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Triage Meter Pro

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Table of Contents

INTRODUCTION OPERATION
How to Use This Guide. . . . . . . . . . . . . . . . . . . I-2 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . O-1
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . I-4 Run Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . O-2
Description . . . . . . . . . . . . . . . . . . . . . . . . . . I-4 Purpose. . . . . . . . . . . . . . . . . . . . . . . . . . . . O-2
Unpacking. . . . . . . . . . . . . . . . . . . . . . . . . . . I-5 QC Device . . . . . . . . . . . . . . . . . . . . . . . . O-3
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . I-8 QC Sample . . . . . . . . . . . . . . . . . . . . . . . O-5
Test Device Specifications . . . . . . . . . . . . . . I-8 Patient Sample . . . . . . . . . . . . . . . . . . . . O-7
Warnings, Precautions and Limitations . . . . . . I-9 Recall Results . . . . . . . . . . . . . . . . . . . . . . . . O-10
Last Record. . . . . . . . . . . . . . . . . . . . . . O-10
INSTALLATION Patient Results . . . . . . . . . . . . . . . . . . . O-11
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . N-1 QC Results . . . . . . . . . . . . . . . . . . . . . . O-16
Set Parameters . . . . . . . . . . . . . . . . . . . . . . . N-10 Reagent Lots–QC . . . . . . . . . . . . . . . . . O-22
List of Programmable Parameters . . . . . . N-10 Archive Last Test. . . . . . . . . . . . . . . . . . O-22
Supervisor Access . . . . . . . . . . . . . . . . . . N-10 Print all Results . . . . . . . . . . . . . . . . . . . O-23
How to Set Parameters: Basic Instructions . . N-11 Delete Results . . . . . . . . . . . . . . . . . . . . . . . . O-25
Meter Settings. . . . . . . . . . . . . . . . . . . . . . N-11 Display Backlight . . . . . . . . . . . . . . . . . . . . . O-27
Communication Settings. . . . . . . . . . . . . . N-17 Alpha Numeric Mode . . . . . . . . . . . . . . . . . . O-28
Clock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . N-20
User ID . . . . . . . . . . . . . . . . . . . . . . . . . . . N-21 CARE & MAINTENANCE
Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . N-24 Total Quality Assurance . . . . . . . . . . . . . . . . . M-1
Test Settings . . . . . . . . . . . . . . . . . . . . . . . N-25 Service and Maintenance Procedures . . . . . . M-6
QC Parameters . . . . . . . . . . . . . . . . . . . . . N-27 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . M-9
Bypass. . . . . . . . . . . . . . . . . . . . . . . . . . . . N-28 Return Procedure . . . . . . . . . . . . . . . . . . . . . M-12
Install Code Chip module . . . . . . . . . . . . . . N-29
®

APPENDIX
Glossary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Software Flowchart . . . . . . . . . . . . . . . . . . . . . A-3
Sample Log Sheets . . . . . . . . . . . . . . . . . . . . . A-4
Index of Page Revisions . . . . . . . . . . . . . . . . . A-8
Declaration of Conformity . . . . . . . . . . . . . . . . A-9

Rev A I-1
How to Use This Guide
This manual contains:

• Instructions for the operation and maintenance of the Triage® MeterPro, and;

• Basic instructions for testing samples


Note: To run
specific tests,
such as the Triage®
Cardiac Panel, you
also will need detailed
information contained
in the product-specific
package insert,
included in the test kit.

The Triage MeterPro software has been designed to provide the user step by step

instructions. The meter displays test results and menu options in the upper half of the meter

screen. In smaller letters at the bottom of each screen, the meter displays instructions

pertaining to the task being performed.

The display above is the Main Menu and


appears after the meter has been turned on
and completed an automatic self-test.

I-2 Rev A
The Triage MeterPro User Manual is divided into five sections.

Section 1 – Introduction: Provides an overview of Triage MeterPro.

Section 2 – Installation: Guides the user through first time setup.


Section 3 – Operation: Guides the user through running tests, recalling results and

deleting results.

Section 4 – Care & Maintenance: Total Quality Assurance, Warnings, Precautions

and Limitations, Service and Maintenance, Warranty.

Section 5 – Appendix: Troubleshooting, Sample Log Sheets, Index of Page Revisions,

Certificate of Conformity, Software Flowchart, Glossary

Symbols Meter Keys are indicated by

= Caution = Up key = Down key

= Important = Left key = Right key

= Note = On/Off key = Delete key

= New in Version A = Brightness key = Shift key

= Symbol key (used with Shift key)

= Print key = Paper Feed key

= Enter key = Exit key

Screen commands and options are indicated by A BOLDED FONT WITH SMALL CAPITAL LETTERS

At the bottom of each page appears the page number and revision. A page revision chart is

located in the appendix and will be revised and included whenever a manual update occurs.

Use the Page Revision Chart to periodically verify presence of all pages. You may receive

an updated copy of this chart at any time by calling our Customer Service Department at

1-888-BIOSITE (1-888-246-7483).

Rev A I-3
Introduction
Description
What is the Triage MeterPro?

The Triage MeterPro is a portable fluorescence instrument used to measure the results of

tests manufactured by Biosite® Incorporated. The Triage MeterPro can be used in a

laboratory or in a point-of-care setting.

The Triage MeterPro uses a Class 1 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 more energy the fluorescent dye gives off, the stronger the signal.

Triage Test Devices. A test device holds the


sample and also contains the reagents and
other 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 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. number and the

test results can be printed out on a paper tape.

I-4 Rev A
In addition to testing samples from patients, the Triage MeterPro contains pre-programmed
Note: The
Quality Control (QC) functions that allow the person operating the meter to monitor Triage MeterPro
quality control. accepts test devices
that are designed
specifically for use
with the Triage
Unpacking MeterPro. Please refer
to product-specific
The Triage MeterPro and the items that come with it are provided in a single box. package inserts
Triage test devices are packaged separately and include instructions for running specific included in each
test kit for more
tests. If you have any questions, contact Biosite Incorporated Technical Services information.
at 1-888-BIOSITE (1-888-246-7483).

Contents:

• Triage MeterPro

• QC Device & 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 & Code Chip module Box

• Sticker with Technical Services Hotline Number

Printer paper
located below
QC Device Box

Rev A I-5
Parts of the Triage MeterPro

Thermal printer

LCD (liquid crystal display) Printer cover

Backlight

Delete

Power button

Test device insertion port

Battery cover

Power supply port Printer cover

Data port

Code Chip module port

I-6 Rev A
Power button Used to turn the Triage MeterPro on and off.

Print Button Used to print the test results or display screen.

Delete Button Used to delete data.

Enter Button Allows the operator to select menu items and acknowledge

alarm conditions.

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

Keypad Used to enter identification numbers.

Arrow Buttons Used to toggle through menu items.

Thermal Printer Prints the test result on paper.

Data Port Connection point for the (optional) Bar Code Scanner, allowing

the operator to scan patient or user identification numbers instead

of manually entering numbers on the keypad. May also be used

to connect to a data management system/LIS.

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 Connection point for the supplied AC / DC Power Converter.

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

LCD Screen The LCD (Liquid Crystal Display) Screen shows the menu of

possible tests and tasks and prompts the operator to take the

next step.

Rev A I-7
Specifications
Physical

Size 8.5” x 6.25 “x 2.75” (22.5 cm x 19 cm x 7 cm) D x W x H

Weight 1.5 pounds (0.7 kg) without batteries

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

Keypad Numeric with special function keys (22 total)

Environmental

Temperature 15C – 30C

Humidity 10% – 85%

Location Dry, clean, flat horizontal surface away from direct sunlight

Optical

Light Source Laser Diode – <1 milliwatt

Detector Silicone Photodiode

Memory Capacity

750 Patient Records 20 Reagent Lot Code Chip modules

200 QC Sample Results 30 QC Sample Code Chip modules

250 QC Device Results 4 QC Device Code Chip modules

600 User ID numbers

Miscellaneous

RS-232 computer interface port

Thermal Printer

LCD screen display

Options

• External Bar Code Reader (rapid entry of User, Patient or Auxiliary ID numbers).

• Triage Census® Data Management Software.

• 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 Biosite Incorporated.

I-8 Rev A
Warnings, Precautions and Limitations
• Operate the 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 move the 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 Triage MeterPro. An identifying

tag has been placed on the cord for quick identification.

• Do not drop the Triage MeterPro.

• Do not place objects on the Triage MeterPro.

• Do not immerse the Triage MeterPro in water or any liquids.

Rev A I-9
(Intentionally blank)

I-10 Rev A
Installation
1. Unpack Meter:

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

2. Power Meter On:

Batteries

a. Turn the meter over.

b. Remove battery cover.

c. Install 4 AA batteries, paying attention to battery orientation in the battery

compartment.

d. Replace battery cover and turn meter right side up.

e. Power the meter on by pressing the key. Press the key to run self-test.

When the test is completed, the meter display screen will come to rest at the

main menu.
Low Power Indicator Time and date
Note: The Low
Menu items Power Indicator
monitors the active
power source. To
verify adequate
User instructions battery power:
• Navigate to the
The Main Menu Main Menu
• Remove the AC
AC Power Supply
power supply
a. Remove the power supply from the box. • Press the EXIT key
(the meter attempts
b. Plug one end into an AC outlet. to eject a device)
• Observe the Main
c. Plug the opposite end into the round hole in the back of the meter.
Menu on the
meter’s display.
Replace the batteries
if the power icon is
visible.

Rev A N-1
For more details 3. Install paper:
about Installing
Paper see the CARE & a. Remove the printer cover by pulling up on the cover as indicated by the arrow on
MAINTENANCE section. the back of the cover.

Note: The b. Tear or cut a clean, straight edge to feed into the printer. Do not cut paper at an
printer contains angle, as the printer must sense the edge of the paper along the feed path.
a paper sensor and
will feed the new
paper roll only when
paper with a clean
straight 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 the roll, see picture).

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.


N-2 Rev A
4. Insert Supervisor Code Chip module: For more details about
Code Chips modules
a. Remove the Supervisor Code Chip module Box from the meter box. see page N-29.

b. Remove the Supervisor Code Chip module from its box.

c. Insert the Supervisor Code Chip module into the Code Chip module Port. The port

is located on the left side of the meter, towards the bottom front corner. Note the

orientation of the Code Chip module in the drawing below.

d. Once the Supervisor Code Chip module is installed, verify that two additional menu

items appear on the display screen.

Menu options
accessible only
when the Supervisor
Code Chip module
is inserted.

The Supervisor’s Main Menu

Code Chip module

Code Chip module Port

Rev A N-3
For more details about 5. To Change Meter Settings:
Meter Settings see
page N-11. a. Select SET PARAMETERS using the keys and Press the key.

b. Select METER SETTINGS using the keys and Press the key.

c. Select ID SETTINGS, DISPLAY SETTINGS or COMM SETTINGS using

the keys and Press the key.

d. Select the desired setting using the keys and change the value of the

For reference, record your settings in the space provided.


setting by using the keys.

