Biosite Triage Meter Pro User Manual
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Biosite Triage Meter Pro User Manual

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I
NTRODUCTION
How to Use This Guide. . . . . . . . . . . . . . . . . . . I-2
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . I-4
Description . . . . . . . . . . . . . . . . . . . . . . . . . . I-4
Unpacking. . . . . . . . . . . . . . . . . . . . . . . . . . . I-5
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . I-8
Test Device Specifications . . . . . . . . . . . . . . I-8
I
NSTALLATION
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . N-1
Set Parameters . . . . . . . . . . . . . . . . . . . . . . . N-10
Supervisor Access . . . . . . . . . . . . . . . . . . N-10
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
®
module . . . . . . . . . . . . . . N-29
Rev A
O
PERATION
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . O-1
Run Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . O-2
Purpose. . . . . . . . . . . . . . . . . . . . . . . . . . . . O-2
QC 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
C
& M
ARE
AINTENANCE
Total Quality Assurance . . . . . . . . . . . . . . . . . M-1
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . M-9
Return Procedure . . . . . . . . . . . . . . . . . . . . . M-12
A
PPENDIX
Glossary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Software Flowchart . . . . . . . . . . . . . . . . . . . . . A-3
Sample Log Sheets . . . . . . . . . . . . . . . . . . . . . A-4
Index of Page Revisions . . . . . . . . . . . . . . . . . A-8
Declaration of Conformity . . . . . . . . . . . . . . . . A-9
I-1

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  • Page 1: Table Of Contents

    Table of Contents NTRODUCTION PERATION How to Use This Guide....I-2 Operation ......O-1 Introduction.

  • Page 2: How To Use This Guide

    How to Use This Guide This manual contains: • Instructions for the operation and maintenance of the Triage ® MeterPro, and; • Basic instructions for testing samples Note: To run specific tests, such as the Triage ® Cardiac Panel, you also will need detailed information contained in the product-specific...
  • Page 3 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...

  • Page 4: Introduction

    Description What is the Triage MeterPro? The Triage MeterPro is a portable fluorescence instrument used to measure the results of tests manufactured by Biosite ® Incorporated. The Triage MeterPro can be used in a laboratory or in a point-of-care setting.

  • Page 5: Unpacking

    The Triage MeterPro and the items that come with it are provided in a single box. package inserts included in each Triage test devices are packaged separately and include instructions for running specific 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: •...
  • Page 6 Parts of the Triage MeterPro Thermal printer Printer cover LCD (liquid crystal display) Backlight Delete Power button Test device insertion port Battery cover Printer cover Power supply port Data port Code Chip module port Rev A...
  • 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.

  • Page 8: Specifications

    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 A...

  • Page 9: Warnings, Precautions And Limitations

    Warnings, Precautions and Limitations • Operate the Triage MeterPro on a level, dry surface away from direct sunlight. • The QC Device is light-sensitive and should be stored in its black opaque case when not in use. • Do not move the Triage MeterPro while a test is in progress. •...
  • Page 10 (Intentionally blank) I-10 Rev A...

