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. 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: techsupport@coagusense.com
© 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.
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,
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 CoagSense 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-ofpocket, 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 CoagSense 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 IconDirects 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 CoagSense 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 reintroduced) 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.
Page 17
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
Catalog Number
The system fulfills the Canadian and U.S
safety requirements (NEMKO listed)
Consult Instructions for Use
Page 18
Directions for Use
7. Meter Setup
Operating Conditions
To ensure that your Coag-Sense PT/INR system is working
correctly, be sure the following conditions are met:
Be sure that the meter and strips are at room temperature
before use. Operating conditions are between 65ºF and 95ºF
(18ºC and 35ºC). The meter will not allow a test to proceed
until the meter is at room temperature.
Relative humidity should be between 10% and 90%, without
condensation, for testing.
Avoid dropping the meter or treating it roughly.
Use the meter only on a level, stable surface.
Do not move or touch the meter during testing.
Power ON/OFF
The Coag-Sense PT/INR Patient Self-Test System can be
operated with the power adapter provided. The power adapter
also serves as a charger.
Place the meter on a flat, stable surface. To turn the meter
ON/OFF, press and hold the POWER button of the right side
of the meter.
Page 19
System and User Settings:
The meter is set to default factory
settings, English is the default language
and time/time zone is Pacific Standard
time (UTC-8:00). User may modify User
settings as appropriate. Refer to User
Settings section in this manual for the list
of settings and their function. These
User settings help the User to configure their PT/INR meter.
No.
Action
Image guided instruction
Device Information Setting
1.
Device Information Screen
Page 20
No.
Action
Image guided instruction
2.
Software Version Update
a) If there is a new
software version available,
it can be found in this
screen (only if meter is
connected to the
Internet- Refer to
Section 15).
b) Clicking the new
version will download the
version.
c) User may choose to
Reboot the meter after the
download or push the
reboot to a later time.
Device Settings
1.
Device Settings Screen
Page 21
No.
Action
Image guided instruction
2.
Theme: User chooses
from Mono/Blue/Color
3.
Language Setup
Note: The default language is set to
English.
4.
Date Format Setup
5.
Time Format Setup
6.
Date and Time Setup
Note: The time automatically adjusts
for daylight savings time.
Page 22
No.
Action
Image guided instruction
7.
Time Zone Setup
8.
Brightness: User
chooses from range of 1-7
9.
Sound Setting: User
chooses to Turn sound
ON or OFF
10.
Target Range Setup
11.
Alarm: User can set alarm
as a reminder function
with Time and set to
repeat on selected days of
the week. User may edit/
delete an alarm at any
time.
Page 23
No.
Action
Image guided instruction
Communication Settings
1.
The screen lists the status
of the communication
channels. If connected to
Wireless (Wi-Fi), the
touchscreen displays the
name of the Wi-Fi
network. The forward
button on each type will
direct the User to a
detailed view.
2.
Wireless (Wi-Fi) Setting:
This screen displays icons
that a) Scan for Wireless
networks nearby
b) Wireless ON/OFF icon
Clicking the „Connect‟ icon
will require User to input
passphrase to connect to
the network.
3.
Upon clicking the „Setup‟
icon, the touchscreen
displays the Wireless
Information screen, the
User may a) select a
connection method and b)
input the fields containing
network information. Click
„Confirm‟ to proceed and
input the passphrase for
connecting to a network. If
the desired wireless
network cannot be
automatically connected
Page 24
No.
Action
Image guided instruction
via DHCP then it can be
configured manually.
4.
Wired Setting:
Setup wired network
connection by inputting the
fields displayed in the
screen.
Note: If the connection method is
DHCP, the contents are
automatically assigned if a network
with the DHCP server is plugged in.
5.
Bluetooth Setting:
This screen displays icons
that a) Scan for Bluetooth
enabled devices nearby
b) Bluetooth ON/OFF icon
c) Bluetooth broadcast
icon
This screen displays the
list of scanned Bluetooth
enabled devices.
6.
Broadcast Bluetooth will
pair the Coag-Sense
PT/INR meter to external
device.
Note: Set the external device ready
to connect to the Coag-Sense meter.
7.
The touchscreen displays
a message if the Bluetooth
connection fails.
Note: The screen shot on the right
shows the Bluetooth Connectivity
icons.
Page 25
No.
Action
Image guided instruction
8.
External Connection:
a) Screen lists server IP
address for socket
communication
b) Open/Close port for
serial communication with
external program
c) Connects PT/INR meter
to PC program using
Bypass Mode.
Page 26
8. Performing a Control Test
There are 2 low control strips, 2 high control strips and a control strip
activation solution shipped with each Coag-Sense test strip kit.
Controls should be tested immediately upon receipt of each new lot
number. Extra controls may be ordered separately if more frequent
QC testing is required. Please note that your home testing service
provider may not include control strips in your supply shipment.
Note: The following directions are for running a low control strip.
When this procedure is complete, run a high control strip. The
controls may be run in any order. The meter will display and store the
results in PT seconds only. The meter does not use or require results
from the control strips prior to running a patient test strip.
