)
Printed Message (Lower)
Sample nozzle Z-axis origin
error

140
SAMPZ ORG error
Sample nozzle Z-axis origin
error

141
SAMPZ ORG error
Sample nozzle Z-axis origin
error (STD)142
SAMPZ ORG error (STD)
Sample nozzle Z-axis origin
error (STAT STD)

143
SAMPZ ORG error (INT STD)
Rack conveyance bar origin
error

144
Rack Bar ORG error

Error List

Errors and Clearing Method Displayed On-screen
The Z-axis origin of the sample nozzle was detected abnormal.
<ERROR CANCELLATION>
If the same error occurs after a pass, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[Pass]: Skip the sample.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
The Z-axis origin of the sample nozzle was detected abnormal.
<ERROR CANCELLATION>
If the same error occurs after another attempt, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Detect Z-axis origin again.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
The Z-axis origin of the sample nozzle was detected abnormal.
<ERROR CANCELLATION>
If the same error occurs after another attempt, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Detect the Z-axis origin again, and finish rack processing.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
The Z-axis origin of the sample nozzle was detected abnormal.
<ERROR CANCELLATION>
If the same error occurs after another attempt, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Detect the Z-axis origin again, and finish rack processing.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
Unable to detect the origin of the conveyance line rack conveyancebar.
<ERROR CANCELLATION>
If the same error occurs after another attempt, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Re-initialize and check the origin.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.

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5 Error List

Error No.
ERR#1-

On-screen Message (Upper)
Printed Message (Lower)
Supply unit 1 origin error

145
Supply unit 1 ORG error

146

147

148

Errors and Clearing Method Displayed On-screen
Original position sensor and limit sensor of supply unit1 are on atsame time.
<ERROR CANCELLATION>
If the same error occurs after another attempt, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Check sensors again, and supply or discharge rack.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.

Sample nozzle Theta-axis origin The theta-axis origin of the sample nozzle was detected abnormal.
error<ERROR CANCELLATION>
If the same error occurs after another attempt, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Detect Theta-axis origin again.
[ABORT]: Finish processing. If analysis is underway, it will also
SAMPT ORG error
terminate.
Sample nozzle P-axis origin
The P-axis origin of the sample nozzle was detected abnormal.
error<ERROR CANCELLATION>
If the same error occurs after another attempt, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Detect P-axis origin again.
[ABORT]: Finish processing. If analysis is underway, it will also
SAMPP ORG error
terminate.
Sample nozzle Jamming sensor Jamming sensor of sample nozzle is on.
error<ERROR CANCELLATION>
If the same error occurs after another attempt, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Detect Z-axis original position again, and check jamming
sensor.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
SAMP Jamming Sensor error
Sample nozzle P-axis origin
error

149
SAMPP ORG error
No STAT Rack

150
(Message not printed)

The P-axis origin of the sample nozzle was detected abnormal.
<ERROR CANCELLATION>
If the same error occurs after another attempt, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[SKIP]: Skip the sample.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
No STAT Rack is detected.
Set the rack.
<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Recheck for a rack at the STAT rack position.
[RETURN]: Return to the STAT screen.

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5

Error No.
ERR#1-

On-screen Message (Upper)
Printed Message (Lower)
Sample nozzle Jam

180
SAMP Jam
Rack on conveyance line
(RSTART)

181
Rack on conveyance line
(RSTART)
Residue in cell (soaking)188
Residue in cell (soaking)Sample nozzle Liquid level
error

189
SAMP Liquid level error(soaking)
Sample nozzle Jam (Cellsoaking)

190
SAMP Jam (Soaking)Error List

Errors and Clearing Method Displayed On-screen
The sample nozzle jammed.
The nozzle may be misaligned.
<ERROR CANCELLATION>
If misalignment of the rack is not the cause of the jamming of thesample nozzle, remove the cause.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Move the nozzle down again.
[ABORT]: Finish processing.
A rack is left on the conveyance line, due to a power failure.
<ERROR CANCELLATION>
Manually remove as many racks on the line as possible.
Manually remove the rack left at the front of supply unit 1 after
touching [START].
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[START]: Discharge the rack at the front of supply unit 1 to theposition for placement of the STAT rack.
[PASS]: Leave the racks on the conveyance line.
A residual liquid was detected in a cell during cell soaking. The
absorption by the washing nozzle may have not been completed
normally.
<ERROR CANCELLATION>
If the same error occurs after another attempt, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Absorb residues in the cell again.
[ABORT]: Finish processing.
The liquid level was detected as abnormal during cell soaking. The
system may be conducting electrically through liquid droplets on the
tip of the sample nozzle.
<ERROR CANCELLATION>
Use cloth, such as gauze, to remove liquid droplets from the tip of thesample nozzle, if any.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Detect the liquid level of the same sample again.
[ABORT]: Finish processing.
The sample nozzle jammed in a cell during cell soaking. The sample
nozzle may be misaligned.
<ERROR CANCELLATION>
If the sample nozzle is in improper alignment with the reaction table,
abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Move the nozzle down again.
[ABORT]: Finish processing.

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5 Error List

Error No.
ERR#1-

195

On-screen Message (Upper)
Printed Message (Lower)
There is no dispensing liquid(dispensing accuracy)
No liquid (dispensing check)

200
202

Illegal receiving command
ILLEGAL COMMAND
No rack was found when therack supply operation wasstarted.
(Message not printed)

Errors and Clearing Method Displayed On-screen(Not displayed on screen)
There is no sample in the container in the first hole of the rack in adispensing accuracy check for samples.
Touch the [Abort] button and finish processing.
(Not displayed on screen)
A fault occurred in communication within the system.
Operation will continue automatically.
No rack was found when rack supply was started. Rack auto start ishalted. If the same error occurs even after repositioning, the auto start
sensor may be malfunctioning.

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5

5.3
Error No.
MES#1-

Error List

MES# 1-001 - 1-007(SS1)
On-screen Message (Upper)
Printed Message (Lower)
Set racks

001(Message not printed)
Detect liquid level002(Message not printed)
Check puncturing component(rack conveyance)

003(Message not printed)
Check squeezing component(rack conveyance)

004(Message not printed)
Check rack on supply unit tray.

005(Message not printed)

Errors and Clearing Method Displayed On-screen(Not displayed on screen)
There are no remaining racks to process.
To continue processing, position racks in the supply unit and touch[CONTINUE].
Touch one of the following buttons to select a process.
[CONTINUE]: Process the newly set rack continuously.
[ABORT]: Finish processing.
(Not displayed on screen)
Processing is halted at the step of liquid level detection. Check whether
the liquid level is detected correctly.
Touch one of the following buttons to select a process.
[CONTINUE]: Detect the liquid level for the next hole.
[RETRY]: Detect the liquid level at the first hole again.
[ABORT]: Finish processing.
(Not displayed on screen)
The puncturing component is brought to a halt.
Check whether the alignment (X, Y, and Z) of the puncturing needle
with the container is correct.
Touch one of the following buttons to select a process.
[CONTINUE]: Continue the process.
[ABORT]: Finish processing.
(Not displayed on screen)
The squeezing component is halted at the container-squeezing step.
Check whether the squeezing component squeezes containers
correctly.
Touch one of the following buttons to select a process.
[CONTINUE]: Continue the process.
[ABORT]: Finish processing.
Return the rack supply unit or the rack on the tray to the front. (See thefigure to the left.)
Notice ： When returning the rack to the front, lift the rack up
temporarily. Failure to observe this precaution may result in the pin
catching and the rack falling over.
PRESS THE FOLLOWING BUTTON[CONTINUE]: Starts cut-in analysis.

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5

Error List

Error No.
MES#1-

On-screen Message (Upper)
Printed Message (Lower)
Check that there is no liquidleaking from the nozzle tip.

006
(Message not printed)

007

The rack supply operation willstart
(Message not printed)

Errors and Clearing Method Displayed On-screen
The setting time has passed. Check that there is no liquid drippingfrom the nozzle tip.
<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[CONTINUE]: Finish the leak check.
(Not displayed on screen)
The rack will be supplied.

