Placeholder
ofPT2Professional
Image
© Copyright 2017, 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 registered trademark of CoaguSense, Inc.
Page 2 For In Vitro Diagnostic Use CoaguSense, Inc.
Contacting CoaguSense
If you have any questions or concerns with the Coag-Sense® PT2
Professional 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: techsupport@coagusense.com
Note ◙: The Coag-Sense PT2 Professional 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 Technical Support,
to return it for testing.
The Coag-Sense PT2 Professional PT/INR Monitoring
System may be used for multiple-patient testing in a
professional healthcare setting.
CoaguSense, Inc. For In Vitro Diagnostic Use Page 3
The Coag-Sense® PT2 Prothrombin Time (PT)/INR Monitoring
System
Intended Use
The Coag-Sense PT2 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 PT2 Professional PT/INR Monitoring System
may be used for multiple-patient testing in a professional
healthcare setting.
Anticoagulation Medication
Oral anticoagulation medications, are typically prescribed to
patients to avoid unwanted clots. The patient’s blood clotting time
must be monitored to ensure that their dosage is correct.
Oral anti-coagulation medication is prescribed to patients with
acute and chronic conditions including, but not limited to:
congestive heart failure, atrial fibrillation, prosthetic heart valve,
myocardial infarction, joint replacement, deep vein thrombosis,
pulmonary embolism, thrombotic stroke, coronary artery disease,
venous thromboembolism and cancer.
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,
Page 4 For In Vitro Diagnostic Use CoaguSense, Inc.
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.
CoaguSense, Inc. For In Vitro Diagnostic Use Page 5
Table of Contents
Contacting CoaguSense ...................................................... 3
Table of Contents ..................................................................... 6
1. About This Manual ........................................................ 7
2. System Description ....................................................... 8
3. Reordering Information ............................................ 1312
4. Warnings and Precautions ...................................... 1312
5. Hazards and Symbols ................................................. 18
Directions for Use .................................................................. 19
6.
Operating Conditions ................................................... 19
7. Power On and Off ........................................................ 20
8. Setting the Time and Date ........................................... 20
9. Performing a Control Test ........................................... 22
10. Performing a PT Test .................................................. 27
11. Collecting a Fingerstick Sample .................................. 33
12. Reviewing the Memory ................................................ 38
13. Printing ........................................................................ 39
14. Control Strips .............................................................. 41
15. Lithium Polymer Battery .............................................. 42
16. Cleaning and Disinfecting the Meter ............................ 44
17. Troubleshooting ........................................................... 46
18. Performance Characteristics ....................................... 53
19. Meter Specifications .................................................... 54
20. Warranty ...................................................................... 55
21. Index ........................................................................... 57
##. Connectivity (USB, Micro USB, Ethernet) ##
Page 6 For In Vitro Diagnostic Use CoaguSense, Inc.
1. About This Manual
The purpose of the Coag-Sense PT2 Professional 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 PT2
Professional 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 Technical 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.
CoaguSense, Inc. For In Vitro Diagnostic Use Page 7
2. System Description
The Coag-Sense PT2 Professional Prothrombin Time (PT)/INR
System is used for quantitative measurement of Prothrombin
Time (PT) in fresh, capillary whole blood. The Coag-Sense PT2
Professional 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.
Page 8 For In Vitro Diagnostic Use CoaguSense, Inc.
Your Coag-Sense PT2 Professional PT/INR Monitoring System
(Catalog number 03P70-01) comes supplied with:
Coag-Sense PT2 Professional PT/INR Meter
Coag-Sense PT2 Professional PT/INR System Monitoring
User’s Manual
Coag-Sense PT2 Professional PT/INR Monitoring System
Quick Reference Guide
Testing Tips Card
Rechargeable Lithium polymer battery (3.7V, 2350mAh)
(Factory installed)
AC Power Supply
Sample Transfer Tubes Capillary
Sample package of Single-use, Auto Sterile Lancets
Carrying Case
You will also need:
Coag-Sense Professional Test Strip Kit-50
(Catalog number 03P56-50), which includes:
50 Patient Test Strips
2 Low Control Strips
2 High Control Strips
1 Control Strip Activation Solution
54 Sample Transfer Tubes
Isopropyl alcohol or alcohol wipes
Gauze
Single-use Auto Lancets, 21 gauge - box of 100
CoaguSense, Inc. For In Vitro Diagnostic Use Page 9
Puncture-resistant bio-hazard (SHARPS) container
The Coag-Sense PT2 Professional Meter: Top View
Meter
Display
Placeholder
Power
On/Off
Button
ofPT2Top
View
Image
Menu
Buttons
Strip
Insertion
The Coag-Sense PT2 Professional Meter: Bottom View
Page 10 For In Vitro Diagnostic Use CoaguSense, Inc.