  • Page 11: Installation

    Installation 1. Unpack Meter: a. Remove the meter from the box and protective plastic bag. 2. Power Meter On: Batteries a. Turn the meter over. b. Remove battery cover. c. Install 4 AA batteries, paying attention to battery orientation in the battery compartment.
  • Page 12 3. Install paper: For more details about Installing a. Remove the printer cover by pulling up on the cover as indicated by the arrow on Paper see the C & section. AINTENANCE the back of the cover. b. 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.
  • Page 13 4. Insert Supervisor Code Chip module: For more details about Code Chips modules a. Remove the Supervisor Code Chip module Box from the meter box. see page N-29. b. Remove the Supervisor Code Chip module from its box. c. Insert the Supervisor Code Chip module into the Code Chip module Port. The port is located on the left side of the meter, towards the bottom front corner.
  • Page 14 5. To Change Meter Settings: For more details about Meter Settings see a. Select S using the keys and Press the key. ARAMETERS page N-11. b. Select M using the keys and Press the key. ETER ETTINGS c. Select ID S or C using ETTINGS...
  • Page 15 ASSWORD 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...
  • Page 16 6. Change Clock: For more details about Clock Settings see a. Select S using the keys and Press the key. ARAMETERS page N-20. b. Select C using the keys and Press the key. LOCK c. Select the H area using the keys.
  • Page 17 8. Change Reference Ranges / Thresholds for Tests: For more details about Ranges Settings a. Select S using the keys and Press the key. ARAMETERS see page N-24. b. Select R using the keys and Press the key. ANGES Note: The lowest value of the c.
  • Page 18 10. Change Bypass settings: For more details about Bypass Settings see a. Select S using the keys and Press the key. ARAMETERS page N-28 b. Select B using the keys and Press the key. YPASS Note: If the bypass is c.
  • Page 19 Self-Test The Triage MeterPro checks the system to verify it is operating properly by running self-tests when powered on and prior to each test. • Power On – includes laser operation, internal standard range, battery power, and software verification. • Each Test – verifies the laser operation, internal standard range and battery power. Code Chip modules Meter data is updated via a disposable Code Chip module.

  • Page 20: Set Parameters

    Set Parameters Purpose The S function allows the supervisor to select a number of settings. ARAMETERS Access to these settings is controlled using the Supervisor Code Chip module. List of Programmable Parameters A supervisor can set the following parameters: Heading Parameters ETER ETTINGS...

  • Page 21: How To Set Parameters: Basic Instructions

    How to Set Parameters: Basic Instructions Note: To save All instructions assume: changes, press the ENTER key. • The meter is on. 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.

  • Page 22: Meter Settings

    5. Use the keys to select the number to the right of C HARACTERS ARAMETERS under the M column. ETER ETTINGS 6. Use the keys to choose the smallest number of characters that will ID S ETTINGS appear in the User ID number. The minimum number of characters possible is 1. 7.
  • Page 23 . ID HARACTERS This setting will set the minimum and maximum number of characters in the Auxiliary ID. ARAMETERS If the setting of A . ID E is E , a number is mandatory for each NABLE ISABLE NABLED ETER ETTINGS patient test.
  • Page 24 ISPLAY ETTINGS ARAMETERS ANGUAGE ETER ETTINGS This setting will determine which language the meter displays. ISPLAY ETTINGS 1. From a list of programmable parameters, choose M ETER ETTINGS using keys. 2. Press the key. 3. Use the keys to select D ISPLAY ETTINGS 4.
  • Page 25 – O OWER This setting will determine the length of time before an inactive meter will power off. ARAMETERS 1. From a list of programmable parameters, choose M ETER ETTINGS ETER ETTINGS using keys. ISPLAY ETTINGS 2. Press the key. 3.
  • Page 26 (Intentionally blank) N-16 Rev B...

  • Page 27: Communication Settings

    Biosite Technical Services at 1-888-BIOSITE (1-888-246-7483). ETER ETTINGS The Biosite Technical Services Representative will provide you with a password that, when ETTINGS entered, will allow data to be transmitted. 1. From a list of programmable parameters, choose M...
  • Page 28 ATIENT ESULT PPROVAL Some institutions may desire patient test results to be verified by the user before printing ARAMETERS or sending to the LIS. Activation of this feature displays the result, then requires the user ETER ETTINGS to accept or reject the result before the record is printed and saved. If the test is rejected, ETTINGS the meter will permanently flag it as rejected by the user.
  • Page 29 E LIS P will appear. NABLED NTER ASSWORD Enter the password provided by Biosite Technical Services. Press the key. 10. Acknowledge the LIS E message by pressing the key. NABLED (This feature is visible after the LIS has been enabled.) PLOAD 1.

