pts Diagnostics CardioChek User Manual
User Guide
For Self-Testing Use
Portable Whole Blood Test System
3
1 Introduction: CardioChek Test System Intended Use ........................ 5
2 About the CardioChek Test System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
The CardioChek Test System
................................................... 8
The MEMo Chip
................................................................ 10
PTS Panels Self-Test Strips
..................................................... 11
3 Setup .........................................................................12
Battery Use and Replacement
................................................. 12
When to Replace the Batteries
................................................ 12
How to Install/Replace the Batteries
.......................................... 13
CardioChek Analyzer Menus
................................................... 13
How to Turn O the Analyzer
.................................................. 16
How to the Set Language
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
How to the Set Time
........................................................... 17
How to the Set Date
........................................................... 18
How to the Set Units
........................................................... 19
How to the Set Sound
......................................................... 20
4 Checking the System .......................................................21
Analyzer Check Strip
........................................................... 21
How to Use the Analyzer Check Strip
.......................................... 21
5 Quality Control Testing ..................................................... 23
Quality Control
................................................................ 23
How to Run a Quality Control Test
............................................. 24
6 Running a Test ............................................................... 25
Blood Testing
.................................................................. 25
Testing Supplies
............................................................... 25
Helpful Hints on Getting a Good Drop of Blood
................................ 25
How to Obtain a Blood Sample from a Fingerstick
............................ 26
Quick Reference - How to Run a Test ......................................27
Table of Contents
Materials Provided
REF 1709 CardioChek® analyzer system (1)
Materials Needed but Not Provided
PTS Panels® self-test strips
Product availability will vary per country
Lot-specic MEMo Chip® included with test strips
Refer to self-test strip package insert for more information.
PTS Collect™ capillary tubes, 15 µL, included with test strips
Appropriate sterile, disposable, auto-disabling, single-use lancet included with
test strips
Alcohol wipes
Gauze pads or cotton balls
Bandages
4 5
CardioChek Test System Intended Use
Thank you for selecting a CardioChek analyzer from Polymer Technology Systems, Inc.
(PTS Diagnostics).
The CardioChek test system (consisting of the CardioChek analyzer and PTS Panels
self-test strips) is for the measurement of glucose, total cholesterol, HDL (high density
lipoprotein) cholesterol and triglycerides in capillary whole blood from the ngertip
and is intended for self-testing use. This system should only be used with single-use,
auto-disabling lancing devices. This system is for in vitro diagnostic use only.
• Cholesterol measurements are used in the diagnosis and treatment of disorders
involving excess cholesterol in the blood and lipid and lipoprotein
metabolism disorders.
• HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid
disorders (such as diabetes mellitus), atherosclerosis, and various liver and
renal diseases.
• Triglycerides measurements are used in the diagnosis and treatment of patients
with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid
metabolism or various endocrine disorders.
• Glucose measurements are used in the diagnosis and treatment of carbohydrate
metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and
idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
The CardioChek analyzer from PTS Diagnostics is intended for in vitro diagnostic use to
test whole blood.
This user guide includes all the information that you need to run tests using the
CardioChek system. Before you begin testing, please read this entire user guide and the
package inserts, which are included with the PTS Panels self-test strips.
Introduction
1
7 Results ........................................................................ 28
8 Memory ...................................................................... 29
How to Review Results Stored in Memory ................................29
How to Clear Results Stored in Memory .....................................30
9 Care and Cleaning ........................................................... 31
Storage and Handling ...................................................31
Cleaning and Disinfection ...............................................31
Cleaning Instructions ................................................... 33
Disinfection Instructions ................................................34
10 Troubleshooting ............................................................ 36
11 Unexpected Results ......................................................... 38
12 Specications ................................................................ 39
13 Contact Information ........................................................ 40
Help ...................................................................40
14 Warranty .....................................................................41
15 Explanation of Symbols .................................................... 42
16 Index ..........................................................................43
6 7
CAUTION: Do not take any decision of medical relevance without rst
consulting your healthcare practitioner.
If the device is being used for the monitoring of an existing disease, only
adapt the treatment if you have received the appropriate training to do so.
The CardioChek analyzer is fast, portable, and reliable. This analyzer is a component of
a test system that includes PTS Panels self-test strips. The PTS Panels self-test strip box
includes a MEMo Chip
that contains the assay calibration curve and other important
information about the assay. The PTS Panels self-test strip box also includes PTS Collect
capillary tubes (
15 µL) and auto-disabling, single-use lancets. PTS Panels self-test
strips are sold separately and are available as single-analyte self-test strips.
This test system uses reectance photometry technology. An enzymatic reaction on the
test strip produces a color change that is detected by the analyzer after whole blood
is applied.
Please remember to return the enclosed warranty card to PTS Diagnostics to ensure that
you receive product updates and other important information.
