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www.iskomed.de
15.4
Notes on documentation
According to the Medical Device Operator Regulation and Medical Device Regulation (EU) 2017/745
(MDR), there is a documentation obligation for:
•
Maintenance
•
Incidents / near misses
If extraordinary hazards for the product are foreseeable at the installation site of the care bed (supply
line lies on the floor; children playing; pets; ...), the electrical lines in particular must be constantly
checked and suitable measures taken to avert hazards.
16
Reuse
Before each reuse of the care bed, a thorough visual and functional check of all electrically operated
functions as well as a current leakage test according to DIN EN 62353:2015-10 must be performed as
described under the item Maintenance intervals. The points on service and care & maintenance
mentioned in the operating instructions must always be observed when cleaning the bed.
17
Disposal
17.1
Disposal of the device
Disposal of the device and accessories, if any, should be carried out in an environmentally
friendly manner and in accordance with the legal regulations. Please adhere to the valid
waste separation regulations! If there are any uncertainties in this matter, please contact
your local municipality or waste disposal company.
17.2
Disposal of the electrical components
*if electrical components are included in the medical device
According to Directive 2012/19/EU - WEEE2, this medical device is classified as an electrical device. All
electrical components are free of unauthorized ingredients classified as harmful according to RoHS II
Directive 2011/65/EU. In addition, replaced electrical components must be disposed of in accordance
with European directives (see Directive 2012/19/EU - WEEE2).
17.3
Disposal of the packaging
The EU Waste Framework Directive 2008/98/EC is decisive for the handling during the disposal of the
packaging. Reusable materials must be fed into a recycling cycle in accordance with national
regulations.
