2.6 Staff requirements
Insufficient qualification
Authorised staff
20.02.2019
As per MPG § 2 and § 3 RK Rose+Krieger GmbH understands the
lifting column to be an accessory part for an existing overall
product as per § 3 MPG.
Observe the following:
n
The manufacturer of medical products is responsible for lawful
viability.
n
A separate risk assessment must be implemented for the
respective medical product.
n
Test the lifting column to determine its suitability for the applica-
tion of the manufacturer of medical products.
n
RK Rose+Krieger GmbH assumes no liability for design errors
or engineering deficiencies, or any risks caused by the drive
system for the specific application (for example, constructional
crushing and shearing points).
Commissioning must not be performed until the medical product
meets the requirements of Regulation (EU) 2017/745 of the Euro-
pean Parliament and the Council of 5 April 2017 on medical prod-
ucts.
Before circulating the medical product, it must meet the require-
ments of the EC directives, including documentation requirements.
WARNING!
Danger in the event of insufficiently qualified per-
sons!
Insufficiently qualified persons are unable to assess
the risks associated with handling the lifting column
and thus put themselves and others at risk of severe or
fatal injury.
–
Only have suitably qualified persons carry out all
work.
–
Insufficiently qualified persons must be kept away
from the work area.
The different tasks described in this manual require the persons to
whom the tasks were assigned to have different qualifications.
Only persons who can be expected to reliably complete the tasks
are approved for all work. Persons whose reactions are impaired
due to drugs, alcohol or medication, for example, are not approved.
Lifting column Multilift I/Multilift II
Safety
Staff requirements
81