Biosite Triage Meter Pro User Manual

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Page 1

Table of Contents

TRODUCTION

How to Use This Guide. . . . . . . . . . . . . . . . . . . I-2

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . I-4

Description . . . . . . . . . . . . . . . . . . . . . . . . . . I-4

npacking. . . . . . . . . . . . . . . . . . . . . . . . . . . I-5

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . I-8

Test Device Specifications . . . . . . . . . . . . . . I-8

Warnings, Precautions and Limitations . . . . . . I-9

STALLATION

Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . N-1

Set Parameters . . . . . . . . . . . . . . . . . . . . . . . N-10

List of Programmable Parameters . . . . . . N-10

Supervisor Access . . . . . . . . . . . . . . . . . . N-10

How to Set Parameters: Basic Instructions

. . N-11

Meter Settings . . . . . . . . . . . . . . . . . . . . . . N-11

Communication Settings. . . . . . . . . . . . . . N-17

Clock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . N-20

User ID . . . . . . . . . . . . . . . . . . . . . . . . . . . N-21

Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . N-24

Test Settings . . . . . . . . . . . . . . . . . . . . . . . N-25

QC Parameters . . . . . . . . . . . . . . . . . . . . . N-27

Bypass. . . . . . . . . . . . . . . . . . . . . . . . . . . . N-28

Install Code Chip

module . . . . . . . . . . . . . . N-29

ERATION

Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . O-1

Run Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . O-2

Purpose. . . . . . . . . . . . . . . . . . . . . . . . . . . . O-2

C Device . . . . . . . . . . . . . . . . . . . . . . . . O-3

QC Sample . . . . . . . . . . . . . . . . . . . . . . . O-5

Patient Sample . . . . . . . . . . . . . . . . . . . . O-7

Recall Results . . . . . . . . . . . . . . . . . . . . . . . . O-10

Last Record. . . . . . . . . . . . . . . . . . . . . . O-10

Patient Results . . . . . . . . . . . . . . . . . . . O-11

QC Results . . . . . . . . . . . . . . . . . . . . . . O-16

Reagent Lots–QC . . . . . . . . . . . . . . . . . O-22

Archive Last Test. . . . . . . . . . . . . . . . . . O-22

Print all Results . . . . . . . . . . . . . . . . . . . O-23

Delete Results . . . . . . . . . . . . . . . . . . . . . . . . O-25

Display Backlight . . . . . . . . . . . . . . . . . . . . . O-27

Alpha Numeric Mode . . . . . . . . . . . . . . . . . . O-28

CARE & MAINTENANCE

Total Quality Assurance . . . . . . . . . . . . . . . . . M-1

Service and Maintenance Procedures . . . . . . M-6

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . M-9

Return Procedure . . . . . . . . . . . . . . . . . . . . . M-12

APPENDIX

Glossary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

e Flowchart . . . . . . . . . . . . . . . . . . . . . A-3

Softwar

Sample Log Sheets . . . . . . . . . . . . . . . . . . . . . A-4

Index of Page Revisions . . . . . . . . . . . . . . . . . A-8

Declaration of Conformity . . . . . . . . . . . . . . . . A-9

Rev A I-1

Page 2

How to Use This Guide

This manual contains:

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

ote: To run

pecific tests,

uch as the Triage

Cardiac Panel, you also will need detailed information contained in the product-specific package insert, included in the test kit.

• Basic instructions for testing samples

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.

Rev AI-2

Page 3

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

Page 4

Introduction

Description

hat is the Triage MeterPro?

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

ests manufactured by Biosite

aboratory or in a point-of-care setting.

he Triage MeterPro uses a Class 1 laser as a light source. Light from the laser hits a test

evice 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.

ncorporated. The Triage MeterPro can be used in a

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.

Rev AI-4

Page 5

n addition to testing samples from patients, the Triage MeterPro contains pre-programmed

uality Control (QC) functions that allow the person operating the meter to monitor

uality control.

Unpacking

The Triage MeterPro and the items that come with it are provided in a single box.

Triage test devices are packaged separately and include instructions for running specific

tests. If you have any questions, contact Biosite Incorporated Technical Services

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

Contents:

• Triage MeterPro

• QC Device & Code Chip

• AC / DC Power Converter

• AA Batteries

• Rolls of Printer Paper (additional rolls are supplied in each box of test devices)

module (in the QC Device box)

Note: The

Triage MeterPro accepts test devices that are designed specifically for use

ith the Triage

eterPro. Please refer

o product-specific

t package inserts included in each test kit for more information.

• 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

Page 6

Parts of the Triage MeterPro

Thermal printer

LCD (liquid crystal display)

Backlight

Delete

Power button

Test device insertion port

Printer cover

Power supply port

Battery cover

Printer cover

Data port

Code Chip module port

Rev AI-6

Page 7

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

Page 8

Specifications

hysical

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

eight 1.5 pounds (0.7 kg) without batteries

lectrical

eypad 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

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

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.

Rev AI-8

Page 9

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

•

ot 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

•

revent internal contamination of the meter.

Use only the AC / DC power adapter provided with the Triage MeterPro. An identifying

•

ag 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.

•

I-9Rev A

Page 10

(Intentionally blank)

Rev AI-10

Page 11

Installation

1. Unpack Meter:

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

2. Power Meter On:

Batteries

. 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

The Main Menu

AC Power Supply

a. Remove the power supply from the box.

b. Plug one end into an AC outlet.

c. Plug the opposite end into the round hole in the back of the meter.

Time and date

Menu items

User instructions

Note: The Low

Power Indicator monitors the active power source. To verify adequate

y power:

batter

Navigate to the

•

Main Menu

• Remove the AC

power supply

• Press the EXIT key

(the meter attempts to eject a device)

• Observe the Main

Menu on the

’s display.

meter

Replace the batteries if the power icon is visible.

N-1Rev A

Page 12

For more details about Installing Paper see the C

INTENANCE

section.

3. Install paper:

a. Remove the printer cover by pulling up on the cover as indicated by the arrow on

the back of the cover.

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.

b. 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.

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.

Rev AN-2

Page 13

4. Insert Supervisor Code Chip module:

a. Remove the Supervisor Code Chip module Box from the meter box.

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

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

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

orientation of the Code Chip module 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.

For more details about Code Chips modules see page N-29.

Code Chip module

The Supervisor’s Main Menu

Code Chip module Port

Rev A N-3

Page 14

For more details about Meter Settings see page N-11.

5. To Change Meter Settings:

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

setting by using the keys.

ID SETTINGS Default Options New Setting

ARACTERSUSER

ID Min 1 1 - 10

Max 10 1 - 10

ARACTERSPAT

. ID Min 1 1 - 12

Max 12 1 - 12

ARACTERSAUX

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.

For reference, record your settings in the space provided.

Rev AN-4

Page 15

ISPLAY SETTINGS Default Options New Setting

NGUAGE

English Multiple

For reference, record your settings in the space provided.

PRINT MODE A

AUTOPO

WER

utomatic Automatic, Manual

hour

our, 1 hour, 2 hour,

/2 h

4 hour, None

SPLAYCONTRAST

4 0 – 8

(8 = heaviest contrast)

INTERCONTRAST

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

Page 16

For more details about Clock Settings see page N-20.

6. Change Clock:

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 DAT E 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.

Rev AN-6

Page 17

8. Change Reference Ranges / Thresholds for Tests:

a. Select SET PARAMETERS using the keys and Press the key.

For more details about Ranges Settings

ee page N-24.

b. Select

RANGES using the keys and Press the key.

c. Select the test panel type using the keys.

d. Select the analyte and level using keys. Type in the new value for

HIGH or LOW cutoff as appropriate.

the

e. Press the key to save changes.

