User ManualFor in vitro diagnostic use.
A symbols glossary can be found at quidel.com/glossary.

Table of Contents
Table of Contents.....................................................................................................................................................2
General Information.........................................................................................................................................................4
Assistance................................................................................................................................................................4
Main Menu Structure...............................................................................................................................................5
Labels and Symbols................................................................................................................................................6
Warnings, Precautions and Limitations...................................................................................................................8
Introduction.....................................................................................................................................................................9How to Use This Guide............................................................................................................................................9
Description...............................................................................................................................................................9
		 What is the Quidel Triage MeterPro?...................................................................................................................9		Unpacking..........................................................................................................................................................10
Installation.....................................................................................................................................................................14
Unpack Meter........................................................................................................................................................14
		 Power Meter On.................................................................................................................................................14
		 Install Paper........................................................................................................................................................15
		 Insert Supervisor CODE CHIP Module..............................................................................................................16
		 To Change Meter Settings..................................................................................................................................17
		 Change Clock.....................................................................................................................................................19
		 Set User ID.........................................................................................................................................................19
		 Change Reference Ranges/Thresholds for Tests:..............................................................................................20
		 Change Test Settings.........................................................................................................................................20
		 Change QC Parameters.....................................................................................................................................20
		 Change Bypass Settings....................................................................................................................................21
Set Parameters......................................................................................................................................................23
		Purpose..............................................................................................................................................................23
		 List of Programmable Parameters.....................................................................................................................23
		 Supervisor Access..............................................................................................................................................23
How to Set Parameters: Basic Instructions...........................................................................................................24
		 Meter Settings....................................................................................................................................................24
		 ID Settings..........................................................................................................................................................24
Install CODE CHIP.................................................................................................................................................42
		Purpose..............................................................................................................................................................42
		 Types of CODE CHIP modules...........................................................................................................................42
		 Installation of Reagent, QC Sample or QC Device CODE CHIP Modules........................................................43
		 Installation of Supervisor CODE CHIP module..................................................................................................43
Operation.......................................................................................................................................................................44
Access to the Quidel Triage MeterPro...................................................................................................................44
Run Test.................................................................................................................................................................45
		Purpose..............................................................................................................................................................45
		Options...............................................................................................................................................................45
Recall Results........................................................................................................................................................55
		Purpose..............................................................................................................................................................55
		Function..............................................................................................................................................................55
		 Last Record........................................................................................................................................................55
		 Patient Results...................................................................................................................................................56
		 Patient ID............................................................................................................................................................562

		 Test Device Lot Number (L/N)............................................................................................................................58
		 User ID................................................................................................................................................................59
		 From Date...........................................................................................................................................................60
		 Till Date...............................................................................................................................................................61
		 QC Results.........................................................................................................................................................62
		 QC Sample Lot Number (L/N)............................................................................................................................63
		 Device Lot Number (L/N)....................................................................................................................................64
		 User ID................................................................................................................................................................65
		 From Date...........................................................................................................................................................66
		 Till Date...............................................................................................................................................................67
		 Reagent Lots – QC.............................................................................................................................................68
		 Archive Last Test................................................................................................................................................68
		 Misc. Test Results..............................................................................................................................................69
		 Misc. Test ID.......................................................................................................................................................69
		 Test Device Lot Number (L/N)............................................................................................................................71
		 User ID................................................................................................................................................................72
		 From Date...........................................................................................................................................................73
		 Till Date...............................................................................................................................................................74
		 Print All Results..................................................................................................................................................75
		 Patient Results...................................................................................................................................................75
		 QC Sample Results............................................................................................................................................75
		 QC Device Results.............................................................................................................................................76
		 Misc. Test Results..............................................................................................................................................76
		 Upload Results to LIS........................................................................................................................................76
Delete Results........................................................................................................................................................77
		Purpose..............................................................................................................................................................77
		 THE Quidel Triage MeterPro Memory................................................................................................................77
		 Delete Patient Result..........................................................................................................................................78
Display Backlight...................................................................................................................................................79
Alpha Numeric Mode.............................................................................................................................................80
Service and Maintenance Procedures..........................................................................................................................81
Paper Replacement...............................................................................................................................................81
		 Changing Paper Between Functions..................................................................................................................81
		 Changing Paper While Printing..........................................................................................................................82
Cleaning.................................................................................................................................................................83
Check Battery Level...............................................................................................................................................83
		 Battery Replacement..........................................................................................................................................83
Total Quality Assurance.........................................................................................................................................84
		Introduction........................................................................................................................................................84
		 Quality Assurance Functions..............................................................................................................................85
		 Internal Device Quality Assurance.....................................................................................................................85
		 Meter Quality Assurance....................................................................................................................................86
		 Software Quality Assurance...............................................................................................................................86		 Quality Control Samples.....................................................................................................................................87
		 Notes Regarding Software Controls..................................................................................................................87
Appendices...................................................................................................................................................................90
Appendix A Specifications.....................................................................................................................................90
Appendix B Troubleshooting..................................................................................................................................91
		 Meter Symptoms................................................................................................................................................91
		 Meter Message or Symptom..............................................................................................................................92
Appendix C Return and Disposal Procedures.......................................................................................................94
		 Return Procedure...............................................................................................................................................94
		 Disposal Procedure............................................................................................................................................94
Appendix D Glossary.............................................................................................................................................94
Appendix E Sample Log Sheets............................................................................................................................95
3

General Information
AssistanceIf you have any questions regarding the use of this product or to report a product problem, pleasecontact Quidel Technical Support at 1.800.874.1517 (in the U.S.) or technicalsupport@quidel.com.
If outside the U.S., further information can be obtained from your distributor, or directly from Quidel
at one of the numbers listed below. Reference quidel.com to see more options for Support.
Country

Phone

E Mail Address

Europe, Middle East and Africa+353 (91) 412 474 (main)
0 1 800 200441 (toll free)emeatechnicalsupport@quidel.com

Austria+43 316 231239

Belgium+32 (2) 793 0180

France0 (805) 371674

Germany+49 7154 1593912

Netherlands

0 800 0224198

Switzerland

0 800 554864

United Kingdom

0 800 3688248

Ireland+353 (91) 412 474

Italy+39 (800) 620 549

North America, Asia-Pacific,
Latin America

858.552.1100

technicalsupport@quidel.com

Canada437.266.1704 (main)
888.415.8764 (toll free)technicalsupport@quidel.com

China

0400 920 9366 or+86 21 3217 8300

chinatechnicalservice@quidel.com

4Main Menu Structure

Run Test

Install New
CODE CHIP

Recall Results

Set
Parameters*

DeleteResults** Supervisor CODE CHIP only

Patient
SampleQC
DeviceQC
Sample

Misc.
Test

Last
RecordQC
Results

Patient
Results

Misc.
Test
Results

Meter
Settings

Print All
Results• QC Sample Results• QC Device Results• Reagent Lots – QC
• Archive Last Test

• Characters User ID• Characters Pat. ID• Characters Aux. ID• Aux. ID Enable/Disable• Characters Misc. ID

Clock

Ranges

Test
Settings

Units• New User ID• Update User ID• Delete User ID• User ID List

UploadResults
to LISID
Settings

User
ID

Display
Settings

Comm
Settings• Language• Print Mode
• Auto Power-Off• Display Contrast• Printer Contrast

5• Baud Rate
• Pat. Result Approval• LIS Enable/Disable• Auto Upload

QC
Parameters

Bypass• QC Device Freq.
• QC Sample Freq.
• Number of Controls• Num Quant Std Devs

RestoreFactory
Defaults

Labels and Symbols
Label/Symbol

Description
Manufacturer
In vitro diagnostic medical device
Consult instructions for use
Authorized representative in the European Community
Temperature limit
Humidity limitation
Waste electrical and electronic equipment (WEEE)
Serial Number
Catalogue Number
CautionImportant

6

CE mark of conformity

Batch code

Date of manufacture

Use-by date

ImporterUpper limit oftemperature

Do not re-use

China RoHS

Patient number

CONTROL
Test device

ControlCalibration Verification

Prescription use only in the
United States

Expected values

Biological risks

Device for near patient testing

Device not for self testing

Transfer pipette

MeanStandard deviation

CODE CHIP™ module

Printer Paper

Peel open here

Add sample here

Use EDTA plasma
sample only

Use urine sample only

Use EDTA whole blood orplasma sample only

Add sample immediately
after opening foil pouch

Thaw

7

Warnings, Precautions and Limitations• For in-vitro diagnostic use• For professional and near patient testing• For use by healthcare professionals.
• The Quidel Triage MeterPro must be used within the operating temperature range required by the specifictest device product being used. Refer to the test device package insert for details.
• Operate the Quidel Triage MeterPro on a level, dry surface away from direct sunlight.
• The QC Device is light-sensitive and should be stored in its black opaque case when not in use.
• Do NOT write or place a label anywhere on the QC device, as it may interfere with the device functionality.
• Do not move the Quidel Triage MeterPro while a test is in progress.
• Ensure all sample fluids have absorbed into the test device prior to running the test to prevent internal
contamination of the meter.
• Use only the AC / DC power adapter provided with the Quidel Triage MeterPro. An identifying tag has beenplaced on the cord for quick identification.
• Do not drop Quidel Triage MeterPro.
• Do not place objects on the Quidel Triage MeterPro.
• Do not immerse the Quidel Triage MeterPro in water or any liquids.

8

Introduction
How to Use This Guide
This manual contains:• Instructions for the operation and maintenance of the Quidel Triage MeterPro, and;• Basic instructions for testing samples
NOTE: To run specific tests, such as the Quidel Triage Cardiac Panel, you also will need detailed information
contained in the product-specific Package Insert, included in the test kit.
The Quidel Triage MeterPro software has been designed to provide the user step by step instructions. The meter
displays test results and menu options in the upper half of the meter screen. In smaller letters at the bottom ofeach screen, the meter displays instructions pertaining to the task being performed.
8:23AM 01•20•18

RUN TESTRECALL RESULTS
INSTALL NEW CODE CHIP
SELECT WITH v OR ^ AND PRESS ENTERPRESS EXIT TO EJECT DEVICEThe Quidel Triage MeterPro User Manual is divided into six sections.
Section 1 – General Information: Contact information, Menu Structure for the Quidel Triage MeterPro,
Symbols, Warnings and Precautions
Section 2 – Introduction: Provides an overview of the Quidel Triage MeterPro.
Section 3 – Installation: Guides the user through first time setup.
Section 4 –	Operation: Guides the user through running tests, recalling results and deleting results.
Section 5 – Service and Maintenance Procedures: Paper Replacement, Cleaning, Batteries,
Total Quality Assurance, and Warranty.
Section 6 –	Appendix: Specifications, Troubleshooting, Return and Disposal, Glossary, Sample Log Sheets

Description
What is the Quidel Triage MeterPro?
The Quidel Triage MeterPro is a portable fluorescence instrument used to measure the results of tests
manufactured by Quidel Cardiovascular Inc. The Quidel Triage MeterPro can be used in a laboratory
or in a point-of-care setting.
Test Principle
The Quidel Triage MeterPro uses a laser as a light source. Light from the laser hits a test device thathas been inserted in the meter. This causes the fluorescent dye in the test device to give off energy.
The more energy the fluorescent dye gives off, the stronger the signal.
9

Triage Test Device. A test device holds the
sample and also contains the reagents andother materials needed for the test.

Overview: Running a Test
After a test sample (for example, blood) from a patient is added to the test device, the test device is inserted in the
Quidel Triage MeterPro. The meter measures how much of the substance (a particular protein marker) is present,
based on standards that have been pre-programmed into the meter. The patient identification, the User I.D. andthe test results can be printed out on a paper tape.

Mete
rPro

Mete
rPro

In addition to testing samples from patients, the Quidel Triage MeterPro contains pre-programmed Quality Control(QC) functions that allow the person operating the meter to monitor quality control.
NOTE: The Quidel Triage MeterPro accepts test devices that are designed specifically for use with the Quidel Triage MeterPro.
Please refer to product-specific Package Inserts included in each test kit for more information.
Unpacking
The Quidel Triage MeterPro and the items that come with it are provided in a single box. Quidel Triage test devices
are packaged separately and include instructions for running specific tests. If you have any questions, contact
Quidel support(refer to the Assistance section).

10

Contents• Quidel Triage MeterPro• QC Device and CODE CHIP module (in the QC Device box)
• AC / DC Power Converter• 4 AA Batteries• 4 Rolls of Printer Paper (additional rolls are supplied in each box of test devices)• Supervisor CODE CHIP module and CODE CHIP module Box
Materials Required But Not Provided• Quidel Triage Test Device

Printer paper
located below
QC Device box.

Mete
rPro

11

Parts of the Quidel Triage MeterPro
Thermal PrinterLCD (liquid crustal display)
Printer Cover

Backlight
DeletePower Button

Test Device Insertion Port

Battery Cover

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Printer CoverPower Supply Port

Serial PortCUS

CODE CHIP Module Port

12

On/Off Key(Power button)

Used to turn the Quidel Triage MeterPro on and off.

Print Key

Used to print the test results or display screen.

Delete Key

Used to delete data.

Enter Key

Allows the operator to select menu items and acknowledge alert conditions.

Exit Key

Used to exit the displayed menu or eject the test device.

Brightness Key

KeypadUsed to set screen brightness

Used to enter identification numbers, letters, and special symbols.
Up
Down

Arrow Keys
Left
Right
Shift Key

Symbol Key

Thermal Printer

Data Port

Paper Feed Key
CODE CHIP
Module Port
Power Supply Port

Used with Shift Key

Prints the test result on paper.
Connection point for the (optional) Bar Code Scanner, allowing the operator to scan patientor user identification data instead of manually entering numbers or letters on the keypad. May
also be used to connect to a data management system/LIS.
Used to feed paper
Insertion point for CODE CHIP modules which contain lot / device specific data for use inproviding test results.
Connection point for the supplied AC / DC Power Converter.

Printer CoverThe cover, which when pulled straight up, reveals the paper roll.

LCD Screen

The LCD (Liquid Crystal Display) Screen shows the menu of possible tests and tasks andprompts the operator to take the next step.

Screen commands and options are indicated by a BOLDED FONT.

13

Installation
		 Unpack Meter

NOTE: The Low Power
Indicator monitors theactive power source.
To verify adequate
batter power:• Navigate to theMain Menu• Remove the AC
power supply• Press the EXIT key(the meter attempts
to eject the device)• Observe the Main Menu
on the meter’s display.
• Replace the batteries if
the power icon is visible.

a. Remove the meter from the box and protective plastic bag.

		Power Meter On

		 Batteriesa.

Turn the meter over.

b.

Remove battery cover.

c.

Install 4 AA batteries, paying attention to battery orientationin the battery compartment.

CUS

d. Replace battery cover and turn meter right side up.
e. Power the meter on by pressing the

key. Press thekey

to run self-test. When the test is completed, the screen meter display
will come to rest at the main menu.
8:23AM 01•20•18
Low Power
Indicator

RUN TESTRECALL RESULTS
INSTALL NEW CODE CHIP

Time and date
Menu items

User Instructions

SELECT WITH v OR ^ AND PRESS ENTERPRESS EXIT TO EJECT DEVICEThe Main Menu

AC Power Supply
Remove the power supply from the box.

b.

Plug one end into an AC outlet.

c.

Plug the opposite end into the round

Me
terP
ro

a.

hole in the back of the meter.

14Install Paper
a. Remove the printer cover by pulling up on the cover as indicated by the arrow on
the back of the cover.

For more details about
Installing Paper see theCare and Maintenancesection.

Me
terP
ro

b.
Tear or cut a clean, straight edge to feed into the printer. Do not cut paper at anangle, as the printer must sense the edge of the paper along the feed path.

