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.

1110
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.

1312
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 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 UNITS.
12. Press Next until EXIT is displayed. Press Enter.
13. Press Next to return the display to RUN TEST.
III. SETUP, continued III. SETUP, continued
How to Set the Time, continued:
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.
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
• To conrm current conguration of the analyzer's units
run a check strip in the RUN TEST mode and observe
the units that are displayed
If your analyzer's units have not been preset, follow the steps
listed below to change your units to mg/dL, mmol/L, or g/L:
1. If RUN TEST is displayed, go to Step 3. If the instrument
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 Next until UNITS is displayed. If UNITS is not
shown on the display, the units on this instrument have
been locked and cannot be changed. If UNITS appears
on the display screen, proceed to the next step.
5. Press Enter. The display will read mg/dL. If mmol/L or g/L
is desired press Next until the desired unit appears on
the display screen.

1312
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 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 UNITS.
12. Press Next until EXIT is displayed. Press Enter.
13. Press Next to return the display to RUN TEST.
III. SETUP, continued
How to Set the Time, continued:
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.
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
• To conrm current conguration of the analyzer's units
run a check strip in the RUN TEST mode and observe
the units that are displayed
If your analyzer's units have not been preset, follow the steps
listed below to change your units to mg/dL, mmol/L, or g/L:
1. If RUN TEST is displayed, go to Step 3. If the instrument
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 Next until UNITS is displayed. If UNITS is not
shown on the display, the units on this instrument have
been locked and cannot be changed. If UNITS appears
on the display screen, proceed to the next step.
5. Press Enter. The display will read mg/dL. If mmol/L or g/L
is desired press Next until the desired unit appears on
the display screen.

1514
IV. 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® 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. It is recommended that you check
your analyzer with the check strip when:
• You rst 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. Hold the check strip at base of strip and 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 the end of this section.)
Remove the check strip and store it in the analyzer
carrying case.
6. Press Next until EXIT is displayed. Press Enter.
7. Press Next until RUN TEST is displayed.
8. Press Enter. The analyzer is ready to run tests.
III. SETUP, continued
How to Set the Units, continued:
6. Press Enter to select the desired units. The display will
then read UNITS.
7. Press Next until EXIT is displayed.
8. Press Enter to return to USER SET.
9. 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 o 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, then Next until SOUND is 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.

1514
IV. 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® 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. It is recommended that you check
your analyzer with the check strip when:
• You rst 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. Hold the check strip at base of strip and 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 the end of this section.)
Remove the check strip and store it in the analyzer
carrying case.
6. Press Next until EXIT is displayed. Press Enter.
7. Press Next until RUN TEST is displayed.
8. Press Enter. The analyzer is ready to run tests.
How to Set the Units, continued:
6. Press Enter to select the desired units. The display will
then read UNITS.
7. Press Next until EXIT is displayed.
8. Press Enter to return to USER SET.
9. 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 o 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, then Next until SOUND is 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.

1716
V. 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. Home users should perform control
testing with each new test strip lot, and whenever it has been
more than a month since using that lot of test strips.
How To Run a Quality Control Test:
1. Install the 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 scrolls across the
display. Press Enter.
5. 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.
6. Remove cap from the Quality Control material and turn
bottle upside down.
CONTROL MUST BE APPLIED TO TEST STRIP
WITHIN 10 SECONDS OF REMOVING THE STRIP
FROM THE VIAL.
IV. CHECKING THE SYSTEM, continued
Note: If the analyzer displays FAILED:
1. Clean the CardioChek®analyzer test strip insert opening
(where the strip is inserted into the analyzer). 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.
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 analyzer, MEMo Chip®, and test
strips. Use Quality Control materials provided by PTS, Inc.
PTS Panels®Multi-Chemistry Controls REF 721
PTS Panels®HDL Controls REF 722
Refer to control package insert for control specications.
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
V. CONTROL TESTING.
To perform a control test you need:
• CardioChek analyzer
• CardioChek test strips
• Quality Control materials
• Quality Control instructions
• Quality Control range insert

