burmeier Regia, Instruction Manual

Page: 83 / 152

6 Maintenance
6.1 Legal principles
ATTENTION
Information for operators
This bed has been designed and built to work safely over a long period of time. When
operated and used properly, the expected service life of this bed is 2 to 8 years. The
bed's service life depends on its frequency of use and the conditions under which it is
used.
All 'serious incidents'
1
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)
1:
Incident that had, could have had, or could have, one of the following direct or indirect
consequences: a) the death of a patient, user or another person, b) the temporary or per-
manent serious deterioration in the health of a patient, user or another person, c) a seri-
ous risk for public health, (source: MDR, Article 2(65))
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/regulations, e.g. in Ger-
many currently the
• German Medical Devices Operator Ordinance § 4 (Maintenance)
• Berufsgenossenschafts-Vorschrift DGUV regulation 3 (Directive of the German Em-
ployers Liability Insurance Association, Testing of mobile electrical equipment in indus-
trial use)
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.
Beds purchased for private use (non-commercial use) are not subject to regular safety in-
spections, but these are recommended by the manufacturer.
Material damage
Failure to heed this note may result in material damage.
Part B: Operator and Technical Personnel 47