Quidel Triage MeterPro User Manual
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Quidel Triage MeterPro User Manual

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  • Page 1 User Manual Page 1 of 86...

  • Page 2: Table Of Contents

    Warnings, Precautions and Limitations......................9 Introduction............................... 10 How to Use This Guide ..........................10 Description ..............................10 What is the Quidel Triage MeterPro? ....................... 10 Unpacking ..............................11 Installation................................. 15 Unpack Meter..............................15 Power Meter On ............................15 Install Paper ..........................
  • Page 3 Types of CODE CHIP modules ........................37 Installation of Reagent, QC Sample or QC Device CODE CHIP Modules ........... 37 Operation ................................39 Access to the Quidel Triage MeterPro ......................39 Run Test ................................. 39 Purpose..............................39 Options ..........................
  • Page 4 Misc. Test Results ............................64 Upload Results to LIS ..........................64 Delete Results..............................64 Purpose..............................64 The Quidel Triage MeterPro Memory ....................... 65 Delete Patient Result..........................65 Display Backlight............................66 Alpha Numeric Mode ............................ 67 Service and Maintenance Procedures.......................

  • Page 5: General Information

    General Information Quidel Contact Information Contact Quidel Technical Support from 7:00 a.m. to 5:00 p.m. Pacific Time Tel: 800.874.1517 (in the U.S.); 858.552.1100 (outside the U.S.) Fax: 858.552.7905 Email: technicalsupport@quidel.com or contact your local distributor Website: quidel.com If outside the U.S. contact local distributor or one of the Technical Support centers listed below. You may also contact us at quidel.com.

  • Page 6: Main Menu Structure

    Main Menu Structure Install New Delete Run Test Recall Results CODE CHIP Parameters* Results* * Supervisor CODE CHIP Only Meter Test Patient Misc. Clock User ID Ranges Bypass Settings Settings Parameters Sample Device Sample Test New User ID QC Device Freq. Misc.

  • Page 7: Labels And Symbols

    Labels and Symbols Label/Symbol Description Manufacturer In vitro diagnostic medical device Consult instructions for use Authorized representative in the European Community Temperature limitation Humidity limitation Waste electrical and electronic equipment (WEEE) Serial Number Catalog Number Warning / Caution Important Page 7 of 86...
  • Page 8 CE mark Batch code Date of manufacture Use by date Intended use Upper limit of temperature Do not re use China RoHS Patient number Test device Control Calibration Verification Contents/contains Prescription use only Expected values Biological risks Thaw Transfer pipette Mean Standard deviation CODE CHIP module...

  • Page 9: Warnings, Precautions And Limitations

    Ensure all sample fluids have absorbed into the test device prior to running the test to prevent internal contamination of the meter. Use only the AC / DC power adapter provided with the Quidel Triage MeterPro. An identifying tag has been placed on the cord for quick identification.

  • Page 10: Introduction

    The Quidel Triage MeterPro uses a laser as a light source. Light from the laser hits a test device that has been inserted in the meter. This causes the fluorescent dye in the test device to give off energy. The more energy the fluorescent dye gives off, the stronger the signal.

  • Page 11: Unpacking

    Control (QC) functions that allow the person operating the meter to monitor quality control. NOTE: The Quidel Triage MeterPro accepts test devices that are designed specifically for use with the Quidel Triage MeterPro. Please refer to product specific Package Inserts included in each test kit for more information. Unpacking The Quidel Triage MeterPro and the items that come with it are provided in a single box.
  • Page 12 Contents Quidel Triage MeterPro QC Device and CODE CHIP module (in the QC Device box) AC / DC Power Converter AA Batteries Rolls of Printer Paper (additional rolls are supplied in each box of test devices) Supervisor CODE CHIP module and CODE CHIP module Box...
  • Page 13 Parts of the Quidel Triage MeterPro Page 13 of 86...
  • Page 14 On/Off Key Used to turn the Quidel Triage MeterPro on and off. (Power button) Print Key Used to print the test results or display screen. Delete Key Used to delete data. Allows the operator to select menu items and acknowledge alarm Enter Key conditions.

  • Page 15: Installation

    Installation Unpack Meter a. Remove the meter from the box and protective plastic bag. Power Meter On Batteries a. Turn the meter over. b. Remove battery cover. c. Install 4 AA batteries, paying attention to battery orientation in the battery compartment. d.