9. Change QC Parameters:

a. Select SET PARAMETERS using the keys and Press the key.

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

ote: The lowest

value of the Range or Threshold may be disabled for some test panels. Refer to the appropriate Product Insert for specific information.

For more details about QC Parameters Settings see page N-27.

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

Press the

key to save changes to QC Parameters.

Rev A N-7

Page 18

For more details about Bypass Settings see page N-28

10. Change Bypass settings:

a. Select SET PARAMETERS using the keys and Press the key.

ote: If the

ypass is

, the user ID feature is disabled and anyone may run a test.

OFF

If the bypass is

, the user ID feature is active and only authorized users may run a test.

To Install User ID numbers, see page N-21.

b. Select

BYPASS using the keys and Press the key.

c. For USER ID select ON or OFF using the keys.

d. Press the key to save changes to the Bypass setting.

11. Prior to commencing patient testing, remove the Supervisor Code Chip module

from the meter, return it to the storage box and place in a safe place for future

use.

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

QC Testing should be performed in the following manner:

1. Run

QC Device (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

Note: The Triage MeterPro will

automatically

n off if left unused

tur for 2 hours, unless programmed otherwise by the supervisor. Optional settings allow

automated tur

/2 hour, 1 hour,

after

nof

2 hours, 4 hours or NONE.

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.

Power

The Triage MeterPro requires 6-volts DC supplied by either AC or DC. The meter will run

approximately 100 tests on batteries. It is recommended to use batteries as a backup

in the event of a power outage.

CAUTION: Use only the power supply provided with the meter, failure to do

so may cause permanent damage to the meter.

Rev AN-8

Page 19

elf-Test

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

elf-tests when powered on and prior to each test.

ower On–includes laser operation, internal standard range, battery power,

• P

nd software verification.

ach Test–verifies the laser operation, internal standard range and battery power.

• E

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

emains in the meter memory. A Code Chip module does not need to remain in the meter

while per

forming 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

MeterPro); contains data about how the meter should r

riage

the T

QC Device. (Dark gray

• Supervisor Access Code Chip module – included with each T

ead its matching

MeterPro;

riage

contains code to activate Super

•

Softwar

upgrades ar

e Upgrade Code Chip module

e available; contains new softwar

visor functions. (Light gray

Software Upgrade Code Chip module

ovided when T

– pr

e for the meter

riage MeterPr

o softwar

N-9Rev A

Page 20

Set Parameters

Purpose

SETPA

ccess to these settings is controlled using the Supervisor Code Chip module.

RAMETERS

unction allows the supervisor to select a number of settings.

List of Programmable Parameters

supervisor can set the following parameters:

Heading Parameters

TERSETTINGS

TTINGS

ID SE

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

COMMUNICATIONS Enable or Disable LIS, Baud Rate, Auto or Manual Upload,

CLOCK Time, Date, and Display Format

USER ID Add New User ID, Update User ID, Delete User ID

RANGES Test Cutoffs

Number of Characters in User ID, Number of Characters

in Patient ID, Number of Characters in Auxiliary ID,

Enable or Disable Auxiliary ID

Printer Contrast

Result Approval

or User ID List

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

module gives the supervisor access to the

function.

o insert the Supervisor Code Chip module into the Triage MeterPro, slide the chip labeled

"SPR" into the meter

Code Chip module

’s Code Chip module port as shown in the picture.

SET PARAMETERS and DELETE RESULTS

. Installing the Code Chip

Code Chip module Port

Rev BN-10

Page 21

How to Set Parameters: Basic Instructions

All instructions assume:

• The meter is on.

The meter screen is displaying the main menu.

•

• The Supervisor Code Chip module is installed.

. Select

SETPA

RAMETERS

2. Press the key.

3. You will see a list of programmable parameters.

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

sing keys.

The Set Parameters Menu

Note: To save changes, press

the

ENTER key.

To cancel changes, press the

EXIT key.

When either the ENTER or EXIT keys are pressed, the meter performs the appropriate function and returns to the

revious menu.

METER SETTINGS, CLOCK, USER ID, RANGES, TEST SETTINGS, QC PARAMETERS,

BYPASSES.

5. Press the key.

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

METER SETTINGS

This menu will allow you to set basic operational criteria for the meter: language, display

contrast, maximum length of the patient and auxiliary ID numbers, printer mode and

automatic power off.

ID SETTINGS

CHARACTERS USER ID

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

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

using keys.

MAIN MENU

SET PARAMETERS

METER SETTINGS

ID SETTINGS

2. Press the key.

Use the

ess the

Rev A N-11

keys to select

key

ID SETTINGS.

Page 22

MAIN MENU

SET PARAMETERS

METER SETTINGS

ID SETTINGS

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

under the MIN column.

se the keys to choose the smallest number of characters that will

6.U

ppear in the User ID number. The minimum number of characters possible is

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

the MAX column.

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.

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.

Use the keys to

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

Press the

key to save changes.

choose the largest number of characters that will appear

12.

Rev AN-12

Page 23

ARACTERSAUX

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

If the setting of

AUX. ID ENABLE/DISABLE is ENABLED, a number is mandatory for each

patient test.

1. From a list of programmable parameters, choose

TERSETTINGS

using keys.

. Press the key.

MAIN MENU

SET PARAMETERS

METER SETTINGS

ID SETTINGS

3. Use the keys to select

ID SE

TTINGS

4. Press the key.

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

ARACTERSAUX

. ID

under the MINcolumn.

Use the keys to

choose the smallest number of characters that will

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

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

MAX column.

Use the keys to

choose the largest number of characters that will appear

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

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

Note: The

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

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

Use the keys to

choose DISABLED or ENABLED. If DISABLED is selected,

AUX. ID ENABLE/DISABLE.

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.

N-13Rev A

Page 24

MAIN MENU

SPLAYSETTINGS

SET PARAMETERS

METER SETTINGS

DISPLAY SETTINGS

NGUAGE

This setting will determine which language the meter displays.

1. From a list of programmable parameters, choose

TERSETTINGS

using keys.

. Press the key.

3. Use the keys to select

SPLAYSETTINGS

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

MANUAL is selected, the user must use the button on the keypad to

QC). If

print out results.

7. Press the key to save changes.

Rev AN-14

Page 25

AUTOPO

his setting will determine the length of time before an inactive meter will power off.

WER

. From a list of programmable parameters, choose

sing keys.

–

TERSETTINGS

2. Press the key.

MAIN MENU

SET PARAMETERS

METER SETTINGS

DISPLAY SETTINGS

3. Use the keys to select

SPLAYSETTINGS

4. Press the key.

5. Use the keys to select the value to the right of

AUTOPO

WER

-OFF.

6. Use the keys to choose the desired timer setting for the meter to power

itself off when not in use. The choices are:

/2 H

OUR

, 1 H

OUR

, 2 H

OURS

, 4 H

or NONE. If NONE is selected, the meter must be manually shut off using the

on/off key.

7. Press the key to save changes.

DISPLAY CONTRAST

This setting will adjust the display contrast.

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

using keys.

2. Press the key.

OURS

Note: When powered only

by batteries, select

/2 hour to conserve

battery life.

Certain screens, when displayed, will not automatically power off. The New Results screen is an example.

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

Page 26

(Intentionally blank)

Rev BN-16

Page 27

INTERCONTRAST

his setting will adjust the printer contrast for meters with a serial number starting

ith 29901.

. From a list of programmable parameters, choose

sing keys.

TERSETTINGS

2. Press the key.

MAIN MENU

SET PARAMETERS

METER SETTINGS

DISPLAY SETTINGS

3. Use the keys to select

. Press the key.

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

INTERCONTRAST

NTRAST

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

Prior to activating the LIS feature, obtain the meter’s serial number located underneath

the meter and call Biosite Technical Services at 1-888-BIOSITE (1-888-246-7483).

