Responsibility Of The Manufacturer Of Medical Products - RK Rose+Krieger Multilift I Manual De Montaje

Safety

Responsibility of the manufacturer of medical products

Additional operator obligations
2.5 Responsibility of the manufacturer of medical products
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n The operator must keep themselves informed of the applicable
occupational health and safety regulations and determine addi-
tional hazards which result from the special work conditions in
the lifting column's place of use during a risk assessment. The
results must be implemented in the form of operating instruc-
tions.
n Throughout the entire period of use of the lifting column, the
operator must check whether the compiled operating instruc-
tions match the current regulations. If necessary, the operating
instructions must be adapted.
n The operator must unambiguously regulate and specify the
responsibilities for assembly, operation, troubleshooting, main-
tenance and cleaning.
n The operator must ensure that all persons handling the lifting
column have read and understood this manual. Furthermore,
they must regularly train the staff and inform them of the haz-
ards. The operator must ensure that the staff have been trained
in compliance with the required staff qualifications.
n The operator must provide the staff with the required protective
equipment and must issue the mandatory order to wear the
required protective equipment.
n The operator must make sure that danger zones during
assembly, operation, troubleshooting, maintenance and
cleaning of the lifting column, are secured.
The operator is further responsible for ensuring that the lifting
column and the place of use are in a technically perfect condition
at all times. Therefore, the following applies:
n The operator must ensure the required clearances and suffi-
cient lighting for safe working, as well as ensuring that the
lifting column and the place of use are kept permanently clean
and tidy.
n The operator must make sure that the maintenance intervals
described in this manual are adhered to.
n The operator must make sure that the maintenance intervals
described in this manual are adhered to.
n The operator must make sure that all work on the lifting column
is carried out in a sufficiently air-conditioned room in which an
excessively hot or cold working environment is not expected.
This manual is only intended for the manufacturer of medical prod-
ucts in order to compile instructions for use for the respective med-
ical product.
The manufacturer of medical products is any manufacturer who
produces products which are classified as per § 3 of the German
Medical Products Law (Medizinproduktegesetz) (referred to in the
following as MPG).
Lifting column Multilift I/Multilift II 20.02.2019