ID SETTINGS Default Options New Setting

CHARACTERS USER ID Min 1 1 - 10


Max 10 1 - 10

CHARACTERS PAT. ID Min 1 1 - 12


Max 12 1 - 12

CHARACTERS AUX ID Min 1 1 - 12


Max 12 1 - 12

AUX. ID ENABLE/DISABLE Disabled Disabled, Enabled

e. Press the key to save changes to ID Settings.

N-4 Rev A
DISPLAY SETTINGS Default Options New Setting

For reference, record your settings in the space provided.


LANGUAGE English Multiple

PRINT MODE Automatic Automatic, Manual

AUTO POWER-OFF 2 hour 1/2 hour, 1 hour, 2 hour,


4 hour, None

DISPLAY CONTRAST 4 0–8


(8 = heaviest contrast)

PRINTER CONTRAST 4 0–8


(8 = heaviest contrast)

f. Press the key to save changes to Display Settings.

COMM SETTINGS Default Options New Setting

BAUD RATE 9600 9600, 38400

PAT. RESULT APPROVAL Enabled Enabled, Disabled

LIS ENABLE/DISABLE Disabled Disabled, Enabled

UPLOAD Manual Manual, Automatic

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
Biosite provided, meter
specific password, see
page N-17.

Rev B N-5
For more details about 6. Change Clock:
Clock Settings see
page N-20. a. Select SET PARAMETERS using the keys and Press the key.

b. Select CLOCK using the keys and Press the key.

c. Select the HOUR : MINUTE area using the keys. Type in the correct time

using the number keys.

d. Press the key to move to AM or PM.

e. Select AM or PM using the keys.

f. Press the key to move to TIME FORMAT.

g. Select AM/PM or 24 HR. using the keys. 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 the key to move to the DATE FORMAT.

k. Select MM-DD-YY, DD-MM-YY or YY-MM-DD using the keys.

The previously entered DATE changes as the DATE FORMAT changes.

l. Press the key to save changes.

Setting Default Options New Setting

TIME FORMAT AM / PM AM / PM; 24HR.

DATE FORMAT MM-DD-YY MM-DD-YY,


DD.MM.YY,
YY-MM-DD

7. Set User ID:

The Triage MeterPro normally requires a User ID to be entered prior to a patient test or

a QC test. Refer to page N-21 for instructions. Alternately, this feature may be

bypassed. See page N-8.

N-6 Rev A
8. Change Reference Ranges / Thresholds for Tests: For more details
about Ranges Settings
a. Select SET PARAMETERS using the keys and Press the key. see page N-24.

b. Select RANGES using the keys and Press the key.


Note: The lowest
value of the
c. Select the test panel type using the keys.
Range or Threshold
may be disabled for
d. Select the analyte and level using keys. Type in the new value for
some test panels. Refer
the HIGH or LOW cutoff as appropriate. to the appropriate
Product Insert for
e. Press the key to save changes. specific information.

9. Change QC Parameters: For more details about


QC Parameters Settings
a. Select SET PARAMETERS using the keys and Press the key. see page N-27.

b. Select QC PARAMETERS using the keys and Press the key.

c. Select the desired setting using the keys and change

the value to the right of the setting by using the keys.

Setting Default Options New Setting

QC DEVICE FREQ. Daily None, 8HR, Daily,


Weekly, Monthly

QC SAMPLE FREQ. Monthly None, 8HR, Daily,


Weekly, Monthly

NUMBER OF CONTROLS 2 1 or 2

d. Press the key to save changes to QC Parameters.

Rev A N-7
For more details about 10. Change Bypass settings:
Bypass Settings see
page N-28 a. Select SET PARAMETERS using the keys and Press the key.

b. Select BYPASS using the keys and Press the key.


Note: If the
bypass is ON, c. For USER ID select ON or OFF using the keys.
the user ID feature is
disabled and anyone d. Press the key to save changes to the Bypass setting.
may run a test.
If the bypass is OFF,
the user ID feature is
active and only 11. Prior to commencing patient testing, remove the Supervisor Code Chip module
authorized users may
from the meter, return it to the storage box and place in a safe place for future
run a test.
use.
To Install User ID
numbers, see
page N-21.

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

QC Testing should be performed in the following manner:

1. Run QC Device (see page O-3).


2. Run QC Sample for each lot of devices (see page O-5).

3. If appropriate, Run Calibration Verification Set as a patient 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 Triage MeterPro should be placed on a dry, clean, flat, horizontal surface away

from direct sunlight.


Note: The Triage
MeterPro will Power
automatically
turn off if left unused The Triage MeterPro requires 6-volts DC supplied by either AC or DC. The meter will run
for 2 hours, unless approximately 100 tests on batteries. It is recommended to use batteries as a backup
programmed
otherwise by the in the event of a power outage.
supervisor. Optional
settings allow
CAUTION: Use only the power supply provided with the meter, failure to do
automated turnoff
after 1/2 hour, 1 hour, so may cause permanent damage to the meter.
2 hours, 4 hours or
NONE.

N-8 Rev A
Self-Test

The Triage MeterPro checks the system to verify it is operating properly by running

self-tests when powered 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 and activated, the information is transferred into the 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 not need to remain in the meter

while performing tests.

There are five types of Code Chip modules which can be distinguished by shape or color.

Standard Code Chip module

• Reagent Test Code Chip module– included in each box of test devices; contains

calibration, expiration date and 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 other data about the QC Sample lot including acceptable range.

(Color varies by test type.)

• QC Device Code Chip module – included in the black QC Device box (comes with

the Triage MeterPro); contains data about how the meter should read its matching

QC Device. (Dark gray.)

• Supervisor Access Code Chip module – included with each Triage MeterPro;

contains code to activate Supervisor functions. (Light gray.)

Software Upgrade Code Chip module

• Software Upgrade Code Chip module – provided when Triage MeterPro software
upgrades are available; contains new software for the meter.
Rev A N-9
Set Parameters
Purpose
The 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:

Heading Parameters

METER SETTINGS
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
DISPLAY SETTINGS Language, Printer Mode, Auto Power-Off, Display Contrast,
Printer Contrast
COMMUNICATIONS Enable or Disable LIS, Baud Rate, Auto or Manual Upload,
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, Display Mode

QC PARAMETERS Minimum frequency for QC Tests, number of controls

BYPASS Disable User ID requirement

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 Triage MeterPro, slide the chip labeled
"SPR" into the meter’s Code Chip module port as shown in the picture.

Code Chip module

Code Chip module Port

N-10 Rev B
How to Set Parameters: Basic Instructions
Note: To save
All instructions assume: changes, press
• The meter is on. the ENTER key.
To cancel changes,
• The meter screen is displaying the main menu.
press the EXIT key.
• The Supervisor Code Chip module is installed.
When either the
ENTER or EXIT keys
1. Select SET PARAMETERS using keys.
are pressed, the
meter performs the
2. Press the key.
appropriate function
3. You will see a list of programmable parameters. and returns to the
previous menu.

The Set Parameters Menu

4. Use the keys to select the parameter you want to program:


METER SETTINGS, CLOCK, USER ID, RANGES, TEST SETTINGS, QC PARAMETERS,
or BYPASSES.

5. Press the key.

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

METER SETTINGS MAIN MENU


This menu will allow you to set basic operational criteria for the meter: language, display SET PARAMETERS
contrast, maximum length of the patient and auxiliary ID numbers, printer mode and METER SETTINGS
automatic power off. ID SETTINGS

ID SETTINGS

CHARACTERS USER ID

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

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

using keys.

2. Press the key.

3. Use the keys to select ID SETTINGS.

4. Press the key.

Rev A N-11
MAIN MENU 5. Use the keys to select the number to the right of CHARACTERS USER ID
SET PARAMETERS under the MIN column.
METER SETTINGS
6. Use the keys to choose the smallest number of characters that will
ID SETTINGS
appear in the User ID number. The minimum number of characters possible is 1.

7. Use the key to select the number to the right of CHARACTERS USER ID under

the MAX column.

8. Use the keys to choose the largest number of characters that will appear

in the User ID number. The maximum number of characters possible is 10.

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 keys.

2. Press the key.

3. Use the keys to select ID SETTINGS.

4. Press the key.

5. Use the keys to select the number to the right of CHARACTERS PAT. ID

under the MIN column.

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

appear in the Patient ID number. The minimum number of characters possible is 1.

7. Use the key to select the number to the right of CHARACTERS PAT. ID under the
MAX column.

8. Use the keys to choose the largest number of characters that will appear

in the Patient ID number. The maximum number of characters possible is 12.

9. Press the key to save changes.

N-12 Rev A
CHARACTERS AUX. ID MAIN MENU
This setting will set the minimum and maximum number of characters in the Auxiliary ID. SET PARAMETERS
If the setting of AUX. ID ENABLE/DISABLE is ENABLED, a number is mandatory for each METER SETTINGS
patient test.
ID SETTINGS
1. From a list of programmable parameters, choose METER SETTINGS

using keys.

2. Press the key.

3. Use the keys to select ID SETTINGS.

4. Press the key.

5. Use the keys to select the number to the right of CHARACTERS AUX. ID

under the MIN column.


Note: The
6. Use the keys to choose the smallest number of characters that will Auxiliary ID is
shown only on the
appear in the Auxiliary ID number. The minimum number of characters possible is 1.
New Result display or
printout. It is not
7. Use the key to select the number to the right of CHARACTERS AUX. ID under the
visible in recalled
MAX column. results. Tracking
may be managed
8. Use the keys to choose the largest number of characters that will appear through the optional
software package,
in the Auxiliary ID number. The maximum number of characters possible is 12.
Triage Census
Data Management.
9. Press the key to save changes.

AUX. ID ENABLE/DISABLE
This setting will turn on or turn off the Auxiliary ID function. The Auxiliary ID number may
be used for recording test order number, physician ID number or other specialized
identifying information.

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


using keys.

2. Press the key.

3. Use the keys to select ID SETTINGS.

4. Press the key.

5. Use the keys to select the word to the right of AUX. ID ENABLE/DISABLE.

6. Use the keys to choose DISABLED or ENABLED. If DISABLED is selected,

the Auxiliary ID prompt screens will never appear. If ENABLED is selected, a number

is mandatory for each patient test.

7. Press the key to save changes.


Rev A N-13
MAIN MENU DISPLAY SETTINGS

SET PARAMETERS
LANGUAGE
METER SETTINGS
This setting will determine which language the meter displays.
DISPLAY SETTINGS
1. From a list of programmable parameters, choose METER SETTINGS
using keys.

2. Press the key.

3. Use the keys to select DISPLAY SETTINGS.

4. Press the key.

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

6. Use the keys to change the language of the Triage MeterPro’s screen.

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 keys.

