Polymer Technology Systems CardioChek P-A User manual

Brand Analyzers
Portable Whole Blood
Test System User Guide
For Professional Use

I. Introduction............................................................................................ 4
II. Introduction to the CardioChek®PA Test System ...................... 5
CardioChek®PA device
MEMo Chip®
PTS Panels®test strips
III. Setup ........................................................................................................ 9
Installing Batteries
CardioChek PA System Menus
How to Turn Device O
Setting Language
Setting Time
Setting Date
Setting Units
Setting Sound
Setup for Print
IV. Checking the System .......................................................................... 18
Check Strip
Quality Control
V. Quality Control Testing ....................................................................... 20
Running a Control Test
VI. Running a Test................................................................22
Blood Testing
Testing Supplies
Quick Reference
VII. Memory .................................................................................................... 26
Recalling Results
Clearing Memory
VIII. Care and Cleaning ................................................................................ 28
Storage and Handling
Cleaning Instructions
IX. Troubleshooting.................................................................................... 30
X. Interpreting Results.................................................................................. 33
XI. CLIA Information ................................................................................... 34
XII. Specications.......................................................................................... 35
XIII. Contact Information............................................................................. 36
Help
XIV. Warranty................................................................................................... 37
XV. Explanation of Symbols ...................................................................... 38
XVI. Index .......................................................................................................... 39
TABLE OF CONTENTS

I. Introduction............................................................................................ 4
II. Introduction to the CardioChek®PA Test System ...................... 5
CardioChek®PA device
MEMo Chip®
PTS Panels®test strips
III. Setup ........................................................................................................ 9
Installing Batteries
CardioChek PA System Menus
How to Turn Device O
Setting Language
Setting Time
Setting Date
Setting Units
Setting Sound
Setup for Print
IV. Checking the System .......................................................................... 18
Check Strip
Quality Control
V. Quality Control Testing ....................................................................... 20
Running a Control Test
VI. Running a Test................................................................22
Blood Testing
Testing Supplies
Quick Reference
VII. Memory .................................................................................................... 26
Recalling Results
Clearing Memory
VIII. Care and Cleaning ................................................................................ 28
Storage and Handling
Cleaning Instructions
IX. Troubleshooting.................................................................................... 30
X. Interpreting Results.................................................................................. 33
XI. CLIA Information ................................................................................... 34
XII. Specications.......................................................................................... 35
XIII. Contact Information............................................................................. 36
Help
XIV. Warranty................................................................................................... 37
XV. Explanation of Symbols ...................................................................... 38
XVI. Index .......................................................................................................... 39
TABLE OF CONTENTS

54
II. INTRODUCTION TO THE
CARDIOCHEK PA TEST SYSTEM
The CardioChek®PA Test System
The CardioChek PA test system consists of three main parts.
These include the device, PTS Panels®test strips, and a
MEMo Chip®.
The CardioChek®PA Test System & Operating Principle
The device employs light reectance to measure an end-
point enzymatic chemical reaction. The test strips are
impregnated with enzymes which are specic for the analyte
to be measured. Refer to the individual PTS Panels test
strip package inserts for detailed information related to the
enzymatic reaction. When blood is applied to the test strip,
the ensuing sequence of chemical reactions results in a
color change on the test strip which is measured by light
reectance. The intensity of this colorimetric substance is
directly proportional to the amount of analyte in the blood.
Using a stored standard calibration curve, the device
calculates and displays the result on the screen.
I. INTRODUCTION
The CardioChek®PA device from Polymer Technology Systems,
Inc. (PTS, Inc.) is intended for in vitro diagnostic use, using
whole blood samples. This point-of-care (POC) test system is
designed for professional use. The CardioChek PA test system
has an optional printer and the CardioChek Link® software
solution to assist in data reporting.
The CardioChek PA device is fast, portable, and reliable. This
device is a component of a test system that includes PTS
Panels®test strips. The PTS Panels test strip box includes a
MEMo Chip® that contains the assay calibration curve and other
important information about the assay. PTS Panels test strips
are sold separately, and are available as single and multiple
analyte test strips.
This test system uses reectance photometry technology. An
enzymatic reaction on the test strip produces a color change
that is detected by the device after whole blood is applied.
This User Guide includes all the information that you need to
run POC assays using the CardioChek PA test system. Before
you begin testing, please read this entire User Guide and the
package inserts, which are included with the PTS Panels test
strips.
Please remember to return the enclosed warranty card to
PTS, Inc. to ensure that you receive product updates and other
important information.
For questions or additional assistance with your CardioChek PA
test system, please contact PTS, Inc. (Hours: 8:00 a.m. to 8:00
p.m. USA Eastern Time) 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.cardiochekpa.com