Note: If an error message appears, consult the „Troubleshooting‟
section of this manual.
WARNING: DO NOT move or touch the meter while it is
running a test. Unreliable results may occur.
Follow these steps to perform a test on a low or high control.
No.
Action
Image guided instruction
1.
Turn the meter ON by
pressing and holding the
(POWER) button on
the right side of the
meter.
After the system starts
the Home Screen will be
displayed.
2.
To perform a control test,
press the Control icon on
display screen.
Select from the following
Low Control Test or High
Control Test.
Page 27
No.
Action
Image guided instruction
Note: The sequence of running the
controls is not important.
3.
Strip lot confirmation
screen displays the Lot
information of the strip
that was last recorded.
Proceed with testing if
the control strip is from
the same lot.
Otherwise, press Change
and scan the NFC tag
(located on the bottom
right corner of test strip
kit box or bag from your
service provider) against
the NFC Tag scanner
(centric rings next to test
strip insertion area) on
the meter, the Lot # (sixdigit numeric identifier)
and Barcode # (eightdigit numeric identifier)
will auto populate.
If the box/bag with NFC
tag is not available, you
may manually enter the
Lot # and Barcode #
using the keypad on the
touchscreen into the
respective fields.
Press the forward button.
Note: Ensure the strip expiration
date on the strip packaging has not
passed. Contact your service
provider for help with reordering.
Representative example only
Page 28
No.
Action
Image guided instruction
4.
Open the packaging of
the selected control strip
by tearing the notched
end.
5.
Holding the round end,
gently push the strip
completely into the
meter. The strip fits
snuggly when pushed all
the way toward the back
wall of the strip insertion
area.
6.
The meter warms the
strip (for 25 seconds) to
operating temperature,
display shows a
countdown in seconds.
Note: Do not apply the control
activation solution until the warmup is complete and the meter
display shows „Apply Control
Solution‟.
7.
Insert the black plastic
plunger into the end of
the glass capillary tube
with the red stripe. Use
care to avoid hitting white
plug.
Note: Your home testing service
provider may have supplied you
with transfer tubes that have the
plungers pre-loaded.
8.
Open the control
activation solution and
hold at an angle to allow
insertion of the sample
transfer tube. Insert
transfer tube into control
Page 29
No.
Action
Image guided instruction
activation solution. Let
capillary action fill until
solution flow stops at
white plug.
9.
The meter beeps once
and displays “Apply
Control Solution” when it
is ready for the control
strip activation solution.
Note: You now have up to 2 ½
minutes to apply the activation
solution to the control strip.
Rest hand on meter or
counter top to steady.
Insert transfer tube tip
into sample application
well of test strip, touching
tip down at flashing
green light in front of
wheel. Depress black
plunger completely to
dispense the activation
solution.
10.
When the control
activation solution is
properly applied and
detected, the flashing
green light will turn off,
and the meter will display
„Testing Please Wait‟.
Note: If this screen is not displayed
within 8 seconds not enough
solution was applied. Remove the
strip. Retest with a new control
strip. DO NOT attempt to add more
solution to the strip.
Page 30
No.
Action
Image guided instruction
11.
When testing is
complete, the Pass/Fail
results are displayed in
PT units. Date and Time
is also displayed.
Note: Control test results only
display PT seconds, this is to avoid
confusing control strip INR results
with patient test strip INR results.
12.
Repeat Steps 3-12 using
the „High control strip‟.
13.
Once the controls have
been successfully tested,
remember to remove and
discard the control strips.
You can now proceed to
testing blood samples. If
you are not going to test,
turn off the meter by
pressing and holding the
POWER button. The
opened control activation
solution may be used
until the expiration date.
Note: If control test fails, repeat the test with a new strip. If the control test
continues to FAIL, contact Coag-Sense Technical Support for assistance.
Page 31
9. Collecting a Fingerstick Sample
Tips for a Successful Fingerstick
Make sure that you have all the supplies needed before
you start.
21g Lancet device (Single use, auto disabling)
Sample Transfer Tubes
For fingerstick blood testing, increasing the flow of blood in the
finger will help you capture a good drop of blood. Before you
prick the finger, warm your hand by washing it in warm water,
holding it under their armpit, or by using a hand warmer. Ensure
that the patient‟s hand is dry prior to testing.
Do not use fingers with tight rings, scars, calluses, or other
features that prevent getting good access to the blood.
One of the middle or index fingers on either hand
is recommended.
Gently squeeze or massage the finger to be lanced, near the tip.
Good circulation can be seen if the patient‟s fingertip changes to
a pinkish shade.
Use a 21g 1.8 mm depth single-use auto-disabling lancet.
Smaller gauge/shallow depth lancets (i.e. diabetes 23g
lancets) should not be used. Refer to the Lancet device
instructions for more information on use.
Lance the fleshy part of the fingertip just slightly left or right of the
center. Press lancet firmly against finger.