2. Press the key.

3. Use the keys to select DISPLAY SETTINGS.

4. Press the key.

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

6. Use the keys to choose AUTOMATIC or MANUAL. If AUTOMATIC is


selected, the meter will immediately print out the results after each test (patient or
QC). If MANUAL is selected, the user must use the button on the keypad to
print out results.

7. Press the key to save changes.

N-14 Rev A
AUTO POWER – OFF MAIN MENU
This setting will determine the length of time before an inactive meter will power off. SET PARAMETERS
1. From a list of programmable parameters, choose METER SETTINGS METER SETTINGS
using keys. DISPLAY SETTINGS

2. Press the key.

3. Use the keys to select DISPLAY SETTINGS.

4. Press the key.

5. Use the keys to select the value to the right of AUTO POWER-OFF.

6. Use the keys to choose the desired timer setting for the meter to power Note: When
itself off when not in use. The choices are: 1/2 HOUR, 1 HOUR, 2 HOURS, 4 HOURS powered only
by batteries, select
or NONE. If NONE is selected, the meter must be manually shut off using the
1/2 hour to conserve

on/off key. battery life.


Certain screens,
7. Press the key to save changes.
when displayed, will
not automatically
power off. The New
DISPLAY CONTRAST Results screen is an
example.
This setting will adjust the display contrast.

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

using keys.

2. Press the key.

3. Use the keys to select DISPLAY SETTINGS.

4. Press the key.

5. Use the keys to select the number to the right of CONTRAST.

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

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

7. Press the key to save changes.

Rev A N-15
(Intentionally blank)

N-16 Rev B
PRINTER CONTRAST MAIN MENU
This setting will adjust the printer contrast for meters with a serial number starting SET PARAMETERS
with 29901. METER SETTINGS
1. From a list of programmable parameters, choose METER SETTINGS DISPLAY SETTINGS
using keys.

2. Press the key.

3. Use the keys to select PRINTER CONTRAST.

4. Press the key.

5. Use the keys to select the number to the right of CONTRAST.

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

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

7. Press the key to save changes.

COMMUNICATION SETTINGS MAIN MENU


Prior to activating the LIS feature, obtain the meter’s serial number located underneath SET PARAMETERS
the meter and call Biosite Technical Services at 1-888-BIOSITE (1-888-246-7483). METER SETTINGS
The Biosite Technical Services Representative will provide you with a password that, when COMM SETTINGS
entered, will allow data to be transmitted.

BAUD RATE

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

using keys.

2. Press the key.

3. Use the keys to select COMM SETTINGS.

4. Press the key.

5. Use the keys to select BAUD RATE.

6. Use the keys to choose 9600 or 38400.

7. Press the key.

Rev A N-17
MAIN MENU PATIENT RESULT APPROVAL

SET PARAMETERS Some institutions may desire patient test results to be verified by the user before printing

METER SETTINGS or sending to the LIS. Activation of this feature displays the result, then requires the user

COMM SETTINGS 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 rejected by the user.

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

using keys.

2. Press the key.

3. Use the keys to select COMM SETTINGS.

4. Press the key.

5. Use the keys to select PAT. RESULT APPROVAL.

6. Use the keys to choose DISABLED or ENABLED.

7. Press the key.

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.

N-18 Rev A
LIS ENABLE MAIN MENU
1. From a list of programmable parameters, choose METER SETTINGS SET PARAMETERS
using keys. METER SETTINGS

COMM SETTINGS
2. Press the key.

3. Use the keys to select COMM SETTINGS

4. Press the key.

5. Use the keys to select LIS.

6. Use the keys to choose DISABLED or ENABLED.

7. Press the key.

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

the key.

9. If ENABLED was selected, a screen showing ENTER LIS PASSWORD will appear.
Enter the password provided by Biosite Technical Services. Press the key.

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 keys.

2. Press the key.

3. Use the keys to select COMM SETTINGS.

4. Press the key.

5. Use the keys to select AUTO UPLOAD.

6. Use the keys to choose ENABLED or DISABLED.

7. Press the key.

Rev A N-19
MAIN MENU CLOCK

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

CLOCK 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 keys.

2. Press the key.

3. Use the keys 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
Note: If you
have selected as you continue to type. To change a single number use keys to move to
AM/PM, AM or PM the number. Then type in the new number.
appears after the
time, as appropriate. 4. Press the key to move to AM or PM. If the 24 HR., format has been

previously selected, the AM or PM will not be visable and the TIME FORMAT will be

highlighted. Procede to step 7 below.

5. Select AM or PM using the keys.

6. Press the key to move to TIME FORMAT.

7. Use the keys to select AM/PM or 24 HR. If selecting 24 HR.,

the previously entered HOUR : MINUTE will change to a 24-hour format and

the AM or PM will disappear.

8. Press the key to move to the DATE.

9. Using the keypad, type in the 6-digit date according to the DATE FORMAT below it.

10. Press the key to move to the DATE FORMAT.

11. Use the keys to select MM-DD-YY, DD-MM-YY or YY-MM-DD.

The previously entered DATE changes as the DATE FORMAT changes.

12. Press the key to save changes.

N-20 Rev A
USER ID MAIN MENU
Up to 600 User ID numbers with 1 – 10 digits may be programmed into the meter. SET PARAMETERS
The User ID may alternately be entered using the external Bar Code Scanner (optional). USER ID

An additional security feature of the User ID is the partial masking of the ID Number on

displays and printouts. This prevents unauthorized individuals from detecting and using an

existing User ID number. When the Supervisor Code Chip module is installed in the meter,

this feature is overridden and all User ID digits are displayed.

NEW USER ID

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


Note: USER ID
using keys.
9999999999
(10-9’s) is a default
2. Press the key.
setting displayed when
the USER ID BYPASS
3. Select NEW USER ID using keys.
is on or when a test
is run with the
4. Press the key.
Supervisor Code Chip
module installed.
5. Type in a number from 1 – 9999999998 (10 digits). To correct, press the key

to clear the entire number, or select the incorrect digit by using the
Note: If you
keys. Then type in the correct number. type in a
User ID number that
6. Press the key. has already been
assigned, the
7. On the next screen, use the keys to select an expiration date to the message on the
right of USER ID STATUS: 6 MONTHS, 12 MONTHS, VALID or EXPIRED. screen states:
USER ###
8. Press the key to save changes. ALREADY EXISTS.
Press the ENTER key
to go back and type
The Triage module MeterPro recognizes leading 0’s as a unique character. Therefore, in a different number.

‘4341’ will be recognized separately from ‘04341.’

Using the barcode scanner or alpha mode will allow the Triage module MeterPro to accept

alpha characters and the following symbols: # ( ) * - . / \

Rev A N-21
MAIN MENU UPDATE USER ID

SET PARAMETERS 1. From the list of programmable parameters, choose USER ID

USER ID using keys.

2. Press the key.

3. Select UPDATE USER ID using keys.

4. Press the key.

5. Type in the user number you want to update. To correct, press the key
Note: If you
type in a to clear the entire number, or select the incorrect digit by using the
User ID number that
keys. Then type in the correct number.
does not exist, the
message on the
6. Press the key.
screen states:
USER ID ### DOES
7. The user ID is displayed with the expiration date. You can change the expiration
NOT EXIST.
If this happens, press date to 6 MONTHS, 12 MONTHS, EXPIRED or VALID by using the keys.
the ENTER key to VALID reconfirms the previously selected interval.
return to the previous
screen and correct 8. Press the key to save changes.
the ID number, or
press the EXIT key.
DELETE USER ID

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

using keys.

2. Press the key.

3. Select DELETE USER ID using keys.

4. Press the key.

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


Note: If you
type in a to clear the entire number, or select the incorrect digit by using
User ID number that
the keys. Then type in the correct number.
does not exist, the
message on the
6. Press the key. The message on the screen states:
screen states:
USER ID ### DOES USER ID ### WILL BE DELETED.
NOT EXIST.
7. Press the key to delete. A message on the screen tells you that the
If this happens, press
the ENTER key to number has been deleted: USER ID ### DELETED.
return to the previous
screen and correct
the ID number, or
press the EXIT key.

N-22 Rev A
USER ID LIST MAIN MENU
1. From the list of programmable parameters, choose USER ID SET PARAMETERS
using keys. USER ID

2. Press the key.

3. Select USER ID LIST using keys.

2. Press the key.

5. A list is displayed.

6. Use the keys to select the type of ID list you want: USER ID,

FROM EXPIRATION DATE, TILL EXPIRATION DATE.

• For a list of all ID numbers, select USER ID.

• For a single ID, select USER ID and type in the number.

• For a range of ID numbers, 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 change a

single number use keys to move to the number. Then type in

the new number.

7. Press the key.

8. To print the list you have chosen, press the key.

Rev A N-23
MAIN MENU RANGES

SET PARAMETERS Depending 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.

Some analytes are designed for three distinct ranges. The meter distinguishes between

two range and three range analytes in the setup screen by differentiating the symbol

between the lower and upper values.

• Analytes with a dash – Two ranges. The normal range is any value between the

two numbers displayed. Depending on the product, the normal range may be

inclusive or exclusive of the upper number. Consult the product package insert or

call Biosite Technical Services 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 the analyte as having only two ranges. If the lower number is not 0.0,

the normal range is any value less than the lower number. The first abnormal range is

any value between the two numbers and is inclusive of these numbers. These values

will be boxed on patient results. The second abnormal range is any value greater

than the upper number. These values will be in reverse video on patient results.

Consult the product package insert or call Biosite Technical Services for

clarification.

Note: The 1. From the list of programmable parameters, choose RANGES


field will be
disabled if the panel using keys.
setting is fixed.
Consult the specific 2. Press the key.
package insert to
determine if the 3. Select the test panel type using the keys.
setting may be
changed. 4. Select the analyte and level using 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 the key to clear the entire number, or select

the incorrect digit by using the keys.

5. To print a list, press the key.

6. Press the key to save changes.

N-24 Rev A
TEST SETTINGS MAIN MENU
In certain cases, the lab supervisor may wish to control which tests are available to be run SET PARAMETERS
at the time of patient testing. The options are:

1. The test is always run and cannot be deselected.

2. The test is never run and is not displayed.

3. The test can be selected by the user at the time of running the test.

4. The test can be deselected by the user at the time of running the test.

If these options are not available for a test, the meter skips over the setting as the

supervisor scrolls through the options. See pages N-26 and 0-8 for more details.

TEST MODE

It also may be appropriate for some test panels to display certain analytes Qualitatively

and others Quantitatively. Presently, Biosite does not have any test that fits this category.

This feature is reserved for future use.

Rev A N-25
MAIN MENU TEST SETTINGS

SET PARAMETERS 1. From the list of programmable parameters, choose TEST SETTINGS

using keys.

2. Press the key.

3. Select the test panel type using the keys.

4. Select the desired mode using the keys.

• ACTIVE (ACTIV on Screen) – The test will run on every patient specimen.

• INACTIVE (INACT on Screen) – The test will never run on a patient specimen and

is dropped from all displays and printouts.

