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Polymer Technology Systems CardioChek PA User Manual

Brand analyzers. portable whole blood test system
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Brand Analyzers
Portable Whole Blood
Test System User Guide
For Professional Use

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Summary of Contents for Polymer Technology Systems CardioChek PA

  • Page 1 Brand Analyzers Portable Whole Blood Test System User Guide For Professional Use...

  • Page 3: Table Of Contents

    PA device MEMo Chip ® PTS Panels test strips ® III. Setup ......................9 Installing Batteries CardioChek PA System Menus How to Turn Device Off Setting Language Setting Time Setting Date Setting Units Setting Sound Setup for Print IV. Checking the System ................18...

  • Page 4: Introduction

    ® has an optional printer and the CardioChek Link software solution to assist in data reporting. The CardioChek PA device is fast, portable, and reliable. This device is a component of a test system that includes PTS ® Panels test strips. The PTS Panels test strip box includes a ®...

  • Page 5: Introduction To The Cardiochek Pa Test System

    II. INTRODUCTION TO THE CARDIOCHEK PA TEST SYSTEM The CardioChek PA Test System ® The CardioChek PA test system consists of three main parts. These include the device, PTS Panels ® test strips, and a MEMo Chip ® The CardioChek PA Test System &...
  • Page 6 II. INTRODUCTION TO THE CARDIOCHEK PA TEST SYSTEM, continued MEMo Chip Port The MEMo Chip port is located at the top of the device. Display (b) Display shows test results, messages, time, date, and stored results. ENTER Button (c) Press this button to turn the device ON or to accept the •...
  • Page 7 II. INTRODUCTION TO THE CARDIOCHEK PA TEST SYSTEM, continued The MEMo Chip ® Each package of PTS Panels 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 8 II. INTRODUCTION TO THE CARDIOCHEK PA TEST SYSTEM, continued The MEMo Chip port is located ® at the top center of the device. The MEMo Chip is inserted into this port with the finger notch facing up. Push firmly, but gently, until the MEMo Chip is fully inserted.

  • Page 9: Setup

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

  • Page 10: Cardiochek Pa System Menus

    III. SETUP, continued CardioChek PA System Menus ® This diagram provides a layout of the menus within the CardioChek PA device. Detailed information on the use • of each menu follows in the Setup section of this User Guide. Buttons ENTER Button: Press this button to turn the device ON or to accept the current menu choice.
  • Page 11 III. SETUP, continued NEXT Button: Press this button to turn the device ON or to advance to the next menu option. • Hold down at the same time to shut off device from one of the main menus (RUN TEST, MEMORY, UTILITY, or USER SET).

  • Page 12: Setting Language

    III. SETUP, continued How to Turn the Device OFF To turn device 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 device will perform a 10 second count down and turn OFF.
  • Page 13 III. SETUP, continued How to Reset the Language: 1. Allow the device 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 14 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. •...
  • Page 15 III. SETUP, continued How to Set the Units: ® The CardioChek PA device may be shipped with preset units. NOTE: • If the USER SET menu does not display "UNITS" the device is locked in preset units • The units cannot be changed if the system has been locked •...
  • Page 16 10. Press Next to return to RUN TEST. Introduction to the CardioChek PA and Printer System The CardioChek PA device (with software version 2.20 and higher) supports printing in two formats, label or paper, on the CardioChek PA Thermal Printer or Portable Printer. To verify CardioChek PA test system software, turn the device ON by pressing either button.
  • Page 17 III. SETUP, continued How to Print Results From Memory: (Up to 30 test results per chemistry; up to 10 Control results) 1. Turn the CardioChek PA device ON by pressing either ® button. 2. Press Enter until RUN TEST is displayed. 3.

  • Page 18: Checking The System

    IV. CHECKING THE SYSTEM Device Check Strip A Quality Control of the device operation can be performed using the gray check strip. The check strip (included in the device carrying case) verifies that the CardioChek ® PA device's electronic and optical systems are functioning properly. Each gray check strip is calibrated to read a specific reflectance.

  • Page 19: 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 check the performance of your test system: CardioChek PA device, MEMo Chip , and test strips. Use Quality Control materials provided by ®...

  • Page 20: Quality Control Testing

    V. QUALITY CONTROL TESTING How To Run a Quality Control Test: Install the correct MEMo Chip for the lot of test strips that ® you are using. Press either button to turn the device ON. Press Next until the display reads UTILITY. Press Enter. Press Next until RUN CONTROL scrolls across the display.
  • Page 21 V. QUALITY CONTROL TESTING, continued How To Run a Quality Control Test, continued: 11. During testing CONTROL is displayed. Results will be displayed within about one to two minutes. 12. Compare control results to the values on the Quality Control Range Insert included with control materials. 13.

