Original instructions

MV5 H00

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 towhen necessary.

Manufacturer: EIKEN CHEMICAL CO., LTD.

4-19-9, TAITO, TAITO-KU, TOKYO

110-8408, JAPANAuthorized Representative: Advena Ltd.
Tower 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 noticein order to make improvements.

•

We are not responsible for any damages or the like if the system is not used in accordance withthis Operation Manual.

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

EN 61010-1:•

IEC 61010-2-101:•

EN 61326-1:•

EN 61326-2-6:

Safety requirements for electrical equipment for measurement,
control, and laboratory use Part 1: General requirements.
Safety requirements for electrical equipment for measurement,
control, and laboratory use - Part 2-101: Particular requirements forin vitro diagnostic (IVD) medical equipment.
Electrical equipment for measurement, control, and laboratory use.
EMC requirements. General requirements.
Electrical equipment for measurement, control, and laboratory use.
EMC requirements. Particular requirements. In vitro diagnostic(IVD) medical equipment.

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NN1-1384 Rev.13

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
who have received specialized education or training in test procedures that use diagnosis systems
outside the body.
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

Chapter 1 Overview: Gives an overview of the system, including measurement

Chapter 2 Operation (Basic): Gives an overview of initial settings prior to use, and describes

Manual, as well as “Safety Precautions” when using the system.
principles, analysis flow, as well as the names and functions ofeach part.
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 as

Chapter 5 Maintenance: Describes inspection and maintenance methods users should

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

Chapter 7 Help

: Describes analysis flow, as well as inspection and maintenance

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

priming and cell blanking.

follow in order to safely use the system, maintain performance,and discover malfunctions and the like as early as possible.

methods after use.

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.

Index/Glossaryii
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Rev.12

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

Indicates a possibility that improper use of the system will cause death orsevere personal injury to the user.

CautionIndicates a possibility that improper use of the system will cause personal
injury to the user or damage to property.

Request

Indicates something the user should do to prevent damage or degradation to
the product and to use the system efficiently.
Severe injuries:

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

◼

Symbols
Caution symbols:

Indicate that users should use caution.

Prohibition symbols:

Indicate prohibited actions.

Attention

Prohibited

Instructional symbol:

Biohazard

Electrical shock

Pinching hazard

Disassembly
prohibited

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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NN1-1384 Rev.0

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.
･ Do not insert or remove the power plug with wet hands.
Prohibited･ 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.
Failure to observe this precaution may lead to electric shock.
Required･ Connect to the appropriate power supply.
RequiredPower supply voltage : ~100-240 V
Frequency: 50/60 Hz
Power 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.
･ Avoid exposure to water.
Required･ 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.
This system should only be installed or moved by a maintenance person who has beencertified by Eiken Chemical.

Required･ 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 operationor maintenance.
(Refer to the following diagram.)

30 cm or more

30 cm ormore

30 cm 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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NN1-1384 Rev.12

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 notprovide adequate protection to radio reception in such environments.
Required･ This 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 performance isaffected 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 the device.
･ Do not use this device in proximity to sources if strong electromagnetic radiation(e.g. unshielded intentional RF sources), as these can interfere with proper
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 of data
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 toensure 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 possibility ofdata 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.

NN1-1384 Rev.17

vii

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 thesample 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.
･ Do not remove any of the system’s exterior parts.
Disassembly
prohibited

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

RequiredCaution・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.
RequiredNN1-1384 Rev.16

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

ix

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 a failure
notice or other notification. Immediately contact the manufacturer or a legal
representative.

Disposing of drainage and waste
Warning

Biohazard･ Dispose of drainage and waste (reagent containers, reaction containers, samplingbottles, 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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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
1.9.2
1.9.3

Exterior parts .................................................................................. 10Internal parts .................................................................................. 12
Accessories/other ........................................................................... 14

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Chapter 2
2.1

Operation (Basic)
Basic Screen Operation
2.1.1
2.1.2
2.1.3

2.2

Starting the System
2.2.1
2.2.2
2.2.3
2.2.4

2.3

2.4.4
2.4.5
2.4.6
2.4.7
2.4.8
2.4.9
2.4.102.4.11
2.4.122.4.132.4.142.4.15

Cleaning parts ................................................................................ 84
Opening the parts check list ........................................................... 86
Opening the error log ..................................................................... 88

System shutdown (Close mode/Long suspense mode)
2.6.1
2.6.2

2.7

Daily operation flow ...................................................................... 36
Setting printer paper ....................................................................... 38
Check the drain tank (connected to system by maintenance person)........................................................ 39
Setting purified water ..................................................................... 40
Setting wash solution ..................................................................... 41
Setting buffer.................................................................................. 42
Priming (normal prime, pipe line activation) ................................. 44
Measure cell blanks ........................................................................ 48
Setting reagents (Pos.-1/Pos.-2/Pos.-3) .......................................... 50
Installing samples ........................................................................... 52
Starting tests ................................................................................... 58
Adding samples (continue testing) ................................................. 71
Additional tests (changing test conditions while testing) .............. 73
Cut-in analysis................................................................................ 78
Completing testing (normal close) ................................................. 81

Inspection/Maintenance after Use
2.5.1
2.5.2
2.5.3

2.6

System settings............................................................................... 32
Protocol settings ............................................................................. 34

Daily Operation
2.4.1
2.4.2
2.4.3

2.5

Shut down normally (with all settings configured to “NO”) ......... 27“Exchange buffer and wash sol to p. water” set to “YES” in Closemode, or Long suspense mode selected ......................................... 28“Cell blank” checked under “Settings of auto start up” in Closemode ............................................................................................... 30“Test” checked under “Settings of auto start up” in Close mode........................................................ 31

Initial Settings
2.3.1
2.3.2

2.4

[MENU] screen and functions ....................................................... 18
Screen composition and button operation ...................................... 19[Monitor] screen and functions ...................................................... 24

Close mode..................................................................................... 89
Long suspense ................................................................................ 94

Drain Tank Processing ...................................................................... 96

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Chapter 3
3.1

Operation (Applied)
Measured Data Processing
3.1.1
3.1.2
3.1.3
3.1.4
3.1.5
3.1.6
3.1.7
3.1.8
3.1.9
3.1.103.1.11
3.1.12

Opening the [Process data] screen ................................................. 98
Displaying the [Test data] screen ................................................. 100
Specifying measured data by measurement date ......................... 104
Specifying measured data by range ............................................. 106
Reading “measured data” not in the list (reading again) ............. 108
Reading “measured data” from external media (switching external
media)........................................................................................... 109
Sorting measured data .................................................................. 110
Searching for measured data ........................................................ 112
Recalculating measured data ........................................................ 116
Outputting measured data ............................................................ 120
Deleting measured data ................................................................ 124
Copying measured data ................................................................ 126

3.2

Editing Sample IDs......................................................................... 128

3.3

List of Positive Samples
3.3.1
3.3.2
3.3.3
3.3.4
3.3.5
3.3.6
3.3.7
3.3.8

3.4

List of Error Samples
3.4.1
3.4.2
3.4.3
3.4.4
3.4.5
3.4.6

3.5

Displaying the list of error samples ............................................. 150
Sorting error sample data ............................................................. 152
Specifying error sample data by range ......................................... 154
Searching error sample data ......................................................... 156
Outputting error sample data........................................................ 158
Deleting error sample data ........................................................... 160

Histogram
3.5.1
3.5.2
3.5.3

3.6

Displaying the positive sample list .............................................. 130
Sorting positive sample data ........................................................ 134
Specifying positive sample data by range .................................... 136
Searching positive sample data .................................................... 138
Recalculating positive sample data .............................................. 140
Calculating cut-off values from positive rates ............................. 142
Outputting positive sample data ................................................... 146
Deleting positive sample data ...................................................... 148

Displaying histograms.................................................................. 162
Changing the histogram range ..................................................... 166
Outputting histograms .................................................................. 168

Positive Rate Change
3.6.1
3.6.2
3.6.3
3.6.4

Displaying positive rate changes.................................................. 170
Configuring calculation conditions for positive rates .................. 172
Changing the range of positive rate change ................................. 174
Outputting positive rate changes .................................................. 176

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3.7

Replicate
3.7.1
3.7.2
3.7.3
3.7.4
3.7.5
3.7.6
3.7.7
3.7.8
3.7.9
3.7.103.7.11
3.7.12
3.7.133.7.143.7.15

3.8

Quality Control
3.8.1
3.8.2
3.8.3
3.8.4
3.8.5
3.8.6
3.8.7
3.8.8
3.8.9
3.8.10

3.9

Displaying the replicate list (samples/STAT samples) ................. 178
Displaying the [Replicate (STD)] screen ..................................... 182
Saving replicate data (STD) to external media ............................ 184
Displaying the [Replicate (QC)] screen ....................................... 186
Sorting replicate data (samples/STAT samples) ........................... 188
Specifying replicate data by range ............................................... 190
Searching replicate data ............................................................... 192
Recalculating replicate data ......................................................... 194
Editing/recalculating calibration curves (samples/STAT samples)...................................................... 197
Editing/recalculating calibration curves (STD) ........................... 200
Reading/registering calibration curves (samples/STAT samples)......................................................................... 202
Displaying/printing time courses (samples/STAT samples) ........ 204
Displaying/printing time courses (STD) ...................................... 205
Changing the range of the time course (samples/STAT samples)...................................................... 206
Changing the range of the time course (STD) ............................. 208
Displaying the QC lot list ([QC lot select] screen) ...................... 210
Selecting QC lots ......................................................................... 214
Deleting QC lots........................................................................... 215
Changing STD/QC measurement process settings from the [QC lot
select] screen ................................................................................ 216
Opening the [Intra-day/Inter-day] screen ..................................... 218
Editing (recalculating) inter/intra-day data .................................. 222
Deleting inter/intra-day data ........................................................ 224
Specifying inter/intra-day data by range ...................................... 226—
Displaying the X-R control graph ............................................... 228—
Changing the range of the X-R control graph ............................. 232

Rack info
3.9.1
3.9.2

Displaying the [Rack info] screen ................................................ 234
Replacing trays (optional) ............................................................ 238

3.10 Measuring Using Sample Cups ...................................................... 239

Chapter 4

Support Functions

4.1

Initialization .................................................................................... 242

4.2

Priming ........................................................................................... 244

4.3

Cell Blanking .................................................................................. 245

4.4

Washing .......................................................................................... 246
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Chapter 5
5.1

MaintenanceInspection/maintenance
5.1.1
5.1.2
5.1.3
5.1.4
5.1.5
5.1.6
5.1.7
5.1.8
5.1.9

5.2

List of Parts to Check and Exchange
5.2.1
5.2.2

Chapter 6
6.1

System settings
Sample barcode settings (common) ............................................. 266
Sample barcode settings (detailed settings by barcode type) ....... 268
Rack No./QC No. ......................................................................... 272
Environment settings.................................................................... 276
Data output settings - [Destination] ............................................. 280
Data output settings - [Online settings]........................................ 284
Output format ............................................................................... 290
Alarm ........................................................................................... 292
Screen saver ................................................................................. 296
STD/QC analysis process settings ............................................... 298
Sample cup ................................................................................... 302
Printing information on system settings....................................... 305
Backing up information on system settings/protocol settings ..... 306
Restoring information on system settings/protocol settings ........ 307

Protocol settings
6.2.1
6.2.2

Chapter 7

Opening the [Parts check list] screen ........................................... 262
Changing parts ............................................................................. 263

Settings
6.1.1
6.1.2
6.1.3
6.1.4
6.1.5
6.1.6
6.1.7
6.1.8
6.1.9
6.1.106.1.11
6.1.12
6.1.136.1.14

6.2

Opening the [Maintenance] screen .............................................. 250
Clean touch panel (daily) ............................................................. 251
Clean conveyance line (daily) ...................................................... 252
Clean washing nozzle (weekly) ................................................... 253
Clean sample & reagent nozzles (weekly) ................................... 254
Clean tray (weekly) ...................................................................... 255
Clean racks (weekly) .................................................................... 256
Clean tank (monthly) ................................................................... 257
Replacing measurement cells (when cell blank value is abnormal)......................................................................... 258

Samp/QC protocol settings .......................................................... 308
CC No. 1 to CC No. 6 protocol settings....................................... 314

Help

7.1

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

7.2

Opening the [Help] Screen from the [Monitor] Screen.................. 320

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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

Appendix1

2

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 and Qualitative
Assessment ..................................................................................... 351

1.5

Prozone check ................................................................................. 352

1.6

Reagent Blank Check (A1 Check) ................................................. 354

1.7

Calculate Cell Blank ....................................................................... 355

Test Operations
2.1

Operation when first measuring a sample using a “sample rack” (firsttest) ................................................................................................. 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

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

3

4

5

2.5

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

2.6

Operation when performing cut-in analysis ................................... 370

Printing examples
3.1

Positive sample printing ................................................................. 375

3.2

Final result printing when using a dilute test rack or when analyzing
15-times dilution simultaneously ................................................... 376

3.3

1 day, 2 day, 3 day printing ............................................................. 378

3.4

Printing when measuring STD/QC samples................................... 379

3.5

Error message printing ................................................................... 381

Handling the Printer4.1

Setting printer paper ....................................................................... 382

4.2

LED lamp display ........................................................................... 383

Error List
5.1

ERR# 0-1001 - 0-2005 (Main) ....................................................... 384

5.2

ERR# 1-000 - 1-200(SS1) .............................................................. 391

5.3

MES# 1-001 - 1-007(SS1) .............................................................. 409

5.4

ERR# 2-001 - 2-200(SS2) .............................................................. 411

5.5

MES# 2-001 - 2-007(SS2) .............................................................. 418

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6

Save to External Media
6.1

Sample Measured Data Information ............................................... 420

6.2

Sample Replicate Information......................................................... 422

6.3

QC Measured Data Information...................................................... 424

6.4

QC Replicate Information ............................................................... 425

6.5

STD Measured Data Information .................................................... 427

6.6

STD Replicate Information ............................................................. 428

6.7Time Course Data Information ....................................................... 429

6.8

Histogram Information.................................................................... 430

6.9

Positive Rate Change Information .................................................. 431

6.10 List of Error for Output to External Media ..................................... 433

7Management USB Stick Setting
7.1

How to Set a Management USB Stick ............................................ 437

Index/Glossaryxxi
NN1-1384 Rev.14

xxii
NN1-1384 Rev.13

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
NN1-1384 Rev.0

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 of measurements,
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 andthe 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
NN1-1384 Rev.11

1.4

System Configuration
Check the configuration prior to using the system.

Name
Body

Accessories

Fully automated fecal occult blood
analyzer(movable and discrete clinicalchemistry automatic analysis
system)
OC-SENSOR PLEDIA(1) Software package･ Software program

Model
OC-3201Preinstalled in harddisk(SSD)

OC-RK-41A

2 boxes

10 units/box･ STD/QC racks

OC-RK-42A

1

2 units/box

OC-RK-33C

1

1 unit/box

OC-RK-34C

1

1 unit/box

NBU-4033-W1

1

NBU-4033-W2

1

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

NBU-4033-W3

1

10 L tankw/ maximum-level sensor

NBU-4033-W4

1

5 L tank
5 L tank

5BL

1･ Empty bottle (for buffer)

PB-11

1

･ Beaker

PP200ML1
2･ Tank nozzles(4) Others･ End ring･ Cap spacer

OC-RING-2･ Cap spacer･ Cap spacer

Attached to tank (for wash
solution preparation) andauxiliary tank1
1

For 10 L tank1

For 5 L tank

1

For buffer bottle･ Sample cups

DSP-SC-20B

1 bag･ Power cable

CP-114or K-CP-700

1Consumable supplies･ Measurement cells

LX-CELL-1B5

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

P-58-40

1 rollConsumable supplies

NN1-1384

1

3 sheets･ Barcode labels for rack

･ Certificate of compliance･ Tank label

NN1-1384 Rev.16

Remark(2) Racks･ Sample racks･ Retest rack
･ Dilute test rack(3) Tanks/bottles･ Tank(for purified water)･ Tank(for wash solution)･ Tank(for drain)･ Tank(for wash solution preparation)･ Auxiliary tank

PapersNumber1

1
1

Affixed to tank

3

1.4

System Configuration◼

Options
Name
Rack trays
Two-dimension code reader
Temperature change driver board

Model
OC-TR-20
OC-320-OP1
OCP-NBP-4033-502DU

Number1
1
1

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

4
NN1-1384 Rev.12

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

Sample dispensing

2

Reagent/buffer dispensing

Number of cycles (T)

3

Mix

4
5
...
...

Measure

38
39
...
...
...
43
...
...
...
47
...
...
...
...
...
...
...
...
51

The sample nozzle dispenses samples to cells.

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

The mixer mixes the sample, reagent, and buffer.

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

Wash cells(flushing wash solution)

First wash
The washing nozzle absorbs the finished reaction liquid andthen dispenses the wash solution.

Wash cells(flushing of purified water)

Second wash
The washing nozzle absorbs the wash solution, and dispenses
the purified water.

Wash cells(flushing of purified water)

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

During this time, the cell blank value is measured.

Wash cells(absorption of purified water)

Explanatory note

Fourth wash
The washing nozzle absorbs purified water.

: 11.3 seconds are required for a single cycle.

5
NN1-1384 Rev.11

1.6 System Specifications◼

Basic specifications
Name

Specification

Measurement Principles

Latex turbidimetry

MethodDiscrete method, random access method

Test mode

1-Step rate

Samples

Feces

Processing capacity

320 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
Latex reagent

Temperature control system(24-hour control) 25°C-30°C heat block method

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

Light source

LED (Wavelength: 660 nm)

Detector

Photo diode

Operation control/dataprocessing

Multi-CPU system on internal LAN

External online

RS-232C, Ethernet

40±0.5°C air bath method

6
NN1-1384 Rev.12

1.6
Name

Specification

Sample dispensing accuracy

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

20 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 ±10% 50/60 Hz 500 VA or lessSound level

65 dBA or less

Explanatory note

System Specifications: The acceptable range of dimensions is within ±5%; The acceptable range of weight is within ±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.

