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tioning aids, this can lead to pressure sores. The manufactur-
er of the care bed is not liable for this in any way.
Electrically operated care beds are active medical devic-
es and must be maintained according to Article 7 of the
German Medical Device Operator Ordinance (MedProd-
BetrV). These maintenance measures must be carried out
regularly (at least once per year). This must involve visual
and operational inspections of functional and electrical safe-
ty in line with VDE0751.
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 certified 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 devices.
Electrically operated care beds are active medical devices
and must be listed in an inventory for each site in line with
Article 13 of the German Medical Device Operator Ordi-
nance (MedProd-BetrV). It is advisable to also document
the correct implementation of the required checks and
servicing in this inventory and to specify the date of the
next inspection. The required protocols concerning 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 device 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 in order to reduce the risk of injury caused by
falling out of bed.
If the mains connection cable is damaged, the bed can no
longer be used and must immediately be taken out of oper-
ation.
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
Summary of Contents for AYLEEN CARE BED
Page 1: ...CARE DESIGN AYLEEN CARE BED INSTRUCTION MANUAL...
Page 2: ...2...
Page 13: ...13...
Page 43: ...43 NOTES...
