ASKLÉ
SANTÉ
- 3 -
In order to comply with risk assessment under ISO standard 14971, an assessment was
carried out on all "hospital bed - therapeutic mattresses (Axtair) - accessories". The
risk assessment shows that there may be a risk of bodily trapping if the bedridden
person presents mental confusion and/or agitation. Use of the device has been
approved in order to improve the service rendered in terms of therapeutic aid
and/or prevention of bedsores.
We have approved this product in order to improve the service offered in the
prevention and aid in treatment of bedsores versus the risk of trapping of the
bedridden person.
Keep packaging, the transporting bag as well as the mattress out of reach of
children in order to avoid any risk of suffocation.
In order to avoid any risk, any modification of this product or unspecified use of its
accessories is prohibited.