54
II. INTRODUCTION TO THE
CARDIOCHEK PA TEST SYSTEM
The CardioChek®PA Test System
The CardioChek PA test system consists of three main parts.
These include the device, PTS Panels®test strips, and a
MEMo Chip®.
The CardioChek®PA Test System & Operating Principle
The device employs light reectance to measure an end-
point enzymatic chemical reaction. The test strips are
impregnated with enzymes which are specic for the analyte
to be measured. Refer to the individual PTS Panels test
strip package inserts for detailed information related to the
enzymatic reaction. When blood is applied to the test strip,
the ensuing sequence of chemical reactions results in a
color change on the test strip which is measured by light
reectance. The intensity of this colorimetric substance is
directly proportional to the amount of analyte in the blood.
Using a stored standard calibration curve, the device
calculates and displays the result on the screen.
The CardioChek®PA device from Polymer Technology Systems,
Inc. (PTS, Inc.) is intended for in vitro diagnostic use, using
whole blood samples. This point-of-care (POC) test system is
designed for professional use. The CardioChek PA test system
has an optional printer and the CardioChek Link® software
solution to assist in data reporting.
The CardioChek PA device is fast, portable, and reliable. This
device is a component of a test system that includes PTS
Panels®test strips. The PTS Panels test strip box includes a
MEMo Chip® that contains the assay calibration curve and other
important information about the assay. PTS Panels test strips
are sold separately, and are available as single and multiple
analyte test strips.
This test system uses reectance photometry technology. An
enzymatic reaction on the test strip produces a color change
that is detected by the device after whole blood is applied.
This User Guide includes all the information that you need to
run POC assays using the CardioChek PA test system. Before
you begin testing, please read this entire User Guide and the
package inserts, which are included with the PTS Panels test
strips.
Please remember to return the enclosed warranty card to
PTS, Inc. to ensure that you receive product updates and other
important information.
For questions or additional assistance with your CardioChek PA
test system, please contact PTS, Inc. (Hours: 8:00 a.m. to 8:00
p.m. USA Eastern Time) 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.cardiochekpa.com

76
The MEMo Chip®
Each package of PTS Panels®test strips contains a
color-coded MEMo Chip. The color-coded MEMo Chip
contains the settings for each test.
The top of the MEMo Chip has a
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 device 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
The MEMo Chip contains proper settings for the test strip lot
you are using. The MEMo Chip:
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 device display must match.
• If the expiration date in the MEMo Chip has expired, the
device will display EXPIRED LOT.
• If your MEMo Chip is lost or missing, please call PTS, Inc.
Customer Service for a replacement.
II. INTRODUCTION TO THE
CARDIOCHEK PA TEST SYSTEM, continued
MEMo Chip
(Top and Bottom)
II. INTRODUCTION TO THE
CARDIOCHEK PA TEST SYSTEM, continued
a
c
b
d
e
MEMo Chip Port (a)
The MEMo Chip port is located at the top of the device.
Display (b)
Display shows test results, messages, time, date, and
stored results.
ENTER Button (c)
Press this button to turn the device ON or to accept the
current menu choice.
NEXT Button (d)
Press this button to turn the device 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 device. The test strip is inserted here with the
raised lines facing up.

76
The MEMo Chip®
Each package of PTS Panels®test strips contains a
color-coded MEMo Chip. The color-coded MEMo Chip
contains the settings for each test.
The top of the MEMo Chip has a
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 device 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
The MEMo Chip contains proper settings for the test strip lot
you are using. The MEMo Chip:
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 device display must match.
• If the expiration date in the MEMo Chip has expired, the
device will display EXPIRED LOT.
• If your MEMo Chip is lost or missing, please call PTS, Inc.
Customer Service for a replacement.
II. INTRODUCTION TO THE
CARDIOCHEK PA TEST SYSTEM, continued
MEMo Chip
(Top and Bottom)
Top Bottom
MEMo Chip Port (a)
The MEMo Chip port is located at the top of the device.
Display (b)
Display shows test results, messages, time, date, and
stored results.
ENTER Button (c)
Press this button to turn the device ON or to accept the
current menu choice.
NEXT Button (d)
Press this button to turn the device 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 device. The test strip is inserted here with the
raised lines facing up.