NOTE: The printercontains a paper sensor
and will feed the newpaper roll only whenpaper with a cleanstraight line is pressed
into the paper roller.

c. Position the paper such that the paper will feed from under the roll (as opposed toover the top of the roll, see picture).

Me
terP
ro

d. Insert the paper edge under the paper roller (platen) until it firmly
seats or resistance is felt.
e. Press the

key twice, paper will feed through the printer andextend out the meter.
f. Place the roll of paper into the paper compartment.
g. Replace the printer cover and continue operation.

15

Insert Supervisor CODE CHIP Modulea.

Remove the Supervisor CODE CHIP module Box from the meter box.

b.

Remove the Supervisor CODE CHIP module from its box.

c.

Insert the Supervisor CODE CHIP module into the CODE CHIP module Port.
The port is located on the left side of the meter, towards the bottom front corner.
Note the orientation of the CODE CHIP module in the drawing below.

d.

Once the Supervisor CODE CHIP module is installed, verify that two additional
menu items appear on the display screen.

8:23AM 01•20•18

Two additional menu
options accessible whenSupervisor CODE CHIP
module is inserted.

RUN TESTRECALL RESULTS
INSTALL NEW CODE CHIPSET PARAMETERS
DELETE RESULTS
SELECT WITH v OR ^ AND PRESS ENTERPRESS EXIT TO EJECT DEVICEThe Supervisor’s Main Menu

CODE CHIP Module

CODE CHIP Module Port16

For more details, see
CODE CHIP Modules(page 43).

To Change Meter Settingsa. Select SET PARAMETERS using thekeys and press the

key.

b. Select METER SETTINGS using thekeys and press the

key.

c. Select ID SETTINGS, DISPLAY SETTINGS or COMM SETTINGS using thekeys and press the

key.

d. Select the desired setting using thesetting by using the

ID Settings
Characters User ID
Characters Pat. ID
Characters Aux ID
Characters Misc ID
Aux. ID Enable/Disable

keys and change the value of the

keys.

Default

Options

Min 1

1-16

Max 16

1-16

Min 1

1-20

Max 20

1-20

Min 1

1-12

Max 12

1-12

Min 1

1-20

Max 201-20

Disabled

Disabled, Enabled

New Settings

For reference, record your settings in the space provided.

e. Press the

ID Settings

key to save changes to ID Settings.

Default

Options

Language

EnglishEnglish, French, Italian,
German, Spanish,Portuguese, Greek,
Danish, Swedish,Japanese, Chinese,
RussianPrint Mode

Automatic

Automatic, Manual

Auto Power-Off

2 hour

1/2 hour, 1 hour, 2 hour,
4 hour, None

Display Contrast

4

0-8(8 = Heaviest contrast)

Printer Contrast4

0–8(8 = heaviest contrast)

New Settings

For reference, record your settings in the space provided.

17

f. Press

to save changes to Display Settings.

COMM Settings

Default

Options

Baud Rate

38400

9600, 38400

Pat. Result Approval

Disabled

Enabled, Disabled

LIS Enable/Disable

Disabled

Disabled, Enabled

Auto Upload

Disabled

Disabled, Enabled

New Settings

LIS Password

g. Press the

key to save changes to Communication Settings.

h. Press the

key to save changes to Meter Settings.

18

For more details about
Communications, including
entry of a Quidel provided,
meter specific password,
see Communication Settings(page 30).

		

Change Clocka. Select SET PARAMETERS using theb. Select CLOCK using thekeys and press thekeys and press thec. Select the HOUR : MINUTE area using the

key.

key.

keys. Type in the correcttime using the number keys.
d. Press the

key to move to AM or PM.

e. Select AM or PM using thef. Press thekeys.

key to move to TIME FORMAT.

g. Select AM/PM or 24 HR. using thekeys. If selecting 24 HR.,

the previously entered HOUR : MINUTE will change to a 24-hour format andthe AM or PM will disappear.
h. Press the

key to move to the DATE.

i. Type in the 6-digit date according to the DATE FORMAT below it.
j. Press the

key to move to the DATE FORMAT.

k. Select MM-DD-YY, DD-MM-YY or YY-MM-DD using thekeys.

The previously entered DATE changes as the DATE FORMAT changes.
l. Press the

key to save changes.

Setting

Default

Options

TIME FORMAT

AM / PMAM / PM; 24HR.

DATE FORMAT

MM-DD-YY

MM-DD-YY,
DD.MM.YY,YY-MM-DD

New Settings

		

Set User ID

		The Quidel Triage MeterPro normally requires a User ID to be entered prior to runninga patient test, QC test, or Misc test, and prior to recalling patient results. Refer to page
34 for instructions. Alternately, this feature may be bypassed. See page 21.

19

		

Change Reference Ranges/Thresholds for Tests
a. Select SET PARAMETERS using theb. Select RANGES using thekeys and press thekeys and press thec. Select the test panel type using the

key.

key.
NOTE: Thisfeature may not
be available for sometest panels. Refer tothe appropriate
Product Insert for
specific information.

keys.

d. Select the analyte and level using thekeys. Type in the newvalue for the HIGH or LOW cutoff as appropriate.
e. Press the		

key to save changes.

Change Test Settingsa. Select SET PARAMETERS using thekeys and press theb. Select TEST SETTINGS using thekeys and press thec. Select the test panel type using thekeys.

d. Select the analyte using the

key.
key.

f. Press the

For more details, see Test
Settings section (page 38).

keys.

e. Select the test setting (ACTIV, INACT, USR A, or USR I) using the		For more details about
Ranges Settings, see
Ranges (page 37).

keys.

key to save changes.

NOTE: The ability tochange test settings
may be disabled for sometests in specific panels.
Refer to the appropriate
Product Insert for specificinformation.

Change QC Parameters
a. Select SET PARAMETERS using thekeys and press

b. Select QC PARAMETERS using thekeys and press

c. Select the desired setting using thekeys and change

the value to the right of the setting by using the

.

keys.

Setting

Default

Options

QC Device Freq.

Daily

None, 8HR, Daily,
Weekly, Monthly

QC Sample Freq.

Monthly

None, 8HR, Daily,
Weekly, Monthly

Number Of Controls

2

1 or 2

Num Quant Std Devs

3

2 or 3d. Press the.

New Settings

key to save changes to QC PARAMETERS.

20

For more details about QC
Parameters Settings, see
QC Parameters (page 40).

For more details, see
Bypass User ID section(page 41).

Change Bypass Settingsa. Select SET PARAMETERS using theb. Select BYPASS using theNOTE: If the
bypass is ON, theuser ID feature is disabled
and anyone may run atest. If the bypass is OFF,the user ID feature is
active and only authorizedusers may run a test. To
Install User ID’s, see New
User ID section (page 34).

keys and press thekeys and press thec. For USER ID select ON or OFF using thed. Press the

key.

key.

keys.

key to save changes to the Bypass setting.

Prior to commencing patient testing, remove the Supervisor CODE CHIP module fromthe meter, return it to the storage box and place in a safe place for future use.

The meter is now ready to run QC Tests in preparation for Patient Testing.

QC Testing should be performed in the following manner:
1.		

Run QC DEVICE (see QC Device section (page 46).

2.		

Run QC SAMPLE for each lot of devices (see QC Sample section (page 48).

3.		

If appropriate, run CALIBRATION VERIFICATION SET as a Misc Test sample for eachtest panel type to be used. (Refer to the applicable Procedure Manual and Calibration
Verification Set Package Insert for detailed instructions).

Location
The Quidel Triage MeterPro should be placed on a dry, clean, flat, horizontal surface awayfrom direct sunlight.

Power
The Quidel Triage MeterPro requires 6-volts DC supplied by either AC or DC. The meter
NOTE: The Quidel
Triage MeterProwill automatically turn off ifleft unused for 2 hours,
unless programmed
otherwise by thesupervisor. Optionalsettings allow automatedturnoff after 30 minutes,
1 hour, 2 hours, 4 hours or
NONE.

will run approximately 100 tests on batteries. It is recommended to use batteries as a
backup in the event of a power outage.

C
 AUTION: Use only the power supply provided with the meter, failure to do so
may cause permanent damage to the meter.

21

Self-Test
The Quidel Triage MeterPro checks the system to be sure it is operating properly by running self-tests when poweredon and prior to each test.
• Power On – includes laser operation, internal standard range, battery power, and software verification.
• Each Test – verifies the laser operation, internal standard range and battery power.

CODE CHIP Modules
Meter data is updated via a disposable CODE CHIP module. The CODE CHIP module contains microchip circuitry
embedded into a plastic housing. When inserted into the meter CODE CHIP module port and activated, theinformation is transferred into the Quidel Triage MeterPro’s memory. A CODE CHIP module typically needs to beinstalled only once and remains in the meter memory. A CODE CHIP module does not need to remain in the meter
while performing tests.
There are five types of CODE CHIP modules which can be distinguished by shape or color.

Standard CODE CHIP module•

Reagent Test CODE CHIP module – included in each box of test devices; contains calibration, expiration date andother data about the device lot. (Color varies by test type.)•

QC Sample CODE CHIP module – included in each box of QC Sample; contains expiration date and other data about
the QC Sample lot including acceptable range. (White.)•

QC Device CODE CHIP module – included in the black QC Device box (comes with the Quidel Triage MeterPro);
contains data about how the meter should read its matching QC Device. (Dark gray.)•

Supervisor Access CODE CHIP module – included with each Quidel Triage MeterPro; contains code to activate
Supervisor functions. (Light gray.)

Software Upgrade CODE CHIP Module•

Software Upgrade CODE CHIP module – provided when Quidel Triage MeterPro software upgrades areavailable; contains new software for the meter.

22Set Parameters
PurposeThe SET PARAMETERS function allows the supervisor to select a number of settings.
Access to these settings is controlled using the Supervisor CODE CHIP module.

List of Programmable Parameters
A supervisor can set the following parameters:

HeadingParameters

ID Settings

Number of Characters in User ID, Number of Characters in Patient ID,
Number of Characters in Auxiliary ID, Enable or Disable Auxiliary ID,
Number of Characters in Misc Test ID

Display Settings

Language, Printer Mode, Auto Power-Off, Display Contrast, Printer Contrast

Communications

Baud Rate, Enable or Disable LIS, Enable or Disable Auto Upload,
Enable or Disable Patient Result Approval

ClockTime, Date, and Display Format

User ID

Add New User ID, Update User ID, Delete User ID or User ID List

RangesTest Cutoffs

Test Settings

Block Analytes

Units

Units of measure for each analyte are displayed

QC Parameters

Minimum Frequency for QC Tests, Number of Controls,
Number of Standard Deviations (Quantitative Tests)

BypassDisable User ID requirement

Restore Factory Defaults

Restores instrument to factory setting and erases all data and results.

Supervisor Access
A Supervisor CODE CHIP module is shipped with each meter. Installing the CODE CHIP module
gives the supervisor access to the SET PARAMETERS and DELETE RESULTS function.
To insert the Supervisor CODE CHIP module into the Quidel Triage MeterPro, slide the chiplabeled “SPR” into the meter’s CODE CHIP module port as shown in the picture.

CODE CHIP-Module

CODE CHIP Module Port23

How to Set Parameters: Basic Instructions
All instructions assume:• The meter is on.
• The meter screen is displaying the main menu.
• The Supervisor CODE CHIP module is installed.
• If a feature is not available for a test, no selection may be made.
1. Select SET PARAMETERS using the
2. Press the

NOTE: To savechanges, press the
ENTER key. To cancel
changes, press the EXIT
key. When either the
ENTER or the EXIT keys
are pressed, the meter
performs the appropriate
function and returns to theprevious menu.

keys.

key.

3. You will see a list of programmable parameters.

METER SETTINGS
CLOCK
USER ID
RANGESTEST SETTINGSUNITSQC PARAMETERS
BYPASSRESTORE FACTORY DEFAULTS
SELECT WITH v OR ^ AND PRESS ENTER
OR PRESS EXITThe Set Parameters Menu
4. Use thekeys to select the parameter you want to program:

METER SETTINGS, CLOCK, USER ID, RANGES, TEST SETTINGS, UNITS,
QC PARAMETERS, BYPASS or RESTORE FACTORY DEFAULTS.
5. Press thekey.

6. Follow the directions for setting the selected parameter (see the next section).
Main Menu

Meter Settings
This menu will allow you to set basic operational criteria for the meter: language,
display contrast, maximum length of the user, patient, auxiliary and misc. ID’s,
printer mode and automatic power off.

Set Parameters
Meter Settings
ID Settings

ID Settings
Characters User ID

Main Menu

This setting will set the minimum and maximum number of characters in

Set Parameters

the User ID.

Meter Settings

1. From a list of programmable parameters, choose INSTRUMENT SETTINGS using
the

keys.

2. Press the

key.

24

ID Settings

keys to select ID SETTINGS.

3. Use the4. Press thekey.
keys to select the number to the right of CHARACTERS USER ID

5. Use theunder the MIN column..
6. Use thekeys to choose the smallest number of characters that willappear in the User ID. The minimum number of characters possible is 1.
7. Use thekey to select the number to the right of CHARACTERS USER ID under

the MAX column.
8. Use thekeys to choose the largest number of characters that will appear

in the User ID. The maximum number of characters possible is 16.
9. Press the

key to save changes.

Characters Pat. ID
This setting will set the minimum and maximum number of characters in the Patient ID.
1. From a list of programmable parameters, choose INSTRUMENT SETTINGS using
the

keys.

2. Press thekey.
keys to select ID SETTINGS.

3. Use the4. Press thekey.
keys to select the number to the right of CHARACTERS PAT. ID

5. Use theunder the MIN column.
6. Use thekeys to choose the smallest number of characters that willappear in the Patient ID. The minimum number of characters possible is 1.
7. Use thekey to select the number to the right of CHARACTERS PAT. ID under

the MAX column.
8. Use thekeys to choose the largest number of characters that will appear

in the Patient ID. The maximum number of characters possible is 20.
9. Press the

key to save changes.

25Characters Aux. ID

Main Menu

This setting will set the minimum and maximum number of characters in the Aux ID.

Set Parameters

If the setting of AUX. ID ENABLE/DISABLE is ENABLED, an Auxiliary ID is mandatory

Meter Settingsfor each patient test.

ID Settings

1. From a list of programmable parameters, choose METER SETTINGS
using the2. Press the

keys.
key.
keys to select ID SETTINGS.

3. Use the4. Press thekey.
keys to select the number to the right of CHARACTERS AUX.

5. Use theID under the MIN column.
6. Use thekeys to choose the smallest number of characters that willappear in the Auxiliary ID. The minimum number of characters possible is 1.
7. Use thekey to select the number to the right of CHARACTERS AUX. ID

under the MAX column.
8. Use the

NOTE: The
Auxiliary ID isshown only on the New
Result display or printout.
It is not visible in recalled
results. Tracking may be
managed through theoptional software package,
Quidel Triage Census.

keys to choose the largest number of characters that will appear

in the Auxiliary ID. The maximum number of characters possible is 12.
9. Press the

key to save changes.

Aux. ID Enable/Disable

Main Menu

This setting will turn on or turn off the Auxiliary ID function. The Auxiliary ID
may be used for recording a test order number, physician ID or otherspecialized identifying information.

2. Press the
3. Use the4. Press the
5. Use the

keys.
key.
keys to select ID SETTINGS.
key.
keys to select the word to the rightof AUX. ID ENABLE/DISABLE.
6. Use thekeys to choose DISABLED or ENABLED. If DISABLED

is selected, the Auxiliary ID prompt screens will never appear. If ENABLED is
selected, an Auxiliary ID is mandatory for each patient test.
7. Press theMeter Settings
ID Settings

1. From a list of programmable parameters, choose METER SETTINGS
using theSet Parameters

key to save changes.

