Polymer Technology Systems CardioChek User manual

Brand Analyzers
Portable Whole Blood
Test System User Guide
For Self-Testing Use

3
I. 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
strips/MEMo Chip®.This test system is intended for in vitro
diagnostic use to test whole blood. Using this test system,
you can quickly measure various blood components from a
small sample size. The CardioChek test system is capable
of screening lipids (including Cholesterol, HDL Cholesterol,
and Triglycerides) and testing for diabetes and other disease
states.
The CardioChek analyzer uses reectance photometry for
testing. The analyzer 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 test system.
Please remember to return the enclosed warranty card to
ensure you receive product updates.
For questions or assistance with your CardioChek test
system, please contact PTS, Inc. using the following contact
information:
Polymer Technology Systems, Inc.
7736 Zionsville Road
Indianapolis, IN 46268 USA
[phone] (Direct)
[phone] (Toll-free inside the US)
[e-mail] (E-mail)
www.cardiochek.com
Hours: 8:00 a.m. - 8:00 p.m., US Eastern Standard
Time, Monday-Friday.
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 O
Setting Language
Setting Time
Setting Date
Setting Units
Setting Sound
IV. Checking the System........................................................................15
Check Strip
Quality Control
V. Control Testing ...................................................................................17
Running a Control Test
VI. Running a Test ...................................................................................19
Blood Testing
Testing Supplies
Quick Reference
VII. Results....................................................................................................23
VIII. Memory.................................................................................................24
Recalling Results
Clearing Memory
IX. Care and Cleaning .............................................................................26
Storage and Handling
Cleaning Instructions
X. Troubleshooting.................................................................................27
XI. Unexpected Results..........................................................................29
XII. Specications......................................................................................31
XIII. Contact Information .........................................................................32
Help
XIV. Warranty................................................................................................33
XV. Explanation of Symbols ..................................................................34
XVI. Index ......................................................................................................35
TABLE OF CONTENTS

3
I. 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
strips/MEMo Chip®.This test system is intended for in vitro
diagnostic use to test whole blood. Using this test system,
you can quickly measure various blood components from a
small sample size. The CardioChek test system is capable
of screening lipids (including Cholesterol, HDL Cholesterol,
and Triglycerides) and testing for diabetes and other disease
states.
The CardioChek analyzer uses reectance photometry for
testing. The analyzer 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 test system.
Please remember to return the enclosed warranty card to
ensure you receive product updates.
For questions or assistance with your CardioChek test
system, please contact PTS, Inc. using the following contact
information:
Polymer Technology Systems, Inc.
7736 Zionsville Road
Indianapolis, IN 46268 USA
[phone] (Direct)
[phone] (Toll-free inside the US)
infor[email protected] (E-mail)
www.cardiochek.com
Hours: 8:00 a.m. - 8:00 p.m., US Eastern Standard
Time, Monday-Friday.
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 O
Setting Language
Setting Time
Setting Date
Setting Units
Setting Sound
IV. Checking the System........................................................................15
Check Strip
Quality Control
V. Control Testing ...................................................................................17
Running a Control Test
VI. Running a Test ...................................................................................19
Blood Testing
Testing Supplies
Quick Reference
VII. Results....................................................................................................23
VIII. Memory.................................................................................................24
Recalling Results
Clearing Memory
IX. Care and Cleaning .............................................................................26
Storage and Handling
Cleaning Instructions
X. Troubleshooting.................................................................................27
XI. Unexpected Results..........................................................................29
XII. Specications......................................................................................31
XIII. Contact Information .........................................................................32
Help
XIV. Warranty................................................................................................33
XV. Explanation of Symbols ..................................................................34
XVI. Index ......................................................................................................35

54
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
nger notch. The bottom has a label
with the test name and lot number.
Always make sure you insert the
MEMo Chip into the port with the
nger notch facing up.
What does the MEMo Chip do?
• Reads the test strip expiration date
• Tells the analyzer which test(s) to run
• Contains the calibration curve and the lot number for the
specic test strip lot
• Controls test sequences and timing
• Establishes the measuring range for the test
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
test 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, Inc.
Customer Service for a replacement.
MEMo Chip
(Top and Bottom)
II. INTRODUCTION TO THE
CARDIOCHEK TEST SYSTEM
a
c
b
d
e
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. 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 located at the top of the analyzer.
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 test strip is inserted here with the
raised lines facing up.