For better blood flow, you may have the patient hold their hand
below their heart. If necessary, squeeze the finger from the
sides to open up the wound for proper blood flow to produce
pea sized drop.
Page 32
The best test sample is when:
The blood is collected right after the fingerstick and put
into the sample well without delay. If there is any delay in sample
collection or application, repeat with a fresh fingerstick and a new
strip.
There are no bubbles or air pockets in the tube or sample.
WARNING: Patient samples, controls, used test strips,
transfer tubes and lancets are potentially infectious.
Dispose of strips and collection devices using universal
precautions.
No.
Action
Image guided instruction
1.
Wash your hands with
soap and warm water.
Dry completely. If
cleaning with an
alcohol wipe, the finger
must be wiped dry with
sterile gauze (air drying
is insufficient to
remove residual
alcohol in time)
2.
Dry the fingertip with
gauze to remove any
excess water or alcohol.
Note: Residual alcohol or water will
affect results. Be certain that finger
is completely dry.
Page 33
No.
Action
Image guided instruction
3.
Choose a site just off
center near the top of
one of the middle fingers
to lance.
Note: Avoid the more sensitive
area in the center. Avoid any
calluses or scars.
4.
Remove the cap from the
single use lancet. Place it
against the skin. Holding
the body of the lancet,
push down firmly against
the finger to lance the
surface of the skin. Do
not lance finger until
meter displays “APPLY
SAMPLE”. A minimum
of 10µl of collected blood
sample is required.
Note: The blood should flow freely.
If it doesn‟t, gently squeeze the
finger to get it started. Lowering the
patient‟s hand and arm so that the
fingertip is below the heart helps
the blood drop form.
5.
When ready to collect the
drop of blood, hold the
Sample Transfer Tube
horizontal. Touch tip to
bead of blood and let
capillary action fill until
blood flow stops at white
plug. Squeeze finger to
generate additional blood
if required to completely
fill to white plug.
Note: Blood must reach the white
Page 34
No.
Action
Image guided instruction
plug
WARNING: Squeezing the fingerstick site excessively
(milking releases interstitial “tissue layer” fluid that cause
unreliable results.
6.
Once you have collected
the blood sample,
IMMEDIATELY put it into
the sample well on the
test strip. See
“Performing a PT Test”
section of this manual.
WARNING: If there is a bubble or an air pocket present in
the blood sample in the transfer tube, start the test over
with a fresh fingerstick on a different finger.
Page 35
10. Performing a PT Test
WARNING: Place the meter on a stationary, level surface
for testing. DO NOT move the meter or allow it to vibrate
during the test. Unreliable results may occur.
Follow the steps below to perform a patient test:
No
Action
Image guided instruction
1.
Turn the meter ON by
pressing and holding the
(POWER) button on
the right side of the
meter.
After startup and selfcheck, the display will
show the Home Screen.
2.
To perform a Patient test,
press the Test icon on
display screen.
3.
Patient Strip lot
confirmation screen
displays the Lot
information of the strip
that was last recorded.
Proceed with testing if the
test strip is from the same
lot.
Otherwise, touch the NFC
tag against the NFC tag
scanner on the meter, the
Lot # (six-digit numeric
identifier) and Barcode #
(eight-digit numeric
identifier) will auto
populate.
Page 36
No
Action
Image guided instruction
If NFC tag information is
not available, you may
manually enter the Lot #
and Barcode # using the
keypad on the
touchscreen into the
respective fields.
Press the forward button.
Note: Make sure the expiration date
on the strip packaging has not
passed. Contact your Coag-Sense
distributor for help with reordering.
4.
Open the packaging of
the test strip by tearing
the notched end.
5.
Holding the round end,
gently push the strip
completely into the meter.
The strip fits snuggly
when pushed all the way
toward the back wall of
the strip insertion area.
6.
The meter warms the
strip (for 25 seconds) to
operating temperature.
The display shows a
countdown in seconds.
Note: Do not apply test sample
until the warm-up is complete
and the meter display shows
„Apply sample‟.
Patient ID is not displayed on personal
meter version
While the meter is warming up, get ready to perform a
fingerstick. See “Collecting a Fingerstick Sample” section in
this manual.
Page 37
No
Action
Image guided instruction
When the warm-up is
complete, the meter
beeps (if sound is turned
ON) the screen displays
„Apply Sample‟ message.
Note: You now have up to 2 ½
minutes to perform a fingerstick
and apply the sample to the test
strip.
7.
IMMEDIATELY after
collecting your blood
sample, place the tip of
the sample transfer tube
at a 45º angle into the
sample well on the test
strip in front of the wheel
where you see the
flashing green light.
Gently touch the tip down
onto the sample well.
Depress the plunger
completely to dispense
blood sample.
Note: Depress black plunger
completely to dispense the blood.
8.
When the sample is
detected, the meter
displays a „Testing
Please Wait‟ message.
Note: If this screen is not displayed
within 8 seconds not enough blood
sample was applied. DO NOT
attempt to add more sample. Stop
the test and retest with a new strip
and fingerstick.
Page 38
No
Action
Image guided instruction
9.
