Intended Use - wissner-bosserhoff sentida 7-i Notice D'utilisation

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2.3 Intended use

The digital nursing bed sentida 7-i is a Class Im (non-sterile with measuring function) medical
device. It is intended exclusively for human medical treatment and should only be used in the
application environments 3 and 5 in accordance with the standard IEC 60601-2-52:2010 +
A1:2015: Application environment 3 includes longterm care in nursing homes and homes for
the elderly, in geriatric and rehabilitation facilities. These institutions require medical super-
vision and, if necessary, monitoring. A ME DEVICE used for medical purposes can be made
available to maintain or improve the resident's condition.
Application environment 5 includes the ambulant care area in a hospital or other medical
institution with medical supervision at hand. A ME DEVICE is made available for persons with
illness, injuries or disabilities for treatment, diagnosis or supervision.
Any other application must be agreed beforehand in writing with Wissner-Bosserhoff GmbH.
The product must be used as nursing equipment and is subject to the regulations of the rele-
vant professional organization.
This nursing bed is a medical product in the sense of the regulations and standards named
in the following chapter „product safety / excerpt of applied standards". Accordingly, this pro-
duct may only be used under medical supervision. The decisive factor in whether nursing is
medically supervised or not depends on whether nursing takes place under the instructions
of medical personnel or not.
It is designed for a safe working load of 250 kg (lifting force), with a maximum patient or
resident weight of 215 kg and a mattress and accessory weight of 35 kg. If other, heavier
or further loose or attached accessories are used, the maximum patient weight is reduced
accordingly.
The bed may only be operated by persons who can guarantee correct handling because of
their training or knowledge and practical experience. The users of the digital nursing bed must
have received instructions for correct use and must have familiarized themselves with the
equipment with the help of these instructions. The digital nursing bed may only be used in
complete accordance with the instructions for use.
We assume no liability for potential product damage or personal injuries caused by unappro-
ved accessories or mutual cancellation of the intended use.
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