98
III. SETUP
Battery Use and Replacement
The CardioChek®PA device requires two (2) AAA 1.5 volt
high quality alkaline batteries.
When to Replace the Batteries
The device 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 PA
device 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 device to turn the CardioChek PA
device ON.
WARNING! Dispose of the old batteries properly.
II. INTRODUCTION TO THE
CARDIOCHEK PA TEST SYSTEM, continued
The MEMo Chip®port is located
at the top center of the device. The
MEMo Chip is inserted into this
port with the 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
Test strips are designed for specic analytes. A test strip is
inserted into the device, then blood is applied to the blood
application window. As previously described, the ensuing
chemical reaction produces a color change, which the device
measures and compares to the calibration curve stored in
the MEMo Chip. The device 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 specic for each test. Please read
the instructions completely before testing.
Example of a PTS Panels®
test strip
Blood Application
Window

98
III. SETUP
Battery Use and Replacement
The CardioChek®PA device requires two (2) AAA 1.5 volt
high quality alkaline batteries.
When to Replace the Batteries
The device 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 PA
device 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 device to turn the CardioChek PA
device ON.
WARNING! Dispose of the old batteries properly.
The MEMo Chip®port is located
at the top center of the device. 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
Test strips are designed for specic analytes. A test strip is
inserted into the device, then blood is applied to the blood
application window. As previously described, the ensuing
chemical reaction produces a color change, which the device
measures and compares to the calibration curve stored in
the MEMo Chip. The device 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 specic for each test. Please read
the instructions completely before testing.

1110
III. SETUP, continued
CardioChek®PA System Menus
This diagram provides a layout of the menus within the
CardioChek PA device. Detailed information on the use
of each menu follows in the Setup section of this User Guide.
Buttons
ENTER Button: Press this button to turn the
device ON or to accept the current menu choice.
III. SETUP, continued
• Hold and down at the same time to shut o
device from one of the main menus (RUN TEST,
MEMORY, UTILITY, or USER SET).
NEXT Button: Press this button to turn the
device 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)
* Units may be locked, and therefore UNITS will not appear.

1110
CardioChek®PA System Menus
This diagram provides a layout of the menus within the
CardioChek PA device. Detailed information on the use
of each menu follows in the Setup section of this User Guide.
Buttons
ENTER Button: Press this button to turn the
device ON or to accept the current menu choice.
III. SETUP, continued
• Hold and down at the same time to shut o
device from one of the main menus (RUN TEST,
MEMORY, UTILITY, or USER SET).
NEXT Button: Press this button to turn the
device 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)
PRINT
SOUND
SET TIME
SET DATE
UNITS*
EXIT return to
USER SET
return to
PRINT
* Units may be locked, and therefore UNITS will not appear.

1312
III. SETUP, continued
How to Turn the Device OFF
To turn device OFF press both buttons at the same time for
three seconds at any of the following Main Menu headings:
RUN TEST, MEMORY, UTILITY, or USER SET. After three
minutes of idle time (without a test strip or check strip
inserted) the device will perform a 10 second count down
and turn OFF. To stop shutdown press either button. You can
also remove the batteries to turn the device 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 device 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 device 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 device to automatically turn OFF or remove
the batteries and replace them.
2. Press and hold Enter down for approximately
5 seconds, during the analyzer power-up stage until
LANGUAGE is displayed.
3. 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 device is OFF, press either button to turn the device
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 Turn the Device OFF
To turn device OFF press both buttons at the same time for
three seconds at any of the following Main Menu headings:
RUN TEST, MEMORY, UTILITY, or USER SET. After three
minutes of idle time (without a test strip or check strip
inserted) the device will perform a 10 second count down
and turn OFF. To stop shutdown press either button. You can
also remove the batteries to turn the device 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 device 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 device 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 device to automatically turn OFF or remove
the batteries and replace them.
2. Press and hold Enter down for approximately
5 seconds, during the analyzer power-up stage until
LANGUAGE is displayed.
3. 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 device is OFF, press either button to turn the device
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.