NN1-1384 Rev.177

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

◼

Reagents for hemoglobin measurement

Product Name

Product CodePackage

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

Product Name

Product CodePackage

OC-SENSOR Sample Diluent

V-PH1945 mL x 3◼

Common8
NN1-1384 Rev.11

1.8 System Dimensions

Top view

Front view9
NN1-1384 Rev.0

1.9 Names and Functions of Parts
1.9.1

Exterior parts(3) Cover of theanalysis chamber(4) Thermal printer(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
NN1-1384 Rev.12

1.9(11) Wash solution tank(12) Purified water tank

Zero-level sensor

Name(1) Primary power switch(2) Standby switch(3) Cover of the analysis
chamber(4) Thermal printer(5) Control panel(6) Port to external media(7) Ethernet(8) RS-232C(9) Power cord(10) Installation location
for tanks(11) Wash solution tank
(Wash Solution)(12) Purified water tank(Purified Water)(13) Drain tank
(Drain)Zero-level sensor

Names and Functions of Parts(13) Drain tank

Maximum-level sensor

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.
If the standby switch is turned on, the system starts and controls thetemperature of the reaction table.
Safety feature to prevent accidents during system operation.
Prints setup conditions, measurement results, error messages, or other
data.
Page 382 “Handling the Printer”
Shows operation screens and analytical results.
The screen can be touched directly to operate.
Allows connection to external media for storage of measured data.
Connects to the host computer.
Connects to the host computer.
The power cord for this system.
Connects piping and wiring to the tanks (for wash solution, purified
water, and drainage).
Filled with wash solution.
Filled with purified water.
Stores liquid disposed by washing the sample nozzle, reagent nozzle,
mixer, and cells.

11
NN1-1384 Rev.0

1.9

Names and Functions of Parts

1.9.2

Internal parts(14) Sample dispensing pump(inside the cover)(13) Reagent dispensing pump(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(19) Supply bar(7) Discharge 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
NN1-1384 Rev.11

1.9

(4)

Puncturing system (enlarged)

Name(1) Rack supply unit
(2) Conveyance bar(3) Buffer compartment(4) Puncturing system
(5)
(6)
(7)
(8)

Names and Functions of Parts

Rack discharge unit
STAT rack position
Discharge bar
Overflow cell (OF)(9) Reagent compartment(10) Reagent nozzle(11) Reaction table(12) Mixer(13) Reagent dispensing pump(14) Sample dispensing pump(15) Washing nozzle(16) Sample nozzle(17) Squeezing system(18) Conveyance line(19) Supply bar(20) Sample ID barcode reader

Function
Location where racks are placed.
Up to 20 racks can be placed.
Conveys a rack along the conveyance line.
Location for setting the special 500 mL bottle for buffer. Constantly
maintained at 35°C-41°C.
Punctures the double-layered aluminum seal attached to samplingbottles.
Location where racks are discharged from.
Location where rack is placed for cut-in analysis.
Feeds a rack to the rack discharge unit at the end of analysis.
For sample nozzles
Washes the inner and outer wall of sample nozzles using purified
water and wash 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.
Location to set hemoglobin reagents. Simultaneous installation is
not possible.
Constantly maintained at 25°C-30°C.
Dispenses reagents.
Performs antigen-antibody reaction and photometry.
Mixes samples and reagents.
Absorbs and flushes reagents and buffers.
Absorbs and flushes samples.
Washes measurement cells.
Dispenses samples. Also creates calibrator dilution series anddilutes during dilute tests.
Raises the sample’s level of liquid in the sampling bottle.
Conveys racks from the rack supply unit to the rack discharge unit.
Feeds racks placed in the rack supply unit to the conveyance line.
Reads barcodes on reagent bottles and racks.

13
NN1-1384 Rev.11

1.9

Names and Functions of Parts

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

14
NN1-1384 Rev.0

1.9

Name
(1) Buffer bottle(2) Reagent bottle(3) Sample racks(4) Retest rack(5) Dilute test rack(6) STD/QC racks(7) Tray (optional)

Names and Functions of Parts

Function
Holds the buffer.
Holds the latex reagent.

Holds sampling bottles and sample cups.

Used to place each rack.

15
NN1-1384 Rev.0

MEMO

16
NN1-1384 Rev.0

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/Longsuspense mode)
2.7 Drain Tank Processing

17
NN1-1384 Rev.0

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).

b

Set latex

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

Prep functions

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

Data processing

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

e

Help

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

fSettings

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

g

MaintenanceConfirm parts to check and exchange, or perform maintenance.

h

Close

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

c

d

18
NN1-1384 Rev.0

2.1

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}
buttonTouching 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.

19
NN1-1384 Rev.0

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.

20
NN1-1384 Rev.8

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 thehard disk(SSD). To update data, touch the {Register} button.

[Latex settings] screen
Touching the {Continue} button opens the dialog box.

Dialog box

NN1-1384 Rev.16{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

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

e
c
[CC No. 1 protocol] screen

Numerical input
 Touch the input field (a).
 Touch the numeric keypad (b) and input the numerical value.
 Touch {enter} (e) (confirm the numerical value).
Single character insertion
 Touch the input field (a).
 Move the cursor to the left of the character to insert using the {←} and {→} buttons (c).
Single character deletion
 Touch the input field (a).
 Move the cursor to the left of the character to delete using the {←} and {→} buttons (c).
 Touch the {del} key (d).
Explanatory note

: 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 the bottom 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.

22
NN1-1384 Rev.8

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.

gf[Output format] screenfRadio buttons

Allow selection of a single item.

gCheck buttons

Allow selection of several items.

Switches between uppercase
and lowercase letters.

KeypadSwitches input to symbols.

[Search word settings] screen

23
NN1-1384 Rev.0

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 73 “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 78 “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”

24
NN1-1384 Rev.8

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

State of process

The current state of processing is displayed.
The following is displayed:
Dispensing sample
Dispensing latex
MixingReacting [# min]
The time until analytical results are output is shownin the brackets ([ ]).
Data(when the measurement has completed normally)
Err*(when the measurement has not completed normally)
Explanatory note

Comment: *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.

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

Expected end time Display the expected time that washing will complete for all reaction cells and(min) the system will stop.
Explanatory noteg

{Information}: This time will not change while sample dispensing continues.

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 68 “ Viewing information”

25
NN1-1384 Rev.11

2.1

Basic Screen Operation

h

j

i

[Monitor] screenhRack 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
and the communication is disconnected, the {Connect} button isdisplayed.
Resume communication using the following method.
 Resolve the communication error.
 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.

26
NN1-1384 Rev.8

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
NN1-1384 Rev.0

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.
Remove the bottle filled with purified water andthe wash solution.



Set a buffer bottle filled with buffer.

Fill the wash solution tank with wash solution.

Touch the {Start} button.
* Pipe line activation begins.

28
NN1-1384 Rev.8

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

4

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

{Pause}:{Start}:{Abort}:5

Processing pauses.
Resume processing.
If the Pause button is touched, it will change to
the Start button.
Abort processing.

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

29
NN1-1384 Rev.0

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.

30
NN1-1384 Rev.8

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.

NN1-1384 Rev.12

2

Self check begins.

3

The [Monitor] screen opens and testing begins.

31

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 beselected 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 thefollowing page.)32
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2.3 Initial Settings

a

c

b

d

f

e

g

i

h

m
j
k
[System settings] screenlaBarcodeSet 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

ConfigdData OutputeOutput format

f

Alarm

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

Sample cup

Configure conditions for checking measured data for STD samples/QC
samples.
Register the shape of the sample cup.

jBack up

Save system setting/protocol setting information to external media.

k

Restorel

Print

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

m

Menu

The system returns to the [MENU] screen.

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Initial Settings

2.3.2

Protocol settings
1

Touch the {Settings} button.

2

Touch the {Protocol settings} tab.

3

Touch the {Button} for the item to configure.
* The settings screen for each is displayed. (See thefollowing page.)34
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2.3

a

Initial SettingscbdProtocol settings screenaSamp/QC protocol

Set test conditions when measuring samples and QC samples.

b

CC1 to CC6 protocol

Allows for registration of calibration curves for protocols No. 1 throughNo. 6.

c

Manufacturer use
only

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

d

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

Test start

Explanatory note

: 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” on

Page 27

Confirm initial settings

Page 32

Preparations prior to testing

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, andbuffer to piping (priming)

Page 46

Measure cell blanks

Page 48

Set reagent

Page 50

Place sample

Page 52

To next page

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

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Test start

2.4

Open the [Test] screen

Page 58

Configure “Test mode & Measure mode”

Page 58

Configure “Latex/CC settings”

Page 63

Confirm calibration curves

Page 65

Start test

Page 67

SystemTesting
Inspection/
shutdown maintenance completed

Testing<When required>

Add samples

Page 71

Additional test

Page 73

Cut-in analysis

Page 78

Rack info

Page234

Daily Operation

Page 81

Finish testing
Normal close
Pause
Abort

Page 84, 250

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

Page 89*The standby switch shuts off automatically.

Place sample

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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
cutter.
Failure to observe this precaution may
Required

Preparations prior to testing

LED lamp FEED button

lead to injury.

Manual cutter

Raise the paper cover open lever and open the
cover.

Paper cover

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

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


Manual cutter

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

FEED button

Touch the FEED button.

Cut the paper using the manual cutter.

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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).

2

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.

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2.4.4

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) to eachpurified water tank port (two).

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 side of
the system.

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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%.
Preparations prior to testing

Explanatory note

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

2

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

3

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

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 side of
the system.

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

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2.4.6

Setting buffer

Set the buffer bottle to the “buffer compartment.”

RequestPreparations prior to testing･ After setting the buffer bottle (including adding purified water), be sure to primeit.

Explanatory note

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

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

1

Set the buffer bottle (a) to the buffer
compartment (b).

2Remove the cap of the buffer bottle, and insert
the hose (c).
Make a flat surface of the connector to the front.

Flat surface

3

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

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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 for the
buffer and use the numeric keypad tomodify the value.

5

Touch the {Close} button.
* Pipe line activation begins.

Preparations prior to testing* The system returns to the [MENU] screen.

Explanatory note: 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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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
during operation.
Pinching hazard◼

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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3
1

Daily Operation

Select normal priming.
Check Normal prime.

Select items to prime.
 YES: Prime.

2

 NO: Do not prime.
Select whether or not to reset the buffer volume([YES] or [NO]).


3

Touch the {Start} button.
* Normal priming begins.

4

Priming

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

Explanatory note

{Pause}:Processing pauses.

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

{Abort}: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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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.


Check “Pipe line activation.”

Select “Volume reset.”

Touch the {Start} button.
* Pipe line activation begins.

2

3

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4

Daily Operation

Activate prime* When priming is complete, the dialog closes.

Processing pauses.

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

{Abort}:Abort processing.

: If the cover of the analysis chamber is opened during pipe line activation, “Cover open” isdisplayed at the bottom right of the screen.

Preparations prior to testing

Explanatory note

{Pause}:47
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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.
Pinching hazard

Preparations prior to testing

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

1

1

Touch the {Prep functions} button.

2

Touch the {Cell blank} tab.

3

Select measurement cell washing.


Check “YES.”

Touch the {Start} button.
* Cell blank measurement begins.

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4

Daily Operation

Cell blank measure

Preparations prior to testing* When measurement is complete, the {Abort} button
will change to {Close}.

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 to the{Start} button.

{Print}:Print the measurement results.

{Close}:Displayed when processing completes.
The system returns to the measurement cell washingselection 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)
After reading the reagent barcodes for Pos.-1, Pos.-2, and Pos.-3, set the reagent bottle to the reagent
compartment. The positioning of the reagent bottles is Pos.-1, Pos.-2, and Pos.-3 in order, from theleft 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.
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)

Preparations prior to testingD:
Explanatory note

Check digit (alphanumeric): Reagents can be set from the [Test] screen or the [Monitor] screen.

1

Touch the {Set latex} button.

2

Enter the reagent barcode.

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

2

Explanatory noteUse the numeric keypad to enter the seven digits ofthe eight-digit barcode affixed to the reagent bottle,
excluding the last digit (check digit).

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

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Daily Operation

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>Touch the barcode field for the appropriate reagent.



Lower the barcode reader lever.

Place the reagent bottle into the barcode reading
port with the barcode surface facing to the front.

* The check box turns blue.

Barcode reading port

* The seven-digit barcode (excluding the checkdigit) is displayed.

Preparations prior to testing

Barcode reader lever3

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.

Reagent bottleOpen the lid of the reagent compartment.



Remove the cap of the reagent bottle.



Insert the reagent bottles into the reagent insertion
port, with the barcode surface facing to the front.



After setting all reagents, close the lid of the reagent
compartment.

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}:Explanatory note

Update the buffer information. Pipe line
activation automatically begins when thereagent is set.

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

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

Explanatory note･

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.”(There is no need to specify the mode.)
Page 55 “Setting STD/QC samples”

Preparations prior to testing･

When running a dilute test on a sample, use a “dilute test rack” (there is no need to specify amode).
Page 54 “Setting samples when running a dilute test”

Explanatory note

： 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 58 “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.

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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Daily Operation<2 day>First sampling bottle of test subject A

Arrange two sampling bottles (twoday’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.

<3 day>First sampling bottle of test subject A

Arrange three sampling bottles (three
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.

Explanatory note

: 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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Daily Operation

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, and10.
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.

Empty
sample cup

SamplingbottleEmptysample cup

SamplingbottleEmptysample cup

Specified retest
diluent*
Samplingbottle* Approximately 2 mL of retest
diluent is required.

SamplingbottleEmptysample cup

SamplingbottleEmptysample cup

SamplingbottleEmptysample cup<Measuring at 15-times dilution>

Specified retest
diluent*

Preparations prior to testing<Measuring at both 15-times dilution and 250-times dilution, or at 250-times dilution>* Approximately 2 mL of retest
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

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

Explanatory note

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

Preparations prior to testing

QC3 QC4

Empty sample cup

QC1 QC2<Figure 1>
Calibrator

Calibrator buffer*

Explanatory note

<Figure2> (when a dilution series has been created)

Calibrator

Calibrator buffer*

Sample cups for which a dilution series has been created(In order of concentration weakness, from left to right.)* Approximately 2 mL ofcalibrator buffer is required.

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.

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Daily Operation

Calibration curve creation method (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.
Page 55 “Setting STD/QC samples” (Figures 1)(2) Enter the concentration listed in the INSTRUCTIONS FOR USE“Conc.” in [Protocol settings] - [CC No. # protocol settings].

for the calibrator into

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.

Calibration curve creation method (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.

Preparations prior to testing(3) Set the calibrator buffer to rack position No. 3.
Page 55 “Setting STD/QC samples” (Figure 2)
Explanatory note

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

(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.

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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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.
If the barcode is facing the system, a barcode read error could occur.
Required

Front of system

1

Pull the tray lever (b) to the front.

Pull* The guide lock releases.

Preparations prior to testing

Tray lever

Front of system
Push

2'-2

2

Set the rack to the tray.


Insert the groove on the left edge of the rack into theguide (a).



Align the groove on the right edge of the rack withthe guide (c).

Push the tray lever (b) and lock it.

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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2.4.11 Starting tests
Open the [Test] screen, and configure the test conditions displayed on the screen after selecting the{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.

1 Opening the [Test] screen
Touch the {Test} button.

2

Touch the {Test mode} button.

Test start

1

2 Setting test modes, measurement methods, and measurement modes
1

Configure items (see the following page).

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Item

Range/Selection

Sample No.
G  - SEQ *, 1-91 - 99999

Daily Operation

Details
Configure the number of the head sample.
A sample number consists of a group number(G) and a sequence number (SEQ).
Enter “*” to skip configuring a group number.

Group No. (G)Sequence No. (SEQ)(Maintained in memory until thesystem power is turned off.)

NumberingIf there is a rack position in which a sample has notbeen set, configure how to allocate sequencenumbers.

(Maintained in memory even if
the system power is turned off.)

YES:

Allocate sequence numbers only to set samples.

Test start

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

NO:

Allocate sequence numbers even to positions inwhich samples are not set.

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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Explanatory note

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

Item

Range/Selection

Sample barcode

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
power is turned off.)

YES:

Use sample barcodes.

NO:

Do not use sample barcodes.

Measurement method(Configuration maintained inmemory even if the system
power is 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 inmemory until the system poweris turned off.)･ Measured data when remeasuring a sample inremeasure/retest mode is applied to the positive
rate.

Test start･ Measured data when using a retest rack or dilutetest rack is not applied to the positive rate.

Test:

Test/remeasure test
start position

Select when first making a measurement.

Retest:Select when remeasuring or retesting a sample.

1 - 10Configure the head rack test start position.

(position in rack)･ Sequence numbers are allocated from the test start
position configured here.

(Not applied when starting new
test.)･ This setting does not apply to retest or dilute test
racks.

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2

Touch the {Continue} button.

3

Touch the {Register} button.

Daily Operation* The settings were registered.

Test start→ Page 63
3 Configuring [Latex/CC settings]

Explanatory note

: Touch the {MENU} button to return to the [MENU] screen after registration.

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How to use the(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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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
for the calibration curve (CC No.).
･ If a calibration curve has not been prepared, do so prior to starting the test.

Test start

If testing is started with mismatched reagent lots, a “No CC” error message will be
displayed.

1

Touch the {Latex/CC settings} button.

2

Configure the reagent and calibration curve.
(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 canbe performed here.

Explanatory note

Page 314 “6.2.2 CC No. 1 to CC No. 6 protocol settings”: 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 65 “ Calibration curve confirmation”

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Item
Reagents used by system
Pos.- ← CC No. 

Range/Selection

2nd latex

Details
1-3
1-6

Configure the number of the reagent bottle to use.
Configure the calibration curve number to use
when measuring the sample.

1-6

Configure the calibration curve number to use
when measuring the sample.

Pos.-2←CC No. 

Explanatory note

3rd latex

set as the 1st latex.
It is automatically configured when the
1st latex is set.

1-3
1-6

Configure the number of the reagent bottle to use.
Enter Save as CC No. for the reagent andcalibration curve used when drawing thecalibration curve.

Pos.-3← CC No. 
Latex for CC
Pos.-  → Save as CC
No. : The 2nd latex is the reagent that was not

1-6

Test start

A list showing “Date” and “Latex lot” for the registeredCC number is displayed. If no calibration curve isregistered, nothing is displayed.

