Triage Meter Pro
Triage Meter Pro
Triage Meter Pro
INTRODUCTION OPERATION
How to Use This Guide. . . . . . . . . . . . . . . . . . . I-2 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . O-1
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . I-4 Run Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . O-2
Description . . . . . . . . . . . . . . . . . . . . . . . . . . I-4 Purpose. . . . . . . . . . . . . . . . . . . . . . . . . . . . O-2
Unpacking. . . . . . . . . . . . . . . . . . . . . . . . . . . I-5 QC Device . . . . . . . . . . . . . . . . . . . . . . . . O-3
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . I-8 QC Sample . . . . . . . . . . . . . . . . . . . . . . . O-5
Test Device Specifications . . . . . . . . . . . . . . I-8 Patient Sample . . . . . . . . . . . . . . . . . . . . O-7
Warnings, Precautions and Limitations . . . . . . I-9 Recall Results . . . . . . . . . . . . . . . . . . . . . . . . O-10
Last Record. . . . . . . . . . . . . . . . . . . . . . O-10
INSTALLATION Patient Results . . . . . . . . . . . . . . . . . . . O-11
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . N-1 QC Results . . . . . . . . . . . . . . . . . . . . . . O-16
Set Parameters . . . . . . . . . . . . . . . . . . . . . . . N-10 Reagent Lots–QC . . . . . . . . . . . . . . . . . O-22
List of Programmable Parameters . . . . . . N-10 Archive Last Test. . . . . . . . . . . . . . . . . . O-22
Supervisor Access . . . . . . . . . . . . . . . . . . N-10 Print all Results . . . . . . . . . . . . . . . . . . . O-23
How to Set Parameters: Basic Instructions . . N-11 Delete Results . . . . . . . . . . . . . . . . . . . . . . . . O-25
Meter Settings. . . . . . . . . . . . . . . . . . . . . . N-11 Display Backlight . . . . . . . . . . . . . . . . . . . . . O-27
Communication Settings. . . . . . . . . . . . . . N-17 Alpha Numeric Mode . . . . . . . . . . . . . . . . . . O-28
Clock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . N-20
User ID . . . . . . . . . . . . . . . . . . . . . . . . . . . N-21 CARE & MAINTENANCE
Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . N-24 Total Quality Assurance . . . . . . . . . . . . . . . . . M-1
Test Settings . . . . . . . . . . . . . . . . . . . . . . . N-25 Service and Maintenance Procedures . . . . . . M-6
QC Parameters . . . . . . . . . . . . . . . . . . . . . N-27 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . M-9
Bypass. . . . . . . . . . . . . . . . . . . . . . . . . . . . N-28 Return Procedure . . . . . . . . . . . . . . . . . . . . . M-12
Install Code Chip module . . . . . . . . . . . . . . N-29
®
APPENDIX
Glossary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Software Flowchart . . . . . . . . . . . . . . . . . . . . . A-3
Sample Log Sheets . . . . . . . . . . . . . . . . . . . . . A-4
Index of Page Revisions . . . . . . . . . . . . . . . . . A-8
Declaration of Conformity . . . . . . . . . . . . . . . . A-9
Rev A I-1
How to Use This Guide
This manual contains:
• Instructions for the operation and maintenance of the Triage® MeterPro, and;
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
I-2 Rev A
The Triage MeterPro User Manual is divided into five sections.
deleting results.
Screen commands and options are indicated by A BOLDED FONT WITH SMALL CAPITAL LETTERS
At the bottom of each page appears the page number and revision. A page revision chart is
located in the appendix and will be revised and included whenever a manual update occurs.
Use the Page Revision Chart to periodically verify presence of all pages. You may receive
an updated copy of this chart at any time by calling our Customer Service Department at
1-888-BIOSITE (1-888-246-7483).
Rev A I-3
Introduction
Description
What is the Triage MeterPro?
The Triage MeterPro is a portable fluorescence instrument used to measure the results of
The Triage MeterPro uses a Class 1 laser as a light source. Light from the laser hits a test
device that has been inserted in the meter. This causes the fluorescent dye in the test device
to give off energy. The more energy the fluorescent dye gives off, the stronger the signal.
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
I-4 Rev A
In addition to testing samples from patients, the Triage MeterPro contains pre-programmed
Note: The
Quality Control (QC) functions that allow the person operating the meter to monitor Triage MeterPro
quality control. accepts test devices
that are designed
specifically for use
with the Triage
Unpacking MeterPro. Please refer
to product-specific
The Triage MeterPro and the items that come with it are provided in a single box. package inserts
Triage test devices are packaged separately and include instructions for running specific included in each
test kit for more
tests. If you have any questions, contact Biosite Incorporated Technical Services information.
at 1-888-BIOSITE (1-888-246-7483).
Contents:
• Triage MeterPro
• AC / DC Power Converter
• AA Batteries
• Rolls of Printer Paper (additional rolls are supplied in each box of test devices)
Printer paper
located below
QC Device Box
Rev A I-5
Parts of the Triage MeterPro
Thermal printer
Backlight
Delete
Power button
Battery cover
Data port
I-6 Rev A
Power button Used to turn the Triage MeterPro on and off.
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.
Data Port Connection point for the (optional) Bar Code Scanner, allowing
Code Chip module Port Insertion point for Code Chip modules which contain lot / device
Power Supply Port Connection point for the supplied AC / DC Power Converter.
Printer Cover Cover, which when pulled straight up, reveals the paper roll.
LCD Screen The LCD (Liquid Crystal Display) Screen shows the menu of
possible tests and tasks and prompts the operator to take the
next step.
Rev A I-7
Specifications
Physical
Environmental
Location Dry, clean, flat horizontal surface away from direct sunlight
Optical
Memory Capacity
Miscellaneous
Thermal Printer
Options
• External Bar Code Reader (rapid entry of User, Patient or Auxiliary ID numbers).
Test device specific information is provided in the applicable product insert. The
I-8 Rev A
Warnings, Precautions and Limitations
• Operate the Triage MeterPro on a level, dry surface away from direct sunlight.
• The QC Device is light-sensitive and should be stored in its black opaque case when
not in use.
• Ensure all sample fluids have absorbed into the test device prior to running the test to
• Use only the AC / DC power adapter provided with the Triage MeterPro. An identifying
Rev A I-9
(Intentionally blank)
I-10 Rev A
Installation
1. Unpack Meter:
a. Remove the meter from the box and protective plastic bag.
Batteries
compartment.
e. Power the meter on by pressing the key. Press the key to run self-test.
When the test is completed, the meter display screen will come to rest at the
main menu.
Low Power Indicator Time and date
Note: The Low
Menu items Power Indicator
monitors the active
power source. To
verify adequate
User instructions battery power:
• Navigate to the
The Main Menu Main Menu
• Remove the AC
AC Power Supply
power supply
a. Remove the power supply from the box. • Press the EXIT key
(the meter attempts
b. Plug one end into an AC outlet. to eject a device)
• Observe the Main
c. Plug the opposite end into the round hole in the back of the meter.
Menu on the
meter’s display.
Replace the batteries
if the power icon is
visible.
Rev A N-1
For more details 3. Install paper:
about Installing
Paper see the CARE & a. Remove the printer cover by pulling up on the cover as indicated by the arrow on
MAINTENANCE section. the back of the cover.
