CoaguSense Coag-Sense User manual

Coag-Sense™
Prothrombin Time (PT)/INR
Monitoring System
Professional User’s Manual

Page 2 For In Vitro Diagnostic Use CoaguSense, Inc.
© Copyright 2012, 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 trademark of CoaguSense, Inc.

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Contacting CoaguSense
If you have any questions or concerns with the Coag-Sense™
Prothrombin Time (PT)/INR Monitoring 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: [e-mail]
Note ◙:The Coag-Sense Prothrombin Time (PT)/INR Monitoring
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.
The Coag-Sense PT/INR System may be used for multiple-
patient testing in a professional healthcare setting.

Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual
Page 4 For In Vitro Diagnostic Use CoaguSense, Inc.
The Coag-Sense™Prothrombin Time (PT)/INR Monitoring
System
Intended Use
The Coag-Sense Prothrombin Time (PT)/INR Monitoring System
is an in vitro diagnostic device that provides quantitative
prothrombin time (PT) results, expressed in seconds and INR
units. It uses fresh capillary whole blood. It is intended for use
by health care professionals at the point of care to monitor
patients who are on warfarin-type (coumarin) anticoagulation
therapy. The device is not intended to be used for screening
purposes.
The Coag-Sense PT/INR System may be used for multiple-
patient testing in a professional healthcare setting.
Anticoagulation Medication
Oral anticoagulation medications, also known as blood thinners,
are typically prescribed to patients to avoid unwanted clots. The
patient’s blood clotting time must be monitored to ensure that
their dosage is correct.
Oral anti-coagulation medication is prescribed to patients with
acute and chronic conditions including, but not limited to:
congestive heart failure, atrial fibrillation, prosthetic heart valve,
myocardial infarction, joint replacement, deep vein thrombosis,
pulmonary embolism, thrombotic stroke, coronary artery disease,
venous thromboembolism and cancer.
Blood-clotting Time
The rate at which blood clots is measured in units is called
International Normalized Ratio (INR). It is very important for
patients to stay within their individual target INR range. If the INR

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is too low, the risk of blood clots increases. If the INR is too high,
the risk of hemorrhaging increases. The patient’s physician will
determine the most appropriate INR range for the patient,
depending upon the patient’s indication and how they respond to
the oral anticoagulant.

Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual
Page 6 For In Vitro Diagnostic Use CoaguSense, Inc.
Table of Contents
Contacting CoaguSense........................................................3
Table of Contents.......................................................................6
1. About This Manual ..........................................................7
2. System Description .........................................................8
3. Reordering Information .................................................12
4. Warnings and Precautions............................................12
5. Hazards and Symbols...................................................17
Directions for Use ....................................................................18
6. Operating Conditions ....................................................18
7. Power On and Off .........................................................19
8. Setting the Time and Date ............................................19
9. Performing a Control Test.............................................21
10. Performing a PT Test....................................................26
11. Collecting a Fingerstick Sample....................................31
Sample Collection and Transfer Methods .............................36
12. Reviewing the Memory..................................................40
13. Printing..........................................................................41
14. Control Strips ................................................................43
15. Replacing the Batteries.................................................43
16. Cleaning and Disinfecting the Meter.............................46
17. Troubleshooting ............................................................48
18. Performance Characteristics.........................................54
19. Meter Specifications......................................................55
20. Warranty........................................................................56
21. Index..............................................................................58

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1. About This Manual
The purpose of the Coag-Sense Prothrombin Time (PT)/INR
Monitoring System User Manual is to help you understand your
Coag-Sense PT/INR system, its parts, and its intended function.
It provides you with the information you need to perform a PT
test with the Coag-Sense PT/INR system.
You must complete proper training on the Coag-Sense PT/INR
system before you begin using the system. It is also important
to read this entire User Manual and the inserts that come with
the disposable Coag-Sense test strips. 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
contact CoaguSense Tech Support at 1-866-903-0890
(USA).
Note ◙:Notes provide additional information that is useful or
important. All notes are displayed in italics. Words in
BOLD ALL-CAPITALS refer to buttons on the Coag-
Sense meter.

Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual
Page 8 For In Vitro Diagnostic Use CoaguSense, Inc.
2. System Description
The Coag-Sense Prothrombin Time (PT)/INR System is used for
quantitative measurement of Prothrombin Time (PT) in fresh,
capillary whole blood. The Coag-Sense PT/INR system is
intended for use outside the body (in vitro diagnostic use) to test
patients taking warfarin-type 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 Technical 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 the 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 series of self-checks.

System Description
CoaguSense, Inc. For In Vitro Diagnostic Use Page 9
Your Coag-Sense PT/INR Professional System
(Catalog number 03P60-01) comes supplied with:
Coag-Sense PT/INR Meter
Coag-Sense PT/INR System Professional User’s Manual
Coag-Sense PT/INR System Professional Quick
Reference Guide
Four AA 1.5 V Alkaline Batteries (not installed)
AC Power Supply
Sample package of Single-use, Auto Sterile Lancets
2 MiniPipettes
1 Rack of Pipette Tips (96 tips) for use with MiniPipette
You will also need:
Coag-Sense Professional Test Strip Kit-50
(Catalog number 03P56-50), which includes:
50 Patient Test Strips
1 Control Strip Activation Solution
54 Sample Transfer Tubes
2 Low Control Strips
2 High Control Strips
Isopropyl alcohol or alcohol wipes
Gauze
Single-use Auto Lancets, 21 gauge - box of 100
Puncture-resistant bio-hazard (SHARPS) container

Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual
Page 10 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