When testing is complete,
the meter beeps (if sound
is turned ON). The results
(INR and PT seconds)
are displayed on the
screen along with date
and time of the test.
Note: Memo field allows you to
make notes such as medication or
diet change along with the results.
Upon clicking the Check mark icon,
the main screen is displayed.
Note: Refer to the
“Troubleshooting” section of this
manual if the meter displays
messaging, for example:
CLOT TIME TOO SHORT or NO
CLOT DETECTED.
10.
Remove the test strip and
properly dispose.
Note: Repeat the test if the
results seem unusually low or
high. If the results still seem
unusual after a second test, contact
Technical Support.
11.
You may print the results
if you purchased the
optional portable printer.
Refer to the “Printing”
section in this manual.
Note: The meter stores about 2000
patient test results in memory with
the time and date stamp. Refer to
“Reviewing the Memory” in this
manual for more information.
12.
Turn the meter OFF
by pressing and
holding the
POWER button
when you are
finished testing. If
Page 39
No
Action
Image guided instruction
left unattended for
a set time, (User
preferred Setting)
the meter powers
itself OFF.
WARNING: Unexpected results
An unexpected result may include any result that falls
outside the patient‟s therapeutic target range, or a
result that falls inside the target range but is not
consistent with the patient‟s current health status (e.g.
patient is experiencing bleeding or bruising).
What can cause unexpected results:
Certain prescription drugs (for example, heparin) and certain over-
the-counter medications (for example, antibiotics) can affect the
action of oral blood thinners and the INR value.
Changes in diet, lifestyle, or taking nutritional supplements such as
ginkgo biloba can affect the action of oral blood thinners and the
INR value.
Liver diseases, congestive heart failure, thyroid dysfunction,
Lupus, antiphospholipid antibody syndrome (APS) and other
diseases or conditions can affect the action of oral blood thinners
and the INR value.
Notify your doctor if you have any of these conditions before you
begin testing, and any time there are changes in your health status
or medications after you have begun testing.
What to do when you get an unexpected result:
Follow instructions for re-testing on the Coag-Sense PT/INR meter.
For unexpected results, contact Technical Support at 1-866-903-
0890. Always follow your doctor‟s instructions for adjusting your
dose of anticoagulant medication, or any other corrective action.
Page 40
11. Reviewing the Memory
The Coag-Sense meter stores up to 2000 patient test results and
500 control test results, along with the respective date and time of
the test performed. When the memory has reached maximum
storage capacity, the oldest result is automatically deleted and gets
replaced with the most recent result. This meter records all test
results, i.e. patient tests, and control tests. Memory is not lost if
there is a break in power for any length of time. Test results stored
in the Memory cannot be manually erased by the user.
Follow the steps below to review results in memory:
No.
Action
Image guided instruction
1. 1
Turn the meter ON by press
and holding the
(POWER) button on the
right side of the meter.
User is directed to the Home
screen. Press the Results
icon on display screen.
2. 2
The „Results‟ screen lists
Patient test results and
Control test results.
3. 3
User can select an
individual result from the list
of results stored in memory
to view details or select the
graph icon in the lower right
corner to plot the results
over a time period.
Note: The results shown here are for
representation only.
Page 41
No.
Action
Image guided instruction
4. 4
Clicking the chart icon
displays the test results for
the selected time interval.
Note: The target range lines are set in
"Settings>Device Settings>Target
range".
The unit of the x-axis value of the chart
depends on the period selected. The
User may choose to view up to one
month.
5. 5
When an individual result is
viewed, a memo can be
added or changed and the
result can be printed to an
optional portable printer.
Page 42
12. Printing
With the portable printer (optional accessory) available from
CoaguSense, results from the Coag-Sense meter memory can be
printed on thermal paper.
What you‟ll need:
Coag-Sense meter
Optional Portable Printer, Catalog # 03P52-55
2” Thermal Paper, Catalog # PD99906-OM
Follow the general steps below for printing results. Steps may vary
slightly depending upon the model of printer purchased.
No.
Action
Image guided instruction
1.
Plug the USB cable from
the portable printer into the
USB port of the meter.
2. 2
.
From the individual result
display click the printer
icon in the lower-right
hand corner of the screen
to print the result.
3.
You may choose from
three different printer
connection modes.
Network and Bluetooth
modes will require
configuration using the
setup icon prior to printing.
Press Print to print the
result.
Page 43
If the results fail to print, confirm that the printer is ON and charged
as it automatically turns OFF after a few minutes. Note that the
meter can only print to specific printers qualified and supplied by
CoaguSense. The meter cannot print directly to your home
computer printer.
For assistance with the printing function call Technical Support at 1866-903-0890
Page 44
13. Network Connectivity and Security
The Coag-Sense meter offers the ability to receive product software
updates from the manufacturer via the Internet. The Coag-Sense meter
can be connected to a Local Area Network (LAN) via either a direct
Ethernet connection or wirelessly using Wi-Fi. If this meter is connected
to a local area network, the network must be protected against
unauthorized access. Customers are responsible for the security of their
local area network, especially in protecting it against malicious software
and attacks. This protection might include measures, such as a firewall
to separate the device from uncontrolled networks and intrusion
detection that ensure that the connected network is free of malicious
code including intrusion detection.
