SANOFI 0273971 SoloSmart Injection Pen Adapter User Manual
- June 4, 2024
- SANOFI
Table of Contents
SANOFI 0273971 SoloSmart Injection Pen Adapter
Main features
SoloSmart is a smart sensor whichcan be mountedona Sanofi 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.
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 peninjectors.
SoloSmart is intended to be used by all users of the Sanofi 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.
Package contents
SoloSmart
x1
PN : 0273971
|
USB cable
x1
1 PN : 0373707
|
User manual x1
& Technical **note x1
**
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NOTE: the USB charger is not included. Use a Class II USB wall charger, with output 5V and at least 500mA.
Getting to knowSoloSmart andthe pen
Getting started
Charge andactivate SoloSmart
- Connect SoloSmart to the supplied USB cable.
- Connect the cable to a powered USB wall charger.
- Let thedevice charge for at least 10minutes beforeits first use.
- Unplug the cable and SoloSmart, then unplugthe charger.
The blue light signal indicates that the device is not paired.
Downloadthe App andpairSoloSmart
Before you can use yourSoloSmart, you will need topair it with a mobile application. Check the SoloSmart™ website for a list of free applications compatible with your SoloSmart: www.solosmart.sanofi.com
- 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.
- Activate the Bluetooth on your smartphone,if not already activated.
- Keep SoloSmart less than 10 cm away from your smartphone.
- Open the app and follow the on-screen instructions to pair SoloSmart, and select the type of pen the device will be mounted on.
Assemble SoloSmart on the pen
At the end of the pairing step, the light signal turns green, then off.
-
Hold the pen with one hand, keeping the dose button accessible, and protect the needle (if already mounted) with thepen cap.
-
With yourother hand,holdSoloSmart by the wheel, without pressing on its button.
-
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.
-
Make sure that SoloSmart is fully inserted on the pen dose button: the pen dose selector is completely covered.
-
Activate the « mounted » mode by pressing firmlyon the SoloSmart button for at least 5 seconds, until you see the purple light. Lift your finger, 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.
UsingSoloStar
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. Monitor your treatment and glycaemia as instructed by
yourhealthcare provider.
If you have any doubts about your treatment, please consult your healthcare
provider.
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TIPS FOR USE
Keep the same position and finger duringinjection
| 
Inject in one single and continuous thrust.
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Stay still.
| 
Press at the center of thebutton, using your indexfinger if it is uncomfortable or not precise enough with your thumb.
NOTE: Safety tests performed to check the insulin flow (priming),will also be automatically detected andrecordedby SoloSmart. Perform the safety test to check theinsulinflow as described in the Instructions for Use of your pen. Please check yourmobileapplicationfor correct identification ofthe safety tests performed.
Charging Solo Smart
The SoloSmart battery has a 1-weekminimum autonomy innormal use conditions. When the battery is low,the light is orange.
Connect SoloSmart to the supplied USB cable, thenconnect the cable to a powered USB wall charger,in order to charge SoloSmart.
| 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 flashing green and dose recording and detection is inactivated.
| Never use SoloSmart while it is charging.
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NOTE: Once the battery is fully charged, the lightturns off (a full charge shouldnot take more than2 hours).
Reset and activation
The reset procedure of SoloSmart may be necessary:
-if SoloSmart is not working properly (no response, etc…),
-if youneed topair SoloSmart with another mobile phone(smartphone),
-if you want to delete your personal health data from the device
Resetting SoloSmart deletes all the data stored onthe device and its pairing parameters.
To reset SoloSmart:
-Connect the supplied USB cable to SoloSmart.
-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 flashes red and turns off.
-Wait for 30seconds after the flashing light turnsoff: SoloSmart has beenreset.
To restart SoloSmart:
– Connect the supplied USB cable to a USB wall charger,and thento SoloSmart.
-Unplug SoloSmart: the light turns blue, indicating that itis ready to bepaired.
