SEFAM EcoStar, Practitioner And Home Care Provider Manual, Page: 5 / 26

EcoStar Before starting

5
Intended use
The EcoStar device is a Positive Pressure device
indicated for the mask treatment of Sleep Apnea
Syndrome (SAS) in patients weighing more than
30 kg (66 lbs). It can be used at home or in a
sleep center. It is not suitable to be used in close
proximity to CT scanners, MRT devices, RF
surgical devices or in transportation vessels (on
land, sea or in the air).
The device can be used with the GoodKnight
H
2
O humidifier if a prescription for heated
humidification has been added to the patient's
treatment. The heated humidifier is designed to
heat and raise the humidity of the air delivered
to the patient through the Continuous Positive
Airway Pressure (CPAP) device.
Contraindications
Studies have shown that the use of positive
airway pressure is contraindicated for certain
patients with one of the following pre-existing
conditions:

Severe bullous emphysema or emphysema
previously complicated by pneumothorax.

Pneumoencephalus, trauma or recent
surgery with sequela of cranio-
nasopharyngeal fistula.

Decompensated cardiac insufficiency or
hypotension, particularly in case of
decreased blood volume or cardiac
arrhythmia.

Dehydration

Massive epistaxis or history of massive
epistaxis.

Acute sinusitis, otitis media, or perforated
tympanic membrane.

Tracheotomy.
Moreover, as the effect of positive airway
pressure on cardiac output is clear for some
patients, close monitoring of the patient's blood
pressure and heart rate are recommended when
beginning treatment at the effective pressure.
The risks and benefits of continuous positive
airway pressure must be assessed on a case-
by-case basis for these patients.
List of authorized
accessories
Unless otherwise indicated, the EcoStar
device can be used with the following
optional accessories:

Power supply
P/N M-413910-00
(EU plug)

Air inlet filter
P/N M-415930-01
P/N M-415910-03
(plug except EU)

GoodKnight H
2
O
P/N M-114600

Carrying case
P/N M-214531-01
WARNINGS

Use only those accessories authorized
according to the list above, or which comply
with standard EN ISO 17510-2:2007.

Use only those accessories which can
guarantee treatment pressure and reduce re-
inhalation of CO
2
.

When a facial mask is necessary, always use
a mask which is equipped with an anti-
asphyxia valve.