3
CC No.
1
2
3

Date
14/10/16 14:27
14/10/16 14:28
14/10/16 14:29

Latex lot
12345
12346
12347

Touch the {Continue} button.
CC No.
4
5
6

4

Date

Latex lot

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

→ Page 67
4 Starting tests

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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.
Touch the {CC#} tab, and switch the calibration
curve information.

Test start

To edit or remeasure the calibration curve,
page 66 “ 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 66 “ 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 “6.1.10 STD/QC analysis process settings”

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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.


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

Input the value.

1

3

Touch the {Recal} button .
* The results of recalculating the calibration curve and
QC are displayed on the [Check CC] screen.

Test start

2

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.)66
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4 Starting tests
This section will explain the procedure from the [Test] screen.
1

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

Test start2

Confirm the following diagnostic results
1.

Optical unit (Detector)

2.

Cell

3.

Latex temp high (Reagent abnormal
temperature)4.

Buffer temp high (Buffer abnormal
temperature)

5.

Reaction table (Reaction table abnormal
temperature)6.

Latex (25°C or higher)

7.

Buffer temperature

If self check results in “Fail”,
page 70 “ 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 the calibration
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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Viewing information
There is an {Information} button on the [Monitor] screen. The lot number, remaining tests for the reagent,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 lessReagent Lot No.: Reagent lot number (five digits)
Remaining tests: Displays how many tests(approximate) can be processed based on the amount ofreagent and buffer in the bottles.

Touch the {Information} button.

2

Confirm the information.

Testing

1

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

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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.
1

Touch the {Settings} button.

2

Touch the button of the setting to confirm.

Testing* 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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4

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

◼

Self check failed

Testing

The method for handling a “Fail” result varies according to the diagnostic item.
Refer to the following chart.
Diagnostic Item

Handling Method

Optical unit

(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 the reagent.

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 the set
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.
(If [Config] - [Rack auto start] is set to “YES”
Explanatory note

page 276 “6.1.4 Config”): 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
to the front after the rack is supplied.

2

Place the rack in the supply unit.

Testing

Trays (optional) can also be individually placed inracks.

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.
Failure to observe this precaution could cause a barcode reading error.
Required

Explanatory note

: 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>
Remove the empty tray.

(2)

Place the tray to which the rack has been set
in the supply unit.

Testing(1)

3

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

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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

Range/Selection

Rack No. *(default)
1-99

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.

Sample No.
G  - SEQ 
Group No. (G)Sequence No. (SEQ)*, 1-91 - 99999

If there is a position in which a sample has notbeen set, configure how to allocate sequencenumbers.

Numbering

Testing

Configure the number of the head sample.
A sample number consists of a group number(G) and a sequence number (SEQ).
Enter “*” to skip configuring a group number.
If “*” is input for the sequence number,sequence numbers will be assigned in sequence
from the previous sample number.

YES:

Allocate sequence numbers only to set samples.

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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Item

Range/Selection

NumberingNO:

Daily Operation

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

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

Configure whether or not to use sample barcodes.

Testing･ Settings are also applied to [Settings] - [Systemsettings] - [Samp barcode settings].

YES:

Use sample barcodes.

NO:

Do not use sample barcodes.

Measurement method

1 day:
2 day:
3 day:
Measure mode

Select the measurement method.
(If S-Hb is selected, [Method] cannot be
configured.)
Measure using 1 day method.
Measure using 2 day method.
Measure using 3 day method.
Select the measurement mode.
･ Measured data when remeasuring a sample inremeasure/retest mode is applied to the positiverate.
･ Measured data when using a retest rack or dilutetest rack is not applied to the positive rate.

Test:
Retest:Test/remeasure test
start position(position in rack)

1-10

Select when first making a measurement.
Select when remeasuring a sample.
Configure the head rack dispensing start position.
･ This setting does not apply to retest or dilute test
racks.
･ Sequence numbers are allocated from the test
start position.

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2.4

Daily Operation

4

Touch the {Continue} button.

5

Touch the {Register} button.

{Register}:

Register configured settings.

{Close}:Cancel test mode and measure mode selection, andreturn 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.

Testing

Explanatory note◼

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

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.


Touch the {Continue} button.
* The dialog box is displayed.



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

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2.4.14 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, thenplace 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.

Required

Request･ Do not stop cut-in analysis when measuring an STD sample.
The data being measured will be deleted.
Prohibited

Explanatory note: If a retest rack or dilute test rack is cut-in during cut-in analysis, the system will display “Rackbarcode Unavailable” and the rack will be discharged to the STAT rack position.

1

Select the {STAT} tab.

Testing* 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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3

Item
Latex for CC

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

Details
Select the reagent to use.

Configure the registration destination CC numberof the created calibration curve.

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.

Testing

Save CC No.

Range/Selection
Pos.-1
Pos.-2
Pos.-3
CC 1-CC 6

Daily Operation* The rack is conveyed to the right.

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6

Check the rack supply unit and the rack on the
tray.
<Cut-in STD/QC rack>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 andthe rack falling over.

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.

Remove the STAT rack.

Touch the {Cancel} button.
* Normal testing resumes.

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2.4.15 Completing 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 82 “ Pausing testing.”
To “abort” testing, see page 83 “ Aborting testing.”
1

Touch the {CLOSE} button.

Testing completed

To continue testing, place the sample rack in therack supply unit.
Page 71 “2.4.12 Adding samples(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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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.

2

Touch the {Restart} button.

Testing completed* Operation is resumed.

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Aborting testing

Testing completed

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

1

Touch the {Completed} button.

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.

Cleaning parts

Inspection/maintenance

2.5.1

1

Touch the {Maintenance} button.

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
5. Clean trays (weekly)
6. Clean racks (weekly)
7. Clean tanks (monthly)

Explanatory note: 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.

Display a list of parts that need to be inspected or exchanged.
Page 86 “2.5.2 Opening the parts check list”{Error log}:

The error log is displayed. Up to 1000 error log entries can be viewed.
Page 88 “2.5.3 Opening the error log”
Return to the [MENU] screen.

{Maintenance}:

Adjust the system and check operation. (This is for maintenance people.)

Inspection/maintenance[MENU]:

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Inspection/Maintenance after Use

2.5.2

Opening the parts check list

Inspection/maintenance

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.

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 andnumber of times used, the background of the partturns yellow.

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(1)

Item
Parts

Details
Name of the part to exchange(2)

Changed at(3)

The number of months
used
(
)
Test

Date the part was exchanged(YY/MM/DD)
The number of months used sincelast exchange
Maximum months used
The number of times used since lastexchange
Maximum times used

No.

(4)

(

)

4

Inspection/maintenance1

Inspection/Maintenance after Use

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

Exchange the part.


Select the part to exchange (in yellow).

Exchange the part.



Touch the {Exchange} button.
* A confirmation dialog box asking “Exchange parts?” isdisplayed.

{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.

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

3

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

Opening the error log

The [Error log] screen displays the date the error occurred, the error code, and the name of the error(details).

Inspection/maintenance

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.

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. (The primary powerswitch is not turned off.)

Close mode1

Touch the {Close} button.

2

If there are parts for which the exchange period
has been exceeded, “Some parts should beexchanged. Please check list of parts to check andexchange.” is displayed.

System shutdown

2.6.1

Touch the {Close} button and then the {MENU}
button in order to return to the [MENU] screen.
Page 86 “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.
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System shutdown (Close mode/Long suspense mode)

Item
Cell wash

System shutdown

Exchange buffer andwash sol to p. water
Nozzle/cell soak wash

12

Range/Selection
YES:
NO:
YES:
NO:
YES:
NO:

Details
Wash measurement cells when complete.
Do not wash measurement cells when complete.
Exchange with purified water.
Do not exchange with purified water.
Run soaking preservation.
Do not run soaking preservation.

4

Touch the {Settings of auto start up} button.

5

Configure the day of the week and time toautomatically start the system next (see thefollowing chart).

3

Check the day of the week.

Input the time.

Configure the operation to run automatically after
start up, for each day of the week (see thefollowing chart).


6

Check either “Nothing,” “Cell blank,” or “Test.”

Register configured settings.
Touch the {Continue} button.

Touch the {Register} button.

* The dialog box opens.

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Item
None

Range/Selection⚫ Check:

Cell blank⚫ Check:

 Do not check: Do not check:

Test⚫ Check:

System shutdown

 Do not check:

System shutdown (Close mode/Long suspense mode)

Details
Display the [MENU] screen after starting.
Run the selected operation after starting.
Run [Prep functions] - [Cell blank] after starting, thendisplay the results.
Do not run cell blank measurement after starting.
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.
Testing does not start automatically after starting.

7

Touch the {Continue} button.

8

Run close mode.
Confirm that the “purified water tank” and “washsolution tank” are not empty.

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

Touch the {Start} button.

{Start}:Run close mode.

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

3{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”).


Remove the piping connected to the buffer bottle.

Connect a container filled with purified water to thepiping in .



Remove the piping connected to the wash solution
tank.



Connect a container filled with purified water to thepiping in .

Touch the {Continue} button.

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

System shutdown* 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“Cell blank” and “Test” are set to run (⚫ check) in the automatic start settings.

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System shutdown (Close mode/Long suspense mode)

MEMO

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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
Exchange buffer andwash sol to p. water
Nozzle/cell soak wash

Range/Selection
YES:
NO:
YES:
NO:
YES:
NO:

Details
Wash cells when complete.
Do not wash cells when complete.
Exchange with purified water.
Do not exchange with purified water.
Cannot be selected.

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System shutdown (Close mode/Long suspense mode)4

Touch the {Continue} button.

5

Run close mode.
Confirm that the “purified water tank” and “washsolution tank” are not empty.

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

Touch the {Start} button.

{Start}:Run close mode.

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

System shutdown{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 and wash
solution to purified water” is set to “YES”).

Explanatory note

Remove the piping connected to the buffer bottle.

Connect a container filled with purified water to thepiping in .



Remove the piping connected to the wash solution
tank.



Connect a container filled with purified water to thepiping in .

Touch the {Continue} button.

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

System shutdown

Biohazard

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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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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 have beenreached 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

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

Touch the {Process data} button.

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1

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

2

1lEnter a password (displayed when a password
was registered in [System settings] -[Config]).
Enter a password.

Touch the {enter} key.

2l3

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 thetime the system started up.
If there is no data to process, the time is
not displayed.

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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, thesystem startup time.) Data measured until the standby switch is turned off is saved to the harddisk(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 note100

: 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

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}:

4

Return to the [MENU] screen.

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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Content displayed on [Test data] screen (Samp/STAT samp)
Display
Date
RACK
SEQ.
Data [ng/mL]
Flag

Comment

Sample ID
CC

Dil

Details
Date and time sample was measured
Rack No. - Position number in rack
Group No. - Sequence No.
Measurement results(concentration value)-, +, 1 +, 2 +, 3 +Error information (excluding reading errors)UR: Under range

OR: Over range
PRC: Prozone
Barcode information on sampling bottles
Calibration curve used to calculate measured data
(CC No.)Dilution information: No dilution
Space(test mode, remeasure mode): No dilution
A(Retest mode): 15-times dilution
A15(Dilution test mode): 250-times dilution
A250(Dilution test mode)

RemarkBlank output for measured dataand judgment result
Output only judgment result
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Content displayed on [Test data] screen (QC)
Display
Date

Details
Date and time QC sample was measured

RACK

Rack No. - Position number in rack

QC No.
QC LOTSEQ.

QC No.1 - 4
QC lot (five digits)
QC sequence number
Measurement results(concentration value)
Error information (excluding reading errors)UR: Under range
OR: Over range
PRC: Prozone
Calibration curve used to calculate measured data
(CC number)
QC ID of QC sample at cursor position

Data [ng/mL]

Comment

CC
QC ID

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

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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, thesystem will begin a search from the latest measurement date to find the measured data withthe 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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3

Specify the measurement date.
1

Measured Data Processing

Touch the input field and enter the year, month, andday.
If part of the year, month, or day is omitted, thesystem will begin a search from the latest
measurement date to find the data with the latest datethat matches the entered conditions.

(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 2013:2

2013/10/05 10:10 (displayed)
2013/10/05 10:15 (displayed)
2013/10/05 10:20 (displayed)
2012/10/05 14:25 (not displayed)
2012/10/05 14:30 (not displayed)
2012/10/05 14:35 (not displayed)3

 Touch the {Continue} button.
 Touch the {Start} button.
{Start}:Search for data using the specified measurement
date.

{Close}:Cancel measurement date specification, and returnto 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 therange 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
12

Explanatory note

Specify the measurement date and time at the startpoint.


Touch the date and time that will be the start point.

Touch the {Select-s} button.
* The measurement date and time at the start point was
confirmed. (The text turns blue)* When the start point is confirmed, the {Select-s}
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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1

Measured Data Processing

Specify the measurement date and time at the end
point.


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

Touch the {Select} button.
* The measurement date at the end point is confirmed.
* When the end point is confirmed, the {Select} buttonchanges to the {Clear} button.

2{Clear}:4

Explanatory note

Clear the range specification.

The measured data for the specified range isdisplayed.

: ･If the dates and times specified for the start and end points are the same, the system will handle itas though only a single sample of measured data was specified.
･To specify a new range, 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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Measured Data Processing

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 from thelist, 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.
Touch the measurement date and time that will be thestart point.
(The cursor buttons at the bottom right of thescreen can also be used to select this.)12Touch the {Read again} button.



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

Selection
Get data before the date on the cursor.

Get new data after the date on the cursor.

{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 touched on
the monitor screen.){MENU}:

Return to the [MENU] screen.

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.)
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

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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 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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Measured Data Processing

4

Touch the {Sort} button.

5

Touch the {Date sort} button or the {Group sort}button.
* The sorted measured data is displayed.

{Date sort}:

Sort measured data in ascending order bymeasurement date and time.

{Group Sort}:

Sort measured data in ascending order bysample 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
range” 2111
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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 andtime.
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 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 databy range” 2

3

Touch the {Test data} button.

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4

1

Measured Data Processing

Search for target samples.
Touch the target tab.

Touch the {Search} button.

2

5

Select the type of keyword to search.
 Sample ID
 Sample No.
 Rack No.
 Date612Enter a keyword.
Touch the “input field” next to the name of the
keyword.

Enter a keyword using the keypad.

Touch the {enter} key.

Explanatory note
3

Explanatory note

: The {A/a} and {Sign} buttons areavailable when the cursor is in the
input field.

: Entry of the group number and measurement date and time can be omitted. However, if a measurement
date and time box is checked, it is necessary to input at least one of the following: year, month, date,hour, and minute.
{A/a}:

Switch input between uppercase and lowercase.

{Sign}: Allows for input of symbols.

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Measured Data Processing

7

Touch the {Continue} button.

8

Touch the {Start} button.
* Start searching.

9

Search results are displayed.

{Search}: Allows search to continue.

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MEMO

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Measured Data Processing

3.1.9

Recalculating measured data

Recalculate measured data using modified cut-off values, as well as factors A and B.
Explanatory note

Explanatory note
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.
: If the factor value differs according to the measured data, factor A and factor B are displayed
as 1.00 and 0.00, respectively.
: 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 torecalculate.
{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” 2

3

Touch the {Test data} button.

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Measured Data Processing

4

Touch the {Recal} button.

5

Configure the recalculation conditions.


Touch the “input field” next to the setting.
• Cut off 1• Cut off 2• Cut off 3• FACTOR A

2• FACTOR B


SettingCut off 1
Cut off 2
Cut off 3
FACTOR A
FACTOR B

Enter numbers using the numeric keypad.

Input Range
0-9,999,999
0 to 9,999,999; * (input omitted)
0 to 9,999,999; * (input omitted)
0.001-99,999.999-999.99-999.99

6

Touch the {Recal} button.

{Cancel}: Cancel recalculation and return to the [Test data]
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7

The recalculated measured data was displayed.
To update the recalculated data:Touch the {Continue} button.

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] 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] is configured and recalculated so that theresult will be OR, the result will be OR.
･ If the minimum measurement value [ng/mL] is configured and recalculated so that thedilute recalculation data will not result in UR, data that resulted in UR will have a result
other than UR.
･ If the minimum measurement value [ng/mL] 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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Measured Data Processing

Request･ If the external media runs out of space during output, exchange it with a new device
and touch the {Retry} button.
Required4

Specify the output range.
The procedure is the same as in the [Measured data
selection] screen.
Page 106 “3.1.4 Specifying measured data by
range” 2

5

Touch the {Output} button.

6

Output the measured data.




2
1

Explanatory note

Select the output destination.
PrinterExternal media

OnlineTouch the {Start} button.

{Cancel}: The dialog box closes.

: If an error has occurred in communicating the measurement results, “Online” cannot be selected inthe [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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Measured Data Processing

MEMO

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Measured Data Processing

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} tabExplanatory 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 bedeleted.

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
was deleted.

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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} tab2

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.
Page 106 “3.1.4 Specifying measured
data by range” 2

3

Touch the {Test data} button.

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Measured Data Processing: When copying measured data to other data, individual data obtained through replicate testing will
not be copied.

Explanatory note

4

Specify the measured data to copy.
Touch the measured data to copy (the cursor
buttons on the bottom right of the screen canalso be used).



Touch the {Copy} button.

1

2

5

Specify the measured data to copy to.
Touch the measured data to copy to (the cursor
buttons on the bottom right of the screen canalso be used).



Touch the {Copy} button.

1

2

6

Touch the {Start} button.
* Copying is performed.

{Cancel}: Cancel copying, and return to the [Test data]
screen.

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Editing Sample IDs

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 [System settings] ･ [Sampbarcode 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 “dilute test
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 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” 2

3

Touch the {Test data} button.

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4

Editing Sample IDs

Select the sample ID.
Touch the sample ID to edit (sample IDs can also be
selected by using the {Cursor} buttons to move thecursor).



Touch the {ID edit} button.

1

2

5
1
2

Input the sample ID.
Touch the “input field” of the sample ID.

Enter the sample ID using the keypad.

{A/a}:

Switch input between uppercase and lowercase.

{Sign}: Allows for input of symbols.

6

Update the sample ID.
Touch the {Continue} button.

Touch the {OK} button in the dialog box.
* The edited sample ID is stored.

12{Cancel}:Cancel editing the sample ID, and return to the[Test data] screen.

{Cancel}:The dialog box closes.

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List of Positive Samples

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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List of Positive Samples

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.
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).

