220822
SCHUPP GmbH & Co KG
72280 Dornstetten-Aach | Glattal Straße 78 | T: +49 (0) 7443/243-0 | F: +49 (0) 7443/243-255 | [email protected] | www.schupp.shop
5
OPAL
SAFETY
2.2 Standards applied
The therapy couch has been developed and manufactured according to the latest state of the art and in compliance
with national/international guidelines. It complies with the following guidelines:
EU MDR (Medical Device
Regulation) 2017/745
This product is a class I medical device according to the EU Medical Device
Regulation.
DIN EN ISO 10993-1:2017-04
Biological evaluation of medical devices
DIN EN 60601-1:2013-12
Medical electrical equipment: General requirements for safety including
essential performance characteristics
DIN EN 62366-1:2015 + A1:2020
Medical devices - Application of fitness for use to medical devices
Machinery Directive 2006/42/EC
Medical hydraulic equipment - General requirements for safety
2.3 Intended use
The therapy couch of the company Schupp GmbH & Co KG is a medical device of class 1.
(EU MDR 2017/745) and is intended exclusively for professional use by medically trained personnel and instructed
users for the proper positioning and storage of patients during therapeutic healing and medical treatments or for the
short-term examination of patients in the rooms provided for this purpose.
The Schupp company gives no guarantee regarding the suitability of the therapy couch for a specific therapeutic or
diagnostic purpose. The therapist determines the appropriate form of application.
The therapy couch is not intended or equipped for hydrotherapy or for domestic or radiological applications. Also, the
electrically operated couches must not be used in areas with flammable gases, vapours or increased humidity. In case
of non-observance, this can lead to considerable damage to the couch as well as endanger the patient, user or third
parties.
