pts Diagnostics CardioCheck PA User Manual
User Guide
For Professional Use
Portable Whole Blood Test System
Test System
2 3
Materials Provided
REF 1708 CardioChek® PA analyzer (1)
Materials Needed but not Provided
Appropriate sterile, disposable, auto-disabling, single-use lancet
PTS Panels® test strips are available in single- and multi-analyte tests
Product availability will vary per country
Lot-specic MEMo Chip® included with test strips
PTS Collect™ capillary tubes, laboratory pipet, or capillary blood collector—
appropriate volume specic to PTS Panels test strip.
Refer to test strip package insert for required sample size.
Alcohol wipes
Gauze pads or cotton balls
Bandages
Optional
The CardioChek PA test system may be used with optional CardioChek/PTS Connect™
solutions, which include: printer and optional software solutions (a software
accessory to provide personalized health-related information using cholesterol
results).
1 Introduction: CardioChek PA System Intended Use ........................5
2 About the CardioChek PA Test System ..................................8
The CardioChek PA Test System and Operating Principle ...........................8
The
MEMo Chip .............................................................10
PTS Panels Test Strips ........................................................11
PTS Panels Lipid Panel Test Strips - Limitations of the Procedure ....................12
PTS Panels Glucose Test Strips - Limitations of the Procedure .......................13
3 Setup ....................................................................14
Battery Use and Replacement .................................................14
How to Install/Replace the Batteries ............................................15
CardioChek PA Analyzer Menus ................................................15
How to Turn O the Analyzer ..................................................18
How to Set the Language (First-Time Use) .......................................18
How to Reset the Language ...................................................18
How to Set the Time .........................................................19
How to Set the Date. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
How to Set the Units .........................................................21
How to Set the Sound ........................................................22
Introduction to the CardioChek PA and Printer System .............................23
How to Set Up the CardioChek PA for Printing ....................................23
Testing the Printer ...........................................................23
How to Print Results from Memory .............................................23
4 Checking the System ....................................................24
Analyzer Check Strip .........................................................24
How to Use the Analyzer Check Strip ............................................24
5 Quality Control Testing .................................................26
Quality Control ..............................................................26
How to Run a Quality Control Test ..............................................27
6 Running a Test ..........................................................28
Blood Testing ...............................................................28
Table of Contents
4 5
Testing Supplies .............................................................28
Helpful Hints on Getting a Good Drop of Blood ...................................28
How to Obtain a Blood Sample From a Fingerstick ................................29
Quick Reference - How to Run a Test ............................................30
7 Memory ..................................................................31
How to Review Results Stored in Memory .......................................31
How to Clear Results Stored in Memory .........................................32
8 Care and Cleaning .......................................................33
Storage and Handling ........................................................33
Cleaning and Disinfection .....................................................33
Cleaning Instructions ........................................................35
Disinfection Instructions ......................................................36
9 Troubleshooting ........................................................38
10 Interpreting Results ....................................................40
11 CLIA Information ........................................................41
General CLIA Information (US Only) ............................................
41
12 Specications ...........................................................42
CardioChek PA Analyzer ......................................................
42
PTS Panels Test Strips ........................................................
42
Optional CardioChek/PTS Connect Printer/Power Supply ...........................
42
13 Contact Information ....................................................43
Help .......................................................................43
14 Warranty ................................................................44
CardioChek PA Analyzer Limited One-Year Warranty ..............................
44
15 Explanation of Symbols .................................................45
Symbols ...................................................................45
16 Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46
CardioChek PA System Intended Use
The CardioChek PA test system (consisting of the CardioChek PA analyzer and PTS Panels
test strips) is for the quantitative determination of glucose, total cholesterol, HDL (high
density lipoprotein) cholesterol and triglycerides in venous whole blood and capillary
whole blood from the ngertip and is intended for multiple patient use in professional
healthcare settings. 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.
A Chol/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are
calculated by the CardioChek PA analyzer.
The CardioChek PA
analyzer from PTS Diagnostics 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.
Introduction
1
6 7
For questions or additional assistance with your CardioChek PA 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
Users should adhere to standard precautions when handling or using this analyzer. All
parts of the glucose monitoring system should be considered potentially infectious and
are capable of transmitting bloodborne pathogens between patients and healthcare
professionals. For more information, refer to “Guideline for Isolation Precautions:
Preventing Transmission of Infectious Agents in Healthcare Settings 2007”,
http://www.cdc.gov/hicpac/2007ip/2007isolationprecautions.html.
The analyzer should be cleaned and disinfected after use on each patient. This system
may only be used for testing multiple patients when Standard Precautions and the
manufacturer’s disinfection procedures are followed.