• USER INACTIVE (USR I on Screen) – At the time of patient testing, the user has

the ability to select the test.


Note: When
• USER ACTIVE (USR A on Screen) – At the time of patient testing, the user has
the analyte is
deselected, the value the ability to deselect the test.
is not calculated nor • QUALITATIVE (QUAL), QUANTITATIVE (QUANT) or
stored.
SEMI-QUANTITATIVE (SEMI) using the keys.

5. Press the key to save changes.

6. To print a list, press the key.

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 will need to run before a patient sample can report a
result for that test.

N-26 Rev A
QC PARAMETERS MAIN MENU
The QC Parameters menu provides the user the options for determining what the SET PARAMETERS
maximum frequency is for running the QC Device and QC Sample and whether 1 or 2 QC PARAMETERS
levels of control are required for the QC Sample.

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 keys.

2. Press the key.

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

4. Using keys, select on of these options: NONE, 8 HOURS, DAILY,

WEEKLY, MONTHLY.

5. Press the key to save changes.

QC SAMPLE FREQUENCY

The QC SAMPLE FREQUENCY setting determines the maximum interval between

QC Sample tests that a user is allowed to run patient tests on a particular

device lot number. When the interval has lapsed, all users are locked out of

the RUN PATIENT TEST menu until a QC Sample has been successfully
run. To view when a particular device lot’s QC Sample will expire, use the

RECALL REAGENT LOTS – QC feature.

It is recommended that the QC Sample be run with every new shipment, new lot or

monthly, whichever is less when performing patient testing.

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

the keys.

2. Press the key.

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

4. Using keys, select on of these options: NONE, 8 HOURS, DAILY,

WEEKLY, MONTHLY.

5. Press the key to save changes.

Rev A N-27
MAIN MENU NUMBER OF CONTROLS

SET PARAMETERS 1. From the list of programmable parameters, choose QC PARAMETERS

QC PARAMETERS using the keys.

2. Press the key.

3. Use keys to select the information to the right of NUMBER OF CONTROLS.

4. Using keys, select one of these options: 1 or 2.

5. Press the key to save changes.

BYPASS USER ID
Note: If the This function allows the supervisor to selectively bypass the requirement to enter
bypass
a user ID before performing any test.
is ON, the User ID
requirement is 1. From the list of programmable parameters, choose BYPASS
disabled and therefore using the keys.
not required.
When the bypass is 2. Press the key.
OFF, the User ID
requirement operates 3. Select USER ID using the keys.
as normal and is
required. 4. Use keys to select from two options: ON or OFF.

5. Press the key.

N-28 Rev A
Install Code Chip
Purpose
The 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

of controls. Lot number begins with a C.

• QC Device Code Chip module – included in the black

QC Device box (comes with the Triage MeterPro) and

is labeled with the serial number of the QC Device.

• Supervisor Access Code Chip module – included with

each Triage® MeterPro. Lot Number begins with SPR.

• Software Upgrade Code Chip module – sent

separately when Triage MeterPro software


Software
upgrades are available. Version Number

CAUTION: Running tests with the Supervisor Code Chip module installed disables all

QC Lockouts. Remove the Supervisor Code Chip module prior to running tests.
Rev A N-29
MAIN MENU Installation of Reagent, QC Sample or QC Device Code Chip modules.
INSTALL CODE CHIP

1. From the MAIN MENU select INSTALL CODE CHIP using keys.

2. Press the key.

3. Slide the Code Chip module into the Code Chip module Port in the Triage

MeterPro, as shown in the picture.

Code Chip module

Code Chip module Port

4. Press the key.

5. The meter will display a confirmation message that the information was installed

into the Triage MeterPro’s memory.

6. Press the key to return to acknowledge the message.

7. Remove the Code Chip module from the Code Chip module Port.

Installation of Supervisor Code Chip module


The Supervisor Code Chip needs only to be inserted into the Code Chip module Port to

activate the supervisor functions. This is an automatic function and standard Code Chip

module installation is not necessary.

N-30 Rev A
Operation
Access to The Triage MeterPro
Function Use Restricted to

RUN TEST Patient Testing operators with valid User ID numbers*


Quality Control Testing operators with valid User ID numbers*

RECALL RESULTS Patient Testing


Quality Control Testing

INSTALL CODE CHIPS Types of Code Chips


Installation Procedure

SET PARAMETERS Access Control Supervisor


Programmable Settings Supervisor

DELETE RESULTS Patient Test Results Supervisor


Note: Access
* Unless User ID is bypassed or the Supervisor Code Chip module is installed.
to various
parts of the software
is user (institution)
defined
IMPORTANT: The last two functions, SET PARAMETERS, and DELETE RESULTS,

appear on the main menu only when the Supervisor Code Chip module is inserted

into the Code Chip module Port. The Supervisor Code Chip module should be

removed from the meter during routine patient and quality control testing.

Rev A O-1
Run Test
Purpose
Run Test is used for the analysis of a test.

Options
The Run test function allows you to test:

• QC Device

• QC Sample

• Patient Sample

In order to run a patient sample, the meter requires:

1. A valid User ID has been entered (unless this feature is bypassed or a Supervisor

Code Chip module is installed). See page N-21.


Note: The
Supervisor 2. A QC Device has passed within the specified time period. See page O-3.
Code Chip module
3. A QC Sample for the test device lot has passed within the specified time
provides access to
functions that may period. See page O-5.
override these
Lockouts. If any of these conditions exist, the meter will not continue and will prompt the user to

perform the required steps.

Note: If the IMPORTANT: The Triage MeterPro will alert the user if QC has not been performed
Triage MeterPro’s
for the device lot being tested.
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
the test using a new
device.

O-2 Rev A
QC DEVICE MAIN MENU
The QC Device should be run on each day of patient testing. It is desirable to run the RUN TEST
QC Device after the meter has been inactive for at least 30 minutes.

To run the QC Device test:

1. Press the key to power The Triage MeterPro on.

2. Select RUN TEST using keys.

The Main Menu

3. Press the key.

4. Type in your identification number (User ID). To correct, press the key to Note: If the
clear the entire number, or select the incorrect digit by using the User ID bypass
is ON, the meter will
keys then type in the correct number. not ask you to enter a
User ID.
5. Press the key

6. Select QC DEVICE using keys.

“EXP” indicates that the


QC Device re-test
frequency has expired.

Menu screen as it looks when operator


selects QC Device.
Note: The meter
7. Press the key. will prompt the
user to install the QC
8. Gently insert the QC Device into the Triage MeterPro until you feel Device Code Chip
module if the QC
the QC Device catch on the pin and hear an audible ‘click.’ Device has not been
run before.
9. Press the key.

Rev A O-3
MAIN MENU 10. The Triage MeterPro pulls in the QC Device and scans it. The test

RUN 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 the meter’s screen.

12. Press the key to make a printed copy of the results.

IMPORTANT INSTRUCTIONS FOR ALL TESTS:

After the test a. Gently insert the test device into the Triage MeterPro until you feel
device has been the
inserted, do not push
device catch on the pin. You will hear an audible ‘click’ that tells you
the device in further or
attempt to pull it out. the test device has been inserted properly.
The device may be
ejected by returning to b. Press the key to start the test.
the Main Menu and
pressing the EXIT key. c. The 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.

IMPORTANT INSTRUCTIONS FOR QC DEVICE TESTS:

• Dust, lint, fibers and other small particles may interfere with the QC Device.

Keep the QC Device free of contaminants.

• The QC Device is light-sensitive and should be stored in its black

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, call

Biosite Incorporated Technical Services at 1-888-BIOSITE.

• Note: the QC Device does not expire.

O-4 Rev A
QC SAMPLE MAIN MENU
To run the Quality Control sample: RUN TEST

1. Press the key to power The Triage MeterPro on.

2. Select RUN TEST using keys.

The Main Menu


3. Press the key.

4. Type in your identification number (User ID). To correct, press the key to Note: If the
clear the entire number, or select the incorrect digit by using the User ID bypass
is ON, the meter will
keys then type in the correct number. not ask you to enter a
User ID.
5. Press the key.

6. Select QC SAMPLE using keys.

Menu screen as it looks when operator


selects QC Sample.
7. Press the key.

8. Enter the QC lot number from the label on the side of the vial containing the QC
Note: Only
Sample. enter the four
digit numeric value of
the QC lot number
Do not enter the
preceding alpha
character.

Rev A O-5
MAIN MENU 9. To correct, press the key to clear the entire number, or select the
RUN TEST incorrect digit by using keys. Then type in the correct number.

Note: If you 10. Press the key.


enter a QC lot
number for which 11. Perform the test according to the instructions provided in the package of test
there is no data in the
devices you are using.
Triage MeterPro’s
memory, you will see a
IMPORTANT INSTRUCTIONS FOR ALL TESTS:
message on the
meter’s screen:
a. Gently insert the test device into the Triage MeterPro until you feel
NO QC SAMPLE
DATA IN MEMORY. the
To correct this:
device catch on the pin. You will hear an audible ‘click’ that tells you
Install the QC Sample
the test device has been inserted properly.
Code Chip module
(see picture on page
b. Press the key to start the test.
N-29).
Press the ENTER key
c. The Triage® MeterPro pulls in the test device and scans it.
to continue.
d. When the test is complete, the meter will beep and display the results
After the test
on the meter’s screen.
device has been
inserted, do not push
e. Press the key to make a printed copy of the results.
the device in further or
attempt to pull it out.
The device may be
ejected by returning to 12. Repeat steps for each quality control sample.
the Main Menu and
pressing the EXIT key.

IMPORTANT INSTRUCTIONS FOR QC SAMPLE TESTS

a. If the test device’s internal quality control (QC) results are unacceptable,

the results for the affected analyte(s) will not appear on the screen.

b. If any of the QC Sample results are out of range, the results for that

particular analyte will be in reverse video (light text on a dark background)

and flagged with a # symbol.

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.

d. If an individual analyte is outside the specified range, the 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.

O-6 Rev A
PATIENT SAMPLE MAIN MENU
1. Press the key to power The Triage® MeterPro on. RUN TEST

2. Select RUN TEST using keys.

The Main Menu

3. Press the key.

4. Type or scan in your identification number (User ID). To correct, press the key Note: If the
to clear the entire number, or select the incorrect digit by using the User ID bypass
is ON, the meter will
keys then type in the correct number.
not ask you to enter a
User ID.
5. Press the key.

6. Select PATIENT SAMPLE using keys.

Menu screen as it looks when operator


selects Patient Sample.

7. Press the key.

8. Type or scan the patient’s identification number (Patient ID). To correct, press the
Note: If the
key to clear entire number or select the incorrect digit using Bar Code
then type in the correct number. Scanner is being
used, simply point
9. Press the key. the scanner at the
bar code, press the
button on the scanner
handle and wait for
the beep. The number
will appear on the
display.