  • Page 30: Clock

    LOCK The clock menu sets the time and date of the meter and the format for displaying both. If ARAMETERS the meter has lost power, the time and date will blink on the Main Menu. LOCK 1. From the list of programmable parameters, choose C using keys.
  • Page 31 Up to 600 User ID numbers with 1 – 10 digits may be programmed into the meter. ARAMETERS The User ID may alternately be entered using the external Bar Code Scanner (optional). An additional security feature of the User ID is the partial masking of the ID Number on displays and printouts.
  • Page 32 PDATE 1. From the list of programmable parameters, choose U ARAMETERS using keys. 2. Press the key. 3. Select U ID using keys. PDATE 4. Press the key. 5. Type in the user number you want to update. To correct, press the Note: If you type in a to clear the entire number, or select the incorrect digit by using the...

  • Page 33: User Id

    ID L 1. From the list of programmable parameters, choose U ARAMETERS using keys. 2. Press the key. 3. Select U ID L using keys. 2. Press the key. 5. A list is displayed. 6. Use the keys to select the type of ID list you want: U XPIRATION XPIRATION •...

  • Page 34: Ranges

    Depending on the product, the normal range may be inclusive or exclusive of the upper number. Consult the product package insert or call Biosite Technical Services for clarification. These values will be in reverse video on the patient results.
  • Page 35 See pages N-26 and 0-8 for more details. 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.

  • Page 36: Test Settings

    ETTINGS 1. From the list of programmable parameters, choose T ETTINGS ARAMETERS using keys. 2. Press the key. 3. Select the test panel type using the keys. 4. Select the desired mode using the keys. on Screen) – The test will run on every patient specimen. •...

  • Page 37: Qc Parameters

    QC P ARAMETERS The QC Parameters menu provides the user the options for determining what the ARAMETERS maximum frequency is for running the QC Device and QC Sample and whether 1 or 2 QC P ARAMETERS levels of control are required for the QC Sample. QC D EVICE REQUENCY...

  • Page 38: Bypass

    UMBER OF ONTROLS 1. From the list of programmable parameters, choose QC P ARAMETERS ARAMETERS using the keys. PARAMETERS 2. Press the key. 3. Use keys to select the information to the right of N UMBER OF ONTROLS 4. Using keys, select one of these options: 1 or 2.

  • Page 39: Install Code Chip

    Install Code Chip Purpose The Triage MeterPro will prompt the user to install a Code Chip module when required. However, the I function may be used as an alternate method to transfer NSTALL 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.

  • Page 40: Module

    Installation of Reagent, QC Sample or QC Device Code Chip modules. NSTALL 1. From the M select I using keys. NSTALL 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.

  • Page 41: Operation

    Operation Access to The Triage MeterPro Function Restricted to Patient Testing operators with valid User ID numbers* Quality Control Testing operators with valid User ID numbers* Patient Testing ECALL ESULTS Quality Control Testing Types of Code Chips NSTALL HIPS Installation Procedure Access Control Supervisor ARAMETERS...

  • Page 42: Run Test

    Run Test Purpose Run Test is used for the analysis of a test. Options The Run test function allows you to test: • QC Device • QC Sample • Patient Sample In order to run a patient sample, the meter requires: 1.
  • Page 43 QC D EVICE The QC Device should be run on each day of patient testing. It is desirable to run the QC Device after the meter has been inactive for at least 30 minutes. To run the QC Device test: 1.
  • Page 44 QC Device. After cleaning the device, repeat the QC Device test. • If the QC Device test fails after you have cleaned the device, call Biosite Incorporated Technical Services at 1-888-BIOSITE. • Note: the QC Device does not expire. Rev A...
  • Page 45 QC S AMPLE To run the Quality Control sample: 1. Press the key to power The Triage MeterPro on. 2. Select R using keys. The Main Menu 3. Press the key. 4. Type in your identification number (User ID). To correct, press the key to Note: If the User ID bypass...
  • Page 46 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 10. Press the key. enter a QC lot number for which 11. Perform the test according to the instructions provided in the package of test there is no data in the devices you are using.
  • Page 47 ATIENT AMPLE 1. Press the key to power The Triage ® MeterPro on. 2. Select R using keys. The Main Menu 3. Press the key. 4. Type or scan in your identification number (User ID). To correct, press the Note: If the User ID bypass to clear the entire number, or select the incorrect digit by using the is ON, the meter will...
  • Page 48 10. If the information is correct, press the key to confirm the Patient ID. If the information is incorrect: • Select C ID using keys. ORRECT ATIENT • Press the key. • Press the key to clear the entire number or select the incorrect digit using keys, then type in the correct number.
  • Page 49 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 •...

