• 6 •
• 7 •
Warning
Be careful, do not use the device under any conditions other than
those specified in this manual.
5. Introduction
FeetMe device, intended for healthcare professionals and patients,
makes it possible to represent walking parameters in order to
perform a biomechanical analysis. The medical device comprises :
•
FeetMe
®
Monitor insoles for measuring plantar pressure and
spatio-temporal parameters of walking.
•
The FeetMe
®
Evaluation mobile application which allows
the visualization of parameters and the recording of these
parameters.
Applied parts: connected insoles.
•
Accessible parts: double head induction charger; wall adapter
( see §15 Technical Specifications).
6. Safety instructions
Both the installation and use of FeetMe
®
Evaluation do not
Characteristics
Weight
< 120 kg
Sex
W/M
Health
conditions
All
In contact with
Foot
Age
> 12 years old (sizes from 35 and
at least 8 years of education)
Required Skills
Use of a mobile application
Use of a website
4. About this manual
We recommend that you read this entire manual carefully before
starting to use the device. This manual will provide you with
the necessary information for a proper use and maintenance
of the device. For more information, please contact FeetMe
by email at : [email protected]
2. Product scope
Warning
This device is a medical device consisting of connected insoles
(FeetMe
®
Monitor) that allow the collection of the gait parameters
and a mobile application (FeetMe
®
Evaluation) that allows
visualization in real time of these parameters.
3. User profile
There are two types of users:
- Health professionals who deliver insoles to their patients, record
and analyze the data.
- Patients wearing insoles during walking tests.
Referring health professional prerequisite : health professional
ackowledges having read and fully understood the information
on uncertainty of measurement (section 15 page 13 Technical
Specifications). For any further information concerning
interpretations of uncertainty of measurement of the device,
contact FeetMe at [email protected]
require additional training. However, the following points must be
respected :
•
FeetMe
®
Monitor insoles are not intended to be in contact with bare
skin nor wounds. They should be worn with socks.
•
Make sure that FeetMe
®
Monitor insoles are charged (please refer to
the corresponding section of this manual).
•
Do not use FeetMe® Monitor insoles while they are charging.
•
Always plug your device into a wall outlet.
•
In the event of a defect (please refer to this manual for the
identification of potential defects), do not use the device and notify
the manufacturer or distributor for a repair or replacement.
•
Do not drop FeetMe
®
Monitor insoles or let them be subject to a severe
shock.
•
Do not place the power cable around your neck.
•
Do not use this device in conjunction with other Bluetooth devices.
•
All mobile app updates should be accepted.
•
FeetMe
®
Evaluation device requires special precautions in regards
to electromagnetic compatibility. The device must be installed and
operated according to the electromagnetic compatibility information
provided in this manual.
