pts Diagnostics CardioCheck PA User manual
User Guide
For Professional Use
PortableWhole BloodTest 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 PATest System and Operating Principle ...........................8
The
MEMo Chip .............................................................10
PTS PanelsTest Strips ........................................................11
PTS Panels Lipid PanelTest Strips - Limitations of the Procedure ....................12
PTS Panels GlucoseTest 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 toTurn O the Analyzer ..................................................18
How to Set the Language (First-Time Use).......................................18
How to Reset the Language...................................................18
How to Set theTime .........................................................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 ControlTest ..............................................27
6 Running a Test ..........................................................28
BloodTesting ...............................................................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 aTest............................................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 PanelsTest 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 PAanalyzer 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
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:
PreventingTransmission 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 Chipthat 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
2Display
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 eachpackage 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 concentra-
tions 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.
16 17
CHOL
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
LIPIDS
EXIT
**If the units are locked, the UNITS screen does not appear.*Memory results will only be shown for chemistries that have been run.
CHECK STRIP
RUN CONTROL
CLEAR MEMORY
EXIT
UTILITY SETTINGS
( to select)
return to UTILITY
return to CHECK STRIP
( to select)
PRINT
SOUND
SETTIME
SET DATE
UNITS**
EXIT return to SETTINGS
return to PRINT
18 19
How to Turn O the Analyzer
To turn o the analyzer, press both buttons (Enter and Next) at the same time for three
seconds. After three minutes of idle time (without a test strip or check strip inserted),
the analyzer will perform a 10-second countdown and turn o.To stop shutdown, press
either button.You can also remove the batteries to turn o the analyzer.
Setting Language
The rst time the analyzer is turned on, you will be required to set the language, date,
and time.The language menu consists of the following choices: English (ENGLISH),
Spanish (ESPAÑOL), Italian (ITALIANO), German (DEUTSCH), French (FRANÇAIS),
Portuguese (PORTUGSE), Dutch (NEDERL), Chinese (中文), and Russian (РУССКИЙ).
Note: Languages may vary based on analyzer version used.
How to Set the Language (First-Time Use)
1. Turn on the analyzer 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 date and time, proceed to How to Set the Time and
How to Set the Date sections.
How to Reset the Language
1. Turn off the analyzer.
2. Press and hold down Enter for approximately 5 seconds during the analyzer
power-up stage until LANGUAGE is displayed.
3. Press Enter. Press Enter again to select English or press Next to scroll through the
language choices.
4. Press Enter to select the desired language that is displayed.
How to Set the Time
1. If the analyzer is off, press either button to turn on the analyzer. Wait for
the display to read either INSTALL MEMO CHIP (if a current MEMo Chipis not
installed) or INSERT STRIP (if a current MEMo Chip is installed). Press Enter.
The display will read RUN TEST.
2. Press Next until SETTINGS 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 lower
left 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.
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.
20 21
How to Set the Date
1. If RUN TEST is displayed, go to Step 3. If the analyzer is off, press either button to
turn on the analyzer. 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 SETTINGS 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.
12. Press Next until EXIT is displayed. Press Enter.
13. Press Next to return the display to RUN TEST.
How to Set the Units
The CardioChek PA analyzer may be shipped with preset units.
Note:
• If the SETTINGS menu does not display UNITS, the analyzer is locked in preset units
• The units cannot be changed if the system has been locked
• To conrm current conguration of the analyzer’s units, run a check strip in the RUN
TEST mode and observe the units that are displayed
If your analyzer’s units have not been preset, follow the steps listed below to
change your units to mg/dL, mmol/L, or g/L:
1. If RUN TEST is displayed, go to Step 3. If the analyzer is off, press either button to
turn on the analyzer. 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 SETTINGS 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 analyzer have been locked and cannot be changed. If UNITS appears on
the display screen, proceed to the next step.
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 SETTINGS.
10. Press Next to return to RUN TEST.
22 23
How to Set the Sound
The CardioChekPA analyzer sound has been preset to BEEP ON.To turn the sound on or
o, please follow the steps listed below:
1. If RUN TEST is displayed, go to Step 3. If the analyzer is off, press either button to
turn on the analyzer. 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 SETTINGS 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 ON or BEEP OFF .