Touch the {Select-s} button.
* The text in the row of the specified date and time turns
blue. (Start point)

2* The {Select-s} button changes to the {Select} button.

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).

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” 4131
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List of Positive Samples

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.:Touch the {Continue} button.

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 asfactors 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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List of Positive Samples

Content displayed on the [Positive data] screen
Display
Date
RACK
SEQ.

Data [ng/mL]
Flag

Comment

Sample ID
CC

DilExplanatory note

Details
Date and time sample was measured
Rack No. - Position number in rack
Group No. - Sequence No.

RemarkMeasurement results(concentration value)-. +, 1 +, 2 +, 3 +Error information (excluding reading errors)UR: Under range

OR: Over range
PRC: Prozone
Barcode information on sampling bottles
Calibration curve used to calculate measured
data (CC No.)
Dilution information: No dilution
Space(test mode, remeasure mode): No dilution
A(Retest mode): 15-times dilution
A15(Dilution test mode): 250-times dilution
A250(Dilution test mode)

Blank output for measured
data and judgment result
Output only judgment result
Output only judgment result: 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 Positive Samples

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”

1

through5

Explanatory note: 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

1

Select the display mode for positive samples tosort (by sample/testee).
Touch the {Sample} or {Testee} buttons.

Touch the {Sort} button.

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 bymeasurement 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

List of Positive Samples

Positive sample data was sorted.

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List of Positive Samples

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 through 5
1
1

Specify the measured data at the start point.
Touch the date and time that will be the start point.

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.
Touch the date and time that will be the end point.

Touch the {Select} button.
* The measured data at the end point was confirmed.
* When the end point is confirmed, the {Select} buttonchanges to the {Clear} button.

1
2{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

List of Positive Samples: If the measured data specified for the start and end points is the same, the system will handle it asthough 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 is displayed,
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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List of Positive Samples

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” 1 through 5
Explanatory note: If a range is not specified, all positive samples displayed on the [Positive data] screen will be

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 thesearched. Measured data cannot be searched for using the rack position number.

same 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.
 Date3123Enter a keyword.
Touch the “input field” next to the name of the
keyword.

Enter a keyword using the keypad.

Touch the {enter} key.

{A/a}:

Switch input between uppercase and lowercase.

{Sign}:

Allows for input of symbols.

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Explanatory note

List of Positive 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 {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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List of Positive Samples

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.
Page 130 “3.3.1 Displaying the positive sample list” 1 through 5
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.
･ 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.


Touch the “input field” next to the setting.

Enter numbers using the numeric keypad.

Touch the {enter} key.
･ Cut off 1･ Cut off 2

2･ Cut off 3
3･ FACTOR A･ FACTOR B

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SettingCut off 1
Cut off 2
Cut off 3
FACTOR A
FACTOR B

List of Positive Samples

Input Range
0 - 9,999,999
0 to 9,999,999; * (input omitted)
0 to 9,999,999; * (input omitted)
0.001 - 99,999.999-999.99 - 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:Touch the {Continue} button.

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 the{Memory} button on the [Check CC] screen first, and then recalculate.
RequiredPage 197 “3.7.9 Editing/recalculating calibration curves (samples/STAT samples)”141
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List of Positive Samples

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.


Touch the input field for the positive rate.

Enter the positive rate using the numeric keypad.
Input range: 0.0 to 100.0Touch the {enter} key.
* Calculate the cut-off value.

2

3

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4

List of Positive Samples

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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List of Positive Samples

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 samples”

When changes have been applied to cut-off value 1 on the [Recal settings] screen, cut-off values 2 and 3change 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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◼

List of Positive Samples

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 thenumber. (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 thespecifications listed in 2 and 3 above.
Example: There are 29 samples with measured data of 200 and 71 samples with measured dataof 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 whenless 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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List of Positive Samples

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”

1

through5

Explanatory note: If an error has occurred in communicating the measurement results, “Online” cannot be

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.

Explanatory note

: When outputting time code course data, set “Time course to Ext. media” to YES in [Settings] -selected in the [Output destination selection] dialog box.

[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

List of Positive Samples

Select the output destination.
PrinterExt. media (External media)

OnlineTouch the {Start} button.
* Specified positive sample data is output to theselected output destination.
* When output has completed, the system returns to the[Positive data] screen.

2{Cancel}:Cancel output, and return to the [Positive data]
screen.

Explanatory note

: When “Ext. media” has been selected for the output destination and no external media is connected,“Not connected with external media.” is displayed. Connect the external media and touch 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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List of Positive Samples

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 databy 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

List of Positive Samples

Confirm the specified date and time, and touch the{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:Touch the {Continue} button.

Touch the {Register} button in the dialog box.

1

2

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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

2Specify the measurement date and time.
Page 104 “3.1.3 Specifying measured data bymeasurement date and time” 2 Specify therange.
Page 106 “3.1.4 Specifying measured data by
range” 2

3

Touch 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
Date
RACK
SEQ.
Data [ng/mL]
Flag

Comment

Sample ID
CC

DilExplanatory note

Details
Date and time sample was measured
Rack No. - Position number in rack
Group No. - Sequence No.
Measurement results-, +, 1 +, 2 +, 3 +Error information (excluding reading errors)UR: Under range

OR: Over range

PRC: Prozone

RemarkBlank output for measured
data and judgment result
Output only judgment
resultOutput only judgment
resultBarcode information on sampling bottles
Calibration curve used to calculate measured
data (CC No.)
Dilution information: No dilution
Space(test mode, remeasure mode): No dilution
A(Retest mode): 15-times dilution
A15(Dilution test mode): 250-times dilution
A250(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” 1 through 4
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 bymeasurement 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.
Touch the {Continue} button.

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 [Processdata] 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” 1 through 5
1
1

Specify the error sample data at the start point.
Touch the date and time that will be the start point.

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.
(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} buttonchanges to the {Clear} button.

1
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.
Touch the {Continue} button.

Touch the {Register} button.
* Specified data was registered.

{Register}:Specified data is registered.

{Close}:Cancel registration, and return to the [Processdata] 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”
Explanatory note

1 through5: If a range is not specified, all error samples displayed on the [Err sample] screen will besearched.

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 [Errsample] 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.
 Date1323Enter a keyword.
Touch the “input field” next to the name of the
keyword.

Enter a keyword using the keypad.

Touch the {enter} key.

{A/a}:

Switch input between uppercase and lowercase.

{Sign}:

Allows for input of symbols.

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List of Error Samples

Explanatory note

: Entry of the group number and measurement date and time can be omitted. However, if a

Explanatory notemeasurement date and time box is checked, it is necessary to input at least one of the following:
year, month, date, hour, and minute.
: 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.

5

Touch the {Start} button.
* Searching begins.
* Search results are displayed.

6

Register the search results.
Touch the {Continue} button.

Touch the {Register} button in the dialog box.

{Register}:

Search data is registered.

{Close}:Cancel registration, and return to the [Processdata] 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.
Page 150 “3.4.1 Displaying the list of error samples” 1 through 5
Explanatory note: If an error has occurred in communicating the measurement results, “Online” cannot be selected inthe [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 foreither 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)

OnlineTouch the {Start} button.

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”

1

1 through5

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 databy range” 2

Explanatory note2

Touch the {Del} button.

3

Confirm the specified date and time, and touch the{OK} button.

{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:1Touch the {Continue} button.

Touch the {Register} button in the dialog box.

2

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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 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
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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 ofmeasurement 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).

Touch the {Select-s} button.
* The text in the row of the specified date and timeturns blue (start point).

2* The {Select-s} button changes to the {Select} button.

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).

Touch the {Select} button.
* The text in the row of the specified range turns blue
(end point).

1
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.

5

Touch the {Histogram} tab.

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Histogram

6

The histogram was displayed.

{Close}:Explanatory note

#.# 
a

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.

#.# # sample


b
c

a
b
c

: Measured data minimum: Measured data maximum: Number of samples within the range between the measured
data maximum and minimum

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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.
Touch the {Range change} button.

Touch the input field for the condition to change.

1

2
2

2



2

･

Max sample･

Min Conc.

･

Max Conc.

･

Class

Modify the setting with the numeric keypad.

3

Setting
Max sample
Min Conc.
Max Conc.
Class

Input Range
0 - 9,999
0 - 999,999,999.9
0 - 999,999,999.9
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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Histogram

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”

through5

1

Touch the {Output} button.

2

Output the measured data.


1

1

Select the output destination.
PrinterExt. media (External media)

2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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Histogram

MEMO

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3.6 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.
Page 130 “3.3.1 Displaying the positive sample list”
Explanatory note

: This applies to samples that were measured in test or remeasure mode andfound 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 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
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3

Touch the {Pos. rate} button.

Explanatory note

4

Positive Rate Change: Selecting “Testee” displays the values
for the number of positive testees/numberof all testees.

The positive rate change graph was displayed.

{Output}:

Output positive rate changes to the selected
location.

{Range change}:

Change the maximum/minimum positive
rates.

[MENU]:

Return to the [MENU] screen.

{Close}:Return to the [Process data] screen.

Explanatory note

: The “” symbol displayed on the positive rate change graph can be moved with the cursor buttons.

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.

The cursor’s numeric information is displayed in  (a through d). (Refer to the following diagram.)

Positive rate change
graph

★

a
b
c

Cursor buttons

d

a:

b:
c:
d:

Measurement 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)
Positive rates for all samples (positive rates for all data displayed)
Button to switch between sample mode and testee mode
Calculation condition settings for {Date settings} button positive rates
Page 184 “3.6.2 Configuring calculation conditions for positive rates”

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Positive Rate Change

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.
Page 170 “3.6.1 Displaying positive rate changes”
Explanatory note

: 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.

1Enter a start date (year/month/day).

2Enter a close date (year/month/day).

3

Select a calculation unit (day/week/month).



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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Positive Rate Change

4

Touch the {Continue} button.

5

Touch the {Register} button.
* The positive rates are calculated.

Explanatory note

{Start}:Calculate positive rates.

{Close}:Cancel calculation, and return to the [Positive ratechange] 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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Positive Rate Change

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.

1

4

3
2



Touch the [Max Value] field.

Enter numbers using the numeric keypad.

Touch the {enter} key.

Touch the [Min Value] field.

Enter numbers using the numeric keypad.

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 ratechange] screen.

{Cancel}:The dialog box closes.

5

Touch the {Close} button.
* The system returns to the [Measured data select]
screen.

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Positive Rate Change

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.
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

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.


Select the output destination.
PrinterExt. media (External media)

Touch the {Start} button.
* Positive rate changes are output.
* When output has completed, the system
returns to the [Positive rate change] screen.

1

2{Start}:Output positive rate changes.

{Cancel}:The dialog box closes.

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3.7 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
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3

Touch the {Test data} button.

4

Specify the measured data by range ofmeasurement date and time.

1

Replicate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).

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.

2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).

Touch the {Select} button.
* The text in the row of the specified range turns blue
(end point).

3
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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Replicate

6

{CC}:

The replicate list (samples/STAT samples) was
displayed.

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, andmeasurement date and time.
Page 192 “3.7.7 Searching replicate data”

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ReplicateContent displayed on the [Replicate] screen
Display
Date
RACK
SEQ.
Data [ng/mL]
Flag

Comment

Sample ID
CC

DilExplanatory note

Details
Date and time sample was measured
Rack No. - Position number in rack
Group No. - Sequence No.
Measurement results(concentration value)-, +, 1 +, 2 +, 3 +Error information (excluding reading errors)UR: Under range

OR: Over range
PRC: Prozone
Barcode information on sampling bottles
Calibration curve used to calculate measured
data (CC No.)
Dilution information: No dilution
Space(test mode, remeasure mode): No dilution
A(Retest mode): 15-times dilution
A15(Dilution test mode): 250-times dilution
A250(Dilution test mode)

RemarkBlank output for measured
data and judgment result(displayed during dilute test)
Output only judgment result
Output only judgment result: 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

DA1 comment

Comment for DA1DA2 comment

Comment for DA2{Save data}:

RemarkPage 350“Appendix: 1.3 DA value
calculation”

Save replicate data to external media.
Page 184 “3.7.3 Saving replicate data (STD) to external
media”{CC}:

Edit and recalculate the calibration curve of the specified replicate data.
Page 197 “3.7.9 Editing/recalculating calibration curves”{Time course}: 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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Replicate

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 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” 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
Date
RACK
QC No.
QC LOT
Seq.
Data [ng/mL]
Comment
CC{CC}:

Details
Date and time STD was measured
Rack No. - Position number in rack
QC sample number
QC sample lot number
QC sample sequential number
QC sample measured data
QC IDs and barcode reading errors
Calibration curve numbers (numbers 1 through 6)

RemarkEdit and recalculate the calibration curve of the specified replicate data.
Page 197 “3.7.9 Editing/recalculating calibration curves (samples/STAT
samples)”{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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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 bymeasurement date and time.

{Group Sort}:

Sort measured data in ascending order bysample number group.

{Cancel}:The dialog box closes.

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3

Replicate data was sorted.

4

Touch the {Continue} button.

5

Touch the {Register} button.

Replicate{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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Replicate

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)”through 5
1
1

1

Specify replicate data at the start point.
Touch the date and time that will be the start point.

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}
button changes to the {Select} button.

2

2

Specify replicate data at the end point.
Touch the date and time that will be the end point.
* The text in the row of the specified range turns blue.

Touch the {Select} button.
* The data for the specified range is displayed.

1* When the end point is confirmed, the {Select} buttonchanges 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

Replicate: If the replicate data selected for the start and end points is the same, the system will handle it asthough 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 wasspecified.

3

Replicate data was specified.
* The specified replicate data is displayed.

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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)”Explanatory note1

through5: 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.
 Date3123Enter a keyword.
Touch the “input field” next to the name of the
keyword.

Enter a keyword using the keypad.

Touch the {enter} key.

{A/a}:

Switch input between uppercase and lowercase.

{Sign}:

Allows for input of symbols.

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Explanatory note

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 the following: year,
month, date, hour, and minute.
: 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.
Touch the {Continue} button.

Touch the {Register} button in the dialog box.

2

1

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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)”1

through5: ･The values used for judging replicates for which a range has been specified are shown

Explanatory notein 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 toprotocol 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 [Positivechange] screen.

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Explanatory note: If a range is not specified, all replicate data displayed on the [Replicate] screen will be recalculated.

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 to memory
prior to recalculation.

Page 190 “3.7.9 Editing/recalculating calibration curves”

2
1

7

through8

Configure the recalculation conditions.


Touch the “input field” next to the setting.

Enter numbers using the numeric keypad.

2{Cancel}:･

Cut off 1･

Cut off 2･

Cut off 3･

Factor A･

Factor B

Cancel recalculation, and return to the [Replicate]screen.

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

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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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3.7.9

Replicate

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)”through 3
Explanatory note1

: 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.


Touch the row of the applicable data.

Touch the {CC} button.
* The calibration curve of the specified replicate data
is displayed.

1

2

2

Touch the {CC info} button.

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1

Edit the data.
Touch the input field for the item to edit.

Enter a value.

Explanatory note

: The following items can be input
through calibration curve editing.
STD-1 - STD-5 : DA1
STD-6 : DA1, DA2

2

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 to memory(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

Select the calibration curve.

12Touch the {CC#} tab.



Select the measurement date and time.

Touch the {CC} button.
* The calibration curve is displayed.

3

3

200

Touch the {CC info} button.

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1

Replicate

Edit the calibration curve.


Touch the input field for the item to edit.

Enter a value.

Explanatory note

: The following items can be input
through calibration curve editing.
STD-1 - STD-5 : DA1
STD-6 : DA1, DA2

2

5

Touch 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.)Touch the {CC1} ~ {CC6} buttons.



Select the calibration curve (CC2 through CC3).



Check “Reading.”Touch the {Start} button.

1* 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
the calibration curve selected forreading, the calibration curve is not
read.

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2

Replicate

Register the calibration curve shown on thescreen.
Touch the {CC1} ~ {CC6} buttons.



Select the calibration curve of the registration
destination.



Check “Register.”

Touch the {Start} button.

1* The calibration curve is registered to the hard disk(SSD).

2
3
4{Cancel}:3

Touch the {Continue} button.

{Print}:4

The dialog box closes.

Print the calibration curve.

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

NN1-1384 Rev.16{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

through3

Display the time course.
11Touch the date and time field.
* The specified data is enclosed in a blue box.

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

#Cycle #ABS a
↑
↑
a

b

b

{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.

: Number of cycles: Absorbance (measured data - cell-blank value)204
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3.7.13 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.

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 #ABS
↑
a

↑
b

a

: Number of cyclesb: Absorbance (measured data - cell-blank value)205
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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.
1Touch the date and time field.
* The specified data is enclosed in a blue box.

Touch the {Time course} button.
* The time course of the specified data is displayed.

2

2

206

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)

3

2

4



Touch the [Max Value] input field.

Enter numbers using the numeric keypad.

Touch the [Min Value] input field.

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”: Time course data for which the range has been changed is not saved to the hard disk(SSD).

Explanatory note1

Display the time course.


Touch the date and time field.
* The specified data is enclosed in a blue box.

1

Touch the {Time course} button.
* The time course of the specified data is displayed.

2

1

Touch the {Range change} button.

3Enter the absorbance.
(input range: 0 to 10,000)

3

2

208

2

4



Touch the [Max Value] input field.

Enter numbers using the numeric keypad.

Touch the [Min Value] input field.

Enter numbers using the numeric keypad.

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4

Touch the {Continue} button.

5

Touch the {Start} button.

Replicate{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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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 212 “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>

Touch the {Data processing} button.

Touch the {Process QC} button.

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Quality Control<Opening from the monitor screen>
Touch the {QC screen} tab.

2

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→

←i
↑
h
[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 “6.1.10 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.)

1

2

Touch the QC lot (can also be selected using
the cursor keys).

3Enter the amount of data to process inmonths. (See the Explanatory note for an
example.)

Touch the input field.

Enter numbers using the numeric keypad.

Touch the {enter} key button.

2
3

Explanatory note

: The QC lot list shows data from the month of the latest data to the specified number of months 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” 2 hasbeen completed.
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.
Touch the {Continue} button.

Touch the {Register} button.
* The updated data was saved to the hard disk(SSD).

NN1-1384 Rev.16{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 from the[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 “6.1.10 STD/QC analysis process settings.”

