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Novo Nordisk Dialoq User manual

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On
1.
Attach
Dialoq®
2.
Download
app and pair
3.
Use Dialoq®
with your
FlexTouch®
pen
4.
Export
doses to
app
Figure A
• Look at the back of your FlexTouch® pen to make sure it has
a small attachment knob.
FlexTouch® pens with this knob can be used with Dialoq®
(see a list of compatible FlexTouch® pens at
www.mydialoq.com).
• You can remove Dialoq® from your FlexTouch® pen by
using the slide button on the back.
Never use excessive force to remove Dialoq®.
“Click”
Figure B
• Attach Dialoq® to your FlexTouch® pen. Make sure the dose
counter window on your FlexTouch® pen lines up with the
dose counter window on your Dialoq®.
• Leave it on until your FlexTouch® pen is empty. Remove
Dialoq® before you dispose of your FlexTouch® pen.
Figure D Figure E
• Check your phone to make sure you are connected to the
internet and Bluetooth is turned on. To ensure a secure
connection, avoid pairing your Dialoq® in public places.
• Go to: www.mydialoq.com on your phone to see where you
can download a compatible app. You can skip this step if you
already have a Dialoq® compatible app on your phone.
• Open the app and follow the instructions to pair your
Dialoq® with the app.
Figure F
• Dialoq® is now paired with the app, and you are ready to
start using Dialoq® with your FlexTouch® pen.
Always check the app to see if pairing succeeded.
If not, repeat the steps for figures D and E.
When you attach Dialoq® to a new FlexTouch® pen,
you do not need to pair your Dialoq® again.
Figure G Figure H
• Make sure Dialoq® is paired (see section 2) and is correctly
attached to your FlexTouch® pen (see section 1).
• Turn the dose selector on your Dialoq® to select your dose.
Figure I
Figure K
• Open the app on your phone.
• Check that the dose counter on your FlexTouch® pen shows 0,
unless you are taking a dose, see section 3.
Figure J
• Make sure Bluetooth on your phone is turned on and Dialoq®
is attached to your FlexTouch® pen.
• Press and release the dose button on your Dialoq® to
export your doses to the app.
• Check the app to see if the export was successful.
It is recommended to export your doses from Dialoq®
whenever you want to consult your dose log and at
least once every month.
User guide
How it
works
Dialoq® works with FlexTouch® to track
your doses
While Dialoq® is attached to your FlexTouch® pen, it records
and remembers:
• the drug brand name and strength
• the number of units dosed
• the time and date of your doses.
Dialoq® stores up to 1200 doses including your priming
doses. Dialoq® is a medical device.
Read this user guide before you start using Dialoq® to learn
how to use Dialoq® correctly.
Use Dialoq® with your phone
You can export the doses in your Dialoq® to a compatible
app on your phone. That way you can keep a digital insulin
log.
Export your doses
Dialoq® sends your injected doses and priming doses to the
app when you press and release the dose button. Make sure
Bluetooth® on your phone is turned on and that the app is
open.
Dialoq® overview
Dose button
Dose selector
Dose counter
window
Need help?
Call us at 1-833-4-DIALOQ
Slide
button
• Insert the needle into your skin.
• Press and hold down the dose button on your Dialoq®
until the dose counter shows 0, then count slowly to 6
before dosing is complete.
• Your Dialoq® records the size, time and date of the
injected dose.
Dialoq® exports the dose when you inject if you keep
the app open, keep your phone within reach of your
Dialoq®, and Bluetooth turned on. If you export this
way, you can skip the steps in section 4.
Always follow the instructions for use that comes with
your FlexTouch® pen to ensure you receive the correct
dose.
Front Back
Dialoq® ID
and markings
On
Get started
www.mydialoq.com
On Dialoq®
Regulatory Operations
Novo Nordisk template no.:
X0_2010-380x447-001-dev
Current 1
Full laquer on both side
Leaflet
Colour: CMYK +
PMS 280C +
PMS 289C
8-0054-X0-003-1
UT207
Figure C
Attachment
knob
Slide button
• To pair your Dialoq® with the app, make sure that the dose
selector shows 0 on your FlexTouch® pen.
• Then press and release the dose button on Dialoq®.
• Check that the Dialoq® ID in the app matches the ID you can
find on the back of your Dialoq®. (See Dialoq® overview in
How it works section of this User guide)
• Follow the instructions in the app to complete pairing.
8-0054-X0-003-1_v1-17.indd 1 05-11-2020 12:26:13
Frequently
asked
questions
How your Dialoq® works
• What does Dialoq® record?
When Dialoq® is attached to a compatible FlexTouch® pen
(see a list of compatible FlexTouch® pens at
www.mydialoq.com) it records:
• the drug brand name and strength
• the number of units dosed
• the time and date of all your injected doses and
priming doses
Your FlexTouch® pen dose counter always shows the
number of units selected for injection or priming.
Always keep Dialoq® attached to your FlexTouch®
pen. Please note, Dialoq® only records doses taken
while it is attached to a compatible FlexTouch® pen.
