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.

11
IV. SET UP, 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. Press Enter. Press Next to scroll through the language
choices.
4. Press Enter to select the language that is displayed.
SET TIME will be displayed.
How to Set the Time:
1. If the analyzer is OFF, press either button to turn the
analyzer ON. Wait for the display to read either INSTALL
MEMO CHIP (if a current MEMo Chip is not installed)
or INSERT STRIP (if a current MEMo Chip is installed).
Press Enter. The display will read RUN TEST.
2. Press Next until USER SET is displayed.
3. Press Enter. Press Next until SET TIME is displayed.
4. Press Enter and the clock format is displayed: 12/24 HR.
5. Press Next to alternately display the 12 hour am/pm
clock or the 24-hour clock. Press Enter to accept the dis-
played clock format. The display will read HOUR and the
numerical hour.
6. Press Next to increment the hour. Note: AM/PM in the
upper right hand corner of the display.
7. Press Enter to accept the displayed hour. The display
will read MINUTE and the numerical minute.
8. Press Next to increment the minutes.
9. 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. Press Next to return the display to RUN TEST.

12
How to Set the Date:
1. If RUN TEST is displayed, go to Step 3. If the analyzer
is OFF, press either button to turn the analyzer ON. Wait
for the display to read INSTALL MEMO CHIP or INSERT
STRIP.
2. Press Next. The display will read RUN TEST.
3. Press Next until USER SET is displayed. Press Enter.
4. Press Next until SET DATE is displayed.
5. Press Enter and the numerical month is displayed.
6. Press Next to increment the month.
7. Press Enter to accept the displayed month. The display
will read DAY and the numerical day of the month.
8. Press Next to increment the day.
9. Press Enter to accept the displayed day. The display will
read YEAR and the numerical set year.
10. Press Next to increment the year.
11. Press Enter to accept the displayed year. The display
will read SET DATE. To set the units, proceed to
How to Set the Units.
12. Press Next until EXIT is displayed. Press Enter.
13. Press Next to return the display to RUN TEST.
How to Set the Units:
The CardioChek has been preset to US units (e.g. mg/dL).
To change your units to INTL (International Standard Units)
(i.e. mmol/L) follow the steps listed below:
1. If RUN TEST is displayed, go to Step 3. If the analyzer is
OFF, press either button to turn the analyzer ON. Wait
for the display to read INSTALL MEMO CHIP or INSERT
STRIP.
2. Press Enter. The display will read RUN TEST.
3. Press Next until USER SET is displayed.
4. Press Enter. The display will read SOUND.
5. Press Next until UNITS is displayed.
IV. SET UP, continued

13
How to Set the Units, continued:
6. Press Enter. The display will read US. If INTL units are
desired press Next to display INTL.
7. Press Enter to select the units. Display will read UNITS.
8. Press Next until EXIT is displayed.
9. Press Enter to return display to USER SET.
10. Press Next to return to RUN TEST.
How to Set the Sound:
The CardioChek 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 to turn the analyzer ON. Wait
for the display to read INSTALL MEMO CHIP or INSERT
STRIP.
2. Press Next. The display will read RUN TEST.
3. Press Next until USER SET is displayed.
4. Press Enter. SOUND will be displayed.
5. Press Enter. The display will read BEEP ON or BEEP
OFF.
6. Press Next to select either BEEP OFF or BEEP ON.
7. Press Enter to accept the sound choice displayed.
8. Press Next until EXIT is displayed.
9. Press Enter to return display to USER SET.
10. Press Next to return to RUN TEST.
Introduction to the CardioChek P•A and Printer System
The CardioChek P•A analyzer (with software version 2.20
and higher) supports printing in two formats, label or paper,
on the CardioChek P•A Thermal Printer or Portable Printer.
To verify CardioChek P•A system software, turn the analyzer
ON by pressing either button. The software version will
appear on the display.
IV. SET UP, continued

14
IV. SET UP, continued
How to Set Up the CardioChek P•A for Printing:
For complete details, refer to each printer’s User Guides and
Set Up / Operating Instruction Sheets.
1. Turn the CardioChek P•A ON by pressing either button.
2. Press Enter until RUN TEST is displayed.
3. Press Next until USER SET is displayed. Press Enter.
4. PRINT will be displayed. Press Enter. MEDIA will be
displayed.
5. Press Enter to select the type of print material (MEDIA).
Select L for LABEL or P for PAPER. MEDIA will be
displayed. Note: Default is set to labels (L).
6. Press Next. COPIES will be displayed. Note: Default is
set to one copy.
7. Press Enter to select COPIES, press Next to scroll to the
number of copies of the test results to be printed. 1, 2, or
3.
8. Press Enter to select the number of copies to be printed.
COPIES will be displayed.
9. Press Next until EXIT is displayed. Press Enter.
10. Repeat this step until you return to RUN TEST. Make
sure the printer power switch is turned OFF.
11. Connect the instrument to the CardioChek P•A Thermal
Printer via the Communication Cable. Insert the 9-pin
end of the Communication Cable into the printer. Insert
the other end of the cable into the analyzer MEMo Chip
port.
12. Install the MEMo Chip into the top end of the
Communication Cable connected to the analyzer.