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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>Touch the {Data processing} button.

Touch the {Process QC} button.

<Opening from the monitor screen>
Touch the {QC screen} tab.

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2

Quality Control

The [QC lot select] screen opened.
* The recently used QC lots are displayed in order.
(Displayed from left to right, up to down.)

3

Select the QC and QC lot.

Page 214 “3.8.2 Selecting QC lots”

4

Touch the {Intra-day/Inter-day} tab.
* The [Intra-day/Inter-day] screen is displayed.
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b
a

c

d
g

j
e

f

h

i

[Screen]: Intra-day/inter-day data

220

a

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.

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.

Intra-day data selected
The measurement time and mean value of the specified QC/QC lot isdisplayed.

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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

2

Select the data to edit.
Inter-dayIntra-dayTouch the {Edit} button.

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3
1

Quality Control

Edit inter-day data (or intra-day data).
Touch the input field for the data.

Enter numbers using the numeric keypad.

Touch the {enter} key button.

2
3

4

Touch the {Recal} button.

{Cancel}:5

Cancel editing inter-day or intra-day data. The
system returns to the [Intra-day/Inter-day]screen.

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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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

2

Select the data to edit.
Inter-dayIntra-daySpecify the range of data to delete.
* Only the selected data is displayed.

Page 226 “3.8.8 Specifying
inter/intra-day data by range”

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3

Touch the {Del} button.

4

Touch the {OK} button.

Quality Control* Data in memory is updated.
* Data specified on the screen is deleted.

{Cancel}:Cancel the deletion of inter/intra-day data.

5

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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Quality Control

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

2

Select the data to specify.
Inter-dayIntra-daySpecify the measurement date at the startpoint.


Touch the measurement date that will be the startpoint.



Touch the {Select-s} button.

1* The data at the start point was confirmed.
* When the start point is confirmed, the {Select-s}
button changes to the {Select} button.

2

3

Specify the measurement date at the end point.
Touch the measurement date that will be the end
point.



Touch the {Select} button.
* The data at the end point was confirmed.

1* 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}: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 asingle 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 fromthe [QC lot select] screen first, all data will be specified.

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Quality Control

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

: 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>Touch the {Data processing} button.

Touch the {Process QC} button.

<Opening from the monitor screen>
Touch the {QC screen} tab.

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2

Quality Control

The [QC lot select] screen opened.
* The recently used QC lots are displayed in order.
(Displayed from left to right, up to down.)

3

Select the QC and QC lot.

Page 214 “3.8.2 Selecting QC lots”

4

Touch the {Intra-day/Inter-day} tab.

5

Select the data to display an X-R control graphfor.

—Page 226 “3.8.8 Specifying inter/intra-day
data by range”

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Quality Control

Explanatory note—

6

S Touch the {X-R control graph} tab.

7

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 of measurements.

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c

Quality Control

e
d

a

b
f
—

[Screen]: X-R control grapha

X graph(upper graph)

･
･
･

･
b

R graph(lower 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 lessthan ULC value + 1 is plotted in red.
A range of data is displayed for the measurement date andmeasurement 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 valued (in graph)･･Shows that a calibration curve that was used has changed.
The reagent lot is displayed next to the  symbol.

e{}, {}･Move the cursor (vertical line) displayed in the graph.

f{Range change}･

Change the range (maximum concentration, minimum concentration,c—

R maximum) of the X-R control graph.

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Quality Control—

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.
Touch the input field for the setting.

Enter numbers using the numeric keypad.

1



･

Max Conc.

･

Min Conc.

･

R max

Touch the {enter} key.

2
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 isdisplayed.

{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 returnto the [Data process selection] screen.

{Cancel}:The dialog box closes.

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3.9 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

3.9.1

: 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 (rack information
remains if power is lost due to a power outage or the like).

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

b

a

a

c

d

e

d

f

e

[Screen]: Rack information
a

b

c

d

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

OR/PRC

Yellowish orange

Positive sample

Light green

Normal sample

White

Unfinished

Black

Unset

RACK No.

Rack number and measurement rack (displayed to left of rack number)
Gray

Sample rack (normal)

Blue

STD/QC rack

Green

Retest rack

OrangeDilute test rack

{Stop unloading racks.}
Or, {Restart unloading
racks.}

Change the tray.

{Clear}Delete rack information.
<Procedure><Procedure>(1) Touch the {Stop unloading racks.} button.
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.

(1) Touch the {Clear} button.
(2) Touch the {OK} button in the confirmation dialog box.
(Touching the {Cancel} button cancels rack information deletion.)ef{Print}{Close}Print rack information.
Return to the [Test] screen.

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Rack info

Explanatory note : If “Numbering” is set to “NO” in [Test] - [Request test/select operation], Unset (white) is displayed 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

Touch the {Stop unloading racks.} button.

2

Exchange the rack.

3

Remove the tray from the rack discharge unit.

Place an empty tray.

Touch the {Restart unloading racks.} button.

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3.10 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/QC sequence number settings”◼

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･ Mixer･ Reaction table･ Puncturing system･ Squeezing system･ Supply bar･ Conveyance bar･ Cell washing nozzle･ 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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4.2 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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4.3 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 89 “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 89 “2.6.1 Close mode”

1

Touch the {Prep functions} button.

2

Touch the {Wash} tab.

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3

Wash Part Washing
S-nozzle (Sample nozzle)
R-nozzle (Reagent nozzle)
Mixer
W-nozzles(Cell washing nozzle)
Wash cells
 Preservation processing
Nozzles

Cells

Range/Selection

Select whether or not to wash each part (“YES” or“NO”).

Details

YES: Wash sample nozzle.
NO: Do not wash sample nozzle.
YES: Wash reagent nozzle.
NO: Do not wash reagent nozzle.
YES: Wash mixer.
NO: Do not wash mixer.
YES: Wash cell washing nozzle.
NO: Do not wash cell washing nozzle.
YES: Washes measurement cells.
NO: Do not wash measurement cells.
YES: Run soaking preservation for nozzles and mixer.
NO: Do not run soaking preservation for nozzles andmixer.
YES: Run soaking preservation for measurement cells.
NO: Do not run soaking preservation for measurement
cells.

4

Touch the {Start} button.

[MENU]:

Explanatory note

Washing

Return to the [MENU] screen.

: Soaking preservation of measurement cells is a process where residual liquid in cells is absorbed
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.

 Procedure Soak a soft cloth in mild detergent.
 Use the cloth from  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.

 Procedure Soak a soft cloth in ethanol.
 Use the cloth from  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 todisplay the cleaning procedure.

 Procedure Soak a soft cloth in ethanol.
 Use the cloth from  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

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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.

 Procedure Soak a soft cloth in mild detergent.
 Use the cloth from  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 to display
the cleaning procedure.

 Procedure Check that there are no foreign objects in the rackholes.
 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 to display
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>
 Clean the tank thoroughly with tap water.
 Fill the tank with tap water and LX wash
solution. Tap water: 2 L, LX wash solution:
20 mL
 Close the tank lid tightly and shake the tank(if very dirty, set it aside for around onehour).
 Rinse the tank thoroughly with tap water, sothat no wash solution remains.
 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.
Failure to observe this precaution may lead to injury.
Finger pinchinghazard1

Measurement cells that cannot be used are shownin red.
Touch the {Close} button.

2

Touch the {MENU} button.

3

Shut off the system.


Touch the {Close} button.

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2

Inspection/maintenanceSelect “NO” for “Cell wash,” “Exchange buffer andwash sol to p. water” and “Nozzle/cell soak wash.”

Touch the {Continue} button.

Touch the {Start} button.

3

4

4

If the sample nozzle and reagent nozzle are on thereaction table, move them by hand so as to nothinder work.

5

Remove the light blocking cover.

Reaction table
Sample nozzle

Reagent nozzle

Light blocking
cover

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Inspection/maintenance

6

Remove the cell holder.


Loosen the screw.

Remove the cell holder.

Cell holder

7

Replace the measurement cells.


Remove the dirty measurement cells.



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 not lined up

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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.
Touch the row of the part that was changed.

Touch the {Exchange} button.

Touch the {Start} button.

2* The months used and number of uses are reset to “0.”* The dialog box closes.
3{Cancel}:Cancel resetting the months used and number ofuses counters.

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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

Choice/Setting
YES:
NO:

Duplicated check
YES:
NO:

Decode accord times
Explanatory note

Numerical input

System settings

Configure the settings in the {Common} tab.

Details
Barcodes are affixed to samples.
Barcodes are not affixed to samples.
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.
However, even if this is set to “YES” duplicated check is
not performed when the measure mode is “retest” or“dilute test.”
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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6.1

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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Touch the {Register} button.

{Register}: Register configured settings.

{Close}: Cancel registration of sample barcode settings, andreturn to the [System settings] screen.

{Cancel}: The dialog box closes.

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System settings: 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.

Explanatory note

Chart 6.1.1 Samp barcode settings
Setting

Choice/Setting

Details

Use this type (4 types
available at once)

Check the barcode to use.
Up to four types of barcodes can be selected at thesame time.

Digit
Sample  digits

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
DeleteInput Range
Upper Limit

Lower 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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Chart 6.1.3

Input No. and Calculation
methodSystem settings

Chart 6.1.4 Barcode Type and Calculation
MethodInput No.

Calculation Method

Barcode TypeCalculation Method

1

Modulus 10/3 weight

CODE39Modulus 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

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6.1.3

Rack No./QC No.

Configure the STD/QC rack number, retest rack number, dilute test rack number, and QC
sequence number. The system identifies the type of rack from the rack number. During testing,racks with numbers 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

Configure each item.
(See page 274.)

3

Touch the {Continue} button.

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System settings

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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Chart 6.1.5 Rack/QC Sequence Settings
Choice/Setting

Setting

Details

STD/QC Rack No. (QC1･QC2)
Min:
Max:

1 - 999

Configure a range of STD/QC rack numbers(QC1/QC2).
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 forthe minimum and maximum (maximum =minimum).

STD/QC Rack No. (QC3･QC4)
Min:
Max:

1 - 999

Configure a range of STD/QC rack numbers(QC3/QC4).
Enter “*” to disable range specification.

QC sequence No.

1 - 99999

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, sequence numbers
will be allocated in sequence from QC1 for QC2
on.

QC1:
QC2:
QC3:
QC4:

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.

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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 apassword is registered or not.

Password not registered

Password registered276
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Setting

Choice/Setting

Date
20YY, MM, DD, HH, MM

System settings

Details

YY: 0 to 99,
MM: 1 to 12,
DD: 1 to 31,
HH: 1 to 24,
MM: 0 to 59

Water connection

Configure the year, month, day, and time.

Select the water supply/drainage methods.
Supply:Tank
Auto water supply(opt)

Drain:Tank
Sink

Drain water to tank.
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.
Automatically supply water (optional).

0 to 60

When “Rack auto start” is set to “YES,”
configure the time from when the rack is placedin the supply unit, to when all racks arecompletely 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 the automatic
logout time passes while the [MENU] screen isstill displayed after logging in, automatic logout
occurs.
The automatic logout function is disabled
setting 0 minutes.
Page 329 “Chapter 9 Operator/Latex
Management Function (Option)”

Save

Select whether to register a password or not fordata processing.
YES:

Password:
Old password

Register a password.

NO:
5 to 30 characters(0 to 9, -, X, Y, Z, ., /)Do not register a password.
Enter a 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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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

Choice/Setting

Output to printer

System settings

Details
Select whether to print measured data or not.

YES

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

Select whether to automatically send measured
data to external media when testing iscomplete.

Output to Ext. media

YES

Output to external media.

NO

Do not output to external media.
Select whether to output time course toexternal media or not.

Time course to Ext. media
YES

Output to external media.

NO

Do not output to external media.
Select whether to output measured data online
or not.
Detailed online output settings are made on the[Online settings] screen.

Output data online

YES

Output online.

NO

Do not output online.
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.”STAT online output

Explanatory note

Do not print measured data.

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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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.
･ 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
Com mode

Choice/Setting
OC sensor io
OC sensor DIANA
LAN
ASTM

Baud rate
2400
4800
9600
19200
38400
LengthDetails
Select the communication mode.
OC sensor io compatibility mode.
OC sensor DIANA compatibility mode.
LAN communication mode.
ASTM communication mode.
Select the communication speed.
2400 baud rate
4800 baud rate
9600 baud rate
19200 baud rate
38400 baud rate
Select the data length.

7(bit)

8(bit)
Parity
None
Even
Odd
Stop bit
1
2
Trans.
NONE
ACK/NAK
Delimiter

Select when sending two-byte characters.
Select parity checking.
Do not check parity.
Run even number parity checking.
Run odd number parity checking.
Select 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

STX/ETX
CR/LF
CF
Chk. char

Select the error detection method.
BCC
SUM
None

Separator
YESNO

Do not use check character.
Select whether or not to insert a separator comma (,) in
between data items.
Separate using a comma.
Do not separate.

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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System settings

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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System settings

6.1.7

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

3. Rack No.

Printer

External media
Online4. Sample No.
External media
Online5. Sample ID
External media
Online6. DA value
Printer
External media
7. Flag(+-)
External media
Online8. DateOnline9. Value format############.#
Explanatory note

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)
Printer
2. New line

System settings

Details
Line spacing when printing to a printer is narrowed.
A new line is inserted in the following locations when printing to a
printer.
･ Between measured data
･ Between items when multiple items were tested(This applies to printing during real time printing and measured dataprocessing.)
The rack number and rack position number are output.
The rack number and rack position number are output.
Output the sample number.
Output the sample number.
Output the sample ID.
Output the sample ID.
Print the DA value to a printer.
Output the DA value.
Output the judgment results.
Output the judgment results.
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 rounded up).

: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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6.1.8

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

Details

1. FinishedSounds when testing of the sample placed in the rack supply unit isfinished, and the system is waiting.
Endlessmin
TimesContinues 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

Type aType bType cAlarm sounds with type a.
Alarm sounds with type b.
Alarm sounds with type c.

2. Waiting

Sounds to notify the user when the rack supply is fed from the rack
supply unit.
Endlessmin
TimesContinues 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

Type aType bType cAlarm sounds with type a.
Alarm sounds with type b.
Alarm sounds with type c.

3. Judging CC

Sounds when the system is waiting for the operator’s determination
following calibration curve judgment.
Endlessmin
TimesContinues 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

Type aType bType cAlarm sounds with type a.
Alarm sounds with type b.
Alarm sounds with type c.

4. No reagent
Tank fullSounds when the system detects insufficient reagent, buffer, wash
solution, or purified water, or when the drain tank is full.
Endlessmin
TimesContinues 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

Type aType bType cAlarm 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

Details

5. Cover open

Sounds when the protective cover is opened during operation.
Endlessmin
TimesContinues 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 of times

Type aType bType cAlarm sounds with type a.
Alarm sounds with type b.
Alarm sounds with type c.

6. ErrorSounds when an operational error has occurred.
Endlessmin
TimesContinues 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 of times

Type aType bType cAlarm sounds with type a.
Alarm sounds with type b.
Alarm sounds with type c.

7. Key input error

Sounds when an incorrect entry is made using the keypad.
Times

Configure the number of times for the alarm to sound. (1 to 99)
The alarm will stop once it has sounded the specified number of times

Type aType bType cAlarm sounds with type a.
Alarm sounds with type b.
Alarm sounds with type c.

8. Output error

Sounds when there is an error with the output destination when
outputting to a printer or online.
Times

Configure the number of times for the alarm to sound. (1 to 99)
The alarm will stop once it has sounded the specified number of times

Type aType bType cAlarm sounds with type a.
Alarm sounds with type b.
Alarm sounds with type c.

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System settings

6.1.9

Screen 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

Waiting time
Character

System settings

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/SettingONOFF
1 to 99 minutes
Character 1
Character 2
Character 3

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 starts.
Character 2 starts.
Character 3 starts.

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System settings

6.1.10STD/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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System settings

4

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

Choice/Setting

Details
Select whether or not the operator makes ajudgment following STD/QC measurement.

Operator judgment

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 system entersstandby and waits for the operator’s judgment.

STD Spec

Configure specifications for each STD point.
The system will determine STD pass/fail using
the configured specifications.

STD-6 Min DA
STD-6 Max DA
STD-6 to 3 back fit±(%)
STD-1 Min DA
STD-1 Max DA
STD-2 DA back fit±(%)
Explanatory note

-9999 - 99999-9999 - 99999
0 - 100-9999 - 99999-9999 - 99999
0 - 100

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
the measured 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]Max limit[ng/mL]

0.0 - 9999999.9

QC LOTA string of characterscomposed from 0
through 9, X, Y, and Z.
(Up to five half-widthcharacters.)

SD coefficient

 SD

1-9

Configure so that minimum < maximum.

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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System settings

6.1.11

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.
Required

If an incorrect size is configured, the nozzle may be inserted into the liquid too deeply whenabsorbing 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 thesettings screen.

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4

System settings

Configure the information for sample cup{Cup 2} (see page 304).

5Check “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} tabs

← Upper most partof container← 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 face ofrackf0.0 - 10.0 (mm)Length of straight part at the uppermost part ofthe containerg

8.0 - 22.0 (mm)Inside diameter of straight part at the uppermost
part of the container

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6.1.12

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 [Systemsettings] will be printed.

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System settings

6.1.13

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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6.1.14

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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6.2 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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6.2

Protocol settings

3

Touch the {Samp/QC protocol} button.

4

Configure items (see page 311).

5

Touch the {Page 2} tab.

6

Configure items (see page 312).

{Print}:Print [Sample/QC protocol] settings.

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Protocol settings

7

Touch the {Continue} button.

8

Touch the {Register} button.

{Register}:

Register configured settings.

{Close}:Cancel [Sample/QC protocol] settings, and returnto the [Protocol settings] screen.

{Cancel}:The dialog box closes.

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6.2

Protocol settings{Page 1} tab
Setting

Settings

Details1

Sample Replicate

1 to 10 times

Configure the number of times to measure samples.

2

QC Replicate

1 to 10 times

Configure the number of times to measure QC samples.

3

Cut off 1

Configure the judgment criteria for Cut off 1.
0- 9999999(integer)4

Cut off 2-

Measured data is “above Cut off 1 value” or “Cutoff 2 or lower”
Measured data is “setting value or lower”

Configure the judgment criteria for Cut off 2.

