Roche CoaguChek INRange User manual

Free up your life with
CoaguChek®INRange
CoaguChek INRange
Sales Pack
On warfarin?

Freephone Care Line 0808 100 7666 (ROI 1 800 992 868) or visit shop.coaguchek.com 3
Hello
ank you for purchasing the CoaguChek®INRange self-monitoring
meter. is brochure provides you with all the information you need about
anticoagulation therapy and regularly monitoring your International
Normalised Ratio (INR) with your CoaguChek INRange meter.
It also explains how the CoaguChek INRange works and how
self-monitoring with it could benet you, both in terms of your
therapy management and your lifestyle.
If you’d like more information about your CoaguChek INRange meter,
please call Freephone 0808 100 7666 (ROI 1 800 992 868) or
visit shop.coaguchek.com
Please read the returns policy on page 4 before opening your CoaguChek INRange box.
Included with this pack are:
• Contact Card with contact details
• Training DVD
• CoaguChek INRange meter kit
• Pack of 6 strips

4Freephone Care Line 0808 100 7666 (ROI 1 800 992 868) or visit shop.coaguchek.com
Return Options
For your CoaguChek®INRange
We make every effort to ensure your order reaches you in perfect condition.
However, if there is a problem with your order, or your goods are damaged or faulty, please contact
us as soon as possible by calling our customer Care Line on 0808 100 7666 (ROI 1 800 992 868).
Alternatively, email us at burge[email protected] or you can write to us at:
Roche Diagnostics Limited
Charles Avenue
Burgess Hill
West Sussex
RH15 9RY
United Kingdom.
Please read this
section before
opening your
CoaguChek INRange meter box

5Freephone Care Line 0808 100 7666 (ROI 1 800 992 868) or visit shop.coaguchek.com
Return Options
For your CoaguChek®INRange
Your 14 day cooling-off period
Please watch the training DVD that accompanied this pack before opening your meter box
(please call the above number if you did not receive this).
You have the legal right to cancel your purchase up to 14 days after receiving your meter from us.
You must return the meter in its original condition (original box unopened and the meter therefore
unused) within the 14 day deadline to exercise your right to cancel, in which case we shall issue a
full refund for the price you paid for the meter.
Further details of your rights of cancellation, return and refund are set out in our terms and
conditions of sale, which can be found here:
shop.coaguchek.com/sale-terms-and-conditions/
CoaguChek Warranty
To activate your two year warranty, please visit shop.coaguchek.com/warranty/

6Freephone Care Line 0808 100 7666 (ROI 1 800 992 868) or visit shop.coaguchek.com
CoaguChek®INRange
What’s in the Pack?
Now that you have purchased your CoaguChek INRange
meter, you can test at a time more convenient to you, even
on holiday. So this can save you time and expense by
cutting down the number of clinic visits you need to make.
We provide a 2 year warranty on every CoaguChek INRange
meter purchase.
What’s in the pack?
CoaguChek INRange meter
6 test strips
CoaguChek Softclix
lancing device
20 Softclix XL lancets
4 x AAA batteries
Carry case – for all of
the above
User manual, including
short instruction guide
Self-Monitoring gives you the freedom
and exibility to test when you want

7Freephone Care Line 0808 100 7666 (ROI 1 800 992 868) or visit shop.coaguchek.com
Accuracy and precision in INR monitoring1
Results you can trust,
wherever you are
CoaguChek INRange meter:
• Uses the same technology as clinic-based
CoaguChek devices
• CoaguChek strip technology to ensure
accuracy of results
• Allows you to set your own therapeutic range
• Easy to handle, intuitive functionality and
battery powered
Test strips
• On-Board Control System for accurate day
to day running of the meter, without needing
control solutions
• The strip can be filled from the top or side
to make sampling easier and reduce any
contamination risk.
• Strips can be stored at room temperature
(2 - 30ºC)
• Available on NHS prescription in the UK only
(at your GP’s discretion)
• Strips available in packs of 24
CoaguChek®INRange
Designed for today’s lifestyles

