CoaguSense Coag-Sense User manual

Coag-Sense™
Prothrombin Time (PT)/INR
Monitoring System
Professional User’s Manual

Page 2 For In Vitro Diagnostic Use CoaguSense, Inc.
© Copyright 2012, CoaguSense, Inc. All rights reserved.
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.
Coag-Sense is a trademark of CoaguSense, Inc.

Contacting CoaguSense
CoaguSense, Inc. For In Vitro Diagnostic Use Page 3
Contacting CoaguSense
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
Toll Free: 1-866-903-0890
E-Mail: [e-mail]
Note ◙:The Coag-Sense Prothrombin Time (PT)/INR Monitoring
System meter is packaged in a special box. Do not
discard this box. Re-use the package to transport the
meter or, if directed by Customer Service, to return it for
testing.
The Coag-Sense PT/INR System may be used for multiple-
patient testing in a professional healthcare setting.

Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual
Page 4 For In Vitro Diagnostic Use CoaguSense, Inc.
The Coag-Sense™Prothrombin Time (PT)/INR Monitoring
System
Intended Use
The Coag-Sense Prothrombin Time (PT)/INR Monitoring System
is an in vitro diagnostic device that provides quantitative
prothrombin time (PT) results, expressed in seconds and INR
units. It uses fresh capillary whole blood. It is intended for use
by health care professionals at the point of care to monitor
patients who are on warfarin-type (coumarin) anticoagulation
therapy. The device is not intended to be used for screening
purposes.
The Coag-Sense PT/INR System may be used for multiple-
patient testing in a professional healthcare setting.
Anticoagulation Medication
Oral anticoagulation medications, also known as blood thinners,
are typically prescribed to patients to avoid unwanted clots. The
patient’s blood clotting time must be monitored to ensure that
their dosage is correct.
Oral anti-coagulation medication is prescribed to patients with
acute and chronic conditions including, but not limited to:
congestive heart failure, atrial fibrillation, prosthetic heart valve,
myocardial infarction, joint replacement, deep vein thrombosis,
pulmonary embolism, thrombotic stroke, coronary artery disease,
venous thromboembolism and cancer.
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

Contacting CoaguSense
CoaguSense, Inc. For In Vitro Diagnostic Use Page 5
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 anticoagulant.

Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual
Page 6 For In Vitro Diagnostic Use CoaguSense, Inc.
Table of Contents
Contacting CoaguSense........................................................3
Table of Contents.......................................................................6
1. About This Manual ..........................................................7
2. System Description .........................................................8
3. Reordering Information .................................................12
4. Warnings and Precautions............................................12
5. Hazards and Symbols...................................................17
Directions for Use ....................................................................18
6. Operating Conditions ....................................................18
7. Power On and Off .........................................................19
8. Setting the Time and Date ............................................19
9. Performing a Control Test.............................................21
10. Performing a PT Test....................................................26
11. Collecting a Fingerstick Sample....................................31
Sample Collection and Transfer Methods .............................36
12. Reviewing the Memory..................................................40
13. Printing..........................................................................41
14. Control Strips ................................................................43
15. Replacing the Batteries.................................................43
16. Cleaning and Disinfecting the Meter.............................46
17. Troubleshooting ............................................................48
18. Performance Characteristics.........................................54
19. Meter Specifications......................................................55
20. Warranty........................................................................56
21. Index..............................................................................58

CoaguSense, Inc. For In Vitro Diagnostic Use Page 7
1. About This Manual
The purpose of the Coag-Sense Prothrombin Time (PT)/INR
Monitoring System User Manual is to help you understand your
Coag-Sense PT/INR system, its parts, and its intended function.
It provides you with the information you need to perform a PT
test with the Coag-Sense PT/INR system.
You must complete proper training on the Coag-Sense PT/INR
system before you begin using the system. It is also important
to read this entire User Manual and the inserts that come with
the disposable Coag-Sense test strips. This User Manual has
different formats and symbols to distinguish warnings, notes,
and meter buttons.
WARNING: This indicates a warning or precaution.
Please read and understand all warnings and precautions.
They tell you about potential safety hazards and situations
that may cause injury. If you have any questions, please
contact CoaguSense Tech Support at 1-866-903-0890
(USA).
Note ◙:Notes provide additional information that is useful or
important. All notes are displayed in italics. Words in
BOLD ALL-CAPITALS refer to buttons on the Coag-
Sense meter.

Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual
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2. System Description
The Coag-Sense Prothrombin Time (PT)/INR System is used for
quantitative measurement of Prothrombin Time (PT) in fresh,
capillary whole blood. The Coag-Sense PT/INR system is
intended for use outside the body (in vitro diagnostic use) to test
patients taking warfarin-type oral anticoagulant (blood thinning)
therapy who need to monitor clotting time.
The meter performs a self-test when it is first turned on. If there
are any problems with the meter, an error message is shown on
the display. Refer to the “Troubleshooting” section of this manual
or contact Technical Support.
A test strip is inserted and heated in the meter prior to sample
application. The strip contains a tiny wheel with spokes that pull
the sample into the reaction well. The spokes quickly and
completely mix the sample with the clot initiating component of
the test strip.
The PT time is determined from when (a) the sample is drawn
into the reaction well of the test strip and detected by a beam of
light until (b) a clot forms and interrupts the beam of light. The PT
result is converted to an INR (International Normalized Ratio)
using the calibration data stored in the meter. INR is a
mathematical correction of the PT result that adjusts for
sensitivity differences among different PT systems.
The meter continues to check every feature of its operation
through a series of self-checks.

System Description
CoaguSense, Inc. For In Vitro Diagnostic Use Page 9
Your Coag-Sense PT/INR Professional System
(Catalog number 03P60-01) comes supplied with:
Coag-Sense PT/INR Meter
Coag-Sense PT/INR System Professional User’s Manual
Coag-Sense PT/INR System Professional Quick
Reference Guide
Four AA 1.5 V Alkaline Batteries (not installed)
AC Power Supply
Sample package of Single-use, Auto Sterile Lancets
2 MiniPipettes
1 Rack of Pipette Tips (96 tips) for use with MiniPipette
You will also need:
Coag-Sense Professional Test Strip Kit-50
(Catalog number 03P56-50), which includes:
50 Patient Test Strips
1 Control Strip Activation Solution
54 Sample Transfer Tubes
2 Low Control Strips
2 High Control Strips
Isopropyl alcohol or alcohol wipes
Gauze
Single-use Auto Lancets, 21 gauge - box of 100
Puncture-resistant bio-hazard (SHARPS) container

Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual
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The Coag-Sense Meter: Top View
The Coag-Sense Meter: Bottom View
Meter
Display
Power
On/Off
Button
Menu
Buttons
Strip
Holder
Battery
Door
Battery
Door
Release

System Description
CoaguSense, Inc. For In Vitro Diagnostic Use Page 11
The Coag-Sense Meter: Rear View
The Coag-Sense Test Strip
AC
Adapter
Jack
Data
Port
Handle
Sample
Application
Area (Green light
flashing when
ready for sample)
Mixing Wheel and
Reaction Well
Bar Code
(Faces down when
inserted into meter)

Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual
Page 12 For In Vitro Diagnostic Use CoaguSense, Inc.
3. Reordering Information
For a description of the products listed below, please see the
information above.
Product
Catalog #
Coag-Sense PT/INR Professional System
03P60-01
Coag-Sense Test Strip Kit, Box of 50
03P56-50
Coag-Sense Control Strip Kit -10
03P69-10
MiniPipette, Pack of 2
03P55-02
Pipette Tips, Rack of 96
03P54-02
Sample Transfer Tubes, Pack of 54
03P53-54
Lancets, Normal Depth (Box of 100)
03P58-03
AC Power Adapter
03P64-01
4. Warnings and Precautions
General
This test system is not recommend for patients who
have recently taken or are currently taking any type of
Heparin anticoagulant.

Warnings and Precautions
CoaguSense, Inc. For In Vitro Diagnostic Use Page 13
Test Site and Blood Sample
The Coag-Sense PT/INR system is for in vitro diagnostic
use only.
The Coag-Sense meter will not produce a result if the
test strip is past its expiration date
The quality of the blood sample can affect PT test
results. A blood sample of poor quality can produce
unreliable results. Read the section on “Collecting a
Fingerstick Sample” for more information.
Blood samples must be applied to the test strip
immediately after collection or the blood begins to clot,
causing unreliable results.
The blood sample transferred to the test strip must be a
minimum of 10 µL in volume. Low sample volume may
cause an error message.
Use only fresh fingerstick capillary blood for testing. The
blood should only come in contact with the products
provided with the Coag-Sense PT/INR system. Other
products may have anti-coagulant agents on their
surfaces and result in unreliable test results.
Squeezing the fingerstick site excessively (milking)
releases interstitial “tissue layer” fluid that can cause
unreliable results.
The fingerstick site can be washed with warm water and
soap, and then completely dried. The site must be clean
of all hand oils/lotions and foreign matter, which may
cause unreliable results.
If Isopropyl Alcohol (IPA) wipes are used, wipe the
fingerstick site with a gauze pad and make sure the site

Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual
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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.
Refer to the package inserts provided with the Lancets
and Sample Transfer Tubes for more information.
Meter
If using batteries, use only AA 1.5 V alkaline batteries in
the Coag-Sense meter. Rechargeable batteries cannot
be used as they may damage the meter.
Use only the included Coag-Sense AC 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.