*,
0-9999999(integer)5

1+

Cut off 3

2+

Measured data is “above setting value,” “larger
than Cut off 1,” or “Cut off 3 or less”
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 - 999999(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” orlower during dilute testing.

7

Max Value

0.0 9999999.9

OR

Displayed when measured data is larger than “Max
Value.”

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6.2

Protocol settings{Page 2} tab
Setting

312

Settings

Details
Set whether or not to run RBC checking. Check to have itrun.
Page 352 “ RBC method”

8

RBC check9

RBC coefficient10

PRC check11

PRC coefficient

0.01-2.00

12

Factor A

0.001 9999.999

13

Factor B-999.999999.999

1.0 - 2.0

Samples with an absorbance larger than the absorbance ×“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 to have itrun.
Page 353 “ PRC method”
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 method”

Measured data = A × concentration value + B

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Protocol settings

MEMO

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6.2

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 306 “6.2.1 Sample/QC protocol settings”
1 Touch the {CC No. # protocol settings} button (#is the protocol number).

2

Configure items (see page 316).

3

Touch the {Page 2} tab.

{Print}:Print [CC No. # protocol] settings.

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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
Setting

Settings

Details1

Replicate

1 to 10 times

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.

{Page 2} tab
Setting

Settings

Details3

STD-6

0.1 9999999.9

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 the first page isset.
Settings for STD-2 through STD-6 can be changed using the keypad.

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Chapter 7 Help

1 Opening the [Help] Screen from the[MENU] Screen
7.2 Opening the [Help] Screen from the[Monitor] Screen

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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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7.1

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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7.2 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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7.2

Opening the [Help] Screen from the [Monitor] Screen

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MEMO

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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, the following
page is displayed. Touch {Next err}to display errors.

8.1 How to Read [Error] Screens
f
↓
← e
a →

b →

← c

← d
[Error] screen

a
b
c

d

e
f

Error status
Error location
Error cause andcancellation method

Displays the error number and name.

Page buttons

Switch pages when the handling method for a single error spans
multiple pages.

{Back}{Next}
Error cancellation buttons
Error switching buttons{Last err}
{Next}

Display the previous page.

Displays the location of the error using a graphic.
Displays the cause of the error and how to clear it.

Display the next page.
Buttons to recover from errors.
Switch the error display when multiple errors have occurred.
Display the previous error.
Display the next error.

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8.2

Error Cancellation Buttons

8.2 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{RETRY}{PASS}{ABORT}{CONTINUE}{CLOSE}{MUTE}
Explanatory note

Function
Retry processing on the sample for which an error had occurred.
Cancel processing for the sample that is being tested, and process the next
sample.
Terminate processing.
If selected during testing, terminates processing for the sample being tested.
Restart the operation of the working part that was halted due to error detection
Close the screen
Mute the alarm.
: The cancellation buttons that are displayed depend on what error has occurred.

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8.3 Clearing Errors
Clear errors using the following procedure:

1

Confirm the error.


Confirm the error and its location.



Select the cancellation button from the error
cancellation methods and touch it.
Page 323 “8.2 Error Cancellation Buttons”

2

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>
Touch the {ABORT} button.

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 thesystem 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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MEMO

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Chapter 9 Operator/Latex Management Function（Option）

9.1 LOGIN・LOGOUT
9.2 Registering, Modifying, and Deleting
Operators (ID Information)
9.3 Managing Latex/QC Lots

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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 when using
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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9.1.1LOGIN

Start the system and run either introduction priming or cell blank measurement to open the[LOGIN] screen.
1 Enter 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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4

A confirmation message {OK} is displayed.

Touch [LOGIN].

5

Explanatory note

The [MENU] screen is displayed, with the IDof the logged in user shown next to the[key]icon on the bottom of the screen.

: Touching 【enter】 without entering ID information will display that [MENU] screen without logging
in.

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9.1.2LOGOUT
1 Touch the[key] icon (the ID of the logged in user isshown 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, and the ID
display area switches to a message {Please login.}.
You are now logged out.

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9.2 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 the operator
that is displayed.

3Enter the password and then touch [enter].

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Touch [Update].A confirmation message{ Register the entered information.} is displayed.
4

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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9.2.2

Change ID

This method is used to change ID information that has already been registered.
Enter the ID and then touch [enter]. Confirm thename of the operator that is displayed.

1

2 Enter the PASSWORD and then touch [enter].

3

Explanatory note

Touch [Change Info].The PASSWORD field iscleared.

: Entering an ID and password that have already been registered will activate the 【Change Info】
button.

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4 Enter 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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9.2.3

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.
1 Enter 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 information except administrator
in the registration list" confirmation message
is displayed.

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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 expirationdate.

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.
The lot of the QC that was used.

QC lot(*1)
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 thebuffer340
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Appendix

1
2
3
4
5
6
7

Calculation Processing
Test Operations
Printing examples
Handling the PrinterError List
Save to External MediaManagement USB Stick Setting

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1

Calculation Processing

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 check

1.6

Reagent Blank Check (A1 Check)1.7

Calculate Cell Blank

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1.1

STD/QC Sample Measured Data Check
Check whether the measurement results for STD or QC samples are correct.

1. STD sample measured data check(1) Check that the calibration curve is rising from bottom left to top rightfrom the 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-6 “Abnormal” if outside DA upper/lower range

2. 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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1

Calculation Processing

1.2

Calibration curve calculation
There are two curve types: Aloka curve, linear and cubic 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 Value

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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1

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 Value

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 ValueZeroconcentration
DA value

STD concentration X

Explanatory note

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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1

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 Value

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>“348
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1

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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1

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 a sample,
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[Cycle]Figure 5

T1: 1st detection point

A1: T1 absorbanceT2: 2nd detection point

A2: T2 absorbanceT3: 3rd detection point

A3: T3 absorbance

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

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 thanminimum 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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1

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

Prozone sample

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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1

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
Prozone sample

DA2 sample[Cycle]Figure 7DA2sample: DA2 value of prozone sample
DA2STD-6: DA2 value of STD-6

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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 iscompared with the maximum and minimum values of the A1 check.

If either of the following conditions is met, an error message appears displaying “Latex blank error.”

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.

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1.7

Calculation Processing

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 the periodof time between dispensing of purified water with the 3rd nozzle and absorbing of purified waterwith 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 as withthe 55th cell, and calculate a cell-blank value according to the following equation.

Cell-blank value = Log10 (Reference value ÷ ADC average)
× 10,000

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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 testrack” (dilute test)

2.5

Operation when measuring STD/QC samples

2.6

Operation when performing cut-in analysis

2.1 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.

Explanatory note

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

Explanatory note: If the accessory end ring is attached to a rack, racks from the one with the ring will not be analyzed.

to right.

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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)

Squeeze the sampling bottle (when using a sampling bottle)

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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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)

Squeeze the sampling bottle (when using a sampling bottle)

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/QC sequence number settings” 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 determines

Empty sample
cup

SamplingbottleEmpty sample
cup

SamplingbottleEmpty sample
cup

SamplingbottleSpecified retest diluent

which to use based on the containers arranged on the rack.

15-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 tocreate a 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, andthen 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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Test Operations

Dilute test
Read rack and sample barcodes

Confirm that sampling bottles or sample cups are set to the rack
(check for containers)

Dispense 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

Dilute test
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 thesamples 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.

Empty sample cup

Calibrator

Calibrator buffer

Page 63 “Configuring [Latex/CC settings]”

Set the sample cups to the STD/QC rack asshown in the diagram to the left.

Dispense No. 1 calibrator buffer to thesample cups in rack position numbers 3 through 6.

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STD/QC sample

Test Operations

Confirm that the No. 1 through No. 6 sample cups are set to therack (check for containers)

Dispense No. 1 calibrator buffer to the No. 3 through No. 6
sample cups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 liquid

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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Test Operations

MEMO

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Test Operations

MEMO

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Test Operations

MEMO

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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

Empty sample cup

Calibrator

STD/QC racks

Calibrator buffer

Sample racks

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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>

Confirm the position and quantityof sample cups set to the rack

Confirm that the containers are set

Create the dilution series

Puncture the sampling bottles

Squeeze the sampling bottles

Dispense the dilution series
sample/QC sample to themeasurement cells

Dispense the sample tomeasurement cells

Wash the sample nozzle

Dispense reagent/buffer to measurement cells
Wash the reagent nozzle

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2

Test Operations

From previous pageMix 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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Printing examples

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********************************
POWER ON
15/01/14 11:42****************************************************************
START
15/01/15 17:51********************************CC No.1
15/01/12 14:27********************************

Time and data ofsystem power on

Test start data and Time
Calibration curve number
and measurement date
and time

Rack No.Rack position No.
Qualitative
assessment result
DA

Sample No.
Group No.-Sequence No.

Test complete date005-01
1-00001+
183

AB00123xx* 124.2ng/mL

005-02

1-00002

NO Tube005-031-00003 L. Dispense Err****************************************************************
END
15/01/15 17:56********************************

Sample ID
DATA
Messageindicating
Error message (Reagent
dispensing error)
Page 381“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.

005-02-

1-0000260

AB12345
61 ng/mL

005-03+1-00003120

CD23456
112 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 )005-02
1-00002
AB12345
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>********************************
040-031-00001
EF23456zz+
700 A*
10000 ng/mL

Result of 15-times dilution isprinted.

040-04+

Result of 250-times dilution isprinted.

1-00001
35 A**

EF23456zz
10500 ng/mL============================
040-031-00001
EF23456zz+
700 A*
10000 ng/mL~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~********************************

Final results are printed.

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Printing examples<When replicate number > 1>********************************
040-031-00001
EF23456zz+
700 A*
10000 ng/mL+
700 A*
10000 ng/mL-------------------------------+
700 A*
10000 ng/mL
0.00
0.0

Result of 15-times dilution isprinted.

040-041-00001
EF23456zz+
35 A**
10500 ng/mL+
35 A**
10500 ng/mL-------------------------------+
35 A**
10500 ng/mL
0.00
0.0

Result of 250-times dilution isprinted.

================================
040-031-00001
EF23456zz+
700 A*
10000 ng/mL~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Final results are printed.

********************************

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Printing examples

3.3

1 day, 2 day, 3 day printing
Sample number 1

1-day

2-day

3-day

005-01
1-00001+
183

AB00123xx
124.2ng/mL
Sample number 2005-02
1-00002
5

BC11234zz
0.0ng/mL

006-01
1-00001/1+
295

CD99346dd
200.0ng/mL

006-02
1-00001/2+
310

CE45813rr
210.0ng/mL

006-031-00002/1
4

ES74125dd
0.0ng/mL

006-041-00002/2
25

ET68542rr
17.0ng/mL

007-01
1-00001/1+
295

GH78314dd
200.0ng/mL

007-02
1-00001/2+
310

GI95155rr
210.0ng/mL

007-031-00001/3
4

GJ94357ss
0.0ng/mL

006-041-00002/1
25

GH68542dd
17.0ng/mL

006-051-00002/2+ 183

GI77445rr
124.2ng/mL

006-051-00002/3
81

GJ68585ss
55.0ng/mL

Sample number 1
First day sample
Second day sample

Sample number 2First day sample
Second day sample

Sample number 1
First day sample
Second day sample

Third day sample

Sample number 2First day sample
Second day sample

Third day sample

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3.4

Printing examples

Printing when measuring STD/QC samples

DA1 value********************************STD･QC START********************************
091-01 STD1

Point number of STD
DA1 value used bycalibration curve
CV value of DA1

6
0
5
0
6
0
-------------------------------6
0
0.0
0.0
091-02 STD6

Replicate number 1
Replicate number 2
Replicate number 3

CC No.

2621
172
2580
168
2655
173
-------------------------------2621
172
0.0
0.0

STD/QC sample
test startDA2 valueDA2 value used bycalibration curve
CV value of DA2

The result and mean values
are printed for each STD
point.

********************************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)

OriginSTD6DA1(Back fit value
Regression

1000.0 ng/mL 2621
172
1002 ng/mL+0.2)

CAL CURVE TYPE = LNR-LNR
DIMENSION= ALOKACAL CURVE EQUATIONDA1 F(0)=-2.743169e+001
F(1)=3.708265e+001
F(2)=-1.804965e+00
F(3)=2.978363e+000

DX (%)
Calibration curve type
Dimensions ofcalibration curve*Cubic : 3
Aloka curve : ALOKA********************************
Continued on next pageNN1-1384 Rev.8

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3

Printing examples

Continued on next page

QC sample number

SD value of measured
data********************************QC C1/C2********************************
005-09 C-00001
183
133 ng/mL
185
135 ng/mL
183
133 ng/mL-------------------------------184
133 ng/mL
0.97
0.7005-10 C-00002
940
451 ng/mL
952
447 ng/mL
935
461 ng/mL-------------------------------942
453 ng/mL
7.35
1.6

Measurement date andtime of calibration curve********************************
15/01/15 16:58
47017

STD/QC sample
measurement start

Data

Mean value of measureddata
CV value of measured
data

The result and mean values
are printed for each QC

Reagent lot

Calibration curve
graph********************************STD･QC END
CAL.CURVE･QC REGISTER********************************CANCEL is printed if
the calibration curve
was canceled.

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3.5

Printing examples

Error message printing
The meanings of error messages are shown in the chart below.

********************************
POWER ON
15/01/14 11:42****************************************************************
START
15/01/15 17:51********************************CC No.1
15/01/12 14:27********************************
005-01
1-00001
AB00123xx+
183* 124.2ng/mL
005-02

1-00002

NO Tube005-031-00003 L. Dispense Err

Error message********************************
Error Message Text
Sample ShortNo Latex
Latex Short
Mixing Error
Latex Blank Error
No Cal. Curve
Cal.Curve1 Error
Cal.Curve2 Error
S. Dispense Err
L. Dispense Err
Puncture Error
None Result
Order Error
No TubeB/C Duplication
B/C Read NG
No OrderPrinter Offline
Explanatory note

Meaning
Sample insufficient
No reagent
Reagent insufficient
Mixing error
Reagent blank error
No calibration curve
STD error (DA1)
STD error (DA2)
Sample dispensing error
Reagent dispensing error
Puncture error
No final results
Order error
Sample not placed
Double barcode
Barcode reading error
No OrderPrinter connection error and re-connection: There are cases where before and after the printing of the "Printer Offline" is overlapping.

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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
cutter.
Failure to observe this precaution may
Required

LED lamp

4.1

FEED button

lead to injury.

Manual cutter

Setting printer paperRaise the paper cover open lever and open the
cover.

Paper cover

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

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


Manual cutter

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

FEED button

Touch the FEED button.

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

5

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)
G communication error

1001
1003
1005
1006

G Communication error
Unexpected command received
Unexpected command received
No reply from GLIFE command
No Reply from GLIFE
Command
No reply from G command
No Reply from G Command
Abort failed

1007
Abort failed

Errors and Clearing Method Displayed On-screen(Not displayed on screen)
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[SHUT DOWN]: Turn off the system power.
[CLOSE]: CLOSE ERROR DISPLAY(Not displayed on screen)
Operation will continue automatically.
(Not displayed on screen)
Touch the [SHUT DOWN] button to turn off the system power.
Finish the sample process currently being tested.
(Not displayed on screen)
Touch the [SHUT DOWN] button to turn off the system power.
Finish the sample process currently being tested.
(Not displayed on screen)
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[SHUT DOWN]: Turn off the system power.
[CLOSE]: CLOSE ERROR DISPLAYERR# 0-1100 1101
1102
1103
1111
1112

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
Online transmission error[Reception failed]
Online transmission error[Reception failed](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.
(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-

1113

1114

On-screen Message (Upper)
Printed Message (Lower)
Online transmission error[Faulty data received]
Online transmission error[Faulty data received]
Online transmission error[Timeout error]
Online transmission error[Timeout error]

Error List

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.

ERR# 0-1400 Detector error

1404
Detector error
Insufficient test reagents

1409
Insufficient test reagents
Insufficient test buffer

1410
Insufficient test buffer
No buffer left

1412

1415

1416

(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.
Reagent low volume. Analysis stopped. Reagents need 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 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.
(Not displayed on screen)(1) Open the [Set reagents] screen.
(2) Add buffer.
(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.

No buffer left
Reference cell acquisition failed Reference data Value of cell blank measurement is out of Standard.
<ERROR CANCELLATION>
Reference cell acquisition failed PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[ABORT]: Finish cell blank measurement without updating thereference value.
[COERCE]: Update the reference value and continue cell blankmeasurement.
Double sample barcode(Not displayed on screen)
A sample barcode is duplicated. This sample will not be tested.
Operation will continue automatically.
Double sample barcode

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Error List

Error No.
ERR#0-

1417

On-screen Message (Upper)
Printed Message (Lower)
Sample barcode reading error
Sample barcode reading error
Sample barcode digit error

1418
1419

1420

Sample barcode digit error
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

1425
Drain tank fullErrors and Clearing Method Displayed On-screen(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
1431
1435
1436
1437
1438

1439

On-screen Message (Upper)
Printed Message (Lower)
Cell check error
Cell check error
All cell blank error
All cell blank error
Reagent blank error
Reagent blank error
Cell Blank Error

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.
(Not displayed on screen)
Cell blank status is abnormal. Operation will continue automatically.
To replace the cells, touch the [Abort] button.

Cell Blank Error
Transportation Result Data Error (Not displayed on screen)
Transportation Result Data Error An error is detected in a reagent barcode check digit inspection.
Try reading again. Operation will continue automatically.
Container check results error(Not displayed on screen)
SAMPLE CHECK FAIL
Container check results error
This sample will not be tested. Operation will continue automatically.
Maximum number of samples
Rack loading stopped due to reaching maximum number of sample
reached Warning
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
Maximum number of samples[CLOSE]: CLOSE ERROR DISPLAY
reached
Program error

1440
Program Error

Close error display. Close the instrument under main analysis screenof [Completed]<ERROR CANCELLATION>PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[CLOSE]: CLOSE ERROR DISPLAY

387
NN1-1384 Rev.8

5

Error List

Error No.
ERR#0-

On-screen Message (Upper)
Printed Message (Lower)

Errors and Clearing Method Displayed On-screen

ERR# 0-1500 1501
1502
1503

1504

1505
1506
1509

Startup failed
Startup failed
Analysis end processing failed
Analysis end processing failed
Program end processing failed
Program end processing failed
A required file cannot be found.