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5

5.4
Error No.
ERR#2-

ERR# 2-001 - 2-200(SS2)
On-screen Message (Upper)
Printed Message (Lower)
Unknown error000
Unknown error
Reagent nozzle Jam (reagent
bottle)081

Reagent Jam (bottle)

082

084

085

086
088

Error List

Reagent nozzle Jam (reagent
absorption)
Reagent Jam (REAG SIP)

Errors and Clearing Method Displayed On-screen(Not displayed on screen)
A fault occurred in communication within the system.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
The reagent nozzle jammed during detection of the liquid level of areagent.
The reagent nozzle may be in improper alignment with the reagent
bottle mouth.
<ERROR CANCELLATION>
Check for orientation of inserted reagent bottles.
If the reagent nozzle tip does not cover the reagent bottle mouth, abort
processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[CONTINUE]: Resume reagent dispensing in the next cycle.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
(Not displayed on screen)
The reagent nozzle jammed during absorption of a reagent.
Operation will continue automatically.

Reagent nozzle Jam (dispensing The reagent nozzle jammed when it was dispensing to a cell.
to cell)<ERROR CANCELLATION>
If the reaction table is in improper alignment with the reagent nozzle,
abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[CONTINUE]: Resume reagent dispensing in the next cycle.
Reagent Jam (REAG DISP)[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
Reagent nozzle Jam (OF)The reagent nozzle jammed in the OF position.
The reagent nozzle may be misaligned.
<ERROR CANCELLATION>
If the reaction table is in an incorrect OF position, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[CONTINUE]: Wash the nozzle.
[ABORT]: Finish analysis.
Reagent Jam (OF)No reagent
No reagent
Reagent nozzle Abnormal
liquid level detected
Reagent Incorrect level(REAG)(Not displayed on screen)
No reagent is left.
Operation will continue automatically.
(Not displayed on screen)
Detected liquid level is abnormal.
Operation will continue automatically.

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5

Error List

Error No.
ERR#2-

On-screen Message (Upper)
Printed Message (Lower)
Reagent nozzle Jam (reagent
bottle)091

Reagent Jam (bottle)
Reagent nozzle Jam (OF)093
Reagent Jam (OF)
Mixer Operation error

095
Mixer Operation error
Mixer Operation error

096
Mixer Operation error
Mixer Jam

097
Mixer Jam
Mixer Jam

099
Mixer Jam

Errors and Clearing Method Displayed On-screen
The reagent nozzle jammed during detection of the liquid level of areagent.
The reagent nozzle may be in improper alignment with the reagent
bottle mouth.
<ERROR CANCELLATION>
Check for orientation of inserted reagent bottles.
If the reagent nozzle tip does not cover the reagent bottle mouth, abort
processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Move the nozzle down again.
[ABORT]: Finish processing.
The reagent nozzle jammed in the OF position.
The reagent nozzle may be misaligned.
<ERROR CANCELLATION>
If the reaction table is in an incorrect OF position, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Move the nozzle down again.
[ABORT]: Finish processing.
The mixer did not work normally.
<ERROR CANCELLATION>
If the same error occurs after another attempt, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Start the mixer again.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
The mixer did not work normally.
<ERROR CANCELLATION>
Abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
The mixer jammed.
<ERROR CANCELLATION>
If the same error occurs after continuation, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[CONTINUE]: Start the mixer in the next cycle.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
The mixer jammed.
<ERROR CANCELLATION>
If the same error occurs after another attempt, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Start the mixer again.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.

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5

Error No.
ERR#2-

On-screen Message (Upper)
Printed Message (Lower)

Error List

Errors and Clearing Method Displayed On-screen

ERR# 2-101 ～ 200
Cell washing component
Operation error

101
Cell washing Operation error
Cell washing component
Absorption error

103

Cell washing Absorption error

104

The cell washing component did not work normally.
<ERROR CANCELLATION>
If the same error occurs after another attempt, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Start the cell washing component again.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
The cell washing component detected liquid leakage during cellwashing.
The contents of a cell could not be absorbed due to a problem such as
breakage or clogging of the piping to the drain tank.
<ERROR CANCELLATION>
Check for pipe breakage to the drain tank, and continue processing.
If the same error occurs, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[CONTINUE]: Start the cell washing operation in the next cycle.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.

Cell washing component Liquid The cell washing component detected a liquid leakage.
spill
The contents of a cell may have spilled over or splashed during cellwashing.
<ERROR CANCELLATION>
If the same error occurs after continuation, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[CONTINUE]: Start the cell washing operation in the next cycle.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
Cell washing Liquid spill
Cell washing component Jam

105
Cell washing Jam
Cell washing component
Absorption error

106

Cell washing Absorption error

The cell washing component jammed.
<ERROR CANCELLATION>
The washing nozzle may be in improper alignment with a cell.
If the same error occurs after continuation, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[CONTINUE]: Start the cell washing operation in the next cycle.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.

The cell washing component detected liquid leakage during cellwashing.
The contents of a cell could not be absorbed due to a problem such as
breakage or clogging of the piping to the drain tank.
<ERROR CANCELLATION>
Check for pipe breakage to the drain tank, and perform anotherattempt.
If the same error occurs, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Start absorbing the contents of the cell.
[ABORT]: Finish processing.

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5 Error List

Error No.
ERR#2-

On-screen Message (Upper)
Printed Message (Lower)
Cell washing component Jam

107
Cell washing Jam

108

Errors and Clearing Method Displayed On-screen
The cell washing component jammed.
The washing nozzle may be in improper alignment with a cell.
<ERROR CANCELLATION>
If the same error occurs after another attempt, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Move down the cell washing component again.
[ABORT]: Finish processing.

Cell washing component Liquid The cell washing component detected a liquid leakage.
spill
The contents of a cell may have spilled over or splashed during cellwashing.
<ERROR CANCELLATION>
If the same error occurs after another attempt, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Check liquid spill sensor again.
[ABORT]: Finish processing.
Cell washing Liquid spill
Insufficient purified water

110
Insufficient purified water
Insufficient wash solution

111
Insufficient wash solution
Drain tank Full112
Drain tank full

The volume of purified water in the corresponding storage tank isinsufficient.
<ERROR CANCELLATION>
Continue processing after adding purified water.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[CONTINUE]: Continue the process.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
The volume of wash solution in the corresponding storage tank isinsufficient.
<ERROR CANCELLATION>
Perform another attempt after adding wash solution.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[CONTINUE]: Continue the process.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
The drain tank is full.
<ERROR CANCELLATION>
Discard the contents of the tank. Continue processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[CONTINUE]: Continue the process.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.

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5

Error No.
ERR#2-

On-screen Message (Upper)
Printed Message (Lower)
Reagent dispensing instruction
error

114
Reagent dispensing instruction
error
Detection Error (retry)130
Detection Error (retry)
Detection Error

131
Detection Error

132
133

Reagent nozzle Liquid level
detection error
Reagent Liquid level error(REAG)
Timeout
Timeout
Timeout

134
Timeout
Mixer Rotation error

135
Mixer error
Mixer Rotation error

136

Mixer error
Reagent nozzle Z-axis origin
error

140
Reagent Z ORG error

Error List

Errors and Clearing Method Displayed On-screen
Unable to continue operation due to a program problem.
<ERROR CANCELLATION>
Abort and check the settings.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
(Not displayed on screen)
An error occurred in detection, so another attempt was madeautomatically.
Operation will continue automatically.
(Not displayed on screen)
An error occurred in detection. Another attempt was madeautomatically, again resulting in abnormal results.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Perform detection again.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
Liquid level was detected as abnormal. Continue processing
automatically.
The process timed out.
Continue processing automatically.
The process timed out.
Check system status, which is output to INF1, INF2, and INF3. Please
let our company know of this status.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Attempt the timed-out process again.
[ABORT]: Finish processing. The menu screen will appear duringsystem startup. If analysis is underway, it will also terminate.
Unable to mix as the mixer rotation component is malfunctioning.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
Unable to mix as the mixer rotation component is malfunctioning.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
A reagent nozzle Z-axis origin error was detected.
<ERROR CANCELLATION>
Is the reagent compartment cover open?
If the cover is open, close it.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[CONTINUE]: Continue the process.
[ABORT]: Finish processing.

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Error List

Error No.
ERR#2-

On-screen Message (Upper)
Printed Message (Lower)
Reagent nozzle Z-axis origin
error

141
Reagent Z ORG error
Reagent nozzle Theta-axis
origin error

142

Reagent T ORG error

Reagent nozzle P-axis origin
error

143
Reagent P ORG error

144

147

150

Errors and Clearing Method Displayed On-screen
A reagent nozzle Z-axis origin error was detected.
<ERROR CANCELLATION>
Is the reagent compartment cover open?
If the cover is open, close it.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Detect Z-axis origin again.
[ABORT]: Finish processing.
Reagent nozzle Theta-axis original position detection error.
<ERROR CANCELLATION>
If the same error occurs after another attempt, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Detect Theta-axis origin again.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
The P-axis origin of the reagent nozzle was detected abnormal.
<ERROR CANCELLATION>
If the same error occurs after another attempt, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Detect P-axis origin again.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.