Freephone Care Line 0808 100 7666 (ROI 1 800 992 868) or visit shop.coaguchek.com
A Step by Step Guide
How to test with the CoaguChek®INRange
8
Select Set Targets
and press the Enter
button to open the
corresponding menu.
After startup, Test is pre-
selected. Press the enter
button to start the test.
Once complete, you have
180 seconds to apply
blood to the test strip.
48
A beep tone indicates that you have applied
enough blood (if you have activated the
beeper function). The blood drop symbol
disappears and the test starts.
Do not add more blood. Do not touch the
test strip until the result is displayed.
The meter now performs an automatic quality
control check on the test strip. Following a
successful outcome of the quality control
check, the coagulation measurement starts.
The circular progress bar spins until the meter
has determined the result.
Test
Blood applied
Quality check complete
Test
Measuring...
Testing a Capillary Blood Sample
CoaguChek INRange User’s Manual
Set Targets
Performing a test
Select the desired time
period for results to be
displayed. Press the Enter
button to confirm the
selected time period.
Insert code chip if
prompted.
Lance the side of a
fingertip, apply the first
blood drop to test strip.
The current selected
option is indicated by a
green dot on the right.
Apply the blood to the
sample application area
within 15 seconds.
Select the value you wish
to set and press the Enter
button to proceed.
Slide the test strip into the
guide in the direction of
the arrows.
A beep tone indicates
that you have applied
enough blood.
Repeat last steps to set
the second value. Select
Confirm and press the
Enter button to save.
The meter reads the strip
information (from the
barcode on the test strip).
The meter now performs an
automatic quality control
check on the test strip.
Once test strip is checked
successfully, screen shows
test strip warming up.
Please review these tips for
getting a good drop of blood.
Increasing the blood flow in your
finger will help you get a good
drop of blood:
• Warm your hand. Hold it under
your arm, use a hand warmer,
and/or wash with warm water.
• Let your arm hang by your side.
• Massage your finger from its
base.
Use these techniques until your
fingertip has good colour.
1. Wash Hands
Wash your hands in warm,
soapy water. Make sure your
fingertip is thoroughly dry.
2. Get Ready
Take a test strip out of the
container. Close the container
tightly. Note: You have 10
minutes to use a test strip once
you remove it from the container.

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A Step by Step Guide
Interpreting and Analysing your results
To add a comment, highlight
Add Comment and go to
the comment list.
Green bar if within target
range. (Arrow shows
whether results are higher
or lower than before.)
Result Display
If your results are displayed in INR:
Use and to
highlight, confirm and
proceed with settings.
Blue bar if above target
range (with words
underneath).
If the list of previously
selected comments is
correct, press .
Yellow bar if below
target range (with
corresponding text).
The result screen now
shows the Comment
symbol . Test is complete.
Remove test strip, turn the
meter off and dispose of
the test strip.
From the Main Menu,
use to open the My
Results menu, select
Trend and press to
display the report.
The report above is
shown as Graph view.
Displaying a Trend report Displaying a Target report
In Table view test results
are shown in a list. The
oldest date is shown at
the bottom and the most
recent date at the top.
Use to select the
time period you want.
Test results above or
below the measuring
range are marked
accordingly. These test
results appear in red in the
table and are not displayed
in the trend graph.
From the Main Menu,
use to open the My
Results menu, select
Target and press to
display the report.
Use
to select the
time period you want to
evaluate. Press to toggle
between graph and table
display. Press the Back
button to return to the My
Results menu.
29 Jun 2015