The Biosite Technical Services Representative will provide you with a password that, when

entered, will allow data to be transmitted.

BAUD RATE

MAIN MENU

SET PARAMETERS

METER SETTINGS

COMM SETTINGS

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

using keys.

2. Press the key.

Use the keys to select

COMM SETTINGS.

4. Press the key.

5. Use the keys to select

Use the keys to

BAUD RATE .

choose 9600 or 38400.

7. Press the key.

Rev A N-17

Page 28

MAIN MENU

SET PARAMETERS

METER SETTINGS

COMM SETTINGS

TIENTRESULTAPPROVAL

ome institutions may desire patient test results to be verified by the user before printing

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

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

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

. From a list of programmable parameters, choose

sing keys.

METER SETTINGS

2. Press the key.

3. Use the keys to select

COMM SETTINGS.

4. Press the key.

5. Use the keys to select

Use the keys to

PAT. RESULT APPROVAL.

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 r

esults will display an

R befor

the patient ID.

N-18 Rev A

Page 29

IS E

ABLE

. From a list of programmable parameters, choose

sing keys.

TERSETTINGS

MAIN MENU

SET PARAMETERS

METER SETTINGS

2. Press the key.

3. Use the keys to select

COMMSE

TTINGS

4. Press the key.

5. Use the keys to select

Use the keys to

LIS.

choose DI

SABLED

or EN

ABLED

7. Press the key.

8. If

SABLED

was selected, a screen showing LIS DI

SABLED

will appear. Press

the key.

ENABLED was selected, a screen showing ENTER LIS PASSWORD will appear.

9. If

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.)

COMM SETTINGS

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

using keys.

2. Press the key.

Use the keys to select

COMM SETTINGS.

4. Press the key.

5. Use the keys to select

Use the keys to

AUTO UPLOAD.

choose ENABLED or DISABLED.

7. Press the key.

N-19Rev A

Page 30

MAIN MENU

SET PARAMETERS

CLOCK

OCK

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

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

Note: If you

have selected AM/PM, AM or PM appears after the time, as appropriate.

1. From the list of programmable parameters, choose CL

OCK

using keys.

2. Press the key.

3. Use the keys to select

the HOUR: MI

NUTE

area. Using the keypad, type

in the correct time. The numbers you type will appear from the right and move left

s you continue to type. To change a single number use keys to move to

the number. Then type in the new number.

4. Press the key to move to

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

AM or PM. If the 24 HR., format has been

RMAT

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.

will be

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 DAT E FORMAT.

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

The pr

eviously enter

DATEchanges as the DATEFORMATchanges.

12. Press the key to save changes.

Rev AN-20

Page 31

USERI

p to 600 User ID numbers with 1 – 10 digits may be programmed into the meter.

he User ID may alternately be entered using the external Bar Code Scanner (optional).

An additional security feature of the User ID is the partial masking of the ID 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.

NEWUSERID

1. From the list of programmable parameters, choose USERID

using keys.

2. Press the key.

3. Select

NEWUSERID using keys.

4. Press the key.

5. Type in a number from 1 – 9999999998 (10 digits). To correct, press the key

MAIN MENU

SET PARAMETERS

USER ID

Note: USER ID 9999999999

(10-9’s) is a default setting displayed when

USER ID BYPASS

the is on or when a test is run with the Supervisor Code Chip module installed.

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

keys. Then type in the correct number.

6. Press the key.

7. On the next screen, use the keys to select an expiration date to the

right of

USER ID STATUS: 6 MONTHS, 12 MONTHS, VALID or EXPIRED.

8. Press the key to save changes.

ecognizes leading 0’s as a unique character. Therefore,

The Triage module MeterPr

‘4341’ will be recognized separately fr

o r

om ‘04341.’

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

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

Note: If you

type in a User ID number that has already been assigned, the message on the screen states:

USER ### ALREADY EXISTS

Press the

ENTER key

to go back and type in a different number.

Rev A N-21

Page 32

MAIN MENU

SET PARAMETERS

USER ID

DATEUSER

. From the list of programmable parameters, choose

sing keys.

2. Press the key.

3. Select

ID using keys.

DATEUSER

4. Press the key.

USERI

ote: If you

ype in a

t User ID number that does not exist, the message on the screen states:

USER ID ### DOES NOT EXIST

If this happens, press

ENTER key to

the return to the previous screen and correct the ID number, or press the

EXIT key.

5. Type in the user number you want to update. 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.

6. Press the key.

The user ID is displayed with the expiration date. You can change the expiration

date to

LID

6 M

ONTHS

, 12 M

ONTHS

, E

XPIRED

or VALID by using the keys.

reconfirms the previously selected interval.

8. Press the key to save changes.

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.

Note: If you

type in a User ID number that does not exist, the message on the screen states:

USER ID ### DOES NOT EXIST

If this happens, pr

ENTER key to

the

ess

return to the previous screen and correct the ID number, or press the

EXIT key.

4. Press the key.

5. Type in the user number to be deleted. 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.

Press the key. The message on the screen states:

USER ID ### WILL BE DELETED.

7. Press the key to delete. A message on the screen tells you that the

number has been deleted: USER ID ### DELETED.

Rev AN-22

Page 33

D L

USERI

. From the list of programmable parameters, choose

sing keys.

2. Press the key.

USERI

MAIN MENU

SET PARAMETERS

USER ID

3. Select

USERID LISTusing keys.

2. Press the key.

5. A list is displayed.

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

FROMEX

For a list of all ID numbers, select

•

• For a single ID, select

PIRATIONDATE

USERID and type in the number.

, TILLEX

• For a range of ID numbers, enter the

PIRATIONDATE

USERID.

FROM and/or the TO dates. The

USERID,

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

Page 34

MAIN MENU

SET PARAMETERS

NGES

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

FERENCERANGES

s set to ‘0’ and is unchangeable.

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

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

etween the lower and upper values.

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

• A

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

orTH

RESHOLDS

The low end, when the test displays thresholds,

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

Note: The

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

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.

1. From the list of programmable parameters, choose

RANGES

using keys.

2. Press the key.

Select the test panel type using the keys.

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

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

ess the

o corr

ect digit by using the

key to save changes.

keys.

key.

values. T

the incor

o print a list, press the

Rev AN-24

Page 35

TESTSE

n certain cases, the lab supervisor may wish to control which tests are available to be run

TTINGS

t the time of patient testing. The options are:

. 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.

MAIN MENU

SET PARAMETERS

TESTMO

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.

N-25Rev A

Page 36

MAIN MENU

SET PARAMETERS

TESTSE

TTINGS

. From the list of programmable parameters, choose

sing keys.

2. Press the key.

3. Select the test panel type using the keys.

4. Select the desired mode using the keys.

TESTSE

TTINGS

Note: When

the analyte is deselected, the value is not calculated nor stored.

•

• IN

TIVE

ACTIVE

(AC

TIV

on Screen) – The test will run on every patient specimen.

ACT

(IN

on Screen) – The test will never run on a patient specimen and

is dropped from all displays and printouts.

•

USERIN

ACTIVE

(USRI on Screen) – At the time of patient testing, the user has

the ability to select the test.

• USERAC

TIVE

(USRA on Screen) – At the time of patient testing, the user has

the ability to deselect the test.

IVE

ALITAT

•

(QUAL), QU

ANTITAT

IVE

(QU

ANT

) or

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

esult for that test.

N-26 Rev A

Page 37

C P

RAMETERS

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

aximum frequency is for running the QC Device and QC Sample and whether 1 or 2

evels 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

MAIN MENU

SET PARAMETERS

QC PARAMETERS

using the

keys.

