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Wissner-Bosserhoff Carisma - Employer Responsibility for Bed Safety; Maintenance According to Medical Products Directive; Documentation of Inspections and Maintenance; Servicing Standards and Documentation

Wissner-Bosserhoff Carisma
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T 08 9351 7500 E info@unicarehealth.com.au W www.unicarehealth.com.au
• Furthermore, electrically-operated hospital and nursing home beds are electrical resources, for
the safety of which the employer is responsible. The monitoring function for this obligation is
the responsibility of the German professional association for health service and welfare care
(BGW) and the German industrial inspectorate. The regulations of the professional associations
for Health and Safety at the Workplace (abbreviated BGV, formerly VBG) apply. In particular,
BGV A3 (formerly VBG “Electrical Facilities and Resources“ (BGV A2)) applies to repeat
inspections of movable electrical resources with a guideline of six months, but at least once per
year. These inspections may only be performed by a qualifi ed electrician or a person instructed
in electrotechnical matters, using a special measuring and testing device. The inspections in
accordance with BGV A3 may also be performed by specialist staff trained by the manufacturer, in
the context of the Technical Safety Inspections for Medical Devices, since these BGV inspections
form a part of the Technical Safety Inspections.
• Electrically-operated hospital and nursing home beds are active medical products and must be
maintained, in accordance with the German Medical Products Operator Directive (MedProdBetrV)
in an inventory sheet for each premises. It is recommended that the correct implementation of the
stipulated TSIs are also documented in this inventory sheet and that the next test date is specifi ed.
The required records for the technical safety inspections already performed should be attached to
the inventory sheet.
• The proper implementation and traceable documentation of the technical inspections, maintenance
and service work specifi ed by the manufacturer, as well as the technical safety inspections, is a
necessary prerequisite on the part of the purchaser that he may acquire rights of guarantee. If the
operator of a medical product does not meet his obligations, risk of damage and accident may
arise from this that are explicitly not the responsibility of the manufacturer.
• Servicing work must be performed in accordance with VDE0751-1 and be concluded with a
documented technical safety inspection