Rev A O-7
MAIN MENU 10. If the information is correct, press the key to confirm the Patient ID.
RUN TEST If the information is incorrect:

• Select CORRECT PATIENT ID using keys.

• Press the key.

• Press the key to clear the entire number or select the

incorrect digit using keys, then type in the correct number.

• Press the key.

11. If the Auxiliary ID feature is activated, type or scan in the number. To correct,

press the key to clear entire number or select the incorrect digit using
keys, then type in the correct number.

12. Press the key.

13. Prepare the test sample and perform the test in accordance to the instructions

provided in the package of test devices you are using.

14. If the testing facility has authorized an analyte to be selected or deselected at the

time of running a patient test, the user will be prompted to select desired analytes

or deselect undesired analytes. After the test device has been pulled into the meter,

the meter will display a message similar to the following:

SELECT TESTS CARDIAC


✓ CKMB
1 MYO
2 ✓ TNI
Note: At least
one analyte
PRESS ^ TO PAUSE OR 0-9 FOR TEST
must be selected in PRESS ENTER TO CONTINUE OR EXIT
order to continue
testing. A check mark ✓ indicates tests which are selected. Example: ✓ TNI

The absence of a check mark indicates which tests have not been selected.

Example: MYO

A number to the left of the test indicates tests which can be selected or deselected.

Example: 1 MYO indicates that MYO is currently not selected, but can be

selected by pressing 1 on the numeric keypad to display 1 ✓ MYO.

Example: 2 ✓ TNI indicates that TNI is currently selected, but can be deselected

by pressing 2 on the numeric keypad to display 2 TNI.

Pressing the number again toggles the test between select and deselect.

O-8 Rev A
No number to the left of the test indicates tests which cannot be altered.
Note: If no key
is pressed on
Example ✓ CKMB indicates that CKMB is always selected, and cannot be
the Select Tests
deselected. screen, the meter
waits 30 seconds then
• Press the key. proceeds using only
the selected default
• If the information is correct, press the key to continue. tests. Similarly, if no
key is pressed on the
• If the information is incorrect, select CORRECT TEST using keys
Confirmation Screen,
and press the key to return to the lists of tests. the test proceeds after
waiting 30 seconds.
IMPORTANT INSTRUCTIONS FOR ALL TESTS:

a. Gently insert the test device into the Triage® MeterPro until you feel the After the test
device catch on the pin. You will hear an audible ‘click’ that tells you device has been
inserted, do not push
the test device has been inserted properly. the device in further or
attempt to pull it out.
b. Press the key to start the test. The device may be
ejected by returning to
c. The Triage® MeterPro pulls in the test device and scans it. the Main Menu and
pressing EXIT.
d. When the test is complete, the meter will beep, eject the device and

display the results on the meter’s screen.

e. Press the key to make a printed copy of the results.

IMPORTANT INSTRUCTIONS FOR PATIENT TESTS:

a. If the test device’s Internal Quality Control (QC) results are unacceptable,

the results for the affected analyte(s) will not appear on the screen.

b. If any of the QC Sample results for the lot being tested were out of range,

the results for that particular analyte will not appear on the screen.

Screen displaying patients results Screen displaying patients results


below the cut off levels and above the cut off levels and TNI
accept or reject instructions. results in the indeterminate range.

Rev A O-9
Recall Results
Purpose
Recall Results is used to retrieve results stored in the Triage MeterPro’s memory.

Function

Note: If a result The Recall Results function can retrieve these results:
was rejected by • Last Record • QC Results
the user, an “R” will
• Patient Results – Internal QC Results
appear next to the
recalled result. – Patient ID – QC Sample Results

– Panel Type – QC Device Results

– Test Device Lot Number (L/N) – Reagent Lots – QC

– User ID – Archive Last Test

– From Date • Print all Results

– Till Date – Patient Results

– QC Sample Results

– QC Device Results
• Upload Results to LIS

IMPORTANT NOTE: To safeguard the User ID Lockout, displayed and printed

User ID numbers are partially masked. The Supervisor Code Chip module is

required to be installed to view the full User ID.

MAIN MENU LAST RECORD

RECALL RESULTS 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 Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using keys.

3. Press the key.

4. Select LAST RECORD using the keys.

5. Press the key.

6. The results from the last test run appear on the screen.

7. Use to view the entire patient record.

8. Press the key to make a printed copy.

O-10 Rev A
PATIENT RESULTS MAIN MENU
Options: Patient results can be retrieved based on a variety of criteria: RECALL RESULTS
• Patient ID

• Test Device Lot Number (L/N)

• User ID

• From Date

• Till Date

PATIENT ID MAIN MENU

To retrieve results based on the patient ID: RECALL RESULTS

PATIENT RESULTS
1. Press the key to power The Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using the keys.

3. Press the key.

4. Select PATIENT RESULTS using keys.

5. Press the key.

6. Choose the results you want to see: Note: You may


choose more
• If you want to see all patient results, press the key. All the patient than one of the options
results in the Triage MeterPro’s memory will be displayed. for recalling results in
order to define more
• For individual patient results: precisely the
information you want
a. Select Patient ID using keys. to recall from the
Triage MeterPro’s
b. Type or scan in the patient ID number. To correct, press the key to clear memory. When you
choose multiple
the entire number, or select the incorrect digit by using the keys. options, first input
Then type in the correct number. numbers in all the
categories you have
c. To select a patient ID number with alpha characters, use the key in chosen. Then press
the ENTER key.
place of the alpha character.

d. Press the key. All results of the requested patient ID number

will be displayed.

7. Press the key to make a printed copy.

Rev A O-11
MAIN MENU TEST DEVICE LOT NUMBER (L/N)

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

PATIENT RESULTS

The lot number of the test device is found on


the device and on the outer box

1. Press the key to power The Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using the keys.

3. Press the key.

4. Select PATIENT RESULTS using keys.

5. Press the key.

6. Select DEVICE L/N using keys.

7. To display all results, press the key.

8. To display results specific to one lot, type in the lot number of the test device.
Note: Only enter
the five digit To correct, press the key to clear the entire number, or select the incorrect
numeric value of the
digit by using the keys. Then type in the correct number.
QC lot number

9. Press the key.

10. All results from test run on the requested lot number are displayed.

11. Press the key to make a printed copy.

O-12 Rev A
USER ID MAIN MENU
To retrieve results from tests run on the Triage MeterPro starting with the user you select: RECALL RESULTS

PATIENT RESULTS
1. Press the key to power The Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using the keys.

3. Press the key.

4. Select PATIENT RESULTS using keys.

5. Press the key

6. Select USER ID using keys.

7. To display all results, press the key.

8. To display results specific to one User ID, type in the User ID number. To

correct, press the key to clear the entire number, or select the

incorrect digit by using the keys. Then type in the correct number.

9. Press the key.

10. All results from tests run by requested user are displayed.

11. Press the key to make a printed copy.

Rev A O-13
MAIN MENU FROM DATE

RECALL RESULTS To retrieve results from tests run on the Triage MeterPro starting with a date you select:

PATIENT RESULTS
1. Press the key to power The Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using the keys.

3. Press the key.

4. Select PATIENT RESULTS using keys.

5. Press the key

6. Select FROM DATE using keys.

7. To display all results, press the key.

8. To display results specific to one date, type in the date. To correct,

press the key to clear the entire number, or select the incorrect digit

by using the keys. Then type in the correct number.

9. Press the key.

10. All results from tests run from the date selected are displayed.

11. Press the key to make a printed copy.

O-14 Rev A
TILL DATE MAIN MENU
To retrieve results from tests run on the Triage MeterPro before and including a date RECALL RESULTS
you select: PATIENT RESULTS

1. Press the key to power The Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using the keys.

3. Press the key.

4. Select PATIENT RESULTS using keys.

5. Press the key

6. Select TILL DATE using keys.

7. To display all results, press the key.

8. To display results specific to one date, type in the date. To correct,

press the key to clear the entire number, or select the incorrect digit

by using the keys. Then type in the correct number.

9. Press the key.

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

are displayed.

11. Press the key to make a printed copy.

Rev A O-15
MAIN MENU QC RESULTS

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

Triage MeterPro’s memory:

Note: You may Quality Control (QC test) Results can be retrieved by:
choose more
Internal QC Results (on Patient Tests) Panel Type
than one of the
Device Lot Number (L/N)
options for recalling
results in order to User ID Number
more precisely define From Date
the information you Till Date
want to recall from View All (Default)
the Triage MeterPro’s
memory. When you QC Sample Results Panel Type
choose multiple QC Sample Lot Number (L/N)
options, first make Device Lot Number (L/N)
selections and input User ID Number
numbers in all the From Date
categories you have
Till Date
chosen. Then press
View All (Default)
the ENTER key.
QC Device Results User ID Number
From Date
Till Date
View All (Default)

Reagent Lots – QC (Defaults to View All)

To retrieve QC Results for the Internal QC, the QC Sample and the QC Device, select

the option you want and follow the directions.

O-16 Rev A
QC SAMPLE LOT NUMBER (L/N) MAIN MENU
To retrieve results based on the lot number of the QC Sample used: RECALL RESULTS

QC RESULTS
1. Press the key to power The Triage MeterPro on.
QC SAMPLE RESULTS
2. From the MAIN MENU select RECALL RESULTS using the keys.

3. Press the key.

4. Select QC RESULTS using keys.

5. Press the key.

6. Select QC SAMPLE RESULTS using keys.

7. Press the key.

8. Select QC SAMPLE L/N using keys.

9. Type in the QC Sample lot number. To correct, press the key to

clear the entire number, or select the incorrect digit by using the

keys. Then type in the correct number.

10. Press the key.

11. All QC results that have been run on the requested QC Sample lot number are

displayed.

12. Press the key to make a printed copy.

Note: To display
all results, leave
the QC Sample L/N
blank.

Rev A O-17
MAIN MENU DEVICE LOT NUMBER (L/N)

RECALL RESULTS To retrieve QC Sample results based on the lot number of the test devices used:

QC RESULTS

INTERNAL QC RESULTS
QC SAMPLE RESULTS

The lot number of the test devices is on the


box that contains the test devices.

1. Press the key to power The Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using the keys.

3. Press the key.

4. Select QC RESULTS using keys.

5. Press the key.

6. Select the appropriate menu, INTERNAL QC RESULTS or QC SAMPLE RESULTS


using keys.

7. Press the key.

8. Select DEVICE L/N using keys.

9. Type in the device lot number from the side of the box of test devices. To

correct, press the key to clear the entire number, or select the
incorrect digit by using the keys. Then type in the correct number.

10. Press the key.

11. All QC results that have been run on the requested lot number are displayed.

12. Press the key to make a printed copy.

O-18 Rev A
USER ID MAIN MENU
To retrieve QC results from tests run on the Triage MeterPro starting with the user you select: RECALL RESULTS

QC RESULTS
1. Press the key to power The Triage MeterPro on.
QC SAMPLE RESULTS
2. From the MAIN MENU select RECALL RESULTS using the keys. QC SIMULATOR RESULTS

3. Press the key.

4. Select QC RESULTS using keys.

5. Press the key.

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

using keys.