14. Bluetooth App Security
For security reasons, it is recommended that you only connect your
Coag-Sense meter to Bluetooth apps that have been provided to you by
your home testing service provider or CoaguSense.
15. Meter Software Update
When connected to the Internet the CoagSense meter will check for the availability of
meter software updates which can be
downloaded. If the meter is not
continuously connected to the Internet, you
should make it a practice to periodically
connect the meter to the Internet to check
for software updates. If a critical update is available, the meter may
require the installation of an update prior to proceeding with testing.
Make sure to check if the battery is charged enough before performing
an update. If the battery‟s charge is not enough and then the meter is
abruptly turned off during update, an error may occur on the meter.
Page 45
16. Battery
The Coag- Sense meter has a factory installed Rechargeable
Lithium Polymer Battery, that charges when the power adapter
(provided with the meter) is plugged into the wall socket. A charged
battery (6 hours to fully charge) can run approximately 200 tests.
Please be aware that battery life may be affected by many factors
such as operating conditions (e.g. ambient temperature), frequency
of use, and test duration.
Note: The Battery is not User replaceable.
When the battery is running low the
status bar on the touchscreen of the
meter displays a red indicator in the
„Battery status‟ icon. The touchscreen
displays a „Low Battery‟ warning. The
battery begins charging as soon as
the power adapter is connected to the
power supply.
WARNING: Lithium Polymer batteries may
explode or combust if mishandled. Do not subject
the meter to prolonged exposure to sunlight or
place the meter on or in heating appliances such
as microwave, conventional oven or radiator. Only
charge battery using the power adapter provided
along with the Coag-Sense meter. Use of other
power cables may result in damage to the meter.
Do not disassemble or dispose battery in fire. Do
not charge/discharge battery out of recommended
temperature range.
Page 46
17. Cleaning and Disinfecting the Meter
No maintenance is required other than routine cleaning and/or
disinfecting.
When the power is off and the USB cable is not connected, the
meter housing can be cleaned and disinfected. Wipe all exposed
surfaces with Healthcare Bleach Germicidal Wipes containing
Sodium Hypochlorite (EPA No. 67619-12) for a contact time of 1
minute to pre-clean blood and other body fluids. Caution should be
taken to not get fluids inside the meter through the test strip port,
data transmission port or battery compartment. Dispose of the
used towelette. The meter should be allowed to air dry before use.
The test strip is designed to contain the patient sample, preventing
it from entering the meter. Do not clean/disinfect inside the meter
where the test strip is inserted. Cleaning this area should be
avoided. Please call Technical Support at 1-866-903-0890 if this
area requires cleaning/disinfecting.
WARNING: Do not put the meter in liquid. Do not
allow liquids to get inside the meter or into any of
the connectors or plugs on the meter. If you
suspect any physical damage or deterioration of
the meter (such as cracking or gross distortion),
or if the meter does not turn on after cleaning,
call Technical Support.
Page 47
Always refer to local, state and federal disinfecting guidelines.
More information on bloodborne pathogen safety and proper
disinfecting techniques can be found at:
“FDA Public Health Notification: Use of Fingerstick Devices on
More than One Person Poses Risk for Transmitting Bloodborne
Pathogens: Initial Communication” (2010)
http://wayback.archiveit.org/7993/20170111013014/http://www.fda.gov/MedicalDevices/S
afety/AlertsandNotices/ucm224025.htm
“CDC Clinical Reminder: Use of Fingerstick Devices on More than
One Person Poses Risk for Transmitting Bloodborne Pathogens”
(2010)https://www.cdc.gov/injectionsafety/fingerstick-
devicesbgm.html
Page 48
18. Troubleshooting
The Coag-Sense Meter continually checks its systems for
unexpected conditions. These may arise because of defective
components or consumables, environmental factors or due to User
handling and procedure errors. This section details how to resolve
most problems that you might encounter. If you have any
questions or problems during the troubleshooting process, note
the display wording and contact Technical Support at 866-903-
0890 or email techsupport@coagusense.com.
Meter
Display
Possible Cause(s)
Solution
ROOM TEMP
INCORRECT
SEE
MANUAL
The temperature of the room
is either below or above the
operating temperature range
of the meter.
Battery was depleted and
then plugged into AC adapter
while testing continued. The
charging of the battery can
generate enough heat to
raise the internal temperature
of the meter outside the
operating range.
Move the meter to a
place that is within the
operating temperature
range of the meter
(65ºF to 90ºF, 18ºC to
32ºC) and allow meter
time to adjust to correct
temperature. Repeat
testing.
Allow meter to
complete charging prior
to initiating testing.
REMOVE
STRIP
Meter turned off with used
strip in it.
If no strip present, possible
shipment damage.
Remove the strip and
begin again.
