CoaguSense PT/INR User manual

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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. 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
1. Introduction...........................................................................1
2. System Description.................................................................3
3. Meter Specifications .............................................................10
4. Performance Characteristics................................................11
5. Warnings and Precautions ...................................................12
6. Hazards and Symbols ..........................................................17
Directions for Use .................................................................................18
7. Meter Setup..........................................................................18
8. Performing a Control Test ....................................................26
9. Collecting a Fingerstick Sample...........................................31
10. Performing a PT Test ...........................................................35
11. Reviewing the Memory.........................................................40
12. Printing..................................................................................42
13. Network Connectivity and Security.......................................44
14. Bluetooth App Security.........................................................44
15. Meter Software Update.........................................................44
16. Battery ..................................................................................45
17. Cleaning and Disinfecting the Meter ....................................46
18. Troubleshooting....................................................................48
19. Warranty...............................................................................57
20. Reordering Information.........................................................58
21. Index.....................................................................................59

Page 1
1. Introduction
The Coag-Sense®Prothrombin Time (PT)/INR
Monitoring System
Intended Use
For self-test users, 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.
The device is intended for use by properly selected and suitably
trained patients or their caregivers on the order of the treating
physician to monitor patients who are on anticoagulation therapy.
Patients should be stabilized on warfarin-type (coumarin)
anticoagulation therapy prior to self- testing.
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,
cancer and venous thromboembolism.
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.
The Coag-Sense system should only be used with a doctor‟s
prescription. Do not adjust your medication without talking
with your doctor or health care professional.
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 symbol 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.

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 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 pulls
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 detected by a beam of light until
a clot forms and interrupts the beam of light. The PT result is
converted to an INR (International Normalized Ratio) using the

Page 5
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
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
allows transmission of the test strip kit information to the meter.
The NFC Tag is touched or brought in close proximity of the

Page 6
NFC scanner built into the meter. The scanner reads the data
stored in the NFC tag and auto populates the relevant
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 Patient Self-Test 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 Patient Self-Test System (Catalog
#03P70-01) is supplied with the following items;
Catalog Name
Qty
Coag-Sense PT/INR Meter
1
Coag-Sense PT/INR System Self-Test User's Manual
1
Coag-Sense PT/INR System Self-Test Quick Reference Guide
1
A/C Micro USB Power Supply
1
Sample Transfer Tubes, Preloaded plungers
54
Single-Use, 21g Auto Safety Lancets (sample pack)
8
Carrying Case
1

Page 7
If you participate in a testing service, your service provider will
provide you with all the necessary testing accessories. If you
run out of testing supplies, please contact the service provider
that gave you your meter for more supplies. If you purchased
a Coag-Sense Test Strip Kit (Catalog# 03P56-50) out-of-
pocket, it will include the following items necessary to perform
a test:
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 and may be supplied by your testing service
provider:
Single-Use- 21g Auto Safety Lancets
Note: These materials are not provided with the PT/INR system. The Coag-
Sense Patient Self-Test Test Strip Kit- 50 may be ordered from your meter
distributor or home testing service provider 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
messages and their description are provided in
„Troubleshooting‟ section.
Buttons/Icons
Meaning
Power ON/OFF
To power ON/OFF the
meter, press and hold
Power Button. To
Enter/Exit Sleep Mode
press the button twice
quickly.
Cancel or return to
previous screen
Go to the home screen
View additional menu
Common Keypad
input:
a and 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
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 their
appropriate INR therapeutic range.
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.
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.

Page 13
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 dry. If any alcohol remains (or is re-
introduced) on the finger, it may cause 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

Page 14
The meter has a built-in rechargeable lithium polymer battery
(3.7V, 2350mAh).
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.
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.

Page 15
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 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.”

Page 16
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, 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.