Only auto-disabling, single-use lancing devices should be used with this analyzer.
The CardioChek PA analyzer is fast, portable, and reliable. This analyzer 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 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.
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 Diagnostics to ensure that
you receive product updates and other important information.
The CardioChek PA test system has many dierent 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 test strip prior
to use.
8 9
The CardioChek PA Test System and Operating Principle
The CardioChek PA test system consists of three main parts. These include the analyzer,
PTS Panels test strips, and a lot-specic MEMo Chip.
The analyzer employs light reectance technology to measure an enzymatic chemical
reaction. When blood is applied to a reectance test strip, a chemical reaction occurs
that produces a color change on the test strip. This color is measured and compared to a
calibration curve stored in the lot-specic MEMo Chip. The analyzer converts this color
into a test result (the darker the color, the higher the analyte concentration). The test
result appears on the display screen.
A
B
D
C
E
About the CardioChek PA
Test System
2
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.
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.
MEMo Chip Port
The MEMo Chip port is located at the top of the analyzer.
Next Button
Press this button to turn on the analyzer or to advance to the next menu option.
A
B
C
D
E
10 11
The MEMo Chip
Each package of PTS Panels 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.
Lot#
X000
Cholesterol
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 Test Strips
PTS Panels test strips are designed for specic analytes. A test strip is inserted into
the analyzer, then blood is applied to the blood application window for reectance
tests. As previously described, the ensuing chemical reaction produces a color
change, which the analyzer measures and compares 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 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.
Apply blood to
application window
Examples of reectance test strips
The CardioChek PA test system has many dierent analyte test strips
available for use. The test strips outlined in this section are only an
example of the available test strips. Not all test strips are available
for use in all countries. Please refer to the package insert of each
PTS Panels test strip prior to use.
12 13
PTS Panels Lipid Panel Test Strips – Limitations of the Procedure
Studies were performed to test for substances that may interfere with these tests. The
results are below.
1. PRESERVATIVES: EDTA and heparin in venous blood collection tubes had no
effect on the results of the test strip.
2. DRUGS: Dopamine and methyldopa decreased the results of all the lipids.
3. METABOLITES: Extremely high doses of ascorbic acid (Vitamin C) decreased the
results of all the lipids.
4. HEMATOCRIT: No hematocrit effect was observed for samples between 30 and
45% HCT.
5. NEONATAL USE: This product has not been tested using neonatal blood. This
test system should not be used with these samples.
6. HAND LOTIONS/COSMETICS: Cosmetics such as handcreams or lotions often
contain glycerol. Use of these products may cause inaccurate results.
7. Displayed results are rounded.
Each test strip is for a single test only. Do not reuse the strips. Use a new test strip
each time you test. Use only fresh capillary whole blood from the nger or venous
whole blood (EDTA or heparin). Performance testing was done using EDTA and heparin
preserved whole blood. Do not use serum or plasma unless specied in the package
insert. Each test strip has a package insert which contains instructions for use specic to
that test strip.
Only auto-disabling, single-use lancing devices should be used with this analyzer.
PTS Panels Glucose Test Strips – Limitations of the Procedure
1. The analyzer should not be used to test critically ill patients.
2. Blood samples from patients in shock, patients with severe dehydration, or
patients in a hyperosmolar state (with or without ketosis) have not been tested.
It is not recommended to test those samples with this system.
3. Not for use on patients who are severely hypotensive.
4. PRESERVATIVES: Blood samples preserved with Fluoride or Oxalate should not
be used for testing with this system.
5. NEONATAL USE AND ARTERIAL BLOOD: This product has not been tested using
neonatal or arterial blood. This test system should not be used with these
blood samples.
6. Acetaminophen (Tylenol) and dopamine may interfere causing the test result to
be higher than the actual glucose. Not every drug was tested.
7. METABOLITES: This test system is specific for glucose. Other sugars and other
reducing substances such as ascorbic acid (Vitamin C) at normal blood concentrations have no significant effect on test results.
8. HEMATOCRIT: Hematocrit values above 55% or lower than 30% may incorrectly
lower the glucose result.
9. ALTITUDE: Testing at altitudes up to 10,000 feet has no effect on results.
10. DEHYDRATION: Severe dehydration and excessive water loss may produce
falsely low results.
Note: Please refer to package insert for each test strip for Limitations of the Procedure.
14 15
Battery Use and Replacement
The CardioChek PA 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 PA 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 PA analyzer.
Warning: Dispose of the old batteries properly.
CardioChek PA Analyzer Menus
The following diagram provides a layout of the menus within the CardioChek PA
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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