2. Press the key.

3. Use

keys to select the information to the right of QC DE

VICEFREQ

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

RUN PATIENT TEST menu until a QC Sample has been successfully

the

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.

Use

keys to select the infor

mation to the right of

QC SAMPLE FREQ.

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

WEEKLY, MONTHLY.

ess the key to save changes.

N-27Rev A

Page 38

MAIN MENU

SET PARAMETERS

PARAMETERS

MBER OFCONTROLS

. From the list of programmable parameters, choose QC P

sing the keys.

2. Press the key.

RAMETERS

Note: If the bypass

ON, the User ID requirement is disabled and therefore not required.

When the bypass is OFF, the User ID requirement operates as normal and is required.

3. Use

keys to select the information to the right of NU

MBER OFCONTROLS

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

5. Press the key to save changes.

PASSUSER

This function allows the supervisor to selectively bypass the requirement to enter

a user ID before performing any test.

1. From the list of programmable parameters, choose BY

PASS

using the keys.

2. Press the key.

3. Select USER ID using the keys.

4. Use keys to select from two options: ON or OFF.

5. Press the key.

N-28 Rev A

Page 39

Install Code Chip

Purpose

he Triage MeterPro will prompt the user to install a Code Chip module when required.

owever, the

nformation from a Code Chip module into the meter’s memory. The meter will direct the user

o install a Code Chip module if it is attempting to run a test and does not have the data in

ts memory.

INSTALL CODE CHIP f

unction may be used as an alternate method to transfer

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

upgrades are available.

Software

ersion 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

Page 40

MAIN MENU

Installation of Reagent, QC Sample or QC Device Code Chip modules.

STALLCODECHIP

1. From the MAINMENUselect IN

STALLCODECHIP

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.

Rev AN-30

Page 41

Operation

Access to The Triage MeterPro

Function Use Restricted to

RUNTE

RECALL RESULTS Patient Testing

INSTALL CODE CHIPS Types of Code Chips

SETPA

* Unless User ID is bypassed or the Supervisor Code Chip module is installed.

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

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

RAMETERS

LETERESULTS

IMPORTANT: The last two functions, SET PARAMETERS, and DELETE RESULTS,

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

Patient Testing operators with valid User ID numbers*

Quality Control Testing operators with valid User ID numbers*

Quality Control Testing

Installation Procedure

Access Control Supervisor

Programmable Settings Supervisor

Patient Test Results Supervisor

Note: Access

to various parts of the software is user (institution) defined

O-1Rev A

Page 42

Run Test

Purpose

un Test is used for the analysis of a test.

ptions

he 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

Note: The

Supervisor Code Chip module provides access to functions that may override these Lockouts.

Note: If the

Triage MeterPro’s internal quality control (QC) results are unacceptable, exclamation points (!) will be displayed on the screen in the place of the patient results.

o obtain r

T the test using a new device.

esults, repeat

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

2. A QC Device has passed within the specified time period. See page O-3.

3. A QC Sample for the test device lot has passed within the specified time

period. See page O-5.

If any of these conditions exist, the meter will not continue and will prompt the user to

perform the required steps.

IMPORTANT: The Triage MeterPro will alert the user if QC has not been performed

for the device lot being tested.

O-2 Rev A

Page 43

C D

VICE

he QC Device should be run on each day of patient testing. It is desirable to run the

C 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.

MAIN MENU

RUN TEST

2. Select

RUNTESTusing keys.

The Main Menu

3. Press the key.

4. Type in your identification number (User ID). 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.

5. Press the key

6. Select

QC DEVICE using keys.

Note: If the User ID bypass

ON, the meter will

is not ask you to enter a User ID.

Menu scr

Press the key.

Gently insert the QC Device into the T

“EXP” indicates that the QC Device r frequency has expired.

een as it looks when operator

selects QC Device.

riage MeterPro until you feel

e-test

the QC Device catch on the pin and hear an audible ‘click.’

ess the

Rev A O-3

key

Note: The meter

will prompt the user to install the QC Device Code Chip module if the QC Device has not been run before.

Page 44

MAIN MENU

RUN TEST

0. The Triage MeterPro pulls in the QC Device and scans it. The test

evice 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.

PORTANT INSTRUCTIONS FOR ALL TESTS

After the test

device has been inserted, do not push the device in further or attempt to pull it out. The device may be ejected by returning to the Main Menu and pressing the

EXIT key.

a. Gently insert the test device into the Triage MeterPro until you feel

the

device catch on the pin. You will hear an audible ‘click’ that tells you

the test device has been inserted properly.

b. Press the key to start the test.

c. The 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 stor

•

ed in its black

opaque case when not in use.

If the QC Device tests fail, wipe the QC Device clean with a lint

•

ee cloth to remove any oils, dust, fibers, or fingerprints. Do not apply

any liquid to the QC Device. After cleaning the device, r

epeat

the QC Device test.

If the QC Device test fails after you have cleaned the device, call

•

Biosite Incorporated Technical Ser

Note: the QC Device does not expir

•

vices at 1-888-BIOSITE.

Rev AO-4

Page 45

C S

MPLE

o run the Quality Control sample:

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

MAIN MENU

RUN TEST

2. Select

RUNTESTusing keys.

The Main Menu

3. Press the key.

4. Type in your identification number (User ID). 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.

5. Press the key.

6. Select

QC SAMPLE using keys.

Note: If the User ID bypass

ON, the meter will

is not ask you to enter a User ID.

Menu scr

een 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

Sample.

Rev A O-5

Note: Only

enter the four digit numeric value of the QC lot number Do not enter the preceding alpha character

Page 46

MAIN MENU

RUN TEST

9. To correct, press the key to clear the entire number, or select the

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

Note: If you

enter a QC lot number for which there is no data in the

riage MeterPro’s

T memory, you will see a message on the meter’s screen:

NO QC SAMPLE DATA IN MEMORY

To correct this:

Install the QC Sample Code Chip module (see picture on page N-29).

Press the

ENTER key

to continue.

After the test

device has been inserted, do not push the device in further or attempt to pull it out. The device may be ejected by returning to the Main Menu and pressing the

EXIT key.

10. Press the key.

11. Perform the test according to the instructions provided in the package of test

devices you are using.

PORTANT INSTRUCTIONS FOR ALL TESTS

entlyinsert the test device into the Triage MeterPro until you feel

a.G

the

device catch on the pin. You will hear an audible ‘click’ that tells you

the test device has been inserted properly.

b. Press the key to start the test.

c. The 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.

12. Repeat steps for each quality control sample.

IMPORTANT INSTRUCTIONS FOR QC SAMPLE TESTS

nal quality control (QC) results are unacceptable,

a. If the test device’

esults for the af

the r

b. If any of the QC Sample r

particular analyte will be in r

s inter

fected analyte(s) will not appear on the screen.

esults ar

e out of range, the results for that

everse video (light text on a dark backgr

and flagged with a # symbol.

A panel with multiple analytes will still be able to repor

t patient r

those analytes which passed QC. An analyte that failed QC will not be

ted on patient tests.

epor

If an individual analyte is outside the specified range, the Triage MeterPro

un only the failed analyte on the next QC Sample

allows the user to r

est. When all analytes have passed, the QC Sample timer is set to the

date of the first passing analyte.

ound)

esults on

Rev AO-6

Page 47

TIENTSAMPLE

. Press the key to power The Triage

2. Select RUNTESTusing keys.

The Main Menu

3. Press the key.

eterPro on.

MAIN MENU

RUN TEST

4. Type or scan in your identification number (User ID). 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.

5. Press the key.

6. Select

PATIENT SAMPLE using keys.

Menu scr

een 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

key to clear entire number or select the incorrect digit using

then type in the correct number.

Press the key.

Note: If the User ID bypass

ON, the meter will

is not ask you to enter a User ID.

