Potential Undesirable Side Effects; Target Patient Groups; Intended Users; Environment Of Use - SEFAM nea Patient Manual

M-170DFU00-20 - V7 - Mise en activité le 01/08/2024
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The device has to be controlled to check the proper operation, whenever it is located near AM, FM or
broadcast antennas.
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Please do not use the device where radio frequency emission is prohibited.
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The ModCom+ communication module is delivered with the SIM card installed and configured to work with
a specific computer server responsible for receiving and managing the data transmitted. Installing another
SIM card could cause it to malfunction.

Potential undesirable side effects

Potential undesirable side effects, which in some cases may require temporary discontinuation of treatment,
include: unusual chest pain, severe headache, increased dyspnea, dryness of the airways or nose, skin sensitivity,
runny or bleeding nose (epistaxis), ear or sinus discomfort or pain, bloating, daytime sleepiness, mood changes,
disorientation, irritability, memory loss, eye irritation, sleep disruption, claustrophobia or anxiety, heat-related
discomfort (only when using the humidifier), discomfort (reduced mobility due to mask or tubing, device noise)
or apnea in case of device failure.

Target patient groups

Néa and its accessories may only be used for the treatment of obstructive sleep apnea-hypopnea syndrome
(OSAHS) in patient over 30 kg and with spontaneously breathing.

Intended users

The various potential users of this device are: patients weighing over 30 kg, healthcare professionals and
homecare providers.
Patients can receive rapid training from healthcare professionals or homecare providers. This prior training is
not essential, but reading this instruction manual is necessary for a correct use of the device.

Environment of use

The Néa is intended for use at home or in a care centre (hospital or clinic). It is also designed to be easily
transported and can be used on aircraft (see paragraph "Transport of the device ").
It is not suitable to be used in close proximity to CT scanners, MRI devices, RF surgical devices or in
transportation vessels (on land, sea or in the air).

Clinical benefits

There is no direct clinical benefit for the patient.
Furthermore, in terms of indirect benefits, regular use of the positive pressure device every night will be
accompanied by a reduction in sleepiness, cognitive deficits, deterioration in health, hypertension and metabolic
disorders associated with OSAHS.

Essential performance of the device

The device has no essential performance. It was designed to maintain basic safety without maintenance
regarding electromagnetic disturbance during the lifetime of the device. However, in case of failure the device
has to be repaired by authorized persons who will use original parts only.
Néa
Manuel patient NEA Anglais
Product description ▪ 7
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