7. Press Enter to accept the sound choice displayed.
8. Press Next until EXIT is displayed.
9. Press Enter to return display to SETTINGS.
10. Press Next to return to RUN TEST.
Introduction to the CardioChek PA and Printer System
The CardioChek PA analyzer (with software version 2.55 and higher) supports printing in
two formats, label or paper, on the CardioChek/PTS Connect™ printer or portable printer.
To verify CardioChek PA test system software, turn on the analyzer 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.
Testing the Printer
1. If the analyzer is off, press either button to turn on the analyzer.
Wait for the display to read INSTALL MEMO CHIP or INSERT STRIP.
Note: If RUN TEST is displayed, go to Step 3.
2. Press Next. The display will read RUN TEST.
3. Press Next until SETTINGS is displayed.
4. Press Enter, then Next until PRINT is displayed.
5. Press Enter, then Next until TEST PRINTER is displayed.
6. Press Enter and a sample printout will be generated.
How to Print Results From Memory
(Up to 30 test results per chemistry and up to 10 control results are alternatively stored)
1. Turn the CardioChek PA analyzer 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.
24 25
Analyzer Check Strip
A check of the analyzer operation and optics can be performed using one of the two gray
check strips.Two are included in the analyzer carrying case. The check strip veries that
the CardioChek PA analyzer’s electronic and optical systems are functioning properly.
To perform this verication, insert the check strip into the analyzer.The analyzer will
read the reectance of the gray check strip and indicate if the reading is within the
acceptable range by displaying PASSED.When the check strip is not in use, please store
it in the analyzer carrying case. It is recommended that the check strip verication be
performed:
• Daily
• If the analyzer has been dropped
• When a result is not consistent with expected results
How to Use the Analyzer Check Strip:
1. Turn on the analyzer 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 CHECK STRIP is displayed.
4. Hold the check strip at the base and insert the check strip, ribbed side up, into the
test strip slot when INSERT STRIP is displayed.
5. The analyzer should display PASSED. (If the display reads FAILED, see the note
at the end of this section.) Remove the check strip and store it in the analyzer
carrying case.
Checking the System
4
Check Strip
6. Press Next until EXIT is displayed. Press Enter.
7. Press Next until RUN TEST is displayed.
8. Press Enter. The analyzer is ready to run tests.
Note: If the analyzer displays FAILED:
1. Clean the CardioChek PA analyzer test strip slot (where the check strip is inserted
into the analyzer). See Section 8, Care and Cleaning.
2. Inspect the check strip to make sure it is not dirty or damaged. Use the spare
check strip and repeat.
3. See Section 9, Troubleshooting in this user guide.
26 27
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 analyzer, MEMo Chip, and PTS Panels
test strips. Use quality control materials provided by PTS Diagnostics.
Refer to the range card provided with the controls or visit
http://www.ptsdiagnostics.com for control specications.
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:
• With each new shipment
• With each new lot number
• According to state, local, and federal regulations
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 the instructions below.
To perform a control test you need:
• CardioChek PA analyzer
• PTS Panels test strips
• Quality control materials
• Quality control instructions
• Quality control range card
Quality Control Testing
5
How to Run a Quality Control Test
Refer to the instructions for use provided with your quality control materials.
If Quality Control Results Are Not in Range
IMPORTANT: Patient tests should not be performed until control results are
within range.
1. Ensure test strip slot 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.
28 29
Blood Testing
A test strip package insert is included with each box of test strips. Please read the test
strip package insert and this section of the user guide completely and carefully
before testing.
Testing Supplies
To perform a blood test you need:
• CardioChekPA analyzer
• PTS Panelstest strips
• Lot-specic MEMo Chip
• Sterile, auto-disabling, single-use lancet
• Pipet or capillary blood collector
• Gauze or cotton balls
• Alcohol wipe
This analyzer requires whole blood for testing. Do not operate the analyzer in direct
light. See Section 8, Care and Cleaning for more information.
Helpful Hints on Getting a Good Drop of Blood
1. Instruct the patient to wash hands in warm, soapy water.
2. Rinse well and dry completely. If an alcohol wipe is used, let the finger air dry
before testing. Clean gauze may be used to dry alcohol.
