Polymer Technology Systems CardioChek P-A User manual

User Guide
CardioChek®
Brand Analyzers
Portable Whole Blood Test
Systems
(CardioChek and CardioChek P•A)
For Professional and Self-Testing Use

TABLE OF CONTENTS
The CardioChek®Analyzer
I. Introduction.................................................................4
II. How to Use the User Guide........................................5
III. Introduction to the CardioChek...................................6
Analyzer - CardioChek Test System
MEMo ChipTM
Test Strip
IV. Set Up ........................................................................9
Installing Batteries
Setting Language
Setting Time
Setting Date
Setting Units
Setting Sound
V. Checking the System .................................................16
Check Strip
Quality Control
VI. Control Testing............................................................18
Running a Control Test
VII. Running a Test............................................................20
Blood Testing
Testing Supplies
Quick Reference
VIII. Memory.......................................................................24
Recalling Results
Clearing Memory
IX. Care and Cleaning .....................................................25
Storage and Handling
X. Troubleshooting..........................................................26
XI. CLIA Information.........................................................29
XII. Specifications .............................................................30
XIII. Contact Information ....................................................31
Help
Catalog Numbers
XIV. Warranty .....................................................................32
XV. Explanation of Symbols ..............................................33
XVI. Index....................................................................34

4
I. INTRODUCTION
Thank you for selecting CardioChek Analyzer from Polymer
Technology Systems, Inc. (PTS).
The analyzer is available in two models: the CardioChek
and the CardioChek P•A. The CardioChek P•A has an
optional printer available and will run all PTS PANELS Test
Strips, including all multiple Test Strips (e.g. Lipid Panel,
CHOL+GLU, etc.).
The CardioChek is a fast, portable and reliable whole blood
analyzer. The CardioChek test system includes an analyzer
and separately available PTS PANELSTM Test Strips/MEMo
ChipTM. This system is intended for in vitro diagnostic use to
test whole blood. Using this system, you can quickly mea-
sure various blood components from a small sample size.
The CardioChek test system is capable of screening lipids
(including Cholesterol, HDL Cholesterol and Triglycerides)
and monitoring for diabetes and other disease states.
The CardioChek uses reflectance photometry for testing. It
reads color changes that occur on a Test Strip after blood is
placed on the Test Strip.
Before you begin testing, please read this entire User Guide
and the Test Strip package insert completely. This provides
the necessary information for the use of this system. Please
remember to return the enclosed warranty card to ensure
you receive product updates.
Polymer Technology Systems, Inc.
7736 Zionsville Road
Indianapolis, IN 46268 USA
[phone]
www.cardiochek.com

5
II. HOW TO USE THE USER GUIDE
This guide includes all the information you need to properly
test using CardioChek Analyzer. For additional information
and specific information for each individual chemistry test,
please make sure you read the package insert included with
the Test Strips. This User Guide is arranged in the order a
new user would need the information. Each section can be
used separately, after you have read the entire guide.
If you have questions about this system, please contact
PTS Customer Service. Customer Service assistance is
available 8:00 AM - 5:00 PM US Eastern Standard Time,
Monday through Friday. If you need help interpreting your
test results, please contact your healthcare provider.
For questions or assistance with the CardioChek, call:
PTS Customer Service
Hours: 8:00 AM - 5:00 PM US Eastern Standard Time
Monday - Friday
1-877-870-5610 (Toll-free inside US)
1-317-870-5610
Fax: [phone]
E-mail: [email protected]

6
III. INTRODUCTION TO THE
CARDIOCHEK ANALYZER
The CardioChek Test System:
The CardioChek test system consists of three main parts.
These include the analyzer, PTS Panels Test Strips and a
MEMo Chip. When a blood sample 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.
The analyzer converts this color reading into a test result,
that is displayed on the screen.
MEMo Chip Port (a)
The MEMo Chip Port is on the top of the analyzer. A lot specific
MEMo Chip is inserted into this port.
Display (b)
Display shows test results, messages, time, date, and stored results.
ENTER Button (c)
Press this button to turn the analyzer ON or to accept the current
menu choice.
NEXT Button (d)
Press this button to turn the analyzer ON or to advance to the next
menu option.
Test Strip Insert Opening (e)
The Test Strip Insert Opening is positioned in the lower front of the
analyzer. The strip is inserted here with the raised lines facing up.