10 Freephone Care Line 0808 100 7666 (ROI 1 800 992 868) or visit shop.coaguchek.com
CoaguChek INRange keeps you
connected with your clinic
•
Built-in reminders for testing, medication, and appointments to help you
• Bluetooth technology keeps you connected by letting you transmit your results, so you can
keep on track and in range - anytime, anywhere
• Easy-to-use app can be downloaded free and is available in areas where the anticoagulation
clinic has signed up for the service.
• If your clinic has not signed up for connectivity options or you wish to learn more, please
contact the Care Line team who can advise
CoaguChek®INRange
New Features of the CoaguChek INRange
Self-test your INR at home whilst staying connected to the clinic, giving you
confidence and control of your warfarin therapy

11Freephone Care Line 0808 100 7666 (ROI 1 800 992 868) or visit shop.coaguchek.com
A Step by Step Guide
New connectivity soware of the CoaguChek®INRange
The INRange is able
to communicate with
a computer and/or
other devices either via
Bluetooth or USB.
From the Main Menu, use
to open the
My Results.
Open the My Results
menu. Select Transfer
Data and press the
Enter button to start the
data transfer mode.
Data Transfer
Data Transfer
Data Transfer
Bluetooth
None
USB
Save
Data Transfer
Bluetooth
None
USB
Save
Transfer Data
Data Transfer
Data Transfer
Complete
Data Transfer
Data Transfer
Complete
The Step by Step Guide information is based on the CoaguChek INRange User Manual (07408811001) V1. Please see full document for detailed instructions
Date Transfer - to enable transfer mode on your CoaguChek INRange meter
Data Transfer – USB
Data Transfer – Bluetooth
The setting for “Data
Transfer” are either “None”,
“Bluetooth” or “USB”.
Select ‘USB’ from the list
of options.
Press to open the
My Results menu.
The settings for “Data
Transfer” are either “None”,
“Bluetooth” or “USB”.
Select ‘Bluetooth’ from the
list of options.
Connect the cable to the
INRange meter first and
then connect to your
laptop or PC.
Select Transfer Data and
press to start the data
transfer mode.
The meter now waits for a
connection to the paired
device to start.
Data transfer must be
actively triggered by the
computer or device.
When the connection has
started and the download
command has been sent,
the meter informs you
about the progress.
Once complete, remove
the USB cable to save
battery power.
An information screen
may appear after the
data transfer is complete.
It may contain, e.g.,
information about
available software updates
or a change of settings
applied to the meter.
You can now connect your CoaguChek INRange device to your PC / laptop (via USB cable) or phone (via an App) if you prefer.
Once transfer mode has been enabled, you then have the option transfer via USB or Bluetooth (if your clinic supports the use of Apps for sending
results) if you wish. You do not need to use the connectivity functions if you would prefer not to.

12 Freephone Care Line 0808 100 7666 (ROI 1 800 992 868) or visit shop.coaguchek.com
Calls to this number will be charged at your standard network rate. Roche has no control over and accepts no responsibility for calls made to this number.
CoaguChek®INRange
e Connected Solution
Connectivity options are available in certain locations across the
UK & Ireland. Details of two options are described here:
LumiraDx now offers a range of care
programmes for individuals delivered via
engage – an easy-to-use patient app which
is fully integrated with INRstar and designed
to give patients the knowledge, skills and
confidence to gain freedom and better
control of their health. engage is available on
smartphone, web and tablet.
Seamless connection – reduces data entry errors
engage integrates with CoaguChek INRange
so that existing and new self- testers can send
their INR result directly to their INRstar patient
record where the clinic can review and send
you back your dose
We do all the training and give you full support
engage provides all the step-by-step training
and support you need to get started with self-
testing with engage.
LumiraDx Engage App
To learn more, contact
LumiraDx on 01209 710999 (option 2) or call the CoaguChek Care Line