3. Warm the fingers to increase blood flow.
4. Let the arm hang down at the patient’s side briefly to allow blood flow to the
fingertips.
Running a Test
6How to Obtain a Blood Sample from a Fingerstick
A new pair of clean gloves should be worn by the user
before testing each patient.
1. Use either the middle or ring finger for fingersticking.
2. Select the site to allow for convenient collection.
3. Clean the site with an alcohol wipe.
4. Apply gentle pressure to the finger with lancet
and stick the finger left or right of center.
5. Gently apply pressure (squeeze and release) to the
finger to produce a large drop of blood. Note: Avoid
milking the finger. This may cause tissue fluid dilution
or hemolysis and affect the accuracy of results.
6. Use cotton or gauze to wipe away first drop for all
test strips.
7. Hold the capillary tube just below the bulb and
level with the angle of the finger. Note: Do NOT
squeeze the bulb during collection if applicable.
8. Place the tip just touching the drop of blood allowing
the capillary action to draw the blood into the capillary
tube until sample reaches the fill line.
Precaution: Handle and dispose of all materials coming in
contact with blood according to universal precautions and
guidelines. All parts of the system should be considered potentially infectious and
are capable of transmitting bloodborne pathogens between patients and healthcare
professionals.
It is recommended that users refer to the following practice guidelines:
Biosafety in Microbiological and Biomedical Laboratories (BMBL) found at
http://www.cdc.gov/biosafety/publications/bmbl5/.
“Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline-
Third Edition”Clinical and Laboratory Standards Institute (CLSI) M29-A3.
30 31
Test results are automatically stored in the CardioChek PA analyzer’s memory.The
analyzer can store up to 30 results of each chemistry and 10 results for control tests.The
analyzer allows review of the results in order from the most recent to the oldest. Each
result is displayed with time and date. Results stored in memory are not deleted when
the batteries are changed.
How to Review Results Stored in Memory:
1. Press either button to turn on the analyzer. If the display reads INSTALL MEMO
CHIP, go to Step 2. If the display reads INSERT STRIP, press Enter.
2. Press Next until MEMORY is displayed.
3. Press Enter. CHEM is displayed.
4. Press Enter, then Next to select the desired chemistry.
Note: Until the chemistry has been run at least once, the test name is
not displayed.
5. Press Enter to view the test result including time and date.
a. To recall control results, press Next until EXIT is displayed. Press Enter. Press
Next until CONTROL is displayed.
b. Press Enter when the desired control test is displayed.
c. For example, to review lipid panel results, from the CHEM display, press
Next until LIPIDS is displayed, then Enter. The time and date will be
displayed. Press Enter when the desired test time and date is displayed.
Press Next to scroll through results.
6. To exit, press Next until the display reads EXIT, then press Enter. Repeat this step
until you return to RUN TEST.
Memory
7
Quick Reference - How to Run a Test
1. Press either button to turn the analyzer on.
2. Remove the MEMo Chip from the box of test strips.
3. Insert the MEMo Chip in the port at the top of the
analyzer with the lot code number facing down.
4. When INSERT STRIP is displayed, remove a test strip
from the vial and immediately replace the cap.
5. Insert the strip. Ensure that the test strip is inserted
fully and the display reads APPLY SAMPLE.
6. Obtain a blood drop following the correct
technique. (If venous blood is used, collect in an
EDTA or heparin tube. Invert gently 5-7 times to
mix completely. Immediately collect sample with
capillary tube or precision pipet and dispense
correct volume* as specified in test strip instructions
for use (package insert) on to the test strip.)
7. Hold the capillary tube by the bulb and position
above the blood application window on the test
strip. Use care to avoid touching the test strip with
the capillary tube. Squeeze the bulb gently to
deposit the entire sample on the strip.
8. Once the sample is applied, results will appear on
the analyzer display in about 90 seconds depending
on type of test strip.
9. Remove test strip and dispose of properly.
10. If the analyzer is idle for more than 3 minutes, it will
count down 10 seconds and automatically turn off.
CHOL
mg/dL
215
* Refer to each specific test strip package insert for sample volume and sample application instructions.
Each test strip is for a single test only. Do not reuse the test strips. Use a new test strip each time you test.