Reagent nozzle Jamming Sensor Jamming sensor of reagent nozzle is on.
error<ERROR CANCELLATION>
Reagent Jamming Sensor error If the same error occurs after another attempt, abort processing.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Detect Z-axis original position again, and check jamming
sensor.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
Reagent nozzle P-axis origin
The P-axis origin of the reagent nozzle was detected abnormal.
error<ERROR CANCELLATION>
If the same error occurs after another attempt, abort processing.
Reagent P ORG error
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[CONTINUE]: Continue the process.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
Liquid leak check
The time designated for checking leaks has passed.
Check for leaks on the nozzle tip.
Press the button below to complete the check after nozzle washing.
Liquid leak check[CONTINUE]: Resume the operation.

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Error No.
ERR#2-

On-screen Message (Upper)
Printed Message (Lower)
OF purified water supply error

151
OF purified water supply error
OF purified water supply error

152

OF purified water supply error
Reagent nozzle Jam

192

Error List

Errors and Clearing Method Displayed On-screen
The reagent nozzle was dropped at the OF position, but the system
was unable to check the purified water. Check the OF position purified
water supply component.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Resume purified water supply.
[ABORT]: Finish processing.
The reagent nozzle was dropped at the OF position, but the system was
unable to check the purified water.
Check the OF position purified water supply component.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Resume purified water supply.
[ABORT]: Finish processing.
The reagent nozzle jammed.
<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[RETRY]: Move the nozzle down again.
[ABORT]: Finish processing.

Reagent Jam (maintenance)
No reagent

193
200

No reagent (dispensing test)
Illegal receiving command
ILLEGALCOMMAND(Not displayed on screen)
No reagent was remaining in a dispensing accuracy check for reagents.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[ABORT]: Finish processing.
(Not displayed on screen)
A fault occurred in communication within the system.
Continue processing automatically.

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Error List

5.5
Error No.
MES#2-

MES# 2-001 - 2-007(SS2)
On-screen Message (Upper)
Printed Message (Lower)
Check dispensing volume001(Message not printed)
Position sample cup

002(Message not printed)
Check liquid level detection
position

003(Message not printed)
Import purified water into
buffer/wash solution lines.

004(Message not printed)
Drain water from the system

005(Message not printed)

Check absorption performance

006(Message not printed)

Errors and Clearing Method Displayed On-screen(Not displayed on screen)
Check the dispensing volume for cell washing.
The line in the central area of the cell indicates the proper liquid level.
To continue processing, return the cell to the reaction table, and touch[CONTINUE].
Touch one of the following buttons to select a process.
[CONTINUE]: Check the dispensing volume of the next nozzle.
[ABORT]: Finish processing.
(Not displayed on screen)
Position a sample cup in the 2nd reagent position.
Position a sample cup and continue processing.
Touch one of the following buttons to select a process.
[CONTINUE]: Dispense latex or buffer into the newly positioned
sample cup.
[ABORT]: Finish processing.
(Not displayed on screen)
Processing is halted at the step of liquid level detection.
Check whether the liquid level is detected correctly.
Touch one of the following buttons to select a process.
[CONTINUE]: Put the nozzle back to the OF position.
[RETRY]: Move the nozzle up and detect liquid level again.
[ABORT]: Finish processing.
Import purified water into buffer/wash solution lines.
Buffer and wash solution will be replaced with purified water up to theline. Connect a container filled with purified water to these connected
pipes.
Touch the [CONTINUE] button.
Touch one of the following buttons to select a process.
[CONTINUE]: Start importing purified water into the lines.
[ABORT]: Finish processing.
(Not displayed on screen)
Drain water from the system.
Remove the pipes from the purified water tank, wash solution tank,and buffer bottles.
Touch one of the following buttons to select a process.
[CONTINUE]: Start draining off water.
[ABORT]: Finish processing.
(Not displayed on screen)
Check absorption performance.
Position a bottle containing a reagent, such as tap water, in the firstreagent position, and continue processing.
Touch one of the following buttons to select a process.
[CONTINUE]: Start liquid level detection.
[ABORT]: Finish processing.

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Error No.
MES#2-

On-screen Message (Upper)
Printed Message (Lower)
Dispensed volume # [µL] #
times

007

Error List

Errors and Clearing Method Displayed On-screen(Not displayed on screen)“Dead volume” is defined as the difference between the volume ofa liquid placed in the reagent bottle (before measurement of deadvolume) and the total dispensed volume.
Touch the following button to finish processing.
[ABORT]: Finish processing.

Dispensed volume: # Times: #417
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Save to External Media
Saves the following data to external media: sample measured data information, sample replicate
information, QC measured data information, QC replicate information, STD measured data information,
STD replicate information, time course data information, histogram information, and positive ratechange information.
Output data are variable-length data.

6.1

Sample Measured Data Information
Saves measured data information on samples and stat samples■[File name: ocsamp.csv]

No. Item

Reference ( △ : Blank [20H])

1

Data type2

Date of analysis

3Time of analysis

4

Rack No.

Measured data: ‘N △ ’ Stat data: ‘S △ ’
Retest (including dilution test) data: ‘A △ ’
When data is edited, △ becomes E.
(Example) Measured data is edited :‘NE’
Date of analysise.g.) Sep. 23, 2016 → 2016/09/23
Time of analysis (24-hour indication)e.g.) 2:5 pm → 14:05
Barcode information on racks

Do

5

Position in rack

Position in rack: 1–10

Do6

Sample ID

Barcode information on sampling bottles (*2)

Do

7

Sample group No.

Do

8

Sample sequence no.

9

Measurement method counter10

Number of replicatesGroup number of a sample: 0–9（Stat samples: △）(If “*” is set to this number, “0” is given.)
Serial number of measurement: 1–99999• Number ranges are predetermined.
Samples: 1–99999
Stat samples: 1–99999
Classification of measurement method by day: 1–3(Number of samples for each subject)(Dilute remeasure: ‘ △ ’)Number of replicates for a replicate test: 1–10

11

DA value

Values at 1st to 3rd detection points.
See Appendix 1.3 “Calculate DA Value.”Do

Output
-

-

Do

-

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Save to External MediaNo. Item

Reference ( △ : Blank [20H])

12

Measured data

13

Flag (+, -)14

SD values

Calculated data: Up to 7 digits in the integer part and 1
digit in the decimal part. (*1) (the number of digits inthe decimal part can be changed from “Output Format
Settings.”)
Qualitative Flag (+, -) of measured data by the cut-off
values: (*1) △ -, △ +, 1+, 2+ and 3+
SD values of measured data (statistic)

15

CV values

CV values of measured data (statistic)

16

Error code

17

Final results

18

Test item code

19

Test item name

20

Unit

See Appendix 6.10, “List of Error Codes for Output toExternal Media.”“*” is recorded as final results of 15- or 250-times
dilution tests. (*1)
Test item code
Do (*3)It does not output at the time of order error. For the
CSV format is displayed as ",,".
Test item name
Do (*3)It does not output at the time of order error. For the
CSV format is displayed as ",,".
Unit of test item
Do (*3)21

Cut off 1

Value of cut off 1

22

Cut off 2

Value of cut off 2 (Undefined is "*".)

23

Cut off 3

Value of cut off 3 (Undefined is "*".)

24

Operator ID

ID of the operator that LOGIN

Do (*3)25

Latex lotLot of using Latex

26

Latex expiration date

The expiration date of the Latex

27

Buffer lot

Lot of using Buffer28

Buffer expiration date

The expiration date of the Buffer

Do (*3)(*4)
Do (*3)(*4)
Do (*3)(*4)
Do (*3)(*4)

Output-Do-

Do (*3)

Explanatory note

• The name of an item is given in the header of a file, and is followed by data.
• Items are divided by commas (,).
• Delimiter CR/LF follows a comma that follows an error code. A file ends with “EOF.”• Zero suppression is performed on items other than the date and time of analysis.
• If “Do” is set to “Output” for an item, you can change the setting so as not to output the item at “Output
Format Settings.”(*1) “*” is not recorded if final results of 15- or 250-times dilution tests consist of UR data, OR data, PRC data, or datafree errors.
In these cases, spacing is provided to fields of measured data and to Flag (+, -) of 15- or 250-times dilution tests.
(*2) When Two-dimensional code is used (optional), sample ID is output up to 50 digits.
(*3) Contact us for changing No.18-No.28.
(*4 )If dispense operation cannot be performed, " " is displayed for the lot and expiration date.