  • Page 16: Install Paper

    AC Power Supply a. Remove the power supply from the box. b. Plug one end into an AC outlet. c. Plug the opposite end into the round hole in the back of the meter. Install Paper a. Remove the printer cover by pulling up on the cover as indicated by the arrow on the back of the cover. For more details about Installing Paper see the Care and Maintenance section.

  • Page 17: Insert Supervisor Code Chip Module

    d. Insert the paper edge under the paper roller (platen) until it firmly seats or resistance is felt. e. Press the key twice, paper will feed through the printer and extend out the meter. Place the roll of paper into the paper compartment. g.
  • Page 18 c. Select ID SETTINGS, DISPLAY SETTINGS or COMM SETTINGS using keys and press the key. d. Select the desired setting using the keys and change the value of the setting by using the keys. ID Settings Default Options New Settings Min 1 1 16 HARACTERS...

  • Page 19: Change Clock

    Communication Settings. h. Press the key to save changes to Meter Settings. For more details about Communications, including entry of a Quidel provided, meter specific password, see page 29. Change Clock a. Select SET PARAMETERS using the keys and press the key.

  • Page 20: Set User Id

    Set User ID The Quidel Triage MeterPro normally requires a User ID to be entered prior to running a patient test, QC test, or Misc test, and prior to recalling patient results. Refer to page 31 for instructions. Alternately, this feature may be bypassed.

  • Page 21: Change Qc Parameters

    Change QC Parameters a. Select SET PARAMETERS using the keys and press b. Select QC PARAMETERS using the keys and press c. Select the desired setting using the keys and change the value to the right of the setting by using the keys.
  • Page 22 Self Test The Quidel Triage MeterPro checks the system to be sure 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.

  • Page 23: Set Parameters

    Software Upgrade CODE CHIP module – provided when Quidel Triage MeterPro software upgrades are available; contains new software for the meter. 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.

  • Page 24: How To Set Parameters: Basic Instructions

    To insert the Supervisor CODE CHIP module into the Quidel Triage MeterPro, slide the chip labeled "SPR" into the meter’s CODE CHIP module port as shown in the picture. How to Set Parameters: Basic Instructions All instructions assume: The meter is on.

  • Page 25: Meter Settings

    Main Menu Meter Settings Set Parameters This menu will allow you to set basic operational criteria for the meter: language, Meter Settings display contrast, maximum length of the user, patient, auxiliary and misc. ID's, ID Settings printer mode and automatic power off. ID Settings Main Menu Characters User ID...
  • Page 26 NOTE: The Auxiliary ID is shown only on the New Result display or printout. It is not visible in recalled results. Tracking may be managed through the optional software package, Quidel Triage Census. Aux. ID Enable/Disable Main Menu This setting will turn on or turn off the Auxiliary ID function.
  • Page 27 5. Use the keys to highlight the name to the right of LANGUAGE. 6. Use the keys to change the language of the Quidel Triage MeterPro’s screen and printouts. 7. Press the key to save changes. Print Mode This setting will determine if the meter prints automatically or only when requested.
  • Page 28 3. Use the keys to select DISPLAY SETTINGS. 4. Press the key. 5. Use the keys to select highlight the word to the right of PRINT MODE. 6. Use the keys to choose AUTOMATIC or MANUAL. If AUTOMATIC is selected, the meter will immediately print out the results after each test (patient, QC or Misc Test).
  • Page 29 Prior to activating the LIS feature, obtain the meter’s serial number located Set Parameters underneath the meter and contact Quidel (Refer to the Assistance section). Meter Settings The Quidel Representative will provide you with a password that, when entered, Comm Settings will allow data to be transmitted. Baud Rate 1.
  • Page 30 8. If DISABLED was selected, a screen showing a LIS DISABLED will appear. Press key. 9. If ENABLED was selected, a screen showing a ENTER LIS PASSWORD will appear. Enter the password provided by the Quidel Representative. Press the key. 10. Acknowledge the LIS ENABLED message by pressing the key.
  • Page 31 Clock Main Menu The clock menu sets the time and date of the meter and the format for displaying Set Parameters both. If the meter has lost power, the time and date will blink on the Main Menu. Clock 1. From the list of programmable parameters, choose CLOCK using the keys.
  • Page 32 The Quidel Triage MeterPro recognizes 0’s as a unique character. Therefore, ‘4341’ will be recognized separately from ‘04341’. Using the barcode scanner or alpha mode (shift key) will allow the Quidel Triage MeterPro to accept alpha characters and the following symbols: # ( ) * .
  • Page 33 Select DELETE USER ID using the keys. Press the key. Type in the user ID to be deleted. To correct, press to clear the entire ID, or select the incorrect character by using the keys. Then type in the correct ID. Press the key.
  • Page 34 Quidel for clarification. These values will be in reverse video on the patient results. Analytes with a comma – Three ranges possible. If the lower number is 0.0, the meter treats 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.
  • Page 35 USER ACTIVE (USR A ON SCREEN) – At the time of patient testing, the user has the ability to deselect the test. 6. Press the key to save changes. NOTE: When the analyte is deselected, the value is not calculated nor stored QC Tests With Test Settings Activated Any test which the Supervisor has set to ACTIVE, USER ACTIVE or USER INACTIVE will run on the QC Sample panel.
  • Page 36 From the list of programmable parameters, choose QC PARAMETERS using the keys. Press the key. 3. Use the keys to select the information to the right of QC SAMPLE FREQ. 4. Using the keys, select one of these options: NONE, 8 HOURS, DAILY, WEEKLY, MONTHLY. Press the key to save changes.