7. Press the key.

8. Select USER ID using keys.

9. Press the key

10. Type in the user ID number. To correct, press the key to clear the

entire number, or select the incorrect digit by using the keys.

Then type in the correct number.

11. Press the key.

12. All QC results from tests run by requested user are displayed.

13. Press the key to make a printed copy.

Rev A O-19
MAIN MENU FROM DATE

RECALL RESULTS To retrieve QC results from tests run on the Triage MeterPro starting with a date you select:

QC RESULTS
1. Press the key to power The Triage MeterPro on.
INTERNAL QC RESULTS
QC SAMPLE RESULTS 2. From the MAIN MENU select RECALL RESULTS using the keys.
QC SIMULATOR RESULTS
3. Press the key.

4. Select QC RESULTS using keys.

5. Press the key.

6. Select the appropriate menu, INTERNAL QC RESULTS, QC SAMPLE RESULTS

or QC DEVICE RESULTS using keys.

7. Press the key.

8. Select FROM DATE using keys.

9. Press the key

10. Type in the date. To correct, press the key to clear the entire

number, or select the incorrect digit by using the keys.

Then type in the correct number.

11. Press the key.

12. All results from tests run from the date selected are displayed.

13. Press the key to make a printed copy.

O-20 Rev A
TILL DATE MAIN MENU
To retrieve QC results from tests run on the Triage MeterPro before and including a date RECALL RESULTS
you select: QC RESULTS

INTERNAL QC RESULTS
1. Press the key to power The Triage MeterPro on.
QC SAMPLE RESULTS
2. From the MAIN MENU select RECALL RESULTS using the keys. QC SIMULATOR RESULTS

3. Press the key.

4. Select QC RESULTS using keys.

5. Press the key.

6. Select the appropriate menu, INTERNAL QC RESULTS, QC SAMPLE RESULTS


or QC DEVICE RESULTS using keys.

7. Press the key.

8. Select TILL DATE using keys.

9. Press the key

10. Type in the date. To correct, press the key to clear the entire

number, or select the incorrect digit by using the keys.

Then type in the correct number.

11. Press the key.

12. All results from tests run before and including the date selected are displayed.

13. Press the key to make a printed copy.

Rev A O-21
MAIN MENU REAGENT LOTS – QC

RECALL RESULTS A list of Reagent Code Chip modules in memory, along with corresponding expiration

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

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

• 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 module 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.

The Reagent Lots – QC Screen

ARCHIVE LAST TEST

This function will save detailed information regarding the last performed test for analysis

by Biosite. Use this function when requested by Biosite Technical Services.

This function should be used when a very unusual test result is received and when the

laboratory wishes to have the meter evaluated further. ARCHIVE LAST TEST will only be

able to save data from the most recent test run.

O-22 Rev A
PRINT ALL RESULTS MAIN MENU
Options: All stored results can be printed from the Triage MeterPro’s memory. RECALL RESULTS
• Patient Results

• QC Sample Results

• QC Device Results

PATIENT RESULTS MAIN MENU

To print all Patient Results: RECALL RESULTS

PRINT ALL RESULTS


1. Press the key to power The Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using the keys.

3. Press the key.

4. Select PRINT ALL RESULTS using keys.

5. Press the key.

6. Select PATIENT RESULTS using keys.

7. Press the key to make a printed copy.

QC SAMPLE RESULTS

To print all QC Sample Results:

1. Press the key to power The Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using the keys.

3. Press the key.

4. Select PRINT ALL RESULTS using keys.


Note: When
printing
5. Press the key.
large quantities of
patient results, it is
6. Select QC SAMPLE RESULTS using keys.
recommended to
first insert a full roll
7. Press the key to make a printed copy.
of paper.

Rev A O-23
MAIN MENU QC DEVICE RESULTS

RECALL RESULTS To print all QC Device Results:

PRINT ALL RESULTS


1. Press the key to power The Triage MeterPro on.

2. From the MAIN MENU select RECALL RESULTS using the keys.

3. Press the key.

4. Select PRINT ALL RESULTS using keys.

5. Press the key.

6. Select QC DEVICE RESULTS using keys.

7. Press the key to make a printed copy.

MAIN MENU UPLOAD RESULTS TO LIS

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

QC 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.

O-24 Rev A
Delete Results
Purpose
The Delete function is used to remove patient test information from the Triage MeterPro

memory. This becomes necessary when the meter memory becomes full. Note: The
delete function
Triage MeterPro Memory is available only when
the Supervisor Code
Within the Triage MeterPro, Patient Result memory can hold 750 data sets, QC Sample
Chip is inserted in
can hold 200 data sets and QC Device memory can hold 250 data sets. When the the Triage MeterPro
memory is full, the oldest result is automatically overwritten when a new result is added. Code Chip module
Port.
The meter display alerts the user as the memory becomes full.

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 Results will not be deleted.

Rev A O-25
MAIN MENU DELETE PATIENT RESULT

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

reversible, the meter will require two confirmations of intent to delete results.

1. Insert the Supervisor Code Chip module in the Code Chip module Port.

Code Chip module

Code Chip module Port

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

The Supervisor’s Main Menu

3. Press the key.

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

the key).

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

7. Press the key to delete all results. (If you do not want to delete all
Note: Press
the EXIT key results, press the key).
to cancel at any time
before step 7.

O-26 Rev A
Display Backlight
DISPLAY BACKLIGHT
The 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 button on the keypad.

When the backlight button is pressed, the backlight initially comes on at maximum

brightness. Subsequent presses cycle the backlight from bright to dim and then to off.

To save power, the backlight turns off if no keys have been pressed for 15 seconds.

Pressing any key will restore the backlight to the previous level.

Rev B O-27
Alpha Numeric Mode
ALPHA NUMERIC MODE
The Triage MeterPro has the capability for the operator to enter both numeric and alpha

characters from 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 word ALPHA shown on the display,

until the key is pressed again.

When in alpha mode, pressing any key causes the alpha character to be displayed.

1– – , / 7–P Q R S

2–A B C 8–T U V

3–D E F 9–W X Y Z

4–G H I 0 – no alpha character is displayed

5–J K L . – no alpha character is displayed

6–M N O

The first press of a button causes the first letter to be displayed. The second press of the

same button within three seconds causes the second letter to be displayed. The third

press of the same button within three seconds causes the third letter to be displayed.

After the last character in a sequence is displayed, the next button press of the same

button within 3 seconds displays the first character and the sequence is repeated.

If more than three seconds pass without the operator pressing the button, the next press

of that button causes the first character to be displayed. If a new button is pressed, the

first character of the new button is displayed with subsequent presses repeating the

sequence.

O-28 Rev A
Total Quality Assurance
Introduction
Quality assurance programs control and monitor analytical methods. The quality control Note: For more
detailed
of analytical methods achieves two basic goals: information, call Biosite
Technical Services at
1. Ensures that the reagents and instrument are working properly 1-888-BIOSITE
2. Ensures that the procedure was performed correctly (1-888-246-7483)
24 hours a day/7 days
The mechanism by which analytical methods are traditionally controlled is through the a week.

use of liquid control specimens containing known amounts of analytes.

Over the last 15 years advances in technology have changed the manner in which the

diagnostic reagents are configured. Assay systems for the Point-of-Care are generally

unitized testing devices that are distinct from traditional laboratory based analyzers.

The Triage tests are unitized tests that do not require additional reagents. Each device

contains a full complement of reagents that are required to perform the immunoassay.

The Triage tests have been designed to include assay controls in each test device that

monitor the assay procedure and the reagent integrity. The assay controls present 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 Triage® tests require the need to
re-think the frequency with which external quality control specimens should be tested.

The Triage tests have been designed to yield long-term reagent stability. In addition, the

system provides quality control parameters in three separate and distinct categories:

• Internal device controls

• Meter electronic controls

• Software controls.

The combination of these quality control features provides more information about the

validity of each assay than can be provided by the more traditional methods of reagent

and assay procedure validation.

Rev A M-1
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 Positive Control Zone is a functional immunoassay. This control verifies that

the device functioned properly and that the assay was correctly performed. The Internal

Positive Control Zone ensures that the antibodies, the reagent reconstitution, the timegate

and the device flow are functioning properly. The manufacturer sets acceptable ranges for

the control zone for each lot of reagents.

The Baseline Control Zone monitors the presence of interfering substances in the patient
sample that may alter the immunoassay process. If a specimen contains a substance that

has a major effect on the high and low controls and the baseline control and thereby on

the immunoassay, the results are not displayed and erroneous results are not reported.

The Timing Control Zone monitors assay completion. If an inadequate amount of


specimen is added to the test device or if a specimen clots in the device, this control will

prevent the display of the results.

A Trace QC algorithm has been programmed which evaluates the size, location and signal
to noise ratio of each zone on the device. Aberrations in zone quality exceeding preset
limits will cause rejection of one or more of the assay results.

M-2 Rev A
Meter Quality Assurance
The Self-Test Mode is initiated each time the meter is turned ON. In the self-test mode the
meter scans an Internal Calibration Chip. Each calibration chip scan is used to validate
and adjust, if necessary, the meter calibration. In the self-test mode, the available memory
for patient results is checked. When the capacity is below a pre-set limit, the remaining
capacity is related via a screen message. The software program is evaluated and is
terminated if corrupted. Software test 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 pre-programmed acceptable ranges for the six zones. In addition, the
zones allow the meter to check for horizontal and vertical alignment of the zone measurement
to verify 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 prevent the use of expired reagents.

Software Quality Assurance


The software QA is controlled through a variety of software features, some of which can
be optional depending on the environment in which the assay is performed. In a Point-of-
Care location, a designated supervisor 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 to meter functions not available to the routine user. The additional functions
are selection of parameter settings and downloading and deletion of results from the
meter memory.

A User ID# can be assigned in the software to limit access to the patient testing mode to
only those individuals 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 patient results generated by the user. This allows the
supervisor to review users’ testing frequency, and in the event of frequent test failures, to
identify potential problems in training.

An additional security feature of the User ID is the partial masking of the ID Number on displays
and printouts. This prevents unauthorized individuals from detecting and using an existing User
ID number. This feature is overridden when the Supervisor Code Chip module is installed

A Patient ID# is required for all patient tests performed. All QC sample and patient results
are stored in the meter’s memory and can be downloaded to a laboratory information
system (LIS) or an external data management software program for further viewing and
printing of quality control reports.

Rev A M-3
The Supervisor can select the QC Frequency for performing external liquid control

samples. When it is time to perform external QC samples, the user must test the 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 communicated to and used by the physician.

Additionally, if test devices are expired, a QC Lockout function is activated and prevents

testing using expired test devices.

Quality Control Samples


It is still valuable to apply the traditional approach to quality control by testing quality

control samples. These controls will check the total integrity of the system. The interval for

analyzing these controls, however, can be extended due to the many other Total Quality

Assurance features inherent in the Triage tests.