32 33
How to Clear Results Stored in Memory:
1. Press either button to turn on the analyzer. Wait for the display to read either
INSTALL MEMO CHIP or INSERT STRIP.
2. Press Enter, then press Next until UTILITY is displayed. Press Enter.
3. Press Next until CLEAR MEMORY is displayed. Press Enter.
4. Press Next until the display reads CLEAR, YES. Press Enter. The display will read
ERASE and then CLEAR MEMORY.
5. To exit, press Next until the display reads EXIT, then press Enter. Press Next until
you return to RUN TEST.
Storage and Handling
• Handle the CardioChek PA analyzer with care; do not drop.
• Do not store or operate the analyzer in direct light, such as sunlight, spotlight,
under a lamp, or by a window.
• Do not expose the analyzer or any of the supplies or accessories to high humidity,
extreme heat, cold, dust, or dirt. The analyzer may be stored at a temperature of
50-104ºF (10-40ºC) and 20-80% Relative Humidity (RH). Do not freeze.
• If storage temperature is below 68ºF (20ºC) allow the device to warm to room
temperature 68ºF (20ºC) before using. If the device has been stored under excessive
conditions, allow at least 30 minutes at room temperature for the device to
equilibrate to these temperatures.
• Do not scratch or damage the surface of the check strip.
• Please read the test strip package insert for storage and handling information that
applies to each test strip.
Cleaning and Disinfection
Cleaning and disinfection of analyzers that come in contact with blood or blood
products is critical to avoid transmitting bloodborne pathogens between patients and
healthcare professionals.
IMPORTANT SAFETY INSTRUCTIONS: It is critical to properly clean and disinfect
analyzers that are used with blood products each time they are used,
between each patient. Additionally, to avoid transmissions of bloodborne
pathogens, only use auto-disabling, single-use lancing devices. Please see
references at the end of this section for further information.
Care and Cleaning
8
34 35
Frequency: Always clean after each use. Always clean and disinfect before storing and
between each patient test. Please read the disinfectant manufacturer’s product label.
Recommended Disinfectant: Super Sani-Cloth® wipes or any disinfectant with
the same EPA Reg. No. (EPA Reg. No. 9480-4, Professional Disposables International,
Inc. (PDI), Orangeburg, NY), concentration of active ingredients (0.25%) and with
a contact time of 2 minutes.The active ingredients in this disinfectant are n-Alkyl
dimethyl ethylbenzyl ammonium chlorides. Super Sani-Cloth was tested and found
to be eective per recommended guidelines when used with this system. Please only
use this disinfectant. Use of other disinfectants may cause damage to your
analyzer. Do not use bleach, peroxide, or window cleaners on this analyzer. If
you have any questions or need to know where to purchase the disinfectant wipes, call
PTS Diagnostics Customer Service at 1-877-870-5610 (US) or +1-317-870-5610.There
are a large number of distributors of this disinfectant. If you cannot obtain from the
distributor who supplies your other supplies, please contact us for assistance.
The entire case surface should be cleaned and disinfected.
Display
Enter Button
Test Strip Slot
(Optical Block and Glass)
MEMo Chip Port
Next Button
Cleaning Instructions
Cleaning removes visible soil, organic material, and most importantly, blood products.
Always clean before disinfecting.
1. Please see picture above. Clean and disinfect all surfaces of this analyzer.
2. Obtain recommended wipes.
3. Using a fresh wipe, wring out excess liquid and carefully wipe to clean.
4. Allow to air dry or dry with cotton gauze.
A
B
C
D
E
A
B
C
D
E
36 37
Disinfection Instructions
After cleaning, the next step is to disinfect. Always both clean and disinfect.
1. Using a fresh wipe, wring the wipe to remove excess liquid and wipe all
areas thoroughly.
2. Keep area wet for 2 minutes to ensure disinfectant remains in contact for a
sufficient time to kill all bloodborne pathogens.
3. Allow to air dry completely.
Note: It is important that the analyzer be thoroughly dry before using.
4. The optical glass should be carefully wiped clean with an alcohol wipe and dried
with gauze to remove any residue from the disinfectant.
5. Inspect the glass and ensure it is clean when held at different angles. If it is not,
repeat Step 4.
