User Manual
Page 1 of 89

A symbols glossary can be found at quidel.com/glossary.

Table of Contents
Table of Contents ............................................................................................................................................ 2
General Information ............................................................................................................................................ 6
Assistance ........................................................................................................................................................ 6
Main Menu Structure ...................................................................................................................................... 7
Labels and Symbols ......................................................................................................................................... 8
Warnings, Precautions and Limitations ......................................................................................................... 10
Introduction ....................................................................................................................................................... 11
How to Use This Guide .................................................................................................................................. 11
Description .................................................................................................................................................... 11
What is the Quidel Triage MeterPro?........................................................................................................ 11
Overview: Running a Test ...................................................................................................................... 12
Unpacking .................................................................................................................................................. 12Contents ................................................................................................................................................ 13
Parts of the Quidel Triage MeterPro ..................................................................................................... 14
Installation ......................................................................................................................................................... 16
Unpack Meter ................................................................................................................................................ 16
Power Meter On ........................................................................................................................................ 16
Batteries ................................................................................................................................................ 16
AC Power Supply.................................................................................................................................... 17
Install Paper ............................................................................................................................................... 17
Insert Supervisor Code Chip Module ......................................................................................................... 18
To Change Meter Settings ......................................................................................................................... 18
Change Clock ............................................................................................................................................. 20
Set User ID ................................................................................................................................................. 21
Change Reference Ranges/Thresholds for Tests ....................................................................................... 21
Change Test Settings ................................................................................................................................. 21
Change QC Parameters.............................................................................................................................. 22
Change Bypass Settings ............................................................................................................................. 22
Location ................................................................................................................................................. 23
Power..................................................................................................................................................... 23
Self-Test ................................................................................................................................................. 23
CODE CHIP Modules .............................................................................................................................. 23

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Set Parameters .............................................................................................................................................. 24
Purpose ...................................................................................................................................................... 24
List of Programmable Parameters ............................................................................................................. 24
Supervisor Access ...................................................................................................................................... 25
How to Set Parameters: Basic Instructions ................................................................................................... 25
Meter Settings ........................................................................................................................................... 26
ID Settings .................................................................................................................................................. 26
Characters User ID ................................................................................................................................. 26
Characters Pat. ID .................................................................................................................................. 26
Characters Aux. ID ................................................................................................................................. 27
Aux. ID Enable/Disable .......................................................................................................................... 27
Characters Misc. ID ................................................................................................................................ 28
Display Settings...................................................................................................................................... 28
Display Contrast..................................................................................................................................... 29
Communication Settings ....................................................................................................................... 30
Clock ...................................................................................................................................................... 32
User ID ................................................................................................................................................... 32
New User ID ........................................................................................................................................... 32
Update User ID ...................................................................................................................................... 33
Delete User ID........................................................................................................................................ 33
User ID List ............................................................................................................................................. 34
Ranges ................................................................................................................................................... 34
Sample Select ........................................................................................................................................ 35
Test Settings .......................................................................................................................................... 36
QC Tests With Test Settings Activated .................................................................................................. 36
QC Parameters....................................................................................................................................... 37
Bypass User ID ....................................................................................................................................... 38
Restore Factory Defaults ....................................................................................................................... 38
Install Code Chip ............................................................................................................................................ 39
Purpose ...................................................................................................................................................... 39
Types of CODE CHIP modules .................................................................................................................... 39
Installation of Reagent, QC Sample or QC Device CODE CHIP Modules ................................................... 39
Install Code Chip .................................................................................................................................... 39
Installation of Supervisor CODE CHIP module ........................................................................................... 40

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Operation .......................................................................................................................................................... 41
Access to the Quidel Triage MeterPro .......................................................................................................... 41
Run Test ......................................................................................................................................................... 42
Purpose ...................................................................................................................................................... 42
Options ...................................................................................................................................................... 42
QC Device .............................................................................................................................................. 42
QC Sample ............................................................................................................................................. 44
Patient Sample....................................................................................................................................... 46
Patient Sample....................................................................................................................................... 47
Misc. Test Sample .................................................................................................................................. 49
Recall Results ................................................................................................................................................. 51
Purpose ...................................................................................................................................................... 51
Function ..................................................................................................................................................... 51
Last Record ................................................................................................................................................ 51
Patient Results ........................................................................................................................................... 52
Patient ID ................................................................................................................................................... 52
Test Device Lot Number (L/N) ................................................................................................................... 53
User ID ....................................................................................................................................................... 54
From Date .................................................................................................................................................. 54
Till Date ...................................................................................................................................................... 55
QC Results .................................................................................................................................................. 56
QC Sample Lot Number (L/N) .................................................................................................................... 57
Device Lot Number (L/N) ........................................................................................................................... 57
User ID ....................................................................................................................................................... 58
From Date .................................................................................................................................................. 59
Till Date ...................................................................................................................................................... 60
Reagent Lots – QC ..................................................................................................................................... 60
Archive Last Test ........................................................................................................................................ 61
Misc. Test Results ...................................................................................................................................... 61
Misc. Test ID .............................................................................................................................................. 61
Test Device Lot Number (L/N) ................................................................................................................... 62
User ID ....................................................................................................................................................... 63
From Date .................................................................................................................................................. 64
Till Date ...................................................................................................................................................... 64
Print All Results.......................................................................................................................................... 65

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Patient Results ........................................................................................................................................... 65
QC Sample Results ..................................................................................................................................... 66
QC Device Results ...................................................................................................................................... 66
Misc. Test Results ...................................................................................................................................... 66
Upload Results to LIS ................................................................................................................................. 67
Delete Results ................................................................................................................................................ 67
Purpose ...................................................................................................................................................... 67
The Quidel Triage MeterPro Memory ....................................................................................................... 67
Delete Patient Result ................................................................................................................................. 67
Display Backlight ............................................................................................................................................ 68
Alpha Numeric Mode .................................................................................................................................... 69
Service and Maintenance Procedures ............................................................................................................... 70
Paper Replacement ....................................................................................................................................... 70
Changing Paper Between Functions .......................................................................................................... 70
Changing Paper While Printing .................................................................................................................. 71
Cleaning ......................................................................................................................................................... 72
Check Battery Level ....................................................................................................................................... 72
Battery Replacement ................................................................................................................................. 73
Total Quality Assurance ................................................................................................................................. 73
Introduction ............................................................................................................................................... 73
Quality Assurance Functions ..................................................................................................................... 74
Internal Device Quality Assurance............................................................................................................. 74
Meter Quality Assurance ........................................................................................................................... 75
Software Quality Assurance ...................................................................................................................... 75
Quality Control Samples ............................................................................................................................ 76
Notes Regarding Software Controls .......................................................................................................... 76
Appendices ........................................................................................................................................................ 78
Appendix A Specifications ............................................................................................................................. 78
Appendix B Troubleshooting ......................................................................................................................... 79
Meter Message or Symptoms ................................................................................................................... 79
Appendix C Return and Disposal Procedures ................................................................................................ 82
Return Procedure ...................................................................................................................................... 82
Disposal Procedure .................................................................................................................................... 82
Appendix D Glossary...................................................................................................................................... 82
Appendix E Sample Log Sheets ...................................................................................................................... 84

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General Information
AssistanceIf you have any questions regarding the use of this product, please contact Quidel Technical Support at +353
(91) 412.474 (outside the U.S.) or one of the Technical Support Centers listed below. You may also contact
us at quidel.com or emeatechnicalsupport@quidel.com.
RegionTelephone Number

Fax Number(Option 2 for Technical Support)
Austria+43 316 231239+43 316 231240

France0 (805) 371674+33 (1) 856 40308

Germany+49 7154 1593912+49 7154 1593913

Ireland (Main)+353 (91) 412 474+353 (91) 412 478

Ireland (Toll-Free)

1800 200441+353 (91) 412 478

Netherlands

0 800 0224198+31 20 888 1320

Switzerland

0 800 554864+41 31 560 2913

United Kingdom

0 800 3688248+44 (20) 397 04114

Europe, Middle East
and Africa+353 (91) 412 474+353 (91) 412 478

E-mail: emeatechnicalsupport@quidel.com

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Main Menu Structure

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Labels and Symbols
Label/Symbol Description
Manufacturer

In vitro diagnostic medical device

Consult instructions for use

Authorized representative in the European Community

Temperature limitation

Humidity limitation

Waste electrical and electronic equipment (WEEE)

Serial Number
Catalog Number

Warning / Caution

Important

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CE mark

Batch code

Date of manufacture

Use-by date

Intended use

Upper limit of temperature

Do not re-use

China RoHS

Patient number

Test device

ControlCalibration Verification

Prescription use only

Contents/contains

Expected values

Biological risks

Thaw

Transfer pipette

MeanStandard deviation

CODE CHIP module

Printer Paper

Peel open here

Add sample here

Use urine sample only

Use EDTA whole blood or plasma
sample only

Use EDTA plasma sample only

Add sample immediately after
opening foil pouch

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Warnings, Precautions and Limitations
 The Quidel Triage MeterPro must be used within the operating temperature range required by the
specific test 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
been placed on the cord for quick identification.
 Do not drop the Quidel Triage MeterPro.
 Do not place objects on the Quidel Triage MeterPro.
 Do not immerse the Quidel Triage MeterPro in water or any liquids.