The Triage tests have been designed to maximize Total Quality Assurance in any testing

environment. The combination of the QC features of the 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, Biosite Incorporated makes the following QC recommendations:

• Run two levels or POS and NEG external liquid control samples as appropriate with

each new lot of reagents and once every thirty days with continued use of the same

reagent lot number

• Run the QC Device daily

Notes Regarding Software Controls


1. User ID Access

• To prevent untrained persons from performing a test, a User ID (1-9 digits 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.

• 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 RESULTS from memory or

INSTALL NEW CODE CHIP.

M-4 Rev A
2. Out-of-Range Flags

• If a patient is outside the normal range for any of the analytes, then the result will

be flagged by reverse video, that is, the background of the result will be black and

the value in white numbers. A warning will be displayed below the results:

• If the Internal QC zones for the device or a specific analyte are unacceptable, the

analyte(s) in question display an exclamation point ( ! ) in place of a value and a

warning is displayed: ! INTERNAL QC OUT OF RANGE.

• If the QC Sample for a specific analyte on that device lot is unacceptable, the

analyte 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

a warning is displayed: # QC SAMPLE ! INT. QC 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. 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 Triage MeterPro.

Rev A M-5
Service and Maintenance Procedures
Service and Maintenance Procedures
If any service or maintenance is required, the Triage MeterPro should be sent to the

manufacturer. No maintenance other than paper / battery replacement and periodic

external cleaning is required of the operator.

Paper Replacement

Changing Paper Between Functions

1. Tear off any excess paper sticking out of the Triage MeterPro.

2. Remove the paper compartment cover by pulling up on the cover as indicate by

the arrow on the back of the cover.

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
Note: The
printer contains angle, as the printer must sense the edge of the paper along the feed path.
a paper sensor and
will feed the new
paper roll only when
paper with a clean
straight line is pressed
into the paper roller.

Note: If PAPER
FEED button is
pressed before the
5. Insert the new roll of paper into the paper compartment.
printer senses the
paper, the printer will 6. Position the paper such that the paper will feed from under the roll (as opposed
not respond to the
to over the top of the roll, see picture, above).
command.
7. Insert the paper edge under the paper roller (platen) until it firmly seats or

Note: The resistance is felt.


printer utilizes
8. Press the key.
thermal paper, if the
printed paper is blank 9. Replace the cover of the printer and continue operation.
after replacing a roll,
verify that the paper
roll is not upside down.

M-6 Rev A
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 indicated

by the arrow on the back of 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 printer must 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 clean
straight 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
Note: If PAPER
to over the top of the roll, see picture, above). FEED button is
7. Insert the paper edge under the paper roller (platen) until it firmly seats or a pressed before the
printer senses the
resistance is felt. paper, the printer will
8. Press the key. not respond to the
command.
9. When the printer begins to pull the paper in, release the paper. The printer will

feed a few lines and re-commence the print job. To ensure no data is lost, the
Note: The
printer will reprint up to the previous 5 lines. printer utilizes
10. After the paper has appeared above the printer, replace the printer cover, taking thermal paper, if the
printed paper is blank
care to ensure the paper does not get caught inside the meter.
after replacing a roll,
verify that the paper
roll is not upside down.

Rev A M-7
Cleaning

The 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 and water solution on the outside of the meter, wipe the
Note: Never
insert any tools, meter dry using a soft cloth or absorbent tissue. Do not allow water to seep into the
swabs, or cleaning printer. Do not immerse the meter in water or other liquids.
materials into the
device track. If blood or other fluids are not

allowed enough time to fully


Note: The meter absorb into test devices, the
is designed to
device track door may occasionally
perform and print at
least 100 tests before require cleaning. Using a cotton
replacement batteries swab dampened with isopropyl
are required. When
the meter is not in alcohol and a pair of tweezers,
use, it should be carefully lift the door and clean
turned off. To
preserve battery life, both front and back of the door.
ensure the AUTO
POWER-OFF function
is set to 1/2 HOUR. Check Battery Level

The Triage MeterPro checks the active power source after ejecting a device or printing.

To check the battery power, navigate to the Main Menu, disconnect the AC power

supply, press the key (the meter attempts to eject the device), and look for the
Note:
Low Power Indicator on the Main Menu of the meter display. If the flashing indicator
Rechargeable
batteries are appears, replace the batteries.
authorized for use,
however, due to the
nature of these types
Battery Replacement
of batteries, it is
expected they will • Turn off the meter.
require recharging • Remove the battery cover from
more frequently. The
Triage MeterPro does the bottom of the meter by
not contain a built-in sliding the cover in the direction
battery charger,
rechargeable batteries of the arrow.
must be recharged • Remove the batteries and
outside of the meter.
discard them in an appropriate

waste container.
Note: If the
meter does not • Insert four size AA 1.5 volt batteries into the battery compartment. Be sure that the
power on after plus (+) and minus (-) signs of the batteries match the same signs embossed in the
replacing batteries,
verify the batteries are battery compartment.
lined up according to • Replace the cover to the battery compartment.
the symbols in the
battery compartment.
M-8 Rev A
Troubleshooting — Meter Symptoms
Symptom Probable Cause Corrective Action

Invalid Results a. Inappropriate body fluid or improperly a. Retest sample using a new test device
anticoagulated sample. with a proper specimen.

b. Sample size incorrect—too little sample. b. Retest sample on a new test device. Make
Test device’s internal QC controls will be sure the entire tube is full. Be certain the
out of range. lower bulb on the pipette tube contains a
small amount fluid before you press the
top bulb.

c. Meter was picked up or carried vertically c. If less than 30 minutes has passed since
while test was running. The test device’s preparing the test device, place meter on
internal QC controls will be out of range. flat surface and reinsert the test device. If
more than 30 minutes has passed, retest
sample on new test device. If meter must
be moved during test, carry the meter
parallel to the floor.

Meter will not pull test Hook that pulls test device into the meter If meter repeatedly fails to pull the device in,
device in. may be broken. the meter may need to be replaced. Call
Technical Services.

Code Chip module will not a. Code Chip module may have been a. Re-insert Code Chip module right side up.
fit in meter. inserted upside down.

b. Code Chip module or Meter contacts b. Try new Code Chip module, if available. If
could be bent. still not a good fit, call Technical Services.

Printer works but no print Paper may be installed backwards. Install paper reverse to current position.
appears on paper.

Printer jam. Paper may have been fed into the meter Carefully remove old paper out of the printer.
improperly. Do not insert any tools into the printer.

Printer stops printing Battery power low. Replace batteries or verify power cord is
or skips a line. installed in the meter and wall outlet.

Meter will not power on a. Batteries not installed, drained or a. Verify batteries are installed and correctly
or meter powers off when incorrectly aligned. aligned (+) and (-); replace batteries if
running a test. necessary.

b. Power source not plugged in. b. Verify power cord is installed in the meter
and wall outlet.

Blinking battery icon. Low battery power. Replace batteries.

Meter contains no batteries All data is saved in the Meter except date
or batteries are low when and time. Reset date and time.
facility has loss of power.

Biosite Technical Services 1-888-BIOSITE (1-888-246-7483 24 hours a day/7 days a week)

Rev A M-9
Troubleshooting — Meter Message or Symptom
Message Probable Cause Corrective Action
>XXX.X Patient sample concentration is above the See instructions that came in the box of
dynamic range. test devices or call Technical Services.
<XX.X Patient result is below the dynamic range or For some parameters, a 0.0 ng/ml patient
is a concentration below the statistically result may be appropriate.
determined lowest test concentration.
BATTERY LOW. Batteries need replacement. Replace with 4-AA batteries or use the AC
power adapter as a power source.

CANNOT READ BAR CODE Damaged bar code or meter hook may be Look for particles on the bar code of the
broken. (The meter hook pulls the test device test device. wipe off with a dry cloth.
into the meter.) Repeat the test.

CANNOT READ a. Code Chip module error. a. • Ensure Code Chip module is completely
CODE CHIP. inserted.
• Try a reagent Code Chip module from a
different box of devices of the same lot
number.
• If a new Code Chip module eliminates
the message, the original Code Chip
module is at fault, discard Code Chip
b. Meter error. module.

b. If the new Code Chip module does not


work, install a known working Code Chip
module to verify proper operation. If the
Code Chip module fails to work, contact
Technical Services.

DETECTOR FAILURE Optics Detector did not properly power on. Power meter off and wait 15 seconds. Power
meter on. If message fails to clear, contact
Technical Services.

MEASUREMENT FAILURE. a. Inappropriate body fluid or improperly a. Retest sample using new device with a
anticoagulated sample. proper specimen.

b. Sample size incorrect – too little sample. b. Retest sample on new device. Be certain
the lower bulb on pipet contains a small
amount of fluid and the entire tube is full
before dispensing contents.

c. Meter picked up or carried vertically while c. Retest sample and leave meter on bench
test is running. top while performing assay. If meter must
be transported during assay, carry meter
parallel to the floor. If more than 30 minutes
since inoculation, use a new device.
d. Sample running slowly
d. Possibly due to cold devices or sample,
high hematocrit with a whole blood
sample, or mechanical issue with device.
Have customer immediately reinsert
device into meter (if within 30 minutes of
sample addition).
Biosite Technical Services 1-888-BIOSITE (1-888-246-7483 24 hours a day/7 days a week)
M-10 Rev A
Troubleshooting — Meter Message or Symptom
Message Probable Cause Corrective Action

MOTOR FAILURE. Motor ceases to function. Eject and inspect the device for any
• Meter may slow or stop due to object sticky substances, labels on top of the
lodged on the Meter track. device or other items that may interfere
with the meter. If problem persists, contact
• Test device may stick on the meter track. Technical Services.

NO DEVICE DATA IN Reagent Code Chip® has not been installed. Install the Code Chip included in the box of
MEMORY. test devices (the Reagent Code Chip).

OPTIC FAILURE. a. Internal standard is out of specification. 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 Technical
Services.

b. Meter exposed to extreme temperatures. b. Power meter off. Allow meter to sit at
room temperature for 1–2 hours. Power
meter back on.

PROGRAM CHECK OK. Message appears when the ON/OFF Press the ENTER key.
Press ENTER to start button is pressed when the meter has
existing program or press been without power.
EXIT to load a new program.

QC Device—calibration, a. May be due to lint or dust affecting a. Clean QC Device with a lint-free cloth or
alignment or laser failed. reading. spray with canned air and repeat
Messages: the test.
CALIB PASS (or FAIL)
LASER PASS (or FAIL) b. QC Device was not run regularly. b. QC Device should be run regularly even if
ALIGN PASS (or FAIL) patient samples are not run.

c. If problem persists, call Technical Services.

TIME/DATE IS BLINKING Meter temporarily lost all power. Reset time and date if required. Check the
AC/DC power converter plug and batteries.

