Product Description; Intended Purpose; Indications; Contra-Indications - SEFAM nea Patient Manual

M-170DFU00-20 - V7 - Mise en activité le 01/08/2024

Product description

Please read this manual carefully before using your Néa to understand the usage constraints of the device.

Intended purpose

Néa is Positive Pressure medical device connected by a flexible tube to a mask worn by a patient suffering from
obstructive sleep apneas and hypopneas during sleep. The device delivers a continuous flow of air to avoid upper
airway obstruction during sleep.

Indications

The Néa device is indicated for the treatment of obstructive sleep apnea and hypopnea syndrome (OSAHS).

Contra-indications

Studies have shown that using positive pressure is contraindicated in certain patients with one of these pre-
existing medical conditions :
▪ Air leak syndrome (pneumothorax with bronchopleural fistula or Severe bullous emphysema)
▪ Decompensated cardiac insufficiency or hypotension, particularly in case of decreased blood volume or
cardiac arrhythmia
▪ Dehydration
▪ Tracheotomy.
▪ Children under 30kg
▪ Patients who do not breath spontaneously
▪ Uncooperative or extremely anxious patients
▪ Reduced consciousness and inability to protect their airway
▪ Facial trauma or burns
▪ Patients having recently undergone facial, oesophageal, or gastric surgery
▪ Copious respiratory secretions
▪ Severe nausea with vomiting
Furthermore, due to the fact that positive pressure affects the cardiac output in certain heart failure patients, it
is recommended that patient blood pressure and heart rate are carefully monitored when starting treatment at
an effective pressure. The risks and benefits of treatment by Continuous Positive Airway Pressure must be
individually evaluated in such subjects. This evaluation must take into account the fact that the device can be
adjusted to deliver pressures up to 20 cmH
cmH O are possible. The device must not be used then, if such pressure level presents a risk to the patient.
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4 ▪ Product description
Manuel patient NEA Anglais
O, and under certain defect conditions, static pressures up to 40
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Néa
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