13Freephone Care Line 0808 100 7666 (ROI 1 800 992 868) or visit shop.coaguchek.com
CoaguChek®INRange
Connect to the clinic via an
App on your phone
App connectivity options are offered by third party companies, separate from Roche Diagnostics Limited. Roche has no control over and accepts no responsibility for
the content of the third party websites listed. Please note that the contact information provided above are for direct contact with the suppliers of the App connectivity
options. App connectivity options are dependent on your location. To learn more, contact us via the details below
Track, monitor and manage your INR with My
Inhealthcare. My Inhealthcare connects you to
your nurse or doctor meaning you can receive
your warfarin regime and submit INR readings
wherever you are. With Bluetooth connectivity to the
CoaguChek INRange device, staying on top of your
INR has never been easier.
This handy app will enable you to:
• Send INR readings directly to your doctor or nurse
• Review historic readings and results over time
• Receive new dosage instructions from your
GP or nurse
Where the App is available, a registration code is
needed to connect you to your surgery. This will
have been given to you by your GP or nurse.
Inhealthcare My Inhealthcare App
To learn more, visit
www.inhealthcare.co.uk/inrange or call the CoaguChek Care Line

14 Freephone Care Line 0808 100 7666 (ROI 1 800 992 868) or visit shop.coaguchek.com
Training
CoaguChek®INRange Training Check List
e training check list can be used in conjunction with the User Manual and
training resources (summarised on the opposite page) to help guide you through
training of your meter. Please read your entire User Manual before you use the
meter. e User Manual accompanies every CoaguChek INRange meter purchase
and can be found in the same box as your meter.
Criteria
Meter Set Up
Batteries
Display check
Date Format
Date Setting
Time Format
Time Setting
Set Test
Measurement Value
Beep Tone
Therapeutic Range
Setting
CoaguChek INRange Test
Strips
Storage conditions
Handling test strip
Calibration Code Chip
Changing Code Chip
Onboard Quality Control
Sample dosing area
Criteria
Performing A Test
Switch meter on
Checking screen
Insertion of test strip
Confirm code lot number
Strip warming
Operation of Softclix device
Device components
Removal of protective cap
Insertion of lancet
Priming device
Depth setting
Firing lancet
Ejecting lancet
Criteria
Obtaining a
fingerprick sample
Handwashing
Sites for taking a sample
Time limits
Sampling problems
Recording results
Anticoagulation
Record Book
Memory
Retrieving saved results
Maintenance &
Troubleshooting
Cleaning meter
Common error codes
Technical support
CoaguChek Patient
Care line:
0808 100 7666

15Freephone Care Line 0808 100 7666 (ROI 1 800 992 868) or visit shop.coaguchek.com
Support
How can we help?
Naturally any help you need to get you started and support you along the way
is provided and includes:
• Freephone access to CoaguChek®Care Line (including one to one telephone training)
and free technical support
• Videos, articles and testimonials available at shop.coaguchek.com
• Start-up patient support pack including step-by-step guide and training DVD
• 2-year warranty - activate now at shop.coaguchek.com/warranty/
• Helicon Health Limited have created eLearning courses, designed to provide the knowledge,
skills and confidence to monitor oral anticoagulation therapy. Introductory modules are available
free of charge and offer educational content on:
- The benefits of self-monitoring, testing your INR using a coagulometer and how anticoagulants
affect blood clotting.
- Visit www.strokeprevent.live to learn more
• Support from patient charities including:
- AntiCoagulation Europe www.anticoagulationeurope.org
- Arrhythmia Alliance www.heartrhythmcharity.org.uk
- AF Association www.atrialfibrillation.org.uk
- Children’s Heart Federation www.chfed.org.uk
The links listed above are for patient charity websites and Helicon Health Limited training.
Roche has no control over and accepts no responsibility for the content of any of these third party websites.