WARNING: INTERNAL QC Warning indicates that the internal quality Repeat sample using a new test device. If
OUT OF RANGE control on the test device was out of range. problem persists, call Technical Services.
This may be sample specific.
This may be device related.

WARNING: PATIENT Message is displayed when meter is turned Options:


MEMORY HAS SPACE FOR on if there is space left for less than 100 a. Print all results.
### MORE RECORDS. patient records or space left for less than 20 b. Delete patient results.
patient records when running patient sample. c. No action is required as the meter
will delete the oldest result once the
memory is full.

Biosite Technical Services 1-888-BIOSITE (1-888-246-7483 24 hours a day/7 days a week)

Rev A M-11
Return Procedure
Return Procedure

Should a malfunction occur, call your designated Technical Services Department. If the

Technical Services Department determines that the meter should be returned, you will

be assigned a return authorization number and be provided shipping instructions.

In the USA: Biosite Technical Services – 888-BIOSITE (888-246-7483)

Immediately after the return has been authorized, Biosite will send out a replacement

Triage MeterPro. Return the malfunctioning meter to Biosite. Note the return

authorization number on both the shipping box and the airbill and send the meter back

to Biosite as soon as possible following receipt of the replacement meter.

For International assistance, call your distributor or Country Manager.

M-12 Rev A
Glossary
Analyte: Chemical substance being In vitro: Made to occur in a laboratory
measured. vessel or other controlled experimental
environment rather than in a living
Assay: Test. organism (literally, in glass).

Calibration: Comparison of result to a In vitro diagnostic use: For use in a


reference standard. controlled setting.

Code Chip module : Any of several kinds of Laser diode: Light source used in the
chips bearing information that can be Triage MeterPro.
downloaded in the Triage MeterPro,
including Reagent, QC Sample, QC LCD: Liquid crystal display; the screen
Device, Supervisor and Program. on the Triage MeterPro. Shows the
menu of possible tests and procedures
Code Chip module Port: The small slot on and prompts the operator to take the
the underneath side of the Triage next step.
MeterPro where a Code Chip module can
be inserted. Lot number: L/N; identification number
given to a group of test devices.
Date formats: DD-MM-YY: Day-Month-Year
MM-DD-YY: Month-Day-Year L/N: Lot number; the number that identifies
YY-MM-DD: Year-Month-Day a batch of test devices.

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. Lot Numbers

Digit: One part of a longer number; for Menu: List of choices displayed on the
example, in the number 231, the 2, 3, Triage MeterPro’s screen.
and 1 are each a digit.
MMX: The Multi Marker IndexTM value is a
Fluorescence: The characteristic of a number calculated from the measured
chemical substance that enables it to values of the analytes in a Test Device.
give off light when stimulated. Not all Triage test panels have the MMX
feature.
ID: Identification.
Parameters: Options; functions.
Immunoassay: A test that uses antibodies
to measure substances. Photodiode: Detects the light emitted from
the fluorescent dye in the test devices
Internal QC: Quality controls in place as
used in the Triage MeterPro.
part of the Triage MeterPro’s software or
zones built into the test device. Point of Care (POC): Not in a laboratory;
at the place where care is being given to
a patient.

Rev A A-1
Glossary
QC: Quality Control. Reagent: Substance that causes chemical
reactions; used in analysis.
QC Sample: External controls; a liquid
solution containing chemicals that, when Reagent Code Chip module: Code Chip
dispensed into a test device, react with module loaded with information about a
the test reagents. Used to verify proper specific test and lot number.
performance of test devices after
shipment or long periods of storage. Retrieve: Find, bring back.

QC Sample Code Chip module: Code Chip Reverse Video: Light text displayed on a
module that can be downloaded into the dark background.
Triage MeterPro memory to give the meter
information needed about the specific lot Screen: The part of the Triage MeterPro that
of QC Sample. displays words and numbers.

QC Device (previously called QC Simulator): Scroll to:


Test device containing Use arrow keys to
6 independent zones go to the information you want on the
that verifies proper screen.
operation of the Triage
MeterPro’s ability to Set Parameters: A function of the
properly read patient Triage MeterPro; requires the use of
tests across varying the Supervisor Code Chip module.
analyte concentrations.
Software Upgrade Code Chip:
QC Device Code Chip module: Code Chip Code Chip used to
module that can be downloaded into the download new
Triage MeterPro’s memory to give the software onto the
meter information needed about the Triage MeterPro.
specific QC Device’s performance
Supervisor Code Chip module: The Code
in the assigned meter.
Chip module that allows a supervisor to
Quantify, quantifying: To give the results of set parameters and delete results.
a test as number.
Test device: Holds the sample (for example,
blood) from the patient so that it can be
inserted into the Triage MeterPro for
testing. Contains reagent zones that cause
reactions to occur 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.

A-2 Rev A
MENU STRUCTURE

RECALL INSTALL NEW SET DELETE


RUN TEST
RESULTS CODE CHIP® PARAMETERS* RESULTS*

* Supervisor Code Chip Only

PATIENT QC METER TEST QC


QC DEVICE CLOCK USER ID RANGES BYPASS
SAMPLE SAMPLE SETTINGS SETTINGS PARAMETERS

• NEW USER ID • QC DEVICE FREQ.


• UPDATE USER ID • QC SAMPLE FREQ.
• DELETE USER ID • NUMBER OF CONTROLS
UPLOAD • USER ID LIST
LAST QC PATIENT PRINT ALL
RESULTS
RECORD RESULTS RESULTS RESULTS
TO LIS

• INTERNAL QC RESULTS
• QC SAMPLE RESULTS
ID DISPLAY COMM
• QC DEVICE RESULTS
SETTINGS SETTINGS SETTINGS
• REAGENT LOTS – QC
• ARCHIVE LAST TEST
• CHARACTERS USER ID • BAUD RATE
• CHARACTERS PAT. ID • PAT. RESULT APPROVAL
• CHARACTERS AUX. ID • LIS ENABLE/DISABLE
• AUX. ID ENABLE/DISABLE • AUTO UPLOAD

• LANGUAGE
• PRINT MODE
• AUTO POWER-OFF
• DISPLAY CONTRAST
• PRINTER CONTRAST

Biosite Technical Service: 1-888-246-7483


A-3 Rev B
Labelling Symbols
Manufacturer

Authorized Representative in the Eurpoean Community

In Vitro Diagnostic Medical Device

Temperature Limitation

Sample Log Sheets


The following log sheets are provided as alternate methods of tracking test results.

The Triage MeterPro is capable of tracking and printing out test history and providing

QC Lockouts to prevent patient testing when outside QC requirements.

A-4 Rev A
Patient Test Log Sheet Used as an alternate method of tracking patient test history.

Month _______________________ Laboratory Name _______________________________________________ Testing Site ________________________________________________

Date/ Patient User Name/ Lot Analyte Analyte Analyte Analyte Analyte Analyte Analyte Analyte Analyte Tech
Time ID Number ID Number Number 1 2 3 4 5 6 7 8 9 Comments Initials
1

10

11

12

13

14

15

16

17

18

19

20

Biosite Technical Service: 1-888-246-7483 Reviewed by:______________________________________________________________ Date: _______________________________________


A-5 Rev A
QC Device Test Log Sheet Used as an alternate method of tracking QC Device test history
Month _______________________ Laboratory Name _______________________________________________ Testing Site ________________________________________________
Date/ User Name/ Calibration Laser Alignment Tech
Time ID Number (pass/fail) (pass/fail) (pass/fail) Comments Initials
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
Biosite Technical Service: 1-888-246-7483 Reviewed by:______________________________________________________________ Date: _______________________________________
A-6 Rev A
QC Sample Test Log Sheet Used as an alternate method of tracking QC Sample test history.

Month _______________________ Laboratory Name _______________________________________________ Testing Site ________________________________________________

Date/ QC Sample Expiration Analyte Analyte Analyte Analyte Analyte Analyte Analyte Analyte Analyte Tech
Time Lot Number Date Level 1 2 3 4 5 6 7 8 9 Comments Initials
Level I Low
1
Level II High
Level I Low
2
Level II High
Level I Low
3
Level II High
Level I Low
4
Level II High
Level I Low
5
Level II High
Level I Low
6
Level II High
Level I Low
7
Level II High
Level I Low
8
Level II High
Level I Low
9
Level II High
Level I Low
10
Level II High
Level I Low
11
Level II High
Level I Low
12
Level II High
Level I Low
13
Level II High
Level I Low
14
Level II High
Level I Low
15
Level II High

Biosite Technical Service: 1-888-246-7483 Reviewed by:______________________________________________________________ Date: _______________________________________


A-7 Rev A
Index of Page Revisions
This chart may be used to page check your User Manual. Additional pages may be
requested from your Biosite Customer Services. This page will be updated and included
with any manual updates.

Page # Rev ✔ ✔ ✔ Page # Rev ✔ ✔ ✔


I-1 A O-6 A
I-2 A O-7 A
I-3 A O-8 A
I-4 A O-9 A
I-5 A O-10 A
I-6 A O-11 A
I-7 A O-12 A
I-8 A O-13 A
I-9 A O-14 A
I-10 A O-15 A
N-1 A O-16 A
N-2 A O-17 A
N-3 A O-18 A
N-4 A O-19 A
N-5 B O-20 A
N-6 A O-21 A
N-7 A O-22 A
N-8 A O-23 A
N-9 A O-24 A
N-10 B O-25 A
N-11 A O-26 A
N-12 A O-27 B
N-13 A O-28 A
N-14 A M-1 A
N-15 A M-2 A
N-16 B M-3 A
N-17 A M-4 A
N-18 A M-5 A
N-19 A M-6 A
N-20 A M-7 A
N-21 A M-8 A
N-22 A M-9 A
N-23 A M-10 A
N-24 A M-11 A
N-25 A M-12 A
N-26 A A-1 A
N-27 A A-2 A
N-28 A A-3 B
N-29 A A-4 A
N-30 A A-5 A
O-1 A A-6 A
O-2 A A-7 A
O-3 A A-8 C
O-4 A A-9 A
O-5 A A-10 C

First Page Checked Performed: Signature ___________________________ Date__________________

Second Page Checked Performed: Signature ___________________________ Date__________________

Third Page Checked Performed: Signature ___________________________ Date__________________


A-8 Rev C
(Intentionally blank)

Rev A A-9
Biosite Incorporated BIOSITE FRANCE S.A.S.
9975 Summers Ridge Road, Espace Jouy – Bâtiment C
San Diego, California 92121 USA 21 Rue Albert Calmette
78350 JOUY-EN-JOSAS FRANCE
+1 (858) 805-4808
+33 (0) 1 39 20 21 00
www.biosite.com

Purchase of this product licenses its use under U.S. Patent Number 6,074,616.
Biosite®, Triage®, Code Chip®, Triage Census®, the Biosite logo and Triage logo are registered trademarks of
Biosite Incorporated.
© 2007, Biosite Incorporated
Part No. 22719 Rev. C 2007/02/09

A-10

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