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.