CoaguSense Coag-Sense PT/INR User manual

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including, but not limited to, electronic, magnetic, optical, chemical, manual, or otherwise without
written permission of CoaguSense. CoaguSense has made every reasonable effort to ensure
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.

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Anticoagulation Medication:
Oral anticoagulation medications, 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.
Important Information Regarding 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 and configure the meter to your needs 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 Technical Support at 1-866-903-0890 (USA).

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2. System Description
The Coag-Sense Prothrombin Time (PT)/INR System is used for
quantitative measurement of INR (International Normalized Ratio)
based on a Prothrombin Time (PT) response to monitor the effect
of therapy with vitamin K antagonists like Coumadin® (warfarin).
The system uses fresh, capillary whole blood.

Page 4
Meter:
The meter has a TFT color LCD Touch screen that shows results,
information, icons and results recalled from memory. To select an
option, gently click on display button. There are three touch
buttons, Cancel or Previous Screen Button, Home Screen
Button and View Button Screen for the Guided User Interface
(GUI) operation. The Power ON/OFF button is located on the right
side of the meter. The NFC (Near Field Communication) Tag
scanner is a built-in scanner that is used to scan the NFC card
containing the strip (Control and Test Strip) data. Strip Insertion
Area guides the test strip into the meter. Micro USB/Power
Adapter port is a micro USB port used to plug to the power
adapter. Multipurpose USB port can be used to connect the meter
to a) portable printer, b) computer, c) barcode scanner or other
Coag-Sense approved accessories. Ethernet Port is used to
connect the Ethernet cable for a wired connection, this port is
provided with a port cover. Reset button (enclosed within the
ethernet port cover) is used to reset the meter in case of
software or power-cycle issues.
The meter performs a self-check when it is first powered ON and
every time a test strip is inserted. If there are any problems
detected during self-check, an error message is displayed on the
touchscreen. Refer to the “Troubleshooting” section of this manual
or contact Technical Support for assistance.
Test Strips:
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 the sample is drawn into the
reaction well of the test strip and is detected by a beam of light
until a clot forms and interrupts another beam of light. The PT

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seconds result (a true prothrombin time) is converted to an INR
(International Normalized Ratio) using the calibration data
communicated by the NFC tag and subsequently stored in the
meter. INR is a mathematical correction of the PT result that
adjusts for sensitivity differences among different PT/INR systems.
Control Strips and Control Activation Solution
Quality control is an important part of PT testing to verify the integrity of
the performance characteristics of the testing system. The Coag-Sense
Meter has been designed with multiple internal systems to ensure proper
system function. When powered ON, the meter runs an extensive self-
check protocol to ensure, for example, that operating temperature, timing
functions, battery level and optical and mechanical functions are within
specification. There are 2 low control strips, 2 high control strips and a
control activation solution shipped with each test strip kit. Each control
strip contains plasma of known INR. Real plasma allows for a fully
functional liquid quality control test of both the a) reagent‟s ability to
generate a clot and b) the analyzer‟s ability to detect a clot. Control
testing confirms the performance of the system and should be completed
immediately for each new lot of test strips received
NFC Tag:
Near Field Communication (NFC) Tag is a micro data tag with
antenna that contains the required test strip kit information. It

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allows transmission of the test strip kit information to the meter.
The NFC Tag is located on the bottom right front corner of the test
strip kit and is touched or brought in close proximity of the NFC
scanner built into the meter. The scanner reads the data stored in
the NFC Tag and auto populates the relevant test strip kit lot
information on the touch screen.
In the absence of NFC Tag, the user may manually enter the lot
and Barcode number present on the strip packaging using the
keypad on the touch screen. A stylus with a rubber capacitive tip
may be used to facilitate typing.
Power Supply and Battery:
Coag-Sense PT/INR Professional System can be operated only
with the power adapter provided. The power adapter also serves
as a charger. It charges the in-built Lithium Polymer Battery.
Note: The battery is not user replaceable.
To save power, the meter automatically powers itself OFF if left
unattended for a set time (user configurable). When the meter
powers itself OFF, all results obtained up to that point remain in
the memory.
Coag-Sense PT/INR Professional System (Catalog # 03P70-02) is
supplied with the following items;
Catalog Name
Qty
Coag-Sense PT/INR Meter
1
Coag-Sense PT/INR System Professional User's Manual
1
Coag-Sense PT/INR System Professional Quick Reference Guide
1
A/C Micro USB Power Supply
1
Sample Transfer Tubes
54
Single-Use, 21g Auto Safety Lancets (sample pack)
8
Carrying Case
1