|
11
In addition, the safe working load should not be
exceeded.
If an immobile occupant remains in the same posi-
tion for a long period without the use of positioning
aids, this can lead to pressure sores. The manufac-
turer of the care bed is not liable for this in any way.
Electrically operated care beds are medical prod-
ucts and, as such, are subject to so-called technical
safety checks in accordance with the Medical De-
vice Directive (MPG) and § 6 of the Medical De-
vice Operator Ordinance (MedProd-BetrV). These
regular safety checks must be carried out at least
once a year. This must involve carrying out a
visual and operational inspection of functional
and electrical safety in accordance with VDE0751.
F
p. 29 Maintenance
Furthermore, electrically operated care beds are
electrical appliances and their safety is the re-
sponsibility of the employer. The supervisory func-
tion of this obligation is the responsibility of the
Berufsgenossenschaft für Gesundheitsdienst und
Wohlfahrtspflege (Employers’ Liability Insurance
Association for Health Service and Welfare Work
– BGW) and the Gewerbeaufsichtsamt (Trade Su-
pervisory Board). The regulations of the Employers’
Liability Insurance Association for Health Service
and Welfare Work apply in the place of work (ab-
breviated to BGV, formerly VBG). In particular, BGV
A2 (formerly VBG “Electrical Units and Equipment”)
applies, which requires regular inspection of mov-
able electrical equipment with a guideline of six
months, but at least once a year. These inspections
may only be carried out by an electrical specialist
or someone with electrical training using a special
measurement and inspection device. Inspections
in accordance with BGV A2 can be carried out by
specialist staff trained by the manufacturer as part
of the technical safety checks for medical products,
as these BGV inspections are included in the tech-
nical safety checks.
Electrically operated care beds are active medical
products and must be listed in an inventory for each
site in accordance with the Medical Device Oper-
ator Ordinance (MedProd-BetrV). We recommend
you also document the proper implementation of
the required technical safety checks in this inven-
tory and note the date of the next inspection. The
required notes on technical safety checks already
carried out should be appended to the inventory.
Proper execution and traceable documentation of
the technical checks, maintenance and servicing
work prescribed by the manufacturer, as well as
the technical safety checks, are required in order to
preserve the warranty rights of the purchaser. If the
operator of a medical product does not meet their
obligations, this could lead to the risk of damage
and accidents for which the manufacturer is explic-
itly not liable.
Any maintenance work is to be carried out in ac-
cordance with VDE0751-1 and the subsequent
technical safety check is to be documented.