Note: The b. Tear or cut a clean, straight edge to feed into the printer. Do not cut paper at an
printer contains angle, as the printer must sense the edge of the paper along the feed path.
a paper sensor and
will feed the new
paper roll only when
paper with a clean
straight line is
pressed into the
paper roller.
c. Position the paper such that the paper will feed from under the roll (as opposed to
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
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
d. Once the Supervisor Code Chip module is installed, verify that two additional menu
Menu options
accessible only
when the Supervisor
Code Chip module
is inserted.
Rev A N-3
For more details about 5. To Change Meter Settings:
Meter Settings see
page N-11. a. Select SET PARAMETERS using the keys and Press the key.
b. Select METER SETTINGS using the keys and Press the key.
d. Select the desired setting using the keys and change the value of the
N-4 Rev A
DISPLAY SETTINGS Default Options New Setting
LIS PASSWORD
Rev B N-5
For more details about 6. Change Clock:
Clock Settings see
page N-20. a. Select SET PARAMETERS using the keys and Press the key.
c. Select the HOUR : MINUTE area using the keys. Type in the correct time
the previously entered HOUR : MINUTE will change to a 24-hour format and
i. Type in the 6-digit date according to the DATE FORMAT below it.
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
N-6 Rev A
8. Change Reference Ranges / Thresholds for Tests: For more details
about Ranges Settings
a. Select SET PARAMETERS using the keys and Press the key. see page N-24.
NUMBER OF CONTROLS 2 1 or 2
Rev A N-7
For more details about 10. Change Bypass settings:
Bypass Settings see
page N-28 a. Select SET PARAMETERS using the keys and Press the key.
The meter is now ready to run QC Tests in preparation for Patient Testing.
3. If appropriate, Run Calibration Verification Set as a patient sample for each test
panel type to be used. (Refer to the applicable Procedure Manual and Calibration
Location
The Triage MeterPro should be placed on a dry, clean, flat, horizontal surface away
N-8 Rev A
Self-Test
The Triage MeterPro checks the system to verify it is operating properly by running
• Each Test – verifies the laser operation, internal standard range and battery power.
Meter data is updated via a disposable Code Chip module. The Code Chip module
contains microchip circuitry embedded into a plastic housing. When inserted into the
meter Code Chip module port and activated, the information is transferred into the Triage
MeterPro’s memory. A Code Chip module typically needs to be installed only once and
remains in the meter memory. A Code Chip module does not need to remain in the meter
There are five types of Code Chip modules which can be distinguished by shape or color.
• 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.)
expiration date and other data about the QC Sample lot including acceptable range.
• QC Device Code Chip module – included in the black QC Device box (comes with
the Triage MeterPro); contains data about how the meter should read its matching
• Supervisor Access Code Chip module – included with each Triage MeterPro;
• Software Upgrade Code Chip module – provided when Triage MeterPro software
upgrades are available; contains new software for the meter.
Rev A N-9
Set Parameters
Purpose
The SET PARAMETERS function allows the supervisor to select a number of settings.
Access to these settings is controlled using the Supervisor Code Chip module.
Heading Parameters
METER SETTINGS
ID SETTINGS Number of Characters in User ID, Number of Characters
in Patient ID, Number of Characters in Auxiliary ID,
Enable or Disable Auxiliary ID
DISPLAY SETTINGS Language, Printer Mode, Auto Power-Off, Display Contrast,
Printer Contrast
COMMUNICATIONS Enable or Disable LIS, Baud Rate, Auto or Manual Upload,
Result Approval
USER ID Add New User ID, Update User ID, Delete User ID
or User ID List
Supervisor Access
A Supervisor Code Chip module is shipped with each meter. Installing the Code Chip
module gives the supervisor access to the SET PARAMETERS and DELETE RESULTS
function.
To insert the Supervisor Code Chip module into the Triage MeterPro, slide the chip labeled
"SPR" into the meter’s Code Chip module port as shown in the picture.
N-10 Rev B
How to Set Parameters: Basic Instructions
Note: To save
All instructions assume: changes, press
• The meter is on. the ENTER key.
To cancel changes,
• The meter screen is displaying the main menu.
press the EXIT key.
• The Supervisor Code Chip module is installed.
When either the
ENTER or EXIT keys
1. Select SET PARAMETERS using keys.
are pressed, the
meter performs the
2. Press the key.
appropriate function
3. You will see a list of programmable parameters. and returns to the
previous menu.
6. Follow the directions for setting the selected parameter (see the next section).
ID SETTINGS
CHARACTERS USER ID
This setting will set the minimum and maximum number of characters in the User ID.
using keys.
Rev A N-11
MAIN MENU 5. Use the keys to select the number to the right of CHARACTERS USER ID
SET PARAMETERS under the MIN column.
METER SETTINGS
6. Use the keys to choose the smallest number of characters that will
ID SETTINGS
appear in the User ID number. The minimum number of characters possible is 1.
7. Use the key to select the number to the right of CHARACTERS USER ID under
8. Use the keys to choose the largest number of characters that will appear
CHARACTERS PAT. ID
This setting will set the minimum and maximum number of characters in the Patient ID.
using keys.
5. Use the keys to select the number to the right of CHARACTERS PAT. ID
6. Use the keys to choose the smallest number of characters that will
7. Use the key to select the number to the right of CHARACTERS PAT. ID under the
MAX column.
8. Use the keys to choose the largest number of characters that will appear
N-12 Rev A
CHARACTERS AUX. ID MAIN MENU
This setting will set the minimum and maximum number of characters in the Auxiliary ID. SET PARAMETERS
If the setting of AUX. ID ENABLE/DISABLE is ENABLED, a number is mandatory for each METER SETTINGS
patient test.
ID SETTINGS
1. From a list of programmable parameters, choose METER SETTINGS
using keys.
5. Use the keys to select the number to the right of CHARACTERS AUX. ID
AUX. ID ENABLE/DISABLE
This setting will turn on or turn off the Auxiliary ID function. The Auxiliary ID number may
be used for recording test order number, physician ID number or other specialized
identifying information.
5. Use the keys to select the word to the right of AUX. ID ENABLE/DISABLE.
the Auxiliary ID prompt screens will never appear. If ENABLED is selected, a number
SET PARAMETERS
LANGUAGE
METER SETTINGS
This setting will determine which language the meter displays.
DISPLAY SETTINGS
1. From a list of programmable parameters, choose METER SETTINGS
using keys.
6. Use the keys to change the language of the Triage MeterPro’s screen.
PRINT MODE
This setting will determine if the meter prints automatically or only when requested.
using keys.
5. Use the keys to select highlight the word to the right of PRINT MODE.
N-14 Rev A
AUTO POWER – OFF MAIN MENU
This setting will determine the length of time before an inactive meter will power off. SET PARAMETERS
1. From a list of programmable parameters, choose METER SETTINGS METER SETTINGS
using keys. DISPLAY SETTINGS
5. Use the keys to select the value to the right of AUTO POWER-OFF.
6. Use the keys to choose the desired timer setting for the meter to power Note: When
itself off when not in use. The choices are: 1/2 HOUR, 1 HOUR, 2 HOURS, 4 HOURS powered only
by batteries, select
or NONE. If NONE is selected, the meter must be manually shut off using the
1/2 hour to conserve
using keys.
Rev A N-15
(Intentionally blank)
N-16 Rev B
PRINTER CONTRAST MAIN MENU
This setting will adjust the printer contrast for meters with a serial number starting SET PARAMETERS
with 29901. METER SETTINGS
1. From a list of programmable parameters, choose METER SETTINGS DISPLAY SETTINGS
using keys.