  • Page 50: Recall Results

    Recall Results Purpose Recall Results is used to retrieve results stored in the Triage MeterPro’s memory. Function The Recall Results function can retrieve these results: Note: If a result • Last Record • QC Results was rejected by the user, an “R” will •...
  • Page 51 ATIENT ESULTS Options: Patient results can be retrieved based on a variety of criteria: ECALL ESULTS • Patient ID • Test Device Lot Number (L/N) • User ID • From Date • Till Date ATIENT To retrieve results based on the patient ID: ECALL ESULTS ATIENT...
  • Page 52 (L/N) EVICE UMBER To retrieve results based on the lot number of the test devices used: ECALL ESULTS ATIENT ESULTS 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.
  • Page 53 To retrieve results from tests run on the Triage MeterPro starting with the user you select: ECALL ESULTS ATIENT ESULTS 1. Press the key to power The Triage MeterPro on. 2. From the M select R using the keys. ECALL ESULTS 3.
  • Page 54 To retrieve results from tests run on the Triage MeterPro starting with a date you select: ECALL ESULTS ATIENT ESULTS 1. Press the key to power The Triage MeterPro on. 2. From the M select R using the keys. ECALL ESULTS 3.
  • Page 55 To retrieve results from tests run on the Triage MeterPro before and including a date ECALL ESULTS you select: ATIENT ESULTS 1. Press the key to power The Triage MeterPro on. 2. From the M select R using the keys. ECALL ESULTS 3.

  • Page 56: Reagent Lots-Qc

    QC R ESULTS Options: The results of these quality control (QC) tests can be retrieved from the ECALL ESULTS Triage MeterPro’s memory: Quality Control (QC test) Results can be retrieved by: Note: You may choose more Internal QC Results (on Patient Tests) Panel Type than one of the Device Lot Number (L/N)
  • Page 57 QC S (L/N) AMPLE UMBER To retrieve results based on the lot number of the QC Sample used: ECALL ESULTS QC R ESULTS 1. Press the key to power The Triage MeterPro on. QC S AMPLE ESULTS 2. From the M select R using the keys.
  • Page 58 (L/N) EVICE UMBER To retrieve QC Sample results based on the lot number of the test devices used: ECALL ESULTS QC R ESULTS QC R NTERNAL ESULTS QC S AMPLE ESULTS The lot number of the test devices is on the box that contains the test devices.
  • Page 59 To retrieve QC results from tests run on the Triage MeterPro starting with the user you select: ECALL ESULTS QC R ESULTS 1. Press the key to power The Triage MeterPro on. QC S AMPLE ESULTS 2. From the M select R using the keys.
  • Page 60 To retrieve QC results from tests run on the Triage MeterPro starting with a date you select: ECALL ESULTS QC R ESULTS 1. Press the key to power The Triage MeterPro on. QC R NTERNAL ESULTS 2. From the M select R using the keys.
  • Page 61 To retrieve QC results from tests run on the Triage MeterPro before and including a date ECALL ESULTS you select: QC R ESULTS QC R NTERNAL ESULTS 1. Press the key to power The Triage MeterPro on. QC S AMPLE ESULTS QC S IMULATOR...

  • Page 62: 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.
  • Page 63 RINT ESULTS Options: All stored results can be printed from the Triage MeterPro’s memory. ECALL ESULTS • Patient Results • QC Sample Results • QC Device Results ATIENT ESULTS To print all Patient Results: ECALL ESULTS RINT ESULTS 1. Press the key to power The Triage MeterPro on.