Warnings and Precautions
CoaguSense, Inc. For In Vitro Diagnostic Use Page 15
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.
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 is designed to provide a reasonable
protection against harmful interference when the
equipment is operated in a clinical or home environment.
If not installed and used in accordance with these
instructions, it may cause harmful interference to other
devices in the vicinity. If this equipment does cause
harmful interference to other devices, which can be
determined by turning the equipment on and off, the user
is encouraged to try to correct the interference by one or
more of the following measures:
Reorient or relocate the receiving device.
Increase the separation between the equipment.
Connect the equipment to an outlet on a circuit
different from that to which the other devices are
connected.
Any equipment connected to the data port must be
certified to IEC 60601-1. If you connect any equipment
that is not recommended by CoaguSense, you are
responsible for meeting the requirements of this
standard.
In the unlikely event of an electric power surge (i.e.,
severe static discharge during a thunderstorm), when

Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual
Page 16 For In Vitro Diagnostic Use CoaguSense, Inc.
using the optional AC 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 or your health care provider to
arrange for service.
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 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.

Hazards and Symbols
CoaguSense, Inc. For In Vitro Diagnostic Use Page 17
5. Hazards and Symbols
Warning. This indicates a warning or precaution,
requiring special attention
Class II Equipment. The AC Adapter is double
insulated
Biological Risks: Disposable items pose biological
risks. The strips and fingerstick materials should be
disposed in appropriate biohazard waste containers
Electronic device. Dispose of unit and batteries
properly
Use by/Expiration Date
Lot number
For In vitro diagnostic use
Storage temperature range
Manufacturer
Single Use Only –Do Not Reuse
This product meets the provisions of Council
Directive 98/79/EC for In Vitro Diagnostic Devices
Authorized/European Representative

Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual
Page 18 For In Vitro Diagnostic Use CoaguSense, Inc.
Directions for Use
Note ◙:The Coag-Sense PT/INR system is packaged in a
special box. Do not discard this box. Re-use the
package to transport the meter or, if directed by
Customer Service to return it for testing.
6. 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 strip are at room temperature
before use. Room temperature is between 65ºF and
90ºF (18ºC and 32ºC). The meter will not allow a test
to proceed until the meter is at room temperature.
Relative humidity should be between 10% and 85%,
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.
Do not place the meter in direct sunlight or high
intensity light.

Power On and Off
CoaguSense, Inc. For In Vitro Diagnostic Use Page 19
7. Power On and Off
Install the AA 1.5 V batteries, which are needed to
maintain the time and date settings. (See “Replacing the
Batteries” for more information). The AC adapter can
be connected at this time.
Place the meter on a flat, stable surface. To turn the
meter on. Press the POWER button, which is on the
topside of the meter, beneath the display. To turn the
meter off, press the same POWER button again.
8. Setting the Time and Date
Action
Meter Display
1. If the date and time have
not been set before on the
meter or the setting has
been lost, the display
looks like this with blinking
characters.
2. The blinking characters
may be changed by
pressing + to increase or
–to decrease. When
correct, press NEXT to
advance to the next
character.
Press NEXT to advance
to next character.
12:00PM
1/01/04
+
-
DONE
NEXT

Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual
Page 20 For In Vitro Diagnostic Use CoaguSense, Inc.
Action
Meter Display
3. Once you have entered
the correct date and time,
press DONE to exit this
function.
4. Once the date and time
are set, the display looks
like this.
5. If you need to change the
date or time in the future,
press SET. The meter
display shows the set time
and date.
6. Adjust the time and date
by pressing +to increase
or –to decrease. When
the time and date are
correct, press DONE
when finished.
Note ◙: The clock time does not adjust for daylight savings time.
The date format is mm/dd/yy.
Press SET to adjust date and
time again (if necessary)
READY
INSERT
STRIP
SET
MEM
OFF
Press DONE when date and
time are correct
8:00AM
3/07/09
+
-
DONE
NEXT
+
-
DONE
NEXT
Press DONE when date and
time are correct
12:00PM
1/01/10