BAUD RATE
using keys.
Rev A N-17
MAIN MENU PATIENT RESULT APPROVAL
SET PARAMETERS Some institutions may desire patient test results to be verified by the user before printing
METER SETTINGS or sending to the LIS. Activation of this feature displays the result, then requires the user
COMM SETTINGS to accept or reject the result before the record is printed and saved. If the test is rejected,
using keys.
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
N-18 Rev A
LIS ENABLE MAIN MENU
1. From a list of programmable parameters, choose METER SETTINGS SET PARAMETERS
using keys. METER SETTINGS
COMM SETTINGS
2. Press the key.
8. If DISABLED was selected, a screen showing LIS DISABLED will appear. Press
the key.
9. If ENABLED was selected, a screen showing ENTER LIS PASSWORD will appear.
Enter the password provided by Biosite Technical Services. Press the key.
AUTO UPLOAD (This feature is visible after the LIS has been enabled.)
using keys.
Rev A N-19
MAIN MENU CLOCK
SET PARAMETERS The clock menu sets the time and date of the meter and the format for displaying both. If
CLOCK the meter has lost power, the time and date will blink on the Main Menu.
3. Use the keys to select the HOUR : MINUTE area. Using the keypad, type
in the correct time. The numbers you type will appear from the right and move left
Note: If you
have selected as you continue to type. To change a single number use keys to move to
AM/PM, AM or PM the number. Then type in the new number.
appears after the
time, as appropriate. 4. Press the key to move to AM or PM. If the 24 HR., format has been
previously selected, the AM or PM will not be visable and the TIME FORMAT will be
the previously entered HOUR : MINUTE will change to a 24-hour format and
9. Using the keypad, type in the 6-digit date according to the DATE FORMAT below it.
N-20 Rev A
USER ID MAIN MENU
Up to 600 User ID numbers with 1 – 10 digits may be programmed into the meter. SET PARAMETERS
The User ID may alternately be entered using the external Bar Code Scanner (optional). USER ID
An additional security feature of the User ID is the partial masking of the ID Number on
displays and printouts. This prevents unauthorized individuals from detecting and using an
existing User ID number. When the Supervisor Code Chip module is installed in the meter,
NEW USER ID
to clear the entire number, or select the incorrect digit by using the
Note: If you
keys. Then type in the correct number. type in a
User ID number that
6. Press the key. has already been
assigned, the
7. On the next screen, use the keys to select an expiration date to the message on the
right of USER ID STATUS: 6 MONTHS, 12 MONTHS, VALID or EXPIRED. screen states:
USER ###
8. Press the key to save changes. ALREADY EXISTS.
Press the ENTER key
to go back and type
The Triage module MeterPro recognizes leading 0’s as a unique character. Therefore, in a different number.
Using the barcode scanner or alpha mode will allow the Triage module MeterPro to accept
Rev A N-21
MAIN MENU UPDATE USER ID
5. Type in the user number you want to update. To correct, press the key
Note: If you
type in a to clear the entire number, or select the incorrect digit by using the
User ID number that
keys. Then type in the correct number.
does not exist, the
message on the
6. Press the key.
screen states:
USER ID ### DOES
7. The user ID is displayed with the expiration date. You can change the expiration
NOT EXIST.
If this happens, press date to 6 MONTHS, 12 MONTHS, EXPIRED or VALID by using the keys.
the ENTER key to VALID reconfirms the previously selected interval.
return to the previous
screen and correct 8. Press the key to save changes.
the ID number, or
press the EXIT key.
DELETE USER ID
using keys.
N-22 Rev A
USER ID LIST MAIN MENU
1. From the list of programmable parameters, choose USER ID SET PARAMETERS
using keys. USER ID
5. A list is displayed.
6. Use the keys to select the type of ID list you want: USER ID,
• For a range of ID numbers, enter the FROM and/or the TO dates. The
dates are entered by typing the month number, the day number and the
year number in the format you have chosen. The numbers you type will
appear from the right and move left as you continue to type. To change a
Rev A N-23
MAIN MENU RANGES
SET PARAMETERS Depending on the panel type, the range on the display and printout will be titled
REFERENCE RANGES or THRESHOLDS. The low end, when the test displays thresholds,
Some analytes are designed for three distinct ranges. The meter distinguishes between
two range and three range analytes in the setup screen by differentiating the symbol
• Analytes with a dash – Two ranges. The normal range is any value between the
two numbers displayed. Depending on the product, the normal range may be
inclusive or exclusive of the upper number. Consult the product package insert or
call Biosite Technical Services for clarification. These values will be in reverse video
• Analytes with a comma – Three ranges possible. If the lower number is 0.0, the
meter treats the analyte as having only two ranges. If the lower number is not 0.0,
the normal range is any value less than the lower number. The first abnormal range is
any value between the two numbers and is inclusive of these numbers. These values
will be boxed on patient results. The second abnormal range is any value greater
than the upper number. These values will be in reverse video on patient results.
Consult the product package insert or call Biosite Technical Services for
clarification.
for each of the analytes can be changed using the keypad to type in the
values. To correct, press the key to clear the entire number, or select
N-24 Rev A
TEST SETTINGS MAIN MENU
In certain cases, the lab supervisor may wish to control which tests are available to be run SET PARAMETERS
at the time of patient testing. The options are:
3. The test can be selected by the user at the time of running the test.
4. The test can be deselected by the user at the time of running the test.
If these options are not available for a test, the meter skips over the setting as the
supervisor scrolls through the options. See pages N-26 and 0-8 for more details.
TEST MODE
It also may be appropriate for some test panels to display certain analytes Qualitatively
and others Quantitatively. Presently, Biosite does not have any test that fits this category.
Rev A N-25
MAIN MENU TEST SETTINGS
SET PARAMETERS 1. From the list of programmable parameters, choose TEST SETTINGS
using keys.
• ACTIVE (ACTIV on Screen) – The test will run on every patient specimen.
• INACTIVE (INACT on Screen) – The test will never run on a patient specimen and
• USER INACTIVE (USR I on Screen) – At the time of patient testing, the user has
If the Supervisor changes the test from INACTIVE to ACTIVE, to USER ACTIVE or to USER
INACTIVE that test may be out of QC Sample date. As always for a test with an expired QC
Sample, a passing QC Sample test will need to run before a patient sample can report a
result for that test.
N-26 Rev A
QC PARAMETERS MAIN MENU
The QC Parameters menu provides the user the options for determining what the SET PARAMETERS
maximum frequency is for running the QC Device and QC Sample and whether 1 or 2 QC PARAMETERS
levels of control are required for the QC Sample.
QC DEVICE FREQUENCY
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
It is recommended that the QC Device be run daily when performing patient testing.
WEEKLY, MONTHLY.
QC SAMPLE FREQUENCY
device lot number. When the interval has lapsed, all users are locked out of
the RUN PATIENT TEST menu until a QC Sample has been successfully
run. To view when a particular device lot’s QC Sample will expire, use the
It is recommended that the QC Sample be run with every new shipment, new lot or
the keys.
WEEKLY, MONTHLY.
Rev A N-27
MAIN MENU NUMBER OF CONTROLS
BYPASS USER ID
Note: If the This function allows the supervisor to selectively bypass the requirement to enter
bypass
a user ID before performing any test.
is ON, the User ID
requirement is 1. From the list of programmable parameters, choose BYPASS
disabled and therefore using the keys.
not required.