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Introduction
How to Use This Guide
This manual contains the following: 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 thebottom of each 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 apoint-of-care setting.
The Quidel Triage MeterPro uses a laser as a light source. Light from the laser hits a test device that has
been inserted in the meter. This causes the fluorescent dye in the test device to give off energy. The moreenergy the fluorescent dye gives off, the stronger the signal.

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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. and the test results can be printed out on a paper tape.

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).

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Contents







Quidel Triage MeterPro
QC Device and CODE CHIP module (in the QC Device box)
AC / DC Power Converter
AA Batteries
Rolls of Printer Paper (additional rolls are supplied in each box of test devices)Supervisor CODE CHIP module and CODE CHIP module Box

Printer paper
located below
QC Device box.

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Parts of the Quidel Triage MeterPro

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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 alertconditions

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
Used to toggle through menu items:
Up

Arrow Keys

Down
Left
Right

Shift Key
Symbol Key
Thermal Printer

Data Port

Used with Shift Key
Prints the test result on paper
Connection point for the (optional) Bar Code Scanner, allowing theoperator to scan patient or user identification data instead of manuallyentering numbers or letters on the keypad. May also be used to connect
to a data management system/LIS

Paper Feed Key

Used to feed paper

CODE CHIP
Module Port

Insertion point for CODE CHIP modules which contain lot / device
specific data for use in providing test results

Power Supply Port
Printer CoverConnection point for the supplied AC / DC Power Converter
The cover, which when pulled straight up, reveals the paper roll

The LCD (Liquid Crystal Display) Screen shows the menu of possible tests
and tasks and prompts the operator to take the next step
Screen commands and options are indicated by a BOLDED FONT.
LCD Screen

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Installation
Unpack Meter
a. Remove the meter from the box and protective plastic bag.

Power Meter On
Batteries
a. Turn the meter over.
b. Remove battery cover.
c. Install 4 AA batteries, paying attention to battery orientation in thebattery compartment.
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 mainmenu.

8:23AM 01•20•18

Low Power Indicator

RUN TESTTime and date

Menu items

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

User Instructions

The Main Menu

NOTE: The Low Power Indicator monitors the active power source. To verify adequate battery power:






Navigate to the Main 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

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AC Power Supply
a. Remove the power supply from the box.
b. Plug one end into an AC outlet.
c. Plug the opposite end into the round hole in the back of the meter.

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 the Care and Maintenance section.
b. Tear or cut a clean, straight edge to feed into the printer. Do not cut paper at an angle, as the printermust sense the edge of the paper along the feed path.

NOTE: The printer contains a paper sensor and will feed the new paper roll only when paper 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 to over the top of theroll, see picture).

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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 and extend out the meter.
f. Place the roll of paper into the paper compartment.
g. Replace the printer cover and continue operation.

Insert Supervisor Code Chip Module
a. 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 inthe drawing below.
d. Once the Supervisor CODE CHIP module is installed, verify that two additional menu items appear on thedisplay screen.
8:23AM 01•20•18

Two additional menu options
accessible when Supervisor
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

For more details, see CODE CHIP Modules section.

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

key.

b. Select METER SETTINGS using thekeys and press the

key.

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

key.

d. Select the desired setting using theby using thekeys and change the value of the setting

keys.

ID Settings

Default

Options

CHARACTERS USER ID

Min 1

1 - 16

Max 161 - 16Min 1

1 - 20Max 201 - 20Min 1

1 - 12

Max 12

1 - 12

Min 1

1-20

Max 201-20

Disabled

Disabled, Enabled

CHARACTERS PAT. ID
CHARACTERS AUX ID
CHARACTERS MISC ID
AUX. ID ENABLE/DISABLE

New Settings

For reference, record your settings in the space provided.

e. Press the

key to save changes to ID Settings.

Display Settings

Default

Options

LANGUAGE

EnglishPRINT MODE

Automatic

English, French, Italian,
German, Spanish,Portuguese, Greek,
Danish, Swedish,Japanese, Chinese,
RussianAutomatic, Manual

AUTO POWER-OFF

2 hour

1/2 hour, 1 hour, 2hour, 4 hour, NoneDISPLAY CONTRAST

4PRINTER CONTRAST

40-8(8 = Heaviest contrast)
0–8(8 = heaviest contrast)

New Settings

For reference, record your settings in the space provided.

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f.

Press

to save changes to Display Settings.

COMM Settings

Default

Options

BAUD RATE

38400

9600, 38400

New Settings

PAT. RESULT APPROVALDisabled

Enabled, Disabled

LIS ENABLE/DISABLE

Disabled

Disabled, Enabled

AUTO UPLOAD

Disabled

Disabled, Enabled

LIS PASSWORD

g. Press the

key to save changes to Communication Settings.

h. Press the

key to save changes to Meter Settings.

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

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

keys. Type in the correct time using the number

key to move to AM or PM.

e. Select AM or PM using the
f.

key.

keys.

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 and the 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 thekey to move to the DATE FORMAT.

k. Select MM-DD-YY, DD-MM-YY or YY-MM-DD using thethe DATE FORMAT changes.
l.

Press thekey to save changes.

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keys. The previously entered DATE changes asSetting

Default

Options

New Settings

TIME FORMATDATE FORMAT

AM / PM
MM-DD-YY

AM / PM; 24HR
MM-DD-YY,
DD.MM.YY,YY-MM-DD

Set User ID
The Quidel Triage MeterPro normally requires a User ID to be entered prior to running a patient test, QC
test, or Misc test, and prior to recalling patient results. Refer to User ID section for instructions. Alternately,
this feature may be bypassed. See Change Bypass Settings section.

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.

keys.

d. Select the analyte and level using theas appropriate.
e. Press the

key.

keys. Type in the new value for the HIGH or LOW cutoff

key to save changes.

NOTE: The lowest value of the Range or Threshold may be disabled for some test panels. Refer to theappropriate Product Insert for specific information.
For more details about Ranges Settings, see Ranges section.

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 thed. Select the analyte using thePress the

key.

keys.
keys.

e. Select the test setting (ACTIV, INACT, USR A, or USR I) using the
f.

key.

keys.

key to save changes.

NOTE: The ability to change test settings may be disabled for some tests in specific panels. Refer to theappropriate Product Insert for specific information.
For more details, see Test Settings section.

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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 byusing the

d.

keys.

Setting

Default

Options

QC DEVICE FREQ

Daily

QC SAMPLE FREQ

Monthly

NUMBER OF CONTROLSNUM QUANT STD DEVS

2
3

None, 8HR, Daily,
Weekly, Monthly
None, 8HR, Daily,
Weekly, Monthly
1 or 22 or 3Press theNew Settings

key to save changes to QC PARAMETERS.

For more details about QC Parameters Settings, see QC Parameters section.

Change Bypass Settingsa. Select SET PARAMETERS using theb. Select BYPASS using thekeys 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.

NOTE: If the bypass is ON, the user ID feature is disabled and anyone may run a test. If the bypass is OFF, the user ID
feature is active and only authorized users may run a test. To Install User ID's, see New User ID section.
For more details, see Bypass User ID section.
PRIOR TO COMMENCING PATIENT TESTING, REMOVE THE SUPERVISOR CODE CHIP MODULE FROM THE
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 (seeQC Device section).
2. Run QC SAMPLE for each lot of devices (seeQC Sample section).

