Intended Use - wissner-bosserhoff SafeSense Manual De Instrucciones

2.3 Intended use

SafeSense is classified as a Class I medical device as an accessory for medically used beds.
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It is intended exclusively for human medical and nursing purposes and for use in the physical
environment of nursing homes, outpatient care facilities and clinics in accordance with appli-
cation environment 3 and/or 5 as per IEC 60601-2-52 (current status). SafeSense
be used in combination with the wissner-bosserhoff nursing beds of the sentida and movita
model series and hospital beds of the image 3 and eleganza 2 model series.
We assume no liability for potential property damage or personal injuries caused by unappro-
ved accessories, inappropriate handling, accidental tripping or mutual cancellation of the in-
tended use. The specified use is the intended use. Its sole source for the operator or user is
the labeling and the instructions for use.
Indication and target patient group
SafeSense is intended for monitoring general presence parameters in bed. ItIt informs the
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nursing staff about leaving the bed. At night, it provides the resident with automatic underbed-
light.
SafeSense is intended for persons who are at least 146 cm tall, weigh at least 40 kg, and
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have a BMI ≥ 17. Reliable signal transmission can only be guaranteed under these conditions.
Other applications must be agreed in writing with wissner-bosserhoff GmbH in advance. The
product is to be used as work equipment for care applications and is subject to the regulations
of the responsible professional associations.
Application restrictions and contraindications
Use only under medical supervision. The determining factor as to whether or not care is me-
dically supervised is whether that care is provided under the direction of medical personnel.
SafeSense is not intended for use as an emergency call or lifesaving call for help. Rather, it is
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a tool to facilitate everyday care activities in nursing homes.
Intended users
The system may only be used by persons who, based on their training or knowledge and practi-
cal experience, can guarantee proper handling. In addition, the user of the system must have
been instructed in its correct use and must have familiarized himself with the product on the
basis of these instructions for use. Common users include: nursing staff, physicians, physical
and occupational therapists and house technicians.
may only
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