When the bypass is 2. Press the key.
OFF, the User ID
requirement operates 3. Select USER ID using the keys.
as normal and is
required. 4. Use keys to select from two options: ON or OFF.
N-28 Rev A
Install Code Chip
Purpose
The Triage MeterPro will prompt the user to install a Code Chip module when required.
However, the INSTALL CODE CHIP function may be used as an alternate method to transfer
information from a Code Chip module into the meter’s memory. The meter will direct the user
to install a Code Chip module if it is attempting to run a test and does not have the data in
its memory.
CAUTION: Running tests with the Supervisor Code Chip module installed disables all
QC Lockouts. Remove the Supervisor Code Chip module prior to running tests.
Rev A N-29
MAIN MENU Installation of Reagent, QC Sample or QC Device Code Chip modules.
INSTALL CODE CHIP
1. From the MAIN MENU select INSTALL CODE CHIP using keys.
3. Slide the Code Chip module into the Code Chip module Port in the Triage
5. The meter will display a confirmation message that the information was installed
7. Remove the Code Chip module from the Code Chip module Port.
activate the supervisor functions. This is an automatic function and standard Code Chip
N-30 Rev A
Operation
Access to The Triage MeterPro
Function Use Restricted to
appear on the main menu only when the Supervisor Code Chip module is inserted
into the Code Chip module Port. The Supervisor Code Chip module should be
removed from the meter during routine patient and quality control testing.
Rev A O-1
Run Test
Purpose
Run Test is used for the analysis of a test.
Options
The Run test function allows you to test:
• QC Device
• QC Sample
• Patient Sample
1. A valid User ID has been entered (unless this feature is bypassed or a Supervisor
Note: If the IMPORTANT: The Triage MeterPro will alert the user if QC has not been performed
Triage MeterPro’s
for the device lot being tested.
internal quality control
(QC) results are
unacceptable,
exclamation points (!)
will be displayed on the
screen in the place
of the patient results.
To obtain results, repeat
the test using a new
device.
O-2 Rev A
QC DEVICE MAIN MENU
The QC Device should be run on each day of patient testing. It is desirable to run the RUN TEST
QC Device after the meter has been inactive for at least 30 minutes.
4. Type in your identification number (User ID). To correct, press the key to Note: If the
clear the entire number, or select the incorrect digit by using the User ID bypass
is ON, the meter will
keys then type in the correct number. not ask you to enter a
User ID.
5. Press the key
Rev A O-3
MAIN MENU 10. The Triage MeterPro pulls in the QC Device and scans it. The test
RUN TEST device may partially move in and out of the meter several times.
11. When the test is complete, the meter will beep, eject the device and display the
After the test a. Gently insert the test device into the Triage MeterPro until you feel
device has been the
inserted, do not push
device catch on the pin. You will hear an audible ‘click’ that tells you
the device in further or
attempt to pull it out. the test device has been inserted properly.
The device may be
ejected by returning to b. Press the key to start the test.
the Main Menu and
pressing the EXIT key. c. The Triage MeterPro pulls in the test device and scans it.
d. When the test is complete, the meter will beep and display the results
• Dust, lint, fibers and other small particles may interfere with the QC Device.
• If the QC Device tests fail, wipe the QC Device clean with a lint
free cloth to remove any oils, dust, fibers, or fingerprints. Do not apply
• If the QC Device test fails after you have cleaned the device, call
O-4 Rev A
QC SAMPLE MAIN MENU
To run the Quality Control sample: RUN TEST
4. Type in your identification number (User ID). To correct, press the key to Note: If the
clear the entire number, or select the incorrect digit by using the User ID bypass
is ON, the meter will
keys then type in the correct number. not ask you to enter a
User ID.
5. Press the key.
8. Enter the QC lot number from the label on the side of the vial containing the QC
Note: Only
Sample. enter the four
digit numeric value of
the QC lot number
Do not enter the
preceding alpha
character.
Rev A O-5
MAIN MENU 9. To correct, press the key to clear the entire number, or select the
RUN TEST incorrect digit by using keys. Then type in the correct number.
a. If the test device’s internal quality control (QC) results are unacceptable,
the results for the affected analyte(s) will not appear on the screen.
b. If any of the QC Sample results are out of range, the results for that
c. A panel with multiple analytes will still be able to report patient results on
those analytes which passed QC. An analyte that failed QC will not be
allows the user to rerun only the failed analyte on the next QC Sample
Test. When all analytes have passed, the QC Sample timer is set to the
O-6 Rev A
PATIENT SAMPLE MAIN MENU
1. Press the key to power The Triage® MeterPro on. RUN TEST
4. Type or scan in your identification number (User ID). To correct, press the key Note: If the
to clear the entire number, or select the incorrect digit by using the User ID bypass
is ON, the meter will
keys then type in the correct number.
not ask you to enter a
User ID.
5. Press the key.
8. Type or scan the patient’s identification number (Patient ID). To correct, press the
Note: If the
key to clear entire number or select the incorrect digit using Bar Code
then type in the correct number. Scanner is being
used, simply point
9. Press the key. the scanner at the
bar code, press the
button on the scanner
handle and wait for
the beep. The number
will appear on the
display.
Rev A O-7
MAIN MENU 10. If the information is correct, press the key to confirm the Patient ID.
RUN TEST If the information is incorrect:
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.
13. Prepare the test sample and perform the test in accordance to the instructions
14. If the testing facility has authorized an analyte to be selected or deselected at the
time of running a patient test, the user will be prompted to select desired analytes
or deselect undesired analytes. After the test device has been pulled into the meter,
The 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
Example: 2 ✓ TNI indicates that TNI is currently selected, but can be deselected
Pressing the number again toggles the test between select and deselect.
O-8 Rev A
No number to the left of the test indicates tests which cannot be altered.
Note: If no key
is pressed on
Example ✓ CKMB indicates that CKMB is always selected, and cannot be
the Select Tests
deselected. screen, the meter
waits 30 seconds then
• Press the key. proceeds using only
the selected default
• If the information is correct, press the key to continue. tests. Similarly, if no
key is pressed on the
• If the information is incorrect, select CORRECT TEST using keys
Confirmation Screen,
and press the key to return to the lists of tests. the test proceeds after
waiting 30 seconds.
IMPORTANT INSTRUCTIONS FOR ALL TESTS:
a. Gently insert the test device into the Triage® MeterPro until you feel the After the test
device catch on the pin. You will hear an audible ‘click’ that tells you device has been
inserted, do not push
the test device has been inserted properly. the device in further or
attempt to pull it out.
b. Press the key to start the test. The device may be
ejected by returning to
c. The Triage® MeterPro pulls in the test device and scans it. the Main Menu and
pressing EXIT.
d. When the test is complete, the meter will beep, eject the device and
a. If the test device’s Internal Quality Control (QC) results are unacceptable,
the results for the affected analyte(s) will not appear on the screen.
b. If any of the QC Sample results for the lot being tested were out of range,
the results for that particular analyte will not appear on the screen.
Rev A O-9
Recall Results
Purpose
Recall Results is used to retrieve results stored in the Triage MeterPro’s memory.
Function
Note: If a result The Recall Results function can retrieve these results:
was rejected by • Last Record • QC Results
the user, an “R” will
• Patient Results – Internal QC Results
appear next to the
recalled result. – Patient ID – QC Sample Results
– QC Sample Results
– QC Device Results
• Upload Results to LIS
User ID numbers are partially masked. The Supervisor Code Chip module is
RECALL RESULTS Purpose: Last Record is used to retrieve the test results for the last test run.