15
IV. SET UP, continued
How to Print Test Results:
At the completion of testing on the CardioChek P•A, the
selected number of copies of results will automatically be
printed.
How to Print Results From Memory:
(Up to 30 test results per chemistry; up to 10 Control results)
1. Turn the CardioChek P•A ON by pressing either button.
2. From the RUN TEST menu press Next.
3. Press Enter until RUN TEST is displayed.
4. MEMORY will be displayed. Press Enter.
5. Press Enter to select CHEM.
6. Press Next to select the type of test, LIPIDS for example.
7. Press Next to select the date/time of the test result you
want to print.
8. Press Enter to print the selected number of copies of
results.
9. Control results can be printed by selecting CONTROL
instead of CHEM and then selecting the type of result as
above.

16
V. CHECKING THE SYSTEM
Instrument Check Strip
A gray Instrument Check Strip (included in the analyzer
carrying case) can be used to verify proper functioning of the
CardioChek’s electronic and optical systems. The
Instrument 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.
It is recommended that you check your analyzer with the
Instrument Check Strip when:
• You first receive it.
• You drop the analyzer.
• You get a result that is not expected.
How to Use the Instrument Check Strip:
1. Turn the analyzer ON by pressing either button.
2. When INSTALL MEMO CHIP or RUN TEST is displayed,
press Next until UTILITY is displayed. Press Enter.
3. Press Enter when CK STRIP is displayed.
4. Insert the Check Strip, ribbed side up, into the Test Strip
Insert opening when INSERT STRIP is displayed.
5. The analyzer should display PASSED. (If the display
reads FAILED, see the NOTE at end of this section.)
Remove the Check Strip and store it in the analyzer
carrying case.
7. Press Next until EXIT is displayed. Press Enter.
8. Press Next until RUN TEST is displayed.
9. Press Enter. 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.
2. Inspect the Check Strip to make sure it is not dirty or
damaged. Use the spare Check Strip and repeat.
3. See the Troubleshooting section.

17
Quality Control
Controls (also known as “quality control materials”) are solu-
tions for which an expected analyte concentration range has
been established. Controls are tested to check the perfor-
mance of your test system: CardioChek analyzer, MEMo
Chip and Test Strips. Use quality control materials provided
by PTS.
PTS PANELS Multi-Chemistry Controls REF/Cat. No. 721
PTS PANELS HDL Controls REF/Cat. No. 722
Refer to control package insert for control specifications.
Healthcare professionals testing with this system should
follow their facility’s guidelines and policies regarding the use
of quality control materials.
IMPORTANT: Do not use control solutions that have expired.
Check the expiration date printed on the control bottles.
For performing a quality control test, see Section VI.
CONTROL TESTING
To perform a control test you need:
• CardioChek Analyzer
• PTS PANELS Test Strips
• Quality Control Materials
• Quality Control Instructions
• Quality Control Range Insert
V. CHECKING THE SYSTEM

18
VI. CONTROL TESTING
Control Testing
Control testing, also known as quality control testing, is used
to ensure all the parts of the test system are working properly
together and the test results are accurate and reliable
within the limits of the system. A quality control material, or
control, is a liquid containing an analyte known to be within a
certain range. This range is supplied with the Quality Control
Material or is available online at www.cardiochek.com.
Healthcare professionals should follow their facility’s policies
on when controls should be tested (for example: with each
new Test Strip lot; monthly as a continued check on storage
conditions; whenever issues (storage, operator, or other) are
identified or there are questions about the results).
How To Run a Quality Control Test:
1. Install correct MEMo Chip for the lot of strips that you are
using.
2. Press either button to turn the analyzer ON.
3. Press Next until the display reads UTILITY. Press Enter.
4. Press Next until RUN CONTROL is displayed. Press
Enter.
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.
a. Immediately replace the vial cap, making sure the
strip vial is closed tightly.
6. Remove cap from the Control Material and turn bottle
upside down.
a. CONTROL MUST BE APPLIED TO TEST STRIP
WITHIN 10 SECONDS OF REMOVING THE STRIP
FROM THE VIAL.
7. Hold bottle directly over and perpendicular to the blood
application window on the Test Strip.

19
VI. CONTROL TESTING, continued
How To Run a Quality Control Test (continued):
8. Squeeze bottle, so a small drop of control solution is
formed.
9. Allow the drop of control solution to fall onto the
application widow of the Test Strip. Do not allow the tip of
the bottle to touch the Test Strip.
10. Replace cap on the Control Material.
11. 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. The control result(s) will also be stored in the analyzer’s
Memory.
14. To exit the control testing menu press Enter twice. RUN
CONTROL will be displayed.
15. Press Next until EXIT is displayed. Press Enter.
16. Press Next until RUN TEST is displayed.
If Quality Control Results are not in Range:
1. Ensure Test Strip insert opening area is clean.
2. Make sure neither the Test Strips nor the controls are
past the expiration date printed on the label.
3. Make sure MEMo Chip matches strip lot.
4. Repeat the test again using fresh materials.
5. Call Customer Service for assistance.

20
VII. 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:
• CardioChek Analyzer
• PTS PANELS Test Strips
• Lot specific MEMo Chip
• Sterile lancet
• Capillary blood collector or pipet
• Gauze or cotton balls
• Alcohol wipe (optional)
This analyzer requires whole blood for testing. Do not
operate the analyzer in direct light. Reference the Care and
Cleaning section.
Helpful Hints on Getting a Good Drop of Blood:
1. Warm the fingers to increase blood flow.
2. Let the arm hang down at the person’s side briefly to
allow blood flow to the finger tips.
3. Instruct the patient to wash hands in warm, soapy water.
Rinse well and dry completely. If an alcohol wipe is used,
let the finger air dry before testing.
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.