If you prime a dose or inject a dose without Dialoq®
attached, your dose log in the app will not show that
dose.
If you are in doubt about how much insulin you need to inject,
monitor your blood sugar level as instructed by your doctor
or nurse, before selecting the dose for your next injection.
Otherwise, you may get too much or too little insulin.
Dialoq® is only for single person use. Never share your Dialoq®
with other people. Otherwise, it may record doses from other
people.
Do not stop and resume during injection as Dialoq® then may
be unable to detect the dose sizes.
Dialoq® records both priming doses and injected doses. All
recorded doses will be included in the dose log sent to the
app. Check with your app provider for more information on
how the doses will be shown.
Dialoq® and its functions are intended to be used by diabetes
patients, health care professionals and caregivers.
• Does Dialoq® automatically export my doses to my
phone?
When you take your injection, Dialoq® will automatically export your
dose if:
• your Dialoq® is paired with the app
• the app is open
• your phone is within reach of Dialoq®
• Bluetooth is turned on
Your dose will then be exported the moment you release the dose
button.
If you wish to export your doses at another time, see section 4.
Please note, if you try to export your doses while Dialoq® is
not attached to a FlexTouch® pen, the dose log in the app will
not be updated.
• What if I do not export my doses regularly?
Dialoq® will always store the most recent 1200 doses including
priming doses.
It is recommended that you export your doses at least once
every month to ensure that all your doses are contained in your
app.
It is recommended that you leave Dialoq® on your FlexTouch®
pen until the FlexTouch® pen is empty. This makes sure that all
doses with the FlexTouch® pen are recorded.
• Which information is exported to the app?
The information exported to the app includes:
• drug brand name and strength
• number of units dosed
• time and date of all injected doses and priming doses
• Dialoq® status information.
Caring for your Dialoq®
• Where do I keep my Dialoq®?
Storage:
When Dialoq® is not attached to your
FlexTouch® pen, store Dialoq® at temperatures
above 36° F (2° C) and below 104° F (40° C).
When Dialoq® is attached to your FlexTouch® pen, follow
the instructions for storage conditions that came with your
FlexTouch® pen.
During use:
Dialoq® is intended to be used at home or in a
normal public environment at these conditions:
Temperature: 41° F (5° C) to 104° F (40° C)
Humidity: 15% RH to 90% RH
Atmospheric pressure: 700 hPa to 1060 hPa
When Dialoq® is attached to your FlexTouch® pen, follow the
instructions for maximum in-use temperature that came with your
FlexTouch® pen.
• How do I take care of my Dialoq®?
Do not try to repair your Dialoq® or pull it apart.
This will break it.
Keep your Dialoq® away from dust, dirt,
and liquid.
Do not attach Dialoq® to a FlexTouch® pen with a visibly
scratched, damaged, or dirty dose button.
Otherwise, Dialoq® may not be able to identify the drug brand
name and strength in your FlexTouch® pen correctly.
Do not modify Dialoq® in any way.
Do not try to insert any foreign objects or fingers in your
Dialoq®. If you do, Dialoq® may not work as intended.
Do not use your Dialoq® if it is visibly damaged. If you think your
Dialoq® is not working the right way, call 1-833-4-DIALOQ.
• How should I clean Dialoq®?
You can only clean the outside of Dialoq®. Use a mild detergent on a
moistened cloth. Do not use products containing bleaching agents,
such as chlorine, iodine, or alcohol to clean Dialoq® as this may
damage it. Do not wash, soak, or lubricate your Dialoq®.
• How long does the battery last?
If Dialoq® is used as described in this user guide, the battery will
run out after two years and the app will alert you about 30 days
before. The battery may run out sooner, for example if you have
more than one app paired with your Dialoq®, or if the dose button
on Dialoq® is pressed and released very often, unrelated to injecting
or exporting doses.
Remember to export your doses before the battery runs out for
when it does, Dialoq® will no longer record your doses or be able
to export your doses to the app. Contact your supplier to get a new
Dialoq®. You can still use your FlexTouch® pen for injections.
The battery cannot be replaced or recharged.
• How do I dispose of Dialoq®?
Please dispose of electronic equipment separately as
according to local regulations.
Dialoq® must not be disposed of as household waste. Please
consider the environment when you dispose of Dialoq®, as it
contains a lithium battery and electronic parts. The packaging
and paper materials can be recycled.
Troubleshooting
• What if Dialoq® does not export my doses to
the app?
• Make sure that Dialoq® is properly attached to a
compatible FlexTouch® pen, see figure A.
• Keep your phone within reach of your Dialoq®.
• Make sure that Bluetooth on your phone is turned on
and that the app is open.
• Keep your phone and Dialoq® at least 12 in (30 cm)
away from other mobile phones, tablets, pc’s, etc. to
avoid interference. If your doses are still not exported,
move your phone and Dialoq® even further away from
other devices.
• Or check the compatible app to see if there is an alert of
low battery in your Dialoq®. The battery may have run
out after the alert.
