Possible Side Eff Ects - Livassured NightWatch Mode D'emploi

3.4 User profi le
3.4.1 Intended users
Users of the NightWatch are people diagnosed
with epilepsy from the age 4 and up, having
nocturnal motor seizures and caregivers thereof.
3.4.2 Contra-indications
NightWatch is not intended to be used by:
• Persons not diagnosed with epilepsy
• Persons diagnosed with epilepsy having other
than nocturnal motor seizures.
• Persons diagnosed not having limbs to wear the
device on.
3.4.3 Intended use environment
The NightWatch is intended to be used at home or
at residential care facilities.
The NightWatch is not intended to be used in
EN
intensive care environments.
3.5 Possible side eff ects
There are possible side eff ects related to wearable
devices that involve sensor application on the skin.
These include the following:
• Edema
• Erythema
• Irritation
• Sensitization
PLEASE NOTE: Wearing the arm module
can cause skin irritation, such itching or
temporary rash. Regularly cleaning the arm
module before use can help resolve this.
If the problem persists, there are special
plasters available which will relieve the
symptoms in most cases. Please contact
your supplier in this case. See section 9 for
contact details.
3.6 Clinical benefi ts
The NightWatch assists caregivers in nocturnal
supervision by detecting more nocturnal motor
seizures compared to supervision without such
58
device and notifying caregivers of such seizures to
allow timely intervention. This reduces the chance
of harm as a result of missed seizures when no
assistance is provided to the person having seizure.
Less missed seizures and decreased probability
of harm lead to reduced stress for people with
epilepsy and their caregivers.
3.7 NightWatch package contents
The NightWatch package contains the following
items:
1. Base station
2. The GS-0500200A power adapter for the
base station (black)
3. Arm module
4. Charger for arm module (white):
4.1 Compact Fixed Blade Charger 2.75W
4.2 USB to USB-C cable 1 meter with 6.5 mm
connector
5. Elastic strap (1m)
6. Armband clips (4 in total, including 2 spare
clips)
7. Travel case
8. Manual
9. Alert card
v5.3 NightWatch