Malsch bakare IMPULSE, Instruction Manual

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least once per year). This must involve visual and operation-
al inspections of functional and electrical safety in line with
VDE0751.

p. 46 Maintenance
Furthermore, electrically operated care beds are electrical
appliances and their safety is the responsibility of the em-
ployer. The supervisory function of this obligation is the re-
sponsibility of the Employers’ Liability Insurance Association
for Health Service and Welfare Work (BGW) and the Trade
Supervisory Board (Gewerbeaufsichtsamt). The regulations
of the employers’ liability insurance associations apply, par-
ticularly those of the German statutory accident insurance
body (DGUV), rule 3 of which stipulates regular inspections
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 certifi ed electrician or person
with electrical training using specialist measurement and in-
spection equipment. The inspections according to DGUV
rule 3 can be conducted by specialist staff trained by the
manufacturer as part of the inspections and maintenance
service for medical products.
Electrically operated care beds are active medical products
and must be listed in an inventory for each site in line with
Article 13 of the German Medical Devices Operator Or-
dinance (MedProd-BetrV). It is advisable to also document
the correct implementation of the required technical safety
checks in this inventory and to specify 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 tech-
nical 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 explicitly not
liable.
Maintenance work must be carried out and documented by
trained staff .
The bed must be left in the lowest position if the resident is
unattended to reduce the risk of injury caused by falling out
of bed.
If the mains connection cable is damaged, the bed must
no longer be used and must immediately be taken out of
operation.
Improper use of the mains connection cable can result
in hazards (e. g. electric shock). Examples of this are cable
breaks due to kinking, shearing or other mechanical damage.
When using other ME devices in conjunction with the care
bed, precautions must be taken to prevent damage to the
device cable or other components of the ME device result-
ing from crushing between the movable parts of the medi-
cally used bed.
The care bed is not suitable for use in the vicinity of active
facilities that use high-frequency surgical devices.