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this can lead to pressure sores. The manufacturer
of the clinical bed is not liable for this in any way.
Electrically powered clinical beds are medical
products and are subject to technical safety checks
in accordance with the Medical Devices Directive
and Medical Devices Operator Ordinance § 6.
These regular checks must be carried out at least
once a year. A visual and operational inspection
of functional and electrical safety in accordance
with VDE0751 must be carried out to ensure this.
Furthermore, electrically operated clinical beds
are electrical appliances, the safety of which is
the responsibility of the employer. The supervisory
function 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 (abbreviated to BGV, for-
merly VBG). In particular BGV A2 (formerly VBG)
“ Electrical Units and Equipment” applies, which
requires regular inspection of movable electrical
equipment with a guideline of 6 months but at least
once a year. These inspections may only be carried
out by an electrical specialist or someone with elec-
trical training using a special measurement and
inspection device. Inspections in accordance with
BGV A2 within the technical safety checks for med-
ical products may be carried out be specialist staff
trained by the manufacturer as these BGV inspec-
tions are included in the technical safety checks.
Electrically operated clinical beds are active medi-
cal products and must be listed in an inventory per
site in accordance with the Medizinprodukte Betrei-
berverordnung (MedProd-BetrV) Medical Products
Operation Regulations. We recommend you also
document the proper implementation of the re-
quired technical safety checks in this inventory 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 commis-
sioning work prescribed by the manufacturer, as
well as the technical safety checks are required in
order to preserve the warranty right of the purchas-
er. If the operator of a medical product does not
meet their obligations, then this may lead to a risk
of damage and accidents, for which the manufac-
turer is explicitly 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.
Summary of Contents for Impulse 300 KL
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