  • Page 37: Install Code Chip

    Install Code Chip Purpose The Quidel Triage MeterPro will prompt the user to install a CODE CHIP module when required. However, the INSTALL CODE CHIP function may be used as an alternate method to transfer information from a CODE CHIP module into the meter’s memory. The meter will direct the user to install a CODE CHIP module if it is attempting to run a test and does not have the data in its memory.
  • Page 38 3. Slide the CODE CHIP module into the CODE CHIP module Port in the Quidel Triage MeterPro, as shown in the picture. 4. Press the key. 5. The meter will display a confirmation message that the information was installed into the Quidel Triage MeterPro’s memory.

  • Page 39: Operation

    Operation Access to the Quidel Triage MeterPro Function Restricted to Patient Testing Operators with valid User ID's* Quality Control Testing Operators with valid User ID's* Misc. Test Testing Operators with valid User ID's* Last Record If last test run is a patient sample:...
  • Page 40 If any of these conditions do not exist, the meter will not continue and will prompt the user to perform the required steps. IMPORTANT: The Quidel Triage MeterPro will alert the user if QC has not been performed for the device lot being tested. NOTE: The Supervisor CODE CHIP module provides access to functions that may override these Lockouts.
  • Page 41 Menu screen as it looks when operator selects QC Device. Press the key. 8. Gently insert the QC Device into the Quidel Triage MeterPro until you feel the QC Device catch on the pin and hear an audible ‘click.’ Press the key.
  • Page 42 If the QC Device tests fail, wipe the QC Device clean with a lint free cloth to remove any oils, dust, fibers, or fingerprints. Do not apply any liquid to the QC Device. After cleaning the device, repeat the QC Device test. If the QC Device test fails after you have cleaned the device, contact Quidel. QC Sample Main Menu...
  • Page 43 Then type in the correct number. NOTE: If you enter a QC lot number for which there is no data in the Quidel Triage MeterPro’s memory, you will see a message on the meter’s screen: NO QC Sample data in memory.
  • Page 44 If an individual analyte is outside the specified range, the Quidel Triage MeterPro allows the user to rerun only the failed analyte on the next QC Sample Test. When all analytes have passed, the QC Sample timer is set to the date of the first passing analyte.
  • Page 45 Patient Sample Main Menu 10. If the information is correct, press the key to confirm the Patient ID. Run Test If the information is incorrect: Select CORRECT PATIENT ID using the keys. Press the key. Press the key to clear the entire ID, or select the incorrect character using the keys.
  • Page 46 Important instructions for all tests: a. Gently insert the test device into the Quidel Triage Meter until you feel the device catch on the pin. You will hear an audible ‘click’ that tells you the test device has been inserted properly.
  • Page 47 Misc. Test Sample Main Menu 1. Press the key to power the Quidel Triage MeterPro on. Run Test 2. Select RUN TEST using the keys. 8:23AM 01•20•18 RUN TEST RECALL RESULTS INSTALL NEW CODE CHIP SELECT WITH v OR ^ AND PRESS ENTER...
  • Page 48 Important instructions for all tests: a. Gently insert the test device into the Quidel Triage Meter until you feel the device catch on the pin. You will hear an audible ‘click’ that tells you the test device has been inserted properly.

  • Page 49: Recall Results

    Recall Results Purpose Recall Results is used to retrieve results stored in the Quidel Triage MeterPro’s memory. Function The Recall Results function can retrieve these results: Last Record QC Results Patient Results QC Sample Results Patient ID QC Device Results Panel Type Reagent Lots –...