Note: If the

Bar Code Scanner is being used, simply point the scanner at the bar code, press the button on the scanner handle and wait for the beep. The number will appear on the display.

Rev A O-7

Page 48

MAIN MENU

RUN TEST

10. If the information is correct, press the key to confirm the Patient ID.

If the information is incorrect:

• Select CO

RRECTPATIENT

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,

Note: At least

one analyte must be selected in order to continue testing.

the meter will display a message similar to the following:

SELECT TESTS CARDIAC

✓ CKMB

1 MYO

✓ TNI

PRESS ^ TO PAUSE OR 0-9 FOR TEST PRESS ENTER TO CONTINUE OR EXIT

A check mark

✓ indicates tests which are selected. Example: ✓ TNI

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

Example: MYO

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

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.

Rev AO-8

Page 49

o number to the left of the test indicates tests which cannot be altered.

Example ✓ CKMB indicates that CKMB is always selected, and cannot be

deselected.

• Press the key.

• If the information is correct, press the key to continue.

• If the information is incorrect, select

CORRECT TEST using keys

and press the key to return to the lists of tests.

PORTANT INSTRUCTIONS FOR ALL TESTS

ote: If no key

is pressed on the Select Tests screen, the meter waits 30 seconds then proceeds using only the selected default tests. Similarly, if no

ey is pressed on the

onfirmation Screen,

C the test proceeds after waiting 30 seconds.

a. Gently insert the test device into the Triage®MeterPro until you feel the

device catch on the pin. You will hear an audible ‘click’ that tells you

the test device has been inserted properly.

b. Press the key to start the test.

c. The Triage

MeterPro pulls in the test device and scans it.

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,

After the test

device has been inserted, do not push the device in further or attempt to pull it out. The device may be ejected by returning to the Main Menu and pressing

EXIT.

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

Screen displaying patients results

below the cut of

accept or r

f levels and

eject instructions.

Screen displaying patients results

above the cut of

esults in the indeterminate range.

f levels and TNI

O-9Rev A

Page 50

Note: If a result was rejected by

the user, an

ppear next to the

a recalled result.

“R” will

Recall Results

Purpose

ecall Results is used to retrieve results stored in the Triage MeterPro’s memory.

unction

he Recall Results function can retrieve these results:

Last Record • QC Results

•

Patient Results

•

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

Internal QC Results

–

– QC Sample Results

– QC Device Results

• Upload Results to LIS

MAIN MENU

RECALL RESULTS

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.

LAST RECORD

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

To retrieve the last record:

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

2. From the

3. Press the key.

4. Select

5. Press the key.

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

MAIN MENU select RECALL RESULTS using keys.

LAST RECORD using the keys.

7. Use to view the entire patient record.

8. Press the key to make a printed copy.

O-10 Rev A

Page 51

TIENTRESULTS

ptions: Patient results can be retrieved based on a variety of criteria:

Patient ID

•

Test Device Lot Number (L/N)

•

User ID

•

From Date

•

Till Date

•

MAIN MENU

RECALL RESULTS

TIENT

To retrieve results based on the patient ID:

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

2. From the MAINMENUselect RE

CALLRESULTS

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:

• If you want to see all patient results, press the key. All the patient

results in the Triage MeterPro’s memory will be displayed.

• For individual patient results:

a. Select Patient ID using keys.

b. Type or scan in the patient ID number. To correct, press the key to clear

the entire number

Then type in the corr

, or select the incorrect digit by using the keys.

ect number

c. To select a patient ID number with alpha characters, use the key in

place of the alpha character

MAINME

CALLRESULTS

IENT

SULT

Note: You may

choose more than one of the options for recalling results in order to define more precisely the information you want to recall from the Triage MeterPro’s memory. When you choose multiple options, first input numbers in all the categories you have chosen. Then press

ENTER key.

the

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

will be displayed.

7. Press the key to make a printed copy.

O-11Rev A

Page 52

MAIN MENU

RECALL RESULTS

PATIENT RESULTS

TESTDE

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

VICELOTNUMBER

L/N)

(

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.

Note: Only enter

the five digit numeric value of the QC lot number

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.

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

ect number.

digit by using the keys. Then type in the cor

ess the key.

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

11. Press the key to make a printed copy.

Rev AO-12

Page 53

USERI

o retrieve results from tests run on the Triage MeterPro starting with the user you select:

MAIN MENU

RECALL RESULTS

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

2. From the

MAINMENUselect RE

CALLRESULTS

using the keys.

3. Press the key.

4. Select

. Press the key

6. Select

TIENTRESULTS

using keys.

USERID 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.

PATIENT RESULTS

Rev A O-13

Page 54

MAIN MENU

RECALL RESULTS

FROMDA

o 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

MAINMENUselect RE

CALLRESULTS

using the keys.

3. Press the key.

4. Select

. Press the key

6. Select

TIENTRESULTS

using keys.

FROMDATEusing 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.

Rev AO-14

Page 55

TILLDA

o retrieve results from tests run on the Triage MeterPro before and including a date

ou select:

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

MAIN MENU

RECALL RESULTS

PATIENT RESULTS

2. From the

MAINMENUselect RE

CALLRESULTS

using the keys.

3. Press the key.

4. Select

TIENTRESULTS

using keys.

5. Press the key

6. Select

TILLDATEusing 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

Page 56

MAIN MENU

RECALL RESULTS

C R

SULTS

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

riage MeterPro’s memory:

Note: You may

hoose more

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

ENTER key.

the

Quality Control (QC test) Results can be retrieved by:

Internal QC Results (on Patient Tests) Panel Type

Device Lot Number (L/N)

User ID Number

From Date

Till Date

View All (Default)

QC Sample Results Panel Type

QC Sample Lot Number (L/N)

Device Lot Number (L/N)

User ID Number

From Date

Till Date

View All (Default)

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.

Rev AO-16

Page 57

C S

MPLELOTNUMBER

o retrieve results based on the lot number of the QC Sample used:

L/N)

(

MAIN MENU

RECALL RESULTS

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

2. From the

MAINMENUselect RE

CALLRESULTS

using the keys.

3. Press the key.

4. Select

. Press the key.

6. Select

QC RE

QC SA

SULTS

using keys.

MPLERESULTS

using keys.

7. Press the key.

8. Select

QC SA

L/N using keys.

MPLE

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.

QC RESULTS

QC SAMPLE RESULTS

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

Page 58

MAIN MENU

RECALL RESULTS

QC RESULTS

INTERNAL QC RESULTS

C S

AMPLE RESULTS

VICELOTNUMBER

o retrieve QC Sample results based on the lot number of the test devices used:

L/N)

(

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

cor

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

incor

ect 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.

Press the key to make a printed copy.

12.

Rev AO-18

Page 59

USERI

o retrieve QC results from tests run on the Triage MeterPro starting with the user you select:

MAIN MENU

RECALL RESULTS

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

2. From the

MAINMENUselect RE

CALLRESULTS

using the keys.

3. Press the key.

4. Select

. Press the key.

6. Select the appropriate menu,

QC RE

SULTS

using keys.

QC SA

MPLERESULTS

or QC DE

VICERESULTS

using keys.

7. Press the key.

8. Select

USERID 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.

QC RESULTS

QC SAMPLE RESULTS

C S

IMULATOR RESULTS

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

Page 60

MAIN MENU

RECALL RESULTS

FROMDA

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

QC RESULTS

INTERNAL QC RESULTS

C S

AMPLE RESULTS

QC SIMULATOR RESULTS

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

2. From the

MAINMENUselect RE

CALLRESULTS

using the keys.

3. Press the key.

4. Select

. Press the key.

6. Select the appropriate menu,

or QC DE

SULTS

QC RE

VICERESULTS

using keys.

