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医療機器 Askle Sante Winncare Automorpho PlusのPDF ユーザーマニュアルをオンラインで閲覧またはダウンロードできます。Askle Sante Winncare Automorpho Plus 20 ページ。

 Products in the AXTAIR motorized air range are therapeutic supports in the context of

the CEI standard 60601-2-52 regarding the evaluation of protection against

mechanical danger from Electro-Mechanical devices (EM) and EM systems,

particularly against trapping of the patient in non-mobile parts. The requirements in

figures 201.107, 201.108 and table 201.101 involving Axtair type therapeutic mattress

are excluded.

 To satisfy the risk analysis according to the ISO 14971 standard, the evaluation was

conducted on

risk assessment demonstrates that there could be a risk of bodily entrapment in the

case of a person confined to bed who has a confusion

and/or anxiety disorder. The use of the device was approved for improved service

provided in terms of therapeutic support and/or pressure ulcer prevention.

 Attention must be paid when using a patient contention system. See the

manufacturer

s instruction leaflet.

 Keep the packaging, transport bag and the support out of reach of children to

avoid the risk of suffocation.

 In order to avoid any risk, any modification to this product, or use of non specified

accessories is forbidden.

 Meaning of symbols

Note, see user manual and (or) instruction leaflet



Category II device (Dual insulation)

BF type electrical device (applied to aids)

Complies with essential requirements of European directive

93/42/CEE

2007/47/CEE)

Note, electrical and electronic equipment subject to selective

waste collection

Manufacturer

Serial number

Batch number

Patient weight range

Warning

WINNCARE FRANCE

medical bed-therapeutic support (AXTAIR) units - accessories

applicable

medical

devices

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(amended