16 Freephone Care Line 0808 100 7666 (ROI 1 800 992 868) or visit shop.coaguchek.com
Living With Anticoagulation
Nutrition
Oral anticoagulants create a deciency of vitamin k, slowing your
blood’s ability to clot.
Many people being treated with oral anticoagulants such as warfarin wonder if they should restrict
the amount of vitamin K they consume in their food (which might reduce the effectiveness of their
warfarin). In the first instance patients should talk to their health care professional for advice.
It is important to eat a consistent, healthy diet when taking warfarin.
Patients taking oral anticoagulants are advised against dramatically altering their diet e.g. from
eating few vegetables to a strict vegetarian or vegan diet with lots of vegetables. If you would
like to make this switch, your INR should be checked more regularly during the period when the
diet is being changed. A healthy and diversified diet followed by anticoagulant therapy adjusted to
your personal requirements is of core importance.
What is definitely unhelpful for your INR value is irregular consumption of vegetables i.e. eating a
lot of green vegetables one day and none the next.
Does diet or alcohol affect INR monitoring?
Yes, it does. What you eat and drink can raise or lower your INR levels, so it’s important to have
a balanced diet while you’re self-monitoring. Your healthcare professional will be able to give you
further support and information with this.
For more information regarding diet and nutrition with anticoagulation, look at our blog posts on
the shop.coaguchek.com website or visit:
http://webarchive.nationalarchives.gov.uk/+/www.nhs.uk/Conditions/Anticoagulants-
warfarin-/Pages/Interactions---other-medicines.aspx
W
hy anticoagulation self-monitoring makes the difference
Self-monitoring coagulation allows patients to check their INR value – no matter where and when.
Awareness of
dietary impact Joy of eating
Security through
individual testing
This means:
The link above is not owned by Roche Diagnostics. Roche has no control over and accepts no responsibility for the content of any of this third party website.

17Freephone Care Line 0808 100 7666 (ROI 1 800 992 868) or visit shop.coaguchek.com
Living With Anticoagulation
Travel
Airlines dier, so always check before travelling, but a letter from your doctor
explaining why you require your CoaguChek meter as well as packing everything
required in your hand luggage, is strongly advised. Storing your strips in a cool part
of a room, away from direct sunlight, is also recommended (between 2 - 30ºC).
For more information and lifestyle tips, visit our blog on the shop.coaguchek.com website
A
ll information applies to patients taking vitamin K antagonists.
Luggage can get lost. Take
important things on board.
2. When travelling1. Before travelling
Over
In Range
Under Risk area for
a blood clot
Risk area
of bleeding
INR target
range
Coagulation monitoring
for a safe trip
Each body responds differently to lifestyle
changes. This is why it is beneficial to
monitor the coagulation value (mostly as
INR value) during holiday.
Remember, different people will have
different therapeutic ranges to stay within.
Are there any concerns
considering the travel
destination?
See your doctor
to clarify the
following questions:
Is adequate medical
care available at the
travel destination?
3. At the travel destination
Many things are different on vacation, and that’s
what we love about it. However, the holiday lifestyle
can influence coagulation:
Physical activityFood Climate
Self-monitoring
your coagulation…
Why anticoagulation self-monitoring makes the difference
...and gives you the
freedom and security to
fully enjoy your holidays.
…allows you to
check your INR value –
at a time convenient to you...
What to put in the
cabin luggage:
Medication
Insurance
documents
Coagulation
monitoring
devices
Healthcare
Document
(e.g. yellow book)
and GP
contact details
Are you taking any
other medication?
If yes could it impact
your coagulation?
Are vaccinations
required and will
they have any
impact on
warfarin?

18 Freephone Care Line 0808 100 7666 (ROI 1 800 992 868) or visit shop.coaguchek.com
To nd there was a little machine
which you can prick your nger with to
get a drop of blood (and instant result)
was just magic, absolute magic.
Katherine’s
Story
I’m really glad that I asked about
self-monitoring. I genuinely do feel
in control!
Roy’s Story
Learn more and see other people’s experiences with CoaguChek INRange
For more patient stories and videos, visit shop.coaguchek.com/life-stories/
or
visit the Facebook community at www.facebook.com/selfiechek
I can honestly say that my CoaguChek
machine has made a real dierence to
my life.
Diane’s
Story
CoaguChek®INRange
What our users say