54
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
nger notch. The bottom has a label
with the test name and lot number.
Always make sure you insert the
MEMo Chip into the port with the
nger notch facing up.
What does the MEMo Chip do?
• Reads the test strip expiration date
• Tells the analyzer which test(s) to run
• Contains the calibration curve and the lot number for the
specic test strip lot
• Controls test sequences and timing
• Establishes the measuring range for the test
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
test 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, Inc.
Customer Service for a replacement.
MEMo Chip
(Top and Bottom)
Top Bottom
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. 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 located at the top of the analyzer.
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 test strip is inserted here with the
raised lines facing up.

76
III. SETUP
Battery Use and Replacement
The CardioChek®analyzer 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
analyzer 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 of the two buttons
on the front of the analyzer to turn the CardioChek
analyzer ON.
WARNING! Dispose of the old batteries properly.
II. INTRODUCTION TO THE
CARDIOCHEK TEST SYSTEM, continued
The MEMo Chip®port is located at
the top center of the analyzer. The
MEMo Chip is inserted into this
port with the nger notch facing
up. Push rmly, 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®analyzer, use test strips
specic 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 CardioChek test strip
box contains a package insert that provides instructions for
use and information specic for each test. Please read the
instructions completely before testing.
CardioChek
test strip
Blood Application
Window

76
III. SETUP
Battery Use and Replacement
The CardioChek®analyzer 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
analyzer 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 of the two buttons
on the front of the analyzer to turn the CardioChek
analyzer ON.
WARNING! Dispose of the old batteries properly.
The MEMo Chip®port is located at
the top center of the analyzer. The
MEMo Chip is inserted into this
port with the nger notch facing
up. Push rmly, 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®analyzer, use test strips
specic 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 CardioChek test strip
box contains a package insert that provides instructions for
use and information specic for each test. Please read the
instructions completely before testing.

98
III. SETUP, continued III. SETUP, continued
• Hold and down at the same time to shut o
the analyzer from one of the main menus (RUN TEST,
MEMORY, UTILITY, or USER SET).
NEXT Button: Press this button to turn the
analyzer ON or to advance to the next menu option.
CHOL
CK STRIP
RUN CONTROL
CLEAR MEMORY
EXIT
USE CODE #
INSERT STRIP
RUN TEST MEMORY
CHEM
( to select)
CONTROL
( to select)( to select)
EXIT return to
MEMORY
return to
CHEM
GLU
HDL
TRIG
LDL
KET
LIPIDS
EXIT
( to select)
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.
* Units may be locked, and therefore UNITS will not appear.

98
III. SETUP, continued
• Hold and down at the same time to shut o
the analyzer from one of the main menus (RUN TEST,
MEMORY, UTILITY, or USER SET).
NEXT Button: Press this button to turn the
analyzer ON or to advance to the next menu option.
CK STRIP
RUN CONTROL
CLEAR MEMORY
EXIT
UTILITY USER SET
return to
MEMORY
return to
CHEM
( to select)
return to
UTILITY
return to
CK STRIP
( to select)
SOUND
SET TIME
SET DATE
UNITS*
EXIT return to
USER SET
return to
SOUND
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.
* Units may be locked, and therefore UNITS will not appear.

1110
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. To stop shutdown press either button.
You can also remove the batteries to turn the analyzer OFF.
Setting Language
The language menu consists of the following choices:
English (ENGLISH), Spanish (ESPANOL),
Italian (ITALIANO), German (DEUTSCH),
French (FRANCAIS), Portuguese (PORTUGSE), and
Dutch (NEDERL).
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
language is displayed, then press Enter. To set the time
proceed to How to Set the Time.
The rst time the analyzer is turned on you will be required to
set the language, date, and time.
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. 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 displayed clock
format. The display will read HOUR and the numerical hour. If
12 hour clock was chosen, AM/PM appears in the upper right
hand corner of the display.
6. Press Next to increment the hour.
7. Press Enter to accept the displayed hour. The display
will read MINUTE and the numerical minute.
8. Press Next to increment the minutes.