Abilia Emfit Epilepsy Alarm, Руководство пользователя, Страница: 8 / 36

8
3. Introduction

These instructions for use describe the use of the Emfit MM, Tonic-Clonic Seizure
Monitor. The version number and details can be found in chapter 23. Technical
specifications .

Use the device only in the ambient conditions specified by the manufacturer. For
detailed information, refer to Technical Specifications in these instructions for use.

Follow all instructions provided in this document concerning the installation, use and
cleaning of the device.

Based on the intended use, point 1) of section 3.2 below, the Emfit Tonic-Clonic
Seizure Monitor is a medical device as defined in the Medical Device Directive
93/42/EEC. Based on the nature of point 2) regarding the intended use, the device is
not defined as a medical device (Directive 93/42/EEC, Article 1(2), subparagraph a).

The device is a Class I medical device in accordance with the Medical Device
Directive 93/42/EEC and carries the CE marking accordingly.
3.1 Product description
Emfit Tonic-
Clonic Seizure Monitor (later “product”) is a movement monitor that is used to
detect and notify tonic-clonic seizures.
The product consists of a bed sensor located under the mattress and a control unit where
the bed sensor is connected. Control unit should be placed on a table, clipped on bed or
mounted on wall.
The control unit notifies caregiver by flashing led and sound (unless muted) and/or
transfers a notification via external system e.g. a nurse call system or a personal
emergency phone.
Operating environment is typically bedroom at care-home or home.
3.2 Intended use
The product is intended to be used to assist in sensory monitoring and to notify the
caregiver
1) of the body movements of a person lying on a mattress equipped with the under-
mattress sensor due to a tonic-clonic seizure while sleeping.
2) of the presence of the monitored person on the mattress equipped with the under-
mattress bed sensor and if he or she gets up from the mattress.
The device may either be used

solely for the task described in point 1) above,

for the tasks described in points 1) and 2) above simultaneously.
NOTE 1
The manufacturer cannot guarantee that the device will detect all episodes of tonic-clonic
seizure-induced body movements of the monitored person.
NOTE 2
The device may trigger a false body movement notification, especially if the person lying
on the mattress fitted with the under-mattress bed sensor is awake.