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Polymer Technology Systems CardioChek User Manual

Brand analyzers portable whole blood test system
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Brand Analyzers
Portable Whole Blood
Test System User Guide
For Self-Testing Use

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Summary of Contents for Polymer Technology Systems CardioChek

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

  • Page 2: Table Of Contents

    TABLE OF CONTENTS I. Introduction ...................3 II. Introduction to the CardioChek ® Test System ......4 CardioChek Analyzer MEMo Chip ® CardioChek test strips III. Setup ......................7 Installing Batteries CardioChek System Menus How to Turn Analyzer Off Setting Language Setting Time...

  • Page 3: Introduction

    ® Thank you for selecting a CardioChek analyzer from Polymer Technology Systems, Inc. (PTS, Inc.). The CardioChek analyzer is a fast, portable, and reliable whole blood analyzer. The CardioChek test system includes an analyzer and separately available CardioChek test ®...

  • Page 4: Introduction To The Cardiochek Test System

    CARDIOCHEK TEST SYSTEM The CardioChek Test System ® The CardioChek test system consists of three main parts. These ® include the analyzer, CardioChek 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 5 II. INTRODUCTION TO THE CARDIOCHEK TEST SYSTEM, continued The MEMo Chip ® ® Each package of CardioChek test strips contains a color-coded MEMo Chip. The color-coded MEMo Chip contains the settings for each test. The top of the MEMo Chip has a finger notch.
  • Page 6 MEMo Chip. The analyzer converts this color reading into a test result, displayed on the screen. Each CardioChek test strip box contains a package insert that provides instructions for use and information specific for each test. Please read the instructions completely before testing.

  • Page 7: Setup

    How to Install/Replace the Batteries: Open the battery door on the back of the CardioChek analyzer by pressing and sliding it in the direction of the ®...

  • Page 8: Cardiochek System Menus

    III. SETUP, continued CardioChek System Menus ® This diagram provides a layout of the menus within the CardioChek analyzer. Detailed information on the use of • each menu follows in this section of the User Guide. Buttons ENTER Button: Press this button to turn the analyzer ON or to accept the current menu choice.
  • Page 9 III. SETUP, continued NEXT Button: Press this button to turn the analyzer ON or to advance to the next menu option. • Hold down at the same time to shut off the analyzer from one of the main menus (RUN TEST, MEMORY, UTILITY, or USER SET).
  • Page 10 III. SETUP, continued How to Turn the Analyzer OFF To turn the analyzer OFF press both buttons at the same time for three seconds at any of the following Main Menu headings: RUN TEST, MEMORY, UTILITY, or USER SET. After three minutes of idle time (without a test strip or check strip inserted) the analyzer will perform a 10 second count down and turn OFF.
  • Page 11 III. SETUP, continued How to Reset the Language: 1. Allow the analyzer to automatically turn OFF or remove the batteries and replace them. 2. Press and hold Enter down for approximately 5 seconds during the analyzer power-up stage until LANGUAGE is displayed. 3.
  • Page 12 III. SETUP, continued How to Set the Time, continued: Press Enter to accept the displayed minute. The display will read SET TIME. To set the date, proceed to How to Set the Date - Step 4. • 10. To exit, press Next until EXIT is displayed. Press Enter. 11.
  • Page 13 III. SETUP, continued How to Set the Units: ® The CardioChek analyzer may be shipped with preset units. NOTE: • If the USER SET menu does not display "UNITS" the instrument is locked in preset units • The units cannot be changed if the system has been locked •...
  • Page 14 Press Next to return to RUN TEST. How to Set the Sound: ® The CardioChek analyzer sound has been preset to BEEP ON. To turn the sound on or off please follow the steps listed below: If RUN TEST is displayed, go to Step 3. If the analyzer is OFF, press either button to turn the analyzer ON.

  • Page 15: Checking The System

    A gray instrument check strip (included in the analyzer carrying case) can be used to verify proper functioning of the ® CardioChek analyzer's electronic and optical systems. The check strip provides a color standard read by the analyzer. When the check strip is not in use, please store it in the analyzer carrying case.

  • Page 16: Quality Control

    Controls are tested to check the performance ® of your test system: CardioChek analyzer, MEMo Chip , and test strips. Use Quality Control materials provided by PTS, Inc. ®...

  • Page 17: Control Testing

    Press Next until RUN CONTROL scrolls across the display. Press Enter. ® Insert the test strip into the analyzer. The CardioChek analyzer will display APPLY SAMPLE. This indicates the system is ready for a sample (control) to be applied. Immediately replace the vial cap, making sure the strip vial is closed tightly.
  • Page 18 V. CONTROL TESTING, continued Hold bottle directly over and perpendicular to the blood application window on the test strip. Squeeze bottle so a small drop of control solution is formed. Allow the drop of control solution to fall onto the application window of the test strip.

