Otto Bock Evolight 476C00 SK350, Инструкция по эксплуатации

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Ottobock | 7 Evolight – 476C00=SK350
5 CE-Konformität
Das Produkt erfüllt die Anforderungen der Richtlinie 93/42/EWG für Medizinprodukte. Aufgrund
der Klassifizierungskriterien für Medizinprodukte nach Anhang IX der Richtlinie wurde das Produkt
in die Klasse I eingestuft. Die Konformitätserklärung wurde deshalb von Ottobock in alleiniger
Verantwortung gemäß Anhang VII der Richtlinie erstellt.
English
INFORMATION
Date of the last update: 2014-03-25
• Please read this document carefully.
• Follow the safety instructions.
Explanation of Symbols
CAUTION
Warnings regarding possible risks of accident or injury.
NOTICE
Warnings regarding possible technical damage.
INFORMATION
Additional information on the fitting / use.
INFORMATION
Please read the Instructions for Use carefully. Pay special attention to the safety instructions!
1 Description
1.1 Intended Use
The wheelchair seat cushion Evolight is used for decubitus prophylaxis and therapy in patients
with paraplegia, hemiplegia, geriatrics, neurological deficits, and rheumatic as well as neural and
muscular diseases. It is intended
exclusively
for use in a wheelchair.
For hygienic reasons, re-use of the seat cushion or use by another patient is not recommended
by the manufacturer.
1.2 Field of application
The Evolight seat cushion can be used without restrictions for patients up to a body weight of
125 kg. Use in patients up to a body weight of 180 kg is categorically possible, however prior
consultation with the treating therapist is recommended.
CAUTION
Risk of redness of the skin/decubitus when exceeding the maximum permissible patient
weight.
When exceeding the maximum permissible patient weight, we highly recommend that the
user test the cushion for a few hours under medical supervision, during which time it should be
determined that no reddening of the skin occurs, before using the cushion on a permanent basis.