  • Page 22: Running A Test

    VI. RUNNING A TEST Blood Testing A test strip package insert is included with each box of test strips. Please read the test strip package insert along with this section of the User Guide completely and carefully before testing. Testing Supplies To perform a blood test you need: •...
  • Page 23 VI. RUNNING A TEST, continued How to Obtain a Blood Sample: To perform a fingerstick: 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 24 VI. RUNNING A TEST, continued How to Run a Test: Insert correct MEMo Chip for the lot of strips in use. ® Insert MEMo Chip with finger notch (top) side up, lot number code facing down. Turn CardioChek ® PA device ON by pressing either button.

  • Page 25: Quick Reference

    VI. RUNNING A TEST, continued 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 PA device ON. ® Device will display lot code. 2.

  • Page 26: Memory

    VII. MEMORY Test results are automatically stored in the device's memory. A CardioChek ® PA device can store up to 30 results of each chemistry and at least 10 results of each control test. The device allows review of the results in order from the most recent to the oldest.
  • Page 27 VII. MEMORY, continued How to Clear Results Stored in Memory: Press either button to turn the device 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 28: Care And Cleaning

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

  • Page 29: Cleaning Instructions

    VIII. CARE AND CLEANING, continued Cleaning Instructions Locate the optical glass and the test strip insert opening. Open an alcohol wipe/prep pad. Fold the wipe and carefully wipe the optical glass and test strip guides clean. If the area is especially dirty, this may require additional wipes.

  • Page 30: Troubleshooting

    IX. TROUBLESHOOTING MESSAGE or PROBABLE WHAT TO DO ISSUE CAUSE Desired language Language has been set Turn device 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 31 (Printer ensuring that the Printer indicator indicator light is red.) light is green. Reprint test results stored in memory. Labels/paper were not See CardioChek PA & Printer loaded in the printer. System Setup/Operating System Instruction Sheet packaged with thermal printer.
  • Page 32 IX. TROUBLESHOOTING, continued PROBABLE MESSAGE or WHAT TO DO ISSUE CAUSE Results are not as Test strips improperly Repeat test, using a different expected. stored. vial of test strips. Run controls, confirm that results are in range. Batteries are defective. Change batteries.

  • Page 33: Interpreting Results

    X. INTERPRETING RESULTS All test results must be assessed by a qualified medical professional. Depending on the analyte being assessed, high or low results may have 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.

  • Page 34: Clia Information

    XI. CLIA INFORMATION General CLIA Information (US Only) (Please read before testing) 1. CLIA-waived. Each laboratory or testing site using the PTS Panels ® test strips MUST have a CLIA Certificate of Waiver (or other CLIA operating license) before testing. To obtain a Certificate of Waiver or any other type of laboratory license, call your state health department or PTS, Inc.

  • Page 35: Specifications

    (without batteries): 4-6 oz. (113.4 - 170.1 g) PTS Panels test strips ® Please read the instructions (package insert) included with the test strips for information specific to each chemistry. Optional CardioChek PA Thermal Printer/Power Supply For complete details, refer to each printer’s User Guide.

  • Page 36: Contact Information

    XIII. CONTACT INFORMATION Help For assistance with the CardioChek ® PA test system, please contact: Polymer Technology Systems, 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.cardiochekpa.com...

  • Page 37: Warranty

    XIV. WARRANTY CardioChek PA Device Limited One Year Warranty ® PTS, Inc. warrants to the original purchaser only, that the device shall be free of any defects in materials or workmanship for a period of one year from the date of original purchase.

  • Page 38: Explanation Of Symbols

    XV. EXPLANATION OF SYMBOLS CardioChek PA Test System Symbols ® Consult Instructions for Use Temperature Limitation In vitro diagnostic medical device Serial Number Manufacturer Catalog Number Authorized representative in the European Community This product fulfills the requirements of the European Directive 98/79 EC for in vitro diagnostic medical devices.

  • Page 39: Index

    XVI. INDEX Device Introduction..............4-6 Battery Installation ...............9 Blood Testing ................22-24 CLIA Information ............... 34 Check Strip ................18-19 Cleaning ..................28-29 Contact Information ..............36 Date (Setting) ................14 Help ....................36 Interpreting Results ..............33 Language (Setting) .............12-13 MEMo Chip .................7-8 Memory ...................26-27 Quick Reference (For Running a Test) ......
  • Page 40 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.cardiochekpa.com 0197 Authorized European Representative MDSS Schiffgraben 41 30175 Hannover Germany © Copyright 2010 Polymer Technology Systems, Inc. PS-002461E Rev. 3 11/10...

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