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User Guide
v1.12 or after
For Professional Use
Portable Whole Blood Test System

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Summary of Contents for pts Diagnostics CardioChek Plus

  • Page 1 User Guide v1.12 or after For Professional Use Portable Whole Blood Test System...
  • Page 2: Table Of Contents

    Introduction: CardioChek Plus System Intended Use . . . . . . . . . . . . . . . . .
  • Page 3 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 This user guide is for professional users . The CardioChek Plus test system may be used Index .
  • Page 4: Important Safety Instructions

    PTS Panels glucose test strips and PTS Panels lipid panel test strips . The PTS Panels test contact PTS Diagnostics (Hours: M-F, 8:00 a . m . to 8:00 p . m . USA Eastern Time) using the...
  • Page 5: About The Cardiochek Plus Test System

    Display shows test results, messages, time, date, and stored results . The CardioChek Plus Test System and Operating Principle The CardioChek Plus test system consists of three main parts . These include the Enter Button CardioChek Plus analyzer, PTS Panels test strips, and a lot-specific MEMo Chip .
  • Page 6: The Memo Chip

    • If your MEMo Chip is lost or misplaced, please call for the test strip lot you are using . Lipid+eGLU PTS Diagnostics Customer Service for a replacement or use Q301 The MEMo Chip: another MEMo Chip from another vial of the same lot number .
  • Page 7: Pts PanelsĀ® Test Strips

    10 . DEHYDRATION: Severe dehydration and excessive water loss may produce falsely low results . The CardioChek Plus test system has many different analyte test strips available for use. The test strips outlined in this section are only an example of the available test strips. Not all test strips are available for use in all countries.
  • Page 8: Pts Panels Glucose Test Strips - Limitations Of The Procedure

    PTS Panels Glucose Test Strips – Limitations of the Procedure PTS Panels Lipid Panel Test Strips – Limitations of the Procedure Studies were performed to test for substances that may interfere with these tests . The 1 . The analyzer should not be used to test critically ill patients . results are below .
  • Page 9: Setup

    Setup How to Install/Replace the Batteries 1 . Open the battery door on the back of the CardioChek Plus analyzer by releasing the latch and pulling the door away from the back of the analyzer . Battery Use and Replacement 2 .
  • Page 10 CardioChek Plus Menu Map v1 . 1 2 or after Press either button to turn on the analyzer . The Main Menu will appear . Note: If the units are locked, the UNITS screen does not appear . Main Menu...
  • Page 11: How To Turn Off The Analyzer

    How to Turn Off the Analyzer How to Set the Time and Date To turn off the analyzer, press both buttons (Enter and Next) at the same time and 1 . Press either button to turn analyzer on . The Main Menu will appear . hold for three seconds .
  • Page 12: How To Set The Units

    How to Set the Units How to Set the Sound The CardioChek Plus analyzer may be shipped with preset units . If the SETTINGS menu The CardioChek Plus analyzer sound has been preset to on . does not display UNITS, the analyzer is locked in preset units . The units cannot be To turn the sound on or off, follow the steps listed below: changed if the system has been locked .
  • Page 13: How To Set Up The Cardiochek Plus Analyzer For Printing

    5-digit completed test counter . (LIPIDS for example) . 4 . Press Enter to return to the ABOUT CardioChek Plus screen . 5 . Press Next to display the time/date of the test result you want to print .
  • Page 14: Checking The System

    Check Strip Note: If the analyzer displays FAILED: 1 . Clean the CardioChek Plus analyzer test strip slot (where the check strip is inserted into the analyzer) . See Section 8, Care and Cleaning . 2 . Inspect the check strip to make sure it is not dirty or damaged . Use the spare check strip and repeat .
  • Page 15: Quality Control Testing

    . Controls are tested to check the If Quality Control Results Are Not in Range performance of your test system: CardioChek Plus analyzer, MEMo Chip, and PTS Panels IMPORTANT: Patient tests should not be performed until control results are test strips .
  • Page 16: Running A Patient Test

    (Pressure should be intermittent and it is important not to To perform a blood test you need: milk the finger . ) • CardioChek Plus analyzer v1 . 1 2 or after If running an electrochemical test with a reflectance test: • PTS Panels test strips Apply a blood sample to the tip of the electrochemical test •...
  • Page 17: How To Run A Reflectance Test

    How to Run an Electrochemical Test It is recommended that users refer to the following practice guidelines: Biosafety in Microbiological and Biomedical Laboratories (BMBL) found at 1 . Press either button to turn the analyzer on . http://www . c dc . g ov/biosafety/publications/bmbl5/ . 2 .
  • Page 18: How To Run An Electrochemical Test With A Reflectance Test

    How to Run an Electrochemical Test with a Reflectance Test 13 . For the reflectance test: After applying blood to the electrochemical test strip, wipe the finger to 1 . Press either button to turn the analyzer on . remove any blood with a clean piece of gauze . 2 .
  • Page 19: Memory

    Memory To Review CONTROL Results Test results are automatically stored in the CardioChek Plus analyzer’s memory . The analyzer can store up to 50 results of each chemistry (CHEM) and 10 results for control 1 . From the Main Menu, press Next until MEMORY is highlighted .
  • Page 20: Care And Cleaning

    Please see references at the end of this section for further information. • Handle the CardioChek Plus analyzer with care; do not drop . • Do not store or operate the analyzer in direct light, such as sunlight, spotlight, Frequency: Always clean after each use .
  • Page 21: Cleaning Instructions

    Disinfection Instructions The entire case surface should be cleaned and disinfected . After cleaning, the next step is to disinfect. Always both clean and disinfect. 1 . Using a fresh wipe, wring the wipe to remove excess liquid and wipe all areas thoroughly .
  • Page 22: Troubleshooting

    . set correctly . and Date . The CardioChek Plus has been validated for 11,001 cleaning and disinfection cycles . For example, if you test 10 patients/day for 365 days/year for 3 years, you will have FAILED is displayed during Analyzer needs to be cleaned .
  • Page 23: Interpreting Results

    Interpreting Results Message or Issue Probable Cause What to Do Results will not print . Communication cable was Check all connections . Reprint test results improperly connected . stored in memory . All test results must be assessed by a qualified medical professional . Depending on the Printer cover is not closed properly .
  • Page 24: Clia Information

    To obtain a Certificate of Waiver or any other type of laboratory license, call your Note: The analyzer temperature must be within the test strip temperature state health department or PTS Diagnostics at 1-877-870-5610 (Toll-free) or specifications to function as a system .
  • Page 25: Contact Information

    Help CardioChek Plus Analyzer Limited Two-Year Warranty For assistance with the CardioChek Plus test system, please contact PTS Diagnostics PTS Diagnostics warrants to the original purchaser only, that the CardioChek Plus Customer Service (M-F, 8:00 a . m . to 8:00 p . m . USA Eastern Time) or your local authorized analyzer shall be free of any defects in materials or workmanship for a period of two CardioChek dealer .
  • Page 26: Index

    Explanation of Symbols Index Symbols Analyzer Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Battery Installation .
  • Page 29 Polymer Technology Systems, Inc . 4600 Anson Boulevard, Whitestown, IN 46075 USA Direct: +1-317-870-5610 · Toll-free inside the US: 1-877-870-5610 · Fax: +1-317-870-5608 Email: customerservice@ptsdiagnostics . c om · Website: ptsdiagnostics . c om UK Responsible MDSS-UK RP Ltd . Person: 6 Wilmslow Rd .

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