  • Page 64: Print All Results

    QC D EVICE ESULTS To print all QC Device Results: ECALL ESULTS RINT ESULTS 1. Press the key to power The Triage MeterPro on. 2. From the M select R using the keys. ECALL ESULTS 3. Press the key. 4. Select P using keys.

  • Page 65: Delete Results

    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.
  • Page 66 ELETE ATIENT ESULT This function will delete all patient results in meter memory. Since this action is not ELETE ESULTS reversible, the meter will require two confirmations of intent to delete results. 1. Insert the Supervisor Code Chip module in the Code Chip module Port. Code Chip module Code Chip module Port 2.

  • Page 67: Display Backlight

    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.

  • Page 68: Alpha Numeric Mode

    Alpha Numeric Mode ALPHA NUMERIC MODE The Triage MeterPro has the capability for the operator to enter both numeric and alpha characters from the keypad. The keypad operates in numeric mode until alpha mode is activated by pressing the key. The meter stays in alpha mode, indicated by the word A shown on the display, LPHA until the...

  • Page 69: Total Quality Assurance

    Note: For more Quality assurance programs control and monitor analytical methods. The quality control 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 (1-888-246-7483) 2.
  • Page 70 Quality Assurance Functions 1. Internal Device Quality Assurance • Internal Positive Control Zone • Baseline Control Zone • Timing Control Zone • Zone Quality Requirements (Trace QC) 2. Meter Quality Assurance • Self Test Mode • Internal Calibration Chip • Electronic QC Device •...
  • 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.
  • Page 72 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...
  • Page 73 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: •...

  • Page 74: Service And Maintenance Procedures

    Service and Maintenance Procedures Service and Maintenance Procedures If any service or maintenance is required, the Triage MeterPro should be sent to the manufacturer. No maintenance other than paper / battery replacement and periodic external cleaning is required of the operator. Paper Replacement Changing Paper Between Functions 1.
  • 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.
  • Page 76 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 meter dry using a soft cloth or absorbent tissue.

  • Page 77: Troubleshooting

    Meter contains no batteries All data is saved in the Meter except date or batteries are low when and time. Reset date and time. facility has loss of power. Biosite Technical Services 1-888-BIOSITE (1-888-246-7483 24 hours a day/7 days a week) Rev A...
  • Page 78 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...
  • Page 79 ECORDS patient records when running patient sample. c. No action is required as the meter will delete the oldest result once the memory is full. Biosite Technical Services 1-888-BIOSITE (1-888-246-7483 24 hours a day/7 days a week) Rev A M-11...

  • Page 80: Return Procedure

    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.

  • Page 81: Glossary

    Glossary Analyte: Chemical substance being In vitro: Made to occur in a laboratory measured. vessel or other controlled experimental environment rather than in a living Assay: Test. organism (literally, in glass). Calibration: Comparison of result to a In vitro diagnostic use: For use in a reference standard.
  • Page 82 Glossary QC: Quality Control. Reagent: Substance that causes chemical reactions; used in analysis. QC Sample: External controls; a liquid Reagent Code Chip module: Code Chip solution containing chemicals that, when dispensed into a test device, react with module loaded with information about a the test reagents.

  • Page 84: Sample Log Sheets

    Labelling Symbols Manufacturer Authorized Representative in the Eurpoean Community In Vitro Diagnostic Medical Device Temperature Limitation Sample Log Sheets The following log sheets are provided as alternate methods of tracking test results. The Triage MeterPro is capable of tracking and printing out test history and providing QC Lockouts to prevent patient testing when outside QC requirements.
  • Page 88 Index of Page Revisions This chart may be used to page check your User Manual. Additional pages may be requested from your Biosite Customer Services. This page will be updated and included with any manual updates. Page # Page #...
  • Page 89 (Intentionally blank) Rev A...
  • Page 90 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.

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