TERNAL

QC RE

using keys.

SULTS

, QC SA

MPLERESULTS

7. Press the key.

8. Select

FROMDATEusing 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.

Rev AO-20

Page 61

TILLDA

o retrieve QC results from tests run on the Triage MeterPro before and including a date

ou select:

MAIN MENU

RECALL RESULTS

QC RESULTS

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

2. From the

MAINMENUselect RE

CALLRESULTS

using the keys.

3. Press the key.

4. Select

QC RE

SULTS

using keys.

5. Press the key.

6. Select the appropriate menu,

or QC DE

VICERESULT

using

TERNAL

QC RE

keys.

SULTS

, QC SA

MPLERESULTS

7. Press the key.

8. Select TILL DATEusing 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.

INTERNAL QC RESULTS

C S

AMPLE RESULTS

QC SIMULATOR RESULTS

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

Page 62

MAIN MENU

RECALL RESULTS

QC RESULTS

AGENTLOTS

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

ates for a QC Sample can be recalled from memory.

he 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 FAILEDwill appear in place of an

•

xpiration 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.

Rev AO-22

Page 63

INTALLRESULTS

ptions:All stored results can be printed from the Triage MeterPro’s memory.

Patient Results

•

QC Sample Results

•

QC Device Results

•

MAIN MENU

RECALL RESULTS

TIENTRESULTS

To print all Patient Results:

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

2. From the MAINMENUselect RE

CALLRESULTS

3. Press the key.

4. Select PR

INTALLRESULTS

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.

using the keys.

MAINME

CALLRESULTS

INTALLRESULTS

From the

Press the key.

MAIN MENU select RECALL RESULTSusing the

keys.

4. Select PRINT ALL RESULTS using keys.

5. Pr

Select

ess the

QC SAMPLE RESULTSusing

key.

keys.

7. Press the key to make a printed copy.

Rev A O-23

Note: When

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

Page 64

MAIN MENU

RECALL RESULTS

C D

VICERESULTS

o print all QC Device Results:

PRINT ALL RESULTS

MAIN MENU

RECALL RESULTS

QC RESULTS

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

2. From the

MAINMENUselect RE

CALLRESULTS

using the keys.

3. Press the key.

4. Select

. Press the key.

6. Select

INTALLRESULTS

VICERESULTS

QC DE

using keys.

7. Press the key to make a printed copy.

UPLOAD RESULTS TO LIS

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

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

Parameter menu item using the Supervisor Code Chip module.

Rev AO-24

Page 65

Delete Results

Purpose

he Delete function is used to remove patient test information from the Triage MeterPro

emory. This becomes necessary when the meter memory becomes full.

Triage MeterPro Memory

ithin the Triage MeterPro, Patient Result memory can hold 750 data sets, QC Sample

an hold 200 data sets and QC Device memory can hold 250 data sets. When the

emory is full, the oldest result is automatically overwritten when a new result is added.

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

Note: The

delete function is available only when the Supervisor Code

hip is inserted in

C the Triage MeterPro Code Chip module Port.

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

Page 66

MAIN MENU

DELETE RESULTS

LETEPATIENTRESULT

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

eversible, 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

MAINMENU, select DE

The Supervisor’s Main Menu

LETERESULTS

using keys.

3. Press the key.

4. A warning message on the screen states: DELETE PATIENT RESULT.

If this is acceptable, press the key. (If this is not acceptable, press

the key).

A message on the screen states:

ATIENT RESULTS WILL BE DELETED

ALL

Note: Press

EXIT key

the to cancel at any time before step 7.

ess the key to delete all r

7. Pr

esults, pr

ess the key).

esults. (If you do not want to delete all

Rev AO-26

Page 67

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.

O-27Rev B

Page 68

Alpha Numeric Mode

ALPHA NUMERIC MODE

he Triage MeterPro has the capability for the operator to enter both numeric and alpha

haracters from the keypad.

he keypad operates in numeric mode until alpha mode is activated by pressing the

ey. The meter stays in alpha mode, indicated by the word

ntil 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

hown on the display,

PHA

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

Page 69

Total Quality Assurance

Introduction

Quality assurance programs control and monitor analytical methods. The quality control

of analytical methods achieves two basic goals:

1. Ensures that the reagents and instrument are working properly

2. Ensures that the procedure was performed correctly

The mechanism by which analytical methods are traditionally controlled is through the

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 T

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

Note: For more

detailed information, call Biosite Technical Services at

1-888-BIOSITE

1-888-246-7483)

(

4 hours a day/7 days

week.

monitor the assay pr

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

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.

ocedure and the reagent integrity. The assay controls present a

tests require the need to

M-1Rev A

Page 70

Quality Assurance Functions

. Internal Device Quality Assurance

Internal Positive Control Zone

•

Baseline Control Zone

•

Timing Control Zone

•

Zone Quality Requirements (Trace QC)

•

. 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

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 contr

The

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.

ol zone for each lot of reagents.

Baseline Control Zone monitors the presence of interfering substances in the patient

race QC algorithm has been pr

A T

to noise ratio of each zone on the device. Aber

limits will cause r

ejection of one or mor

ogrammed which evaluates the size, location and signal

e of the assay r

rations in zone quality exceeding pr

esults.

eset

Rev AM-2

Page 71

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

ntegrity 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.

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 memor

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

oficiency. A User ID# and expiration date ar

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 fr

ID number

e programmed into the meter memory and

om detecting and using an existing User

. 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

ed in the meter

e stor

system (LIS) or an external data management software program for further viewing and

printing of quality control reports.

Rev A M-3

’s memory and can be downloaded to a laboratory information

Page 72

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

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.

QC Lockout function

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.

Rev AM-4

Page 73

. Out-of-Range Flags

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

•

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

he 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

•

nalyte(s) in question display an exclamation point (

arning is displayed: !INTERNAL QC OUT OF RANGE

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

•

in place of a value and a

! )

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

SET PARAMETERS. If the time interval has expired, QC Samples must be

under

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 RESULTSmenu.

visor Access

Super

event misuse, the Supervisor Code Chip module is r

o pr

ARAMETERS

SET P

visor Code Chip is universal and may be used on any T

Super

Rev A M-5

and DELETE RESULTSfunctions of the softwar

equired for access to the

e. The

riage MeterPro.

Page 74

Service and Maintenance Procedures

f any service or maintenance is required, the Triage MeterPro should be sent to the

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

xternal cleaning is required of the operator.

aper Replacement

hanging Paper Between Functions

. 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.

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.

Note: If PAPER

button is

FEED

essed before the

pr printer senses the paper, the printer will not respond to the command.

Note: The

printer utilizes thermal paper, if the printed paper is blank

eplacing a r

after r verify that the paper roll is not upside down.

oll,

3. Remove unused paper or the empty paper spindle from paper compartment.

4. Tear or cut a clean, straight edge to feed into the printer. Do not cut paper at an

angle, as the printer must sense the edge of the paper along the feed path.

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

6. Position the paper such that the paper will feed from under the roll (as opposed

to over the top of the roll, see picture, above).

7. Insert the paper edge under the paper roller (platen) until it firmly seats or

resistance is felt.

8. Press the key.

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

M-6 Rev A

Page 75

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.

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

6. Position the paper such that the paper will feed from under the roll (as opposed

to over the top of the roll, see picture, above).

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

resistance is felt.

8. Press the key.

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

printer will reprint up to the previous 5 lines.

10. After the paper has appeared above the printer, replace the printer cover, taking

care to ensure the paper does not get caught inside the meter.

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.

Note: If PAPER

button is

FEED

pressed before the printer senses the paper, the printer will not respond to the command.

Note: The

printer utilizes thermal paper, if the printed paper is blank after r

eplacing a r

oll, verify that the paper roll is not upside down.