Call Technical Support
WHEEL
PROBLEM
The test strip was not
inserted fully or may have
been inserted at an incorrect
angle or incorrect speed.
There may be a problem with
the wheel on the strip or with
the meter.
Reinsert the strip
holding the back of the
meter steady with one
hand while inserting the
strip completely using a
quick smooth motion
with the other hand. If
display persists, try
again with another new
strip.
Page 49
Meter
Display
Possible Cause(s)
Solution
If the message displays
again contact Technical
Support.
DETECT
PROBLEM
There may be a problem with
the strip insertion or with the
motor carriage in the meter.
Take the strip out and
reinsert holding the
back of the instrument
steady with one hand
while inserting the strip
completely with the
other hand. Insert the
strip using a quick
smooth motion.
Try again with another
strip.
If the message persists,
contact Technical
Support.
LIQUID
PROBLEM
There may be a problem with
the strip or with the optical
system of the meter.
Take the strip out and
reinsert holding the
back of the instrument
steady with one hand
while inserting the strip
completely with the
other hand. Insert the
strip using a quick
smooth motion.
Try again with another
strip.
If the message persists,
contact Technical
Support.
MOTOR
PROBLEM
There may be a problem with
the motor function of the
meter.
Turn the meter off then
back on. Try again with
another strip. If the
message persists,
contact Technical
Support.
HEATER
PROBLEM
The meter is too warm, too
cold, or there may be a
Move the meter to a
place that is within the
Page 50
Meter
Display
Possible Cause(s)
Solution
problem with the meter.
operating temperature
range of the meter
(65ºF to 90ºF, 18ºC to
32ºC) and allow meter
time to adjust to correct
temperature. Repeat
testing.
Turn meter off then on
again after 5-7 minutes
Try again with another
strip.
If the display persists,
contact Technical
Support.
TEST STRIP
EXPIRED
SEE
MANUAL
The lot of strips have expired.
Meter date is not set
correctly.
Use a different lot of
strips that has not
expired.
Verify the date setting
on the meter is current.
NO SAMPLE
DETECTED
Either no sample or not
enough sample was applied
to the strip within 2 1/2
minutes after the “Apply
Sample” message was
displayed. This can also
happen if sample is applied
on the strip but outside of the
sample application well.
Repeat the entire
procedure (including
fingerstick on a
different finger) with a
new strip.
Apply the sample
within 2 1/2
minutes after
display of the
“Apply Sample”
message.
Ensure that the transfer
tube is filled to the
white plug and touches
the sample well before
dispensing sample.
CONTROL
FAIL- NO
CLOT
There was no clot formation;
sample clotting time was very
long and out of testing range.
Repeat the entire
procedure with a new
strip. If the same
Page 51
Meter
Display
Possible Cause(s)
Solution
DETECTED
There was insufficient control
activation solution transferred
to the test strip. Possible
causes include; an air bubble
in the sample or not allowing
control activation solution to
completely fill transfer tube.
This may be due to a
problem with the
shipment/storage of the
control strips or the control
activation solution. Plasma
on control strips is sensitive
to exposure to temperatures
outside the storage range.
message persists and if
you have additional
inventory of the test
strip kit from the same
kit lot, use the control
strip from that box(es).
If the error message
persists, contact your
service provider.
This does not indicate
meter malfunction
CONTROL
FAIL- CLOT
TIME TOO
SHORT
The clotting time was very
short and out of testing range
(<8 seconds).
An air bubble was detected in
the control activation solution
sample.
The sample transfer tube was
not filled with the control
activation solution to the
white plug
Applying the control
activation solution to the test
strip before ¨Apply Control
Solution¨ displayed on
screen.
Repeat the entire
procedure (including
fingerstick on a
different finger) with a
new strip.
Visually confirm that no
air bubbles are in the
control activation
solution sample before
applying to test strip.
Ensure that the tube
is filled to the white
plug.
Depress black plunger
completely to dispense
the control activation
solution sample.
Repeat the entire
procedure with a new
control strip.
CONTROL
FAIL-OUT OF
The control strip result is
outside of its acceptable
range (FAIL- out of range).
Repeat test with
another control strip. If
the second test is out of
Page 52
Meter
Display
Possible Cause(s)
Solution
RANGE
This may be due to a
problem with the
shipment/storage of the
control strips or the control
activation solution. Plasma
on control strips has a limited
shelf life and the clotting time
will change when exposed to
temperatures outside the
storage range.
range, contact
Technical Support.
Control strips should be
tested immediately
upon receipt of your
shipment of new test
strips as they have a
limited shelf life.
This does not indicate
meter malfunction.
CLOT TIME
TOO
SHORT
The clotting time was very
short and out of testing range
(<8 seconds).
An air bubble was detected in
the sample.
Lancing the finger before
¨Apply Sample¨ displayed on
screen.
Taking too long to collect the
sample in transfer tube
(make sure 21g needle
lancets are used for good
flow of blood).
Repeat the entire
procedure (including
fingerstick on a
different finger) with a
new strip.
Visually confirm that no
air bubbles are in the
sample before applying
to test strip.