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Save to External Media■

Example of Sample Measured Data Information Output

Data type, Date of analysis, Time of analysis, Rack number, Rack position, Sample ID, Sample group
number, Sample sequence number, Measurement method counter, Number of replicates, DA Value,
Measured data, Flag (+, -), SD value, CV value, Error code, Final result, Test item code, Test item name,
Unit, Cut off 1 , Cut off 2, and Cut off 3,Operator ID, Latex lot, Latex expiration date, Buffer lot, Buffer
expiration date
Example1 : Only 15 times dilution measurement result （F-Hb）
A ,2016/07/18,11:39,032,1,123456789012345,0,1,1,1,110,1058,3+,0,0,,,90,F-Hb,ng/mL,100,200,300
Example2 : Only 250 times dilution measurement result （F-Hb）
A ,2016/07/18,11:39,032,1,123456789012345,0,1,1,1,110,17633,3+,0,0,,,90,F-Hb,ng/mL,100,200,300
Example3 : The final result is 250 times with 15 times and 250 times dilution measurement （FCa）(15 times dilution result)
A ,2016/07/18,11:39,032,1,123456789012345,0,1,1,1,4523,,,,,,,,05,53,FCa,ug/g,100,200,300(250 times dilution result)
A ,2016/07/18,11:39,032,1,123456789012345,0,1,1,1,110,17633,3+,0,0,,*,53,FCa,ug/g,100,200,300
Example4 : When operator / reagent management function is enabled （F-Hb）
N,2018/02/24,14:02,5,1,123456789012345,0,1,1,10,272,148,+,3.3,2.2,,,90,F-Hb,ng/mL,100,*,*,eiken,7Z02
7,2018/12/31,7Y019,2018/11/30

6.2

Sample Replicate Information
Saves information on each replicate of samples or stat samples■[File name: ocrsamp.csv]

No. ItemRemark

Output1

Data typeSee Appendix 6.1, “Sample Measured Data Information.”-

2

Date of analysis

See Appendix 6.1, “Sample Measured Data Information.”-

3

Time of analysis

See Appendix 6.1, “Sample Measured Data Information.”-

4

Relative cell No.

Cell No..: 1–55-

5

Rack No.

See Appendix 6.1, “Sample Measured Data Information.”Do

6

Rack position

See Appendix 6.1, “Sample Measured Data Information.”Do

7

Sample ID

Do

8

Sample group No.

See Appendix 6.1, “Sample Measured Data Information.”(*1)
See Appendix 6.1, “Sample Measured Data Information.”

9

Sample sequence No.

See Appendix 6.1, “Sample Measured Data Information.”

Do

Do

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Save to External MediaNo. ItemRemark10

CC No.

CC No. for sample measurement: 1–6-

11

Replicate counter

Replicate No. for a replicate test: 1–10-

12

A1 value

See Appendix 1.3, “ Calculate DA Value.”-

13

A2 value

See Appendix 1.3, “ Calculate DA Value.”-

14

A3 value

See Appendix 1.3, “ Calculate DA Value.”-

15

DA1 value

See Appendix 1.3, “ Calculate DA Value.”Do

16

DA2 value

Do

17
18
19
20
21
22
23
24
25
26
27
28

Measured data
Flag (+, -)Error code
Final result
Test item code
Test item nameUnit
Cut off 1
Cut off 2
Cut off 3
Operator ID
Latex lot

See Appendix 1.3, “ Calculate DA Value.” The value is
output even if no measured data are obtained.
See Appendix 6.1, “Sample Measured Data Information.”
See Appendix 6.1, “Sample Measured Data Information.”
See “List of Error Codes for Output to External Media.”
See Appendix 6.1, “Sample Measured Data Information.”
Test item code
Test item name
Unit of test item
Value of cut off 1
Value of cut off 2 (Undefined is "*".)
Value of cut off 3 (Undefined is "*".)
ID of the operator that LOGIN
Lot of using Latex

29

Latex expiration date30

Buffer lot

31

Buffer expiration date

OutputDo
Do(*2)
Do(*2)
Do(*2)
Do(*2)

Do(*2)
Do(*2)(*3)
The expiration date of the Latex
Do(*2)(*3)
Lot of using Buffer（If not input “,,” ）Do(*2)(*3)
The expiration date of the Buffer（If the deadline cannot Do(*2)
be determined “,,” ）(*3)

Explanatory note

• The name of an item is given in the header of a file, and is followed by data.
• Items are divided by commas (,).
• Delimiter CR/LF follows a comma that follows an error code. A file ends with “EOF.”• Zero suppression is performed on items other than the date and time of analysis.
• If “Do” is set to “Output” for an item, you can change the setting so as not to output the item at “Output
Format Settings.”• “SAMPLE UNSET” is not output as an item of Sample Replicate Information.
• Sample Replicate information is not output in case of “No order” or “Order error”.
(*1) When Two-dimensional code is used (optional), sample ID is output up to 50 digits.
(*2) Contact us for changing No.21-No.31.
(*3) If dispense operation cannot be performed, " " is displayed for the lot and expiration date.

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Save to External Media■

Example of Sample Replicate Information Output

Data type, Date of analysis, Time of analysis, Relative cell number, Rack number, Rack position, Sample ID,
Sample group number, Sample sequence number, CC number, Replicate counter, A1 value, A2 value, A3 value,DA1 value, DA2 value, Measured data, Flag (+, -), Error code, Final result, Test item code, Test item name, Unit,
Cut off 1, Cut off 2, and Cut off 3,Operator ID, Latex lot, Latex expiration date, Buffer lot, Buffer expiration date
Example1 : cut-off of 1 only (F-Hb)
N ,2016/07/18,11:39,1,032,1,123456789012345,0,1,5,1,1353,1369,1569,216,16,147.0,+,,,90,F-Hb,ng/
mL,100,*,*N ,2016/07/18,14:39,2,032,1,123456789012345,0,1,5,2,1354,1369,1572,218,15,148.0,+,,,90,F-Hb,ng/
mL,100,*,*
Example2 : cut-off 1, 2, 3 (F-Hb)
N,2016/07/18,11:40,3,032,2,33333,0,2,5,1,1392,1448,2490,1098,56,452.0,3+,,,90,F-Hb,ng/
mL,100,200,300
N,2016/07/18,14:40,4,032,2,33333,0,2,5,2,1384,1439,2447,1063,55,443.0,3+,,,90,F-Hb,ng/
mL,100,200,300

Example3: When the operator/reagent control function is activated (F-Hb)
N,2018/2/24,14:02,1,5,1,123456789012345,0,1,1,1,1409,1430,1692,283,21,152,+,,,90,F-Hb,ng/mL,100,*,*,eiken,7Z027,2018/12/31,7Y019,2018/11/30
N,2018/2/24,14:02,2,5,1,123456789012345,0,1,1,2,1389,1408,1657,268,19,146,+,,,90,F-Hb,ng/mL,100,*,*,eiken,7Z027,2018/12/31,7Y019,2018/11/30
N,2018/2/24,14:02,3,5,1,123456789012345,0,1,1,3,1389,1411,1669,280,22,151,+,,,90,F-Hb,ng/mL,100,*,*,eiken,7Z027,2018/12/31,7Y019,2018/11/30

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6.3

Save to External MediaQC Measured Data Information
Saves QC measured data■

[File name: ocqc.csv]

No. ItemRemark

Output1

Data type

QC Data: ‘Cx’ x: QC no. of 1–4.

-

2

Date of analysis

See Appendix 6.1, “Sample Measured Data Information.”-

3

Time of analysis

See Appendix 6.1, “Sample Measured Data Information.”-4

Rack no.

See Appendix 6.1, “Sample Measured Data Information.”Do

5

Rack position

See Appendix 6.1, “Sample Measured Data Information.”Do

6

Sample sequence no.

See Appendix 6.1, “Sample Measured Data Information.”Do

7

QC lot

QC lot number-

8

Number of replicates

See Appendix 6.1, “Sample Measured Data Information.”-

9

DA value

See Appendix 6.1, “Sample Measured Data Information.”Do

10

Measured data

See Appendix 6.1, “Sample Measured Data Information.”-

11

Flag (+, -)Not output.

-

12

SD value

See Appendix 6.1, “Sample Measured Data Information.”-

13

Error code

See “List of Error Codes for Output to External Media.”-14

Test item code

Test item code

Do(*2)

15

Test item name

Test item nameDo(*2)16

QC ID

ID of QC (*1)

Do(*2)

17

Unit

Unit of test item

Do(*2)

18

Operator ID

See Appendix 6.1, “Sample Measured Data Information.”Do(*2)

19

QC expiration date20

Latex lot

See Appendix 6.1, “Sample Measured Data Information.”