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3. If appropriate, run CALIBRATION VERIFICATION SET as a Misc Test sample for each test 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 away from direct
sunlight.

Power
The Quidel Triage MeterPro requires 6-volts DC supplied by either AC or DC. The meter will run
approximately 100 tests on batteries. It is recommended to use batteries as a backup in the event of apower outage.

NOTE: The Quidel Triage MeterPro will automatically turn off if left unused for 2 hours, unlessprogrammed otherwise by the supervisor. Optional settings allow automated turnoff after 30 minutes,
1 hour, 2 hours, 4 hours or NONE.

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

Self-Test
The Quidel Triage MeterPro checks the system to be sure it is operating properly by running self-tests whenpowered on 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 andactivated, the information is transferred into the Quidel Triage MeterPro’s memory. A CODE CHIP module
typically needs to be installed only once and remains in the meter memory. A CODE CHIP module does notneed 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 dateand other 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 otherdata 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)

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 Supervisor Access CODE CHIP module – included with each Quidel Triage MeterPro; contains code toactivate Supervisor functions (Light gray) Software Upgrade CODE CHIP module – provided when Quidel Triage MeterPro software upgrades areavailable; contains new software for the meter

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 IDDISPLAY SETTINGS

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

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

CLOCK

Time, Date, and Display Format

USER ID

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

RANGES

Test Cutoffs

TEST SETTINGS

Block Analytes

QC PARAMETERS

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

BYPASSDisable User ID requirement

RESTORE FACTORY DEFAULTS

Restores instrument to factory setting and erases all data andresults

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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 chip labeled "SPR" into the meter’s CODE CHIP
module port as shown in the picture.

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 made1. Select SET PARAMETERS using the
2. Press the

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).

NOTE: To save changes, 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.

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Meter Settings






Main Menu
Set Parameters
Meter Settings
ID Settings






Main Menu
Set Parameters
Meter Settings
ID Settings

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

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.

ID Settings
Characters User ID
This setting will set the minimum and maximum number of characters in
the User ID.

2. Press thekey.

3. Use the4. Press thekeys to select ID SETTINGS.
key.

5. Use thecolumn.

keys to select the number to the right of CHARACTERS USER ID under the MIN

6. Use thekeys to choose the smallest number of characters that will appear 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
2. 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 PAT. ID under the MIN column.

6. Use thekeys to choose the smallest number of characters that will appear 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.

Page 26 of 89

Characters Aux. ID
This setting will set the minimum and maximum number of characters in the Aux ID.
If the setting of AUX. ID ENABLE/DISABLE is ENABLED, an Auxiliary ID is mandatory foreach patient test.






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

Main Menu
Set Parameters
Meter Settings
ID Settings
keys.

key.
keys to select ID SETTINGS.
key.
keys to select the number to the right of CHARACTERS AUX. ID under the MIN

6. Use thekeys to choose the smallest number of characters that will appear 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 thekeys 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.

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

Aux. ID Enable/Disable
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 other specialized identifying
information.
1. From a list of programmable parameters, choose METER SETTINGS using the
2. Press the
3. Use the4. Press the
5. Use the






Main Menu
Set Parameters
Meter Settings
ID Settings
keys.

key.
keys to select ID SETTINGS.
key.
keys to select the word to the right of AUX. ID ENABLE/DISABLE.

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 patienttest.
7. Press the
key to save changes.
6.

Page 27 of 89

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 the

2. Press the

keys.

key.

3. Use thekeys to select ID SETTINGS.

4. Press thekey.

5. Use thecolumn.

keys to select the number to the right of CHARACTERS MISC. ID under the Min

6. Use thekeys to choose the smallest number of characters that will appear 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
LanguageThis setting will determine which language the meter displays and prints.

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






Main Menu
Set Parameters
Meter Settings
Display Settings
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.

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 the
2. Press the
3. Use thekey.
keys to select DISPLAY SETTINGS.

Page 28 of 89

keys.

4. Press thekey.

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

6. Use thekeys to choose AUTOMATIC or MANUAL. If AUTOMATIC is selected, the meter will
immediately print out the results after each test (patient, QC or Misc Test). If MANUAL is selected, theuser must use the7. Press the

button on the keypad to print out results.

key to save changes.

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






Main Menu
Set Parameters
Meter Settings
Display Settings

keys.

key.
keys to select DISPLAY SETTINGS.
key.
keys to select the value to the right of Auto Power-Off.

6. Use thekeys to choose the desired timer setting for the meter to power itself off when not inuse. The choices are: 1/2 HOUR, 1 HOUR, 2 HOURS, 4 HOURS or NONE. If NONE is selected, the metermust be manually shut off using the ON/OFF key.
7. Press the

key to save changes.

NOTE: When powered only by batteries, select 1/2 hour to conserve battery life. Certain screens, when displayed,
will not automatically power off. The New Results screen is an example.

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

keys.

key.
keys to select DISPLAY SETTINGS.
key.
keys 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 thegreatest contrast).
7. Press the

key to save changes.

Page 29 of 89

Printer Contrast
This setting will adjust the printer contrast for meters with a serial number
29901 or greater.






Main Menu
Set Parameters
Meter Settings
Display Settings

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

keys.

key.
keys to select PRINTER CONTRAST.
key.
keys 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 thegreatest contrast).
7. Press the

key to save changes.

Communication Settings
Prior to activating the LIS feature, obtain the meter’s serial number locatedunderneath the meter and contact Quidel support (Refer to the Assistance section).
The Quidel Representative will provide you with a password that, when entered,will allow data to be transmitted.






Main Menu
Set Parameters
Meter Settings
Comm Settings

Baud Rate
1. From a list of programmable parameters, choose METER SETTINGS using the
2. Press the
3. Use the4. Press thekey.
keys to select COMM SETTINGS.
key.

5. Use thekeys to select BAUD RATE.

6. Use thekeys to choose 9600 or 38400.

7. Press thekey.

Patient Result Approval
Some institutions may wish for patient test results to be verified by the user
before printing or sending to the LIS. Activation of this feature displays the result,then requires the user to accept or reject the result before the record is printed
and saved. If the test is rejected, the meter will permanently flag it as rejectedby the user.
1. From a list of programmable parameters, choose METER SETTINGS using the
2. Press the
3. Use the

keys.

key.
keys to select COMM SETTINGS.

Page 30 of 89






Main Menu
Set Parameters
Meter Settings
Comm Settingskeys.

4. Press thekey.

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. RESULT REJECTED or
RESULTS REJECTED BY USER. Recalled results will display an ‘R’ before the patient ID in the rejected record.
LIS Enable
1. From a list of programmable parameters, choose METER SETTINGS
using thekeys.
2. Press the
3. Use the4. Press the

key.






Main Menu
Set Parameters
Meter Settings
Comm Settings

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. Pressthekey.
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 the
2. Press the
3. Use the4. Press thekey.
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.

Page 31 of 89

keys.

Clock Main Menu
 Set Parameters
 Clock

The clock menu sets the time and date of the meter and the format for displaying
both. If the meter has lost power, the time and date will blink on the Main Menu.
1. From the list of programmable parameters, choose CLOCK using the
2. Press the

keys.

key.

3. Use thekeys to select the HOUR: MINUTE area. Using the keypad, type in the correct time.
The numbers you type will appear from the right and move 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 visible and the TIME FORMAT will be highlighted. Proceed to step 7 below.
5. Select AM or PM using the6. Presskeys.

to move to TIME FORMAT.

7. Use thekeys 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

to move to the DATE FORMAT.

11. Use thekeys 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.

NOTE: If you have selected AM/PM, AM or PM appears after the time, as appropriate.
User ID
Up to 600 User IDs with 1 – 16 characters may be programmed into the meter.
The User ID may alternately be entered using the external Bar Code Scanner(optional).

 Main Menu
 Set Parameters
 User ID

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 is overridden and all User ID characters are displayed.

New User ID
1. From the list of programmable parameters, choose USER ID using the
2. Press thekey.

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

keys.

key.

Page 32 of 89

keys.

5. Type in a User ID with a number of characters within MIN CHARACTERS USER ID and MAX CHARACTERS
USER ID. To correct, press
to clear the entire ID, or select the incorrect character by using thekeys. Then type in the correct ID.
6. Press thekey.

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

NOTE: User ID 9999999999 (10-9’s) is a default setting displayed when the User ID Bypass is on or when atest is run with the Supervisor CODE CHIP module installed.