(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.
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 be (Not displayed on screen)found.
A file cannot be found.
func.ini is abnormal or cannot be Touch the [SHUT DOWN] button to turn off the system power.
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 memory388
NN1-1384 Rev.8

5

Error No.
ERR#0-

Error List

On-screen Message (Upper)
Errors and Clearing Method Displayed On-screen
Printed Message (Lower)
Common memory initialization PROGRAM ERROR (MEMORY) due to file setting failure INF1: Common memory
No. 1-46
failed
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.

1511

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.

389
NN1-1384 Rev.8

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

Waiting(Message not printed)
Supply unit Exchange trays(Message not printed)
Prepare for pipe line activation.

2003(Message not printed)
Shutdown error Warning

2004

2005

390

Shutdown error Warning
Hard disk damaged Warningor
SSD damaged Warning
Hard disk damaged Warningor
SSD damaged Warning

The analysis is completed.
(You can continue testing)
The supply unit tray can be exchanged.
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.
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).

NN1-1384 Rev.16

55.2
Error No.
ERR#1-

000

Error List

ERR# 1-000 - 1-200(SS1)
On-screen Message (Upper)
Printed Message (Lower)
Unknown error
Unknown error
Sample nozzle Jam (liquid level
detection)

001

SAMP Jam (LSU)
Sample nozzle Jam (liquid level
detection)

004

SAMP Jam (LSU)
Sample nozzle Jam (STD)

005

SAMP Jam (STD)

Errors and Clearing Method 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 sample nozzle jammed during detection of the liquid level of asample. If the rack is misaligned, dispensed samples on theconveyance line may become jumbled. In this case, a retest isrecommended.
<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.
The sample nozzle jammed during detection of the liquid level of asample. If the rack is misaligned, dispensed samples on theconveyance line may become jumbled. In this case, a retest isrecommended.
<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.
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.

391
NN1-1384 Rev.8

5

Error List

Error No.
ERR#1-

On-screen Message (Upper)
Printed Message (Lower)
Sample nozzle Jam

007
SAMP Jam (SSIP)
Sample nozzle Jam

008
SAMP Jam (SSIP)
Sample nozzle Jam(Dispensing to cells)

010
SAMP Jam (Cell)
Sample nozzle Jam (STD)

011

SAMP Jam (STD)

Errors and Clearing Method Displayed On-screen
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[Pass]: Skip the sample.
[ABORT]: Finish analysis.
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[CONTINUE]: Continue the process.
[ABORT]: Finish processing.
The sample nozzle jammed when it was dispensing to a cell.
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.
[ABORT]: Finish analysis. 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.
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
terminate.

392
NN1-1384 Rev.9
Rev.8

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

016

SAMP Jam (DIL)
No sample
No sample
No sample (STAT STD)

017
No sample (INT STD)
Sample dispensing error

018

NN1-1384 Rev.8
Rev.9

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.
No sample was detected
Operation will continue automatically.

Sample dispensing error

393

5

Error List

Error No.
ERR#1-

019

020

021
022

023

024

032

On-screen Message (Upper)
Errors and Clearing Method Displayed On-screen
Printed Message (Lower)
Sample nozzle Liquid level error (Not displayed on screen)
Detected liquid level is abnormal.
Operation will continue automatically.
SAMP Liquid level error
Sample nozzle Liquid level
Detected liquid level is abnormal.
error (STAT STD)
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 dropletsfrom the 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
SAMP Liquid level error (INT
terminate.
STD)
Sample nozzle Absorption error
SAMP Absorption error
Insufficient sample(Not displayed on screen)
Absorption by the sample nozzle was not performed normally.
Operation will continue automatically.
(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
terminate.
Insufficient sample (INT STD)
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.
[ABORT]: Finish processing. If analysis is underway, it will also
SAMP Absorption error (INT
terminate.
STD)
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.
[ABORT]: Finish processing. If analysis is underway, it will also
Purified water Pump trouble
terminate.
(OF)

394
NN1-1384 Rev.8

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

Supply unit 1

No tray042

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.

395
NN1-1384 Rev.8

5

Error List

Error No.
ERR#1-

On-screen Message (Upper)
Printed Message (Lower)
Supply unit 1 Rack supply
error

043
Supply unit 1
error
Supply unit 1
return error

Rack supply

Supply unit 1

Return error

Supply bar

044

Discharge unit 1

No tray

Discharge unit 1
Discharge unit 1
discharge

No tray
Abnormal

Discharge unit 1
discharge

Abnormal

Discharge unit 1

Rack full

Discharge unit 1

Rack full

045

046

047

Errors and Clearing Method Displayed On-screen
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[RETRY]: Restart rack supply.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
The supply bar of the supply unit was not returned to the front
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.
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.

396
NN1-1384 Rev.8

5

Error No.
ERR#1-

On-screen Message (Upper)
Printed Message (Lower)
Conveyance bar in system
Working error

048
Conveyance bar Error
Puncturing component
Working error

050
Puncturing Error
Puncturing component Jam

052
Puncturing Jam
Barcode Reader Error

053
Barcode Reader Error
Squeezing Error

054
Squeezing

Error

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.
The puncturing component did not work correctly.
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.
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.

397
NN1-1384 Rev.8

5

Error List

Error No.
ERR#1-

On-screen Message (Upper)
Printed Message (Lower)
Squeezing Error

055
Squeezing Error
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(buffer)

Insufficient

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.
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.

398
NN1-1384 Rev.8

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
No buffer067
No buf.
Insufficient buffer

068

Insufficient buf.

Incorrect

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.
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.

399
NN1-1384 Rev.8

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.

ERR# 1-100 Discharge unit 1

Rack full

Discharge unit 1

Rack full100

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.

400
NN1-1384 Rev.8

5

Error No.
ERR#1-

103
104

On-screen Message (Upper)
Printed Message (Lower)
No buffer
No buf.
Insufficient buffer
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.

401
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5

Error List

Error No.
ERR#1-

On-screen Message (Upper)
Printed Message (Lower)
Sample nozzle Liquid level
error (STD)112
SAMP Liquid level error (STD)

No sample (STD)113
No sample (STD)
Insufficient sample (STD)

114
Insufficient sample (STD)
Sample nozzle Jam (STD)

115

SAMP Jam (STD)
Sample nozzle Absorption
error (STD)

116

Errors and Clearing Method Displayed On-screen
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 dropletsfrom the 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
terminate.
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.
[ABORT]: Finish processing.
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.
[ABORT]: Finish processing.
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[RETRY]: Restart measurement.
[Pass]: Finish processing of the rack.
[ABORT]: Finish processing.
Absorption by the sample nozzle was not performed normally.
<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
terminate.

SAMP Absorption error (STD)402
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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
STD)

Jam (STAT

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
Insufficient buf. (INT STD)

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.

403
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Error List

Error No.
ERR#1-

On-screen Message (Upper)
Printed Message (Lower)
Sample nozzle Jam (STAT
STD)

127

128

129

130

135

SAMP Jam (INT STD)
Sample nozzle Liquid level
error
SAMP Liquid level error
Sample nozzle Liquid level
error (STAT STD)

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 dropletsfrom the tip of the sample nozzle, if any.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[Pass]: Finish processing of the rack.
SAMP Liquid level error (INT [ABORT]: Finish processing. If analysis is underway, it will also
terminate.
STD)
Sample nozzle Liquid level
Liquid level was detected as abnormal.
error<ERROR CANCELLATION>(STD)
Use cloth, such as gauze, to remove water or other liquid dropletsfrom the 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[RETRY]: Restart measurement.
[Pass]: Finish processing of the rack.
SAMP Liquid level error[ABORT]: Finish processing.
(STD)
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.
PRESS THE FOLLOWING BUTTON TO SOLVE THE ERROR[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
Barcode reading Timeout

404
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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

142

SAMPZ ORG error
Sample nozzle Z-axis origin
error
(STD)

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.

405
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5

Error List

Error No.
ERR#1-

145

146

147

148

149

150

On-screen Message (Upper)
Printed Message (Lower)
Supply unit 1 origin error

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.

Supply unit 1 ORG error
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
terminate.
SAMPT ORG error
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
terminate.
SAMPP ORG error
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
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 ERRORSAMPP ORG error[SKIP]: Skip the sample.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
No STAT Rack
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

189

190

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.

Residue in cell (soaking)Sample nozzle Liquid level error 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.
SAMP Liquid level error[ABORT]: Finish processing.
(soaking)
Sample nozzle Jam (CellThe sample nozzle jammed in a cell during cell soaking. The sample
soaking)
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.
SAMP Jam (Soaking)407
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5

Error List

Error No.
ERR#1-

195
200
202

On-screen Message (Upper)
Printed Message (Lower)
There is no dispensing liquid(dispensing accuracy)
No liquid (dispensing check)
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.

408
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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.

409
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5

Error List

Error No.
MES#1-

006

007

On-screen Message (Upper)
Printed Message (Lower)
Check that there is no liquidleaking from the nozzle tip.

(Message not printed)
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.

410
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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
bottle)Jam (reagent

081

082

Reagent Jam (bottle)
Reagent nozzle Jam (reagent
absorption)
Reagent Jam (REAG SIP)
Reagent nozzle Jam(dispensing to cell)

084
Reagent Jam (REAG DISP)
Reagent nozzle Jam (OF)

085

086
088

Error List

Reagent Jam (OF)No reagent
No reagent
Reagent nozzle Abnormal
liquid level detected
Reagent Incorrect level(REAG)

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.
The reagent nozzle jammed when it was dispensing to a 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.
[ABORT]: Finish processing. If analysis is underway, it will also
terminate.
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.
(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.

411
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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
Mixer

Operation error
Operation error

Mixer
Mixer

Operation error
Jam

Mixer
Mixer

Jam
Jam

Mixer

Jam

096

097

099

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

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.

Cell washing component
Absorption error

103

Cell washing

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
Absorption error terminate.

Cell washing component
Liquid spill

The cell washing component detected a liquid leakage.
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.

104

Cell washing

Liquid spill

Cell washing component

105
Cell washing

Jam

Jam

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.

Cell washing component
Absorption error

106

Cell washing

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.
Absorption error [ABORT]: Finish processing.

413
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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
Cell washing component Liquid
spill

108
Cell washing Liquid spill
Insufficient purified water

110
Insufficient purified water
Insufficient wash solution

111
Insufficient wash solution
Drain tank Full112
Drain tank fullErrors 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.
The cell washing component detected a liquid leakage.
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.
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.

414
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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
Detection

Error (retry)
Error

131

132
133

Detection Error
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
error

Z-axis origin

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

142

144

147

150

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 Z ORG error
Reagent nozzle Theta-axis origin Reagent nozzle Theta-axis original position detection error.
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.
Reagent T ORG error
Reagent nozzle P-axis origin
error

143

Errors and Clearing Method Displayed On-screen

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 P ORG error
Reagent nozzle Jamming Sensor Jamming sensor of reagent 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.
Reagent Jamming Sensor error
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.
[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
Reagent Jam (maintenance)
No reagent

193

200

No reagent (dispensing test)
Illegal receiving command
ILLEGALCOMMAND

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.
(Not displayed on screen)
No reagent was remaining in a dispensing accuracy check forreagents. 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)

Errors and Clearing Method Displayed On-screen(Not displayed on screen)“Dead volume” is defined as the difference between the volume of aliquid placed in the reagent bottle (before measurement of deadvolume) and the total dispensed volume.
Touch the following button to finish processing.
Dispensed volume: # Times: # [ABORT]: Finish processing.
Dispensed volume # [L]
times

007

Error List#

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Save to External Media

6

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, timecourse data information, histogram information, and positive rate change 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
1 Data type

Reference (: Blank [20H])
OutputMeasured data: ‘N’ Stat data: ‘S’Retest (including dilution test) data: ‘A’
When data is edited,  becomes E.
(Example) Measured data is edited :‘NE’
2 Date of analysis
Date of analysise.g.) Sep. 23, 2016 → 2016/09/23
3 Time of analysis
Time of analysis (24-hour indication)e.g.) 2:5 pm → 14:05
4 Rack No.
Barcode information on racks
Do
5 Position in rack
Position in rack: 1–10
Do
6 Sample ID
Barcode information on sampling bottles (*2)
Do
7 Sample group No.
DoGroup number of a sample: 0–9（Stat samples:）(If “*” is set to this number, “0” is given.)
8 Sample sequence no. Serial number of measurement: 1–99999
Do• Number ranges are predetermined.
Samples: 1–99999
Stat samples: 1–99999
9 Measurement method Classification of measurement method by day: 1–3
counter(Number of samples for each subject)(Dilute remeasure: ‘’)
10 Number of replicates Number of replicates for a replicate test: 1–10
11 DA value
Values at 1st to 3rd detection points.
Do
See Appendix 1.3 “Calculate DA Value.”
12 Measured data
Calculated data: Up to 7 digits in the integer part and 1 digitin the decimal part. (*1) (the number of digits in thedecimal part can be changed from “Output Format
Settings.”)
13 Flag (+, -)Qualitative Flag (+, -) of measured data by the cut-off
Dovalues: (*1) -, +, 1+, 2+ and 3+
14 SD values
SD values of measured data (statistic)
15 CV values
CV values of measured data (statistic)
16 Error code
See Appendix 6.10, “List of Error Codes for Output toExternal Media.”
17 Final results“*” is recorded as final results of 15- or 250-times dilution
tests. (*1)

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No.
Item
18 Test item code

Reference (: Blank [20H])
Test item code
It does not output at the time of order error. For the CSV
format is displayed as ",,".
19 Test item name
Test item nameIt does not output at the time of order error. For the CSV
format is displayed as ",,".
20 Unit
Unit of test item
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
25 Latex lot
Lot of using Latex
26 Latex expiration date The expiration date of the Latex
27 Buffer lot
Lot of using Buffer
28 Buffer expiration date The expiration date of the Buffer

Save to External Media

OutputDo (*3)Do (*3)Do (*3)Do (*3)Do (*3)Do(*3)(*4)

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
data-free 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.

 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（F-Hb）(15 times dilution result)
A ,2016/07/18,11:39,032,1,123456789012345,0,1,1,1,4523,,,,,,,,05,90,F-Hb,ng/mL,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,,*,90,F-Hb,ng/mL,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,7Z027,2
018/12/31,7Y019,2018/11/30

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Save to External Media

6.2

Sample Replicate Information

Saves information on each replicate of samples or stat samples[File name: ocrsamp.csv]
No.
Item
1 Data type
2 Date of analysis
3 Time of analysis
4 Relative cell No.
5 Rack No.
6 Rack position
7 Sample ID
8 Sample group No.
9 Sample sequence No.
10 CC No.
11 Replicate counter
12 A1 value
13 A2 value
14 A3 value
15 DA1 value
16 DA2 value
17 Measured data
18 Flag (+, -)19 Error code
20 Final result
21 Test item code
22 Test item name23 Unit
24 Cut off 1
25 Cut off 2
26 Cut off 3
27 Operator ID
28 Latex lot
29 Latex expiration date
30 Buffer lot
31 Buffer expiration date

RemarkSee Appendix 6.1, “Sample Measured Data Information.”
See Appendix 6.1, “Sample Measured Data Information.”
See Appendix 6.1, “Sample Measured Data Information.”
Cell No..: 1–55
See Appendix 6.1, “Sample Measured Data Information.”
See Appendix 6.1, “Sample Measured Data Information.”
See Appendix 6.1, “Sample Measured Data Information.”(*1)
See Appendix 6.1, “Sample Measured Data Information.”
See Appendix 6.1, “Sample Measured Data Information.”
CC No. for sample measurement: 1–6
Replicate No. for a replicate test: 1–10
See Appendix 1.3, “ Calculate DA Value.”
See Appendix 1.3, “ Calculate DA Value.”
See Appendix 1.3, “ Calculate DA Value.”
See Appendix 1.3, “ Calculate DA Value.”
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
The expiration date of the Latex
Lot of using Buffer
The expiration date of the Buffer

Output
Do
Do
Do
Do
Do
Do
Do
Do
Do(*2)
Do(*2)
Do(*2)
Do(*2)

Do(*2)
Do(*2)(*3)

Explanatory note

•
•
•
•
•
•
•
(*1)

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”.
When Two-dimensional code is used (optional), sample ID is output up to 50 digits.

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Save to External Media(*2) Contact us for changing No.21-No.31.
(*3)

If dispense operation cannot be performed, " " is displayed for the lot and expiration date.

 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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Save to External Media

6.3

QC Measured Data Information

Saves QC measured data
[File name: ocqc.csv]
No.
Item
Remark
1 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.”
5 Rack position
See Appendix 6.1, “Sample Measured Data Information.”
6 Sample sequence no. See Appendix 6.1, “Sample Measured Data Information.”
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.”
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
15 Test item name
Test item name
16 QC ID
ID of QC (*1)
17 Unit
Unit of test item
18 Operator ID
See Appendix 6.1, “Sample Measured Data Information.”
19 QC expiration date
20 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
See Appendix 6.1, “Sample Measured Data Information.”
date

OutputDo
Do
Do
Do
Do(*2)
Do(*2)
Do(*2)
Do(*2)
Do(*2)
Do(*2)
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. 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,2018/12/31,7Y019,2018/11/30

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6.4

Save to External MediaQC Replicate Information

Saves information on each QC replicate[File name: ocrqc.csv]
No.
Item
1 Data type
2 Date of analysis
3 Time of analysis
4 Relative cell no.
5 Rack no.
6 Rack position
7 Sample sequence no.
8 QC lot
9 CC no.
10 Replicate counter
11 A1 value
12 A2 value
13 A3 value
14 DA1 value
15 DA2 value
16 Measured data
17 Flag (+, -)18 Error code
19 Test item code
20 Test item name
21 QC ID
22 Unit
23 Operator ID
24 QC expiration date
25 Latex lot
26 Latex expiration date
27 Buffer lot
28 Buffer expiration date

RemarkSee Appendix 6.3, “QC Measured Data Information”
See Appendix 6.1, “Sample Measured Data Information”
See Appendix 6.1, “Sample Measured Data Information”
See Appendix 6.2, “Sample Replicate Information”
See Appendix 6.1, “Sample Measured Data Information”
See Appendix 6.1, “Sample Measured Data Information”
See Appendix 6.1, “Sample Measured Data Information”
See Appendix 6.3, “QC Measured Data Information”
See Appendix 6.2, “Sample Replicate Information”
See Appendix 6.2, “Sample Replicate Information”
See Appendix 1.3, “ Calculate DA Value.”
See Appendix 1.3, “ Calculate DA Value.”
See Appendix 1.3, “ Calculate DA Value.”
See Appendix 1.3, “ Calculate DA Value.”
See Appendix 1.3, “ Calculate DA Value.”
See Appendix 6.1, “Sample Measured Data Information”
Not output.
See Appendix 6.10, “List of Error Codes for Output toExternal Media.”
Test item code
Test item nameID of QC (*1)
Unit of test item
See Appendix 6.1, “Sample Measured Data Information.”
See Appendix 6.1, “Sample Measured Data Information.”
See Appendix 6.1, “Sample Measured Data Information.”
See Appendix 6.1, “Sample Measured Data Information.”
See Appendix 6.1, “Sample Measured Data Information.”