26

Main Menu
Set Parameters
Meter Settings
ID Settings

Characters Misc. ID
This setting will set the minimum and maximum number of characters in the Misc. Test ID.
1. From a list of programmable parameters, choose INSTRUMENT SETTINGS
using the2. Press the
3. Use the4. Press the
5. Use the

keys.
key.
keys to select ID SETTINGS.
key.
keys to select the number to the right of

CHARACTERS MISC. ID under the Min column.
6. Use thekeys to choose the smallest number of characters that willappear in the MISC. TEST ID. The minimum number of characters possible is 1.
7. Use thekey to select the number to the right of CHARACTERS MISC. ID

under the MAX column.
8. Use thekeys to choose the largest number of characters that will appear

in the MISC. TEST ID. The maximum number of characters possible is 20.
9. Press the

key to save changes.

Display Settings
Main Menu
Set Parameters
Meter Settings
Display Settings

LanguageThis setting will determine which language the meter displays and prints.
1. From a list of programmable parameters, choose METER SETTINGS
using the2. Press the
3. Use the4. Press the

keys.
key.
keys to select DISPLAY SETTINGS.
key.

5. Use thekeys to highlight the name to the right of LANGUAGE.

6. Use thekeys to change the language of the Quidel Triage MeterPro’s

screen and printouts.
7. Press the

key to save changes.

27Print Mode
This setting will determine if the meter prints automatically or only when requested.
1. From a list of programmable parameters, choose METER SETTINGS
using the2. Press the
3. Use the4. Press the

keys.
key.
keys to select DISPLAY SETTINGS.
key.

5. Use thekeys to select highlight the word to the right of PRINT MODE.

6. Use thekeys to choose AUTOMATIC or MANUAL. If AUTOMATIC isselected, the meter will immediately print out the results after each test (patient,
QC or Misc Test). If MANUAL is selected, the user must use thethe keypad to print out results.
7. Press the

key to save changes.

28

button on

Main Menu
Set Parameters
Meter Settings
Display Settings

Auto Power – OffThis setting will determine the length of time before an inactive meter will power off.
1. From a list of programmable parameters, choose METER SETTINGS
using the2. Press the
3. Use the4. Press the

keys.
key.
keys to select DISPLAY SETTINGS.
key.

5. Use thekeys to select the value to the right of Auto Power-Off.

6. Use thekeys to choose the desired timer setting for the meterto power itself off when not in use. The choices are: 1/2 HOUR, 1 HOUR,
NOTE: Whenpowered only bybatteries, select 1/2 hourto conserve battery life.
Certain screens, whendisplayed, will not
automatically power off.
The New Results screen
is an example.

2 HOURS, 4 HOURS or NONE. If NONE is selected, the meter must be
manually shut off using the ON/OFF key.
7. Press the

key to save changes.

Display Contrast
This setting will adjust the display contrast.
1. From a list of programmable parameters, choose METER SETTINGS
using the2. Press the
3. Use the4. Press the

keys.
key.
keys to select DISPLAY SETTINGS.
key.

5. Use thekeys to select the number to the right of Contrast.

6. Use thekeys to change the contrast of the meter’s screen.

The range is from 0 – 8 (8 being the greatest contrast).
7. Press the

key to save changes.

29

Main Menu
Set Parameters
Meter Settings
Display Settings

Display Contrast
This setting will adjust the display contrast.
1. From a list of programmable parameters, choose METER SETTINGS
using the2. Press the
3. Use the4. Press the

keys.
key.
keys to select DISPLAY SETTINGS.
key.

5. Use thekeys to select the number to the right of Contrast.

6. Use thekeys to change the contrast of the meter’s screen.

The range is from 0 – 8 (8 being the greatest contrast).
7. Press theMain Menu

key to save changes.

Communication Settings

Set Parameters

Prior to activating the LIS feature, obtain the meter’s serial number locatedMeter Settings

underneath the meter and contact Quidel support (Refer to the Assistance section).

Comm Settings

The Quidel Representative will provide you with a password that, when entered,will allow data to be transmitted.
Baud Rate
1. From a list of programmable parameters, choose METER SETTINGS
using the2. Press the
3. Use the4. Press the

keys.
key.
keys to select COMM SETTINGS.
key.

5. Use thekeys to select BAUD RATE.

6. Use thekeys to choose 9600 or 38400.

7. Press the

key.

30

Patient Result Approval

Main Menu

Some institutions may wish for patient test results to be verified by the user before printing

Set Parametersor sending to the LIS. Activation of this feature displays the result, then requires the user

Meter Settings

to accept or reject the result before the record is printed and saved. If the test is rejected,

Comm Settings

the meter will permanently flag it as rejected by the user.

1. From a list of programmable parameters, choose METER SETTINGS
using the2. Press the
3. Use the4. Press the

keys.
key.
keys to select COMM SETTINGS.
key.

5. Use thekeys to select PAT. RESULT APPROVAL.

6. Use thekeys to choose DISABLED or ENABLED.

7. Press thekey.

When enabled, after a patient result is available and displayed on the meter screen,
the user must accept or reject the result before printing, uploading or performing
any other meter functions.
The meter prompts the user to PRESS 1 TO ACCEPT OR 0 TO REJECT. Once the test
has been accepted or rejected, the meter operates normally.
If the test has been rejected, the display and printout will be flagged with PAT. RESULTREJECTED or RESULTS REJECTED BY USER. Recalled results will display an R before
the patient ID in the rejected record.

31

Main Menu
Set Parameters
Meter Settings
Comm Settings

LIS Enable
1. From a list of programmable parameters, choose METER SETTINGS
using the2. Press the
3. Use the4. Press the

keys.
key.
keys to select COMM SETTINGS.
key.

5. Use thekeys to select LIS.

6. Use thekeys to choose DISABLED or ENABLED.

7. Press thekey.

8. If DISABLED was selected, a screen showing a LIS DISABLED
will appear. Press thekey.

9. If ENABLED was selected, a screen showing a ENTER LIS PASSWORD
will appear. Enter the password provided by the Quidel Representative.
Press thekey.

10. Acknowledge the LIS ENABLED message by pressing the

key.

Auto Upload(This feature is visible after the LIS has been enabled)
1. From a list of programmable parameters, choose METER SETTINGS
using the2. Press the
3. Use the4. Press the

keys.
key.
keys to select COMM SETTINGS.
key.

5. Use thekeys to select AUTO UPLOAD.

6. Use thekeys to choose ENABLED or DISABLED.

7. Press the

key.

32

ClockMain Menu

The clock menu sets the time and date of the meter and the format for displaying both.

Set Parameters

If the meter has lost power, the time and date will blink on the Main Menu.

Clock

1. From the list of programmable parameters, choose CLOCK
using the2. Press the
3. Use the

keys.
key.
keys to select the HOUR : MINUTE area. Using the keypad,type in the correct time. The numbers you type will appear from the right andmove left as you continue to type.
4. Press

to move to AM or PM. If the 24 HR. format has been previously

selected, the AM or PM will not be visable and the TIME FORMAT will behighlighted. Proceed to step 7 below.
5. Select AM or PM using the6. Press
7. Use thekeys.

to move to TIME FORMAT.
keys to select AM/PM or 24 HR. If selecting 24 HR.,

the previously entered HOUR : MINUTE will change to a 24-hour format
and the AM or PM will disappear.
8. Press

to move to the DATE.

9. Using the keypad, type in the 6-digit date according to the DATE FORMAT below it.
10. Press
11. Use theto move to the DATE FORMAT.
keys to select MM-DD-YY, DD-MM-YY or YY-MM-DD.

The previously entered DATE changes as the DATE FORMAT changes.
12. Press

to save changes.

33

NOTE: If you
have selected
AM/PM, AM or PM
appears after the time,
as appropriate.

Main Menu
Set Parameters
User ID

User ID
Up to 600 User ID’s with 1 – 16 characters may be programmed into the meter. The User
ID may alternately be entered using the external Bar Code Scanner (optional).
An additional security feature of the User ID is the partial masking of the ID on displays
and printouts. This prevents unauthorized individuals from detecting and using an existing
User ID. When the Supervisor CODE CHIP module is installed in the meter, this feature isoverridden and all User ID characters are displayed.

New User ID
1. From the list of programmable parameters, choose USER ID
NOTE: User ID
9999999999(10-9’s) is a default setting
displayed when the User
ID Bypass is on or whena test is run with theSupervisor CODE CHIP
module installed.

using the2. Press the

keys.
key.

3. Select NEW USER ID using the
4. Press the

keys.

key.

5. Type in a User ID with a number of characters within MIN CHARACTERS USER ID
NOTE: If you
type in a User ID
that has already been
assigned, the message
on the screen states:
USER ### ALREADY
EXISTS. Press ENTER
to go back and type in adifferent ID

and MAX CHARACTERS USER ID. To correct, press
select the incorrect character by using the6. Press theto clear the entire ID, or

keys. Then type in the correct ID.

key.

7. On the next screen, use thekeys to select an expiration date to the rightof USER ID STATUS: 6 MONTHS, 12 MONTHS, VALID or EXPIRED.
8. Press the

key to save changes.

The Quidel Triage MeterPro recognizes 0’s as a unique character. Therefore, ‘4341’ will berecognized separately from ‘04341’.
Using the barcode scanner or alpha mode (shift key) will allow the Quidel Triage MeterPro toaccept alpha characters and the following symbols: # ( ) * - . / \34

Update User ID

Main Menu
Set Parameters
User ID

1. From the list of programmable parameters, choose USER ID
using the2. Press the

keys.
key.

3. Select UPDATE USER ID using the
4. Press the

keys.

key.

5. Type in the user ID you want to update. To correct, press

to clear theentire ID, or select the incorrect character by using the

keys.

Then type in the correct ID.
6. Press the

key.

NOTE: If you typein a User ID that
does not exist, themessage on the screen
states: USER ID ###DOES NOT EXIST. If thishappens, press ENTER toreturn to the previous
screen and correct the ID,
or press the EXIT key.

7. The user ID is displayed with the expiration date. You can change theexpiration date to 6 MONTHS, 12 MONTHS, EXPIRED or VALID by usingthe8. Press the

keys. VALID reconfirms the previously selected interval.
key to save changes.

Delete User ID
NOTE: If you typein a User ID that
does not exist, themessage on the screen
states: USER ID ###DOES NOT EXIST. If thishappens, press ENTER toreturn to the previous
screen and correct the ID,
or press the EXIT key.

1. From the list of programmable parameters, choose USER ID
using the2. Press the

keys.
key.

3. Select DELETE USER ID using the
4. Press the

keys.

key.

5. Type in the user ID to be deleted. To correct, press

to clear theentire ID, or select the incorrect character by using theThen type in the correct ID.
6. Press the

key. The message on the screen

states: USER ID ### WILL BE DELETED.
7. Press the

key to delete. A message on the screen tells youthat the ID has been deleted: USER ID ### DELETED.

35

keys.

Main Menu
Set Parameters
User ID

User ID List
1. From the list of programmable parameters, choose USER ID
using thekeys.

2. Press thekey.

3. Select USER ID LIST using the
4. Press the

keys.

key.

5. A list is displayed.
6. Use thekeys to select the type of ID list you want:

USER ID, FROM EXPIRATION DATE, TILL EXPIRATION DATE.
• For a list of all ID’s, select USER ID.
• For a single ID, select USER ID and type in the ID. To correct,
press

to clear the entire ID, or select the incorrect characterby using thekeys. Then type in the correct ID.

• For a range of ID’s, enter the FROM and/or the TO dates. The dates are enteredby typing the month number, the day number and the year number in the format
you have chosen. The numbers you type will appear from the right and move left
as you continue to type. To correct, press

to clear the entire date.

Then type in the correct date.
7. Press thekey.

8. To print the list you have chosen, press

36.

Ranges

Main Menu

Depending on the panel type, the range on the display and printout will be titled

Set Parameters

REFERENCE RANGES or THRESHOLDS. The low end, when the test displays
thresholds, is set to ‘0’ and is unchangeable.
Some analytes are designed for three distinct ranges. The meter distinguishes between
two range and three range analytes in the setup screen by differentiating the symbol
between the lower and upper values.
• Analytes with a dash – Two ranges. The normal range is any value between the two
numbers displayed. Depending on the product, the normal range may be inclusive or
exclusive of the upper number. Consult the product package insert or contact Quidel
for clarification. These values will be in reverse video on the patient results.
• Analytes with a comma – Three ranges possible. If the lower number is 0.0, themeter treats the analyte as having only two ranges. If the lower number is not 0.0,
the normal range is any value less than the lower number. The first abnormal range
is any value between the two numbers and is inclusive of these numbers. These
values will be boxed on patient results. The second abnormal range is any value
greater than the upper number. These values will be in reverse video on patientresults. Consult the product package insert or contact Quidel for clarification.
1. From the list of programmable parameters, choose RANGES
using the2. Press the

keys.
key.

3. Select the test panel type using the
4. Select the analyte and level using the

keys.
keys. The HIGH and LOW value

for each of the analytes can be changed using the keypad to type in the values.
To correct, press
5. Press theto clear the entire number. Then type in the correct number.

key to save changes.

37

NOTE: The field
will be disabled if
the panel setting is fixed.
Consult the specificpanel package insert todetermine if the setting
may be changed.

Sample SelectIn certain cases, the lab supervisor may wish to control the default sample type fordevices run on the meter. Sample Select allows the supervisor to choose BLOOD,
NOTE: TheSAMPLE TYPE
that is selected by thesupervisor will appear on
the result screen and will
also appear in the printed
results at the end of thetest being performed.

PLASMA, or SELECT options. If BLOOD or PLASMA are selected, then any device runon the meter for PATIENT SAMPLE or MISC will use the chosen sample type option
without prompting the user to make a selection with each test.
If SELECT is chosen, then each time a user runs a PATIENT SAMPLE or MISC test the user
will be prompted to select BLOOD or PLASMA prior to the test being executed by the meter.
This feature is available on software version 05.04.021 or greater, however this feature is notavailable for all tests. If this feature is not available for a test, no selection may be made.
1. From the list of programmable parameters, choose SAMPLE TYPE
using the2. Press the

keys.
key.

3. Select the test panel type using thekeys.

4. Navigate down to the SAMPLE TYPE parameter using thekeys

5. Select the SAMPLE TYPE option of BLOOD, PLASMA, or
SELECT using the6. Press thekeys.

key to save changes.

Units
NOTE: The UNIT
that is selected by
the supervisor will display,print and transmit theresults in the selected unitsof measure including past
results that were using a
different unit of measure.

In select regions, there are alternate units of measure that can be used for certain analytes.
This feature is available on software version 05.04.021 or greater, however this feature is notavailable for all tests. If this feature is not available for a test, no selection may be made.
1. From the list of programmable parameters,
choose UNITS using the
2. Press the

keys.

key.

3. Select the test panel type using the
4. Select the analyte using the

keys.
keys.

5. Select the desired units of measure using the6. Press the

key to save changes.

38

keys.

Test Settings

Main Menu

In certain cases, the lab supervisor may wish to control which tests are available
to be run at the time of patient testing. The options are:Set Parameters

1. ACTIVE (ACTIV ON SCREEN): The test is always run and cannot be deselected.
2. INACTIVE (INACT ON SCREEN): The test is never run and is not displayed.
3. USER INACTIVE (USR I ON SCREEN): The test can be selected by the user
at the time of running the test.
4. USER ACTIVE (USR A ON SCREEN): The test can be deselected by the user
at the time of running the test.
If these options are not available for a test, the meter skips over the setting as the supervisor
scrolls through the options. See Patient Sample section below for more details (page 50).
Test Settings

Main Menu

1. From the list of programmable parameters, choose TEST SETTINGS
using the2. Press the

Set Parameters

keys.
key.