  • Page 50: Patient Results

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

  • Page 51: Test Device Lot Number (L/N)

    To retrieve results based on the lot number of the test devices used: Main Menu Recall Results Patient Results 1. Press the key to power the Quidel Triage MeterPro on. 2. From the MAIN MENU select RECALL RESULTS using the keys. 3. Press the key.

  • Page 52: User Id

    Main Menu User ID Recall Results To retrieve results from tests run on the Quidel Triage MeterPro starting with Patient Results the user you select: 1. Press the key to power the Quidel Triage MeterPro on. 2. From the MAIN MENU select RECALL RESULTS using the keys.

  • Page 53: Till Date

    17. Press the key to upload the selected results to LIS. Till Date Main Menu To retrieve results from tests run on the Quidel Triage MeterPro before and including Recall Results a date you select: Patient Results 1. Press the key to power the Quidel Triage MeterPro on.

  • Page 54: Qc Results

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

  • Page 55: Qc Sample Lot Number (L/N)

    To retrieve results based on the lot number of the QC Sample used: Recall Results QC Results 1. Press the key to power the Quidel Triage MeterPro on. QC Sample Results 2. From the MAIN MENU select RECALL RESULTS using the keys.

  • Page 56: User Id

    LIS. Main Menu User ID Recall Results To retrieve QC results from tests run on the Quidel Triage MeterPro starting QC Results with the user you select: QC Sample Results QC Device Results 1.

  • Page 57: From Date

    16. Press the key to upload the selected results to LIS. Till Date To retrieve QC results from tests run on the Quidel Triage MeterPro before and Main Menu including a date you select: Recall Results 1.

  • Page 58: Reagent Lots Qc

    The Reagent Lots – QC Screen Archive Last Test This function will save detailed information regarding the last performed test for analysis by Quidel. Use this function when requested by Quidel. 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 59: Misc. Test Results

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

  • Page 60: Test Device Lot Number (L/N)

    To retrieve results based on the lot number of the test devices used: Recall Results Misc Test Results Press the key to power the Quidel Triage MeterPro on. 2. From the MAIN MENU select RECALL RESULTS using the keys. 3. Press the key.

  • Page 61: User Id

    15. Press the key to upload the selected results to LIS. From Date Main Menu To retrieve results from test run on the Quidel Triage MeterPro starting with a date Recall Results you select: Misc Test Results Press the key to power the Quidel Triage MeterPro on.

  • Page 62: Till Date

    15. Press the key to upload the selected results to LIS. Till Date Main Menu To retrieve results from test run on the Quidel Triage MeterPro befoe and including Recall Results a date you select: Misc Test Results 1. Press the key to power the Quidel Triage MeterPro on.

  • Page 63: Print All Results

    Print All Results Main Menu Options: All stored results can be printed from the Quidel Triage MeterPro’s Recall Results memory. Misc Test Results Patient Results QC Sample Results QC Device Results Misc. Test Results Patient Results Main Menu To print all Patient Results:...

  • Page 64: Qc Device Results

    Set Parameter menu item using the Supervisor CODE CHIP module. Delete Results Purpose The Delete function is used to remove all patient test information from the Quidel Triage MeterPro memory. NOTE : The delete function is available only when the Supervisor CODE CHIP module is inserted in the Quidel Triage MeterPro CODE CHIP module Port.

  • Page 65: The Quidel Triage Meterpro Memory

    Quidel Triage MeterPro Memory Within the Quidel Triage MeterPro, Patient Result memory can hold 750 data sets, QC Sample can hold 200 data sets, QC Device can hold 70 data sets, and Misc. Test can hold 250 data sets. When the memory is full, the oldest result is automatically overwritten when a new result is added.

  • Page 66: Display Backlight

    (If you do not want to delete all patient results, Display Backlight The Quidel Triage MeterPro has the capability for the operator to backlight the display for providing improved clarity depending on ambient lighting conditions. The backlight feature can be controlled by the backlight button on the keypad.

  • Page 67: Alpha Numeric Mode

    Alpha Numeric Mode The Quidel 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 letters "ABC" shown at the top of the display, until the key is pressed again.

  • Page 68: Service And Maintenance Procedures

    Service and Maintenance Procedures If any service or maintenance is required, the Quidel Triage MeterPro should be sent to the manufacturer. No maintenance other than paper/battery replacement and periodic external cleaning is required of the operator. Paper Replacement Changing Paper Between Functions 1.