Output
Do
Do
Do
Do
Do
Do(*2)
Do(*2)
Do(*2)
Do(*2)
Do(*2)
Do(*2)
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.

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Save to External Media 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,2018/12/31,7Z
027,2018/12/31,7Y019,2018/11/30
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,2018/12/31,7Z
027,2018/12/31,7Y019,2018/11/30
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,2018/12/31,7Z
027,2018/12/31,7Y019,2018/11/30

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6.5

Save to External Media

Standard Measured Data Information

Saves STD measured data information[File name: ocstd.csv]
No.
Item
1 Date of analysis
2 Time of analysis
3 Latex lot
4 Rack No.
5 Rack position
6 STD point No.
7 DA1 value
8 DA2 value
9 DA1 back fit
10 DA1CV value
11 DA2CV value
12 DA1SD value
13 DA2SD value
14 Origin
15 Number of
replicates
16 Error code
17 Test item code
18 Test item name

RemarkSee Appendix 6.1, “Sample Measured Data Information”
See Appendix 6.1, “Sample Measured Data Information”
Latex lot No. (consisting of five alphanumeric characters)
See Appendix 6.1, “Sample Measured Data Information”
See Appendix 6.1, “Sample Measured Data Information”
Detection point No. (STD1–STD6): 1–6
See Appendix 1.3, “Calculate DA Value.”
See Appendix 1.3, “Calculate DA Value.”
Concentration estimated by fitting DA1 to a calibration curve
CV value of DA1 (statistic)
CV value of DA2 (statistic)
SD value of DA1 (statistic)
SD value of DA2 (statistic)
STD concentration of CC protocol
Number of replicates for a replicate test: 1–10

Output
Do
Do
Do
Do
-

See Appendix 6.10, “List of Error Codes for Output to External
Media.”
Test item code
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.”

 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

Save to External Media

6.6

Standard Replicate Information

Saves information on each STD replicate[File name: ocrstd.csv]
No.
Item
1 Date of analysis
2 Time of analysis
3 Latex lot
4 Relative cell no.
5 Rack no.
6 Rack position
7 STD point no.
8 Replicate counter
9 A1 value
10 A2 value
11 A3 value
12 DA1 value
13 DA2 value
14 Error code
15 Test item code
16 Test item name

Remark
OutputSee Appendix 6.1, “Sample Measured Data Information.”
See Appendix 6.1, “Sample Measured Data Information.”
Latex lot No. (consisting of five alphanumeric characters)
See Appendix 6.2, “Sample Replicate Information.”
See Appendix 6.1, “Sample Measured Data Information.”Do
See Appendix 6.1, “Sample Measured Data Information.”Do
See Appendix 6.5, “STD Measured Data Information.”
See Appendix 6.2, “Sample Replicate Information.”
See Appendix 1.3, “Calculate DA Value.”
See Appendix 1.3, “Calculate DA Value.”
See Appendix 1.3, “Calculate DA Value.”
See Appendix 1.3, “Calculate DA Value.”Do
See Appendix 1.3, “Calculate DA Value.”Do
See Appendix 6.10, “List of Error Codes for Output to External
Media.”
Test item code
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.”

 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

6.7

Save to External MediaTime Course Data Information

Saves time course data information[File name: tcourse.csv]
No.
Item
1 Cell information 1∙∙∙
n Cell information n

RemarkTime course information on relative cell 1∙∙∙
Time course information on relative cell nCell information #No.
Item
1 Date of analysis
2 Time of analysis
3 Relative cell no.
4 Reference value
5 Cell-blank value
6 ABS value of cycle 1
7 ABS value of cycle 2∙∙∙

RemarkSee Appendix 6.1, “Sample Measured Data Information.”
See Appendix 6.1, “Sample Measured Data Information.”
See Appendix 6.2, “Sample Replicate Information.”
See Appendix 1.7, “Calculate Cell Blank.”
See Appendix 1.7, “Calculate Cell Blank.”
See Appendix 1.3, “Calculate DA Value.”
See Appendix 1.3, “Calculate DA Value.”∙∙∙

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 nameOutput∙∙∙Output∙∙∙-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.

 Example of Time Course Data Information Output
2016/07/23,16:51,1,14127,14,176,1393,1350,1341,1343,1347,1351,1356,1361,1367,1374,1380,1385,1391,13
98,1404,1410,1417,1424,1430,1436,1441,1448,1453,1459,1463,1471,1476,1480,1482,1490,1494,1496,1499,1
507,1513,1512,1517,0,0,0,0,0,0,0,12,0,0,-1,0,154,156,159,162,163,90,F-Hb
2016/07/23,16:51,2,14127,0,184,1375,1320,1314,1315,1316,1318,1319,1320,1322,1324,1325,1325,1327,132
8,1328,1328,1329,1331,1331,1331,1330,1331,1332,1331,1331,1332,1333,1333,1332,1335,1335,1331,1330,13
32,1333,1335,1334,0,0,0,0,0,0,13,16,0,0,0,2,162,167,170,173,175,90,F-Hb

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6

Save to External Media

6.8

Histogram Information

Saves histogram information[File name: ochstgrm.txt]
No.
Item
1 Title 1
2 Title 2
3 Period of time
4 Period of time
5 Title 3
6 Test item code
7 Test item name.
8 Title 4
9 Measurement range
10 Number of samples
11 Title 5
12 Total number of samples

Remark
Output“Histogram”“Date range”
First date of calculation data
Final date of calculation data
“Test item name”
Test item code
Test item name
“Measurement range”, “Number of samples”
Minimum and maximum limits of each class: Minimum limit Maximum limit
Number of samples in a class“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.”

 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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NN1-1384 Rev.8

6

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.
Item
1 Title 1
2 Title 2
3 Date4 Title 3
5 Test item code
6 Test item name.
7 Title 4
8 Positive rate (%)

Remark“POSITIVE RATE CHANGE ACCORDING TO TESTEE”“Date”
The first date of a week or month in calculation of positive rates by
week or month“Test item name”
Test item code
Test item name
“Positive rate (%)”
Rate of testees with positive rates to the total testees (Positive testees
÷ Total testees  100)

Output-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 TO TESTEE.”
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 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.
Item
1 Title 1
2 Title 2
3 Date4 Title 3
5 Test item code
6 Test item name.
7 Title 4
8 Positive rate (%)

Remark“POSITIVE RATE CHANGE ACCORDING TO SAMPLE”“Date”
The first date of a week or month in calculation of positive rates by
week or month“Test item name”
Test item code
Test item name
“Positive rate (%)”
Rate of samples with positive rates to the total samples (Positive
samples ÷ Total samples  100)

Output-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.”

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6

Save to External Media 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

Save to External Media

6.10 List of Error Codes for output to external Media
Error information is subject to change or addition without notice.
Code

Error

Measured
data
Yes
-

10
20

BARCODE READING ERRORDOUBLE BARCODE ERROR (Check
within a day)

01
02
03
04
05
06
07

INSUFFICIENT SAMPLE/NO SAMPLENO LATEXRBC (PROZONE)
PRC (PROZONE)OR (OVER RANGE)
UR (UNDER RANGE)SAMPLE DISPENSING ERROR (such as
jamming in the sample nozzle)

Yes
*
*
-

08

-

09
0A
0B
0C

LATEX DISPENSING ERROR (such as
jamming in the reagent nozzle)
Mixer error (such as jamming in the mixer)
LATEX BLANK ERROR (A1 CHECK)
NO CC
UNSET

30

Combined error of Errors 10 and 01

90

UNSET

-

11
12
13
14
15
16
17
18
19
1A
1B

Combined error of Errors 10 and 01
Combined error of Errors 10 and 02
Combined error of Errors 10 and 03
Combined error of Errors 10 and 04
Combined error of Errors 10 and 05
Combined error of Errors 10 and 06
Combined error of Errors 10 and 07
Combined error of Errors 10 and 08
Combined error of Errors 10 and 09
Combined error of Errors 10 and 0A
Combined error of Errors 10 and 0B

Yes
*
*
-

-

RemarkDoes not appear if “NO” is selected
for “DUPLICATED SAMPLEBARCODE CHECK”.
Dispensing is not performed.

Dispensing is not performed.
Also appears in the case of apuncturing error.
Dispensing is not performed.
It does not mixing.
Abnormal latex blank
Includes mismatching of CC lot.
It is received an instruction from thehost system without an order.
Order request communication did notcomplete successfully.
An order different from the requested
sample ID and item code wasreturned.
Doesn’t appear if MODE 1 is selected
for NUMBERING MODE.

*“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 L before reagent is dispensed.
Normally, latex is supplied from the second latex bottle before the contents of the first latex bottle become empty (0 L).
Moreover, analysis will be stopped before the contents of the second latex bottle become empty (0 L). The NO LATEX error
will not normally appear.

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6

Save to External Media*

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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250-times

NN1-1384 Rev.11

Final result: Undefined
Measured data: Space
Error code: 0A

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 : Error codein 15-times analysis (*3)

Final result: Undefined
Measured data: Space
Error code: 0A

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 : Error code in
15-times analysis (*3)

UR

OR

RBC

PRC

Error of nomeasured data

Final result: Undefined
Measured data: Space
Error code: UR

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: NoneUR

Final result: Undefined
Measured data
Diana: Space (with Negative
result)io:
9999 Fixed
Error code: OR

Final result: Undefined
Measured data
Diana: Space (with Negative
result)io:
9999 Fixed
Error code: OR

Final result: Undefined
Measured data
Diana: Space(with Negative
result)io:
9999 Fixed
Error code: OR

Final result: Undefined
Measured data
Diana: Space (with Negative
result)io:
9999 Fixed
Error code: OR

Final result: Undefined
Measured data: Space
Error code: 0A

Final result: Undefined
Measured data: Space
Error code: 0AOR(*1) DA1 value in 15-times dilution ≥ DA1 value in 250-times dilution(*2) DA1 value in 15-times dilution < DA1 value in 250-times dilution(*3) Error status
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.
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.
(*4) This varies depending on the communication mode setting.

Final result: Undefined
Measured data: Space
Error code: 0A

Final result: 15 times
Measured data: GainedError code: None

Normal (*2)

NormalNormal (*1)

Final results of 15- or 250-times dilution tests and error codes

15-times

Final result: Undefined
Measured data
Diana : 250-times dilution dataio:
250-times dilution data
Error code: RBC

Final result: Undefined
Measured data
Diana: Space (with Negative
result)io:
9999 Fixed
Error code: PRC

Final result: Undefined
Measured data
Diana : 250-times dilution dataio:
250-times dilution data
Error code: RBC

Final result: Undefined
Measured data
Diana: Space (with Negative
result)io:
9999 Fixed
Error code: OR

Final result: Undefined
Measured data: Space
Error code: 0A

Final result: Undefined
Measured data: Space
Error code: 0A

RBC

Final result: Undefined
Measured data
Diana: Space (with
Negative result)io:
9999 Fixed
Error code: PRC

Final result: Undefined
Measured data
Diana: Space (with
Negative result)io:
9999 Fixed
Error code: PRC

Final result: Undefined
Measured data
Diana: Space (with
Negative result)io:
9999 Fixed
Error code: PRC

Final result: Undefined
Measured data
Diana: Space (with
Negative result)io:
9999 Fixed
Error code: OR

Final result: Undefined
Measured data: Space
Error code: 0A

Final result: Undefined
Measured data: Space
Error code: 0A

PRC

Final result: Undefined
Measured data: Space
Error code : Error code in
250-times analysis (*3)

Final result: Undefined
Measured data: Space
Error code : Error code in
250-times analysis (*3)

Final result: Undefined
Measured data: Space
Error code : Error code in
250-times analysis (*3)

Final result: Undefined
Measured data: Space
Error code : Error code in
250-times analysis (*3)

Final result: Undefined
Measured data: Space
Error code : Error code in
250-times analysis (*3)

Final result: Undefined
Measured data: Space
Error code : Error code in
250-times analysis (*3)

Error of no measured data

6
Save to External Media

435

6

Save to External Media

MEMO

436
NN1-1384 Rev.8

77Management USB Stick Setting

Management USB Stick Setting

When saving measurement data or other data to a USB stick, the USB stick needs to be set as a management USB
stick first.
This section describes the procedure to set a USB stick as a management USB stick.
Explanatory note: If you are using the operator and reagent management function, you need to log in with the administrator
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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NN1-1384 Rev.13

7Management USB Stick Setting

3

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 successfully
set as a management USB stick.

8

Remove the USB stick from the system.

438
NN1-1384 Rev.13

IndexIndex/Glossary
Index
A
Abort

325
73
33, 292
344

Additional test
Alarm
Aloka curve
Automatic start
Automatic start up

30, 31, 90
30, 31, 90

B
Back up
Buffer setting

306
42

C
Calibration curve
Calibration curve calculation
Calibration curve confirmation
Calibration curve editing/recalculation
Calibration curve reading/registration
CC No. # protocol settings
Close mode
Conveyance line
Cut-in analysis
Cut-off value344
65
66, 197, 200
202
35, 31489
12, 13, 252
78,370140, 142, 145,
194, 308

D
DA value calculation
Daily operation flow
Dilution test mode
Drain tank350
36
54, 362
Drain Tank Processing
Drain tank setting

96
39

439
NN1-1384 Rev.13

IndexE
Environment settings
Error

33, 276
Error cancellation
Error Cancellation Buttons
Error Handling
Error log

326
325
324
88

Error sample
Error sample data deletion
Error sample data output
Error sample data searching
Error sample data sorting
Error sample range specification
Error sample list display

160
158
156
152
154
150

External media
External media switching
External media output

109
120, 146, 158,
168, 176

H
Help
Histogram

318
Histogram display
Histogram range change
Histogram output

162
166
168

I
Information
Initialization
Inspection/maintenance

25, 68242
Inspection/maintenance, cleaning parts
Inspection/maintenance, inspection change
parts

84

Intra-day/inter-day data deletion
Intra-day/inter-day data editing
Intra-day/inter-day data range change
Intra-day/inter-day data screen

224
222
226
218

86

Intra-day/Inter-day

440
NN1-1384 Rev.13
Rev.1

IndexL
Linear and cubic curves
Long suspense

348
94Management USB stick
Max limit

437
230, 231, 298

M

Measured data
Measured data copying
Measured data deletion
Measured data measurement datespecification
Measured data output
Measured data range specification
Measured data reading
Measured data recalculation
Measured data screen display
Measured data searching
Measured data select screen display
Measured data sorting
Measurement cells
Measurement method
Measure mode
MENU screen
Min limit
Monitor screen

126
124
104
120
106
108
116
100
112
98
110
258
52, 7552, 7518
230, 231, 298
19, 24N
Normal close

27

O
Online output
Operator information (ID information)
Change ID
Deleting ID information
Registering ID informaton
Operator/latex management function
Output format
Output settings

120, 146, 158
336
338
334
330
33, 290
33, 280, 284, 288

441
NN1-1384 Rev.13
Rev.14

IndexP
Positive Rate Change
Positive rate change calculation conditions
Positive rate change display
Positive rate change output
Positive rate change range change

172
170
176
174

Positive sample data deletion
Positive sample data output
Positive sample data range specification
Positive sample data recalculation

148
146
136
140

Positive sample

Positive sample data searching
Positive sample data sorting
Positive sample list display
Printer output
Printing examples

138
134
130
120, 146, 158, 168,
176
374

Priming
Normal priming
Pipe line activation
Protocol settings
Protocol settings backup
Protocol settings restore
Prozone check
Purified water setting

44
46
34, 308
306
307
352
40

Q
QC lot
QC lot deletion
QC lot list display
QC lot selection
Quality Control

215
210
214
210

442
NN1-1384
NN1-1384Rev.13
Rev.1

IndexR
R graphRack info
Rack/QC sequence number

231
234
33, 272
106, 136, 154, 190,
226

Range specification
Reagent
Reagent setting
Check reagent blank

50
354
52

Replicate data range specification

190

Replicate data recalculation

194

Remeasurement/retest mode
Replicate

Replicate data saving
Replicate data searching
Replicate data sorting
Replicate list display
Replicate screen display
Restore

184
192
188
178
182, 186
33, 307

S
Samp barcode settings
Samp/QC protocol settings
Sample ID settings
Sample cups
Sample cup settings
Samples33, 266, 268
35, 308
128
239
33, 302
Installing samples
Samples adding

Screen saver
Settings
STD/QC analysis process
settings
System settings

52
71
33, 296
24, 69, 265
33, 216, 298

System settings backup
System settings printing
System settings restore

32, 266, 306
306
305
307

443
NN1-1384 Rev.13

IndexT
Test
Analysis abort
Analysis Flow
Analysis normal close
Analysis pause
Analysis start
Test Operations
Test mode
Time course
Time course display/printing
Time course range change

83
5
81
82
58
356
52
204, 205
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

－

232

X-R control graph range change444
NN1-1384 Rev.13
Rev.1

Glossary

GlossaryA
Absorbance
A1, A2, A3Logarithm of ratio of strength of incident light striking sample (Io) and strength oftransmitted 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 and calibration
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.

445
NN1-1384 Rev.13

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 of areaction) of the highest concentration of an STD sample series (STD-6) and apatient 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.

446
NN1-1384 Rev.13

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

447
NN1-1384 Rev.13

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 NN1-1384 Rev.17

Eiken Chemical Co., Ltd.