6. The results from the last test run appear on the screen.
O-10 Rev A
PATIENT RESULTS MAIN MENU
Options: Patient results can be retrieved based on a variety of criteria: RECALL RESULTS
• Patient ID
• User ID
• From Date
• Till Date
PATIENT RESULTS
1. Press the key to power The Triage MeterPro on.
2. From the MAIN MENU select RECALL RESULTS using the keys.
will be displayed.
Rev A O-11
MAIN MENU TEST DEVICE LOT NUMBER (L/N)
RECALL RESULTS To retrieve results based on the lot number of the test devices used:
PATIENT RESULTS
2. From the MAIN MENU select RECALL RESULTS using the keys.
8. To display results specific to one lot, type in the lot number of the test device.
Note: Only enter
the five digit To correct, press the key to clear the entire number, or select the incorrect
numeric value of the
digit by using the keys. Then type in the correct number.
QC lot number
10. All results from test run on the requested lot number are displayed.
O-12 Rev A
USER ID MAIN MENU
To retrieve results from tests run on the Triage MeterPro starting with the user you select: RECALL RESULTS
PATIENT RESULTS
1. Press the key to power The Triage MeterPro on.
2. From the MAIN MENU select RECALL RESULTS using the keys.
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.
10. All results from tests run by requested user are displayed.
Rev A O-13
MAIN MENU FROM DATE
RECALL RESULTS To retrieve results from tests run on the Triage MeterPro starting with a date you select:
PATIENT RESULTS
1. Press the key to power The Triage MeterPro on.
2. From the MAIN MENU select RECALL RESULTS using the keys.
press the key to clear the entire number, or select the incorrect digit
10. All results from tests run from the date selected are displayed.
O-14 Rev A
TILL DATE MAIN MENU
To retrieve results from tests run on the Triage MeterPro before and including a date RECALL RESULTS
you select: PATIENT RESULTS
2. From the MAIN MENU select RECALL RESULTS using the keys.
press the key to clear the entire number, or select the incorrect digit
10. All results from tests run before and including the date you selected
are displayed.
Rev A O-15
MAIN MENU QC RESULTS
RECALL RESULTS Options: The results of these quality control (QC) tests can be retrieved from the
Note: You may Quality Control (QC test) Results can be retrieved by:
choose more
Internal QC Results (on Patient Tests) Panel Type
than one of the
Device Lot Number (L/N)
options for recalling
results in order to User ID Number
more precisely define From Date
the information you Till Date
want to recall from View All (Default)
the Triage MeterPro’s
memory. When you QC Sample Results Panel Type
choose multiple QC Sample Lot Number (L/N)
options, first make Device Lot Number (L/N)
selections and input User ID Number
numbers in all the From Date
categories you have
Till Date
chosen. Then press
View All (Default)
the ENTER key.
QC Device Results User ID Number
From Date
Till Date
View All (Default)
To retrieve QC Results for the Internal QC, the QC Sample and the QC Device, select
O-16 Rev A
QC SAMPLE LOT NUMBER (L/N) MAIN MENU
To retrieve results based on the lot number of the QC Sample used: RECALL RESULTS
QC RESULTS
1. Press the key to power The Triage MeterPro on.
QC SAMPLE RESULTS
2. From the MAIN MENU select RECALL RESULTS using the keys.
clear the entire number, or select the incorrect digit by using the
11. All QC results that have been run on the requested QC Sample lot number are
displayed.
Note: To display
all results, leave
the QC Sample L/N
blank.
Rev A O-17
MAIN MENU DEVICE LOT NUMBER (L/N)
RECALL RESULTS To retrieve QC Sample results based on the lot number of the test devices used:
QC RESULTS
INTERNAL QC RESULTS
QC SAMPLE RESULTS
2. From the MAIN MENU select RECALL RESULTS using the keys.
9. Type in the device lot number from the side of the box of test devices. To
correct, press the key to clear the entire number, or select the
incorrect digit by using the keys. Then type in the correct number.
11. All QC results that have been run on the requested lot number are displayed.
O-18 Rev A
USER ID MAIN MENU
To retrieve QC results from tests run on the Triage MeterPro starting with the user you select: RECALL RESULTS
QC RESULTS
1. Press the key to power The Triage MeterPro on.
QC SAMPLE RESULTS
2. From the MAIN MENU select RECALL RESULTS using the keys. QC SIMULATOR RESULTS
using keys.
10. Type in the user ID number. To correct, press the key to clear the
12. All QC results from tests run by requested user are displayed.
Rev A O-19
MAIN MENU FROM DATE
RECALL RESULTS To retrieve QC results from tests run on the Triage MeterPro starting with a date you select:
QC RESULTS
1. Press the key to power The Triage MeterPro on.
INTERNAL QC RESULTS
QC SAMPLE RESULTS 2. From the MAIN MENU select RECALL RESULTS using the keys.
QC SIMULATOR RESULTS
3. Press the key.
10. Type in the date. To correct, press the key to clear the entire
12. All results from tests run from the date selected are displayed.
O-20 Rev A
TILL DATE MAIN MENU
To retrieve QC results from tests run on the Triage MeterPro before and including a date RECALL RESULTS
you select: QC RESULTS
INTERNAL QC RESULTS
1. Press the key to power The Triage MeterPro on.
QC SAMPLE RESULTS
2. From the MAIN MENU select RECALL RESULTS using the keys. QC SIMULATOR RESULTS
10. Type in the date. To correct, press the key to clear the entire
12. All results from tests run before and including the date selected are displayed.
Rev A O-21
MAIN MENU REAGENT LOTS – QC
RECALL RESULTS A list of Reagent Code Chip modules in memory, along with corresponding expiration
The list will contain: Lot Number, Panel Type, Expiration Date
• If the QC expiration date has passed (expired), the date will be in reverse video
• If the QC for the lot has failed, the word FAILED will appear in place of an
expiration date.
• If a Code Chip module has been installed for a new lot, but QC has yet to be
established, the words NOT RUN will appear in place of the expiration date.
• If QC frequency is set to none, the reagent lot expiration date will be displayed.
This function will save detailed information regarding the last performed test for analysis
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
O-22 Rev A
PRINT ALL RESULTS MAIN MENU
Options: All stored results can be printed from the Triage MeterPro’s memory. RECALL RESULTS
• Patient Results
• QC Sample Results
• QC Device Results
2. From the MAIN MENU select RECALL RESULTS using the keys.
QC SAMPLE RESULTS
2. From the MAIN MENU select RECALL RESULTS using the keys.
Rev A O-23
MAIN MENU QC DEVICE RESULTS
2. From the MAIN MENU select RECALL RESULTS using the keys.
RECALL RESULTS When interfaced directly to an LIS, selecting this feature will send all test results
QC RESULTS to the LIS. Prior to the first upload, the LIS feature must be activated from the Set
O-24 Rev A
Delete Results
Purpose
The Delete function is used to remove patient test information from the Triage MeterPro
memory. This becomes necessary when the meter memory becomes full. Note: The
delete function
Triage MeterPro Memory is available only when
the Supervisor Code
Within the Triage MeterPro, Patient Result memory can hold 750 data sets, QC Sample
Chip is inserted in
can hold 200 data sets and QC Device memory can hold 250 data sets. When the the Triage MeterPro
memory is full, the oldest result is automatically overwritten when a new result is added. Code Chip module
Port.