Connectivity
*USB
*Micro USB
*Ethernet
Placeholder
ofPT2Bottom
View
Image
The Coag-Sense PT2 Professional Meter: Rear View
Data/Printer
Port
Placeholder
ofPT2Rear
View
AC
Adapter
Jack
Image
The Coag-Sense Test Strip
CoaguSense, Inc. For In Vitro Diagnostic Use Page 11
Sample
Application
Area
flashing when
ready for sample)
Mixing Wheel and
Reaction Well
(Green light
Bar Code
Handle
(Faces down when
inserted into meter)
Page 12 For In Vitro Diagnostic Use CoaguSense, Inc.
Reordering Information
3. Reordering Information
For a description of the products listed below, please see the
information above.
Product Catalog #
Coag-Sense PT2 PT/INR Professional
System
Coag-Sense PT2 PT/INR Professional
System
EU Version
Coag-Sense Test Strip Kit, Box of 50 03P56-50
Coag-Sense Control Strip Kit -10 03P69-10
Sample Transfer Tubes, Pack of 54 03P53-54
Lancets, Normal Depth (Box of 100) 03P58-03
AC Power Adapter – U.S. TBD
AC Power Adapter – EU Version TBD
03P70-01
TBD
4. Warnings and Precautions
CoaguSense, Inc. For In Vitro Diagnostic Use Page 13
Test Site and Blood Sample
The Coag-Sense PT2 Professional PT/INR monitoring
system is for in vitro diagnostic use only.
The Coag-Sense meter will not produce a result if the test
strip is past its expiration date.
The quality of the blood sample can affect PT test results.
A blood sample of poor quality can produce unreliable
results. Read the section on “Collecting a Fingerstick
Sample” for more information.
Blood samples must be applied to the test strip
immediately after collection or the blood begins to clot,
causing unreliable results.
The blood sample transferred to the test strip must be a
minimum of 10 µL in volume. Low sample volume may
cause an error message.
Use only fresh fingerstick capillary blood for testing. The
blood should only come in contact with the products
provided with the Coag-Sense PT/INR system. Other
products may have anti-coagulant agents on their
surfaces and result in unreliable test results.
Squeezing the fingerstick site excessively (milking)
releases interstitial “tissue layer” fluid that can cause
unreliable results.
The fingerstick site can be washed with warm water and
soap, and then completely dried. The site must be clean
of all hand oils/lotions and foreign matter, which may
cause unreliable results.
If Isopropyl Alcohol (IPA) wipes are used, wipe the
fingerstick site with a gauze pad and make sure the site is
Page 14 For In Vitro Diagnostic Use CoaguSense, Inc.
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
The meter is designed with rechargeable lithium polymer
battery (3.7V, 2350mAh).
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.
Do not put the meter in liquid. Do not allow liquids to get
into any of the connectors or plugs on the meter.
CoaguSense, Inc. For In Vitro Diagnostic Use Page 15
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 PT2 Professional PT/INR
monitoring 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
using the AC power adapter, the display screen may go
blank. If this occurs, unplug the power supply from the
Page 16 For In Vitro Diagnostic Use CoaguSense, Inc.
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 PT2
Professional Prothrombin Time (PT)/INR Monitoring
System needs special precautions regarding EMC and
needs to be installed and put into service according to the
EMC information provided in this manual.”
“Portable and mobile RF communications equipment can
affect Coag-Sense PT2 Professional 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 PT2 Professional 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 PT2
Professional Prothrombin Time (PT)/INR Monitoring
System should be observed to verify normal operation in
the configuration in which it will be used.”
Test Strips/ Control Strips/Control Strip Activating Solution
CoaguSense, Inc. For In Vitro Diagnostic Use Page 17
The test strips are designed for single use only. Do not
reuse the test strips.