Rev A M-7

Page 76

ote: Never

insert any tools, swabs, or cleaning materials into the device track.

leaning

he Triage MeterPro requires minimal maintenance. Occasional cleaning of the exterior

ith mild soap and water solution is sufficient. After using a damp, not wet, sponge or

loth to apply a mild soap and water solution on the outside of the meter, wipe the

eter dry using a soft cloth or absorbent tissue. Do not allow water to seep into the

rinter. Do not immerse the meter in water or other liquids.

If blood or other fluids are not

allowed enough time to fully

Note: The meter

is designed to perform and print at least 100 tests before replacement batteries are required. When the meter is not in use, it should be turned off. To preserve battery life, ensure the

POWER-OFF

is set to

AUTO

function

/2 HOUR.

Note:

Rechargeable batteries are authorized for use, however, due to the nature of these types of batteries, it is expected they will

equire recharging

r more frequently. The Triage MeterPro does not contain a built-in battery charger,

echargeable batteries

ged

must be r

echar

outside of the meter.

absorb into test devices, the

device track door may occasionally

require cleaning. Using a cotton

swab dampened with isopr

opyl

alcohol and a pair of tweezers,

carefully lift the door and clean

both front and back of the door.

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

Low Power Indicator on the Main Menu of the meter display. If the flashing indicator

appears, replace the batteries.

y Replacement

Batter

urn off the meter.

•

Remove the batter

•

y cover from

the bottom of the meter by

sliding the cover in the direction

of the arrow.

Remove the batteries and

•

discard them in an appropriate

Note: If the

meter does not power on after replacing batteries, verify the batteries are lined up accor

ding to the symbols in the battery compartment.

waste container.

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

plus (+) and minus (-) signs of the batteries match the same signs embossed in the

battery compartment.

• Replace the cover to the battery compartment.

Rev AM-8

Page 77

Troubleshooting — Meter Symptoms

Symptom Probable Cause Corrective Action

nvalid Results a. Inappropriate body fluid or improperly

anticoagulated sample.

. Sample size incorrect—too little sample.

Test device’s internal QC controls will be out of range.

c. Meter was picked up or carried vertically

while test was running. The test device’s internal QC controls will be out of range.

Meter will not pull test device in.

Code Chip module will not fit in meter.

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

a. Code Chip module may have been

inserted upside down.

b. Code Chip module or Meter contacts

could be bent.

. Retest sample using a new test device

with a proper specimen.

. Retest sample on a new test device. Make

sure the entire tube is full. Be certain the lower bulb on the pipette tube contains a small amount fluid before you press the top bulb.

c. If less than 30 minutes has passed since

preparing the test device, place meter on 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.

If meter repeatedly fails to pull the device in, the meter may need to be replaced. Call Technical Services.

a. Re-insert Code Chip module right side up.

b. Try new Code Chip module, if available. If

still not a good fit, call Technical Services.

Printer works but no print appears on paper.

Printer jam. Paper may have been fed into the meter

Printer stops printing or skips a line.

Meter will not power on or meter powers off when running a test.

Blinking battery icon.

Meter contains no batteries or batteries are low when facility has loss of power.

Paper may be installed backwards. Install paper reverse to current position.

Carefully remove old paper out of the printer.

improperly.

Battery power low. Replace batteries or verify power cord is

a. Batteries not installed, drained or

ectly aligned.

incorr

b. Power sour

Low battery power

ce not plugged in.

Do not insert any tools into the printer.

installed in the meter and wall outlet.

a. Verify batteries are installed and correctly

aligned (+) and (-); replace batteries if necessary.

erify power cor

b. V

and wall outlet.

Replace batteries.

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

d is installed in the meter

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

Rev A M-9

Page 78

Troubleshooting — Meter Message or Symptom

Message Probable Cause Corrective Action

>XXX.X Patient sample concentration is above the

dynamic range.

See instructions that came in the box of test devices or call Technical Services.

XX.X

BATTERY LOW. Batteries need replacement. Replace with 4-AA batteries or use the AC

NNOTREADBARCODE

NNOTREAD

CA CODE CHIP.

atient result is below the dynamic range or

P is a concentration below the statistically determined lowest test concentration.

Damaged bar code or meter hook may be broken. (The meter hook pulls the test device into the meter.)

a. Code Chip module error.

b. Meter error.

or some parameters, a 0.0 ng/ml patient

F result may be appropriate.

power adapter as a power source.

Look for particles on the bar code of the test device. wipe off with a dry cloth. Repeat the test.

a. • Ensure Code Chip module is completely

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 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. Inappr

anticoagulated sample.

Sample size incorr

c. Meter picked up or carried vertically while

test is r

d. Sample running slowly

opriate body fluid or impr

ect – too little sample.

unning.

operly

a. Retest sample using new device with a

proper specimen.

Retest sample on new device. Be certain

the lower bulb on pipet contains a small amount of fluid and the entire tube is full

e dispensing contents.

befor

c. Retest sample and leave meter on bench

top while per be transported during assay, carry meter parallel to the floor. If more than 30 minutes since inoculation, use a new device.

d. Possibly due to cold devices or sample,

high hematocrit with a whole blood sample, or mechanical issue with device. Have customer immediately reinsert device into meter (if within 30 minutes of sample addition).

forming assay

. If meter must

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

Rev AM-10

Page 79

Troubleshooting — Meter Message or Symptom

Message Probable Cause Corrective Action

TORFAILURE

. Motor ceases to function.

• Meter may slow or stop due to object lodged on the Meter track.

• Test device may stick on the meter track.

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

NO DE

VICEDATA I N

Reagent Code Chip

has not been installed. Install the Code Chip included in the box of

MEMORY.

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

b. Meter exposed to extreme temperatures.

PROGRAM CHECK OK. Press

ENTER to start

existing program or press

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

EXIT to load a new program.

QC Device—calibration, alignment or laser failed.

a. May be due to lint or dust affecting

reading.

Messages:

CALIB PASS (or FAIL) LASER PASS (or FAIL)

b. QC Device was not run regularly.

ALIGN PASS (or FAIL)

test devices (the Reagent Code Chip).

a. Power meter off then on again. If

TICFAILURE

message clears, run the QC Device to verify proper operation. If message fails to clear, contact Technical Services.

b. Power meter off. Allow meter to sit at

room temperature for 1–2 hours. Power meter back on.

Press the

ENTER key.

a. Clean QC Device with a lint-free cloth or

spray with canned air and repeat the test.

b. QC Device should be run regularly even if

patient samples are not run.

c. If problem persists, call Technical Services.

TIME/DA

BLINKING

Meter temporarily lost all power

Reset time and date if requir

ed. Check the

AC/DC power converter plug and batteries.

WARNING: INTERNAL QC

UT OF RANGE

Warning indicates that the internal quality control on the test device was out of range.

Repeat sample using a new test device. If

problem persists, call Technical Services. This may be sample specific. This may be device related.

WARNING: PATIENT MEMORY HAS SPACE FOR ### MORE RECORDS.

Message is displayed when meter is turned on if there is space left for less than 100 patient records or space left for less than 20 patient records when r

unning patient sample.

Options:

a. Print all results.

b. Delete patient results.

c. No action is requir

ed as the meter

will delete the oldest r

esult 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

Page 80

Return Procedure

eturn Procedure

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

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

e 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.

Rev AM-12

Page 81

Glossary

Analyte: Chemical substance being

measured.

Assay: Test.

Calibration: Comparison of result to a

eference standard.

Code Chip module : Any of several kinds of

chips bearing information that can be downloaded in the Triage MeterPro, including Reagent, QC Sample, QC Device, Supervisor and Program.

Code Chip module Port: The small slot on

the underneath side of the Triage MeterPro where a Code Chip module can be inserted.