3. Select the test panel type using the
4. Select the analyte using the
5. Select the desired mode using the

keys.
keys.
keys.

•

ACTIVE (ACTIV ON SCREEN) – The test will run on every patient specimen.

•

INACTIVE (INACT ON SCREEN) – The test will never run on a patient specimen
and is dropped from all displays and printouts.

•

USER INACTIVE (USR I ON SCREEN) – At the time of patient testing, the user
has the ability to select the test.

•

USER ACTIVE (USR A ON SCREEN) – At the time of patient testing, the user
has the ability to deselect the test.

6. Press the

NOTE: Whenthe analyte isdeselected, the value is
not calculated nor stored

key to save changes.

QC Tests With Test Settings Activated
Any test which the Supervisor has set to ACTIVE, USER ACTIVE or USER INACTIVE will run on the QC Sample
panel. The meter will display and print the test’s QC sample result and update the QC Sample timer for the test. If
the Supervisor has set the test to INACTIVE, the test will have the QC Sample turned OFF. The QC Sample result
won’t show for that test and the QC Sample timer won’t be updated for it.

If the Supervisor changes the test from INACTIVE to ACTIVE, to USER ACTIVE or to USER INACTIVE that test
may be out of QC Sample date. As always for a test with an expired QC Sample, a passing QC Sample test willneed to run before a patient sample can report a result for that test.

39

Main Menu

QC Parameters

Set Parameters

The QC Parameters menu provides the user the options for determining what the

QC Parametersmaximum frequency is for running the QC Device and QC Sample, whether 1 or 2 levelsof control are required for the QC Sample, and whether the allowed QC Sample Range ofquantitative tests is 2 or 3 standard deviations.
QC Device Frequency
The QC DEVICE FREQUENCY setting determines the maximum interval between QC
Device tests that a user is allowed to run patient tests. When the interval has lapsed, allusers are locked out of the Run Test menu until a QC Device has been successfully run.
It is recommended that the QC Device be run daily when performing patient testing.
1. From the list of programmable parameters, choose QC PARAMETERS
using the2. Press the

keys.
key.

3. Use thekeys to select the information to the right of QC DEVICE FREQ.

4. Using thekeys, select one of these options: NONE, 8 HOURS, DAILY,WEEKLY, MONTHLY.
5. Press the

key to save changes.

QC Sample Frequency
The QC SAMPLE FREQUENCY setting determines the maximum interval between QC
Sample tests that a user is allowed to run patient tests on a particular device lot number.
When the interval has lapsed, all users are locked out of the RUN PATIENT TEST menu
until a QC Sample has been successfully run. To view when a particular device lot’s QC
Sample will expire, use the RECALL REAGENT LOTS – QC feature.
It is recommended that the QC Sample be run with every new shipment, new lot or monthly,
whichever is most frequent. The frequency can be programmed in the supervisor setting.
1. From the list of programmable parameters, choose QC PARAMETERS
using the2. Press the

keys.
key.

3. Use thekeys to select the information to the right of QC SAMPLE FREQ.

4. Using thekeys, select one of these options: NONE, 8 HOURS, DAILY,WEEKLY, MONTHLY.
5. Press the

key to save changes.

40Number of Controls

Main Menu

1. From the list of programmable parameters, choose
QC PARAMETERS using the
2. Press the
3. Use theSet Parameters

keys.

QC Parameters

key.
keys to select the information to the rightof Number of Controls.
4. Using the
5. Press thekeys, select one of these options: 1 or 2.
key to save changes.

Number of Control Standard Deviations for Quantitative Tests
1. From the list of programmable parameters, choose
QC PARAMETERS using the
2. Press the
3. Use the

keys.

key.
keys to select the information to the rightof NUM QUANT STD DEVS.
4. Using the
5. Press thekeys, select one of these options: 2 or 3.
key to save changes.

Bypass User ID
This function allows the supervisor to selectively bypass the requirement to entera user ID before performing any test.

Set Parameters

1. From the list of programmable parameters, choose BYPASS
using the2. Press the

5. Press the

Bypasskeys.
key.

3. Select USER ID using the
4. Use thekeys.

keys to select from two options: ON or OFF.
key.

Restore Factory Defaults
This function allows the supervisor to restore the meter to factory default settings. All results anddata will be deleted if this setting is selected. All settings will be reset to factory defaults. This
option should only be selected when the Supervisor desires to delete all data and results stored
on the meter. This feature is available on software version 05.04.021 or greater.
1. From the list of programmable parameters, choose RESTORE FACTORY DEFAULTS
using the2. Press the

keys.
key.

3. Select RESTORE FACTORY DEFAULTS using the
4. Press theMain Menu

key.

41

keys.

NOTE: If the
bypass is ON, theUser ID requirement isdisabled and therefore notrequired. When thebypass is OFF, the User ID
requirement operates asnormal and is required.

NOTE: If the
RESTOREFACTORY DEFAULTS
selection is chosen and theenter key pressed, allresults and data currently
stored on the meter will bedeleted permanently.

Install CODE CHIP
PurposeThe Quidel Triage MeterPro will prompt the user to install a CODE CHIP module whenrequired. However, the INSTALL CODE CHIP function may be used as an alternate method
to transfer information from a CODE CHIP module into the meter’s memory. The meter will
direct the user to install a CODE CHIP module if it is attempting to run a test and does nothave the data in its memory.

Types of CODE CHIP modules
There are five types of CODE CHIP modules.
•

Reagent CODE CHIP module – included in eachbox of test devices. Lot number begins with a W.

•

QC Sample CODE CHIP module – included in eachbox of controls. Lot number begins with a C.

•

QC Device CODE CHIP module – included in the black
QC Device box (comes with the Quidel Triage MeterPro)
and is labeled with the serial number of the QC Device.

•

Supervisor Access CODE CHIP module – included witheach Quidel Triage MeterPro. Lot Number begins with SPR.

•

Software Upgrade CODE CHIP module –sent separately when Quidel Triage MeterProsoftware upgrades are available.

Software Version Number

C AUTION: Running tests with the Supervisor CODE CHIP module
installed disables all QC Lockouts. Remove the Supervisor CODE CHIP
module prior to running tests.

42

Installation of Reagent, QC Sample or QC Device CODE CHIP Modules
Install CODE CHIP
1. From the Main Menu select INSTALL CODE CHIP using the
2. Press the

keys.

key.

3. Slide the CODE CHIP module into the CODE CHIP module Port in the
Quidel Triage MeterPro, as shown in the picture.

CODE CHIP Module

CODE CHIP Module Port

4. Press thekey.

5. The meter will display a confirmation message that the information was installed
into the Quidel Triage MeterPro’s memory.
6. Pressto return to acknowledge the message.

7. Remove the CODE CHIP module from the CODE CHIP module Port.
8. Place the CODE CHIP module back into its original container for storage.
Installation of Supervisor CODE CHIP module
The Supervisor CODE CHIP module needs only to be inserted into the CODE CHIP
module Port to activate the supervisor functions. This is an automatic function andstandard CODE CHIP module installation is not necessary.

43

Main Menu

Operation
Access to the Quidel Triage MeterPro
Function
Run Test

Use

Restricted toPatient Testing

Operators with valid User ID's*

Quality Control Testing

Operators with valid User ID's*

Misc. Test Testing

Operators with valid User ID's*

Last Record

If last test run is a patient sample:
Operators with valid User ID’s*
Otherwise: No restriction

Recall Results

Install Code Chips

Set Parameters
Delete Results

Patient Test Results

Operators with valid User ID's*

Quality Control Results

No Restriction

Misc. Test Results

No Restriction

Types of CODE CHIP modules

If CODE CHIP module is software upgrade:
Supervisor

Installation Procedure

Otherwise: No restriction

Access Control

Supervisor

Programmable Settings

Supervisor

Patient Test Results

Supervisor* Unless User ID is bypassed or the Supervisor CODE CHIP module is installed.

NOTE: Access tovarious parts ofthe software is user
(institution) defined.

IMPORTANT: The last two functions, SET PARAMETERS, and DELETE RESULTS,
appear on the main menu only when the Supervisor CODE CHIP module is inserted
into the CODE CHIP module Port. The Supervisor CODE CHIP module should be
removed from the meter during routine patient, quality control, and Misc. testing.

44

Run Test
PurposeRun Test is used for the analysis of a test.

Options
The Run test function allows you to test:• QC Device• QC Sample• Patient Sample• Misc. Test Sample
In order to run a patient sample, the meter requires:
1. A valid User ID has been entered (unless this feature is bypassed or a Supervisor
CODE CHIP module is installed). See User ID section (page 34).
2. A QC Device has passed within the specified time period. See QC Device section(page 46).
3. A QC Sample for the test device lot has passed within the specified time period.
See QC Sample section (page 48).
If any of these conditions do not exist, the meter will not continue and will prompt the user
to perform the required steps.
IMPORTANT: The Quidel Triage MeterPro will alert the user if QC has not been

NOTE: The
Supervisor CODE
CHIP module provides
access to functions that
may override these
Lockouts.

performed for the device lot being tested.

NOTE: If the
Quidel Triage
MeterPro’s internal quality
control (QC) results areunacceptable, exclamation
points (!) will be displayedon the screen in the placeof the patient results. To
obtain results repeat thetest using a new device.

45

Main Menu
Run Test

QC Device
The QC Device should be run on each day of patient testing.
To run the QC Device test:
1. Press the

key to power the Quidel Triage MeterPro on.

2. Select RUN TEST using thekeys.
8:23AM 01•20•18

RUN TESTRECALL RESULTS
INSTALL NEW CODE CHIP
SELECT WITH v OR ^ AND PRESS ENTERPRESS EXIT TO EJECT DEVICEThe Main Menu

3. Press the
NOTE: If the User
ID bypass is on,
the meter will not ask you
to enter a User ID.

key.

4. Type in your identification (User ID). To correct, press the

key to clear

the entire ID, or select the incorrect character by using the

keys.

Then type in the correct ID.
5. Press thekey.

6. Select QC Device using thekeys.

PATIENT SAMPLE
QC DEVICEQC SAMPLE
MISC. TEST

EXP
EXP

“EXP” indicatesthat the QC
Device re-test
frequency has
expired.

SELECT WITH v OR ^ AND PRESS ENTERPRESS EXIT TO EJECT DEVICE

Menu screen as it looks when operator selects QC Device.

NOTE: The meter
will prompt theuser to install the QC
Device CODE CHIP
module if the QC Device
has not been run before.

7. Press thekey.

8. Gently insert the QC Device into the Quidel Triage MeterPro until you
feel the QC Device catch on the pin and hear an audible ‘click.’9. Press the

key.

46

10. The Quidel Triage MeterPro pulls in the QC Device and scans it. The test device
may partially move in and out of the meter several times.
11. When the test is complete, the meter will beep, eject the device anddisplay the results on the meter’s screen.
12. Press the

key to make a printed copy of the results.

13. Remove the QC Device from the Meter and place in the QC Device Box.
DO NOT DISCARD THE QC DEVICE.

IMPORTANT: Important instructions for all tests:a. Gently insert the test device into the Quidel Triage MeterPro until you
feel the device catch on the pin. You will hear an audible ‘click’ thattells you the test device has been inserted properly.
b. Press the

key to start the test.

c. The Quidel Triage MeterPro pulls in the test device and scans it.
d. When the test is complete, the meter will beep and display the
results on the meter’s screen.
e. Press the

key to make a printed copy of the results.

C AUTION: After the test device has been inserted, do not push the device in further
or attempt to pull it out. The device may be ejected by returning to the Main Menu andpressing the EXIT key.

IMPORTANT: Important Instructions for QC Device tests:• Dust, lint, fibers and other small particles may interfere with the QC Device.
Keep the QC Device free of contaminants.
• The QC Device is light-sensitive and should be stored in its black opaquecase when not in use.
• If the QC Device tests fail, wipe the QC Device clean with a lint free cloth toremove any oils, dust, fibers, or fingerprints. Do not apply any liquid to the
QC Device. After cleaning the device, repeat the QC Device test.
• If the QC Device test fails after you have cleaned the device, contact Quidel.

47

Main Menu
Run Test

QC Sample
To run the Quality Control sample:
1. Press the

key to power the Quidel Triage MeterPro on.

2. Select RUN TEST using thekeys.
8:23AM 01•20•18

RUN TESTRECALL RESULTS
INSTALL NEW CODE CHIP
SELECT WITH v OR ^ AND PRESS ENTERPRESS EXIT TO EJECT DEVICEThe Main Menu

3. Press thekey.

4. Type in your identification (User ID). To correct, press the
NOTE: If the User
ID bypass is ON,
the meter will not ask you
to enter a User ID.

the entire ID, or select the incorrect character by using theThen type in the correct ID.
5. Press thekey.

6. Select QC Sample using theNOTE: Only enter
the four-digit
numeric value of the QC
lot number. Do not enter
the preceding alphacharacter.

key to clear

keys.

PATIENT SAMPLE
QC DEVICEQC SAMPLE
MISC. TESTSELECT WITH v OR ^ AND PRESS ENTER
OR PRESS EXIT TO EJECT DEVICE

Menu screen as it looks when operator selects QC Sample.

7. Press thekey.

8. Enter the QC lot number from the label on the side of the bottle vial
containing the QC Sample.

48

keys.

9. To correct, press the

key to clear the entire number. Then type in thecorrect number.
10. Press thekey.

11. Perform the test according to the instructions provided in the package of test
devices you are using.

IMPORTANT: Important instructions for all tests:a. Gently insert the test device into the Quidel Triage MeterPro until you feel thedevice catch on the pin. You will hear an audible ‘click’ that tells you the test
device has been inserted properly.
b. Press the

key to start the test.

c. The Quidel Triage MeterPro pulls in the test device and scans it.
d. When the test is complete, the meter will beep and display the results on themeter’s screen.
e. Press the

key to make a printed copy of the results.

CAUTION: After the test device has been inserted, do not push the device infurther or attempt to pull it out. The device may be ejected by returning to theMain Menu and pressing EXIT.
12. Repeat steps for each quality control sample.

IMPORTANT: Important instructions for QC Sample Tests
a. If the test device’s internal quality control (QC) results are unacceptable, theresults for the affected analyte(s) will not appear on the screen (instead will be
flagged with a ! symbol).
b. If any of the QC Sample results are out of range, the results for that particularanalyte will be in reverse video (light text on a dark background).
c. A panel with multiple analytes will still be able to report patient results on thoseanalytes which passed QC. An analyte that failed QC will not be reported on
patient tests (instead will be flagged with a # symbol).
d. If an individual analyte is outside the specified range, the Quidel Triage MeterProallows the user to rerun only the failed analyte on the next QC Sample Test.
When all analytes have passed, the QC Sample timer is set to the date of thefirst passing analyte.

49

NOTE: If you enter
a QC lot number
for which there is no datain the Quidel Triage
MeterPro’s memory, youwill see a message on themeter’s screen: NO QC
Sample data in memory.
To correct this: Install the
QC Sample CODE CHIP
(see picture on page 42).
Press ENTER to continue.

Main Menu

Patient Sample

Run Test

1. Press the

key to power the Quidel Triage MeterPro on.

2. Select RUN TEST using thekeys.

8:23AM 01•20•18
NOTE: If theUser ID bypass
is ON, the meter will
not ask you to enter aUser ID.

RUN TESTRECALL RESULTS
INSTALL NEW CODE CHIP
SELECT WITH v OR ^ AND PRESS ENTERPRESS EXIT TO EJECT DEVICE

3. Press thekey.

4. Type or scan in your identification (User ID). To correct, press
the entire ID, or select the incorrect character by using theThen type in the correct ID.
5. Press thekey.