21

Latex expiration date

See Appendix 6.1, “Sample Measured Data Information.”22

Buffer lot

See Appendix 6.1, “Sample Measured Data Information.”23

Buffer expiration date

See Appendix 6.1, “Sample Measured Data Information.”Do(*2)
Do(*2)(*3)
Do(*2)(*3)
Do(*2)(*3)
Do(*2)(*3)

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Save to External Media
Explanatory note

• The name of an item is given in the header of a file, and is followed by data.
• Items are divided by commas (,).
• Delimiter CR/LF follows a comma that follows an error code. A file ends with “EOF.”• Z Zero suppression is performed on items other than the date and time of analysis.
• If “Do” is set to “Output” for an item, you can change the setting so as not to output the item at “Output
Format Settings.”(*1) When Two-dimensional code is used (optional), sample ID is output up to 50 digits.
(*2) Contact us for changing No.14-No.23(*3) If dispense operation cannot be performed, " " is displayed for the lot and expiration date.

■

Example of QC Measured Data Information Output

Data type, Date of analysis, Time of analysis, Rack number, Rack position, Sample sequence number, QC
lot, Number of replicates, DA value, Measured data, Flag (+, -), SD value, Error code, Test item code, Test
item name, QC ID, and Unit, Operator ID,QC expiration date, Latex lot, Latex expiration date, Buffer lot,
Buffer expiration date
Example1 : Normal (F-Hb)
C1,2016/04/23,16:02,099,9,1,14102,3,222,150.7,,2.5,,90,F-Hb, 12345678901234,ng/mL
Example2 : When the operator/reagent control function is activated (F-Hb)
C1,2018/02/24,13:16,098,9,1,7Z007,3,271.148,,2.5,,90,F-Hb,, ng/mL,eiken,2018/12/31,7Z027,2018/12/31,7Y019,2018/11/30

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6.4

Save to External MediaQC Replicate Information
Saves information on each QC replicate■[File name: ocrqc.csv]

No. ItemRemark1

Data typeSee Appendix 6.3, “QC Measured Data Information”-

2Date of analysis

See Appendix 6.1, “Sample Measured Data Information”-

3

Time of analysis

See Appendix 6.1, “Sample Measured Data Information”-

4

Relative cell no.

See Appendix 6.2, “Sample Replicate Information”-

5

Rack no.

See Appendix 6.1, “Sample Measured Data Information”

Do

6

Rack position

See Appendix 6.1, “Sample Measured Data Information”

Do

7

Sample sequence no.

See Appendix 6.1, “Sample Measured Data Information”

Do

8

QC lotSee Appendix 6.3, “QC Measured Data Information”-

9

CC no.

See Appendix 6.2, “Sample Replicate Information”-

10

Replicate counter

See Appendix 6.2, “Sample Replicate Information”-

11

A1 value

See Appendix 1.3, “ Calculate DA Value.”-

12

A2 value

See Appendix 1.3, “ Calculate DA Value.”-

13

A3 value

See Appendix 1.3, “ Calculate DA Value.”-

14

DA1 value

See Appendix 1.3, “ Calculate DA Value.”Do

15

DA2 value

See Appendix 1.3, “ Calculate DA Value.”Do

16

Measured data

See Appendix 6.1, “Sample Measured Data Information”-

17

Flag (+, -)Not output.

-

18

Error code

19

Test item code

See Appendix 6.10, “List of Error Codes for Output toExternal Media.”
Test item code
Do(*2)

20

Test item name

Test item nameDo(*2)21

QC ID

ID of QC (*1)

Do(*2)

22

Unit

Unit of test item

Do(*2)

Output425
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Save to External MediaNo. ItemRemark

Output23

Operator ID

See Appendix 6.1, “Sample Measured Data Information.”Do(*2)

24

QC expiration date25

Latex lot

See Appendix 6.1, “Sample Measured Data Information.”

26

Latex expiration date

See Appendix 6.1, “Sample Measured Data Information.”27

Buffer lot

See Appendix 6.1, “Sample Measured Data Information.”28

Buffer expiration date

See Appendix 6.1, “Sample Measured Data Information.”Do(*2)
Do(*2)(*3)
Do(*2)(*3)
Do(*2)(*3)
Do(*2)(*3)

Explanatory note

• The name of an item is given in the header of a file, and is followed by data.
• Items are divided by commas (,).
• Delimiter CR/LF follows a comma that follows an error code. The file ends with “EOF.”• Zero suppression is performed on items other than the date and time of analysis.
• If “Do” is set to “Output” for an item, you can change the setting so as not to output the item at “Output
Format Settings.”(*1) When Two-dimensional code is used (optional), sample ID is output up to 50 digits(*2) Contact us for changing No.19-No.28(*3) If dispense operation cannot be performed, " " is displayed for the lot and expiration date.

■

Example of QC Replicate Information Output

Data type, Date of analysis, Time of analysis, Relative cell number, Rack number, Rack position, Sample
sequence number, QC lot, CC number, Replicate counter, A1 value, A2 value, A3 value, DA1 value, DA2value, Measured data, Flag (+, -), Error code, Test item code, Test item name, QC ID, and Unit, Operator
ID, QC expiration date, Latex lot, Latex expiration date, Buffer lot, Buffer expiration date
Example1 : Normal (F-Hb)
C1,2016/04/23,16:02,13,099,9,1,14102,1,1,1353,1370,1573,220,17,149.0,,,90,F-Hb,123456789012345,ng/
mL
C1,2016/04/23,16:02,14,099,9,1,14102,1,2,1364,1380,1592,228,16,154.0,,,90,F-Hb,123456789012345,ng/
mL
C1,2016/04/23,16:02,15,099,9,1,14102,1,3,1352,1367,1572,220,15,149.0,,,90,F-Hb,123456789012345,ng/
mL
Example2 : When the operator/reagent control function is activated (F-Hb)
C1,2018/02/24,13:16,28,098,9,1,7Z007,1,1,1395,1416,1670,275,21,149.0,,,90,F-Hb,,ng/mL,eiken,2018/12/
31,7Z027,2018/12/31,7Y019,2018/11/30
C1,2018/02/24,13:16,29,098,9,1,7Z007,1,2,1393,1412,1668,275,19,149.0,,,90,F-Hb,,ng/mL,eiken,2018/12/
31,7Z027,2018/12/31,7Y019,2018/11/30
C1,2018/02/24,13:16,30,098,9,1,7Z007,1,3,1384,1403,1648,264,19,145.0,,,90,F-Hb,,ng/mL,eiken,2018/12/
31,7Z027,2018/12/31,7Y019,2018/11/30

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6.5

Save to External Media

Standard Measured Data Information
Saves STD measured data information[File name: ocstd.csv]■

No. ItemRemark

Output1

Date of analysis

See Appendix 6.1, “Sample Measured Data Information”-

2Time of analysis

See Appendix 6.1, “Sample Measured Data Information”-

3

Latex lot

Latex lot No. (consisting of five alphanumeric characters)-

4

Rack No.

See Appendix 6.1, “Sample Measured Data Information”

Do

5

Rack position

See Appendix 6.1, “Sample Measured Data Information”

Do

6

STD point No.

Detection point No. (STD1–STD6): 1–6-

7

DA1 value

See Appendix 1.3, “Calculate DA Value.”Do

8

DA2 value

See Appendix 1.3, “Calculate DA Value.”Do

9

DA1 back fit-

10

DA1CV value

Concentration estimated by fitting DA1 to a calibration
curve
CV value of DA1 (statistic)

11

DA2CV value

CV value of DA2 (statistic)-

12

DA1SD value

SD value of DA1 (statistic)-

13

DA2SD value

SD value of DA2 (statistic)-

14

OriginSTD concentration of CC protocol-

15

Number of replicates

Number of replicates for a replicate test: 1–10-

16

Error code-

17

Test item code

See Appendix 6.10, “List of Error Codes for Output toExternal Media.”
Test item code

18

Test item name

Test item name

-

-

-

Explanatory note

• The name of an item is given in the header of a file, and is followed by data.
• Items are divided by commas (,).
• Delimiter CR/LF follows a comma that follows an error code. The file ends with “EOF.”• Zero suppression is performed on items other than the date and time of analysis.
• If “Do” is set to “Output” for an item, you can change the setting so as not to output the item at “Output
Format Settings.”