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 a different ID
The Quidel Triage MeterPro recognizes 0’s as a unique character. Therefore, ‘4341’ will be recognizedseparately from ‘04341’.
Using the barcode scanner or alpha mode (shift key) will allow the Quidel Triage MeterPro to accept alphacharacters and the following symbols: # ( ) * - . / \Update User ID
1.

 Main Menu
 Set Parameters
 User ID

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

2. Press thekey.

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

6. Press thekey.
7. The user ID is displayed with the expiration date. You can change the expiration date to 6 MONTHS, 12
MONTHS, EXPIRED or VALID by using thekeys. VALID reconfirms the previously selectedinterval.
8. Press the
key to save changes.
NOTE: If you type in a User ID that does not exist, the message on the screen states: USER ID ### DOESNOT EXIST. If this happens, press ENTER to return to the previous screen and correct the ID, or press the EXIT key.

Delete User ID
1.

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

Press thekey.

Page 33 of 89

keys.

3.

Select DELETE USER ID using the

keys.

4.

Press the5.

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

key.

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

keys. Then type in the correct ID.

6.

Press thekey. The message on the screen states: USER ID ### WILL BE DELETED.

7.

Press thekey to delete. A message on the screen tells you that the ID has been deleted: USER ID### DELETED.

NOTE: If you type in a User ID that does not exist, the message on the screen states: USER ID ### DOESNOT EXIST. If this happens, press ENTER to return to the previous screen and correct the ID, or press the EXIT key.

User ID List

 Main Menu
 Set Parameters
 User ID

1. From the list of programmable parameters, choose USER ID using
the
keys.
2. Press thekey.

3. Select USER ID LIST using thekeys.

4. Press thekey.
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
select the incorrect character by using theto clear the entire ID, or

keys. Then type in the correct ID.

 For a range of ID's, enter the FROM and/or the TO dates. The dates are entered by 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.

RangesDepending on the panel type, the range on the display and printout will be
titled REFERENCE RANGES or THRESHOLDS. The low end, when the test displays
thresholds, is set to ‘0’ and is unchangeable.

 Main Menu
 Set Parameters

Some analytes are designed for three distinct ranges. The meter distinguishes between two range and threerange 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

Page 34 of 89

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, the meter treats theanalyte as having only two ranges. If the lower number is not 0.0, the normal range is any value lessthan the lower number. The first abnormal range is any value between the two numbers and is inclusiveof 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 patient results. Consult the
product package insert or contact Quidel for clarification.
1. From the list of programmable parameters, choose RANGES using the
2. Press thekey.

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
Then type in the correct number.
5. Press thekeys.

to clear the entire number.

key to save changes.

NOTE: The field will be disabled if the panel setting is fixed. Consult the specific product package insert
to determine if the setting may be changed.

Sample SelectIn certain cases, the lab supervisor may wish to control the default sample type for devices run on themeter. Sample Select allows the supervisor to choose BLOOD, PLASMA, or SELECT options. If BLOOD
or PLASMA are selected, then any device run on the meter for PATIENT SAMPLE or MISC will use thechosen 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 beprompted to select BLOOD or PLASMA prior to the test being executed by the meter.
This feature is available on software version 05.04.018 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 the
2. Press thekey.

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.

Page 35 of 89

keys.

NOTE: The SAMPLE TYPE that is selected by the supervisor will appear on the result screen and will also
appear in the printed results at the end of the test being performed.

Test Settings
In certain cases, the lab supervisor may wish to control which tests are available
 Main Menu
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 throughthe options. See Patient Sample section below for more details.
1. From the list of programmable parameters, choose TEST SETTINGS 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 mode using thekeys.
 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 fromall displays and printouts.
 USER INACTIVE (USR I ON SCREEN) – At the time of patient testing, the user has the ability to selectthe test.
 USER ACTIVE (USR A ON SCREEN) – At the time of patient testing, the user has the ability todeselect the test.
6. Press the

key to save changes.

NOTE: When the analyte is deselected, the value is not calculated nor stored.

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.

Page 36 of 89

QC Parameters
The QC Parameters menu provides the user the options for determining what the
maximum frequency is for running the QC Device and QC Sample, whether 1 or 2
levels of control are required for the QC Sample, and whether the allowed QC
Sample Range of quantitative tests is 2 or 3 standard deviations.

 Main Menu
 Set Parameters
 QC Parameters

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, all users 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 the
2. Press the
3. Use thekey.
keys to select the information to the right of QC DEVICE FREQ.

4. Using the
5. Press thekeys.

keys, select one of these options: NONE, 8 HOURS, DAILY, WEEKLY, MONTHLY.
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 arelocked out of the RUN PATIENT TEST menu until a QC Sample has been successfully run. To view when aparticular 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, every 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 the3. Use thekey.
keys to select the information to the right of QC SAMPLE FREQ.

4. Using the5.

Press thekeys, select one of these options: NONE, 8 HOURS, DAILY, WEEKLY, MONTHLY.
key to save changes.

Number of Controls
1. From the list of programmable parameters, choose QC PARAMETERS
using the2.

Press the3. Use the4. Using the5.

Press the

keys.

keys.
key.
keys to select the information to the right of Number of Controls.
keys, select one of these options: 1 or 2.
key to save changes.

Page 37 of 89

 Main Menu
 Set Parameters
 QC Parameters

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 thekey.
keys to select the information to the right of NUM QUANT STD DEVS.

4. Using the
5. Press thekeys.

keys, select one of these options: 2 or 3.
key to save changes.

Bypass User ID

 Main Menu
 Set Parameters Bypass

This function allows the supervisor to selectively bypass the requirement to entera user ID before performing any test.
1. From the list of programmable parameters, choose BYPASS using the
2. Press thekey.

3. Select USER ID using the
4. Use the5. Press the

keys.

keys.

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

NOTE: If the bypass is ON, the User ID requirement is disabled and therefore not required. When thebypass is OFF, the User ID requirement operates as normal and is required.

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 themeter. This feature is available on software version 05.04.018 or greater.
1. From the list of programmable parameters, choose RESTORE FACTORY DEFAULTS using thekeys.
2. Press thekey.

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

keys.

key.

NOTE: If the RESTORE FACTORY DEFAULTS selection is chosen and the enter key pressed, all results anddata currently stored on the meter will be deleted permanently.

Page 38 of 89

Install Code Chip
PurposeThe Quidel Triage MeterPro will prompt the user to install a CODE CHIP module when required. 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 not have the data in its memory.

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

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

 QC Sample CODE CHIP module – included in each box ofcontrols. 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 islabeled with the serial number of the QC Device.

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

 Software Upgrade CODE CHIP module – sent separately
when Quidel Triage MeterPro software upgrades areavailable.

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

Installation of Reagent, QC Sample or QC Device CODE CHIP Modules
Install Code Chip
1. From the Main Menu select INSTALL CODE CHIP using thePage 39 of 89

keys.

 Main Menu

2. Press thekey.

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

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 thesupervisor functions. This is an automatic function and standard CODE CHIP module installation is notnecessary.

Page 40 of 89

Operation
Access to the Quidel Triage MeterPro
Function

Use

Restricted to

RUN TESTPatient 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:

RECALL RESULTS

Operators with valid User ID's*
Otherwise: No restriction

INSTALL CODE CHIPSSET 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:

Installation Procedure

Otherwise: No restriction

Access Control

Supervisor

Programmable Settings

Supervisor

Patient Test Results

Supervisor

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

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.

NOTE: Access to various parts of the software is user (institution) defined.

Page 41 of 89

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 isinstalled). See User ID section.
2. A QC Device has passed within the specified time period. See
QC Device section.
3. A QC Sample for the test device lot has passed within the specified time period. See
QC Sample section.
If any of these conditions do not exist, the meter will not continue and will prompt the user to perform therequired steps.

IMPORTANT: The Quidel Triage MeterPro will alert the user if QC has not been performed forthe device lot being tested.

QC Device
NOTE: The Supervisor CODE CHIP module provides access to functions that may override these Lockouts.
NOTE: If the Quidel Triage MeterPro’s internal quality control (QC) results are unacceptable, exclamation
points (!) will be displayed on the screen in the place of the patient results. To obtain results repeat thetest using a new device.
The QC Device should be run on each day of patient testing.
 Main Menu
 Run Test

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

Page 42 of 89

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

3. Press thekey.
4. Type in yourThe Main Menu

correct, press theidentification (User ID). To
key to clear the entire ID, or

NOTE: If the User ID bypass is on, the meter will not ask you to enter a User ID.
select the incorrect character by using the5.

