Introduction; About Emfit Epilepsy Alarm; Intended Purpose; About This Document - Abilia Emfit 464000 User Manual

1. Introduction

1.1. About Emfit Epilepsy alarm

Emfit Epilepsy alarm 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. The control unit notifies the caregiver with a 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.
The device is not diagnostic and cannot differentiate between a tonic-clonic seizure and other fast
movements. The manufacturer cannot guarantee that the device will detect all episodes of tonic-
clonic seizure-induced body movements of the monitored person. 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. The device cannot be used to verify whether the alerted body
movement was caused by a tonic-clonic seizure
Operating environment is typically a bedroom at a care-home or at home.
NOTE: Emfit Epilepsy alarm is only intended to be used as an aid by care providers. The
product must not replace human supervision.

1.2. Intended purpose

Emfit Epilepsy alarm 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
undermattress sensor due to a tonic-clonic seizure while sleeping.
2. of the presence of the monitored person on the mattress equipped with the
undermattress bed sensor and if he or she gets up from the mattress.
Emfit Epilepsy alarm may either be used:
• solely for the task described in point 1 above.
• for the tasks described in points 1 and 2 above simultaneously.

1.3. About this document

This user manual is intended for persons that support users with using Emfit Epilepsy Alarm.
The user manual describes how to use Emfit Epilepsy Alarm in a safe way.
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