User's Manual
for SoloStar
USER MANUAL
Helping you keep
track of your insulin
injections
SoloSmart is a smart sensor whichcan be
mountedona Sano Solostar® disposable
insulin pen.
SoloSmart allows you to:
-record the injected pen increment (insulin
dose),
-record the date and time of each insulin
injection,
- transmit the dose, date and time of
each injection to a compatible mobile
application on a smartphone, when the
device is paired to it, thanks to Bluetooth
technology.
1
Main features
2
Indications for
use and intended use
The SoloSmart injection pen adapter is
indicated for the capture and wireless
transmission of dosing information from
compatible disposable pen injectors.
SoloSmart is intended to be used by all
users of the Sano Solostar® insulin
pens. SoloSmart can be used with a
compatible mobile App (autonomous
software installed on your smartphone)
to visualize the log of your injected doses.
The SoloSmart injection pen adapter is
intended to be used by patients in the
same use environmentas their compatible
injection pen. There are no known
contraindications to the use of SoloSmart
for these patients.
3
Package
contents
SoloSmart
x1
USB cable
x1
User manual x1
& Technical
note x1
NOTE: the USB char-
ger is not included.
Use a Class II USB
wall charger, with
output 5V and at
least 500mA.
5V
≥500mA
4
Getting to knowSoloSmart and the pen
PN : 0273971
PN : 0373707
Sano SoloStar
®
insulin pen
Dose button
Dose
selector
SoloSmart
Button
Micro-USB port
(charging)
Light
signal
Wheel
External
lines
5
Getting started
Charge andactivate
SoloSmart
1. Connect SoloSmart to the supplied
USB cable.
2. Connect the cable to a powered USB
wall charger.
3. Let the device charge for at least 10mi-
nutes beforeits rst use.
4. Unplug the cable and SoloSmart, then
unplugthe charger.
The blue light signal indicates that the de-
vice is not paired.
1. Download a compatible application
to your smartphone on Google Play™
(Android) or the App Store
®
(Apple)
and follow the on-screen instructions
to create an account and pair your
SoloSmart.
2. Activate the Bluetooth on your smart-
phone,if not already activated.
3. Keep SoloSmart less than 10 cm away
from your smartphone.
4. Open the app and follow the on-screen
instructions to pair SoloSmart, and
select the type of pen the device will
be mounted on.
At the endof the pairing step, the light signal
turns green,then off.
Downloadthe App
and pair SoloSmart
Assemble SoloSmart on the pen
<10cm
Before you can use yourSoloSmart, you will
need to pair it with a mobile application.
Check the SoloSmart™ website for a list
of free applications compatible with your
SoloSmart: www.solosmart.sano.com
1. Hold the pen with one hand, keeping
the dose button accessible, and pro-
tect the needle (if already mounted)
with the pen cap.
2. With your other hand,hold SoloSmart
by the wheel, without pressing on its
button.
3. Insert SoloSmart on the pen dose
button, placing the external lines of
SoloSmart between the pen dose
selector ridges(in orange and black),
and push it all the way on the button,
still holding SoloSmart by the wheel
and without pressing on the button.
4. Make sure that SoloSmart is fully in-
serted on the pen dose button: the
pen dose selector is completely co-
vered.
5. Activate the « mounted » mode by
pressing rmlyon the SoloSmart but-
ton for at least 5 seconds, until you
see the purple light. Lift your nger,
the light turns green, indicating that
SoloSmart miniis ready to be used.
NOTE: Do not forget to deactivate
SoloSmart BEFORE transferringit ona new
pen. Please refer to Section 9 fordetails.
Refer to the Instructions for Use of your pen for the primingand injection instructions.
If you are not certain that you injected your insulin, do not start, or repeat your
injection. Monitoryour treatment and glycaemia as instructed by your healthcare
provider.
If you have any doubts about your treatment, please consult your healthcare
provider.
TIPS FOR USE
Adapt your position in orderto feel comfortable and be able to inject yourdose in one single
thrust, without changing position or nger during the injection. Use your thumb or index
finger.
Press continuously at the center of the button.
Keep the same position and
nger duringinjection
OR
Inject in one single and
continuous thrust.
Press at the center of thebutton,
using your indexnger if it is
uncomfortable or not precise
enough with your thumb.
6
UsingSoloStar
Stay still.
NOTE: Safety tests performed to check the
insulin ow (priming), will also be automatically
detected and recorded by SoloSmart.
Perform the safety test to check the insulinow
as described in the Instructions for Use of your
pen.
Please check yourmobileapplication for correct
identication of the safety tests performed.
7
ChargingSoloSmart
The SoloSmart battery has a 1-weekmini-
mum autonomy innormal use conditions.
When the battery is low, the light is orange.
Connect SoloSmart to the supplied USB
cable, then connect the cable to a powered
USB wall charger,in order to charge SoloS-
mart.
Never use SoloSmart while it is
charging.
>
2h
Donot use any other cable.
Please connect the supplied USB cable to
the USB port of a power adapter (IEC / UL
60950-1or IEC / UL 62368-1certified with
CE or UL marking) suitable for your region.
While charging, the light signal is slowly
ashing green and dose recording and de-
tection is inactivated.
NOTE:Once the battery is fully charged, the
light turns o (a full charge should not take
more than 2 hours).
The reset procedure of SoloSmart may be
necessary:
-if SoloSmart is not working properly (no
response, etc…),
-if you need to pair SoloSmart with another
mobile phone(smartphone),
-if you want to delete your personal health
data from the device
Torestart SoloSmart:
- Connect the supplied USB cable to a
USB wall charger,and thento SoloSmart.
-Unplug SoloSmart: the light turns blue,
indicating that it is ready to be paired.
Resetting SoloSmart deletes all the data
stored onthe device and its pairingparame-
ters.
8
Reset and activation
Toreset SoloSmart:
-Connect the supplied USB cable to SoloS-
mart.
-Plug a USB wall charger to a power outlet
-Take the USB side of the cable and plug
and unplug it in the USB wall charger at
least 3 times, until SoloSmart ashes red
and turns o.
-Wait for 30 seconds after the ashing light
turnso: SoloSmart has been reset.
x3
x1