CoaguSense Assure PT Care Prothrombin Time User manual

A COAGUSENSE PARTNER
Assure®PT Care
Prothrombin Time
PT/INR Monitoring System
Professional Use
UserManual
PRO

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 ARKRAY USA. ARKRAY USAhas made every
reasonable effort to ensure that all the information contained in this manual is correct
at the time of printing. However, ARKRAY USA 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 Assure®PT Care Prothrombin Time
(PT)/INR Monitoring System, please contact ARKRAY USATechnical Support at:
ARKRAY USA
5182 West 76th Street
Minneapolis, MN 55439 U.S.A.
Technical Support: 800.818.8877
Email: [email protected]
© Copyright 2023 ARKRAY USA, Inc. All rights reserved.

Table of Contents
1. Introduction ..................................................................1
2. System Description .........................................................3
3. Meter Specications .....................................................11
4. Performance Characteristics ........................................13
5. Warnings and Precautions ..…......................................14
6. Hazards and Symbols …...............................................18
Directions for Use .............................................................20
7. Meter Setup ....................…..........................................20
8. Performing a Control Test …..........................................34
9. Collecting a Fingerstick Sample …................................40
10. Performing a PT Test …................................................43
11. Performing a STATTest ….............................................48
12. Reviewing the Memory …..............................................51
13. Printing …..................................…................................53
14. Network Connectivity and Security….............................55
15. Meter Software Update…..................................…........56
16. Battery …......................................................................57
17. Cleaning and Disinfecting the Meter ….........................58
18. Troubleshooting …........................................................60
19. Warranty …...................................................................68
20. Reordering Information .................................................70
21. EMC Tables ..................................................................71
22. Index .............................................................................73

Page 1
1. Introduction
Assure®PT Care Prothrombin Time (PT)/INR
Monitoring System
Intended Use
The Assure®PT Care 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
capillarywhole blood. Itisintended foruseby healthcareprofessionals atthe 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:
Therate at whichblood clots ismeasured 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.
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 brillation,
prosthetic heart valve, myocardial infarction, joint replacement, deep vein
thrombosis, pulmonary embolism, thrombotic stroke, coronary artery disease,
venous thromboembolism and cancer.

Page 2
Important Information Regarding Manual
The purpose of the Assure®PT Care Prothrombin Time (PT)/INR Monitoring
System User Manual is to help you understand your Assure®PT Care PT/INR
system, its parts, and its intended function. It provides you with the information you
need to perform a PT test with theAssure®PT Care PT/INR system.
You must complete proper training on the Assure®PT Care PT/INR system and
congure 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 Assure®PT Care 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 ARKRAY USA Technical Support at 800.818.8877.

Page 3
2. System Description
The Assure®PT Care 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 the
display button. There are three touch buttons, Cancel or Previous Screen
Button, Home Screen Button and View Menu 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 Tag 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 Assure®PT Care 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 rst 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:
Atest 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 PTseconds result (a true prothrombin time) is
converted to an INR (International Normalized Ratio) using the INR normalization
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.

Page 5
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. TheAssure®PTCare 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 specication. There are 2 Low and High Control
Strips, and a Control Activation Solution shipped with each test strip kit. Each
control strip contains plasma which is generated from a pool of normal donors
where the Vitamin K dependent proteins are removed and added back at different
levels to represent the ‘Low’ and ‘High’ level ranges. 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 conrms 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 lot specic test strip kit information. Transfer of the lot specic data
to the meter can be accomplished through surface contact of the matching NFC
symbols. The NFC Tag communicates the unique data for each lot of strips to the
meter. The meter reads the data stored in the NFC Tag and auto populates the
relevant test strip information on the screen.

Page 6
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:
Assure®PT Care PT/INR Professional System can be operated only with the
power adapter provided. The power adapter also serves as a charger. It charges
the built-in Lithium Polymer Battery. The battery life is shown in the top right corner
of the meter.
Note: The battery is not user replaceable.
To save power, if left unattended for a set time (user congurable), the meter will
enter sleep mode. To power meter OFF, manual press and hold of the Power
Button is required. The meter retains all results obtained up to that point in its
memory.
Assure®PT Care PT/INR Professional Monitoring System (Product 350222) is
supplied with the following items:
Catalog Name QTY
Assure®PT Care PT/INR Meter 1
Assure®PT Care Professional User’s Manual 1
Assure®PT Care Professional Quick Reference Guide 1
Assure®PT Care Testing Tips Guide 1
A/C Micro USB Power Supply 1
Stylus Pen 1
Carrying Case 1

Page 7
To perform a test, you require the following:
• Assure®PT Care Professional Test Strip Kit- 50 (Product 350218) is
supplied with the following items:
Item Description QTY
Patient Test Strips 50
Low Control Strips 2
High Control Strips 2
Control Activation Solution 1
Lot Info label 1
Sample Transfer Tubes w/ plungers 54
NFC Card 1
Package Insert 1
Note: The Assure®PT Care Professional Test Strip Kit-50 may be ordered
separately from your representative.
Following are standard medical supplies required for each use that are not
provided with the PT/INR system and must be purchased separately:
• Gauze
• Isopropyl alcohol or alcohol wipes
• 21g Auto Safety Lancets, single use
• Puncture-resistant bio-hazard (SHARPS) container

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 descriptions 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:
1. Is the input completion
button. Returns to previ-
ous screen when selected.
2. Change language button.
Enables the user to select
keyboard language.