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Example of STD Measured Data Information Output

Date of analysis, Time of analysis, Latex lot, Rack number, Rack position, STD point number, DA1 value,DA2 value DA1 back fit, DA1CV value, DA2CV value, DA1SD value, DA2SD value, Origin, Number of
replicates, Error code, Test item code, and Test item name2016/08/07,14:34,11111,098,1,1,6,1,0.0,0.0,0.0,0.0,0.0,0.0,3,,90,F-Hb
2016/08/07,14:34,11111,098,3,2,83,7,64.0,0.0,0.0,0.0,0.0,62.5,3,,90,F-Hb
2016/08/07,14:35,11111,098,4,3,191,15,120.0,0.0,0.0,0.0,0.0,125.0,3,,90,F-Hb
2016/08/07,14:36,11111,098,5,4,461,28,257.0,0.0,0.0,0.0,0.0,250.0,3,,90,F-Hb
2016/08/07,14:36,11111,098,6,5,1233,63,496.0,0.0,0.0,0.0,0.0,500.0,3,,90,F-Hb
2016/08/07,14:37,11111,098,2,6,2738,144,1001.0,0.0,0.0,0.0,0.0,1000.0,3,,90,F-Hb

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6.6

Save to External Media

Standard Replicate Information
Saves information on each STD replicate[File name: ocrstd.csv]■

No. ItemRemark

Output1

Date of analysis

See Appendix 6.1, “Sample Measured Data Information.”-

2

Time of analysis

See Appendix 6.1, “Sample Measured Data Information.”-

3

Latex lot

Latex lot No. (consisting of five alphanumeric characters)-

4

Relative cell no.

See Appendix 6.2, “Sample Replicate Information.”-5

Rack no.

See Appendix 6.1, “Sample Measured Data Information.”Do

6

Rack position

See Appendix 6.1, “Sample Measured Data Information.”Do

7

STD point no.

See Appendix 6.5, “STD Measured Data Information.”-

8

Replicate counter

See Appendix 6.2, “Sample Replicate Information.”-

9

A1 value

See Appendix 1.3, “Calculate DA Value.”-10

A2 value

See Appendix 1.3, “Calculate DA Value.”-

11

A3 value

See Appendix 1.3, “Calculate DA Value.”-

12

DA1 value

See Appendix 1.3, “Calculate DA Value.”Do

13

DA2 value

See Appendix 1.3, “Calculate DA Value.”Do

14

Error code-

15

Test item code

See Appendix 6.10, “List of Error Codes for Output toExternal Media.”
Test item code

16

Test item name

Test item name--

Explanatory note

• The name of an item is given in the header of a file, and is followed by data.
• Items are divided by commas (,).
• Delimiter CR/LF follows a comma that follows an error code. The file ends with “EOF.”• Zero suppression is performed on items other than the date and time of analysis.
• If “Do” is set to “Output” for an item, you can change the setting so as not to output the item at “Output
Format Settings.”

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Example of STD Replicate Information Output

Date of analysis, Time of analysis, Latex lot, Relative cell number, Rack number, Rack position, STD point
number, Replicate counter, A1 value, A2 value, A3 value, DA1 value, DA2 value, Error code, Test item
code, and Test item name2016/08/07,14:34,11111,10,098,1,1,1,1345,1346,1351,6,1,,90,F-Hb
2016/08/07,14:34,11111,11,098,1,1,2,1321,1321,1327,6,0,,90,F-Hb
2016/08/07,14:34,11111,12,098,3,2,1,1330,1340,1417,87,10,,90,F-Hb
2016/08/07,14:34,11111,13,098,3,2,2,1336,1342,1419,83,6,,90,F-Hb
2016/08/07,14:34,11111,14,098,4,3,1,1347,1360,1533,186,13,,90,F-Hb
2016/08/07,14:35,11111,15,098,4,3,2,1344,1359,1535,191,15,,90,F-Hb
2016/08/07,14:35,11111,16,098,5,4,1,1372,1400,1848,476,28,,90,F-Hb
2016/08/07,14:35,11111,17,098,5,4,2,1360,1388,1821,461,28,,90,F-Hb
2016/08/07,14:35,11111,18,098,6,5,1,1397,1461,2677,1280,64,,90,F-Hb
2016/08/07,14:35,11111,19,098,6,5,2,1398,1461,2631,1233,63,,90,F-Hb
2016/08/07,14:36,11111,20,098,2,6,1,1480,1626,4218,2738,146,,90,F-Hb
2016/08/07,14:36,11111,21,098,2,6,2,1470,1611,4147,2677,141,,90,F-Hb

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6.7

Save to External MediaTime Course Data Information
Saves time course data information[File name: tcourse.csv]■

No. ItemRemark1

Time course information on relative cell 1

Cell information 1∙nCell information n■

Cell information #Output・・・Time course information on relative cell n

・
・
・
-

No. ItemRemark1

Date of analysis

See Appendix 6.1, “Sample Measured Data Information.”-

2

Time of analysis

See Appendix 6.1, “Sample Measured Data Information.”-3

Relative cell no.

See Appendix 6.2, “Sample Replicate Information.”-

4

Reference value

See Appendix 1.7, “Calculate Cell Blank.”-

5

Cell-blank value

See Appendix 1.7, “Calculate Cell Blank.”-

6

ABS value of cycle 1

See Appendix 1.3, “Calculate DA Value.”-7

ABS value of cycle 2

See Appendix 1.3, “Calculate DA Value.”

-

・
・
・

Output

・
・
・

・
・
・

60

ABS value of cycle 55

See Appendix 1.3, “Calculate DA Value.”-

61

Test item code

Test item code-

62

Test item name

Test item name-

Explanatory note

• There is no header for the file, and only data are shown.
• Items are divided by commas (,).
• Delimiter CR/LF follows a comma that follows reference value and cell information. The file ends with “EOF.”• Zero suppression is performed on items other than the date and time of analysis.

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Example of Time Course Data Information Output

2016/07/23,16:51,1,14127,14,176,1393,1350,1341,1343,1347,1351,1356,1361,1367,1374,1380,1385,
1391,1398,1404,1410,1417,1424,1430,1436,1441,1448,1453,1459,1463,1471,1476,1480,1482,1490,
1494,1496,1499,1507,1513,1512,1517,0,0,0,0,0,0,0,12,0,0,-1,0,154,156,159,162,163,90,F-Hb
2016/07/23,16:51,2,14127,0,184,1375,1320,1314,1315,1316,1318,1319,1320,1322,1324,1325,1325,
1327,1328,1328,1328,1329,1331,1331,1331,1330,1331,1332,1331,1331,1332,1333,1333,1332,1335,
1335,1331,1330,1332,1333,1335,1334,0,0,0,0,0,0,13,16,0,0,0,2,162,167,170,173,175,90,F-Hb

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6.8

Save to External MediaHistogram Information
Saves histogram information[File name: ochstgrm.txt]■

No. ItemRemark

Output1

Title 1

“Histogram”-

2

Title 2

“Date range”-

3

Period of timeFirst date of calculation data-

4

Period of time

Final date of calculation data-

5

Title 3

“Test item name”-

6

Test item code

Test item code-

7

Test item name.

Test item name8

Title 4

“Measurement range”, “Number of samples”

9

Measurement range

10

Number of samples

Minimum and maximum limits of each class:
Minimum limit - Maximum limit
Number of samples in a class11

Title 5

“Total number of samples”

12

Total number of samples

Total number of samples

Explanatory note

• As shown in the example below, a file begins with “HISTOGRAM.”• Items are divided by commas (,).
• Delimiter CR/LF follows the title, date range, number of samples, and total number of samples. A file ends
with “EOF.”

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Example of Histogram Information Output

HISTOGRAM
Date range, 2016/10/22,2016/10/23
Measurement range, Number of samples
Test item name,90,F-Hb
0.0-26.0,25
26.0-52.0,552.0-78.0,12
78.0-104.0,2104.0-130.0,0
130.0-156.0,1
156.0-182.0,2182.0-208.0,1
208.0-234.0,0234.0-260.0,1
Total number of samples, 49

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6.9

Save to External Media

Positive Rate Change Information
Saves positive rate change information

Positive rate change according to testee [File name: socprmps#.txt]■

No. ItemRemark

Output1

Title 1-

2

Title 2“POSITIVE RATE CHANGE ACCORDING TOTESTEE”“Date”

3

Date

-

4

Title 3

The first date of a week or month in calculation of
positive rates by week or month“Test item name”

5

Test item code

Test item code-

6

Test item name.

