burmeier Lenus - MAINTENANCE

Instruction Manual for Lenus Care Bed
Page 65
6 Maintenance
Legal principles
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
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.
All ‘serious incidents’
2
relating to the device must be reported to the manufacturer
and the competent authority of the member state in which the user and/or resident is
established (in Germany: www.BfArM.de)
In other countries outside Germany or the EU, the relevant national regulations must be
complied with.
Information for operators
This bed has been designed and built to work safely over a long period of time if operated
correctly and put to proper use. The expected service life is up to 8 years.
This bed must not be modified without authorisation by the manufacturer.
Frequently transporting, assembling and dismantling the bed, improper operation and
long-term use may cause damage, defects and wear to the bed over time. These
deficiencies can cause hazards if they are not recognised and corrected immediately.
For this reason, there are legal principles for conducting regular inspections in order to
guarantee the safe condition of this medical product.
According to § 4 of the Medical Devices Operator Ordinance (Medizinprodukte-
Betreiberverordnung), it is the responsibility of the operator to maintain this product. For this
reason, the regular visual inspections and functional checks described hereafter must be
performed by both the operator and the users. Only carry out maintenance work on unoccupied
beds.
• Instruct users about the following inspections that are required to be performed! (See
chapter 6.1).
2
Incident that directly or indirectly had, could have had or might have one of the following consequences:
a) The death of a resident, user or other person
b) The temporary or permanent serious deterioration in the state of health of a resident, user or other
person
c) A serious risk to public health
(source: MDR, Article 2(65)