Depress black plunger
completely to dispense
the sample.
If the same message
repeats, contact
Technical Support.
NO CLOT
DETECTED
The sample clotting time was
very long and out of testing
range.
There was insufficient sample
transferred to the test strip.
Possible causes include;
improper lancing (21g lancet
required), an air bubble in the
sample, not allowing sample
to completely fill transfer
You should not use this
test if you are also
taking heparin or other
contraindicated drugs
listed on the test strip
package insert.
Visually confirm that no
air bubbles are in the
sample before applying
to test strip.
Page 53
Meter
Display
Possible Cause(s)
Solution
tube.
Depress black plunger
completely to dispense
the sample
Repeat the entire
procedure (including
fingerstick) with a new
strip. If the same
message displays, use
an alternative testing
method and contact
Technical Support.
LOW
BATTERY
The meter battery is low
The meter can
complete the current
test. The meter
connected to the power
adapter should be
plugged into the wall
socket.
General Troubleshooting
Issue
Possible Causes
Solution
Meter does
not power
ON
Insufficient Battery to Power
ON.
Power Adapter not connected
properly for charging the
battery.
Not pressing and holding
Power button when turning
meter on.
Check if the power
adapter (provided with
the meter) is connected
to the port in the Meter
and the wall socket.
If issue persists, or if the
power adapter is faulty,
contact Technical
Support.
Cannot
Insert Strip
into the
„Strip
Accumulation of dirt, dust,
control activation solution, or
blood in the strip insertion
Contact Technical
Support for assistance
with cleaning the strip
Page 54
Issue
Possible Causes
Solution
Insertion
Area‟
area.
Wheel is not seated properly
into stanchions of test strip.
insertion area.
Use your thumbnails to
push wheel spindles
down to snap wheel into
place.
If issue persists, Contact
Technical Support.
Touch
screen
display
issues
Insufficient/Low Battery
Display faint or low
brightness
Display Screen Flickers
Connect the power
adapter to wall socket.
Change „Brightness‟
User setting in the
“Device Settings‟ menu
of the meter.
Check Battery level and
if issue persists, contact
Technical Support.
Touch
screen not
responding
Dropping or subjecting the
meter to strong shocks.
Contact Technical
Support
Touch
screen
cracked
Dropping or subjecting the
meter to strong shocks
Using pointed or sharp-edged
objects other than the
recommended „finger‟ or
rubber stylus to touch the
screen elements.
Contact Technical
Support
Power
Adapter Not
working
Faulty Adapter (Bent power
cord, Bent power pin in the
meter)
Check adapter
functionality by plugging
the power adapter to a
different wall socket.
If issue persists, contact
Technical Support
Software
Software version update
Power cycle and re-
Page 55
Issue
Possible Causes
Solution
Issues
issue
install new software
version if available
(Settings_Device Information
settings_Software Version)
If issue persists, press
Reset button to restore
factory settings.
If issue still exists,
contact Technical
Support.
Lost NFC
Tag
Misplaced NFC Tag
The NFC tag is affixed
to each test strip kit box.
Otherwise, enter the
strip information
manually into the
touchscreen to perform
the current test.
Alternately, if you have
additional inventory of
the test strip kit from the
same kit lot, use the
NFC tag from that
box(es).
NFC Tag
Issues:
NFC tag
not
working.
Scanned
informatio
n does not
match the
informatio
n on the
strip
packaging
Improper scanning of the
NFC tag.
Faulty NFC Tag scanner in
the meter
Touch or bring the NFC
tag to proximity of the
NFC Tag scanner. If the
issue persists enter the
strip information
manually into the
touchscreen to perform
the current test.
If you have more than
one meter, try scanning
the NFC Tag on another
meter to narrow down
the root cause to either
Page 56
Issue
Possible Causes
Solution
the tag or scanner.
If the issue persists,
contact Technical
Support.
NFC Tag
scanner
issue
Tag Scanner works
intermittently or does not
work.
Scanned NFC scan did not
match the Lot # and Barcode
# on the test strip.
Scan the alternate NFC
tag provided.
Touch or bring the NFC
tag to proximity of the
NFC Tag scanner. If the
issue persists enter the
strip information
manually into the
touchscreen to perform
the current test.
If you have more than
one meter, try scanning
an NFC Tag on another
meter to narrow down
the root cause to either
the tag or scanner.
If the issue persists,
contact Technical
Support.
Page 57
19. Warranty
Limited One (1) Year Warranty
Use of the Coag-Sense PT/INR System
The Coag-Sense PT/INR system is designed for use in monitoring
patients on oral anticoagulant therapy. Proper adherence to the
instructions in this User Manual and package insert are critical to proper
operation. WARNING: Failure to comply with the User Manual could
lead to inaccurate PT/INR results which could lead to incorrect
medication dosing which could lead to injury or death.
Limited Warranty
CoaguSense warrants that the Coag-Sense meter is free from all
defects in material and workmanship for a period of one (1) year from
date of purchase. When the meter is used for the intended purpose and
in the appropriate manner, the remedy is repair or replacement at
CoaguSense‟s option. The warranty does not apply to a meter damaged
by misuse, alteration or tampering to either the hardware or software.
