Malsch AURA, Инструкция по эксплуатации

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§ 6 of the German Medical Device Operator Ordi-
nance (MedProd-BetrV). These regular safety inspec-
tions must be carried out at least once a year. This
must involve visual and operational inspections of
functional and electrical safety in line with VDE0751.
F P. 29 Maintenance
Furthermore, electrically operated care beds are elec-
trical appliances and their safety is the responsibility
of the employer. The supervisory function of this ob-
ligation is the responsibility of the Employers’ Liability
Insurance Association for Health Service and Welfare
Work – (BGW) and the Trade Supervisory Board (Gew-
erbeaufsichtsamt). The regulations of the Employers’
Liability Insurance Association for Health Service and
Welfare Work apply in the place of work (abbreviat-
ed to BGV, formerly VBG). In particular, BGV A2 (for-
merly VBG “Electrical Units and Equipment”) applies.
This requires regular inspection of movable electrical
equipment at a recommended interval of six months,
but at least once a year. These inspections may only
be carried out by a certified electrician or person with
electrical training using specialist measurement and
inspection equipment. Inspections in line 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 in-
cluded in the technical safety checks.
Electrically operated care beds are active medical
products and must be listed in an inventory for each
site in line with the German Medical Device Opera-
tor Ordinance (MedProd-BetrV). We recommend you
also document correct implementation of the required
technical safety checks in this inventory and note the
date of the next inspection. The required protocols
concerning technical safety checks already performed
must be appended to the inventory.
Proper execution and traceable documentation of the
technical checks, maintenance and servicing work pre-
scribed 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 explicitly not liable.
Any maintenance work is to be carried out in line with
VDE0751-1 and the subsequent technical safety in-
spection is to be documented.