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.

Page 2
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).

Page 3
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

Page 5
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

Page 6
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

Page 7
To perform a test, you require the following:
Coag-Sense Test Strip Kit- 50 (Catalog # 03P56-50) is
supplied with the following items;
Item Description
Qty
Patient Test Strips
50
Low Control Strips
2
High Control Strips
2
Control Strip Activation Solution
1
Lot Info label w/NFC Tag (Bottom Right Corner of Box)
1
Sample Transfer Tubes w/ plungers
54
Package Insert
1
Following are standard medical supplies that are required with
each use:
Gauze
Isopropyl alcohol or alcohol wipes,
Single-Use- 21g Auto Safety Lancets,
Puncture-resistant bio-hazard (SHARPS) container
Note: These materials are not provided with the PT/INR system. The Coag-Sense
Professional Test Strip Kit- 50 may be ordered from your distributor separately.

Page 8
Overview of Buttons and Icons
The buttons and icons that appear during normal operation are
shown here, along with their respective meanings. Error message
and the its description are provided in „Troubleshooting‟ section.
Buttons/Icons
Meaning
Power ON/OFF
To power ON the meter,
press and hold Power
Button. To Enter/Exit Sleep
Mode press the button once
quickly and press the
button again and hold for
few seconds.
Cancel or return to previous
screen
Go to the home screen
View additional menu
Common Keypad
input:
aand b) is the input
completion button. Returns
to previous screen when
selected
c) Change language button.
Enables the user to select
keyboard language.
The Status bar:
a) Date and Time
b) Sound ON/OFF
status
c) Alarm Status
d) Bluetooth ON/OFF
status
e) Wi-Fi ON/OFF
status
f) Battery level

Page 9
Buttons/Icons
Meaning
Icons on the
touchscreen:
a) Back Icon- Directs
to the previous
screen
b) Home Icon- Directs
to the home screen
c) Settings Icon-
Directs to the setting
screen
d) User Information
Icon- Directs to the
User Information
screen
e) Log-out Icon-
Directs to the logout
pop up screen.
Home Screen:
a) Test Icon- Directs User to
Test Strip information
screen and subsequently to
testing screen
b) Control Icon- Allows User
to select between High and
low control tests. Then
directs User to Test Strip
information screen and
subsequently to control
screen
c) Results- Allows User to
view Patient and Control
test results. Refer to
Reviewing the memory
section for detailed
information
d) Settings- Directs User to
the Settings menu.

Page 10
3. Meter Specifications
Operating Temperature
65°F to 90°F (18°C to 32°C)
Operating Humidity
10% to 85% (without condensation)
Storage Temperature
32°F to 122°F (0°C to 50°C)
Storage Humidity
20% to 80%
Memory
Capable of storing up to,
2000 patient test results with date and time
500 control test results with date and time
1000 Operator accounts
Lithium Battery
Rechargeable Lithium Polymer Battery
(3.7V, 2350mAh)
Battery Capacity
Fully charged (6 hours of charging)
can run ~200 tests
Power Input
120V AC Adapter (Use with Coag-
Sense Adapter Only)
Power Output
5.0V, 2.0A
Blood Sample Size
10-12 µL
Communication Port
Micro and Standard USB
Size in mm
(Height x Width x Depth)
152 x 100 x 29.5
Weight in g
315g
Equipment Classification
Class II with external power supply.
Internally powered when operated with
battery. IPX0 rating.
WARNING: Use the Coag-Sense meter along with the
provided Power Adapter only.

Page 11
4. Performance Characteristics
Expected Values: Results are reported in INR units equivalent to the
plasma reference method. For PT testing, variations in the source of
thromboplastin may cause some differences in results between
methods. It is recommended that the same method be used to monitor
the anticoagulation therapy over time.
Measuring Range: INR 0.8 to 8.0
Normal Range: The following example represents a common normal
range for the Coag-Sense PT/INR system.
INR: 0.7 to 1.2
PT: 8.0 to 15.0