6. Select PATIENT SAMPLE using thekeys.

PATIENT SAMPLE
QC DEVICEQC SAMPLE
MISC. TESTSELECT WITH v OR ^ AND PRESS ENTER
OR PRESS EXIT TO EJECT DEVICE

7. Press the
NOTE: If the Bar
Code Scanner isbeing used, simply point
the scanner at the barcode, press the button on
the scanner handle andwait for the beep. The ID
will appear on the display

key.

8. Type or scan the patient’s identification (Patient ID). To correct,
press

to clear the entire ID, or select the incorrect character

using the9. Press the

keys. Then type in the correct ID.
key.

50

to clearkeys.

10. If the information is correct, press theinformation is incorrect:

key to confirm the Patient ID. If the

Run Test•

Select CORRECT PATIENT ID using the•Press thekey.

•

Press thekey to clear the entire ID, or select the incorrectcharacter using the•Press theMain Menu

keys.

keys. Then type in the correct ID.

key.

11. If the AUXILIARY ID feature is activated, type or scan in the ID.
To correct, press the

key to clear the entire ID, or select theincorrect character using the
12. Press the

keys. Then type in the correct ID.

key.

13. Prepare the test sample and perform the test in accordance with the instructions
provided in the package of test devices you are using.
14. If the testing facility has authorized the sample type to be selectable at the timeof running a patient test, the user will be prompted to select the desired sample
type. After the test device has been pulled into the meter, the meter will display amessage similar to the following:
SELECT SAMPLE TYPEBLOOD SAMPLE
PLASMA SAMPLESELECT WITH v OR ^ AND PRESS ENTER
OR PRESS EXIT

15. Sample selection type may not be available for all tests.
16. If the testing facility has authorized an analyte to be selected or deselected at thetime of running a patient test, the user will be prompted to select desired analytes
or deselect undesired analytes. After the test device has been pulled into the meter,
the meter will display a message similar to the following:
SELECT TESTSCARDIACCK-MB

2. MYO

3. TNIPRESS ^ TO PAUSE OR 0-9 FOR TESTPRESS ENTER TO CONTINUE OR EXIT

A check mark  indicates tests which are selected.
Example:  TNI		The absence of a check mark indicates which tests have not been selected.
Example: MYO
A number to the left of the test indicates tests which can be selected or deselected.
• E xample: 2 MYO indicates that MYO is currently not selected, but can beselected by pressing 2 on the numeric keypad to display 2  MYO.
• Example: 3  TNI indicates that TNI is currently selected, but can be deselectedby pressing 3 on the numeric keypad to display 3 TNI.
• Pressing the number again toggles the test between select and deselect.

51

NOTE: At least
one analyte must
be selected in order tocontinue testing.

		No number to the left of the test indicates tests which cannot be altered.

	Example  CKMB indicates that CKMB is always selected,
and cannot be deselected.

NOTE: If no key
is pressed on
the SELECT TESTS
screen, the meter waits
30 seconds thenproceeds using only theselected default tests.
Then, if no key ispressed on the
CONFIRMATIONSCREEN, the test
proceeds after waiting
30 seconds.

		•Press the

key.

		

•

If the information is correct, press the		•	If the information is incorrect, select CORRECT TEST using thekeys and press the

key to continue.

key to return to the lists of tests.

IMPORTANT: Important instructions for all tests:a. Gently insert the test device into the Quidel Triage Meter until you
feel the device catch on the pin. You will hear an audible ‘click’ thattells you the test device has been inserted properly.
b. Press the

key to start the test.

c. The Quidel Triage MeterPro pulls in the test device and scans it.
d. When the test is complete, the meter will beep and display the
results on the meter’s screen.
e. Press the

key to make a printed copy of the results.

CAUTION: After the test device has been inserted, do not push the device in further or attempt topull it out. The device may be ejected by returning to the Main Menu and pressing EXIT.

IMPORTANT: Important instructions for patient tests:a. If the test device’s Internal Quality Control (QC) results are unacceptable, theresults for the affected analyte(s) will not appear on the screen (instead will
be flagged with a ! symbol).
b. If any of the QC Sample results for the lot being tested were out of range,
the results for that particular analyte will not appear on the screen (instead
will be flagged with a # symbol).

PAT. ID 89547326
BNP

15 pg/mL

PAT. ID 89547326
BNP

650 pg/mL

PAT. RESULT ABNORMALPRESS 1 TO ACCEPT OR 0 TO REJECTPRESS 1 TO ACCEPT OR 0 TO REJECT

Screen displaying patients result
below the cut off level and accept
or reject instructions.

Screen displaying patients result above
the cut off levels.

52

Misc. Test Sample
Misc. Test Samples include any non-patient test sample or non-quality control testing. Misc. Test
Samples can include calibration verification materials, proficiency testing samples, and method
validation samples. The testing for these samples should be run on the Quidel Triage Test Devicein accordance to the instructions provided in the package of test devices you are using.
1. Press theMain Menu
Run Test

key to power the Quidel Triage MeterPro on.

2. Select RUN TEST using thekeys.

NOTE: If the User
ID bypass is ON,
the meter will not ask you
to enter a User ID.

8:23AM 01•20•18

RUN TESTRECALL RESULTS
INSTALL NEW CODE CHIP
SELECT WITH v OR ^ AND PRESS ENTERPRESS EXIT TO EJECT DEVICE

3. Press thekey.

4. Type or scan in your identification (User ID). To correct, press
the entire ID, or select the incorrect character by using theto clearkeys.

Then type in the correct ID.
5. Press thekey.

6. Select MISC. TEST using thekeys.

PATIENT SAMPLE
QC DEVICEQC SAMPLE
MISC TESTSELECT WITH v OR ^ AND PRESS ENTERPRESS EXIT TO EJECT DEVICE

7. Press thekey.

8. Type or scan the Misc. Test identification (Misc. Test ID). To correct, press
to clear the entire ID, or select the incorrect character using the

keys.

Then type in the correct ID.
9. Press thekey.

10. If the information is correct, press the

key to confirm the Misc. Test ID.

If the information is incorrect:• Select CORRECT MISC. TEST ID using thekeys.

• Press thekey.

• Press the

key to clear the entire ID, or select the incorrectcharacter using the• Press the

keys. Then type in the correct ID.

key.

53

NOTE: If the Bar
Code Scanner isbeing used, simply point
the scanner at the barcode, press the button on
the scanner handle andwait for the beep. The ID
will appear on the display.

Main Menu
Run Test

11. Prepare the test sample and perform the test in accordance to the instructions
provided in the package of test devices you are using.

IMPORTANT: Important instructions for all tests:a. Gently insert the test device into the Quidel Triage Meter until
you feel the device catch on the pin. You will hear an audible‘click’ that tells you the test device has been inserted properly.
b. Press the

key to start the test.

c. The Quidel Triage MeterPro pulls in the test device and scans it.
d. When the test is complete, the meter will beep and display the
results on the meter’s screen.
e. Press the

key to make a printed copy of the results.

CAUTION: After the test device has been inserted, do not push the device in further or attempt topull it out. The device may be ejected by returning to the Main Menu and pressing EXIT.

IMPORTANT: Important instructions for misc. tests:a. If the test device’s Internal Quality Control (QC) results are unacceptable,
the results for the affected analyte(s) will not appear on the screen(instead will be flagged with a ! symbol).

54

Recall Results
PurposeRecall Results is used to retrieve results stored in the Quidel Triage MeterPro’s memory.

Function
The Recall Results function can retrieve these results:• Last Record• QC Results• Patient Results		

–QC Sample Results		–

Patient ID		–QC Device Results		–Panel Type		

–Reagent Lots – QC

		–		Test Device Lot Number (L/N)		

–Archive Last Test		–User ID• Misc. Test Results		–

From Date• Print all Results		–Till Date		

–

Patient Results						–QC Sample Results

					

–

QC Device Results

					

–

Misc. Test Results

NOTE: If a result
was rejected by theuser, an “R” will appear
next to the recalled result.

• Upload Results to LIS		IMPORTANT: To safeguard the User ID Lockout, displayed and printed
User ID’s are partially masked. The Supervisor CODE CHIP module isrequired to be installed to view the full User ID.

Last Record
Main Menu	
Purpose: Last Record is used to retrieve the test results for the last test run.

Recall Results

To retrieve the last record:
1. Press the

key to power the Quidel Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using the
3. Press thekey.

4. Select LAST RECORD using the
5. Press the

keys.

keys.

key.

6. If the last test run is a patient result, type or scan in your identification (User ID). To
correct, presstheto clear the entire ID, or select the incorrect character by using
keys. Then type in the correct ID. Press thekey.

7. The results from the last test run appear on the screen.
8. Use the9. Press thekeys to view the entire record.
key to make a printed copy.

55

NOTE: If the User
ID bypass is ON,
the meter will not ask you
to enter a User ID

Main Menu
Recall Results

Patient Results
Options: Patient results can be retrieved based on a variety of criteria:• Patient ID• Test Device Lot Number (L/N)• User ID• From Date
• Till Date

Main Menu
Recall Results
Patient Results

Patient ID
To retrieve results based on the patient ID:
1. Press the

key to power the Quidel Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using the
3. Press thekey.

4. Select PATIENT RESULTS using the
5. Press the

keys.

keys.

key.

6. Type or scan in your identification (User ID). To correct, press

to clear

the entire ID, or select the incorrect character by using theNOTE: If the User
ID bypass is ON,
the meter will not ask you
to enter a User ID

keys.

Then type in the correct ID.
7. Press thekey.

8. Select PANEL TYPE using the
9. Use thekeys.

keys to select the desired panel.

10. Choose the results you want to see:•If you want to see all patient results, press the

key. All the patient results in

the Quidel Triage MeterPro’s memory for the selected panel will be displayed.
•

For individual patient results:
a. Select Patient ID using thekeys.

b. Type or scan in the patient ID. To correct, press the

key toclear the entire ID, or select the incorrect character by using
thekeys. Then type in the correct ID.

56

c. To select a patient ID with alpha characters, use thekey toenter alpha characters.
d. Press the

key. All results of the requested patient ID for the selected

panel will be displayed.
11. Use thekeys to view the entire record.

12. Press the

key to make a printed copy.

13. Press the

key to upload the selected results to LIS.

57

NOTE: You may
choose more than
one of the options forrecalling results in orderto define more precisely
the information you want
to recall from the Quidel
Triage MeterPro’s
memory. When you
choose multiple options,first input values in all thecategories you havechosen. Then press the
ENTER key.

Main Menu
Recall Results

Test Device Lot Number (L/N)
To retrieve results based on the lot number of the test devices used:

Patient Results

The lot number of the test device is foundon the device and on the outer box.

1. Press the

key to power the Quidel Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using the
3. Press thekey.

4. Select PATIENT RESULTS using the
5. Press the

keys.

keys.

key.

6. Type or scan in your identification (User ID). To correct, press

toclear the entire ID, or select the incorrect character by using
theNOTE: If the User
ID bypass is ON,
the meter will not ask you
to enter a User ID.

keys.
Then type in the correct ID.

7. Press thekey.

8. Select PANEL TYPE using the
9. Use thekeys.

keys to select the desired panel.

10. Select DEVICE L/N using thekeys.

11. To display all results for the selected panel, press thekey.

12. To display results specific to one lot, type in the lot number of thetest device. To correct, press the
NOTE: Only
enter the fivedigit numeric value ofthe lot number.

key to clear the entire number.

Then type in the correct number.
13. Press thekey.

14. All results from tests run on the requested lot number for theselected panel are displayed.
15. Use thekeys to view the entire record.

16. Press the

key to make a printed copy.

17. Press the

key to upload the selected results to LIS.

58

Main Menu

User ID

Recall Results

To retrieve results from tests run on the Quidel Triage MeterPro starting with

Patient Results

the user you select:
1. Press the

key to power the Quidel Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using the
3. Press thekey.

4. Select PATIENT RESULTS using the
5. Press the

keys.

keys.

key.

6. Type or scan in your identification (User ID). To correct, press

toclear the entire ID, or select the incorrect character by usingthe7. Press the

keys. Then type in the correct ID.
key.

8. Select PANEL TYPE using the
9. Use thekeys.

keys to select the desired panel.

10. Select USER ID using thekeys.

11. To display all results for the selected panel, press thekey.

12. To display results specific to one User ID, type in the User ID. To correct,
press

to clear the entire ID, or select the incorrect character byusing theNOTE: If the User
ID bypass is ON,
the meter will not ask you
to enter a User ID

13. Press the

keys. Then type in the correct ID.
key.

14. All results from tests run by the requested user for theselected panel are displayed.
15. Use thekeys to view the entire record.

16. Press the

key to make a printed copy.

17. Press the

key to upload the selected results to LIS.

59

From Date

Main Menu

To retrieve results from tests run on the Quidel Triage MeterPro starting with

Recall Results

a date you select:Patient Results

1. Press the

key to power the Quidel Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using the
3. Press thekey.

4. Select PATIENT RESULTS using the
5. Press the

keys.

keys.

key.

6. Type or scan in your identification (User ID). To correct, press
the entire ID, or select the incorrect character by using theto clearkeys.

Then type in the correct ID.
7. Press the

8. Select PANEL TYPE using the
9. Use the

NOTE: If the User
ID bypass is ON,
the meter will not ask you
to enter a User ID.

key.
keys.

keys to select the desired panel.

10. Select FROM DATE using thekeys.

11. To display all results for the selected panel, press thekey.

12. To display results specific to one date, type in the date. To correct, press
thekey to clear the entire number. Then type in the correct number.

13. Press thekey.

14. All results from tests run from the date selected for the selected panel are
displayed.
15. Use thekeys to view the entire record.

16. Press the

key to make a printed copy.

17. Press the

key to upload the selected results to LIS.

60

Main Menu

Till Date

Recall Results

To retrieve results from tests run on the Quidel Triage MeterPro before and including

Patient Results

a date you select:
1. Press the

key to power the Quidel Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using the
3. Press thekey.

4. Select PATIENT RESULTS using the
5. Press the

keys.

keys.

key.

6. Type or scan in your identification (User ID). To correct, press
the entire ID, or select the incorrect character by using theto clearkeys.

Then type in the correct ID.
NOTE: If the User
ID bypass is ON,
the meter will not ask you
to enter a User ID.

7. Press thekey.

8. Select PANEL TYPE using the
9. Use thekeys.

keys to select the desired panel.

10. Select TILL DATE using thekeys.

11. To display all results for the selected panel, press thekey.

12. To display results specific to one date, type in the date. To correct, press
thekey to clear the entire number. Then type in the correct number.

13. Press thekey.

14. All results from tests run from the date selected for the selected panel are
displayed.
15. Use thekeys to view the entire record.

16. Press the

key to make a printed copy.

17. Press the

key to upload the selected results to LIS.

61

QC Results

Main Menu	
Options: The results of these quality control (QC) tests can be retrieved

Recall Resultsfrom the Quidel Triage MeterPro’s memory:
Quality Control (QC test)

Results can be retrieved by:

QC Sample Results

Panel TypeQC Sample Lot Number (L/N)
Device Lot Number (L/N)
User ID
From Date
Till Date
View All (Default)

QC Device Results

User ID
From Date
Till Date
View All (Default)

Reagent Lots – QC

(Defaults to View All)To retrieve QC Results for the QC Sample and the QC Device,select the option desired and follow the directions.

62

NOTE: You may
choose more than
one of the options forrecalling results in order tomore precisely define theinformation you want torecall from the Quidel
Triage MeterPro’s memory.
When you choose multiple
options, first makeselections and input
values in all the categories
you have chosen. Thenpress the ENTER key.

Main Menu
Recall Results
QC Results

QC Sample Lot Number (L/N)
To retrieve results based on the lot number of the QC Sample used:
1. Press the

key to power the Quidel Triage MeterPro on.

QC Sample Results
2. From the MAIN MENU select RECALL RESULTS using the
3. Press thekey.

