Malsch IMPULSE KL, Instruction Manual

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Electrically operated hospital beds are active medical prod-
ucts and must be maintained according to Article 7 of the
Medical Devices Operator Ordinance (MedProd-BetrV.)
These maintenance measures must be carried out regularly
(at least once per year). They must include visual and func-
tionality checks of functional and electrical safety in line with
VDE0751.
 p. 47 Maintenance
Furthermore, electrically operated hospital beds are electri-
cal appliances whose safety is the responsibility of the em-
ployer. The supervisory function of this obligation is the re-
sponsibility of the Employersʼ Liability Insurance Association
for Health Service and Welfare Work (BGW) and the Trade
Supervisory Board (Gewerbeaufsichtsamt). The regulations
of the employersʼ 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 products.
Electrically operated hospital beds are active medical prod-
ucts and must be listed in an inventory for each site in line
with Article 13 of the German Medical Device Operator
Ordinance (MedProd-BetrV). It is advisable to also docu-
ment 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
technical 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 dam-
age and accidents for which the manufacturer is explicitly
not liable.
Maintenance work must be carried out and documented by
trained staff.
The bed should be left in the lowest position when the
patient is unattended 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
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 hos-
pital bed, precautions must be taken to prevent damage to
the device cable or other components of the ME device
resulting from crushing between the movable parts of the
medically used bed.