Askle Sante Winncare Automorpho Plus Manuale d'uso - Pagina 5
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NDICATIONS
According to the opinion of 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 support for treatment of stage 1 to 4 pressure ulcers (according to
medical advice) for patients up during the day, confined to bed for over 15 hours and
"
"
with a
moderate
scale and clinical judgement. Treatment support: combine with a positioning system
and auxiliary medical intervention or intervention from a close relative at least 3 times
a day.
C
ONTRAINDICATIONS
Patient weight over 165 kg for the AUTOMORPHO® PLUS
(VAXT4/AUTO-P and VAXT4/AUTO100-P)
Use in decompression chamber
Use on a stretcher.
P
RECAUTIONS
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].
Patient treated at home with no possibility for auxiliary medical intervention.
For a patient confined to bed with weight over 135 kg in semi-seated position at 45°
at least.
"
Check by a
guess work
between the buttock area and the support that there is no risk of injury by checking
there is a sufficient volume of air. If applicable, the
add air.
Also check the condition of exposed skin at each treatment and change of position.
W
ARNING
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 AUTOMORPHO PLUS motorized air support.
The characteristics and performance of the motorized air support will be maintained
exclusively through the use of the pump [see references on page 18], combined
with mattress
modification and optionally, with an inflation/deflation kit [see references on page
18]
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.
WINNCARE FRANCE
"
"
to
high
risk of pressure ulcer evaluated according to a validated
"
test by placing the palm of the hand towards the top
topper type supports [see references on page 18] with no
"
comfort
- 4 -
"
setting can be used to