CoaguSense Coag-Sense Prothrombin Time PT/INR Self-test User's Manual
Coag-Sense®
Prothrombin Time (PT)/INR
Monitoring System
Self-Test User’s Manual
Page 2 For In Vitro Diagnostic Use CoaguSense, Inc.
Caution: Federal law restricts this device to sale by or on the
order of a physician.
© Copyright 2013, CoaguSense, Inc. All rights reserved.
No part of this publication may be reproduced, transmitted, transcribed, stored in
a retrieval system or translated into any language or computer language, in any
form or by any means, including, but not limited to, electronic, magnetic, optical,
chemical, manual, or otherwise without written permission of CoaguSense.
Coag-Sense is a registered trademark of CoaguSense, Inc.
CoaguSense, Inc. For In Vitro Diagnostic Use Page 3
Coag-Sense® PT/INR Monitoring System
The Coag-Sense PT/INR Monitoring System is a medical device
for quantitative Prothrombin Time (PT) and International
Normalized Ratio (INR) testing using Coag-Sense Test Strips.
The Coag-Sense system can be used for self-testing of clotting
times by patients at home. However, results obtained should not
be used to adjust your medication without talking with your
doctor or health care professional.
Contacting CoaguSense
If you have any questions or concerns with the Coag-Sense
system, please contact CoaguSense Technical Support at:
CoaguSense, Inc.
48377 Fremont Blvd., STE 113
Fremont, CA 94538
Toll Free: 1-866-903-0890
E-Mail: techsupport@coagusense.com
WARNING: Contact your health care provider if
you have any questions about your test results and any
actions you should take.
Note ◙: The Coag-Sense PT/INR Monitoring System meter is
packaged in a special box. Do not discard this box. Reuse the package to transport the meter or, if directed by
Customer Service to return it for testing.
Coag-Sense® Prothrombin Time (PT)/INR Monitoring System Self-Test User’s Manual
Page 4 For In Vitro Diagnostic Use CoaguSense, Inc.
Table of Contents
Contacting CoaguSense ...................................................................... 3
Table of Contents ................................................................................. 4
1. About This Manual ..................................................................... 5
2. System Description .................................................................... 6
3. Reordering Information ............................................................ 10
4. Warnings and Precautions ....................................................... 10
5. Hazards and Symbols .............................................................. 15
Directions for Use .............................................................................. 16
6. Operating Conditions ............................................................... 16
7. Power On and Off .................................................................... 17
8. Setting the Time and Date ....................................................... 17
9. Performing a Control Test ........................................................ 19
10. Performing a PT Test ............................................................... 24
11. Collecting a Fingerstick Sample ............................................... 29
Sample Collection and Transfer Methods ............ Error! Bookmark not
defined.
12. Reviewing the Memory ............................................................. 34
13. Control Strips ........................................................................... 35
14. Replacing the Batteries ............................................................ 35
15. Cleaning the Meter ................................................................... 38
16. Troubleshooting ....................................................................... 39
17. Performance Characteristics .................................................... 46
18. Meter Specifications ................................................................. 47
19. Warranty .................................................................................. 48
20. Index ........................................................................................ 50
About This Manual
CoaguSense, Inc. For In Vitro Diagnostic Use Page 5
1. About This Manual
The purpose of the Coag-Sense PT/INR Monitoring System
User’s Manual is to help you understand your Coag-Sense
system, its parts, and its intended function. It provides you with
the information you need to perform PT/INR testing with the
Coag-Sense system.
It is important to read this entire User Manual and inserts that
came with the disposable Coag-Sense test strips. You must
complete proper training on the Coag-Sense system and
practice the test with a health care provider before attempting to
use this device. The Coag-Sense system should only be used
with a doctor’s prescription.
This User Manual has different formats and symbols to
distinguish warnings, notes, and meter buttons.
WARNING: This indicates a warning or precaution.
Please read and understand all warnings and precautions.
They tell you about potential safety hazards and situations
that may cause injury. If you have any questions, please
ask your doctor or contact Technical Support (USA) at
1-866-903-0890.
Note ◙: Notes provide additional information that is useful or
important. All notes are italicized. Words in BOLD ALL-
CAPITALS refer to buttons on the Coag-Sense meter.
Coag-Sense® Prothrombin Time (PT)/INR Monitoring System Self-Test User’s Manual
Page 6 For In Vitro Diagnostic Use CoaguSense, Inc.
2. System Description
The Coag-Sense Self-Test PT/INR Monitoring System is used
for measurement of Prothrombin Time (PT) in fresh, capillary
whole blood. The Coag-Sense system is intended for use
outside the body by people taking warfarin or other oral
anticoagulant (blood thinning) therapy who need to monitor
clotting time.