Patient samples, controls, used strips, transfer tubes and
lancets are potentially infectious. Discard used materials
in a puncture resistant, biohazard waste container using
universal precautions.
PT Test Strips, Control Strips, and Control Strip Activating
Solution are perishable goods with a limited shelf life. Do
not use any of these items if the expiration date has
passed.
Refer to the package insert that is supplied with each box
of test strips for more information.
Page 18 For In Vitro Diagnostic Use CoaguSense, Inc.
5. Hazards and Symbols
Warning. This indicates a warning or precaution,
requiring special attention.
Catalog Number / Model Number
Refer to Instructions for Use
Class II Equipment. The AC 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 and batteries
properly.
CoaguSense, Inc. For In Vitro Diagnostic Use Page 19
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
Page 20 For In Vitro Diagnostic Use CoaguSense, Inc.
Directions for Use
Note ◙: The Coag-Sense PT2 Professional PT/INR monitoring
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 PT2 Professional PT/INR
monitoring 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
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.
CoaguSense, Inc. For In Vitro Diagnostic Use Page 21
7. Power On and Off
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.
DONE NEXT
12:00PM
1/01/17
+ -
2. The blinking characters
may be changed by
pressing + to increase or –
to decrease. When
correct, press NEXT to
advance to the next
character.
Page 22 For In Vitro Diagnostic Use CoaguSense, Inc.
Press NEXT to advance
to next character.
Action Meter Display
3. Once you have entered
the correct date and time,
press DONE to exit this
function.
12:00PM
1/01/17
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.
DONE NEXT
Press DONE when date and
time are correct
+
READY
INSERT
STRIP
OFF
Press SET to adjust date and
time again (if necessary)
SET MEM
8:00AM
3/07/17
DONE
NEXT
+
-
-
Press DONE when date and
time are correct
Note ◙: The clock time does not adjust for daylight savings time.
The date format is mm/dd/yy.
CoaguSense, Inc. For In Vitro Diagnostic Use Page 23
9. Performing a Control Test
Control testing confirms the performance of both the meter and
the test strips and should be completed for each new lot of test
strips. Control testing can also be run whenever the PT results are
unexpected to make sure that the system is working properly.
There are 2 low control strips, 2 high control strips and a control
strip activation solution shipped with each test strip kit. Extra
controls may be ordered separately.
Follow these steps to perform a test on a low or high control.
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. If multiple boxes
of test strips are purchased at the same time and they
have the same lot number, only one low and one high
control from that lot needs to be tested.
Note ◙: If an error message appears, consult the
“Troubleshooting” section of this manual.
Page 24 For In Vitro Diagnostic Use CoaguSense, Inc.
Action Meter Display
1. Make sure that the power is
on by pressing the
(POWER) button on the top
of the meter and the display
looks like this.
READY
INSERT
STRIP
SET
MEMOFF
2. Open a low control package,
tearing at the notched end.
Remove the strip. Set the
package aside.
Note ◙: Make sure that the
expiration date has not
passed by checking the
date on the front of the
control package.
3. 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.
4. When the strip is correctly
inserted, the display looks
like this
CoaguSense, Inc. For In Vitro Diagnostic Use Page 25
LOW CONTROL
DETECTED
Action Meter Display
Note ◙: If anything other than this is displayed, refer to the
“Troubleshooting” section.
5. The meter warms the strip.
The display looks like this.
It shows a countdown of
the time remaining during
the warm-up cycle.
STOP
Note ◙: Do not apply the control
activation solution until
the warm-up is complete
and the meter tells you
to do so.
6. The meter beeps once when
it is ready for the control strip
activation solution. The
screen looks like this.
WARMING
PLEASE WAIT
24
Warming count down
in seconds
APPLY
CONTROL
SOLUTION
STOP
Note ◙: You now have up to 2 ½ minutes to apply the activation
solution to the control strip.
7. Open the control activation
solution and hold at an angle
to allow insertion of the
transfer tube.
8. Holding the transfer tube
below the bulb, insert into
control activation solution.
Let capillary action fill glass
portion of tube until flow stops.
Page 26 For In Vitro Diagnostic Use CoaguSense, Inc.
Action Meter Display
Note ◙: DO NOT SQUEEZE THE BULB. Be careful to avoid
getting bubbles in the transfer tube.