1514
III. SETUP, continued
How to Set the Date:
1. If RUN TEST is displayed, go to Step 3. If the device is
OFF, press either button to turn the device 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.
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.
III. SETUP, continued
6. 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.
7. Press Enter to select the desired units. The display will
then read UNITS.
8. Press Next until EXIT is displayed.
9. Press Enter to return to USER SET.
10. Press Next to return to RUN TEST.
How to Set the Units:
The CardioChek®PA device may be shipped with preset
units.
NOTE:
• If the USER SET menu does not display "UNITS" the
device is locked in preset units
• The units cannot be changed if the system has been
locked
• To conrm current conguration of the device's units
run a check strip in the RUN TEST mode and observe
the units that are displayed
If your device'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 device
is OFF, press either button to turn the device 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 PRINT.
5. Press Next until UNITS is displayed. If UNITS is not
shown on the display, the units on this device have been
locked and cannot be changed. If UNITS appears on the
display screen, proceed to the next step.

1514
How to Set the Date:
1. If RUN TEST is displayed, go to Step 3. If the device is
OFF, press either button to turn the device 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.
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.
III. SETUP, continued
6. 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.
7. Press Enter to select the desired units. The display will
then read UNITS.
8. Press Next until EXIT is displayed.
9. Press Enter to return to USER SET.
10. Press Next to return to RUN TEST.
How to Set the Units:
The CardioChek®PA device may be shipped with preset
units.
NOTE:
• If the USER SET menu does not display "UNITS" the
device is locked in preset units
• The units cannot be changed if the system has been
locked
• To conrm current conguration of the device's units
run a check strip in the RUN TEST mode and observe
the units that are displayed
If your device'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 device
is OFF, press either button to turn the device 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 PRINT.
5. Press Next until UNITS is displayed. If UNITS is not
shown on the display, the units on this device have been
locked and cannot be changed. If UNITS appears on the
display screen, proceed to the next step.

1716
III. SETUP, continued
How to Set the Sound:
The CardioChek® PA device 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 device is
OFF, press either button to turn the device 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.
Introduction to the CardioChek PA and Printer System
The CardioChek PA device (with software version 2.20 and
higher) supports printing in two formats, label or paper, on
the CardioChek PA Thermal Printer or Portable Printer. To
verify CardioChek PA test system software, turn the device
ON by pressing either button. The software version will
appear on the display.
How to Set Up the CardioChek PA for Printing
For complete details, refer to each printer’s User Guide.
III. SETUP, continued
How to Print Results From Memory:
(Up to 30 test results per chemistry; up to 10 Control results)
1. Turn the CardioChek®PA device ON by pressing either
button.
2. Press Enter until RUN TEST is displayed.
3. From the RUN TEST menu press Next.
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
stated above.

1716
How to Set the Sound:
The CardioChek® PA device 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 device is
OFF, press either button to turn the device 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.
Introduction to the CardioChek PA and Printer System
The CardioChek PA device (with software version 2.20 and
higher) supports printing in two formats, label or paper, on
the CardioChek PA Thermal Printer or Portable Printer. To
verify CardioChek PA test system software, turn the device
ON by pressing either button. The software version will
appear on the display.
How to Set Up the CardioChek PA for Printing
For complete details, refer to each printer’s User Guide.
III. SETUP, continued
How to Print Results From Memory:
(Up to 30 test results per chemistry; up to 10 Control results)
1. Turn the CardioChek®PA device ON by pressing either
button.
2. Press Enter until RUN TEST is displayed.
3. From the RUN TEST menu press Next.
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
stated above.