4. Select QC RESULTS using the
5. Press the

keys.

key.

6. Select QC SAMPLE RESULTS using the
7. Press thekey.

8. Select PANEL TYPE using the
9. Use the

keys.

keys.

keys to select the desired panel.

10. Select QC SAMPLE L/N using thekeys.

11. Type in the QC Sample lot number of the test device. To correct,
press
12. Press the
NOTE: To display
all results for theselected panel, leave the
QC Sample L/N blank.

to clear the entire number. Then type in the correct number.
key.

13. All results from test run on the requested QC Sample lot number
for the selected panel are displayed.
14. Use thekeys to view the entire record.

15. Press the

key to make a printed copy.

16. Press the

key to upload the selected results to LIS.

63

keys.

Main Menu
Recall Results

Device Lot Number (L/N)
To retrieve QC Sample results based on the lot number of the test devices used:

QC Results
QC Sample Results

The lot number of the test device is foundon the device and on the outer box.

1. Press the

key to power the Quidel Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using the
3. Press thekey.

4. Select QC RESULTS using the
5. Press the

keys.

key.

6. Select QC SAMPLE RESULTS using the
7. Press the

keys.

key.

8. Select PANEL TYPE using the
9. Use the

keys.

keys.

keys to select the desired panel.

10. Select DEVICE L/N using thekeys.

11. Type in the device lot number from the side of the box of test devices. To correct,
press the12. Press the

key to clear the entire number. Then type in the correct number.
key.

13. All QC results that have been run on the requested lot number for theselected panel are displayed.
14. Use thekeys to view the entire record.

15. Press the

key to make a printed copy.

16. Press the

key to upload the selected results to LIS.

64

Main Menu
Recall Results
QC Results
QC Sample Results

User ID
To retrieve QC results from tests run on the Quidel Triage MeterPro startingwith the user you select:
1. Press the

key to power the Quidel Triage MeterPro on.

QC Device Results
2. From the MAIN MENU select RECALL RESULTS using the
3. Press thekey.

4. Select QC RESULTS using the
5. Press the

keys.

keys.

key.

6. Select the appropriate menu, QC SAMPLE RESULTS or QC DEVICE RESULTS
using the7. Press the

keys.
key.

8. If QC SAMPLE RESULTS, select PANEL TYPE using the
9. Use thekeys to select the desired panel.

10. Select USER ID using the
11. Press the

keys.

keys.

key.

12. Type in the device lot number from the side of the box of test devices. To correct,
press the13. Press the

key to clear the entire number. Then type in the correct number.
key.

14. All QC Sample or QC Device results from tests run by the requested user,
for the selected panel if QC Sample, are displayed.
15. Use thekeys to view the entire record.

16. Press the

key to make a printed copy.

17. Press the

key to upload the selected results to LIS.

65

From Date

Main Menu

To retrieve QC results from tests run on the Quidel Triage MeterPro starting

Recall Resultswith a date you select:

QC Results

1. Press the

QC Sample Results

key to power the Quidel Triage MeterPro on.

QC Device Results
2. From the MAIN MENU select RECALL RESULTS using the
3. Press thekey.

4. Select QC RESULTS using the
5. Press the

keys.

keys.

key.

6. Select the appropriate menu, QC SAMPLE RESULTS or
QC DEVICE RESULTS using the
7. Press the

keys.

key.

8. If QC SAMPLE RESULTS, select PANEL TYPE using theUse thekeys to select the desired panel.

9. Select FROM DATE using the
10. Press the

keys.

key.

11. Type in the date. To correct, press the

key to clear the entire number.

Then type in the correct number.
12. Press thekey.

13. All results from tests run from the date selected, for the selected
panel if QC Sample, are displayed.
14. Use thekeys.

keys to view the entire record.

15. Press the

key to make a printed copy.

16. Press the

key to upload the selected results to LIS.

66

Main Menu
Recall Results
QC Results
QC Sample Results
QC Device Results

Till Date	To retrieve QC results from tests run on the Quidel Triage MeterPro before andincluding a date you select:
1. Press the

key to power the Quidel Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using the
3. Press thekey.

4. Select QC RESULTS using the
5. Press the

keys.

keys.

key.

6. Select the appropriate menu, QC SAMPLE RESULTS or
QC DEVICE RESULTS using the
7. Press the

keys.

key.

8. If QC SAMPLE RESULTS, select PANEL TYPE using theUse thekeys to select the desired panel.

9. Select TILL DATE using the
10. Press the

keys.

key.

11. Type in the date. To correct, press the

key to clear the entire number.

Then type in the correct number.
12. Press thekey.

13. All results from tests run from the date selected, for the selected
panel if QC Sample, are displayed.
14. Use thekeys.

keys to view the entire record.

15. Press the

key to make a printed copy.

16. Press the

key to upload the selected results to LIS.

67

Reagent Lots – QC

Main Menu

A list of Reagent CODE CHIP modules in memory, along with corresponding

Recall Results

expiration dates for a QC Sample can be recalled from memory.

QC Results

The list will contain: Lot Number, Panel Type, Expiration Date

Reagent Lots – QC

• If the QC expiration date has passed (expired), the date will be inreverse video (light text on a dark background).
• If the QC for the lot has failed, the word FAILED will appear in placeof an expiration date.
• If a CODE CHIP has been installed for a new lot, but QC has yet to be established,
the words NOT RUN will appear in place of the expiration date.
• If QC frequency is set to none, the reagent lot expiration date will be displayed.
REAGENT LOTS - QC
DLN
47067
48741

PANEL
CARDIACCARDIAC

EXP
12-16-17
09-04-18

48197

BNP

NOT RUN

47827

DRUG SCREEN

FAILEDPRESS PRINT OR PRESS ENTER
The Reagent Lots – QC Screen

Archive Last Test
This function will save detailed information regarding the last performed test for analysis
by Quidel. Use this function when requested by Quidel.
This function should be used when a very unusual test result is received and when thelaboratory wishes to have the meter evaluated further. ARCHIVE LAST TEST will only beable to save data from the most recent test run.

68

Archive Last Test

Main Menu
Recall Results

Misc. Test Results
Options: Misc. Test results can be retrieved based on a variety of criteria:• Misc. Test ID• Test Device Lot Number (L/N)• User ID• From Date
• Till Date

Main Menu
Recall Results
Misc Test Results

Misc. Test ID
To retrieve results based on the Misc. Test ID:
1. Press the

key to power the Quidel Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using the
3. Press thekey.

4. Select MISC. TEST RESULTS using the
5. Press the

keys.

key.

6. Select PANEL TYPE using the
7. Use the

keys.

keys.

keys to select the desired panel.

8. Choose the results you want to see:• If you want to see all Misc. Test results, press the
NOTE: You may
choose more than
one of the options forrecalling results in orderto define more precisely
the information you want
to recall from the Quidel
Triage MeterPro’s
memory. When you
choose multiple options,first input values in all thecategories you havechosen. Then press the
ENTER key.

key. All the Misc. Test resultsin the Quidel Triage MeterPro’s memory for the selected panel will be displayed.
• For individual Misc. Test results:		a. Select MISC. TEST ID using the

keys.

		

b. Type or scan in the Misc. Test ID. To correct, press the

key to clear

the entire ID, or select the incorrect character by using the

keys.

Then type in the correct ID.
		c. To select a Misc. Test ID with alpha characters, use thecharacters or use the		d. Press the

key to enter alpha

key in place of the alpha character.

key. All results of the requested Misc. Test ID for the selected

panel will be displayed.

69

		
9.

Use thekeys to view the entire record.

10. Press the

key to make a printed copy.

11. Press the

key to upload the selected results to LIS.

70

Main Menu
Recall Results

Test Device Lot Number (L/N)
To retrieve results based on the lot number of the test devices used:

Misc Test Results

The lot number of the test device is foundon the device and on the outer box.

1. Press the

key to power the Quidel Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using the
3. Press thekey.

4. Select MISC. TEST RESULTS using the
5. Press thekey.

6. Select PANEL TYPE using the
7. Use the

keys.

keys.

keys to select the desired panel.

8. Select DEVICE L/N using thekeys.

9. To display all results for the selected panel, press thekey.

10. To display results specific to one lot, type in the lot number of thetest device. To correct, press the
NOTE: Only enter
the five-digit
numeric value of the QC
lot number.

key to clear the entire number.

Then type in the correct number.
11. Press thekey.

12. All results from tests run on the requested lot number for theselected panel are displayed.
13. Use thekeys to view the entire record.

14. Press the

key to make a printed copy.

15. Press the

key to upload the selected results to LIS.

71

keys.

User ID

Main Menu

	To retrieve results from test run on the Quidel Triage MeterPro

Recall Results

starting with the user you select:
1. Press theMisc Test Results

key to power the Quidel Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using the
3. Press thekey.

4. Select MISC. TEST RESULTS using the
5. Press the

keys.

key.

6. Select PANEL TYPE using the
7. Use the

keys.

keys.

keys to select the desired panel.

8. Select USER ID using thekeys.

9. To display all results for the selected panel, press thekey.

10. To display results specific to one User ID, type in the User ID. To correct,
press

to clear the entire ID, or select the incorrect character byusing the11. Press the

keys. Then type in the correct ID.
key.

12. All results from tests run by the requested user for the selected panel are displayed.
13. Use thekeys to view the entire record.

14. Press the

key to make a printed copy.

15. Press the

key to upload the selected results to LIS.

72

Main Menu
Recall Results
Misc Test Results

From Date	To retrieve results from test run on the Quidel Triage MeterProstarting with the user you select:
1. Press the

key to power the Quidel Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using the
3. Press thekey.

4. Select MISC. TEST RESULTS using the
5. Press the

keys.

key.

6. Select PANEL TYPE using the
7. Use the

keys.

keys.

keys to select the desired panel.

8. Select FROM DATE using thekeys.

9. To display all results for the selected panel, press thekey.

10. To display results specific to one date, type in the date. To correct, press the
key to clear the entire number. Then type in the correct number.
11. Press thekey.

12. All results from tests run by the requested user for the selected panel are displayed.
13. Use thekeys to view the entire record.

14. Press the

key to make a printed copy.

15. Press the

key to upload the selected results to LIS.

73

Till Date

Main Menu

	To retrieve results from test run on the Quidel Triage MeterPro

Recall Results

before and including a date you select:
1. Press theMisc Test Results

key to power the Quidel Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using the
3. Press thekey.

4. Select MISC. TEST RESULTS using the
5. Press thekey.

6. Select PANEL TYPE using the
7. Use the

keys.

keys.

keys to select the desired panel.

8. Select TILL DATE using thekeys.

9. To display all results for the selected panel, press the
10. To display results specific to one date, type in the date.
To correct, press the

key to clear the entire number.

Then type in the correct number.
11. Press thekey.

12. All results from tests run before and including the date you
selected for the selected panel are displayed.
13. Use thekeys to view the entire record.

14. Press the

key to make a printed copy.

15. Press the

key to upload the selected results to LIS.

74

key.

keys.

Main Menu
Recall Results
Misc Test Results

Print All Results	
Options: All stored results can be printed from the Quidel Triage MeterPro’s memory.
• Patient Results• QC Sample Results• QC Device Results• Misc. Test Results

Main Menu
Recall Results
Print All Results

Patient Results
To print all Patient Results:
1. Press the

key to power the Quidel Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using the
3. Press thekey.

4. Select PRINT ALL RESULTS using the
5. Press the
NOTE: When printing large quantitiesof patient results, it is recommended to first insert afull roll of paper.

keys.

key.

6. Select PATIENT RESULTS using the
7. Press the

keys.

keys.

key.

8. Type or scan in your identification (User ID). To correct, press
entire ID, or select the incorrect character by using theto clear the
keys. Then typein the correct ID.
NOTE: If the User
ID bypass is ON,
the meter will not ask you
to enter a User ID.

9. Press the

key to make a printed copy.

QC Sample Results
To print all QC Sample Results:
1. Press the

key to power the Quidel Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using the
3. Press thekey.

4. Select PRINT ALL RESULTS using the
5. Press thekey.

6. Select QC SAMPLE RESULTS using the
7. Press thekeys.

key to make a printed copy.

75

keys.

keys.

QC Device Results

Main Menu

To print all QC Device Results:
1. Press the

Recall Results

key to power the Quidel Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using the
3. Press the

keys.

key.

6. Select QC DEVICE RESULTS using the
7. Press the

keys.

key.

4. Select PRINT ALL RESULTS using the
5. Press thePrint All Results

keys.

key to make a printed copy.

Misc. Test Results
To print all Misc. Test Results:
1. Press the

key to power the Quidel Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using the
3. Press thekey.

4. Select PRINT ALL RESULTS using the
5. Press the

keys.

key.

6. Select MISC. TEST RESULTS using the
7. Press the

keys.

keys.

key to make a printed copy.

Upload Results to LIS

Main Menu

When interfaced directly to an LIS, selecting this feature will send all test results to the

Recall Results

LIS. Prior to the first upload, the LIS feature must be activated from the Set Parameter

Upload Results to LIS

menu item using the Supervisor CODE CHIP module.

76Delete Results
NOTE: The delete
function isavailable only when the
Supervisor CODE CHIP
module is inserted in the
Quidel Triage MeterPro
CODE CHIP module Port.

PurposeThe Delete function is used to remove all patient test information fromthe Quidel Triage MeterPro memory.

THE Quidel Triage MeterPro Memory
Within the Quidel Triage MeterPro, Patient Result memory can hold 750 data sets, QC Sample
can hold 200 data sets, QC Device can hold 70 data sets, and Misc. Test can hold 250
data sets. When the memory is full, the oldest result is automatically overwritten when a
new result is added. The meter display alerts the user as the patient memory becomes full.
WARNINGPATIENT MEMORY HASSPACE FOR XXX MORE
RECORDSPRESS ENTER
The Memory Alert Screen

IMPORTANT: The Delete function permanently removes all patient datafrom the meter memory. Before continuing, you may wish to first print results(or upload to your data management system/LIS). QC or Misc. Test Resultscannot be manually deleted.

77Delete Patient Result

Main Menu

This function will delete all patient results in meter memory. Since this action is not

Delete Results

reversible, the meter will require two confirmations of intent to delete results.
1. Insert the Supervisor CODE CHIP module in the CODE CHIP module Port.

CODE CHIP Module

CODE CHIP Module Port

2. From the MAIN MENU, select DELETE RESULTS using thekeys.

8:23AM 01•20•18

RUN TESTRECALL RESULTS
INSTALL NEW CODE CHIPSET PARAMETERS
DELETE RESULTS
SELECT WITH v OR ^ AND PRESS ENTERPRESS EXIT TO EJECT DEVICEThe Supervisor’s Main Menu

3. Press thekey.

4. A warning message on the screen states: DELETE PATIENT RESULT.
5. If this is acceptable, press thepress thekey. (If this is not acceptable,

key).

6. A message on the screen states: ALL PATIENT RESULTS WILL BE DELETED.
7. Press the

key to delete all patient results. (If you do not want to delete all

patient results, press the

key).

78

NOTE: Pressthe EXIT key
to cancel at any time
before step 7.

Display Backlight
The Quidel Triage MeterPro has the capability for the operator to backlight the display forproviding improved clarity depending on ambient lighting conditions. The backlight feature
can be controlled by the backlight buttonon the keypad. When the backlight button

is pressed, the backlight initially comes on at maximum brightness. Subsequent
presses cycle the backlight from bright to dim and then to off. To save power, thebacklight turns off if no keys have been pressed for 15 seconds. Pressing any key will
restore the backlight to the previous level.