The meter performs a self-test when it is first turned on. If there
are any problems with the meter, an error message is shown on
the display. Refer to the “Troubleshooting” section of this manual
or contact Tech Support. A test strip is inserted and heated in the
meter prior to sample application.
The strip contains a tiny wheel with spokes that pull the sample
into the reaction well. The spokes quickly and completely mix the
sample with the clot initiating component of the test strip.
The PT time is determined from when (a) the sample is drawn
into the reaction well of the test strip and detected by a beam of
light until (b) a clot forms and interrupts a beam of light. The PT
result is converted to an INR (International Normalized Ratio)
using the calibration data stored in the meter. INR is a
mathematical correction of the PT result that adjusts for
sensitivity differences among different PT systems.
The meter continues to check every feature of its operation
through a system of self-checks.
System Description
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Your Coag-Sense Self-Test PT/INR Monitoring System (Catalog
number 03P50-01) comes supplied with:
Coag-Sense PT/INR Meter
Coag-Sense Self-Test User’s Manual
Coag-Sense Self-Test Quick Reference Guide
Sample Transfer Tubes
Sample package of Single-use, Auto Sterile Lancets
Four AA 1.5 V Alkaline Batteries (not installed)
You will also need:
Coag-Sense Test Strip (catalog number 03P56-50),
which includes:
50 Patient Test Strips
2 Low Control Strips
2 High Control Strips
1 Control Strip Activation Solution
Gauze or cotton balls
Lancets, 21 gauge
An optional AC Power Adapter can be ordered
(catalog number 03P64-01).
Coag-Sense® Prothrombin Time (PT)/INR Monitoring System Self-Test User’s Manual
Page 8 For In Vitro Diagnostic Use CoaguSense, Inc.
The Coag-Sense Meter: Top View
The Coag-Sense Meter: Bottom View
Meter
Display
Power
On/Off
Button
Menu
Buttons
Strip
Holder
Battery
Door
Battery
Door
Release
System Description
CoaguSense, Inc. For In Vitro Diagnostic Use Page 9
The Coag-Sense Meter: Rear View
The Coag-Sense Test Strip
AC
Adapter
Jack
Data/Printer
Port
Handle
Mixing Wheel and
Reaction Well
Bar Code
(Faces down when
inserted into meter)
Sample Application Area
(Green light flashing
when ready for sample)
Coag-Sense® Prothrombin Time (PT)/INR Monitoring System Self-Test User’s Manual
Page 10 For In Vitro Diagnostic Use CoaguSense, Inc.
3. Reordering Information
Product
Catalog #
Coag-Sense Self-Test PT/INR System
03P50-01
Test Strip Kit (Qty 50)
03P56-50
Sample Transfer Tubes (Pack of 54)
03P53-54
Lancets (Box of 100)
03P58-02
AC Power Adapter (optional item)
03P64-01
Control Strip Kit -4
03P72-04
4. Warnings and Precautions
General
Patients taking Warfarin (Coumadin) and other oral
blood thinners should consult with their healthcare
provider before adjusting their dosage.
Patients should consult with their doctor for the
appropriate INR therapeutic range for them.
Patients who have recently taken or are currently taking
any type of Heparin or Low Molecular Weight Heparin
anticoagulant should not use this test system and should
consult their doctor.
Test Site and Blood Sample
The quality of the blood sample can become the
weakest link in any PT test. A blood sample of poor
quality can produce results of poor quality. Read the
Warnings and Precautions
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section on “Collecting a Fingerstick Sample” for more
information.
Use only fresh fingerstick capillary blood for testing. The
blood should only come in contact with the products
provided with the Coag-Sense System. Other products
may have anti-coagulant agents on their surfaces and
result in unreliable test results.
The Coag-Sense PT/INR System is for in vitro diagnostic
use only.
Blood samples must be applied to the test strip
immediately after collection or the blood begins to
clot, causing unreliable results.
Squeezing the fingerstick site excessively (milking)
releases “tissue layer” fluid and tissue factors that can
cause unreliable results.
The fingerstick site should be washed with warm water
and soap, and then completely dried. The site must be
clean of all hand oils/lotions and foreign matter, which
may cause unreliable results.
If Alcohol wipes are used, wipe the fingerstick site with a
gauze pad and make sure the site is completely dry. If
any alcohol remains (or is re-introduced) on the finger, it
may cause unreliable results.
The quality of fingerstick and the sample delivered are
important to the test results. If there is a question
about the sample or sample collection, obtain a new
strip, repeat the fingerstick on a different finger, and
test again.
If a test requires a repeat, use a different finger for the
fingerstick, since blood may have started to clot on the
first finger, which may cause unreliable results.
Coag-Sense® Prothrombin Time (PT)/INR Monitoring System Self-Test User’s Manual
Page 12 For In Vitro Diagnostic Use CoaguSense, Inc.