Page 9
Buttons/Icons Meaning
The Status Bar:
1. Current Date/Time
2. Sound On/Off status
3. Alarm – The presence
or absence of set alarm
4. Bluetooth On/Off status
5. Wi-Fi On/Off Status
6. Battery status Icons on
the Touchscreen
7. Back Icon - Go to
previous screen
8. Home Icon - Go to home
screen when touched
9. Settings Icon - Go to
settings screen
when touched
10. User Information Icon -
Go to user Information
screen when touched
11. Log-out Icon - Go to
log-out pop-up screen
when touched.

Page 10
Buttons/Icons Meaning
Home Screen:
1. Test Icon - Go forward to
test screen when touched.
2. Control Icon - Go forward
to control test screen when
touched.
3. Results Icon - Go forward to
result screen when touched.
4. Settings Icon - Go forward
to setup screen when
touched.
This is a customizable feature.
If the control test fails, patient
measurements are not possible.
5. Results Icon - Displays the
number of results that have
not been synchronized.

Page 11
Operating Temperature 65°F to 90°F (18°C to 32°C)
Operating Humidity 10% to 90% (without conden-
sation)
Storage Temperature 32°F to 122°F (0°C to 50°C)
Storage Humidity 20% to 80% (without conden-
sation)
Altitude 10,000 ft (3,048 m) above sea
level
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 battery (6 hours
of charging) can run ~100 tests
Power Input 120V AC Adapter (Use with
Assure®PT Care Adapter Only)
AC Input 100-240V~, 50-60Hz, 0.5A
(Mains supply voltage uctua-
tion: ±10%
Power Output 5.0V, 2.0A
Pollution Degree 2
Overvoltage Category II
Use Circumstance Indoor only
Blood Sample Size 10-12 µL
Communication Port Micro and Standard USB
3. Meter Specications

Page 12
Size in mm (Height x Width x Depth) 152 x 100 x 29.5
Weight in grams 315 grams
Equipment Classication Class II with external power
supply. Internally powered
when operated with battery.
IPX0 rating.
WARNING: Use the Assure®PT Care meter along
with the provided Power Adapter only. Use only AC adapter
type UES12lCP-050200SPA (Manufacturer: Dongguan
Shilong Fuhua Electronics).

Page 13
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
Assure®PT Care PT/INR Monitoring system.
INR: 0.8 to 1.2
PT: 11.6 to 14.5

Page 14
5. Warnings and Precautions
WARNING: 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 Assure®PT Care PT/INR system is for in vitro diagnostic use only.
• The Assure®PT Care 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 ngerstick capillary blood for testing. The blood should only
come in contact with the Sample Transfer Tubes provided with the Assure®
PT Care PT/INR system. Other products may have anti-coagulant agents on
their surfaces and result in unreliable test results.
• Squeezing the ngerstick site excessively (milking) releases interstitial
“tissue layer” uid that can cause unreliable results.
• The ngerstick site should 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.

Page 15
• If Isopropyl Alcohol (IPA) wipes are used, wipe the ngerstick site with
a gauze pad and make sure the site is completely dry. If any alcohol
remains (or is re-introduced) on the nger, it may cause unreliable
results.
• Do not use wipes containing chlorhexidine gluconate, as it may produce
unreliable results.
• The quality of ngerstick 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 ngerstick on a different nger, and test again.
• If you need to repeat a test, use a different nger for the ngerstick, since
blood may have started to clot on the rst nger, 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 ngerstick (using a different
nger and collection tube) or results may be unreliable.
Meter
• The meter has a built-in rechargeable lithium polymer battery (3.7 V, 2350
mAh).
• Use only the power adapter included with the Assure®PT Care system or
damage to the meter may result.
• The meter shall be in the position that it is easy to disconnect power.
• 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 Assure®PT
Care PT/INR meter.
• Do not move or touch the meter while it is running a test. Unreliable results
may occur.

Page 16
• Do not pull the strip out during a test 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 Assure®PT Care 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 certied to IEC 60601-1. If
you connect any equipment that is not recommended by ARKRAY USA, 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 Assure®PT Care meter does not require any periodic maintenance and
there are no user serviceable parts inside. If you have problems, please
contact Technical Support. TheAssure®PT Care 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 Assure®

Page 17
PT Care Prothrombin Time (PT)/INR Monitoring System.
• The use of accessories, transducers and cables other than those specied
by ARKRAY USA, may result in increased EMISSIONS or decreased
IMMUNITY of the EQUIPMENT.
• TheAssure®PTCareProthrombinTime(PT)/INRMonitoring System should
not be used adjacent to or stacked with other equipment and if adjacent or
stacked use is necessary, theAssure®PT Care Prothrombin Time (PT)/INR
Monitoring System should be observed to verify normal operation in the
conguration 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.
• PTTestStrips, Control Strips, and ControlActivation 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.