7
MEMo Chip
The color-coded MEMo Chip
contains the settings for each test.
The top of the MEMo Chip has a
finger notch. The bottom has a
label with the test name and lot
number.
The MEMo Chip
Each package of PTS Panels Test Strips contains a
color-coded 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:
• Reads the Test Strip expiration date.
• Tells the analyzer which test(s) to run.
• Contains the calibration curve and the lot number for the
specific Test Strip Lot.
• Controls test sequences and timing.
• Establishes the measuring range for the test.
The MEMo Chip contains proper settings for the Test Strip lot
you are using.
Guidelines for using the MEMo Chip:
• The MEMo Chip must be in place to run a test.
• Use only the MEMo Chip that is included with each
package of strips. The lot number code on the Test Strip
vial, MEMo Chip, and analyzer display must match.
• If the expiration date in the MEMo Chip has expired, the
analyzer will display EXPIRED LOT.
• If your MEMo Chip is lost or missing, please call PTS
Customer Service for a replacement.
III. INTRODUCTION TO THE
CARDIOCHEK ANALYZER, continued
MEMo Chip
(Top and Bottom)
Top Bottom

8
III. INTRODUCTION TO THE
CARDIOCHEK ANALYZER, continued
Using the MEMo Chip (continued):
The MEMo Chip Port is on the
top center of the analyzer. 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.
Important: Be careful not to bend
the connector.
Test Strip
To test blood on the CardioChek, use Test Strips specific
for each test. A Test Strip is inserted into the analyzer, then
blood is applied to the blood application window. 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. The analyzer
converts this color reading into a test result, displayed on the
screen. Each PTS Panels 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.
PTS Panels
Test Strip
Blood Application
Window

9
IV. SET UP
Battery Use and Replacement
The CardioChek requires two (2) AAA 1.5 volt high quality
alkaline batteries.
When to Replace the Batteries:
The analyzer will give you an indication on the display that
the batteries need to be changed. When the display reads
CHANGE BATTERY, no more tests can be run until the
batteries are changed. Always replace the batteries with high
quality alkaline batteries. It is recommended to keep a spare
set of batteries on hand. To extend battery life, remove the
Test Strip as soon as a result is displayed. The time/date and
results stored in memory will not be erased when the batteries
are changed.
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).
2. Remove old batteries from the compartment and safely
discard.
3. Insert the new batteries into the battery compartment
with the positive (+) terminal facing to the left on the top
battery, and to the right on the bottom battery as marked
on the inside compartment.
4. Replace the battery door. To make sure the batteries
were installed correctly, push either one of the
two buttons on the front of the analyzer to turn the
CardioChek ON.
WARNING! Dispose of the old batteries properly.

10
IV. SET UP, continued
Buttons
ENTER Button: Press this button to turn the ana-
lyzer ON or to accept the current menu choice.
NEXT Button: Press this button to turn the analyzer
ON or to advance to the next menu option.
How to Turn the Analyzer OFF:
The batteries will have a longer life due to the analyzer’s
automatic shut down feature. 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. To stop
shutdown press down either button. To turn OFF press both
buttons at the same time for three seconds at any of the fol-
lowing Main Menu headings: RUN TEST, MEMORY, UTIL-
ITY, or USER SET. You can also remove the batteries to
turn the analyzer OFF.
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).
How to Set the Language:
1. Turn the analyzer ON by pressing either button (Enter or
Next).
2. The display will read LANGUAGE. Press Enter.
3. ENGLISH will be displayed. Press Enter if English is
desired.
4. For other languages press Next until the desired lan-
guage is displayed, then press Enter. To set the time
proceed to How to Set the Time.