Test item name-7

Title 4

“Positive rate (%)”-

8

Positive rate (%)

Rate of testees with positive rates to the total testees(Positive testees ÷ Total testees × 100)

-

-

-

Explanatory note

• “#” for a file name depends on the file type.
t: Positive rate change for all samples
0–9: Positive rate change for the group indicated by the number (0: Group not specified)• As shown in the example below, a file begins with “POSITIVE RATE CHANGE ACCORDING TOTESTEE.”• Items are divided by commas (,).
• Delimiter CR/LF follows the title, date, positive rate change. A file ends with “EOF.”

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Example of Positive Rate Change According to Testee Output■

POSITIVE RATE CHANGE ACCORDING TO TESTEE
Date, 2016/10/22,2016/10/23
Test item name,90,F-Hb
Positive rate (%), 66.7,46.9

Positive rate change according to sample [File name: socprmsa#.txt]■

No. ItemRemark

Output1

Title 1-

2

Title 2“POSITIVE RATE CHANGE ACCORDING TO
SAMPLE”“Date”

3

Date

-

4

Title 3

The first date of a week or month in calculation of
positive rates by week or month“Test item name”

5

Test item code

Test item code-

6

Test item name.

Test item name-7

Title 4

“Positive rate (%)”-

8

Positive rate (%)

Rate of samples with positive rates to the total samples(Positive samples ÷ Total samples × 100)

-

-

-

Explanatory note

• “#” for a file name depends on the file type.
t: Positive rate change for all samples
0–9: Positive rate change of the group indicated by the number (0: Group not specified)• As shown in the example below, a file begins with “POSITIVE RATE ACCORDING TO SAMPLE.”• Items are divided by commas (,).
• Delimiter CR/LF follows the title, date, positive rate change. A file ends with “EOF.”■

Example of Positive Rate Change According to Sample Output

POSITIVE RATE CHANGE ACCORDING TO SAMPLE
Date, 2016/10/22,2016/10/23
Test item name,90,F-Hb
Positive rate (%), 66.7,46.9

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6.10

Save to External Media

List of Error Codes for output to external Media

Code Error

Measureddata
YesRemark10

BARCODE READING ERROR

20

DOUBLE BARCODE ERROR(Check within a day)

-

01

-

02

INSUFFICIENT SAMPLE/NO
SAMPLENO LATEX03

RBC (PROZONE)

Yes

04

PRC (PROZONE)*05

OR (OVER RANGE)*

06

UR (UNDER RANGE)-07

SAMPLE DISPENSING ERROR(such as jamming in the sample
nozzle)LATEX DISPENSING ERROR(such as jamming in the reagent
nozzle)Mixer error (such as jamming in
the mixer)
LATEX BLANK ERROR (A1
CHECK)-

Dispensing is not performed.
Also appears in the case of a puncturing error.

-

Dispensing is not performed.

-

It does not mixing.

-

Abnormal latex blank

0B

NO CC

-

Includes mismatching of CC lot.

0C

UNSET

-

30

Combined error of Errors 10 and 01-

90

Combined error of Errors 10 and 02-

11

Combined error of Errors 10 and 03-

I received an instruction from the host system
without an order.
Order request communication did notcomplete successfully.
An order different from the requested sample
ID and item code was returned.
Doesn’t appear if MODE 1 is selected for
NUMBERING MODE.

12

Combined error of Errors 10 and 04-

13

Combined error of Errors 10 and 05

Yes

14

Combined error of Errors 10 and 06*

15

Combined error of Errors 10 and 07*

16

Combined error of Errors 10 and 08-

17

Combined error of Errors 10 and 09-

18

Combined error of Errors 10 and 08-

19

Combined error of Errors 10 and 09

-

08
09
0A

Does not appear if “NO” is selected for“DUPLICATED SAMPLE BARCODECHECK”.
Dispensing is not performed.

-

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Code Error
1A

Combined error of Errors 10 and 0A

Measured
data
-

1B

Combined error of Errors 10 and 0B-

Remark* “11” to “1B” errors are combinations of two errors. No other combinations than those stated above are produced under present
circumstances.
* “NO LATEX” error appears when the remaining volume of the first latex bottle is found to be 0 µL before reagent is dispensed.
Normally, latex is supplied from the second latex bottle before the contents of the first latex bottle become empty (0 µL).
Moreover, analysis will be stopped before the contents of the second latex bottle become empty (0 µL). The NO LATEX error
will not normally appear.
* Measured data and Flag (+, -) will be output in the case of an error in which “Yes” appears in the corresponding “Measured
Data” box in the list described above.
Blanks (20H) are output as the Measured data and Flag (+, -) fields in the case of an error in which “-” appears in thecorresponding “Measured Data” box in the list described above.
Blanks as measured data and Flag (+, -) will be output in the case of an error in which “*” appears in the corresponding “Measured
Data” box in the list described above.
* NUMBERING MODE
In the “Mode 1” setting containers are detected and sample numbers are assigned only to container-mounted positions.
In the “Mode 2” setting sample numbers are assigned to all positions, including blank positions (container-free positions). Error
code “90” is output for blank positions.
* If an end ring is positioned in a rack when Mode 2 is selected, no information is output from the ring’s position through the last
position of the rack.
If no end ring is positioned in Mode 2, error code “90” is output on all blank positions.

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Final result: 250 times
Measured data: GainedError code: None

Final result: 250 times
Measured data: GainedError code: None

Final result: 250 times
Measured data: GainedError code: None

OR

RBC

PRC

Final result: 250 times
Measured data: GainedError code: None

Final result: 250 times
Measured data: GainedError code: None

Final result: 250 times
Measured data: GainedError code: None

Final result: Undefined
Measured data: Space
Error code: 0A

Final result: Undefined
Measured data: Space
Error code: UR

Final result: Undefined
Measured data: Space
Error code: 0A

Final result: Undefined
Measured data: Space
Error code: 0A

Final result: Undefined
Measured data: Space
Error code: UR

Final result: 15 times
Measured data: GainedError code: None

Final result: Undefined
Measured data: Space
Error code: 0A(*4) This varies depending on the communication mode setting.

If no error occurs in a 250-times dilution test, the error of a final result indicates an error status in a 15-times dilution test.

Final result: Undefined
Measured data: Space
Error code: 0A

RBC
Final result: Undefined
Measured data: Space
Error code: 0A

PRC

Error of no measured data

Final result: Undefined
Measured data: Space
Error code : Error code in 250-times
analysis (*3)
Final result: UndefinedFinal result: UndefinedFinal result: UndefinedFinal result: Undefined
Measured data: Space
Measured data: Space
Measured data: Space
Measured data: Space
Error code: 0AError code: 0AError code: 0AError code : Error code in 250-times
analysis (*3)
Final result: UndefinedFinal result: UndefinedFinal result: UndefinedFinal result: Undefined
Measured data
Measured data
Measured data
Measured data: Space
Diana:Space (with Negative Diana:
Space (with Negative Diana:
Space (with Negative Error code : Error code in 250-times
result)result)result)analysis (*3)
io: 9999 Fixed
io: 9999 Fixed
io: 9999 Fixed
Error code: OR
Error code: OR
Error code: OR
Final result: UndefinedFinal result: UndefinedFinal result: UndefinedFinal result: Undefined
Measured data
Measured data
Measured data
Measured data: Space
Diana:Space
Diana : 250-times dilution data
Diana:Space (with Negative Error code : Error code in 250-times(with Negative result)io: 250-times dilution data
result)analysis (*3)
io: 9999 Fixed
Error code: RBC
io: 9999 Fixed
Error code: OR
Error code: PRC
Final result: UndefinedFinal result: UndefinedFinal result: UndefinedFinal result: Undefined
Measured data
Measured data
Measured data
Measured data: Space
Diana:Space (with Negative Diana:
Space (with Negative Diana:
Space (with Negative Error code : Error code in 250-times
result)result)result)analysis (*3)
io: 9999 Fixedio:9999 Fixed
io: 9999 Fixed
Error code: OR
Error code: PRC
Error code: PRC
Final result: UndefinedFinal result: UndefinedFinal result: UndefinedFinal result: Undefined
Measured data
Measured data
Measured data
Measured data: Space
Diana:Space (with Negative Diana : 250-times dilution data
Diana:Space (with Negative Error code : Error code in 250-times
result)io: 250-times dilution data
result)analysis (*3)
io: 9999 Fixed
Error code: RBC
io: 9999 Fixed
Error code: OR
Error code: PRC

Final result: Undefined
Measured data: Space
Error code: 0AOR

If an error occurs in a 250-times dilution test, the error of a final result indicates an error status in a 250-times dilution test.