• What if I cannot pair Dialoq® with the app?
Follow the first 4 steps from the section “What if Dialoq® does not
export my doses to the app?”
• Why does the app not show the medicine or dose
amount I expect?
If you stop and resume during injection, Dialoq® may register the
injection as multiple doses without dose sizes.
If you split your dose when transferring to a new FlexTouch® pen,
the two doses will be shown as two separate doses.
If Dialoq® registers an error during injection, it will record the
injection as one dose of without dose size. You may still have
received your full dose, and you do not need to inject again.
If you are in doubt about how much insulin you need to inject,
monitor your blood sugar level as instructed by your doctor or nurse,
before selecting the dose for your next injection. Otherwise, you
may get too much or too little insulin.
• Still need help?
If you are in doubt about how to use Dialoq®, contact your
healthcare professional or call 1-833-4-DIALOQ.
If you experience unexpected events or have any questions,
please visit our support site: www.mydialoq.com.
Warranty
Dialoq® comes with a two-year warranty.
If you find that your Dialoq® is faulty, Novo Nordisk will
replace it. Return it to your supplier for inspection within
two years of receiving it.
This warranty will be invalid and Novo Nordisk cannot be
held responsible in the case of defects or damages arising
from:
• the use of Dialoq® with non-compatible pens (see a list
of compatible FlexTouch® pens at
www.mydialoq.com)
• the use of Dialoq® not in accordance with the
instructions in this user guide
• physical damage to Dialoq® caused by neglect, misuse,
unauthorized repair, accident, or other breakage
Classification
Dialoq® is classified according to IP 52, where:
• 5 indicates that Dialoq® is dust-protected.
• 2 indicates that Dialoq® is protected against vertically falling water
drops when tilted up to 15 degrees.
Protection against electrical shock
Type: Classified for continuous operation. Internally Powered ME
Equipment.
Degree: Type BF Applied Part.
Logging accuracy
Dialoq® registers the dose exactly as selected in more than 99% of
all doses. The remaining doses are registered within +/- 1 increment
of the selected dose.
Electromagnetic compatibility
Dialoq® lives up to the emissions and immunity requirements from
IEC 60601-1-2:2014 for Home Healthcare Environments. See details
on tests in technical description at www.mydialoq.com
Dialoq® 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.
Before you use Dialoq® on an airplane, ask the cabin attendants for
instructions for using a Bluetooth connection on the flight. You can
also ask the airline you fly with for instructions.
Wireless technology
Frequency Band: 2.4-2.4835 GHz
Technology: Bluetooth low energy
Modulation type: Gaussian Frequency Shift Keying (GFSK)
Output power: 0 dBm
Dialoq® and FlexTouch® are registered trademarks of
Novo Nordisk. The Bluetooth® word mark and logos are
registered trademarks owned by Bluetooth SIG, Inc.
Dialoq® is classified as a device receiver category 3: noncritical
communication.
Dialoq® collects data to enable improvements in device
performance. The data can only be reviewed during device
maintenance.
© 2020 Novo Nordisk
For information about Dialoq® contact:
1-833-4-DIALOQ
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
Attention: Customer Care
Manufactured by:
www.novonordisk.com
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd, Denmark
Issued: 2020-XX-XX
Caution
Pay special attention to these notes as they are
important for safe use of Dialoq®.
Useful information and tips.
Name and address of manufacturer.
Dialoq® will last for 2 years during normal use
if used for the first time before the date printed
next to this symbol on the package.
Consult instructions for use.
Temperature range.
The disposal symbol indicates that Dialoq®
must not be disposed of with household
waste.
Keep dry.
Batch no.
BF Applied Part.
Significance of symbols
Turn over to see the user guide.
8-0054-X0-003-1_v1-17.indd 2 05-11-2020 12:26:14
Novo Nordisk A/S Electronic Signature Page 2020/11/05 13:33:05
Commodity no.:
8-0054-X0-003-1
Version: 1.17
Documentum ObjectID : 0911b6048289c147
This is a representation of an electronic record that was signed electronically and this page is
the manifestation of the electronic signature.
Document signed by:
Initials Full Name
Capacity Reason Date and time
of Signature
(Server Time)
SaHR Sanne Holm Rogert
Graphics 1st Approver 2020/11/05 12:28:24
LCTF Lars Carl Tolson Felding
Graphics 2nd Approver 2020/11/05 13:13:21
8-0054-X0-003-1 Version: 1.17 ID: 0911b6048289c147 page 1 of 1
Novo Nordisk A/S Electronic Signature Page
Documentum ObjectID :
This is a representation of an electronic record that was signed electronically and this page is the
manifestation of the electronic signature.
Document signed by:
Initials Full Name
Meaning Date and Time of Signature
(Server Time)
23 Nov 2020 12:29:29
DV3369_MEM-0255-IFU US - ID 004756699
090239b683ca9798
jnkj JNKj - Jan Nicklas Kjønstad
Project Team Approval 23-Nov-2020 12:29 GMT+0000