pts Diagnostics CardioChek User Manual
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pts Diagnostics CardioChek User Manual

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User Guide
For Self-Testing Use
Portable Whole Blood Test System

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Summary of Contents for pts Diagnostics CardioChek

  • Page 1 User Guide For Self-Testing Use Portable Whole Blood Test System...

  • Page 2: Table Of Contents

    Table of Contents Introduction: CardioChek Test System Intended Use . . . . . . . . . . . . . . . . . . . . . . . .
  • Page 3 The CardioChek analyzer from PTS Diagnostics is intended for in vitro diagnostic use to test whole blood. This user guide includes all the information that you need to run tests using the CardioChek system.
  • Page 4 The CardioChek analyzer is fast, portable, and reliable. This analyzer is a component of The analyzer and lancing device are for single patient use. For safety reasons, do not a test system that includes PTS Panels self-test strips.

  • Page 5: Pts Panels® Self-Test Strips

    MEMo Chip Port The MEMo Chip port is located at the top of the analyzer. The CardioChek Test System The CardioChek test system consists of three main parts. These include the analyzer, Display PTS Panels self-test strips, and a MEMo Chip.

  • Page 6: The Memo Chip

    What does the MEMo Chip do? PTS Panels Self-Test Strips The MEMo Chip contains proper settings Cholesterol To test blood on a CardioChek analyzer, use test strips specific for each test. A test strip is Lot# for the test strip lot you are using. X000 inserted into the analyzer, then then blood is applied to the blood application window.

  • Page 7: Setup

    It is recommended to keep a spare set of batteries on hand. To extend battery life, either of the two buttons on the front of the analyzer to turn on the CardioChek remove the test strip as soon as a result is displayed. The time/date and results stored in analyzer.
  • Page 8 RUN TEST UTILITY SETTINGS MEMORY to select) to select) to select) to select) USE CODE CHEM* CHECK STRIP to select) SOUND RUN CONTROL INSERT STRIP CHOL CLEAR MEMORY SET TIME TRIG EXIT EXIT return to UTILITY SET DATE return to CHECK STRIP UNITS** CONTROL EXIT...

  • Page 9: How To Turn Off The Analyzer

    How to Turn Off the Analyzer How to Set the Time To turn off the analyzer, press both buttons (Enter and Next) at the same time for three If the analyzer is off, press either button to turn on the analyzer. Wait for the seconds.

  • Page 10: How To The Set Date

    How to Set the Date: How to Set the Units: The CardioChek analyzer may be shipped with preset units of measure (e.g. mg/dL). If RUN TEST is displayed, go to Step 3. If the analyzer is off, press either button to turn on the analyzer.

  • Page 11: How To The Set Sound

    How to Set the Sound Checking the System The CardioChek analyzer sound has been preset to BEEP ON. To turn the sound on or off, please follow the steps listed below: Analyzer Check Strip If RUN TEST is displayed, go to Step 3. If the analyzer is off, press either button to A gray analyzer check strip (included in the analyzer carrying case) can be used to verify turn on the analyzer.

  • Page 12: Quality Control Testing

    Note: If the analyzer displays FAILED: Quality Control Testing Clean the CardioChek analyzer test strip slot (where the strip is inserted into the analyzer). See Section 9, Care and Cleaning. Quality Control Inspect the check strip to make sure it is not dirty or damaged. Use the spare check Controls (also known as “liquid quality control materials”) are solutions used to ensure...

  • Page 13: How To Run A Quality Control Test

    Ensure test strip slot area is clean. To perform a blood test you need: Make sure neither the test strips nor the controls • CardioChek analyzer are past the expiration date printed on the label. • PTS Panels self-test strips Make sure the MEMo Chip matches the test strip lot.

  • Page 14: How To Obtain A Blood Sample From A Fingerstick

    How to Obtain a Blood Sample from Quick Reference - How to Run a Test a Fingerstick Press either button to turn the analyzer on. Use either the middle or ring finger for fingersticking. Remove the MEMo Chip from the box of test strips. Select the site to allow for convenient collection.

  • Page 15: Memory

    30 results of each chemistry and at least 10 results for control tests. The that your CardioChek analyzer will display. Results higher or lower than this range will analyzer allows review of the results in order from the most recent to the oldest. Each display as >...

  • Page 16: Care And Cleaning

    Storage and Handling Press either button to turn on the analyzer. Wait for the display to read either • Handle the CardioChek analyzer with care; do not drop. INSTALL MEMO CHIP or INSERT STRIP. • Do not store or operate the analyzer in direct light, such as sunlight, spotlight, Press Enter, then press Next until UTILITY is displayed.
  • Page 17 If you have any questions or need to know where to purchase the disinfectant wipes, Display Test Strip Slot call PTS Diagnostics Customer Service at 1-877-870-5610 (US) or +1-317-870-5610. There are a large number of distributors of this disinfectant. If you cannot obtain from Enter Button the distributor who supplies your other supplies, please contact us for assistance.
  • Page 18 Allow to air dry completely. The CardioChek analyzer has been validated for 1,825 cleaning and disinfection cycles. Note: It is important that the analyzer be thoroughly dry before using. Please obtain a new analyzer after cleaning and disinfecting once the lifetime of the The optical glass should be carefully wiped clean with an alcohol wipe and dried analyzer (5 years) has been reached, whichever comes first.

  • Page 19: Troubleshooting

    Troubleshooting Message or Issue Probable Cause What to Do Message or Issue Probable Cause What to Do EXPIRED LOT Test strips are expired, wrong MEMo Check test strip expiration date and make sure Desired language is Language has been set incorrectly. Turn off analyzer.

  • Page 20: Unexpected Results

    Unexpected Results Specifications CardioChek Analyzer High or low results that are incorrect may have serious medical consequences. If the result reads > (greater than) or < (less than) or results are not as expected, always repeat the test correctly with a new unused test strip. If a test result is displayed that Calibration Curve: Input from MEMo Chip per test strip lot is not expected, consult the following table.
  • Page 21 PTS Diagnostics warrants to the original purchaser only, that the CardioChek Service (M-F, 6 a.m.- 9 p.m. US EST) or your local authorized CardioChek dealer. analyzer shall be free of any defects in materials or workmanship for a period of one year from the date of original purchase.

  • Page 22: Specifications

    Index Explanation of Symbols Symbols Analyzer Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 Battery Installation .
  • Page 23 For details, refer to www.ptsdiagnostics.com/patents.html. CardioChek, PTS Panels, MEMo Chip, and PTS Collect are trademarks of Polymer Technology Systems, Inc. All other trademarks and product names are the property of their respective owners. © Copyright 2018 Polymer Technology Systems, Inc.

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