1716
V. 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. Home users should perform control
testing with each new test strip lot, and whenever it has been
more than a month since using that lot of test strips.
How To Run a Quality Control Test:
1. Install the 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 scrolls across the
display. Press Enter.
5. 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.
6. Remove cap from the Quality Control material and turn
bottle upside down.
CONTROL MUST BE APPLIED TO TEST STRIP
WITHIN 10 SECONDS OF REMOVING THE STRIP
FROM THE VIAL.
Note: If the analyzer displays FAILED:
1. Clean the CardioChek®analyzer test strip insert opening
(where the strip is inserted into the analyzer). 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.
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 analyzer, MEMo Chip®, and test
strips. Use Quality Control materials provided by PTS, Inc.
PTS Panels®Multi-Chemistry Controls REF 721
PTS Panels®HDL Controls REF 722
Refer to control package insert for control specications.
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
V. CONTROL TESTING.
To perform a control test you need:
• CardioChek analyzer
• CardioChek test strips
• Quality Control materials
• Quality Control instructions
• Quality Control range insert

1918
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:
• CardioChek®analyzer
• CardioChek test strips
• Lot specic 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 for more information.
:
Helpful Hints on Getting a Good Drop of Blood:
1. Warm the ngers to increase blood ow.
2. Let the arm hang down at the person’s side briey to allow
blood ow to the nger 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 nger air dry before testing.
V. CONTROL TESTING, continued
7. Hold bottle directly over and perpendicular to the blood
application window on the test strip.
8. Squeeze bottle so a small drop of control solution is
formed.
9. Allow the drop of control solution to fall onto the
application window of the test strip. Do not allow the tip
of the bottle to touch the test strip.
10. Replace cap on the Quality Control material.
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 Quality 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 the MEMo Chip®matches the test strip lot.
4. Repeat the test again using fresh materials.
5. Call PTS, Inc. Customer Service for assistance.

1918
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:
• CardioChek®analyzer
• CardioChek test strips
• Lot specic 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 for more information.
:
Helpful Hints on Getting a Good Drop of Blood:
1. Warm the ngers to increase blood ow.
2. Let the arm hang down at the person’s side briey to allow
blood ow to the nger 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 nger air dry before testing.
7. Hold bottle directly over and perpendicular to the blood
application window on the test strip.
8. Squeeze bottle so a small drop of control solution is
formed.
9. Allow the drop of control solution to fall onto the
application window of the test strip. Do not allow the tip
of the bottle to touch the test strip.
10. Replace cap on the Quality Control material.
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 Quality 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 the MEMo Chip®matches the test strip lot.
4. Repeat the test again using fresh materials.
5. Call PTS, Inc. Customer Service for assistance.

2120
VI. RUNNING A TEST, continued
How to Run a Test:
1. Insert correct MEMo Chip®for the lot of strips in use.
2. Insert MEMo Chip with nger notch (top) side up, lot
number code facing down.
3. Turn CardioChek®analyzer ON by pressing either button.
4. When INSERT STRIP is displayed, insert the test strip
into the analyzer as far as it will go.
5. Obtain a blood drop following the correct technique.
6. When APPLY SAMPLE is displayed, apply blood to the
test strip. Refer to each specic test strip package insert
for sample volume and sample application instructions.
7. Within one to two minutes, the results will be displayed.
8. Remove test strip and discard.
9. The analyzer automatically shuts down after three
minutes of idle time with no test strip inserted.
IMPORTANT: Do not leave a used test strip or check
strip in the analyzer test strip opening. This prevents
the analyzer from automatically shutting down and
shortens battery life.
VI. RUNNING A TEST, continued
How to Obtain a Blood Sample:
To perform a ngerstick:
1. Clean the nger. Be sure the nger is completely dry.
2. Use a new sterile, disposable lancet to puncture the skin.
3. Stick the nger on the side of the ngertip, instead of the
center. See picture below:
CORRECT WAY TO
STICK THE FINGER
4. To get a drop of blood, gently apply pressure to the nger
starting at the end of the nger closest to the hand and
moving towards the tip. Wipe away the rst drop of blood
with gauze and use the second blood drop for testing. The
blood drop should be hanging down from the nger to
make it easier to collect the sample with a capillary pipet or
plastic blood collector.
5. Follow the specic instructions found in the test strip
package insert for each test for sample application and
volume ranges. Use of capillary pipet or plastic blood
collector ensures a sucient volume of blood has been
applied to the test strip.
6. Make sure the test strip is inserted all the way into the
test strip insert opening.
7. Use the test strip and lancet one time only. Dispose of
properly.