The meter display alerts the user as the memory becomes full.
IMPORTANT: The Delete function permanently removes all patient data from the
meter memory. Before continuing, you may wish to first print results (or upload
Rev A O-25
MAIN MENU DELETE PATIENT RESULT
DELETE RESULTS This function will delete all patient results in meter memory. Since this action is not
reversible, the meter will require two confirmations of intent to delete results.
1. Insert the Supervisor Code Chip module in the Code Chip module Port.
5. If this is acceptable, press the key. (If this is not acceptable, press
the key).
7. Press the key to delete all results. (If you do not want to delete all
Note: Press
the EXIT key results, press the key).
to cancel at any time
before step 7.
O-26 Rev A
Display Backlight
DISPLAY BACKLIGHT
The Triage MeterPro has the capability for the operator to backlight the display for
providing improved clarity depending on ambient lighting conditions. The backlight feature
can be controlled by the backlight button on the keypad.
When the backlight button is pressed, the backlight initially comes on at maximum
brightness. Subsequent presses cycle the backlight from bright to dim and then to off.
To save power, the backlight turns off if no keys have been pressed for 15 seconds.
Pressing any key will restore the backlight to the previous level.
Rev B O-27
Alpha Numeric Mode
ALPHA NUMERIC MODE
The Triage MeterPro has the capability for the operator to enter both numeric and alpha
The keypad operates in numeric mode until alpha mode is activated by pressing the
key. The meter stays in alpha mode, indicated by the word ALPHA shown on the display,
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
6–M N O
The first press of a button causes the first letter to be displayed. The second press of the
same button within three seconds causes the second letter to be displayed. The third
press of the same button within three seconds causes the third letter to be displayed.
After the last character in a sequence is displayed, the next button press of the same
button within 3 seconds displays the first character and the sequence is repeated.
If more than three seconds pass without the operator pressing the button, the next press
of that button causes the first character to be displayed. If a new button is pressed, the
first character of the new button is displayed with subsequent presses repeating the
sequence.
O-28 Rev A
Total Quality Assurance
Introduction
Quality assurance programs control and monitor analytical methods. The quality control Note: For more
detailed
of analytical methods achieves two basic goals: information, call Biosite
Technical Services at
1. Ensures that the reagents and instrument are working properly 1-888-BIOSITE
2. Ensures that the procedure was performed correctly (1-888-246-7483)
24 hours a day/7 days
The mechanism by which analytical methods are traditionally controlled is through the a week.
Over the last 15 years advances in technology have changed the manner in which the
diagnostic reagents are configured. Assay systems for the Point-of-Care are generally
unitized testing devices that are distinct from traditional laboratory based analyzers.
The Triage tests are unitized tests that do not require additional reagents. Each device
contains a full complement of reagents that are required to perform the immunoassay.
The Triage tests have been designed to include assay controls in each test device that
monitor the assay procedure and the reagent integrity. The assay controls present a
unique and valuable extension to the traditional approach to quality control using liquid
reagents. If the product is stored under specified conditions, proper functioning of the
assay controls indicates that the test device is valid and proper adherence to assay
protocol has been followed. The assay controls in the Triage® tests require the need to
re-think the frequency with which external quality control specimens should be tested.
The Triage tests have been designed to yield long-term reagent stability. In addition, the
system provides quality control parameters in three separate and distinct categories:
• 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
Rev A M-1
Quality Assurance Functions
1. Internal Device Quality Assurance
• Bar Code
• User ID#
• Patient ID#
• QC Frequency
• QC Lockouts
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 Baseline Control Zone monitors the presence of interfering substances in the patient
sample that may alter the immunoassay process. If a specimen contains a substance that
has a major effect on the high and low controls and the baseline control and thereby on
the immunoassay, the results are not displayed and erroneous results are not reported.
A Trace QC algorithm has been programmed which evaluates the size, location and signal
to noise ratio of each zone on the device. Aberrations in zone quality exceeding preset
limits will cause rejection of one or more of the assay results.
M-2 Rev A
Meter Quality Assurance
The Self-Test Mode is initiated each time the meter is turned ON. In the self-test mode the
meter scans an Internal Calibration Chip. Each calibration chip scan is used to validate
and adjust, if necessary, the meter calibration. In the self-test mode, the available memory
for patient results is checked. When the capacity is below a pre-set limit, the remaining
capacity is related via a screen message. The software program is evaluated and is
terminated if corrupted. Software test results and Code Chip module data are verified for
integrity before each use.
A QC Device is provided with each meter to allow the user to further check the integrity of the
meter. The simulator contains six fluorescent zones of varying intensity that are measured by
the meter. There are pre-programmed acceptable ranges for the six zones. In addition, the
zones allow the meter to check for horizontal and vertical alignment of the zone measurement
to verify laser alignment and device transport. The QC Device also confirms laser stability.
A Bar Code is printed on the bottom of every test device to identify the reagent lot number
and to prevent the use of expired reagents.
A Supervisor Code Chip module is provided with each meter. This Code Chip module
allows access to meter functions not available to the routine user. The additional functions
are selection of parameter settings and downloading and deletion of results from the
meter memory.
A User ID# can be assigned in the software to limit access to the patient testing mode to
only those individuals who have been properly trained and have demonstrated testing
proficiency. A User ID# and expiration date are programmed into the meter memory and
are subsequently associated with all patient results generated by the user. This allows the
supervisor to review users’ testing frequency, and in the event of frequent test failures, to
identify potential problems in training.
An additional security feature of the User ID is the partial masking of the ID Number on displays
and printouts. This prevents unauthorized individuals from detecting and using an existing User
ID number. This feature is overridden when the Supervisor Code Chip module is installed
A Patient ID# is required for all patient tests performed. All QC sample and patient results
are stored in the meter’s memory and can be downloaded to a laboratory information
system (LIS) or an external data management software program for further viewing and
printing of quality control reports.
Rev A M-3
The Supervisor can select the QC Frequency for performing external liquid control
samples. When it is time to perform external QC samples, the user must test the external
liquid controls and obtain acceptable results before patient samples can be tested. When
QC samples have been successfully performed, the user is allowed to perform tests on
patient samples. If QC samples are not within an acceptable range, a QC Lockout function
prevents testing of patient samples. If desired, the supervisor in a central lab setting can
bypass this function. If test device controls are out of range, a QC Lockout function is
activated and patient test results are blocked from viewing and printing. This prevents
Additionally, if test devices are expired, a QC Lockout function is activated and prevents
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
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
• 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
• 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.
M-4 Rev A
2. Out-of-Range Flags
• If a patient is outside the normal range for any of the analytes, then the result will
be flagged by reverse video, that is, the background of the result will be black and
the value in white numbers. A warning will be displayed below the results:
• If the Internal QC zones for the device or a specific analyte are unacceptable, the
• If the QC Sample for a specific analyte on that device lot is unacceptable, the
analyte in question will display a pound sign ( # )in place of a value and a warning
• 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
3. Blocked Results
When QC error conditions exist on a test device, whether for a specific analyte or the
entire test panel, the analytes in question are blocked from view and replaced with
an Out of Range Flag. The error condition must be remedied and the test repeated to
obtain a result.
4. QC Sample Frequency
• How often an external liquid control, QC Sample, should be run can be selected
under SET PARAMETERS. If the time interval has expired, QC Samples must be
run and acceptable results obtained before a patient sample can be tested.
