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18 MANUFACTURER .................................................................................................................................... 22
1 General
To safely operate and control the SC 5010 HS / ES please carefully read this user manual before
operating. Please pay attention to all cautionary statements pertaining to the safe operation of the
SC 5010 SEK. Please keep the manual on file at all times while the product is in service.
The manufacturer reserves the right to make technical changes or modifications in accordance with
advanced technical developments. This manual is not subject to an updating service.
1.1
Copyright
© Distributing, copying or any commercial use of this manual is strictly prohibited unless expressly
permitted in writing by the manufacturer. The manufacturer is entitled to compensation for any
violation of this right.
The manufacturer claims any and all rights in case a patent is granted or the design is registered.
1.2
Disclaimer
Manufacturer excludes any and all liabilities in case of improper or not authorized operation or
maintenance or servicing of the product.
1.3
Applicable rules and regulations
The device complies with the following Regulations for medical devices.
o
MDD 93/42 EEC
o
DIN / ISO 60601-1
o
DIN / ISO 60601-1-2 EMC
o
UMDNS No 13-961
o
Medical Device Class I
The device meets the requirements of MDD 93/42/EEC and the corresponding national requirements
of the Medical Devices Act MDA (Medizinprodukte Gesetz MPG).
User must observe the national legal requirements governing the prevention of accidents.
1.4 Warning and cautioning signs
Warning Indicates a hazardous situation which may result in fatal or serious
bodily injury if the appropriate safety precautions are not heeded.
Caution Indicates a hazardous situation which may result in minor injury if the
appropriate safety precautions are not heeded.
This pictograph on the label indicates:
Equipment Category B according to EN 60601-1