(*3) Error status(*2) DA1 value in 15-times dilution < DA1 value in 250-times dilution(*1) DA1 value in 15-times dilution ≥ DA1 value in 250-times dilution

Error of no
Final result: UndefinedFinal result: UndefinedFinal result: Undefinedmeasured data Measured data: Space
Measured data: Space
Measured data: Space
Error code : Error code in Error code : Error code in Error code: UR
15-times analysis (*3)
15-times analysis (*3)

Final result: Undefined
Measured data: Space
Error code: 0A

URURNormal (*2)

Final results of 15- or 250-times dilution tests and error codes

250-times Normal (*1)
15-times
NormalFinal result: 15 times
Measured data: GainedError code: None■

6
Save to External Media

439

7

Management USB Stick Setting
When saving measurement data or other data to a USB stick, the USB stick needs to be set as amanagement USB stick first.
This section describes the procedure to set a USB stick as a management USB stick.

Explanatory note: If you are using the operator and reagent management function, you need to log in with theadministrator ID in order to set up management USB stick.

		 Page 330 “Chapter 9 Operator/Latex Management Function (Option)”

7.1

How to Set a Management USB Stick1

Touch {Maintenance} on the [MENU] screen.
* [Maintenance] screen opens.

		2

Touch {Maintenance} button.

		

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管理 USB 設定

Touch {Create a management USB} button.

*[Create a management USB] screen opens.

4

Insert the USB stick.

5

Touch {Continue}.

6 Touch {Start}.
{Cancel}: Closes the dialog box.
{Close}: Aborts setting and returns to [Maintenance] screen.
{Start}: Set the inserted USB stick as a management USB stick.

7

The inserted USB stick has been success-fully

set as a management USB stick.

8

Remove the USB stick from the system.

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Index/Glossary
Index

A
Abort

325

Additional test

74

Alarm

33,292

Aloka curve

344

Automatic start

30,31,90

Automatic start up

30,31,90

B
Back up306

Buffer setting

42

C
Calibration curve
Calibration curve calculation

344

Calibration curve confirmation

66

Calibration curve editing/recalculation

67,197,200

Calibration curve reading/registration

202

CC No.# protocol settings

35,314Close mode

90

Conveyance line

12,13,252

Cut-in analysis

79,369Cut-off value

140,142,145,
194,308D
DA value calculation

350

Daily operation flow

36

Dilution test mode

54,362

Drain tank
Drain Tank Processing

96

Drain tank setting

39

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IndexE
Environment settings

33,276

Error
Error cancellation

326

Error Cancellation Buttons

325

Error Handling

324

Error log

89

Error sample data deletion

160

Error sample data output

158

Error sample data searching

156

Error sample data sorting152

Error sample range specification

154

Error sample list display

150

External media switching

109

Error sample

External media
External media output

120,146,158,
168,176

H
Help

318

HistogramHistgram display

162

Histgram range change

166

Histgram output

168

I
Information

25,69

Initialization

242

Inspection/maintenanceInspection/maintenance, cleaning parts

85

Inspection/maintenance, inspection change parts

87

Intra-day/inter-day data deletion

224

Intra-day/inter-day data editing

222

Intra-day/inter-day data range change

226

Intra-day/inter-day data screen

218

Intra-day/Inter-day

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IndexL
Linear and cubic curves

348Long suspense

94

Management USB stick440

M
Max limit

230, 231,298

Measured data
Measured data copying

126

Measured data deletion

124

Measured data measurement date specification

104

Measured data output

120

Measured data range specification

106

Measured data reading

108

Measured data recalculation

116

Measured data screen display

100

Measured data searching

112

Measured data select screen display

98

Measured data sorting

110

Measurement cells

258

Measurement method

52,76

Measure mode

52,76

Min limit

230, 231,298

Monitor screen

19,24

Normal close

27

Online output

120,146,158

NO
Operator information (ID information)
Change ID

336

Deleteing ID information

338

Registering ID information

334

Operator/latex management function

330

Output format

33,290

Output settings

33,280,284,288444
NN1-1703 Rev.3

IndexP
Positive Rate Change
Positive rate change calculation conditions

172

Positive rate change display

170

Positive rate change output

176

Positive rate change range change

174

Positive sample data deletion

148

Positive sample data output

146

Positive sample data range specification

136

Positive sample data recalculation

140

Positive sample data searching

138

Positive sample data sorting

134

Positive sample list display

130

Positive sample

Printer output

120,146,158,
168,176

Printing examples

372

Priming
Normal priming

44

Pipe line activation

46

Protocol settings

34,308
Protocol settings backup

306

Protocol settings restore

307

Prozone check

352

Purified water setting

40

Q
QC lotQuality Control

QC lot deletion

215

QC lot list display

210

QC lot selection

214
210

445
NN1-1703 Rev.3

IndexR
R graph231

Rack info

234

Rack/QC sequence number

33,272Range specification

106,136,154,
190,226

Reagent
Reagent setting

50

Check reagent blank354

Remeasurement/retest mode

52

Replicate
Replicate data range specification

190

Replicate data recalculation

194

Replicate data saving

184

Replicate data searching

192

Replicate data sorting

188

Replicate list display

178

Replicate screen display
Restore182,186
33,307S
Samp barcode settings

33,266,268

Samp/QC protocol settings

35,308Sample ID settings

128

Sample cups

239

Sample cup settings

33,302

Samples
Installing samples

52

Samples adding

72

Screen saver

33,206

Settings

24,70,265

STD/QC analysis process settings

33,216,298

Spline curve

348

System settings

32,266,306
System settings backup

306

System settings printing

305

System settings restore

307

446
NN1-1703 Rev.3

IndexT
Test
Analysis abort

84

Analysis Flow

5

Analysis normal close

82

Analysis pause

83

Analysis start

59

Test Operations

356

Test mode

52

Time course
Time course display/printing

204,205

Time course range change

206,208

Tray replacement (optional)

238

Wash solution setting

41

X graph

231

W

X
－

X-R control graph－

X-R control graph display

228－

X-R control graph range change

232

447
NN1-1703 Rev.3

GlossaryA
Absorbance
A1, A2, A3Logarithm of ratio of strength of incident light striking sample (Io) andstrength of transmitted light (I) (i.e. Io/I)
B
Back fit value
The value obtained by fitting absorbance to a calibration curve
D
DA
Absorbance difference. Calculated as the amount of change in absorbance.

For example, DA1 = A3 - A1 [ABS]
DA2=A2-A1[ABS]
DIL(Dil)
Retest diluent
Data
The concentration value of hemoglobin or transferrin.

Calculates measured data (concentration values) using DA values andcalibration curves.
Dilution test mode
Tests the sample once again after the sample is diluted (15 or 250 times).
However, it is not punctured.
J
Jamming
An error where something is touching the sample nozzle or mixer.

448
NN1-1703 Rev.3

GlossaryP
PRC method
Method that compares the DA2 values of STD-6 (the highest concentration of an
STD sample series) and a patient sample
ProzonePhenomenon where there are excessive antibodies or antigens, and observable
reactions in a mixture of specific antigens and antibodies no longer occur.
This is seen in high value samples. Samples where the amount of change
decreases in the late stage of a reaction are referred to as prozone samples.
Q
QC (sample)
Control sample Also referred to as reference material or reference sample
QC value check
Check based on the control limit values set in the [STD/QC measurement
process settings] screen.
Specification: The minimum control limit value is less than 1: abnormal
The maximum control limit value is +1 or greater: abnormalR
RBC method
Method that compares the absorbance at the RBC point (in the initial stage ofa reaction) of the highest concentration of an STD sample series (STD-6) anda patient sample
Remeasure mode
Measures the sample again. One measure mode
Remeasured samples are handled in the same manner as first test samples.
Retest mode
Retests sample depending on test results. However, it is not punctured. One
measure modeS
STD (sample)
The calibrator sample. Also referred to as standard material or standard sample.

449
NN1-1703 Rev.3

GlossaryT
Test mode
Measures a sample for the first time. One measure mode.
Time course
Results (graph) of measuring/recording changes in absorbance as time passes

450
NN1-1703 Rev.3

Manufacturer
EIKEN CHEMICAL CO., LTD.
4-19-9, TAITO, TAITO-KU, TOKYO 110-8408, JAPANTEL : +81-280-56-2822
FAX : +81-280-56-2707
Web Address : http://www.eiken.co.jp/en/ifu
April 2024 NN1-1703 Rev.5

Eiken Chemical Co., Ltd.