13.2.1 Legal principles
13.3 Recommended special varnishes
All “serious incidents” * relating to the device must be reported to the manufacturer and
the competent authority of the member state in which the user and/or patient is establish-
ed (in Germany: www.BfArM.de)
•
Only carry out maintenance work on unoccupied beds.
•
If any damage or malfunction is suspected, take the bed out of service at once until it has
been repaired or the damaged component has been replaced!
•
This bed must not be modified without authorisation by the manufacturer.
In Europe: Operators of medical beds in Europe are obliged, in accordance with the new
Medical Device Regulation (EU) 2017/745 (MDR) and existing relevant national laws/regula-
tions, e.g. in Germany currently the
•
German Medical Devices Operator Ordinance § 4 (Maintenance)
•
DGUV 3 (Testing of Mobile Electrical Equipment in Commercial Use) of the German
Employers’ Liability Insurance Association
to preserve the safe operating condition of medical devices throughout their entire service
life. This also includes regularly carrying out expert maintenance and safety checks.
In other countries outside Germany or the EU, the relevant national regulations must be com-
plied with!
*: Incident that had, could have had, or could have, one of the following direct or indirect con-
sequences: a) the death of a patient, user or another person, b) the temporary or permanent
serious deterioration in the health of a patient, user or another person, c) a serious risk for
public health, (source: MDR (Medical Device Regulation), Art. 2(65)).
Colour Description Stiegelmeyer order number
Silver Varnish (500g tin) 203803
Accelerator (100g tin) 203805
White Varnish (500 g tin) 203804
Tab.3: Special varnishes
Maintenance
Instruction Manual 112
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