Page 12
5. Warnings and Precautions
This test system is not recommended for patients
who have recently taken or are currently taking
any type of Heparin anticoagulants. The system
should also not be used to monitor patients on
direct oral anticoagulants (DOACs) including
Factor Xa and Direct Thrombin inhibitors.
Test Site and Blood Sample
The Coag-Sense PT/INR system is for in vitro diagnostic use only.
The Coag-Sense meter will not produce a result if the test strip is
past its expiration date.
The quality of the blood sample can affect PT test results. A blood
sample of poor quality can produce unreliable results. Read the
section on “Collecting a Fingerstick Sample” for more
information.
Blood samples must be applied to the test strip immediately after
collection or the blood begins to clot, causing unreliable results.
The blood sample transferred to the test strip must be a minimum
of 10 µL in volume. Low sample volume may cause an error
message.
Use only fresh fingerstick capillary blood for testing. The blood
should only come in contact with the products provided with the
Coag-Sense PT/INR system. Other products may have anti-
coagulant agents on their surfaces and result in unreliable test
results.
Squeezing the fingerstick site excessively (milking) releases
interstitial “tissue layer” fluid that can cause unreliable results.
The fingerstick site can 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 Isopropyl Alcohol (IPA) wipes are used, wipe the fingerstick
site with a gauze pad and make sure the site is completely

Page 13
dry. If any alcohol remains (or is re-introduced) on the finger,
it may cause unreliable results.
Do not use wipes containing chlorhexidine gluconate, as it may
produce unreliable results.
The quality of fingerstick and the sample delivery technique
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 you need to repeat a test, use a different finger for the
fingerstick, since blood may have started to clot on the first finger,
which may cause unreliable results.
If there is a bubble or an air pocket showing in the blood sample in
the collection tube, start the test over. Use a new fingerstick (using
a different finger and collection tube) or results may be unreliable.
Meter
The meter has a built-in rechargeable lithium polymer battery
(3.7V, 2350 mAh).
Use only the included Coag-Sense Power adapter with the meter
or damage to the meter may result.
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 Technical Support.
Do not allow any liquids to spill on the meter. If this should occur,
call Technical 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 Manual to clean the
Coag-Sense PT/INR meter.
Do not move or touch the meter while it is running a test.
Unreliable results may occur.

Page 14
Do not pull the strip out while the wheel is spinning. STOP the test,
meter will display “Test Cancelled, Remove Strip‟ The strip should
be removed at this time only.
Store and use the Coag-Sense PT/INR system following the
instructions in this manual.
This equipment is tested to meet the limits for medical devices,
which are designed to provide a reasonable protection against
harmful interference when the equipment is operated in a clinical
or 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.
Any equipment connected to the data port must be certified to IEC
60601-1. If you connect any equipment that is not recommended
by CoaguSense, you are responsible for meeting the requirements
of this standard.
In the unlikely event of an electric power surge (i.e., severe static
discharge during a thunderstorm), when using the 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 meter does not require any periodic
maintenance and there are no user serviceable parts inside. If you
have problems, please contact Technical Support. The Coag-
Sense Prothrombin Time (PT)/INR Monitoring System needs

Page 15
special precautions regarding EMC and needs to be put into
service according to the EMC information provided in this manual.”
“Portable and mobile RF communications equipment can affect
The Coag-Sense Prothrombin Time (PT)/INR Monitoring System.”
“The use of accessories, transducers and cables other than those
specified by CoaguSense, may result in increased EMISSIONS or
decreased IMMUNITY of the EQUIPMENT.”
“The Coag-Sense Prothrombin Time (PT)/INR Monitoring System
should not be used adjacent to or stacked with other equipment
and that if adjacent or stacked use is necessary, the Coag-Sense
Prothrombin Time (PT)/INR Monitoring System should be
observed to verify normal operation in the configuration in which it
will be used.”
Test Strips/ Control Strips/Control Strip Activating Solution
The test strips are designed for single use only. Do not reuse the
test strips.
Patient samples, controls, used strips, transfer tubes and lancets
are potentially infectious. Discard used materials in a puncture
resistant, biohazard waste container using universal precautions.
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.

Page 16
6. Hazards and Symbols
Warning: This indicates a warning or
precaution, requiring special attention.
Class II Equipment. The Power Adapter is
double insulated.
Biological Risks: Disposable items pose
biological risks. The strips and fingerstick
materials should be disposed of in appropriate
biohazard waste containers.
Electronic device. Dispose of unit properly.
Use by/Expiration Date
Lot number
For In vitro diagnostic use
Storage temperature range
Manufacturer
Single Use Only –Do Not Reuse
This product meets the provisions of Council
Directive 98/79/EC for In Vitro Diagnostic
Devices.
Authorized/European Representative
Catalog Number
The system fulfills the Canadian and U.S
safety requirements (NEMKO listed)
Consult Instructions for Use