ASKLÉSANTÉ
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INDICATIONS
According to the National Commission for the Evaluation of Medical Devices and
Health Technologies (CNEDiMTS) dated 22 December 2009 and in accordance with
the expert opinions of clinicians:
Prevention and treatment support for stage 1 to 2 pressure ulcers (above this
according to medical advice) for patients who are up during the day, confined to
bed for over 15 hours and with a “moderate” to “high” risk of pressure ulcer evaluated
according to a validated scale and clinical judgement.
CONTRAINDICATIONS
Patients who are not up during the day, in poor general health and/or with
arteriopathy and/or recent neurological disorder. Stage 3 or 4 pressure ulcers in
support area.
Patients with several pressure ulcers at stage strictly over 2 in support area.
Post-surgery pressure ulcer for 3 months following the procedure.
Patients weighing over 150 kg. Use in decompression chamber. Use on a stretcher.
PRECAUTIONS
Non-stabilized bone and/or muscle injuries in contact with the support.
Initial days for post-surgery pressure ulcer (skin transplant or flap)
[Use the low pressure static mode].
Patients treated at home with no possibility for auxiliary medical intervention .
For a patients confined to bed in semi-seated position at 45° at least: To make sure
that there is no risk of injury, check that there is a sufficient volume of air by placing
the palm of the hand towards the top between the buttock area and the support.
The “comfort” setting can be used to add air, if applicable.
Also check the condition of exposed skin at each treatment and change of position.
WARNING
In accordance with appendix 1 of the 93/42/CEE directive regarding essential
requirements applicable to medical devices, only the compatibility between
systems assembled by the manufacturer ASKLÉSANTÉ, ensures a safe combination
with the use of AXTAIR ONE PLUS motorized air support.
The characteristics and performance of the motorized air support will be maintained
exclusively through the use of a compressor [see references on page 18], combined
with mattress type supports [see references on page 17] with no modification and
optionally, with a rapid inflation/deflation kit [see references on page 17]
The national authority responsible for the safety of health products can at any time
check marketing conditions for products and take the necessary steps in the event
of danger or breach of regulations. Should the conditions for use outlined above not
be followed, the user’s responsibility is likely to be implicated in the event of an
accident.
Products in the AXTAIR motorized air range are therapeutic supports for medical
beds in the context of the CEI standard 60601-2-52 regarding the evaluation of
protection against mechanical hazards from Electro-Mechanical devices (EM) and
EM systems; in this context, they are excluded from the scope of tests according to