Contact Technical Support at 1-866-903-0890 for instructions.
THIS WARRANTY APPLIES ONLY TO THE METER. COAGUSENSE‟S
ENTIRE LIABILITY IN CONNECTION WITH THE METER,
REGARDLESS OF THE LEGAL OR EQUITABLE BASIS OF ANY
CLAIM, IS LIMITED TO THE PURCHASE PRICE OF THE METER. IN
NO EVENT SHALL COAGUSENSE, INC. BE LIABLE TO THE
PURCHASER FOR ANY INCIDENTAL, CONSEQUENTIAL
(INCLUDING BUT NOT LIMITED TO LOSS OF INCOME OR PROFITS)
SPECIAL, INDIRECT, OR PUNITIVE DAMAGES ARISING FROM OR
IN ANY WAY CONNECTED WITH THE PURCHASE OR OPERATION
OF THE METER OR ITS PARTS. NO WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE IS
IMPLIED FROM THE SALE OF THE COAG-SENSE PT/INR SYSTEM.
NO WARRANTY, EXPRESS OR IMPLIED (IF ANY) SHALL EXTEND
FOR A LONGER DURATION THAN THE DURATION OF THE
EXPRESS WARRANTY STATED ABOVE.
Instructions for Meter or Product Return
Upon review and agreement with CoaguSense Technical Service, you
may be directed to return the unit. Should this occur, clean the outside
surface as described in the “Cleaning and Disinfecting the Meter”
section. The original packaging may be required for this purpose.
Page 58
20. Reordering Information
For a description of the products listed below, please see the
information above.
Product
Catalog #
Coag-Sense PT/INR Patient Self-Test
System
03P70-01
Coag-Sense Test Strip Kit, Box of 50
03P56-50
Coag-Sense Control Strip Kit -10
03P69-10
Sample Transfer Tubes with Plungers,
vial of 54
03P52-54
Sample Transfer Tubes with Preloaded
Plungers, vial of 54
03P52-55
Single-Use, 21g 2.2mm depth Auto
Safety Lancets - Box of 100
03P58-04
AC Power Adapter – U.S.
03P74-01
Optional portable Printer
03P76-01
Thermal Printer Paper, 2”
PD-99906
Replacement Carrying Case
03P75-01
Page 59
21. Index
A
Alarm, 22
Alcohol wipes, 13
B
Battery, 6, 45
Battery Low, 53
Blood Flow, 31
Bluetooth, 44
Bluetooth Setting, 24
Brightness, 22
Buttons, 8
C
Calibration, 5
Class II Equipment, 17
Cleaning the Meter, 46
Clot Time Too Long, 50
Clot Time Too Short, 52
Collecting a Fingerstick
Sample, 31
Communication Settings, 23
Control Out of Range, 52
Control Strips, 5
Customer Service, 2, 61
D
Date, 40
Date and Time Setup, 21
Detect Problem, 49
Device Settings, 20
E
E-Mail Support, 61
Ethernet Port, 4
Expected Values, 11
External Connection, 24
F
Fingerstick Sample, 31
H
Hazards And Symbols, 17
Heater Problem, 50
High Control Strip, 26
I
Icons, 8
IEC 60601-1, 14
INR, 4
INR Results, 38
International Normalized Ratio
(INR), 1
L
Lancet, 31, 33
Language Setup, 21
Liquid Problem, 49, 53
Low Control Strip, 26
M
Measuring Range, 11
Memory, 40
Meter Specifications, 10
Motor Problem, 49
N
Near Field Communication
(NFC),4, 5
Network Connectivity, 44
No Sample Detected, 50
Normal Range, 11
O
Operating Conditions, 18
P
Performance Characteristics,
11
Performing a Control Test, 26
Performing a Patient Test, 35
Power, 40
Power ON/OFF, 18
Printing, 42
PT, 38
R
Reordering Information, 58
Reset button, 4
Room Temp Incorrect, 48
S
Software Update, 44
Software Version Update, 20
Sound Setting, 22
Squeezing the Fingerstick
Site, 13
System Description, 3
System Settings, 19
T
Target Range Setup, 22
Test Strip, 6
Time Zone Setup, 22
Troubleshooting, 48
U
Unexpected results, 39
User Settings, 19
W
Warnings and Precautions, 12
Warranty, 57
Wheel Problem, 48
Wired Setting, 24
Wireless (Wi-Fi) Setting, 23
Technical Support
CoaguSense, Inc.
48377 Fremont Blvd., STE 113
Fremont, CA 94538
USA
Toll Free: 1-866-903-0890
E-Mail: techsupport@coagusense.com
CoaguSense, Inc.
48377 Fremont Blvd, STE 113
Fremont, CA 94538 USA
Tel: (510) 270-5442
Fax: (510-226-6540
Manufactured in South Korea.
CSI P/N 200219 Rev AA
61010-01
Loading...