The Nightwatch; Product Description And Intended Use; Essential Performance; Medical Classification - Livassured NightWatch Bedienungsanleitung

3

The NightWatch

3.1

Product description and intended use

The NightWatch is intended to alert the
user to possible night-time epileptic
seizures. While the person with epilepsy
(hereafter: the wearer) sleeps, carers
can be notifi ed when a 'clinically urgent
epileptic seizure' occurs.
Clinically urgent epileptic seizures
are: tonic-clonic seizures, prolonged
tonic seizures (lasting >30 seconds),
hypermotor seizures and series of
myoclonic seizures.
The NightWatch continuously measures
EN
the wearer's movements and heart rate.
It is intended to be used while the wearer
is asleep.
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3.2

Essential performance

No essential performance has been
determined. This product is intended
to be used as an aid. This product does
not guarantee that all epileptic seizures
are detected and does not replace
responsible and appropriate parental or
professional supervision of the patient.
Always ensure this product is used solely
by people who can diagnose epileptic
seizures and who know how to act in the
event of an epileptic seizure.
3.3 Medical classifi cation
The NightWatch is a class 1 device
according to the 93/42/EEC directive.
3.4

Intended users

Patients diagnosed with epilepsy aged 4
and above.
PLEASE NOTE: This product is less eff ective
in detecting potentially dangerous epileptic
seizures in children under the age of 4.
v4.0 NightWatch
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