Date formats: DD-MM-YY: Day-Month-Year

MM-DD-YY: Month-Day-Year YY-MM-DD: Year-Month-Day

Note: All parts of dates should be given as two digit numbers.

For example, the month of May is 05.

In vitro: Made to occur in a laboratory

vessel or other controlled experimental

nvironment rather than in a living

e organism (literally, in glass).

In vitro diagnostic use: For use in a

controlled setting.

Laser diode: Light source used in the

riage MeterPro.

LCD: Liquid crystal display; the screen

on the Triage MeterPro. Shows the menu of possible tests and procedures and prompts the operator to take the next step.

Lot number: L/N; identification number

given to a group of test devices.

L/N: Lot number; the number that identifies

a batch of test devices.

Device L/N: Lot number of a test device

can be found on the side of the box that contains the test devices and on each test device. The device L/N is a five digit number that may be preceded by one or more letters. The meter disregards all letters.

Digit: One part of a longer number; for

example, in the number 231, the 2, 3, and 1 are each a digit.

Fluorescence: The characteristic of a

chemical substance that enables it to give off light when stimulated.

ID: Identification.

Immunoassay: A test that uses antibodies

to measure substances.

Internal QC: Quality controls in place as

t of the Triage MeterPro’s software or

par zones built into the test device.

Lot Numbers

Menu: List of choices displayed on the

Triage MeterPro’s screen.

MMX: The Multi Marker IndexTMvalue is a

number calculated fr values of the analytes in a Test Device. Not all Triage test panels have the MMX

featur

Parameters: Options; functions.

Photodiode: Detects the light emitted from

the fluor used in the Triage MeterPro.

Point of Care (POC): Not in a laboratory;

at the place where care is being given to a patient.

escent dye in the test devices

om the measured

Rev A A-1

Page 82

Glossary

QC: Quality Control.

QC Sample: External controls; a liquid

solution containing chemicals that, when dispensed into a test device, react with the test reagents. Used to verify proper performance of test devices after shipment or long periods of storage.

QC Sample Code Chip module: Code Chip

odule that can be downloaded into the

m Triage MeterPro memory to give the meter information needed about the specific lot of QC Sample.

QC Device (previously called QC Simulator):

Test device containing 6 independent zones that verifies proper operation of the Triage MeterPro’s ability to properly read patient tests across varying analyte concentrations.

QC Device Code Chip module: Code Chip

module that can be downloaded into the Triage MeterPro’s memory to give the meter information needed about the specific QC Device’s performance in the assigned meter.

Quantify, quantifying: To give the results of

a test as number.

Reagent: Substance that causes chemical

reactions; used in analysis.

Reagent Code Chip module: Code Chip

module loaded with information about a specific test and lot number.

Retrieve: Find, bring back.

Reverse Video: Light text displayed on a

dark background.

Screen: The part of the Triage MeterPro that

displays words and numbers.

Scroll to:

Use arrow keys to go to the information you want on the screen.

Set Parameters: A function of the

Triage MeterPro; requires the use of the Supervisor Code Chip module.

Software Upgrade Code Chip:

Code Chip used to download new software onto the Triage MeterPro.

Supervisor Code Chip module: The Code

Chip module that allows a supervisor to set parameters and delete results.

Test device: Holds the sample (for example,

blood) from the patient so that it can be inserted into the 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.

Rev AA-2

Page 83

MENU STRUCTURE

Rev B

BYPASS

AMPLE FREQ.

DELETE

RESULTS*

PARAMETERS

UMBER OF CONTROLS

• QC S

• N

• QC DEVICE FREQ.

TEST

SETTINGS

* Supervisor Code Chip Only

SET

ANGES

PARAMETERS*

ELETE USER ID

PDATE USER ID

SER ID LIST

• D

• U

• NEW USER ID

• U

CLOCK USER ID

CODE CHIP

INSTALL NEW

METER

SETTINGS

LIS

UPLOAD

RESULTS

COMM

SETTINGS

DISPLAY

SETTINGS

• BAUD RATE

• PAT. RESULT APPROVAL

• LIS ENABLE/DISABLE

• AUTO UPLOAD

RINT MODE

• LANGUAGE

•

• AUTO POWER-OFF

• DISPLAY CONTRAST

• PRINTER CONTRAST

ETTINGS

PAT. ID

USER ID

AUX. ID

CHARACTERS

•

UX. ID ENABLE/DISABLE

CHARACTERS

•

• A

RECALL

RESULTS

PRINT ALL

AMPLE

RUN TEST

QC DEVICE

SAMPLE

PATIENT

RESUL

ESULTS

LAST

RECORD

EVICE RESUL

RCHIVE LAST TEST

QC D

• INTERNAL QC RESULTS

• QC SAMPLE RESULTS

•

• REAGENT LOTS – QC

•

A-3

Biosite Technical Service: 1-888-246-7483

Page 84

Labelling Symbols

anufacturer

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.

riage MeterPro is capable of tracking and printing out test history and providing

The T

QC Lockouts to pr

event patient testing when outside QC requirements.

A-4 Rev A

Page 85

Rev AA-5

Patient Test Log Sheet Used as an alternate method of tracking patient test history.

Month _______________________ Laboratory Name_______________________________________________ Testing Site ________________________________________________

Time ID Number ID Number Number 1 2 3 4 5 6 7 8 9 Comments Initials

Date/ Patient User Name/ Lot Analyte Analyte Analyte Analyte Analyte Analyte Analyte Analyte Analyte Tech

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

Page 86

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

A-6 Rev A

Date/ User Name/ Calibration Laser Alignment Tech

Time ID Number (pass/fail) (pass/fail) (pass/fail) Comments Initials

Month _______________________ Laboratory Name_______________________________________________ Testing Site ________________________________________________

QC Device Test Log Sheet Used as an alter

nate method of tracking QC Device test history

Page 87

Rev A

Level I Low

Level II High

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

Month _______________________ Laboratory Name_______________________________________________ Testing Site ________________________________________________

Time Lot Number Date Level 1 2 3 4 5 6 7 8 9 Comments Initials

Date/ QC Sample Expiration Analyte Analyte Analyte Analyte Analyte Analyte Analyte Analyte Analyte Tech

Level I Low

Level II High

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

A-7

Page 88

Index of Page Revisions

his 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

I-2 A

I-3 A

I-4 A

I-5 A

I-6 A

I-7 A

I-8 A

I-9 A

I-10 A

N-1 A

N-2 A

N-3 A

N-4 A

N-5 B

N-6 A

N-7 A

N-8 A

N-9 A

N-10 B

N-11 A

N-12 A

N-13 A

N-14 A

N-15 A

N-16 B

N-17 A

N-18 A

N-19 A

N-20 A

N-21

N-22 A

N-23 A

N-24 A

N-25

N-26 A

N-27

N-28 A

N-29 A

N-30 A

O-1

O-2

O-3 A

O-4 A

O-5

O-6 A

O-7 A

O-8 A

O-9 A

O-10 A

O-11 A

O-12 A

O-13 A

O-14 A

O-15 A

O-16 A

O-17 A

O-18 A

O-19 A

O-20 A

O-21 A

O-22 A

O-23 A

O-24 A

O-25 A

O-26 A

O-27 B

O-28 A

M-1 A

M-2 A

M-3 A

M-4 A

M-5 A

M-6 A

M-7 A

M-8

M-9 A

M-10 A

M-11 A

M-12

A-1 A

A-2

A-3 B

A-4 A

A-5 A

A-6

A-7

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___________________________ Date__________________

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Biosite Incorporated 9975 Summers Ridge Road, San Diego, California 92121 USA

+1 (858) 805-4808 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

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BIOSITE FRANCE S.A.S.

Biosite Incorporated.

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