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Polymer Technology Systems CardioChek User Manual

Portable whole blood test system
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CardioChek
TM
Analyzer
Portable Whole Blood Test System
For Professional and Self-Testing Use
User Guide

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Summary of Contents for Polymer Technology Systems CardioChek

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

  • Page 3: Table Of Contents

    TABLE OF CONTENTS The CardioChek Analyzer I. Introduction ................. 5 II. How to Use the User Guide ..........6 III. Introduction to the CardioChek .......... 7 Analyzer - CardioChek Test System MEMo Chip Test Strip IV. Set Up ................. 10...

  • Page 5: Introduction

    Thank you for selecting the CardioChek Analyzer from Polymer Technology Systems, Inc. (PTS). The CardioChek is a fast, portable and accurate whole blood analyzer. The CardioChek test system includes an analyzer and separately available PTS PANELS test strips/MEMo Chip. This system is intended for in vitro diagnostic use to test whole blood.

  • Page 6: How To Use The User Guide

    II. HOW TO USE THE USER GUIDE This guide includes all the information you need to test properly using the CardioChek Analyzer. For additional information and specific information for each individual chemistry test, please make sure you read the test strip package insert included with the test strips.

  • Page 7: Introduction To The Cardiochek

    CARDIOCHEK ANALYZER The CardioChek Test System: The CardioChek test system consists of three main parts. These include the analyzer, test strips and a MEMo Chip. When a blood sample is applied to the test strip, a chemical reaction occurs producing a color change.

  • Page 8: Memo Chip

    What does the MEMo Chip do? When inserted with the finger notch facing up in your CardioChek, the MEMo Chip does the following: • Tells the analyzer which test(s) to run. • Contains the calibration curve and the lot number code for the specific test strip lot.

  • Page 9: Test Strip

    Test Strip To test blood on the CardioChek , use test strips specific for each test. The test strip is inserted into the analyzer, then blood is applied to the test strip. A chemical reaction occurs producing a color change. The analyzer measures the color reaction and compares the information to the calibration curve stored in the MEMo Chip.

  • Page 10: Set Up

    How to Install/Replace the Batteries: 1. Open the battery door on the back of the CardioChek by pressing and sliding it in the direction of the arrow (toward the MEMo Chip port).

  • Page 11: Setting Language

    IV. SET UP The first time the analyzer is turned on you will be required to set the language, date, and time. Setting Language The language menu consists of the following choices: English, (ENGLISH, German (DEUTSCH), Italian (ITALIANO), French (FRANCAIS), Spanish (ESPANOL), and Portuguese (PORTUGSE).
  • Page 12 IV. SET UP How to Set the Time continued: 5. Press to alternately display the 12 hour am/pm clock or the 24- hour clock. Press to accept the displayed clock format. The display will read HOUR and the numerical hour. 6.
  • Page 13 RUN TEST. How to Set the Sound: The CardioChek P•A sound has been preset to BEEP ON. To turn the sound on or off please follow the steps listed below: 1. If RUN TEST is displayed, go to step 3. If the analyzer is OFF, press either button ( or ) to turn the analyzer ON.

  • Page 14: Checking The System

    9. Press . The analyzer is ready to run tests. Note: If the analyzer displays FAILED: 1. Clean the CardioChek Test Strip Insert Opening (where the strip is inserted into the analyzer) with a soft, lint-free, damp cloth. See the Care and Cleaning section.

  • Page 15: Quality Control

    Controls (also known as “quality control materials”) are solutions for which an expected analyte concentration range has been established. Controls are tested to verify the performance of your entire test system: CardioChek analyzer, MEMo Chip and test strips. Use quality control materials provided by PTS. PTS PANELS HDL Controls REF/Cat.

  • Page 16: Running A Test

    UTILITY. Press 4. Press until RUN CONTROL is displayed. Press . 5. Insert the test strip into the analyzer. The CardioChek will display APPLY SAMPLE. This indicates the system is ready for a sample (control) to be applied.
  • Page 17 VI. RUNNING A TEST How To Run a Quality Control Test (continued): 13. Compare control results to the values on the Quality Control Range Card included with control materials. Make sure to match the correct test strip lot number(s) and levels depending on the control material used.