9. Rest hand on instrument to
steady. Move fingers to flat
sides of bulb being sure to
cover air holes. Insert tip into
sample application well of
test strip, touching tip down
on strip at flashing green
light. Slowly squeeze bulb
until solution leaves tube.
Placeholder to insert
tip into sample
application well of test
strip
10. When the control activation
solution is properly applied
and detected, the flashing
green light will turn off, and
the meter display looks like
this.
TESTING
PLEASE WAIT
Note ◙: If this screen is not displayed, either not enough solution was
applied or the solution had bubbles in it. Remove the strip.
Retest with a new control strip. DO NOT attempt to add more
solution to the strip.
11. When testing is complete,
the display shows “OK” and
looks similar to this.
LO CONTL OK
PT 22.5
10/18/17 8:01 AM
REMOVE STRIP
CoaguSense, Inc. For In Vitro Diagnostic Use Page 27
Action Meter Display
Note ◙: To avoid confusing control strip INR results with patient test
strip INR results, control test results will display in PT
seconds only.
Note ◙: The date and time shown in the display are examples only.
The date and time shown after actual testing is the current
date and time.
Note ◙: If anything other than this is displayed, refer to the
“Troubleshooting” section.
Note ◙: Remember to repeat this entire procedure with a high
control strip.
12. When high control testing is
complete, the display shows
“OK” and looks similar to this.
HI CONTL OK
PT 42.1
10/18/17 8:05 AM
REMOVE STRIP
13. Once the controls have been successfully tested, remember to
throw the control strips into a biohazard container. You can now
proceed to testing patient blood samples. If you are not going to
test, turn off the meter by pressing the POWER button. The
opened control activation solution may be used until the
expiration date.
Page 28 For In Vitro Diagnostic Use CoaguSense, Inc.
10. Performing a PT Test
WARNING:
surface for testing. Do not move the meter or allow it to
vibrate during a test. Unreliable results may occur. Wear
gloves and follow all applicable hygiene and safety
procedures.
Action Meter Display
1. Make sure that the meter is
on by pressing the
(POWER) button on the top
of the meter.
Place the meter on a stationary, level
READY
INSERT
STRIP
Note ◙: If an error message
OFF
appears, refer to the
“Troubleshooting”
section.
2. Open a PT test strip package, tearing at the notched end. Remove
the strip. Set the package aside.
Note ◙: Make sure that the expiration date has not passed.
3. 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 holder.
CoaguSense, Inc. For In Vitro Diagnostic Use Page 29
SET
MEM
Action Meter Display
4. When the patient test strip is
correctly inserted, the
display looks like this.
PAT.
STRIP
DETECTED
5. The meter warms the strip.
The display looks like this.
The meter counts down the
time remaining during the
warm-up cycle.
WARMING
PLEASE WAIT
24
Note ◙: Do not apply any
sample until the
warm-up is complete
and the meter tells you
do so.
STOP
Warming count down
in seconds
While the meter is warming up, get ready to perform a
fingerstick. See “Collecting a Fingerstick Sample” in this
manual.
Page 30 For In Vitro Diagnostic Use CoaguSense, Inc.
Action Meter Display
6. When the warm-up is
complete, the meter
beeps once. The screen
looks like this.
APPLY
SAMPLE
Note ◙: You now have up to 2
½ minutes to perform
fingerstick and apply
the sample to the test
strip.
7. IMMEDIATELY after
collecting the patient
sample, place the tip of the
sample transfer tube at a
45º angle into the sample
well on the test strip where
you see the flashing green
light. Gently touch the tip
down onto the sample well.
8. Slowly squeeze the bulb
until the blood leaves the
tube being careful not to
introduce air bubbles into
the sample. Keep pressure
on bulb while you pull your
hand away to avoid back
suction of sample.
STOP
Placeholdertoshowtip
ofthesampletransfer
tubeintothesample
wellontheteststrip
9. Discard the sample transfer
tube in a biohazard waste
container.
CoaguSense, Inc. For In Vitro Diagnostic Use Page 31
Action Meter Display
10. When the sample is
detected, the meter
display looks like this.
Note ◙: If this screen is not displayed, either not enough blood
sample was applied or the sample had air bubbles in it.