  • Page 19: Running A Test

    User Guide completely and carefully before testing. Testing Supplies To perform a blood test you need: ® • CardioChek analyzer • CardioChek test strips ® • Lot specific MEMo Chip • Sterile lancet • Capillary blood collector or pipet •...
  • Page 20 VI. RUNNING A TEST, continued How to Obtain a Blood Sample: To perform a fingerstick: 1. Clean the finger. Be sure the finger is completely dry. 2. Use a new sterile, disposable lancet to puncture the skin. 3. Stick the finger on the side of the fingertip, instead of the center.
  • Page 21 Insert MEMo Chip with finger notch (top) side up, lot number code facing down. ® Turn CardioChek analyzer ON by pressing either button. When INSERT STRIP is displayed, insert the test strip into the analyzer as far as it will go.
  • Page 22 Quick Reference Testing Guide 1. Insert MEMo Chip with lot number that matches ® test strip vial lot number. Press either button to turn the CardioChek ON. Analyzer will display lot ® code. 2. When INSERT STRIP is displayed, hold by the raised lines and insert test strip into the analyzer as far as it will go.

  • Page 23: Results

    The measuring range for each test is listed in ® the test strip instructions. This is the range that your CardioChek analyzer will display. Results higher or lower than this range will display as > or < followed by a number.

  • Page 24: Memory

    VIII. MEMORY Test results are automatically stored in the analyzer’s ® memory. The CardioChek analyzer can store up to 30 results of each chemistry and at least 10 results of each control test. The analyzer allows review of the results in order from the most recent to the oldest.
  • Page 25 VIII. MEMORY, continued How to Clear Results Stored in Memory: Press either button to turn the analyzer ON. Wait for the display to read either INSTALL MEMO CHIP or INSERT STRIP. Press Enter, then press Next until UTILITY is displayed. Press Enter.

  • Page 26: Care And Cleaning

    IX. CARE AND CLEANING Storage and Handling ® • Handle the CardioChek analyzer with care; do not drop. • Do not store or operate the analyzer in direct light, such as sunlight, spotlight, under a lamp, or by a window.

  • Page 27: Troubleshooting

    X. TROUBLESHOOTING MESSAGE or PROBABLE WHAT TO DO ISSUE CAUSE Desired language Language has been set Turn analyzer OFF. See Section III., is not displayed. incorrectly. Setup - How to Reset the Language. The wrong date Date and time have not See Section III., Setup to set the and/or time is been set correctly.
  • Page 28 X. TROUBLESHOOTING, continued MESSAGE or PROBABLE WHAT TO DO ISSUE CAUSE LOW TEMP Analyzer is below Move to warmer environment and acceptable operating test after analyzer reaches proper temperature. temperature. HI TEMP Analyzer is above Move to acceptable environment acceptable operating and test after analyzer reaches temperature.

  • Page 29: Unexpected Results

    If a test result is displayed that is not expected, consult the following ® table. When using the CardioChek test system to self-test, any result which is inconsistent with your medical history should immediately be reported to your physician or healthcare provider.
  • Page 30 XI. UNEXPECTED RESULTS, continued PROBABLE MESSAGE or WHAT TO DO ISSUE CAUSE A displayed result Result is above the If you have symptoms call reads > (greater measuring range of a healthcare professional than) a value. the test. immediately. Run test again. Run Quality Controls and confirm that Quality Controls are in range.

  • Page 31: Specifications

    3.0 inches (7.62 cm) Length: 5.5 inches (13.97 cm) Height: 1.0 inches (2.54 cm) Weight: (without batteries): 4-6 oz. (113.4 - 170.1 g) CardioChek test strips Please read the instructions (package insert) included with the test strips for information specific to each test.

  • Page 32: Contact Information

    XIII. CONTACT INFORMATION Help ® For assistance with the CardioChek test system, please contact: Polymer Technology Systems, Inc. (PTS, Inc.) +1-877-870-5610 (Toll-free inside USA) +1-317-870-5610 (Direct) +1-317-870-5608 (Fax) E-mail: inforequest@cardiochek.com Web site: www.cardiochek.com...

  • Page 33: Warranty

    XIV. WARRANTY CardioChek Analyzer Limited One Year Warranty ® PTS, Inc. 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.

  • Page 34: Explanation Of Symbols

    XV. EXPLANATION OF SYMBOLS Symbols on the Analyzer and/or Analyzer Box: Consult Instructions for Use Store at/Temperature limitation For in vitro diagnostic use Serial Number Manufacturer Catalog Number Authorized European Representative This product fulfills the requirements of Directive 98/79/EC on in vitro diagnostic medical devices.

  • Page 35: Index

    XVI. INDEX Analyzer Introduction ..............3 Battery Installation ...............7 Blood Testing ................19 Check Strip ................15-16 Cleaning ..................26 Contact Information ..............32 Date (Setting) ................12 Help ....................32 Language (Setting) .............10-11 MEMo Chip .................5-6 Memory ...................24-25 Quick Reference (For Running a Test)........22 Quality Control ..............16-18 Results ...................
  • Page 36 Polymer Technology Systems, Inc. 7736 Zionsville Rd. Indianapolis, IN 46268 USA +1-877-870-5610 (Toll-free inside USA) +1-317-870-5610 (Direct) +1-317-870-5608 (Fax) E-mail: inforequest@cardiochek.com www.cardiochek.com 0197 Authorized European Representative MDSS Schiffgraben 41 30175 Hannover Germany © Copyright 2010 Polymer Technology Systems, Inc. PS-002460E Rev. 1 07/10...

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