  • Page 69: Changing Paper While Printing

    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 70: Cleaning

    : Never insert any tools, swabs, or cleaning materials into the device track. Check Battery Level The Quidel Triage MeterPro checks the active power source after ejecting a device or printing. To check the battery power, navigate to the MAIN MENU, disconnect the AC power supply, press the key (the meter attempts to eject the device), and look for the Low Power Indicator on the Main Menu of the meter display.

  • Page 71: Total Quality Assurance

    : Rechargeable batteries are authorized for use, however due to the nature of these types of batteries, it is expected they will require recharging more frequently. The Quidel Triage MeterPro does not contain a built in battery charger, rechargeable batteries must be recharged outside of the meter.

  • Page 72: Quality Assurance Functions

    Each device contains a full complement of reagents that are required to perform the immunoassay. The Quidel 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.

  • Page 73: Meter Quality Assurance

    low controls and the baseline control and thereby on the immunoassay, the results are not displayed and erroneous results are not reported. The Timing Control Zone monitors assay completion. If an inadequate amount of specimen is added to the test device or if a specimen clots in the device, this control will prevent the display of the results. A Trace QC algorithm has been programmed which evaluates the size, location and signal to noise ratio of each zone on the device.

  • Page 74: Quality Control Samples

    It is still valuable to apply the traditional approach to quality control by testing quality control samples. These controls will check the total integrity of the system. The interval for analyzing these controls, however, can be extended due to the many other Total Quality Assurance features inherent in the Quidel Triage tests.
  • Page 75 (the “LIMITED WARRANTY”). IF THE PRODUCT FAILS TO MEET THE REQUIREMENTS OF THE LIMITED WARRANTY, THEN AS CUSTOMER’S SOLE REMEDY, QUIDEL SHALL EITHER REPAIR OR REPLACE, AT QUIDEL'S DISCRETION, THE PRODUCT. EXCEPT FOR THE LIMITED WARRANTY STATED IN THIS SECTION, QUIDEL...

  • Page 76: Appendices

    External Bar Code Reader (rapid entry of User, Patient, Auxiliary or Misc Test ID's). Quidel Triage Census Data Management Software. Quidel Triage Census Data Management Software with LIS Connectivity. Test Device Specifications Test device specific information is provided in the applicable product insert. The instrument analyzes immunoassay test devices manufactured by Quidel Cardiovascular Inc.

  • Page 77: Meter Symptoms

    Hook that pulls test device into the in, the meter may need to be replaced. test device in. meter may be broken. Contact Quidel. CODE CHIP module a. CODE CHIP module may have been a. Re insert CODE CHIP module right side will not fit in meter.

  • Page 78: Appendix B Troubleshooting

    Patient sample concentration is above See instructions that came in the box of >XXX.X the dynamic range. test devices or contact Quidel. Patient result is below the dynamic range or is a concentration below the For some parameters, a 0.0 ng/ml patient <XX.X...
  • Page 79 Calib Pass (or Fail) b. QC Device was not run regularly. Laser Pass (or Fail) c. If problem persists, contact Quidel. Align Pass (or Fail) Reset time and date if required. Check Time/Date is blinking Meter temporarily lost all power.

  • Page 80: Appendix C Return And Disposal Procedures

    Immediately after the return has been authorized, Quidel will send out a replacement Quidel Triage MeterPro. Return the malfunctioning meter to Quidel. Note the return authorization number on both the shipping box and the airbill and send the meter back to Quidel as soon as possible following receipt of the replacement meter.
  • Page 81 ID: Identification. Immunoassay: A test that uses antibodies to measure substances. Internal QC: Quality controls in place as part of the Quidel Triage MeterPro’s software or zones built into the test device. In vitro: Made to occur in a laboratory vessel or other controlled experimental environment rather than in a living organism (literally, in glass).

  • Page 82: Appendix E Sample Log Sheets

    Screen: The part of the Quidel Triage MeterPro that displays words and numbers. Scroll to: Use arrow keys to go to the information you want on the screen. Set Parameters: A function of the Quidel Triage MeterPro; requires the use of the Supervisor CODE CHIP module. Software Upgrade CODE CHIP: CODE CHIP module used to download new software onto the Quidel Triage MeterPro.
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  • Page 86 55070 – Quidel Triage MeterPro 55071 – Quidel Triage MeterPro MDSS GmBH Schiffgraben 41 30175 Hannover, Germany Quidel Cardiovascular Inc. 9975 Summers Ridge Drive ENSRC26611enA San Diego, CA 92121 USA PN: 26611en Rev. A 2018/03 quidel.com Revision Changes: Initial release for Quidel Cardiovascular Inc.

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