Remove the strip and retest with a new strip.
PLEASE WAIT
TESTING
11. When testing is complete,
the meter beeps once.
The results (INR and PT
in seconds) are shown on
the screen.
INR 2.2
PT 22.2
10/18/17 8:50 AM
REMOVE STRIP
Note ◙: If any display other than the one shown is visible (such as
CLOT TIME TOO SHORT or NO CLOT DETECTED), refer
to the “Troubleshooting” section.
12. Record the results. Then remove the test strip. Throw it away in a
biohazard collection container.
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.
Turn the meter off by pressing the
POWER
button when you
are finished testing. If left unattended, the meter automatically
turns off in a few minutes.
Page 32 For In Vitro Diagnostic Use CoaguSense, Inc.
The last 100 test results are stored in memory with the time
and date. Refer to “Reviewing the Memory” in this manual for
more information.
CoaguSense, Inc. For In Vitro Diagnostic Use Page 33
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.
Be sure to confirm whether the patient has any of these
conditions before you begin testing, and any time there are
changes in health patient 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
. Consider re-testing using an alternative
method prior to adjusting the patient’s dose of anticoagulant
medication, or any other corrective actions.
Page 34 For In Vitro Diagnostic Use CoaguSense, Inc.
11. 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
Sterile alcohol prep pads
Gauze square
Band-Aids
Biohazard waste container (SHARPS)
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, have the patient
warm their 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
CoaguSense, Inc. For In Vitro Diagnostic Use Page 35
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.
Squeeze the finger from the
sides to open up the wound for proper blood flow if
necessary to produce pea sized drop.
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.
Page 36 For In Vitro Diagnostic Use CoaguSense, Inc.
Action Meter Display
1. Have patient wash hands
with soap and warm water.
Dry completely.
2. Choose a site 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.
3. Clean the fingertip with an
alcohol wipe using one side
for the first cleaning. Use
the second side for a final
wipe.
4. Dry the fingertip with gauze
to remove any excess
alcohol.
5. Place the patient’s hand on
a solid surface with the
palm of the hand facing up.
CoaguSense, Inc. For In Vitro Diagnostic Use Page 37
Action Meter Display
6. 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.
WARNING:
Squeezing the fingerstick site
excessively (milking) releases interstitial “tissue layer” fluid
that can cause unreliable results.
Page 38 For In Vitro Diagnostic Use CoaguSense, Inc.
Action Meter Display
7. When ready to collect the
drop of blood, hold the
Sample Transfer Tube
between your thumb and
forefinger below the bulb,
being sure not to cover the
air hole in bulb. DO NOT
SQUEEZE THE BULB.
8. With tube horizontal touch
tip to bead of blood. Let
capillary action fill the glass
portion of tube until the
blood flow stops at the
black line. Squeeze finger
to produce additional blood
if required to completely fill
glass portion of tube.
9. Once you have collected
the sample,
put it into the sample well
on the test strip. See
“Performing a PT Test”
section of this manual.
IMMEDIATELY
WARNING:
If there is a bubble or an air pocket
showing in the blood sample in the transfer tube,
start the test over with a fresh fingerstick on a different
finger.
CoaguSense, Inc. For In Vitro Diagnostic Use Page 39
12. Reviewing the Memory
The Coag-Sense PT2 Professional meter stores up to 100 results,
along with the date and time in its memory. When the 100th result
is reached, the first result 1 is replaced (written over) with test
results for test number 101. This continues with the oldest result
being replaced with the most recent. Memory is not lost if there is
a break in power for any length of time. Memory cannot be erased.
Action Meter Display
The memory can be accessed
from any mode that displays a
MEM button.
1. Press MEM. The meter
displays the last two records.
2. Press PREV or NEXT to
scroll through the result
records.
3. Press DONE when finished.
Example of display with two
most recent records:
2/07/17 12:56 PM
INR 5.2 PT 49.1
2/06/17 12:56 PM
INR 2.9 PT 28.8
NEXT PREVDONE
Page 40 For In Vitro Diagnostic Use CoaguSense, Inc.
13. Printing
With the optional portable printer and cable, results from the
Coag-Sense meter memory can be printed on either thermal
paper or other media such as thermal labels for applying to patient
charts.