Press thekeys. Then type in the correct ID.

key.

6. Select QC Device using thekeys.

PATIENT SAMPLE
QC DEVICEQC SAMPLE
MISC. TEST

EXP

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

EXP

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

Menu screen as it looks when operator selects QC Device.
7. Press thekey.

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

key.

NOTE: The meter will prompt the user to install the QC Device CODE CHIP module if the QC Device has notbeen run before.
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 and display the results on themeter’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 thepin. 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.

Page 43 of 89

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
to pull it out. The device may be ejected by returning to the Main Menu and pressing 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 ofcontaminants.
The QC Device is light-sensitive and should be stored in its black opaque case when not in use.
If the QC Device tests fail, wipe the QC Device clean with a lint free cloth to remove 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 support (refer to theAssistance section).

QC Sample
To run the Quality Control sample:
1. Press the Main Menu
 Run Test

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 theincorrect character by using the

key to clear the entire ID, or select thekeys. 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.
5. Press the

key.

Page 44 of 89

6. Select QC Sample using thekeys.

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.

NOTE: Only enter the four-digit numeric value of the QC lot number. Do not enter the preceding alphacharacter.

9. To correct, press the
key to clear the entire number.
Then type in the correct number.
NOTE: If you enter a QC lot number for which there is no data in the Quidel Triage MeterPro’s memory, youwill see a message on the meter’s screen: NO QC Sample data in memory.
To correct this: Install the QC Sample CODE CHIP (see picture on page 39).
Press ENTER to continue.
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 the device catch on thepin. 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.

Page 45 of 89

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 to pull it out. The device may be ejected by returning to the Main Menu and pressing
EXIT.
12. Repeat steps for each quality control sample.

IMPORTANT: Important instructions for QC Sample Tests
If the test device’s internal quality control (QC) results are unacceptable, the results for theaffected analyte(s) will not appear on the screen (instead will display an exclamation point (!)).
b. If any of the QC Sample results are out of range, the results for that particular analyte will be inreverse video (light text on a dark background).
c. A panel with multiple analytes will still be able to report patient results on those analytes which
passed QC. An analyte that failed QC will not be reported on patient tests (instead will be flaggedwith a pound symbol (#) symbol).
d. If an individual analyte is outside the specified range, the Quidel Triage MeterPro allows 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 the first passing analyte.
 Main Menu
 Run Testa.

Patient 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 DEVICE

3. Press thekey.

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

key.

NOTE: If the User ID bypass is ON, the meter will not ask you to enter a User ID.
6. Select PATIENT SAMPLE using thekeys.

PATIENT SAMPLE

Page 46 of 89

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

7. Press thekey.

8. Type or scan the patient’s identification (Patient ID). To correct, press
select the incorrect character using the9. Press theto clear the entire ID, or

keys. Then type in the correct ID.

key.

NOTE: If the Bar Code Scanner is being used, simply point the scanner at the bar code, press the button on
the scanner handle and wait for the beep. The ID will appear on the display
Patient Sample
10. If the information is correct, press the
If the information is incorrect:

key to confirm the Patient ID.

 Main Menu
 Run Test

Select CORRECT PATIENT ID using thePress thePress thekey to clear the entire ID, or select the incorrect character using theThen type in the correct ID.
Press the
key.



keys.

key.

11. If the AUXILIARY ID feature is activated, type or scan in the ID. To correct, press theentire ID or select the incorrect character using thekeys.

key to clear the

keys. Then type in the correct ID.

12. Press thekey.
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 time of running a patienttest, 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 a message similar to the following:

Page 47 of 89

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 the time of running apatient test, the user will be prompted to select desired analytes or deselect undesired analytes. Afterthe test device has been pulled into the meter, the meter will display a message similar to the following:

SELECT TESTSCARDIAC CKMB

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 above:  TNI
The absence of a check mark indicates which tests have not been selected. Example above: MYO

NOTE: At least one analyte must be selected in order to continue testing.
A number to the left of the test indicates tests which can be selected or deselected. (Refer to the sample
screen display above) Example: 2 MYO indicates that MYO is currently not selected but can be selected by pressing 2 on the
numeric keypad to display 2  MYO.
 Example: 3  TNI indicates that TNI is currently selected, but can be deselected by pressing 3 on the
numeric keypad to display 3 TNI.
 Pressing the number again toggles the test between select and deselect.
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.
f Press thekey.
f If the information is correct, press the

key to continue.

f If the information is incorrect, select CORRECT TEST using theto return to the lists of tests.

keys and press the

NOTE: If no key is pressed on the SELECT TESTS screen, the meter waits 30 seconds then proceeds
using only the selected default tests. Then, if no key is pressed on the CONFIRMATION SCREEN, thetest proceeds after waiting 30 seconds.

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

key to start the test.

Page 48 of 89

key

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
to pull 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, the results for theaffected analyte(s) will not appear on the screen (instead will display an exclamation point (!)).
b. If any of the QC Sample results for the lot being tested were out of range, the results for thatparticular analyte will not appear on the screen (instead will be flagged with a pound symbol (#)
symbol).

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 Device in accordance to the
instructions provided in the package of test devices you are using.
1. Press the

key to power the Quidel Triage MeterPro on.

2. Select RUN TEST using the Main Menu
 Run Test

keys.
8:23AM 01•20•18

RUN TESTRECALL RESULTS
INSTALL NEW CODE CHIP
SELECT WITH v OR ^ AND PRESS ENTERPRESS EXIT TO EJECT DEVICENOTE: If the User ID bypass is ON, the meter will not ask you to enter a User ID.
3. Press thekey.

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

keys. Then type in the correct ID.

key.

6. Select MISC. TEST using theto clear the entire ID, or select thekeys.

PATIENT SAMPLE
QC DEVICE

Page 49 of 89

QC SAMPLEMISC TESTSELECT WITH v OR ^ AND PRESS ENTERPRESS EXIT TO EJECT DEVICENOTE: If the Bar Code Scanner is being used, simply point the scanner at the bar code, press the buttonon the scanner handle and wait for the beep. The ID will appear on the display.
7. Press thekey.

8. Type or scan the Misc. Test identification (Misc. Test ID). To correct, press
select the incorrect character using the9. Press the

keys. Then type in the correct ID.

key.

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

key to confirm the Misc. Test ID.

 Select CORRECT MISC. TEST ID using the Press theto clear the entire ID, or

keys.

key.

 Press the
key to clear the entire ID, or select the incorrect character using theThen type in the correct ID.
 Press the

keys.

key.

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
to pull it out. The device may be ejected by returning to the Main Menu and pressing EXIT.

IMPORTANT: Important instructions for misc. tests:
If the test device’s Internal Quality Control (QC) results are unacceptable, the results for theaffected analyte(s) will not appear on the screen (instead will display an exclamation point (!)).

Page 50 of 89

Page 51 of 89

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
f QC Sample Results
f Patient ID
f QC Device Results
f Panel Typef Reagent Lots – QC
f Test Device Lot Number (L/N)
f Archive Last Test
f User ID
 Misc. Test Results
f From Date Print all Results
f Till Datef Patient Results
f QC Sample Results
f QC Device Results
f Misc. Test Results
 Upload Results to LIS

NOTE: If a result was rejected by the user, an “R” will appear next to the recalled result.
IMPORTANT: To safeguard the User ID Lockout, displayed and printed User ID's are partiallymasked. The Supervisor CODE CHIP module is required to be installed to view the full User ID.

Last Record

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

keys.

key.

4. Select LAST RECORD using the
5. Press theMain Menu
Recall Results

keys.

key.

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

keys. Then type in 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.

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

Page 52 of 89

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 the

keys.

key.

4. Select PATIENT RESULTS using the
5. Press the Main Menu
 Recall Results

keys.

key.

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

c. To select a patient ID with alpha characters, use thed. Press thedisplayed.
11. Use the12. Press the

key to clear the entire ID, or select thekey to enter alpha characters.

key. All results of the requested patient ID for the selected panel will bekeys to view the entire record.
key to make a printed copy.

Page 53 of 89

13. Press the

key to upload the selected results to LIS.

