CoaguSense Coag-Sense PT/INR User manual

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that all the information contained in this manual is correct at the time of printing. However,
CoaguSense reserves the right to make any changes necessary without notice as part of ongoing
product development.
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
USA
Toll Free: 1-866-903-0890
E-Mail: [e-mail]
© Copyright 2019, CoaguSense, Inc. All rights reserved.
Coag-Sense is a registered trademark of CoaguSense, Inc.

Table of Contents
Table of Contents....................................................................................3
Introduction..............................................................................................1
2. System Description.................................................................3
3. Meter Specifications .............................................................10
4. Performance Characteristics................................................11
5. Warnings and Precautions ...................................................12
6. Hazards and Symbols ..........................................................16
Directions for Use .................................................................................17
7. Meter Setup ..........................................................................17
8. Performing a Control Test ....................................................27
9. Collecting a Fingerstick Sample...........................................32
10. Performing a PT Test ...........................................................34
11. Performing an Stat Test........................................................41
12. Reviewing the Memory.........................................................45
13. Printing..................................................................................48
14. Network Connectivity and Security.......................................50
15. Upgrading Meter Software ...................................................51
16. Battery ..................................................................................52
17. Cleaning and Disinfecting the Meter ....................................53
18. Troubleshooting....................................................................55
19. Warranty...............................................................................63
20. Reordering Information.........................................................65
21. Index.....................................................................................66

Page 1
1. Introduction
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 International
Normalized Ratio (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.
Importance of PT/INR Monitoring
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
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 anticoagulants.