1918
IV. CHECKING THE SYSTEM
Device Check Strip
A Quality Control of the device operation can be performed
using the gray check strip. The check strip (included in the device
carrying case) veries that the CardioChek® PA device's electronic
and optical systems are functioning properly. Each gray check
strip is calibrated to read a specic reectance. To perform this
verication, insert the check strip into the device. The device
will read the reectance of the gray check strip and indicate
if the reading is within the acceptable range. When the check
strip is not in use, please store it in the device carrying case. It is
recommended that the check strip verication be performed:
• Daily
• If the device has been dropped
• When a result is not consistent with prior results
How to Use the Device Check Strip:
1. Turn the device 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 and insert the check strip,
ribbed side up, into the test strip insert opening when
INSERT STRIP is displayed.
5. The device should display PASSED. (If the display reads
FAILED, see the NOTE at the end of this section.) Re-
move the check strip and store it in the device
carrying case.
6. Press Next until EXIT is displayed. Press Enter.
7. Press Next until RUN TEST is displayed.
8. Press Enter. The device is ready to run tests.
IV. CHECKING THE SYSTEM, continued
How to Use the Device Check Strip, continued:
Note: If the device displays FAILED:
1. Clean the CardioChek®PA device test strip insert opening
(where the check strip is inserted into the device). See the
Care and Cleaning section (page 29 of this User Guide).
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 PA device, MEMo
Chip®, and test strips. Use Quality Control materials provided by
PTS, Inc. or commercially available Quality Control materials.
Currently PTS, Inc. has available:
PTS Panels®Multi-Chemistry Controls REF 721
PTS Panels®HDL Controls REF 722
Refer to control package insert for control specications.
Healthcare professionals should follow their facility’s guidelines and
policies regarding quality assurance and the use of Quality Control
materials. Quality Control materials should be run whenever a new
lot of PTS Panels®test strips are received.
IMPORTANT: Check the expiration date printed on the control
bottles. Do not use control solutions that have expired.
For performing a Quality Control test, see Section V. QUALITY
CONTROL TESTING.
To perform a control test you need:
• CardioChek PA device
• PTS Panels®test strips
• Quality Control materials
• Quality Control Instructions
• Quality Control Range Insert

1918
Device Check Strip
A Quality Control of the device operation can be performed
using the gray check strip. The check strip (included in the device
carrying case) veries that the CardioChek® PA device's electronic
and optical systems are functioning properly. Each gray check
strip is calibrated to read a specic reectance. To perform this
verication, insert the check strip into the device. The device
will read the reectance of the gray check strip and indicate
if the reading is within the acceptable range. When the check
strip is not in use, please store it in the device carrying case. It is
recommended that the check strip verication be performed:
• Daily
• If the device has been dropped
• When a result is not consistent with prior results
How to Use the Device Check Strip:
1. Turn the device 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 and insert the check strip,
ribbed side up, into the test strip insert opening when
INSERT STRIP is displayed.
5. The device should display PASSED. (If the display reads
FAILED, see the NOTE at the end of this section.) Re-
move the check strip and store it in the device
carrying case.
6. Press Next until EXIT is displayed. Press Enter.
7. Press Next until RUN TEST is displayed.
8. Press Enter. The device is ready to run tests.
IV. CHECKING THE SYSTEM, continued
How to Use the Device Check Strip, continued:
Note: If the device displays FAILED:
1. Clean the CardioChek®PA device test strip insert opening
(where the check strip is inserted into the device). See the
Care and Cleaning section (page 29 of this User Guide).
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 PA device, MEMo
Chip®, and test strips. Use Quality Control materials provided by
PTS, Inc. or commercially available Quality Control materials.
Currently PTS, Inc. has available:
PTS Panels®Multi-Chemistry Controls REF 721
PTS Panels®HDL Controls REF 722
Refer to control package insert for control specications.
Healthcare professionals should follow their facility’s guidelines and
policies regarding quality assurance and the use of Quality Control
materials. Quality Control materials should be run whenever a new
lot of PTS Panels®test strips are received.
IMPORTANT: Check the expiration date printed on the control
bottles. Do not use control solutions that have expired.
For performing a Quality Control test, see Section V. QUALITY
CONTROL TESTING.
To perform a control test you need:
• CardioChek PA device
• PTS Panels®test strips
• Quality Control materials
• Quality Control Instructions
• Quality Control Range Insert

2120
V. QUALITY CONTROL TESTING
How To Run a Quality Control Test:
1. Install the correct MEMo Chip®for the lot of test strips that
you are using.
2. Press either button to turn the device 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 device. The CardioChek®PA
device 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 test
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 TEST
STRIP FROM THE VIAL.
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.
V. QUALITY CONTROL TESTING, continued
How To Run a Quality Control Test, continued:
11. During testing CONTROL is displayed. Results will be
displayed within about one to two minutes.
12. Compare control results to the values on the Quality
Control Range Insert included with control materials.
13. The control result(s) will also be stored in the device'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 Customer Service for assistance.