What you’ll need:
Coag-Sense meter
running software
version 3.94 or greater
Pocket Printer,
Catalog # TBD thermal
portable printer
Thermal Paper,
Catalog #
PD99906-OM or 2”
wide thermal labels
Printing Test Results:
CoaguSense, Inc. For In Vitro Diagnostic Use Page 41
1. Refer to the User Manual provided with the printer for
general operation.
2. Connect the cable to the back side of the Coag-Sense
meter, and the other connector to the printer.
3. When printing is required, turn on the printer after the
Coag-Sense meter has finished testing.
4. Press MEM. The two most recent results in memory will
be shown. If you wish to go further back into the meter’s
memory to print a result press NEXT. Continue to press
NEXT until the desired result(s) are visible in the display.
Press PREV if you need to scroll back to more recent
results.
5. Once you have the result(s) you wish to print displayed,
press PRINT then press PRN1 to print the top result
displayed or PRN2 to print the bottom result displayed.
If the results fail to print, confirm that the printer is on as it
automatically turns off after a few minutes. If the printer turns
off after attempting to print, then the batteries in the printer are
too weak and should be replaced.
For assistance with the printing function call Technical
Support at 1-866-903-0890.
Page 42 For In Vitro Diagnostic Use CoaguSense, Inc.
14. Control Strips
Quality control is an important part of PT testing to verify the
integrity of the performance characteristics of the testing system.
The Coag-Sense Meter has been designed with multiple internal
systems to ensure proper system function. When turned on, the
meter runs an extensive self-check protocol to assure, for
example, that room temperature, timing functions, optical and
mechanical functions are within specification. There are 2 low
control strips, 2 high control strips and a control strip 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 reagents’ ability to
generate a clot and the analyzer’s ability to detect a clot. Control
testing confirms the performance of both the meter and test strips
and should be completed for each new lot of test strips.
15. Rechargeable Lithium Battery
Description and statements to be added.
CoaguSense, Inc. For In Vitro Diagnostic Use Page 43
16. Cleaning and Disinfecting the Meter
No maintenance is required other than routine cleaning and/or
disinfecting. To clean the outside of the meter use a clean damp
non-abrasive cloth.
If instructions for use are properly followed, patients should not
come in direct contact with the Coag-Sense PT2 Professional
meter thereby reducing the possible transmission of bloodborne
pathogens between patients. Sample should always be
transferred from the patient to the meter using a new disposable
sample transfer tube.
The meter housing can be disinfected using a 10% bleach
solution (EPA reg. No. 5813-50) or 70% isopropyl alcohol. Apply
the disinfecting product to a lint-free cloth and wipe the meter for
a minimum contact time of 2 minutes. Alcohol prep pads may also
be used.
Placementonwhereto
cleanoutsidemeter
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
Page 44 For In Vitro Diagnostic Use CoaguSense, Inc.
should be avoided. Please call Technical Support at
1-866-903-0890 if this area requires cleaning/disinfecting.
After disinfecting the meter, gloves should be removed and hands
washed before proceeding to the next patient.
Please call Technical Support at 1-866-903-0890 with any
cleaning or disinfecting questions.
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.
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://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025
.htm
“CDC Clinical Reminder: Use of Fingerstick Devices on More than One
Person Poses Risk for Transmitting Bloodborne Pathogens” (2010)
http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.htm
CoaguSense, Inc. For In Vitro Diagnostic Use Page 45
17. Troubleshooting
You may see the following error messages while using the
Coag-Sense meter. This section discusses 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 Solution
REMOVE
STRIP
NO SAMPLE
DETECTED
Meter turned off with
used strip in it.
If no strip present
possible shipment
damage.
Either no sample or not
enough sample was
applied to the strip
within 2
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.
1/2 minutes
Remove the strip and
begin again.
Call Technical Support
Repeat the entire
procedure (including
fingerstick on a different
finger) with a new strip.
Apply the sample
within 2
after display of the
“Apply Sample”
message.
Ensure that the
transfer tube
touches the sample
well before
dispensing sample.
1/2 minutes
Page 46 For In Vitro Diagnostic Use CoaguSense, Inc.
Meter Display Possible Cause Solution
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 of using 21g
needle lancet for good
flow of blood).
Repeat the entire
procedure (including
fingerstick on a different
finger) with a new strip.
