The Nightwatch; Product Description And Intended Use; Medical Classification; Intended Users - 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 notified when an
'urgent seizure' occurs. This refers to tonic-clonic, prolonged tonic or hypermotor seizures.
The NightWatch continuously measures the wearer's movements and heartbeat. The device
is intended to be used during sleep and will only display alerts when the wearer is in a
recumbent position.
3.1.1 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.

3.2 Medical classification

The NightWatch is a class 1 device according to the 93/42/EEC directive.
EN

3.3 Intended users

Patients with diagnosed epilepsy from 4 to 99 years of age with a light skin type.
PLEASE NOTE: This product should not be used for patients younger than 4 years of
age.
PLEASE NOTE: The use of the arm module on dark skin types could negatively affect
the accurate determination of epileptic seizures.
V3.0
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