pts Diagnostics CardioCheck PA User Manual

pts Diagnostics CardioCheck PA User Manual

Portable whole blood test system
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User Guide
For Professional Use
Portable Whole Blood Test System

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Summary of Contents for pts Diagnostics CardioCheck PA

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

    Table of Contents Introduction: CardioChek PA System Intended Use ......About the CardioChek PA Test System ........The CardioChek PA Test System and Operating Principle .
  • Page 3 ..............The CardioChek PA analyzer from PTS Diagnostics is intended for in vitro diagnostic CardioChek PA Analyzer Limited One-Year Warranty .
  • Page 4 PTS Panels test strips. The PTS Panels test strip box contact PTS Diagnostics (Hours: 6:00 a.m. to 9:00 p.m. US EST) using the following includes a MEMo Chip that contains the assay calibration curve and other important contact information: information about the assay.
  • Page 5: About The Cardiochek Pa Test System

    About the CardioChek PA Display Display shows test results, messages, time, date and stored results. Test System Enter Button The CardioChek PA Test System and Operating Principle Press this button to turn on the analyzer or to accept the current menu choice. The CardioChek PA test system consists of three main parts.
  • Page 6: The Memo Chip

    • If the expiration date in the MEMo Chip has passed, the analyzer will display EXPIRED LOT. • If your MEMo Chip is lost or misplaced, please call PTS Diagnostics Customer Service for a replacement or use another MEMo Chip from another vial of the same lot number.
  • Page 7: Pts Panels Lipid Panel Test Strips - Limitations Of The Procedure

    PTS Panels Lipid Panel Test Strips – Limitations of the Procedure PTS Panels Glucose 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 8: Setup

    Setup Battery Use and Replacement How to Install/Replace the Batteries: The CardioChek PA analyzer requires two (2) AAA 1.5 volt high-quality alkaline batteries. 1. Open the battery door on the back of the CardioChek PA analyzer by pressing and sliding it in the direction of the arrow (toward the MEMo Chip port). When to Replace the Batteries 2.
  • Page 9 UTILITY SETTINGS MEMORY RUN TEST to select) to select) to select) to select) PRINT USE CODE CHEM* CHECK STRIP to select) SOUND RUN CONTROL INSERT STRIP CHOL SET TIME CLEAR MEMORY TRIG LIPIDS EXIT SET DATE return to UTILITY EXIT return to CHECK STRIP UNITS** CONTROL...
  • Page 10: 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 1. If the analyzer is off, press either button to turn on the analyzer. Wait for seconds.
  • Page 11: How To Set The Date

    How to Set the Date How to Set the Units The CardioChek PA analyzer may be shipped with preset units. 1. If RUN TEST is displayed, go to Step 3. If the analyzer is off, press either button to turn on the analyzer. Wait for the display to read INSTALL MEMO CHIP or Note: INSERT STRIP.
  • Page 12: How To Set The Sound

    How to Set the Sound Introduction to the CardioChek PA and Printer System The CardioChek PA analyzer sound has been preset to BEEP ON. To turn the sound on or The CardioChek PA analyzer (with software version 2.55 and higher) supports printing in off, please follow the steps listed below: two formats, label or paper, on the CardioChek/PTS Connect™...
  • Page 13: Checking The System

    Checking the System Analyzer Check Strip 6. Press Next until EXIT is displayed. Press Enter. A check of the analyzer operation and optics can be performed using one of the two gray 7. Press Next until RUN TEST is displayed. check strips.
  • Page 14: Quality Control Testing

    CardioChek PA analyzer, MEMo Chip, and PTS Panels IMPORTANT: Patient tests should not be performed until control results are test strips. Use quality control materials provided by PTS Diagnostics. within range. 1. Ensure test strip slot area is clean.
  • Page 15: Running A Test

    How to Obtain a Blood Sample from a Fingerstick Running a Test A new pair of clean gloves should be worn by the user before testing each patient. Blood Testing Use either the middle or ring finger for fingersticking. A test strip package insert is included with each box of test strips. Please read the test Select the site to allow for convenient collection.
  • Page 16: Quick Reference - How To Run A Test

    Quick Reference - How to Run a Test Memory 1. Press either button to turn the analyzer on. 2. Remove the MEMo Chip from the box of test strips. Test results are automatically stored in the CardioChek PA analyzer’s memory. The 3.
  • Page 17: How To Clear Results Stored In Memory

    Care and Cleaning How to Clear Results Stored in Memory: Storage and Handling • Handle the CardioChek PA analyzer with care; do not drop. 1. Press either button to turn on the analyzer. Wait for the display to read either INSTALL MEMO CHIP or INSERT STRIP.
  • Page 18: Cleaning Instructions

    Display MEMo Chip Port you have any questions or need to know where to purchase the disinfectant wipes, call PTS Diagnostics Customer Service at 1-877-870-5610 (US) or +1-317-870-5610. There Enter Button Next Button are a large number of distributors of this disinfectant. If you cannot obtain from the Test Strip Slot distributor who supplies your other supplies, please contact us for assistance.
  • Page 19: Disinfection Instructions

    Following cleaning and disinfection, inspect the analyzer for the following signs of deterioration. These include: If you have any questions, call PTS Diagnostics Customer Service. • Scratches on optical glass Direct: +1-317-870-5610 · Toll-free inside the US: 1-877-870-5610 •...
  • Page 20: Troubleshooting

    Troubleshooting Message or Issue Probable Cause What to Do Message or Issue Probable Cause What to Do Desired language is Language has been set incorrectly. Turn off analyzer. See Section 3, Setup - How to EXPIRED LOT Test strips are expired, wrong MEMo Check test strip expiration date and make sure not displayed.
  • Page 21: Interpreting Results

    To obtain a Certificate of Waiver or any other type of laboratory license, call your not expected, consult the following table. state health department or PTS Diagnostics at 1-877-870-5610 (Toll-free) or +1-317-870-5610 for an application (form CMS 116). Message or Issue...
  • Page 22: Specifications

    Contact Information CardioChek PA Analyzer Help For assistance with the CardioChek PA test system, please contact PTS Diagnostics Calibration Curve: Input from MEMo Chip per test strip lot Customer Service (M-F, 6 a.m.- 9 p.m. US EST) or your local authorized Batteries: 2 AAA 1.5 volt alkaline...
  • Page 23: Warranty

    Explanation of Symbols CardioChek PA Analyzer Limited One-Year Warranty Symbols PTS Diagnostics warrants to the original purchaser only, that the CardioChek PA analyzer shall be free of any defects in materials or workmanship for a period of one Consult instructions for use Product requires separate year from the date of original purchase.
  • Page 24: Index

    Index Analyzer Introduction ........... . 5 Battery Installation .
  • Page 25 Polymer Technology Systems, Inc. 7736 Zionsville Road, Indianapolis, IN 46268 USA Direct: +1-317-870-5610 · Toll-free inside the US: 1-877-870-5610 · Fax: +1-317-870-5608 Email: customerservice@ptsdiagnostics.com · Website: ptsdiagnostics.com MDSS GmbH Schiffgraben 41 30175 Hannover, Germany The CardioChek® PA test system is covered by one or more patents. For details, refer to www.ptsdiagnostics.com/patents.html.

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