Important Information On The Responsibilities Of A Manufacturer Of Medical Products - RK Rose+Krieger RKPowerlift M Start-Stop/External Notice D'assemblage

2.2 Important information on the responsibilities of a manufacturer
of medical products
This installation and operating manual is only intended for the medical product manufacturer in
order for it to produce a user instruction for the relevant medical product (hereafter also referred
to as "end product"). As set out in the Medical Products Code (hereafter referred to as the
"MPG") §§2 and 3, we understand our product to be an accessory component for a complete
product as defined in § 3 MPG.
Because we are well aware of the end product to which our certified drive system is added, we
draw your attention explicitly to the following points:
•
the medical product manufacturer of the end product is responsible for its feasibility under
the law,
•
a separate risk analysis is to be carried out for the relevant end product,
•
our product is to be tested for fitness for use for a medical product manufacturer's (of the end
product) application,
•
we do not accept any liability for manufacturing defects or even for risks stemming from our
drive system for a special application (e.g. crushing and shear points due to design).
A medical product manufacturer is any manufacturer who manufactures products which comply
with § 3 MPG!
These installation and operating instructions are not intended for operators, patients or users!
We draw your attention explicitly to the fact that only the medical product manufacturer is res-
ponsible for providing the user manual for his medical product for the operator/user!
Commissioning is forbidden until the machine complies with the provisions of EC Directive 93/42/
EEC (Machines Directive). Before bringing into service, this must comply with EC directives, inclu-
ding documentation.
You will find further information and instructions at www.rk-rose-krieger.com.
2. Notes
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