• A list of test device lots and the date that the QC Sample expires can
5. Supervisor Access
To prevent misuse, the Supervisor Code Chip module is required for access to the
Supervisor Code Chip is universal and may be used on any Triage MeterPro.
Rev A M-5
Service and Maintenance Procedures
Service and Maintenance Procedures
If any service or maintenance is required, the Triage MeterPro should be sent to the
Paper Replacement
1. Tear off any excess paper sticking out of the Triage MeterPro.
3. Remove unused paper or the empty paper spindle from paper compartment.
4. Tear or cut a clean, straight edge to feed into the printer. Do not cut paper at an
Note: The
printer contains angle, as the printer must sense the edge of the paper along the feed path.
a paper sensor and
will feed the new
paper roll only when
paper with a clean
straight line is pressed
into the paper roller.
Note: If PAPER
FEED button is
pressed before the
5. Insert the new roll of paper into the paper compartment.
printer senses the
paper, the printer will 6. Position the paper such that the paper will feed from under the roll (as opposed
not respond to the
to over the top of the roll, see picture, above).
command.
7. Insert the paper edge under the paper roller (platen) until it firmly seats or
M-6 Rev A
Changing Paper While Printing
If the meter runs out of paper while in the middle of a printing task and is displaying
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:
4. Tear or cut a clean, straight edge to feed into the printer. Do not cut paper at an
angle, as the printer must sense the edge of the paper along the feed path. Note: The
printer contains
a paper sensor and
will feed the new
paper roll only when
paper with a clean
straight line is pressed
into the paper roller.
6. Position the paper such that the paper will feed from under the roll (as opposed
Note: If PAPER
to over the top of the roll, see picture, above). FEED button is
7. Insert the paper edge under the paper roller (platen) until it firmly seats or a pressed before the
printer senses the
resistance is felt. paper, the printer will
8. Press the key. not respond to the
command.
9. When the printer begins to pull the paper in, release the paper. The printer will
feed a few lines and re-commence the print job. To ensure no data is lost, the
Note: The
printer will reprint up to the previous 5 lines. printer utilizes
10. After the paper has appeared above the printer, replace the printer cover, taking thermal paper, if the
printed paper is blank
care to ensure the paper does not get caught inside the meter.
after replacing a roll,
verify that the paper
roll is not upside down.
Rev A M-7
Cleaning
The Triage MeterPro requires minimal maintenance. Occasional cleaning of the exterior
with mild soap and water solution is sufficient. After using a damp, not wet, sponge or
cloth to apply a mild soap and water solution on the outside of the meter, wipe the
Note: Never
insert any tools, meter dry using a soft cloth or absorbent tissue. Do not allow water to seep into the
swabs, or cleaning printer. Do not immerse the meter in water or other liquids.
materials into the
device track. If blood or other fluids are not
The Triage MeterPro checks the active power source after ejecting a device or printing.
To check the battery power, navigate to the Main Menu, disconnect the AC power
supply, press the key (the meter attempts to eject the device), and look for the
Note:
Low Power Indicator on the Main Menu of the meter display. If the flashing indicator
Rechargeable
batteries are appears, replace the batteries.
authorized for use,
however, due to the
nature of these types
Battery Replacement
of batteries, it is
expected they will • Turn off the meter.
require recharging • Remove the battery cover from
more frequently. The
Triage MeterPro does the bottom of the meter by
not contain a built-in sliding the cover in the direction
battery charger,
rechargeable batteries of the arrow.
must be recharged • Remove the batteries and
outside of the meter.
discard them in an appropriate
waste container.
Note: If the
meter does not • Insert four size AA 1.5 volt batteries into the battery compartment. Be sure that the
power on after plus (+) and minus (-) signs of the batteries match the same signs embossed in the
replacing batteries,
verify the batteries are battery compartment.
lined up according to • Replace the cover to the battery compartment.
the symbols in the
battery compartment.
M-8 Rev A
Troubleshooting — Meter Symptoms
Symptom Probable Cause Corrective Action
Invalid Results a. Inappropriate body fluid or improperly a. Retest sample using a new test device
anticoagulated sample. with a proper specimen.
b. Sample size incorrect—too little sample. b. Retest sample on a new test device. Make
Test device’s internal QC controls will be sure the entire tube is full. Be certain the
out of range. lower bulb on the pipette tube contains a
small amount fluid before you press the
top bulb.
c. Meter was picked up or carried vertically c. If less than 30 minutes has passed since
while test was running. The test device’s preparing the test device, place meter on
internal QC controls will be out of range. flat surface and reinsert the test device. If
more than 30 minutes has passed, retest
sample on new test device. If meter must
be moved during test, carry the meter
parallel to the floor.
Meter will not pull test Hook that pulls test device into the meter If meter repeatedly fails to pull the device in,
device in. may be broken. the meter may need to be replaced. Call
Technical Services.
Code Chip module will not a. Code Chip module may have been a. Re-insert Code Chip module right side up.
fit in meter. inserted upside down.
b. Code Chip module or Meter contacts b. Try new Code Chip module, if available. If
could be bent. still not a good fit, call Technical Services.
Printer works but no print Paper may be installed backwards. Install paper reverse to current position.
appears on paper.
Printer jam. Paper may have been fed into the meter Carefully remove old paper out of the printer.
improperly. Do not insert any tools into the printer.
Printer stops printing Battery power low. Replace batteries or verify power cord is
or skips a line. installed in the meter and wall outlet.
Meter will not power on a. Batteries not installed, drained or a. Verify batteries are installed and correctly
or meter powers off when incorrectly aligned. aligned (+) and (-); replace batteries if
running a test. necessary.
b. Power source not plugged in. b. Verify power cord is installed in the meter
and wall outlet.
Meter contains no batteries All data is saved in the Meter except date
or batteries are low when and time. Reset date and time.
facility has loss of power.
Rev A M-9
Troubleshooting — Meter Message or Symptom
Message Probable Cause Corrective Action
>XXX.X Patient sample concentration is above the See instructions that came in the box of
dynamic range. test devices or call Technical Services.
<XX.X Patient result is below the dynamic range or For some parameters, a 0.0 ng/ml patient
is a concentration below the statistically result may be appropriate.
determined lowest test concentration.
BATTERY LOW. Batteries need replacement. Replace with 4-AA batteries or use the AC
power adapter as a power source.
CANNOT READ BAR CODE Damaged bar code or meter hook may be Look for particles on the bar code of the
broken. (The meter hook pulls the test device test device. wipe off with a dry cloth.
into the meter.) Repeat the test.
CANNOT READ a. Code Chip module error. a. • Ensure Code Chip module is completely
CODE CHIP. inserted.
• Try a reagent Code Chip module from a
different box of devices of the same lot
number.
• If a new Code Chip module eliminates
the message, the original Code Chip
module is at fault, discard Code Chip
b. Meter error. module.
DETECTOR FAILURE Optics Detector did not properly power on. Power meter off and wait 15 seconds. Power
meter on. If message fails to clear, contact
Technical Services.
MEASUREMENT FAILURE. a. Inappropriate body fluid or improperly a. Retest sample using new device with a
anticoagulated sample. proper specimen.
b. Sample size incorrect – too little sample. b. Retest sample on new device. Be certain
the lower bulb on pipet contains a small
amount of fluid and the entire tube is full
before dispensing contents.
c. Meter picked up or carried vertically while c. Retest sample and leave meter on bench
test is running. top while performing assay. If meter must
be transported during assay, carry meter
parallel to the floor. If more than 30 minutes
since inoculation, use a new device.
d. Sample running slowly
d. Possibly due to cold devices or sample,
high hematocrit with a whole blood
sample, or mechanical issue with device.
