Product Description And Intended Use; Operation Mode - Livassured NightWatch Mode D'emploi

3 The NightWatch
3.1

Product description and intended use

NightWatch is intended to notify a caregiver of
the occurrence of a patient's Nocturnal Epileptic
Motor Seizures(*) in order to allow caregivers to
take appropriate caring measures.
(*)Nocturnal Motor Seizures, being the following
seizure types 1 :
• Tonic-Clonic Seizures
• Tonic (if cluster or prolonged)
• Myclonic (if cluster)
• Focal impaired awareness with hyperkinetic
movements
NightWatch is not intended for diagnosis or
treatment purposes.
3.2

Operation mode

NightWatch is a wearable device and consists
of a wireless arm module and a base station.
The arm module is worn during sleep on one of
the limbs, preferably the biceps of the upper
arm. The armband consists of a heart-rate
sensor using PPG (photoplethysmography) and
a ACC (Accelerometry) movement sensor, and a
microprocessor which processes the data from the
sensors using a detection algorithm.
NightWatch does not provide direct monitoring
of the measured heartrate or movement data.
NightWatch is not a heart rate monitor.
The detection algorithm detects if the sensor
readings match preprogramed parameters that
are associated with a nocturnal motor seizures, the
seizure alert is triggered and transferred to the
accompanying base station.
The arm module and base station communicate
using the wireless DECT protocol. When a seizure
1. Nomenclature is based on the classifi cation of epileptic seizures
by the International League Against Epilepsy (ILAE, 2017):
NightWatch
alert is transmitted from the arm module to
the base station, the base station alerts the
caregivers by a ringing sound and a blinking LED
light. A caregiver can then go to if the PWE and, if
necessary, assist according to instructions received
by their physician.
The base station also alerts the caregiver with
beeps and blinking LED lights in case the system is
not able to detect seizures for technical reasons,
such as a depleted battery, a lost connection
between arm module and base or if the arm
module is able to heartrate or movements to
perform seizure detection.
PLEASE NOTE: This product does not
guarantee that all epileptic seizures are
detected. It should be used as an aid to
detect nocturnal seizures. It does not
replace responsible supervision of the
patient.
PLEASE NOTE: This product is not intended
for diagnosis or treatment of epilepsy. This
device may also give seizure alerts if no
seizure is taking place.
PLEASE NOTE: This product tracks
heartrate using photoplethysmography
(PPG) and uses this information to detect
epileptic seizures. The effectivity of reading
heartrate with PPG may vary from person
to person. The device will notify the
caregiver with sound and light signals if the
product cannot track a reliable heartrate
for seizures detection.
3.3 Medical classifi cation
The NightWatch is a class 1 device in accordance
with Annex VIII Classifi cation rules of the
EU regulation concerning medical devices,
(EU)2017/745, dated 5 April 2017 (the "Medical
Device Regulation").
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