Verify that the Sample
Transfer Tubes exhibit
proper capillary action.
Visually confirm that no
air bubbles are in the
sample before applying
to test strip.
Gently squeeze the
transfer tube bulb until
the blood exits being
sure not to introduce air
bubbles.
If the same message
repeats, contact
Technical Support.
CoaguSense, Inc. For In Vitro Diagnostic Use Page 47
Meter Display Possible Cause Solution
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 glass
portion of transfer tube,
or the sample was
drawn back into the
transfer tube before
removing tip from the
test strip well.
Confirm that the patient
has not recently taken
heparin or other
contraindicated drugs
listed on the test strip
package insert.
Verify that the Sample
Transfer Tubes exhibit
proper capillary action.
Visually confirm that no
air bubbles are in the
sample and that the
glass portion of the
transfer tube is full
before applying to test
strip.
Release pressure on the
transfer tube bulb only
after removing transfer
tube from sample
application well.
Repeat the entire
procedure (including
fingerstick) with a new
strip. If the same
message displays, use
an alternative testing
method and contact
Technical Support.
Page 48 For In Vitro Diagnostic Use CoaguSense, Inc.
Meter Display Possible Cause Solution
TEST STRIP
EXPIRED SEE
MANUAL
CONTROL
OUT OF
RANGE
ROOM TEMP
INCORRECT
SEE MANUAL
The lot of strips has
expired.
Date is incorrect.
The control strip result
is outside of its
acceptable 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.
The temperature of the
room is either below or
above the operating
temperature range of
the meter.
Use a different lot of
strips that has not
expired.
Verify the date setting
on the meter is current.
Repeat test with another
control strip. If the
second test is out of
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.
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.
CoaguSense, Inc. For In Vitro Diagnostic Use Page 49
Meter Display Possible Cause Solution
WHEEL
PROBLEM
BAR CODE
READ
FAILURE
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.
The strip was inserted
at an incorrect angle or
speed.
There may be a
problem with the bar
code on the strip or
with the bar code
reader in the meter.
The meter is in direct
sunlight or near a
high-intensity light
source.
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.
If the message displays
again, contact Technical
Support.
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.
Move the meter indoors
into room lighting or
away from light source.
If error persists, try
again with another strip.
If the message displays
again, contact Technical
Support.
Page 50 For In Vitro Diagnostic Use CoaguSense, Inc.
Meter Display Possible Cause Solution
HEATER
PROBLEM
DETECT
PROBLEM
The meter is too warm
or too cold, or there
may be a problem with
the meter.
There may be a
problem with the strip
insertion or with the
motor carriage in the
meter.
Move the meter to a
place that is within the
operating temperature
range of the meter (57ºF
to 90ºF, 14ºC 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.
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.
CoaguSense, Inc. For In Vitro Diagnostic Use Page 51
Meter Display Possible Cause Solution
LIQUID
PROBLEM
MOTOR
PROBLEM
There may be a
problem with the strip
or with the optical
system of the meter.
There may be a
problem with the motor
function 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.
Turn the meter off then
back on. Try again with
another strip. If the
message persists,
contact Technical
Support.
Page 52 For In Vitro Diagnostic Use CoaguSense, Inc.
18. 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
CoaguSense, Inc. For In Vitro Diagnostic Use Page 53
19. Meter Specifications
Operating Temperature 65°F to 90°F (18°C to 32°C)
Operating Humidity 10% to 85% (without condensation)
Storage Temperature -4°F to 122°F (-20°C to 50°C)
Storage Humidity 10% to 85% (without condensation)
Memory
Lithium Battery
AC Input
Power Output 5.0V, 2.0A
Blood Sample Size 10-12 µL
Ports USB, Micro USB, Ethernet
Size 1.2” x 3.9” x 5.9”
Weight 0.67 lbs.
Equipment Classification Class II with external power supply.
Capable of storing 100 tests with time and
date
Rechargeable lithium polymer battery
(3.7V, 2350mAh)
120V AC (Use with Coag-Sense Adapter
Only)
Internally powered when operated with
batteries. IPXO rating.
WARNING:
Use only the Coag-Sense AC adapter or
damage to the meter may result.
Page 54 For In Vitro Diagnostic Use CoaguSense, Inc.