For questions or additional assistance with your CardioChek test system, please contact
PTS Diagnostics (Hours: 6:00 a.m. to 9:00 p.m. US EST) using the following contact
information:
PTS Diagnostics
7736 Zionsville Road, Indianapolis, IN 46268 USA
Direct: +1-317-870-5610 · Toll-free inside the US: 1-877-870-5610
Fax: +1-317-870-5608
Email: customerservice@ptsdiagnostics.com · Website: ptsdiagnostics.com
Important Safety Instructions
This is a medical device and needs to be treated with care. In particular there is the risk
of disease transmission when using blood glucose monitoring systems and they should
be used with caution and care.
1,2
The analyzer and lancing device are for single patient use. For safety reasons, do not
share them with anyone including other family members. Do not use on multiple
patients.
All parts of your device come into contact with your blood and are biohazardous.
Kit parts can potentially transmit infectious diseases, even after being cleaned and
disinfected.
Always wash your hands thoroughly with soap and water and dry well after handling
the analyzer, test strips, or your lancing device.
Always consult your diabetes healthcare professional and follow his or her guidance
about your blood glucose monitoring routine.
Blood samples and blood products are potential sources of hepatitis and
other infectious diseases. Handle all parts of your device with care. Do not
share your analyzer. It is for single-patient use only. Any items that are used
to conduct a test such as test strips, lancets, and alcohol swabs, must be
disposed of safely to avoid the risk of infection. Please follow your healthcare
provider’s instructions for proper disposal.
References:
1. “FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting
Bloodborne Pathogens: Initial Communication” (2010).
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm.
2. “CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne
Pathogens” (2010). http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html.
8 9
The CardioChek Test System
The CardioChek test system consists of three main parts. These include the analyzer,
PTS Panels self-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.
A
B
C
D
E
About the CardioChek
Test System
2
99
MEMo Chip Port
The MEMo Chip port is located at the top of the analyzer.
Display
Display shows test results, messages, time, date, and stored results.
Enter Button
Press this button to turn on the analyzer or to accept the current menu choice.
Next Button
Press this button to turn on the analyzer or to advance to the next menu option.
Test Strip Slot
The test strip slot is positioned in the lower front of the analyzer. The test
strip and/or check strip is inserted here with the raised lines facing up.
A
B
C
D
E
10 11
The MEMo Chip port is located at the top center of the
analyzer. The MEMo Chip is inserted into this port
with the lot number facing down. Push rmly, but
gently, until the MEMo Chip is fully inserted.
Important: Be careful not to bend the connector.
PTS Panels Self-Test Strips
To test blood on a CardioChek analyzer, use test strips specic for each test. A test strip is
inserted into the analyzer, then then blood is applied to the blood application window.
A chemical reaction occurs producing a color change, which the analyzer measures and
compares the information to the calibration curve stored in the lot-specic MEMo Chip.
The analyzer converts this color reading measurement into a test result, displayed on
the screen. Each PTS Panels self-test strip box contains a package insert that provides
instructions for use and information specic for each test. Please read the instructions
completely before testing.
The MEMo Chip
Each package of PTS Panels self-test strips contains a color-coded, lot-specic MEMo
Chip. The MEMo Chip contains the settings for each test. 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?
The MEMo Chip contains proper settings
for the test strip lot you are using.
The MEMo Chip:
• Stores the test strip expiration date
• Tells the analyzer which test(s) to run
• Contains the calibration curve and the lot number for the specic test strip lot
• Controls test sequences and timing
• Provides the measuring range for the test
Guidelines for using the MEMo Chip
• The MEMo Chip must be inserted 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 passed, the analyzer will display
EXPIRED LOT.
• If your MEMo Chip is lost or misplaced, please call PTS Diagnostics Customer
Service for a replacement (or use another MEMo Chip from another vial of the
same lot number).
Apply blood to
application window
Example of a reectance self-test strip
The CardioChek system has various analyte test strips available for use.
Not all test strips are available for use in all countries. Please refer to the
package insert of each PTS Panels self-test strip prior to use.
Finger Notch
Lot#
X000
Cholesterol
12 13
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 REPLACE BATTERIES, 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.
When the REPLACE BATTERIES message is displayed, replace the batteries with 2 new
AAA alkaline batteries of the same brand.
Do not use NiCad or rechargeable batteries.
Caution: Improper installation of batteries can result in decreased battery life or
damage to the analyzer.
Setup
3
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 properly discard.
3. Insert the new batteries into the battery compartment with the positive (+)
terminals correctly facing 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 on the CardioChek
analyzer.
Warning: Dispose of the old batteries properly.
CardioChek Analyzer Menus
The following diagram provides a layout of the menus within the CardioChek analyzer.
Detailed information on the use of each menu follows. Use the following buttons to
navigate the menus:
Enter Button
Press this button to turn on the analyzer or to accept the current menu choice.
Next Button
Press this button to turn on the analyzer or to advance to the next menu option.
Note: Hold
and down at the same time for three seconds to turn o
the analyzer.
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