Is it difficult to use a
CoaguChek®INRange meter?
No. If you can use a mobile phone then you’re
unlikely to find self-monitoring any more
complicated. Support is also offered by Roche
Diagnostics and your anticoagulation clinic.
How should I store my test strips?
They can be stored at room temperature (2-30°C) for
between 12 and 15 months, depending on the expiry
date. Keep the lid on the pot shut tightly between uses.
How quickly should I use the test strip after
removing it from its packaging?
You should use the test strip within 10 minutes from
the time you take it from the container.
Should I talk to my healthcare
professional before I start using a
CoaguChek INRange meter?
Yes. Other medical conditions, such as high
cholesterol levels, anaemia (low iron levels) and lupus
syndrome may sometimes interfere with your results.
Check with your healthcare professional before you
make any decisions about your health.
Are CoaguChek test strips available on
prescription in the UK?
Yes. CoaguChek test strips are available on
prescription if you live in the UK (not applicable in the
Republic of Ireland). This is at your GP’s discretion,
and prescription charges may apply. As with any
decision about your health, it’s best to explore your
options with your healthcare professional before self-
monitoring. If strips are not available on prescription
in your area (or if you reside in the Republic of
Ireland), you can purchase them direct from Roche
via the freephone Care Line number 0808 100 7666
(ROI 1 800 992 868) or shop.coaguchek.com
Is self-monitoring as accurate as the INR tests
my healthcare professional does?
The accuracy of the CoaguChek INRange meter
is equal to that of the equipment used by your
healthcare professional1.
Is self-monitoring suitable for children?
Yes. After a brief training course on self-monitoring,
and with support from a healthcare professional,
you and your child will enjoy the freedom that
self-monitoring offers. As a parent, you must be
prepared to take on some of the responsibility for
managing their care.
Will my CoaguChek®INRange meter
require maintenance?
The CoaguChek INRange meter and test strips
have a number of built-in quality control functions.
Because of this we do not provide maintenance for
your meter. We recommend that, every six months,
you ask a healthcare professional to take tests in
parallel with you on a meter that uses the same
technology. The healthcare professional should
be enrolled in a UK-recognised external quality
assurance anticoagulation programme.
How often should I test my INR levels?
Everyone’s different, so you should follow your
healthcare professional’s advice on how regularly
to test. It has been shown that testing once a week
increases the time spent in therapeutic range.
Can I use the CoaguChek INRange meter if I’m
on other medication?
Many common medicines, including painkillers,
antirheumatics, antibiotics, antidepressants,
diuretics, laxatives and vitamin K, can affect your
INR levels. This doesn’t necessarily mean that
you can’t take them if you’re self-monitoring. Your
healthcare professional will be able to advise you on
what you can and can’t combine.
Can I connect my CoaguChek INRange meter
to an App?
Yes you can! Apps are available which automatically
send your result to the clinic. This option is available
in areas where the clinic have signed up to the
service. If your clinic does not offer App connectivity,
contact the Care Line team and we can investigate
further on your behalf.
Frequently Asked Questions
Visit shop.coaguchek.com/support/faq to read additional FAQs
Freephone Care Line 0808 100 7666 (ROI 1 800 992 868) or visit shop.coaguchek.com 19

COAGUCHEK®and SOFTCLIX®are trademarks of Roche.
© 2017 Roche Diagnostics Limited. All rights reserved.
Roche Diagnostics Limited, Charles Avenue, Burgess Hill, RH15 9RY, UK.
Company registration number: 571546
References:
1. Multicenter performance evaluation of the CoaguChek® INRange system -
White paper, 2016, Roche Diagnostics Limited
08261148001. Date of Preparation 4/17
If you’d like more information, or if you would like to
purchase a CoaguChek®INRange meter, please call freephone:
0808 100 7666
In the Republic of Ireland, please call freephone:
1 800 992 868
or visit:
shop.coaguchek.com
www.facebook.com/selfiechek