  • Page 18: Blood Testing

    Please read the test strip instructions along with this section of the User Guide completely and carefully before testing. Testing Supplies To perform a blood test you need: • CardioChek Analyzer • PTS PANELS Test Strips • Lot specific MEMo Chip •...
  • Page 19 VI. RUNNING A TEST 3. Stick the finger on the side of the fingertip, instead of the center. See picture below. CORRECT WAY TO STICK THE FINGER 4. To get a drop of blood, gently apply pressure to the finger starting at the end of the finger closest to the hand and moving towards the tip.
  • Page 20 2. Insert MEMo Chip with finger notch (top) side up, lot number code facing down. 3. Turn CardioChek ON by pressing either button ( or ). 4. When INSERT STRIP is displayed, insert the strip into the Test Strip Insert Opening as far as it will go.

  • Page 21: Quick Reference

    Press either button ( ) to turn the CardioChek ON. Analyzer will display lot code. 2. When INSERT STRIP is displayed, insert strip into the analyzer as far as it will go.

  • Page 22: Memory

    VII. MEMORY Test results are automatically stored in the analyzer’s memory. CardioChek can store up to 30 results of each chemistry and 10 results of each control test. The analyzer allows review of the results in order from the most recent to the oldest. Each result is displayed with time and date.

  • Page 23: Care And Cleaning

    VIII. CARE AND CLEANING Storage and Handling • The CardioChek is a sensitive electronic device; handle with care. The analyzer should not be dropped. • Do not store or operate the analyzer in direct light, such as sunlight, spotlight, under a lamp or by a window. Direct light may adversely effect test results.

  • Page 24: Troubleshooting

    TEST NOT Analyzer is not able to test with Use a test strip and ALLOWED the inserted MEMo Chip and MEMo Chip that are compatible is displayed. test strip. with the CardioChek analyzer.
  • Page 25 IX. TROUBLESHOOTING, continued High or low results that are incorrect may have serious medical consequences. If the result reads HIGH, > (greater than) or LOW , < ( 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 is not expected, consult the following table.

  • Page 26: Specifications

    X. SPECIFICATIONS CardioChek: CardioChek Analyzer REF/Cat. No. 0744 (U.S.)/1709 (Int’l) Calibration Curve: Input from MEMo Chip per strip lot Battery: 2 AAA 1.5 -volt alkaline, life approximately 300 tests Operating Temperature Range: 50-104°F (10-40°C) Humidity Range: Between 20 and 80% RH Dimensions: Width 3.0 inches (7.62 cm)

  • Page 27: Contact Information

    XI. CONTACT INFORMATION Help For assistance with the CardioChek test system, please contact Polymer Technology Systems, Inc. toll-free at 1-877-870-5610 (toll free inside the USA) or 1-317-870-5610. Fax: 1-317-870-5608, E-mail: inforequest@ptspanels.com. Web site: www.ptspanels.com Catalog Numbers PTS PANELS Test Strip: Int’l...

  • Page 28: Warranty

    XII. WARRANTY CardioChek Limited One Year Warranty: PTS warrants to the original purchaser only, that the analyzer shall be free of any defects in materials or workmanship for a period of one year from the date of original purchase. Activation of this warranty shall be conditioned upon completion and return of the warranty registration card to PTS.

  • Page 29: Explanation Of Symbols

    XIII. EXPLANATION OF SYMBOLS Symbols on the Analyzer and Analyzer Box: See accompanying information Storage temperature For in vitro diagnostic use Attention consult accompanying documents Serial Number Manufactured by Catalog Number Self-Testing...

  • Page 30: Index

    XIV. INDEX Analyzer Introduction ............7 Battery Installation ............10 Blood Testing ..............18 Catalog Numbers ............27 Check Strip ..............14 Cleaning ................. 23 Contact Information ............27 Date (Setting) ..............12 Help ................27 Language ................ 11 MEMo Chip ..............8 Memory ................
  • Page 32 The CardioChek system is covered by one or more patents: US Patent 5, 597, 532 and EP 0, 750, 739 (DE, FR, GB, IT) Other Patents Pending. QuickMedical is an authorized distributor for Polymer See all of Polymer at http://www.quickmedical.com/Polymer...

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