Following cleaning and disinfection, inspect the analyzer for the following signs of
deterioration.These include:
• Scratches on optical glass
• Etching on optical glass
• Liquid under optical glass
- liquid intrusion, or
- condensation
• Loss of adhesion on optical glass
• Liquid under display lens
• Loss of adhesion on display lens
• Deterioration of painted surfaces (polymer crazing, cracking, swelling, softening,
peeling, etc.)
• Any loose parts
IMPORTANT: Keep area wet with disinfectant for two minutes. DO NOT soak, saturate,
or immerse the analyzer or allow liquid to collect on any surface. Always make sure the
analyzer is dry before use.
After disinfection, user’s gloves should be removed and hands should be thoroughly
washed with soap and water before proceeding to the next patient.
The CardioChek PA analyzer has been validated for 11,001 cleaning and disinfection
cycles. Please obtain a new analyzer after cleaning and disinfecting the analyzer 11,001
times or once the lifetime of the analyzer (3 years) has been reached, whichever comes
rst.
Stop using the analyzer and contact Customer Service for a replacement analyzer
immediately if you notice any signs of deterioration.
If you have any questions, call PTS Diagnostics Customer Service.
Direct: +1-317-870-5610 ·Toll-free inside the US: 1-877-870-5610
Fax: +1-317-870-5608
References:
1. “FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk forTransmitting
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.
3. Biosafety in Microbiological and Biomedical Laboratories (BMBL) found at http://www.cdc.gov/biosafety/
publications/bmbl5/.“Protection of Laboratory Workers From Occupationally Acquired Infections; Approved
Guideline-Third Edition”Clinical and Laboratory Standards Institute (CLSI) M29-A3.
38 39
Message or Issue Probable Cause What to Do
Desired language is
not displayed.
Language has been set incorrectly. Turn o analyzer. See Section 3, Setup - How to
Reset the Language.
The wrong date and/or
time is displayed.
Date and time have not been
set correctly.
See Section 3, Setup - How to Set the Date and/or
How to Set theTime.
FAILED is displayed during
a check strip test.
Analyzer needs to be cleaned. Wipe the test strip slot with a clean, damp, and
lint-free cloth.
Check strip is dirty or damaged. Use spare check strip. If check strip still fails,
call Customer Service.
TOO MUCH LIGHT Test is being performed in direct light
or outside.
Test inside, away from windows, and away from
direct lamp light.
MEMO CHIP ERROR MEMo Chip is defective. Use another MEMo Chip from the same lot.
TEST ERROR Insucient sample has been added
to test strip.
Test again with a new test strip and make sure the
correct volume of sample is used.
LANGUAGE Analyzer is new or language option
has not been set.
See Section 3, Setup - Setting the Language.
TEST NOT
ALLOWED
Test selected by MEMo Chip installed
cannot be run on your analyzer.
Check MEMo Chip and make sure that the correct
MEMo Chip is inserted. Call Customer Service.
LOWTEMP Analyzer is below acceptable
operating temperature.
Move to warmer environment and test after
analyzer reaches proper temperature.
HIGHTEMP Analyzer is above acceptable
operating temperature.
Move to acceptable environment and test after
analyzer reaches proper temperature.
INSTALL MEMO CHIP MEMo Chip is not properly inserted
or is defective.
Insert same or new MEMo Chip properly.
Troubleshooting
9
Message or Issue Probable Cause What to Do
EXPIRED LOT Test strips are expired, wrong MEMo
Chip is inserted, or date is not
set properly.
Check test strip expiration date and make sure
correct MEMo Chip is inserted. Check date
setting – see Section 3, Setup – How To Set
the Date and/or How to Set the Time.
REPLACE BATTERIES Batteries need to be replaced. Replace all batteries with new high-quality
AAA batteries. (The analyzer will not run tests
until batteries are replaced.)
TEST ABORTED Test strip was not properly inserted
or was removed before test was
complete.
Test again with a new test strip.
Results will not print. Communication cable was
improperly connected.
Check all connections. Reprint test results
stored in memory.
Printer cover is not closed properly.
(Printer indicator light is red.)
Close printer cover correctly, ensuring that the
printer indicator light is green. Reprint test
results stored in memory.
Labels/paper were not loaded in
the printer.
See Printer System Setup/Operating System
Instruction Sheet packaged with the printer.
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