Have customer immediately reinsert
device into meter (if within 30 minutes of
sample addition).
Biosite Technical Services 1-888-BIOSITE (1-888-246-7483 24 hours a day/7 days a week)
M-10 Rev A
Troubleshooting — Meter Message or Symptom
Message Probable Cause Corrective Action
MOTOR FAILURE. Motor ceases to function. Eject and inspect the device for any
• Meter may slow or stop due to object sticky substances, labels on top of the
lodged on the Meter track. device or other items that may interfere
with the meter. If problem persists, contact
• Test device may stick on the meter track. Technical Services.
NO DEVICE DATA IN Reagent Code Chip® has not been installed. Install the Code Chip included in the box of
MEMORY. test devices (the Reagent Code Chip).
OPTIC FAILURE. a. Internal standard is out of specification. a. Power meter off then on again. If
OPTIC FAILURE message clears, run
the QC Device to verify proper operation.
If message fails to clear, contact Technical
Services.
b. Meter exposed to extreme temperatures. b. Power meter off. Allow meter to sit at
room temperature for 1–2 hours. Power
meter back on.
PROGRAM CHECK OK. Message appears when the ON/OFF Press the ENTER key.
Press ENTER to start button is pressed when the meter has
existing program or press been without power.
EXIT to load a new program.
QC Device—calibration, a. May be due to lint or dust affecting a. Clean QC Device with a lint-free cloth or
alignment or laser failed. reading. spray with canned air and repeat
Messages: the test.
CALIB PASS (or FAIL)
LASER PASS (or FAIL) b. QC Device was not run regularly. b. QC Device should be run regularly even if
ALIGN PASS (or FAIL) patient samples are not run.
TIME/DATE IS BLINKING Meter temporarily lost all power. Reset time and date if required. Check the
AC/DC power converter plug and batteries.
WARNING: INTERNAL QC Warning indicates that the internal quality Repeat sample using a new test device. If
OUT OF RANGE control on the test device was out of range. problem persists, call Technical Services.
This may be sample specific.
This may be device related.
Rev A M-11
Return Procedure
Return Procedure
Should a malfunction occur, call your designated Technical Services Department. If the
Technical Services Department determines that the meter should be returned, you will
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
M-12 Rev A
Glossary
Analyte: Chemical substance being In vitro: Made to occur in a laboratory
measured. vessel or other controlled experimental
environment rather than in a living
Assay: Test. organism (literally, in glass).
Code Chip module : Any of several kinds of Laser diode: Light source used in the
chips bearing information that can be Triage MeterPro.
downloaded in the Triage MeterPro,
including Reagent, QC Sample, QC LCD: Liquid crystal display; the screen
Device, Supervisor and Program. on the Triage MeterPro. Shows the
menu of possible tests and procedures
Code Chip module Port: The small slot on and prompts the operator to take the
the underneath side of the Triage next step.
MeterPro where a Code Chip module can
be inserted. Lot number: L/N; identification number
given to a group of test devices.
Date formats: DD-MM-YY: Day-Month-Year
MM-DD-YY: Month-Day-Year L/N: Lot number; the number that identifies
YY-MM-DD: Year-Month-Day a batch of test devices.
Digit: One part of a longer number; for Menu: List of choices displayed on the
example, in the number 231, the 2, 3, Triage MeterPro’s screen.
and 1 are each a digit.
MMX: The Multi Marker IndexTM value is a
Fluorescence: The characteristic of a number calculated from the measured
chemical substance that enables it to values of the analytes in a Test Device.
give off light when stimulated. Not all Triage test panels have the MMX
feature.
ID: Identification.
Parameters: Options; functions.
Immunoassay: A test that uses antibodies
to measure substances. Photodiode: Detects the light emitted from
the fluorescent dye in the test devices
Internal QC: Quality controls in place as
used in the Triage MeterPro.
part of the Triage MeterPro’s software or
zones built into the test device. Point of Care (POC): Not in a laboratory;
at the place where care is being given to
a patient.
Rev A A-1
Glossary
QC: Quality Control. Reagent: Substance that causes chemical
reactions; used in analysis.
QC Sample: External controls; a liquid
solution containing chemicals that, when Reagent Code Chip module: Code Chip
dispensed into a test device, react with module loaded with information about a
the test reagents. Used to verify proper specific test and lot number.
performance of test devices after
shipment or long periods of storage. Retrieve: Find, bring back.
QC Sample Code Chip module: Code Chip Reverse Video: Light text displayed on a
module that can be downloaded into the dark background.
Triage MeterPro memory to give the meter
information needed about the specific lot Screen: The part of the Triage MeterPro that
of QC Sample. displays words and numbers.
A-2 Rev A
MENU STRUCTURE
• INTERNAL QC RESULTS
• QC SAMPLE RESULTS
ID DISPLAY COMM
• QC DEVICE RESULTS
SETTINGS SETTINGS SETTINGS
• REAGENT LOTS – QC
• ARCHIVE LAST TEST
• CHARACTERS USER ID • BAUD RATE
• CHARACTERS PAT. ID • PAT. RESULT APPROVAL
• CHARACTERS AUX. ID • LIS ENABLE/DISABLE
• AUX. ID ENABLE/DISABLE • AUTO UPLOAD
• LANGUAGE
• PRINT MODE
• AUTO POWER-OFF
• DISPLAY CONTRAST
• PRINTER CONTRAST
Temperature Limitation
The Triage MeterPro is capable of tracking and printing out test history and providing
A-4 Rev A
Patient Test Log Sheet Used as an alternate method of tracking patient test history.
Date/ Patient User Name/ Lot Analyte Analyte Analyte Analyte Analyte Analyte Analyte Analyte Analyte Tech
Time ID Number ID Number Number 1 2 3 4 5 6 7 8 9 Comments Initials
1
10
11
12
13
14
15
16
17
18
19
20
Date/ QC Sample Expiration Analyte Analyte Analyte Analyte Analyte Analyte Analyte Analyte Analyte Tech
Time Lot Number Date Level 1 2 3 4 5 6 7 8 9 Comments Initials
Level I Low
1
Level II High
Level I Low
2
Level II High
Level I Low
3
Level II High
Level I Low
4
Level II High
Level I Low
5
Level II High
Level I Low
6
Level II High
Level I Low
7
Level II High
Level I Low
8
Level II High
Level I Low
9
Level II High
Level I Low
10
Level II High
Level I Low
11
Level II High
Level I Low
12
Level II High
Level I Low
13
Level II High
Level I Low
14
Level II High
Level I Low
15
Level II High
Rev A A-9
Biosite Incorporated BIOSITE FRANCE S.A.S.
9975 Summers Ridge Road, Espace Jouy – Bâtiment C
San Diego, California 92121 USA 21 Rue Albert Calmette
78350 JOUY-EN-JOSAS FRANCE
+1 (858) 805-4808
+33 (0) 1 39 20 21 00
www.biosite.com
Purchase of this product licenses its use under U.S. Patent Number 6,074,616.
Biosite®, Triage®, Code Chip®, Triage Census®, the Biosite logo and Triage logo are registered trademarks of
Biosite Incorporated.
© 2007, Biosite Incorporated
Part No. 22719 Rev. C 2007/02/09
A-10