If there is a bubble or an air pocket showing in the blood
sample in the transfer tube, start the test over. Use a
new strip and fingerstick (using a different finger and
transfer tube) or results may be unreliable.
Note ◙: If you are unable to get a PT/ INR test result contact
Technical Support at 1-866-903-0890, your home testing
service provider or your healthcare provider.
Meter
Use only AA 1.5 V alkaline batteries in the Coag-Sense
meter. Rechargeable batteries cannot be used because
damage to the meter may result. Do not throw used
batteries in the trash. Dispose of properly.
The meter is a delicate instrument, and should be
handled with care. Dropping or other mishandling may
cause damage to the meter. If this should occur, call
Tech Support.
Do not allow any liquids to spill on the meter. If this
should occur, call Tech Support.
Do not put the meter in liquid. Do not allow liquids to get
into any of the connectors or plugs on the meter.
Only use the method provided in this User’s Manual to
clean the Coag-Sense meter.
Do not move or touch the meter while it is running a test.
Unreliable results may occur.
Store and use the Coag-Sense PT/INR Test System
following the instructions in this manual.
Use only the optional Coag-Sense AC power adapter
with the meter or damage to the meter may result.
Warnings and Precautions
CoaguSense, Inc. For In Vitro Diagnostic Use Page 13
The Coag-Sense PT/INR Test System is designed for
indoor use only.
This equipment generates, uses, and can radiate
radiofrequency (RF) energy. If your meter is not set up
and used according to this User Manual, the RF energy
may interfere with other devices in the area.
This equipment is tested to meet the limits for medical
devices, which is designed to provide a reasonable
protection against harmful interference when the
equipment is operated in a home environment. If not
installed and used in accordance with these instructions,
it may cause harmful interference to other devices in the
vicinity. If this equipment does cause harmful
interference to other devices, which can be determined
by turning the equipment on and off, the user is
encouraged to try to correct the interference by one or
more of the following measures:
Reorient or relocate the receiving device.
Increase the separation between the equipment.
Connect the equipment to an outlet on a circuit
different from that to which the other devices are
connected.
In the unlikely event of an electric power surge (i.e.,
severe static discharge during a thunderstorm), when
using the optional AC power adapter, the display screen
may go blank. If this occurs, unplug the power supply
from the back of your meter, wait 5 seconds and plug it
back in. Normal operation should return, but you may
have to reset the time and date.
DO NOT OPEN THE METER. Do not attempt to repair
or modify this meter. The Coag-Sense Self-Test
PT Meter does not require any periodic maintenance
Coag-Sense® Prothrombin Time (PT)/INR Monitoring System Self-Test User’s Manual
Page 14 For In Vitro Diagnostic Use CoaguSense, Inc.
and there are no user serviceable parts inside. If you
have problems, please contact technical support or your
health care provider to arrange for service.
Test Strips/Control Strips/Control Strip Activating Solution
The test strips are designed for single use only. Do not
reuse the test strips.
Discard used strips in a puncture resistant, biohazard
waste (SHARPS) container.
PT Test Strips, Control Strips, and Control Strip
Activating Solution are perishable goods with a limited
shelf life. Do not use any of these items if the expiration
date has passed.
Refer to the package insert that is supplied with each
box of test strips for more information.
Hazards and Symbols
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5. Hazards and Symbols
Warning. This indicates a warning or precaution,
requiring special attention
Class II Equipment. The AC Adapter is double
insulated
Biological Risks: Disposable items pose biological
risks. The strips and fingerstick materials should be
disposed in appropriate biohazard waste containers
Electronic device. Dispose of unit and batteries
properly
Use by/Expiration Date
Lot number
For In vitro diagnostic use
Storage temperature range
Manufacturer
Single Use Only – Do Not Reuse
Coag-Sense® Prothrombin Time (PT)/INR Monitoring System Self-Test User’s Manual
Page 16 For In Vitro Diagnostic Use CoaguSense, Inc.
Directions for Use
Patients taking Warfarin (Coumadin) and/or other oral blood
thinners should consult with their doctor before adjusting their
dosage. Consult your doctor for the appropriate PT and INR
values for you.
Note ◙: The Coag-Sense PT Test System meter is packaged in
a special box. Do not discard this box. Re-use the
package to transport the meter or, if directed by
Customer Service to return it for testing.
6. Operating Conditions
To ensure that your Coag-Sense System is working correctly, be
sure the following conditions are met:
Be sure that the meter and strip are at room temperature
before use. Room temperature is between 65ºF and
90ºF (18ºC and 32ºC).
Relative humidity should be between 10% and 85%,
without condensation, for testing.
Avoid dropping the meter or treating it roughly.
Use the meter only on a level, stable surface.
Do not move or touch the meter during testing.
Do not place the meter in direct sunlight or high intensity
light.
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