20. Warranty
Limited One (1) Year Warranty
Use of the Coag-Sense PT2 Professional PT/INR Monitoring
System
The Coag-Sense PT2 Professional PT/INR monitoring 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
CoaguSense, Inc. For In Vitro Diagnostic Use Page 55
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 using 10% bleach solution as described in the
“Cleaning and Disinfecting the Meter” section. The original
packaging may be required for this purpose. If this is not available,
a cushioned shipping box may be required.
Page 56 For In Vitro Diagnostic Use CoaguSense, Inc.
21. Index
A
AC Adapter, 20
AC Power, 41,42
Air Bubbles, 30
Alcohol Wipe, 33
B
Bar Code Read Failure, 50
Blood Flow, 33
Blood- Minimum Amount, 36
C
Calibration, 8
Class II Equipment, 18
Cleaning the Meter, 44
Clock, 21
Clot Time Too Long, 48
Clot Time Too Short, 47
Collecting a Fingerstick Sample,
33
Control Out of Range, 49
Control Strips, 41
Customer Service, 3, 19, 60
D
Date, 20, 21, 31, 38, 41
Detect Problem, 51
E
E-Mail Support, 60
Expected Values, 53
F
Fingerstick Sample, 33
Flashing Green Light, 29
H
Hazards And Symbols, 18
Heater Problem, 51
High Control Strip, 22, 26
I
IEC 60601-1, 15
INR, 8
INR Results, 30
L
Lancet, 14, 36
Liquid Problem, 52
Lithium Polymer Battery 42
Low Control Strip, 22
M
Measuring Range, 53
Memory, 31, 38
Meter, 10, 14
MiniPipette, 24
Motor Problem, 52
N
No Sample Detected, 46
Normal Range, 53
P
Performing a Control Test, 22
Performing a Patient Test, 27
Power, 38
Printing, 39
PT, 30
PT Test Strip, 27
CoaguSense, Inc. For In Vitro Diagnostic Use Page 57
R
Remove Strip, 46
Room Temp Incorrect, 49
S
Sharps Container, 33
System Description, 8
T
Test Strip, 11
Troubleshooting, 46
U
Unexpected Results, 32, 34
W
Warnings and Precautions, 12
Warranty, 55
Wheel Problem, 49
Page 58 For In Vitro Diagnostic Use CoaguSense, Inc.
FCC Statement
Federal Communication Commission Interference
Statement
This equipment has been tested and found to comply with
the limits for a Class B digital device, pursuant to Part 15 of
the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a
residential installation. This equipment generates, uses and
can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause
harmful interference to radio communications. However,
there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful
interference to radio or television reception, which can be
determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one of the
following measures:
● Reorient or relocate the receiving antenna.
● Increase the separation between the equipment and
receiver.
● Connect the equipment into an outlet on a circuit different
from that to which the receiver is connected.
● Consult the dealer or an experienced radio/TV technician
for help.
This device complies with Part 15 of the FCC Rules.
Operation is subject to the following two conditions: (1) This
device may not cause harmful interference, and (2) this
device must accept any interference received, including
interference that may cause undesired operation.
FCC Caution: Any changes or modifications not expressly
approved by the party responsible for compliance could void
the user’s authority to operate this equipment.
This device and its antenna(s) must not be co-located or
operation in conjunction with any other antenna or
transmitter.
For product available in the USA/Canada market, only
channel 1~11 can be operated. Selection of other channels
is not possible.
This device is going to be operated in 5.15~5.25GHz
frequency range, it is restricted in indoor environment only.
IMPORTANT NOTE:
FCC Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits
set forth for an uncontrolled environment.
This equipment should be installed and operated with
minimum distance 20cm between the radiator & your body.
서식 있음: 영어(미국)
Technical Support
CoaguSense, Inc.
48377 Fremont Blvd., STE 113
Fremont, CA 94538
Toll Free: 1-866-903-0890
E-Mail
:
techsupport@coagusense.com
i-SENS, Inc. www.i-sens.com
43, Banpo-daero 28-gil,
Seocho-gu, Seoul 06646, Korea
EMERGO EUROPE
Prinsessegracht 20
2514 AP, The Hague
The Netherlands
Product Made in U.S.A
. Korea
REF Part No. 100220200220
CSI P/N 100220 200220 Rev AHDRAFT
Loading...