NOTE: You may choose more than one of the options for recalling results in order to 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 the categories you have chosen. Then press the ENTER key.

Test Device Lot Number (L/N)

 Main Menu
 Recall Results
 Patient Results

To retrieve results based on the lot number of the test devices used:

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
incorrect character by using theto clear the entire ID, or select thekeys. 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 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 the test device. To correct, press the
key to clear the entire number. Then type in the correct number.

NOTE: Only enter the five-digit numeric value of the lot number.
13. Press thekey.
14. All results from tests run on the requested lot number for the selected panel are displayed.

Page 54 of 89

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.

User ID
To retrieve results from tests run on the Quidel Triage MeterPro starting withthe 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 the

keys.

key.

4. Select PATIENT RESULTS using the
5. Press the

keys.

key.

6. Type or scan in your identification (User ID). To correct, press
incorrect character by using the
7. Press theto clear the entire ID, or select thekeys. Then type in the correct ID.

key.

8. Select PANEL TYPE using the
9. Use the Main Menu
 Recall Results
 Patient Results

keys.

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

keys. 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

13. Press thekey.

14. All results from tests run by the requested user 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.

From Date
To retrieve results from tests run on the Quidel Triage MeterPro starting witha date you select:

Page 55 of 89

 Main Menu
 Recall Results
 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
incorrect character by using theto clear the entire ID, or select thekeys. 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 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 thenumber. Then type in the correct number.
13. Press the

key to clear the entire

key.

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.

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

key.

Page 56 of 89

keys.

 Main Menu
 Recall Results
 Patient Results

6. Type or scan in your identification (User ID). To correct, press
incorrect character by using theto clear the entire ID, or select thekeys. 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 thenumber. Then type in the correct number.
13. Press the

key to clear the entire

key.

14. All results from tests run before and including the date you 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.

QC Results
Options: The results of these quality control (QC) tests can be retrieved from 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)

Page 57 of 89

 Main Menu
 Recall Results

To retrieve QC Results for the QC Sample and the QC Device, select the option desired and follow thedirections.

NOTE: You may choose more than one of the options for recalling results in order to more precisely
define the information you want to recall from the Quidel Triage MeterPro’s memory. When you choose
multiple options, first make selections and input values in all the categories you have chosen. Then press
the ENTER key.

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.

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 thekeys.

Main Menu
Recall Results
QC Results
QC Sample Results

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
Then type in the correct number.

to clear the entire number.

NOTE: To display all results for the selected panel, leave the QC Sample L/N blank.
12. Press thekey.
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.

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

Page 58 of 89






Main Menu
Recall Results
QC Results
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 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 theclear the entire number. Then type in the correct number.
12. Press the

key tokey.

13. All QC results that have been run on the requested 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.

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.

2. From the MAIN MENU select RECALL RESULTS using the
3. Press theMain Menu
Recall Results
QC Results
QC Sample Results
QC Device Results

keys.

key.

4. Select QC RESULTS using the
5. Press the







keys.

key.

6. Select the appropriate menu, QC SAMPLE RESULTS or QC DEVICE RESULTS using thePage 59 of 89

keys.

7. Press thekey.

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.

key.

12. Type in the user ID. To correct, press theby using the
13. Press thekeys.

key to clear the entire ID, or select the incorrect character

keys. Then type in the correct ID.
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.

From Date
To retrieve QC results from tests run on the Quidel Triage MeterPro startingwith 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 the

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 thedesired panel.
9. Select FROM DATE using thekeys.
10. Press theMain Menu
Recall Results
QC Results
QC Sample Results
QC Device Results

key.

4. Select QC RESULTS using the
5. Press the

keys.







keys. Use thekeys to select thekey.

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 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.

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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.







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

keys.

key.

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

8. If QC SAMPLE RESULTS, select PANEL TYPE using thedesired panel.
9. Select TILL DATE using thekeys.
10. Press the

keys.

keys. Use thekeys to select thekey.

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 before and including the date selected, for the selected panel if QC Sample, aredisplayed.
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.

Reagent Lots – QC
A list of Reagent CODE CHIP modules in memory, along with corresponding
expiration dates for a QC Sample can be recalled from memory.
The list will contain: Lot Number, Panel Type, Expiration Date







Main Menu
Recall Results
QC Results
Reagent Lots – QC
Archive Last Test If the QC expiration date has passed (expired), the date will be in reverse video (light text on a dark
background).
 If the QC for the lot has failed, the word FAILED will appear in place of 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.

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REAGENT LOTS - QC
DLN

PANEL

EXP

47067

CARDIAC

12-16-17

48741

CARDIAC09-04-18

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 thisfunction when requested by Quidel.
This function should be used when a very unusual test result is received and when the laboratory wishes tohave the meter evaluated further. ARCHIVE LAST TEST will only be able to save data from the most recent
test run.

Misc. Test Results
Options: Misc. Test results can be retrieved based on a variety of criteria:






 Main Menu
 Recall Results

Misc. Test ID
Test Device Lot Number (L/N)
User ID
From Date
Till Date

Misc. Test ID

 Main Menu
 Recall Results
 Misc Test Results

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 thekey.

6. Select PANEL TYPE using the
7. Use the

keys.

keys.

keys to select the desired panel.

Page 62 of 89

keys.

8. Choose the results you want to see:

NOTE: You may choose more than one of the options for recalling results in order to 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 the categories you have chosen. Then press the ENTER key.
 If you want to see all Misc. Test results, press the
key. All the Misc. Test results in the Quidel Triage
MeterPro’s memory for the selected panel will be displayed.
 For individual Misc. Test results:
a. Select MISC. TEST ID using thekeys.
b. Type or scan in the Misc. Test ID. To correct, press theincorrect character by using the

key to clear the entire ID, or select thekeys. Then type in the correct ID.

c. To select a Misc. Test ID with alpha characters, use thekey in place of the alpha character.
d. Press the
9. Use thekey to enter alpha characters or use thekey. All results of the requested Misc. Test ID for the selected panel will be displayed.
keys 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.

Test Device Lot Number (L/N)

 Main Menu
 Recall Results
 Misc Test Results

To retrieve results based on the lot number of the test devices used:1.

Press thekey 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.

Page 63 of 89

keys.

6. Select PANEL TYPE using the
7. Use thekeys.

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 the test device. To correct, press the
key to clear the entire number. Then type in the correct number.

NOTE: Only enter the five-digit numeric value of the QC lot number.
11. Press thekey.

12. All results from tests run on the requested lot number 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.

User ID
To retrieve results from test run on the Quidel Triage MeterPro starting withthe 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 the

keys.

key.

6. Select PANEL TYPE using the
7. Use the

keys.

key.

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

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
or select the incorrect character by using the
11. Press the Main Menu
 Recall Results
 Misc Test Results

to clear the entire ID,

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.

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14. Press the

key to make a printed copy.

15. Press the

key to upload the selected results to LIS.

From Date
To retrieve results from test run on the Quidel Triage MeterPro starting with a dateyou select:1.

Press thekey to power the Quidel Triage MeterPro on.

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

keys.

key.

6. Select PANEL TYPE using the
7. Use the

keys.

key.

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

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 thenumber. Then type in the correct number.
11. Press the Main Menu
 Recall Results
 Misc Test Results

key to clear the entire

key.

12. All results from tests run from the date 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.

Till Date
To retrieve results from test run on the Quidel Triage MeterPro before and including
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 MISC. TEST RESULTS using the
5. Press the

keys.

key.

Page 65 of 89

keys.

 Main Menu
 Recall Results
 Misc Test Results

6. Select PANEL TYPE using the
7. Use thekeys.

keys to select the desired panel.

8. Select TILL 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 thenumber. Then type in the correct number.
11. Press the

key to clear the entire

key.

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.

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

Patient Results

 Main Menu
 Recall Results
 Print All 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 the

keys.

key.

6. Select PATIENT RESULTS using the
7. Press the

keys.

key.

4. Select PRINT ALL RESULTS using the
5. Press the Main Menu
 Recall Results
 Misc Test Results

keys.

key.

8. Type or scan in your identification (User ID). To correct, press
incorrect character by using theto clear the entire ID, or select thekeys. Then type in the correct ID.

Page 66 of 89

9. Press the

key to make a printed copy.

NOTE: When printing large quantities of patient results, it is recommended to first insert a full roll of
paper.

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

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 the

keys.

key.