79

Alpha Numeric Mode
The Quidel Triage MeterPro has the capability for the operator to enter both numeric and alphacharacters from the keypad. The keypad operates in numeric mode until alpha mode is activatedby pressing the

key. The meter stays in alpha mode, indicated by the letters “ABC” shown at

the top of the display, until the

key is pressed again. When in alpha mode, pressing any key

causes the alpha character to be displayed.
1/#()*.\

7

PQRS

2

ABC

8

TUV

3

DEF

9

WXYZ

4

GHI

0

no alpha character is displayed

5

JKL

.

no alpha character is displayed

6

MNO

The first press of a button causes the first letter to be displayed. The second press of the same
button within three seconds causes the second letter to be displayed. The third press of the same
button within three seconds causes the third letter to be displayed.
After the last character in a sequence is displayed, the next button press of the same button within
3 seconds displays the first character and the sequence is repeated.
If more than three seconds pass without the operator pressing the button, the next press of that
button causes the first character to be displayed. If a new button is pressed, the first character ofthe new button is displayed with subsequent presses repeating the sequence.

80Service and Maintenance Procedures
If any service or maintenance is required, the Quidel Triage MeterPro should be sent to the
manufacturer. No maintenance other than paper/battery replacement and periodic externalcleaning is required of the operator.

Paper Replacement
Changing Paper Between Functions
1. Tear off any excess paper sticking out of the Quidel Triage MeterPro.
2. Remove the paper compartment cover by pulling up on the cover as
indicate by the arrow on the back of the cover.

Me
terP
ro

3. Remove unused paper or the empty paper spindle from paper compartment.
4. Tear or cut a clean, straight edge to feed into the printer. Do not cut paper at
an angle, as the printer must sense the edge of the paper along the feed path.

NOTE: The printercontains a paper
sensor and will feed thenew paper roll only whenpaper with a clean straightline is pressed into thepaper roller.

5. Insert the new roll of paper into the paper compartment.
6. Position the paper such that the paper will feed from under the roll(as opposed to over the top of the roll, see picture, above).
7. Insert the paper edge under the paper roller (platen) until it firmly
seats or resistance is felt.
8. Press thekey.

9. Replace the cover of the printer and continue operation.

81

NOTE: If PAPER
FEED button ispressed before the printersenses the paper, theprinter will not respond tothe command.

NOTE: The printerutilizes thermal
paper, if the printed paperis blank after replacing aroll, verify that the paperroll is not upside down.

Changing Paper While Printing		

If the meter runs out of paper while in the middle of a printing task and is displaying
the message PRINTER FAILURE, CHECK PRINTER OR REPLACE PAPER, the paper
may be changed and the print job continued without loss of data or reprinting from the
beginning. Perform the following steps prior to pressing any new keys:

		

1.	Remove the paper compartment cover by pulling up on the cover as indicate by thearrow on the back of the cover.

Me
terP
ro

NOTE: The
printer contains
a paper sensor andwill feed the newpaper roll only whenpaper with a cleanstraight line is pressed
into the paper roller.

		

2. Gently pull remaining paper slowly up through the printer.

		

3. Remove paper spindle from the paper compartment.

		

4.	Tear or cut a clean, straight edge to feed into the printer. Do not cut paper at anangle, as the printer must sense the edge of the paper along the feed path.

		

5. Insert the new roll of paper into the paper compartment.

		

6.	Position the paper such that the paper will feed from under the roll (as opposed toover the top of the roll, see picture, above).

NOTE: If PAPER
FEED button ispressed before the printersenses the paper, theprinter will not respond tothe command.

		

7.	Insert the paper edge under the paper roller (platen) until it firmly seats or a
resistance is felt.

		

8. Press the

key.

		

9. When the printer begins to pull the paper in, release the paper. The printer will feeda few lines and re-commence the print job. To ensure no data is lost, the printer will
reprint up to the previous 5 lines.

NOTE: The printerutilizes thermal
paper, if the printed paperis blank after replacing aroll, verify that the paperroll is not upside down.

		

10. After the paper has appeared above the printer, replace the printer cover, taking
care to ensure the paper does not get caught inside the meter.

82

Cleaning		

The Quidel Triage MeterPro requires minimal maintenance. Occasional cleaning of theexterior with mild soap and water solution is sufficient. After using a damp, not wet,sponge or cloth to apply a mild soap and water solution on the outside of the meter,
wipe the meter dry using a soft cloth or absorbent tissue. Do not allow water to seep
into the printer. Do not immerse the meter inwater or other liquids.

		

Mete
rPro

If blood or other fluids are not allowed enoughtime to fully absorb into test devices, thedevice track door may occasionally requirecleaning. Using a cotton swab dampened

NOTE: Neverinsert any tools,
swabs, or cleaningmaterials into thedevice track.

with isopropyl alcohol and a pair of tweezers,
carefully lift the door and clean both front andback of the door.

Check Battery Level
		The Quidel Triage MeterPro checks the active
power source after ejecting a device orprinting. To check the battery power, navigate to the MAIN MENU, disconnect
the AC power supply, press thekey (the meter attempts to eject the device),and look for the Low Power Indicator on the Main Menu of the meter display.

NOTE: The meteris designed toperform and print at least
100 tests before newbatteries are required tobe replaced. When themeter is not in use, it
should be turned off. To
preserve battery life,
ensure the AUTO
POWER-OFF function is
set to 1/2 HOUR.

If the flashing indicator appears, replace the batteries.

Battery Replacement•

Turn off the meter.

•

Remove the battery cover from the bottom of the meter by sliding thecover in the direction of the arrow.

•

Remove the batteries. Some countries require that batteries be disposed ofin accordance with specific governmental regulations (Directive 2006/66/EC).
Dispose of the batteries in compliance with local regulations.

•

Insert four size AA 1.5-volt batteries into the battery compartment. Be sure

NOTE: If the meter
does not power onafter replacing batteries,
verify the batteries are
lined up according to thesymbols in the battery
compartment.

that the plus (+) and minus (-) signs of the batteries match the same signs
embossed in the battery compartment•

Replace the cover to the battery compartment

C
US

83

NOTE:
Rechargeable
batteries are authorized foruse, however due to thenature of these types ofbatteries, it is expected
they will require recharging
more frequently. The
Quidel Triage MeterProdoes not contain a built-in
battery charger,
rechargeable batteries
must be recharged outsideof the meterTotal Quality Assurance
Introduction
NOTE: For moredetailed information,
contact Quidel.

Quality assurance programs control and monitor analytical methods. The quality control ofanalytical methods achieves two basic goals:
1. Ensures that the reagents and instrument are working properly.
2. Ensures that the procedure was performed correctly .
The mechanism by which analytical methods are traditionally controlled is through the useof liquid control specimens containing known amounts of analytes.
Over the last 15 years advances in technology have changed the manner in which thediagnostic reagents are configured. Assay systems for the Point-of-Care are generally
unitized testing devices that are distinct from traditional laboratory-based analyzers. The
Quidel Triage tests are unitized tests that do not require additional reagents. Each device
contains a full complement of reagents that are required to perform the immunoassay.
The Quidel Triage tests have been designed to include assay controls in each test device
that monitor the assay procedure and the reagent integrity. The assay controls present aunique and valuable extension to the traditional approach to quality control using liquid
reagents. If the product is stored under specified conditions, proper functioning of theassay controls indicates that the test device is valid and proper adherence to assay
protocol has been followed. The assay controls in the Quidel Triage tests require the needto re-think the frequency with which external quality control specimens should be tested.
The Quidel Triage tests have been designed to yield long-term reagent stability.
In addition, the system provides quality control parameters in three separate
and distinct categories:• Internal device controls• Meter electronic controls• Software controls.
The combination of these quality control features provides more information about thevalidity of each assay than can be provided by the more traditional methods of reagent
and assay procedure validation.

84

Quality Assurance Functions
1. Internal Device Quality Assurance• Internal Positive Control Zone
• Baseline Control Zone
• Timing Control Zone
• Zone Quality Requirements (Trace QC)
2. Meter Quality Assurance• Self-Test Mode
• Internal Calibration Chip
• Electronic QC Device• Bar Code
3. Software Quality Assurance• Supervisor CODE CHIP module• User ID#• Patient ID#• Result memory storage• QC Frequency• QC Lockouts
4. Quality Control Samples

Internal Device Quality Assurance
The Internal Control Zones are built-in functional immunoassays. This control verifies thatthe device functioned properly and that the assay was correctly performed. The Internal
Positive Control Zone ensures that the antibodies, the reagent reconstitution, the timegate
and the device flow are functioning properly. The manufacturer sets acceptable ranges forthe control zones for each lot of reagents.
The Baseline Control Zone monitors the presence of interfering substances in the patient
sample that may alter the immunoassay process. If a specimen contains a substance thathas a major effect on the high and low controls and the baseline control and thereby on
the immunoassay, the results are not displayed and erroneous results are not reported.
The Timing Control Zone monitors assay completion. If an inadequate amount ofspecimen is added to the test device or if a specimen clots in the device, this control will
prevent the display of the results.
A Trace QC algorithm has been programmed which evaluates the size, location and signal
to noise ratio of each zone on the device. Aberrations in zone quality exceeding preset
limits will cause rejection of one or more of the assay results.

85

Meter Quality Assurance
The Self-Test Mode is initiated each time the meter is turned ON. In the self-test mode the meterscans an Internal Calibration Chip. Each calibration chip scan is used to validate and adjust, if
necessary, the meter calibration. In the self-test mode, the available memory for patient results ischecked. When the capacity is below a pre-set limit, the remaining capacity is related via a screen
message. The software program is evaluated and is terminated if corrupted. Software test resultsand CODE CHIP module data are verified for integrity before each use.
A QC Device is provided with each meter to allow the user to further check the integrity of themeter. The simulator contains six fluorescent zones of varying intensity that are measured by themeter. There are pre-programmed acceptable ranges for the six zones. In addition, the zones allow
the meter to check for horizontal and vertical alignment of the zone measurement to verify laseralignment and device transport. The QC Device also confirms laser stability.
A Bar Code is printed on the bottom of every test device to identify the reagent lot number and toprevent the use of expired reagents.

Software Quality Assurance
The software QA is controlled through a variety of software features, some of which can be optional
depending on the environment in which the assay is performed. In a Point-of-Care location, adesignated supervisor can select program parameters to ensure adherence to quality standards. Ina central laboratory location, selected parameters can be bypassed if desired.
A Supervisor CODE CHIP module is provided with each meter. This CODE CHIP module allows
access to meter functions not available to the routine user. The additional functions are selection ofparameter settings and downloading and deletion of results from the meter memory.
A User ID can be assigned in the software to limit access to the patient testing mode to only thoseindividuals who have been properly trained and have demonstrated testing proficiency. A User
ID and expiration date are programmed into the meter memory and are subsequently associatedwith all patient results generated by the user. This allows the supervisor to review users’ testing
frequency, and in the event of frequent test failures, to identify potential problems in training.
An additional security feature of the User ID is the partial masking of the ID on displays andprintouts. This prevents unauthorized individuals from detecting and using an existing User ID. Thisfeature is overridden when the Supervisor CODE CHIP module is installed.
A Patient ID is required for all patient tests performed. All QC sample and patient results are
stored in the meter’s memory and can be downloaded to a laboratory information system (LIS) oran external data management software program for further viewing and printing of quality control
reports.

86

The Supervisor can select the QC Frequency for performing external liquid control
samples. When it is time to perform external QC samples, the user must test the externalliquid controls and obtain acceptable results before patient samples can be tested. When
QC samples have been successfully performed, the user is allowed to perform tests onpatient samples. If QC samples are not within an acceptable range, a QC Lockout function
prevents testing of patient samples. If desired, the supervisor in a central lab setting can
bypass this function. If test device controls are out of range, a QC Lockout function is
activated and patient test results are blocked from viewing and printing. This preventsunacceptable results to be communicated to and used by the physician.
Additionally, if test devices are expired, a QC Lockout function is activated and prevents
testing using expired test devices.

Quality Control Samples
It is still valuable to apply the traditional approach to quality control by testing quality
control samples. These controls will check the total integrity of the system. The interval for
analyzing these controls, however, can be extended due to the many other Total Quality
Assurance features inherent in the Quidel Triage tests.
The Quidel Triage tests have been designed to maximize Total Quality Assurance inany testing environment. The combination of the QC features of the Quidel Triage tests
reduce the impact of procedural errors, ensure reagent integrity, and assure that patientresults are accurate each and every time a test is performed. Based on the current CLIA
guidelines and other regulating bodies, Quidel makes the following QC recommendations:• Run two levels or POS and NEG external liquid control samples as appropriate witheach new lot of reagents and once every thirty days with continued use of the same
reagent lot number• Run the QC Device daily.

Notes Regarding Software Controls
1. User ID Access• To prevent untrained persons from performing a test, a valid User ID (1-16
characters in length) must be entered before access is given to the RUN TEST
function if the User ID bypass is OFF. If a User ID Bypass is ON, then anyone cananalyze a test.
• To prevent unauthorized persons from accessing patient information, a valid User
ID must be entered before access is given to the RECALL PATIENT RESULTS
functions if the User ID bypass is OFF. If a User ID Bypass is ON, then anyone canrecall patient data. RECALL PATIENT RESULTS functions include recalling patientresults, printing patient results, and recalling the last test run on the meter when thelast test is a patient sample,• The User ID Bypass is controlled by the SET PARAMETERS function, which
requires a Supervisor CODE CHIP module for access.
• Access is available to anyone wanting to RECALL NON-PATIENT RESULTS frommemory or INSTALL CODE CHIP.

87

2. Out-of-Range Flags• If a patient is outside the normal range for any of the analytes, then the result will be flagged
by reverse video, that is, the background of the result will be black and the value in white
numbers. A warning will be displayed below the results:
PATIENT RESULT ABNORMAL• If the Internal QC zones for the device or a specific analyte are unacceptable, the analyte(s)in question display an exclamation point (!) in place of a value and a warning is displayed:! INTERNAL QC OUT OF RANGE.
• If the QC Sample for a specific analyte on that device lot is unacceptable, the analyte inquestion will display a pound sign (#)in place of a value and a warning is displayed:# QC SAMPLE OUT OF RANGE.
• If both QC Sample and Internal QC errors are present for a specific analyte, both a pound
sign and an exclamation point (# !) will be displayed in place of a value and both warnings
are displayed:! INTERNAL QC OUT OF RANGE and # QC SAMPLE OUT OF RANGE.
3. Blocked Results		When QC error conditions exist on a test device, whether for a specific analyte or the entire
test panel, the analytes in question are blocked from view and replaced with an Out of Range
Flag (! and/or #). The error condition must be remedied and the test repeated to obtain a result.

4. QC Sample Frequency• How often an external liquid control, QC Sample, should be run can be selected under
SET PARAMETERS. If the time interval has expired, QC Samples must be run andacceptable results obtained before a patient sample can be tested.
• A list of test device lots and the date that the QC Sample expires can be viewed and printed
by selecting REAGENT LOTS – QC under the RECALL RESULTS menu.
5. Supervisor Access		To prevent misuse, the Supervisor CODE CHIP module is required for access to the
SET PARAMETERS and DELETE RESULTS functions of the software. The Supervisor
CODE CHIP is universal and may be used on any Quidel Triage MeterPro.

88

89

Appendices
Appendix A Specifications
PhysicalSize8.5” x 6.25“ x 2.75” (22.5 cm x 19 cm x 7 cm) D x W x H

Weight1.5 pounds (0.7 kg) without batteries

Electrical

6v DC at 1 amp – supplied via 4 AA batteries or AC/DC Converter

KeypadNumeric with special function keys (22 total)

Environmental
Temperature

15°C – 30°C

Humidity

10% – 85%

LocationDry, clean, flat horizontal surface away from direct sunlight

OpticalLight Source

Laser Diode – <1 milliwatt

Laser Classification1

Detector

Silicon Photodiode

Memory Capacity
750 Patient Records

32 Reagent Lot CODE CHIP modules

200 QC Sample Results

200 QC Sample CODE CHIP modules

70 QC Device Results

4 QC Device CODE CHIP modules

250 Misc Test Results
600 User ID’s
Miscellaneous
RS-232 computer interface port
Thermal Printer
LCD screen display
Options• External Bar Code Reader (rapid entry of User, Patient, Auxiliary or Misc Test ID’s).
• Quidel Triage Census Data Management Software.
• Quidel Triage Census Data Management Software with LIS Connectivity.
Test Device Specifications
Test device specific information is provided in the applicable product insert. The instrument analyzes
immunoassay test devices manufactured by Quidel Cardiovascular Inc.