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

keys.

keys.

key to make a printed copy.

QC Device Results

 Main Menu
 Recall Results
 Print All Results

To print all QC Device 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 QC DEVICE RESULTS using the
7. Press the

keys.

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.

Page 67 of 89

keys.

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

key to make a printed copy.

Upload Results to LIS
When interfaced directly to an LIS, selecting this feature will send all test results
to the LIS. Prior to the first upload, the LIS feature must be activated from the
Set Parameter menu item using the Supervisor CODE CHIP module.

 Main Menu
 Recall Results
 Upload Results to LIS

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

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

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 data from the meter memory.
Before continuing, you may wish to first print results (or upload to your data management
system/LIS). QC or Misc. Test Results cannot be manually deleted.

Delete Patient Result
This function will delete all patient results in meter memory. Since this action is notreversible, the meter will require two confirmations of intent to delete results.
1. Insert the Supervisor CODE CHIP module in the CODE CHIP module Port

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 Main Menu
 Delete Results

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

NOTE: Press the EXIT key to cancel at any time before step 7.
3. Press thekey.

4. A warning message on the screen states: DELETE PATIENT RESULT.
5. If this is acceptable, press the

key. (If this is not acceptable, press thekey).

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

Press thekey to delete all patient results. (If you do not want to delete all patient results, press the

key).

Display Backlight
The Quidel Triage MeterPro has the capability for the operator to backlight the display for providing
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 initiallycomes on at maximum brightness. Subsequent presses cycle the backlight from bright to dim and then tooff. To save power, the backlight turns off if no keys have been pressed for 15 seconds. Pressing any key will
restore the backlight to the previous level.

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Alpha Numeric Mode
The Quidel Triage MeterPro has the capability for the operator to enter both numeric and alpha charactersfrom the keypad. The keypad operates in numeric mode until alpha mode is activated by 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
2
3
4
5
6

-/#()*.\
ABC
DEF
GHI
JKL
MNO

7
8
9
0
.

PQRS
TUV
WXYZ
no alpha character is displayed
no alpha character is displayed

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 threeseconds 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 of the new button isdisplayed with subsequent presses repeating the sequence.

Page 70 of 89

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 external cleaning is required of theoperator.

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 backof the cover.

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 printermust sense the edge of the paper along the feed path.

NOTE: The printer contains a paper sensor and will feed the new paper roll only when paper with a cleanstraight line is pressed into the paper 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 theroll, see picture, above).
7. Insert the paper edge under the paper roller (platen) until it firmly seats or resistance is felt.
8. Press the

key.

NOTE: If PAPER FEED button is pressed before the printer senses the paper, the printer will not respondto the command.

Page 71 of 89

9.

Replace the cover of the printer and continue operation.

NOTE: The printer utilizes thermal paper, if the printed paper is blank after replacing a roll, verify that the
paper roll 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 the arrow on the backof the cover.

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 an angle, as the printermust sense the edge of the paper along the feed path.

NOTE: The printer contains a paper sensor and will feed the new paper roll only when paper with a cleanstraight line is pressed into the paper 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 theroll, see picture, above).
7. Insert the paper edge under the paper roller (platen) until it firmly seats or a resistance is felt.
8. Press the

key.

NOTE: If PAPER FEED button is pressed before the printer senses the paper, the printer will not respondto the command.

Page 72 of 89

9. When the printer begins to pull the paper in, release the paper. The printer will feed a few lines and recommence the print job. To ensure no data is lost, the printer will reprint up to the previous 5 lines.
10. After the paper has appeared above the printer, replace the printer cover, taking care to ensure thepaper does not get caught inside the meter.

NOTE: The printer utilizes thermal paper, if the printed paper is blank after replacing a roll, verify that the
paper roll is not upside down.

Cleaning
The Quidel Triage MeterPro requires minimal maintenance. Occasional cleaning of the exterior with mild
soap and water solution is sufficient. After using a damp, not wet, sponge or cloth to apply a mild soap andwater solution on the outside of the meter, wipe the meter dry using a soft cloth or absorbent tissue. Do notallow water to seep into the printer. Do not immerse the meter in water or other liquids.
If blood or other fluids are not allowed enough time to fully absorb into test devices, the device track door
may occasionally require cleaning. Using a cotton swab dampened with isopropyl alcohol and a pair oftweezers, carefully lift the door and clean both front and back of the door.

NOTE: Never insert any tools, swabs, or cleaning materials into the device track.

Check Battery Level
The Quidel Triage MeterPro checks the active power source after ejecting a device or printing. To check thebattery 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.
If the flashing indicator appears, replace the batteries.

NOTE: The meter is designed to perform and print at least 100 tests before new batteries are required
to be replaced. When the meter 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.

Page 73 of 89

Battery Replacement
 Turn off the meter.
 Remove the battery cover from the bottom of the meter by sliding the cover in the direction of thearrow.
 Remove the batteries. Some countries require that batteries be disposed of in accordance with specificgovernmental 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 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.

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

NOTE: Rechargeable batteries are authorized for use, however due to the nature of these types ofbatteries, it is expected they will require recharging more frequently. The Quidel Triage MeterPro does notcontain a built-in battery charger, rechargeable batteries must be recharged outside of the meter.

Total Quality Assurance
Introduction
NOTE: For more detailed information, contact Quidel.
Quality assurance programs control and monitor analytical methods. The quality control of analyticalmethods 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 use of liquid control
specimens containing known amounts of analytes.

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Over the last 15 years advances in technology have changed the manner in which the diagnostic reagentsare 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 theimmunoassay.
The Quidel Triage tests have been designed to include assay controls in each test device that monitor theassay procedure and the reagent integrity. The assay controls present a unique and valuable extension to
the traditional approach to quality control using liquid reagents. If the product is stored under specified
conditions, proper functioning of the assay 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 theneed to 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 systemprovides 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 the validity of eachassay than can be provided by the more traditional methods of reagent and assay procedure validation.

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 that the device
functioned properly and that the assay was correctly performed. The Internal Positive Control Zone ensuresthat the antibodies, the reagent reconstitution, the timegate and the device flow are functioning properly.
The manufacturer sets acceptable ranges for the control zones for each lot of reagents.

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The Baseline Control Zone monitors the presence of interfering substances in the patient sample that mayalter the immunoassay process. If a specimen contains a substance that has a major effect on the high andlow controls and the baseline control and thereby on the immunoassay, the results are not displayed anderroneous results are not reported.
The Timing Control Zone monitors assay completion. If an inadequate amount of specimen is added to thetest 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 ormore of the assay results.

Meter Quality Assurance
The Self-Test Mode is initiated each time the meter is turned ON. In the self-test mode the meter scans anInternal 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 is checked. When the capacity is
below a pre-set limit, the remaining capacity is related via a screen message. The software program isevaluated and is terminated if corrupted. Software test results and 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 the meter. The
simulator contains six fluorescent zones of varying intensity that are measured by the meter. There are preprogrammed acceptable ranges for the six zones. In addition, the zones allow the meter to check forhorizontal and vertical alignment of the zone measurement to verify laser alignment 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 to preventthe 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, a designatedsupervisor can select program parameters to ensure adherence to quality standards. In a 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 tometer functions not available to the routine user. The additional functions are selection of parametersettings 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 associated with all patientresults generated by the user. This allows the supervisor to review users’ testing frequency, and in the eventof 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 and printouts. This
prevents unauthorized individuals from detecting and using an existing User ID. This feature is overridden
when the Supervisor CODE CHIP module is installed.

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A Patient ID is required for all patient tests performed. All QC sample and patient results are stored in themeter’s memory and can be downloaded to a laboratory information system (LIS) or an external data
management software program for further viewing and printing of quality control reports.
The Supervisor can select the QC Frequency for performing external liquid control samples. When it is timeto perform external QC samples, the user must test the external liquid 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 on patient 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 prevents unacceptable results to be communicatedto 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 in any 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 patient results 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 with each new lot ofreagents 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 can analyze a test.
 To prevent unauthorized persons from accessing patient information, a valid User ID must beentered 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 can recall patient data. RECALL PATIENT RESULTS
functions include recalling patient results, printing patient results, and recalling the last test run on
the meter when the last 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 from memory or INSTALL
CODE CHIP.
2. Out-of-Range Flags

Page 77 of 89

 If a patient is outside the normal range for any of the analytes, then the result will be flagged byreverse 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) inquestion 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 in question 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 and acceptable 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.
Limited Warranty. FOR THE APPLICABLE WARRANTY PERIOD, QUIDEL WARRANTS THAT EACH PRODUCTSHALL BE (I) OF GOOD QUALITY AND FREE OF MATERIAL DEFECTS, (II) FUNCTION IN ACCORDANCE WITH THE
MATERIAL SPECIFICATIONS REFERENCED IN THE PRODUCT MANUAL, AND (III) APPROVED BY THE PROPER
GOVERNMENTAL AGENCIES REQUIRED FOR THE SALE OF PRODUCTS FOR THEIR INTENDED USE(the “LIMITED WARRANTY”). IF THE PRODUCT FAILS TO MEET THE REQUIREMENTS OF THE LIMITEDWARRANTY, THEN AS CUSTOMER’S SOLE REMEDY, QUIDEL SHALL EITHER REPAIR OR REPLACE, AT QUIDEL'SDISCRETION, THE PRODUCT. EXCEPT FOR THE LIMITED WARRANTY STATED IN THIS SECTION, QUIDELDISCLAIMS ANY AND ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY
WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENTREGARDING THE PRODUCT. QUIDEL'S MAXIMUM LIABILITY WITH ANY CUSTOMER CLAIM SHALL NOT
EXCEED THE NET PRODUCT PRICE PAID BY CUSTOMER. NEITHER PARTY SHALL BE LIABLE TO THE OTHERPARTY FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOSSOF BUSINESS, PROFITS, DATA OR REVENUE, EVEN IF A PARTY RECEIVES NOTICE IN ADVANCE THAT THESE
KINDS OF DAMAGES MIGHT RESULT.
The Limited Warranty above shall not apply if the Customer has subjected the Product to physical abuse,misuse, abnormal use, use inconsistent with the Product Manual or Insert, fraud, tampering, unusualphysical stress, negligence or accidents. Any warranty claim by Customer pursuant to the Limited Warranty
shall be made in writing within the applicable Limited Warranty period.

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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

15ºC – 30ºC

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.

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Appendix B Troubleshooting
Meter Message or Symptoms
Symptom

Probable Cause

Corrective Action

Invalid Resultsa. Inappropriate body fluid or
improperly anticoagulated sample.

a. Retest sample using a new test device
with a proper specimen.
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. If less than 30 minutes has passed since
preparing the test device, place meteron flat surface and reinsert the test
device. If more than 30 minutes has
passed, retest sample on new test
device.
If meter repeatedly fails to pull the device
in, the meter may need to be replaced.
Contact Quidel.
a. Re-insert CODE CHIP module right sideup.
b. Try new CODE CHIP module, if
available. If still not a good fit, contact
Quidel.

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

c. Meter was picked up or carriedvertically while test was running.
The test device’s internal QC
controls will be out of range.
Meter will not pulltest device in.

Hook that pulls test device into themeter may be broken.

CODE CHIP module
will not fit in meter.

a. CODE CHIP module may have been
inserted upside down.
b. CODE CHIP module or Meter
contacts could be bent.

Printer works but noprint appears on
paper.

Paper may be installed backwards.

Install paper reverse to current position.

Printer jam.

Paper may have been fed into themeter improperly.

Carefully remove old paper out of theprinter. Do not insert any tools into theprinter.

Battery power low.

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

a. Batteries not installed, drained orincorrectly aligned.

a. Verify 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.

Printer stops
printing
or skips a line.
Meter will not
power on or meter
powers off whenrunning a test.

Blinking battery
icon.
Meter contains nobatteries orbatteries are low
when facility has
loss of power.

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

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Message>XXX.X<XX.X

Probable Cause

Corrective Action

Patient sample concentration is above
the dynamic range.
Patient result is below the dynamic
range or is a concentration below thestatistically determined lowest test
concentration.

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

Battery Low.

Batteries need replacement.

Cannot Read Bar
Code

Damaged bar code or meter hook may
be broken. (The meter hook pulls thetest device into the meter.)a. CODE CHIP module error.
Cannot Read
Code Chip.

b. Meter error

Detector Failure

Optics Detector did not properly poweron.
a. Inappropriate body fluid or
improperly anticoagulated sample.
b. Sample size incorrect – too little
sample.

Measurement
Failure.

c. Meter picked up or carried verticallywhile test is running.

d. Sample running slowly

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

Replace with 4-AA batteries or use the AC
power adapter as a power source.
Look for particles on the bar code of thetest device. wipe off with a dry cloth.
Repeat the test.
a. • Ensure CODE CHIP module iscompletely inserted.
• Try a reagent CODE CHIP module froma different box of devices of the same lot
number.
• If a new CODE CHIP module eliminates
the message, the original CODE CHIP is at
fault, discard CODE CHIP module.
b. 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.
Power meter off and wait 15 seconds.
Power meter on. If message fails to clear,contact Quidel support.
a. Retest sample using new device with aproper specimen.
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. Retest sample and leave meter on bench
top while performing assay. If more than
30 minutes since inoculation, use a new
device.
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 minutesof sample addition).

Message

Motor Failure.

Probable Cause

Corrective Action

Motor ceases to function.
• Meter may slow or stop due to object
lodged on the Meter track.
• Test device may stick on the meter
track.

No Device Data inMemory.

Reagent CODE CHIP module has not been
installed.

a. Internal standard is out ofspecification.
Optic Failure.
b. Meter exposed to extreme
temperatures.
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)
Align Pass (or Fail)

Message appears when the ON/OFF
button is pressed when the meter has
been without power.
a. May be due to lint or dust affecting
reading.

b. QC Device was not run regularly.

Eject and inspect the device for any sticky
substances, labels on top of the device orother items that may interfere with themeter. If problem persists, contact Quidel
support.
Install the CODE CHIP module included in
the box of test devices (the Reagent
CODE CHIP module).
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 support.
b. Power meter off. Allow meter to sit atroom temperature for 1–2 hours.
Power meter back on.

Press the ENTER key.

a. Clean QC Device with a lint-free clothor spray with canned air and repeat
the test.
b. QC Device should be run regularlyeven if patient samples are not run.
c. If problem persists, contact Quidel
support.

Time/Date is blinking

Meter temporarily lost all power.

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

Warning: Internal QC
Out of Range

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

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

Warning: Patient
Memory has Spacefor ### More
Records.

Message is displayed when meter isturned on if there is space left for lessthan 100 patient records or space left forless than 20 patient records whenrunning patient sample.

Reaction Has TimedOut.

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

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Options:a. Print all results.
b. Delete patient results.
c. No action is required as the meter
will delete the oldest result once thememory is full.
Batch mode is not available for use withall test devices. Repeat sample using a
new test device. Run device in meter
immediately after inoculation.

Appendix C Return and Disposal Procedures
Return Procedure
Should a malfunction occur, contact Quidel support. If Quidel determines that the meter should be
returned, you will be assigned 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. Return the malfunctioning meter to Quidel. Note the return authorization number on both theshipping box and the airbill and send the meter back to Quidel as soon as possible following receipt of thereplacement meter.

Disposal Procedure
The product may come into contact with blood during testing. Used products therefore carry a risk ofinfection. When disposing of a meter that has been utilized, please do so in accordance to the regulations
applicable in your country. For information about correct disposal, please contact your local council orauthority. 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-YearYY-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.

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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 ina 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 andprocedures and prompts the operator to take the next step.
Lot number: L/N; identification number given to a group of test devices.
L/N: Lot number; the number that identifies a batch oftest devices.
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 ina Test Device. Not all Quidel Triage test panels havethe 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, react with the test reagents. Used to verify proper performance of test devices after shipment orlong periods of storage.
QC Sample CODE CHIP module: CODE CHIP module that can be downloaded into the Quidel Triage
MeterPro memory 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 read patient 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.

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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 tooccur that allow the meter 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 and providing QC Lockouts
to prevent patient testing when outside QC requirements.

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55070 – Quidel Triage MeterPro
55071 – Quidel Triage MeterPro

MDSS GmBH
Schiffgraben 4130175 Hannover,Germany

Quidel Cardiovascular Inc.
9975 Summers Ridge Drive
San Diego, CA 92121 USA
quidel.com

ENSRC26638enA
PN: 26638en Rev. A 2018/12

Revision Changes:
Initial release for Quidel Cardiovascular Inc.

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