90

Appendix B Troubleshooting
Meter Symptoms
Symptom

Probable Cause

Corrective Actiona. Inappropriate body fluid or
improperly anticoagulated
sample.

a. R
 etest sample using a new test
device with a proper specimen.

b. Sample size incorrect—too
little sample. Test device’s
internal QC controls will be outof range.

b. Retest sample on a new test device.
Make sure the entire tube is full. Be
certain the lower bulb on the pipettetube contains a small amount fluid
before you press the top bulb.

c. Meter was picked up or
carried vertically while test
was running. The test device’s
internal QC controls will be outof range.

c. If less than 30 minutes has passed since
preparing the test device, place meter onflat surface and reinsert the test device.
If more than 30 minutes has passed,
retest sample on new test device.

Hook that pulls test device into
the meter may be broken.

If meter repeatedly fails to pull thedevice in, the meter may need tobe replaced. Contact Quidel.

a. CODE CHIP module may havebeen inserted upside down.

a. R
 e-insert CODE CHIP module
right side up.

b. CODE CHIP module or Meter
contacts could be bent.

b. Try new CODE CHIP module, if available.
If still not a good fit, contact Quidel.

Printer works but no print
appears on paper.

Paper may be installedbackwards.

Install paper reverse to current position.

Printer jam.

Paper may have been fed into themeter improperly.

Carefully remove old paper out ofthe printer. Do not insert any tools
into the printer.

Printer stops printing or
skips a line.

Battery power low.

Replace batteries or verify power cord isinstalled in the meter and wall outlet.

a. Batteries not installed, drained
or incorrectly aligned.

a. V erify batteries are installed andcorrectly aligned (+) and (-); replacebatteries if necessary.

b. Power source not plugged in.

b. Verify power cord is installed in themeter and wall outlet.

Low battery power.

Replace batteries.

Invalid Results

Meter will not pull test
device in.

CODE CHIP module will
not fit in meter.

Meter will not power onor meter powers off whenrunning a test.

Blinking battery icon.

Meter contains nobatteries or batteries are
low when facility has lossof power.

All data is saved in the Meter except
date and time. Reset date and time.

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Appendix B Troubleshooting
Meter Message or Symptom
Message

Probable Cause

Corrective Action>XXX.X

Patient sample concentration isabove the dynamic range.

See instructions that came in the boxof test devices or contact Quidel.

<XX.X

Patient result is below the dynamic
range or is a concentration below
the statistically determined lowest
test concentration.

See instructions that came in the box of thetest devices or contact Quidel support.

Battery Low.

Batteries need replacement.

Replace with 4-AA batteries or use the
AC power adapter as a power source.

Cannot Read
Bar Code

Damaged bar code or meter hookmay be broken. (The meter hookpulls the test device into the meter.)Look for particles on the bar code of
the test device. wipe off with a dry cloth.
Repeat the test.

a. CODE CHIP module error.

a. • Ensure CODE CHIP module iscompletely inserted.
• Try a reagent CODE CHIP modulefrom a different box of devices ofthe same lot number.
• If a new CODE CHIP module
eliminates the message, theoriginal CODE CHIP is at fault,
discard CODE CHIP module.

b. Meter errorb. If the new CODE CHIP module does notwork, install a known working CODE
CHIP module to verify proper operation.
If the CODE CHIP module fails to work,
contact Quidel.

Optics Detector did not properly
power on.

Power meter off and wait 15 seconds.
Power meter on. If message fails to clear,contact Quidel.

a. Inappropriate body fluid or
improperly anticoagulated sample.

a. R
 etest sample using new device witha proper specimen.

b. Sample size incorrect –too little sample.

b. Retest sample on new device. Be certain
the lower bulb on pipet contains a small
amount of fluid and the entire tube is full
before dispensing contents.

c. Meter picked up or carriedvertically while test is running.

c. Retest sample and leave meter onbench top while performing assay.
If more than 30 minutes since
inoculation, use a new device.

d. Sample running slowly

d. Possibly due to cold devices or sample,
high hematocrit with a whole blood
sample, or mechanical issue with device.
Have customer immediately reinsert
device into meter (if within 30 minutes ofsample addition).

Cannot Read
Code Chip.

Detector Failure

Measurement Failure.

92

Message

Probable Cause

Corrective Action

Motor Failure.

Motor ceases to function.
•	Meter may slow or stop due toobject lodged on the Meter track.
•	Test device may stick on themeter track.

No Device Data inMemory.

Reagent CODE CHIP module
has not been installed.

Install the CODE CHIP module includedin the box of test devices (the Reagent
CODE CHIP module).

a.	Internal standard is out ofspecification.

a.	Power meter off then on again. If OPTIC
FAILURE message clears, run the QC
Device to verify proper operation. If
message fails to clear, contact Quidel.

b.	Meter exposed to extreme
temperatures.

b.	Power meter off. Allow meter to sit
at room temperature for 1–2 hours.
Power meter back on.

Message appears when the ON/OFF
button is pressed when the meterhas been without power.

Press the ENTER key.

a.	May be due to lint or dust
affecting reading.

a.	Clean QC Device with a lint-free cloth orspray with canned air and repeat the test.

Optic Failure.

Program Check OK.
Press ENTER to start
existing program orpress EXIT to load a
new program.
QC Device—calibration,alignment or laser failed.
Messages:
Calib Pass (or Fail)
Laser Pass (or Fail)

Eject and inspect the device for any sticky
substances, labels on top of the device orother items that may interfere with the meter.
If problem persists, contact Quidel.

b.	QC Device was not run regularly.

b.	QC Device should be run regularly evenif patient samples are not run.
c.	If problem persists, contact Quidel.

Align Pass (or Fail)
Time/Date is blinking

Meter temporarily lost all power.

Reset time and date if required. Check the
AC/DC power converter plug and batteries.

Warning: Internal QC
Out of Range

Warning indicates that the internal
quality control on the test device
was out of range.
This may be sample specific.
This may be device related.

Repeat sample using a new test device.
If problem persists, contact Quidel.

Warning: Patient
Memory has Space for### More Records.

Message is displayed when meteris turned on if there is space left
for less than 100 patient records
or space left for less than 20 patient
records when running patient sample.

Options:a.	Print all results.
b.	Delete patient results.
c.	No action is required as the meter
will delete the oldest result oncethe memory is full.

Reaction has
timed out.

Too much time elapsed after the test
device was inoculated before it was
run in the meter.

Batch mode is not available for use withall test devices. Repeat sample using a
new test device. Run device in meter
immediately after inoculation.

93

Appendix C Limited Warranty, Return and Disposal Procedures
Limited Warranty
For specific warranty coverage and limitations, please refer to the applicable contract under which the productwas purchased, Quidel’s standard warranty terms at quidel.com/terms-of-sale, or contact your distributor or Quidel
representative for assistance.

Return Procedure
Should a malfunction occur, contact Quidel. If Quidel determines that the meter should be returned, you will beassigned a return authorization number and be provided shipping instructions.
Immediately after the return has been authorized, Quidel will send out a replacement Quidel Triage MeterPro. Returnthe malfunctioning meter to Quidel. Note the return authorization number on both the shipping box and the airbill andsend the meter back to Quidel as soon as possible following receipt of the replacement meter.

Disposal Procedure
The product may come into contact with blood during testing. Used products therefore carry a risk of infection.
When disposing of a meter that has been utilized, please do so in accordance to the regulations applicable in yourcountry. For information about correct disposal, please contact your local council or authority. The product falls outside
the scope of the European Directive 2002/96/EC (directive on Waste Electrical and Electronic Equipment (WEEE)).

Appendix D Glossary
Analyte: Chemical substance being measured.
Assay: Test.
Calibration: Comparison of result to a reference standard.
Character: One part of a longer string of letters and numbers; for example, in the string “ABC”,
the A, B, and C are each a character.
CODE CHIP Module: Any of several kinds of chips bearing information that can be downloaded in the
Quidel Triage MeterPro, including Reagent, QC Sample, QC Device, Supervisor and Program.
CODE CHIP Module Port: The small slot on the underneath side of the Quidel Triage MeterPro where a
CODE CHIP module can be inserted.
Date formats: DD-MM-YY: Day-Month-Year, MM-DD-YY: Month-Day-Year, YY-MM-DD: Year-Month-Day
NOTE: All parts of dates should be given as two-digit numbers. For example, the month of May is 05.

Device L/N: Lot number of a test device can be found on the side of the box that contains the test
devices and on each test device. The device L/N is a five-digit number that may be preceded by
one or more letters. The meter disregards all letters.
Digit: One part of a longer number; for example, in the number 231, the 2, 3, and 1 are each a digit.
Fluorescence: The characteristic of a chemical substance that enables it to give off light when stimulated.
ID: Identification.
Immunoassay: A test that uses antibodies to measure substances.
Internal QC: Quality controls in place as part of the Quidel Triage MeterPro’s
software or zones built into the test device.
In vitro: Made to occur in a laboratory vessel or other controlled experimental
environment rather than in a living organism (literally, in glass).
In vitro diagnostic use: For use in a controlled setting.
Laser diode: Light source used in the Quidel Triage MeterPro.
LCD: Liquid crystal display; the screen on the Quidel Triage MeterPro.
Shows the menu of possible tests and procedures and prompts theoperator to take the next step.

• CK-MB
• MYO
• Tnl

94

PN:

• Add sample
after openin immediately
g foil pouch.

•

Quidel Cardiov
ascular
San Diego,
CA 92121 Inc.
USA

Lot number: L/N; identification number given to a group of test devices.
L/N: Lot number; the number that identifies a batch of test devices.

8°C

XXX
XX

2°C

Rev.
X

IVD

Lot Numbers

Menu: List of choices displayed on the Quidel Triage MeterPro’s screen.
MMX: The Multi Marker Index value, is a number calculated from the measured values of the analytes in a Test Device.
Not all Quidel Triage test panels have the MMX feature.
Parameters: Options; functions
Photodiode: Detects the light emitted from the fluorescent dye in the test devices used in the Quidel Triage MeterPro.
Point of Care (POC): Not in a laboratory; at the place where care is being given to a patient.
QC: Quality Control.
QC Sample: External controls; a liquid solution containing chemicals that, when dispensed into a test device, reactwith the test reagents. Used to verify proper performance of test devices after shipment or long periods of storage.
QC Sample CODE CHIP module: CODE CHIP module that can be downloaded into the Quidel Triage MeterPromemory to give the meter information needed about the specific lot of QC Sample.
QC Device (previously called QC Simulator):
Test device containing 6 independent zones that verifies proper
operation of the Quidel Triage MeterPro’s ability to properly readpatient tests across varying analyte concentrations.
QC Device CODE CHIP: CODE CHIP module that can be downloaded into the Quidel Triage MeterPro’s memory
to give the meter information needed about the specific QC Device’s performance in the assigned meter.
Quantify, quantifying: To give the results of a test as number.
Reagent: Substance that causes chemical reactions; used in analysis.
Reagent CODE CHIP module: CODE CHIPTM module loaded with information about a specific test and lot number.
Retrieve: Find, bring back.
Reverse Video: Light text displayed on a dark background.
Screen: The part of the Quidel Triage MeterPro that displays words and numbers.
Scroll to: Use arrow keys

to go to the information you want on the screen.

Set Parameters: A function of the Quidel Triage MeterPro; requires the use of the Supervisor CODE CHIP module.
Software Upgrade CODE CHIP:
CODE CHIP module used to download new
software onto the Quidel Triage MeterPro.
Supervisor CODE CHIP module: The CODE CHIP module that allows a supervisor to set parameters and delete results.
Test device: Holds the sample (for example, blood)from the patient so that it can be inserted into the
Quidel Triage MeterPro for testing. Contains reagent
zones that cause reactions to occur that allow themeter to determine analyte levels in the patient.
Test panel: Alternate name for Test Device, usually indicative of a Test Device with multiple analytes.

Appendix E Sample Log Sheets
The following log sheets are provided as alternate methods of tracking test results.
The Quidel Triage MeterPro is capable of tracking and printing out test history andproviding QC Lockouts to prevent patient testing when outside QC requirements.

95

Date/Time

Contact Quidel.

20

19

18

17

16

15

14

13

12

11

10

9

8

7

6

5

4

3

2

1

Month

Patient ID

User Name/ID
Lot Number

Analyte 2

Reviewed by:

Analyte 1

Laboratory Name
Analyte 3

96

Analyte 4

Analyte 5

Analyte 6

Analyte 7

Testing Site

Used as an alternate method of tracking patient test history.

Patient Test Log Sheet

Date:

Analyte 8

Analyte 9

Comments

Tech
InitialsDate/Time

Contact Quidel.

20

19

18

17

16

15

14

13

12

11

10

9

8

7

6

5

4

3

2

1

Month

User Name/ ID

Calibration(pass/fail)

Alignment(pass/fail)

Reviewed by:

Laser(pass/fail)Laboratory Name

97

Comments

Testing Site

Used as an alternate method of tracking QC Device test history.

QC Device Test Log Sheet

Date:

Tech
InitialsDate/Time

Contact Quidel.

15

14

13

12

11

10

9

8

7

6

5

4

3

2

1

Month

QC Sample
Lot Number

Expiration
Date

Level II HighLevel I Low

Level II HighLevel I Low

Level II HighLevel I Low

Level II HighLevel I Low

Level II HighLevel I Low

Level II HighLevel I Low

Level II HighLevel I Low

Level II HighLevel I Low

Level II HighLevel I Low

Level II HighLevel I Low

Level II HighLevel I Low

Level II HighLevel I Low

Level II HighLevel I Low

Level II HighLevel I Low

Level II HighLevel I Low

Level

Analyte 2

Reviewed by:

Analyte 1

Laboratory Name
Analyte 3

98

Analyte 4

Analyte 5

Analyte 6

Analyte 7

Testing Site

Used as an alternate method of tracking QC Sample test history.

QC Sample Test Log Sheet

Date:

Analyte 8

Analyte 9

Comments

Tech
Initials

55070 – Quidel Triage MeterPro
55071 – Quidel Triage MeterPro

MDSS GmbH
Schiffgraben 4130175 Hannover
Germany
Quidel Cardiovascular Inc.
9975 Summers Ridge RoadSan Diego, CA 92121 USA
quidel.com
Quidel Ireland Ltd.
2nd Floor, Merchants Square
Merchants Road
Galway, Ireland H91 ETN2
emeatechnicalsupport@quidel.com

ENSRC26611enD
PN: 26611en Rev. D 2022/04

Revision Changes:• Addition of “For in vitro diagnostic use” statement at beginning of User Manual• Update Assistance section• Addition of “Importer”, “Device for near patient testing”, and “Device not for self testing” symbols
to the Labels and Symbols section, reorganize symbols• Addition of the following statements to the Warnings, Precautions and Limitations section:a. For in-vitro diagnostic use
b. For professional and near patient testingc. For use by healthcare professionals• Addition of Test Principle to Description section• Updated Contents section to include the number of batteries and paper rolls provided• Addition of Materials Required But Not Provided section• Addition of Importer symbol and importer information• Moved Limited Warranty statement to Appendix C• Correct typographical errors
99