Stiegelmeyer Seta pro - 3 Target Groups, Qualifications and Duties; Operator; Responsibilities of the Operator

3 Target groups, qualifications and
duties
3.1 Operator
3.2 Responsibilities of the operator
An operator (e.g. clinic, hospital, hospital administration) is every natural and legal person
with property rights to the product. The operator is responsible for the safe operation of this
medical product.
Operators of medical beds in Europe are obliged, in accordance with the new Medical Device
Regulation (EU) 2017/745 (MDR) and any existing additional relevant national laws/regula-
tions, e.g. in Germany the Medical Devices Operator Ordinance (Medizinprodukte-Betreiber-
verordnung, German abbreviation: MPBetreibV), to ensure the long-term safe operation of
this medical product with no risk of danger to patients, users or third parties. In other coun-
tries outside Europe the relevant national regulations concerning the duties of the operator
must be followed!
Only permit persons who have been properly instructed to use this bed!
•
Using this instruction manual, which is provided with this hospital bed, ensure that ev-
ery user is instructed in the safe operation of this bed before using it for the first time!
•
Draw every user’s attention to the possible hazards that can arise if the hospital bed is
improperly used. This applies in particular to the use of electrical drives and safety
sides!
•
Make sure that substitute staff are also sufficiently well instructed in the safe operation
of the hospital bed!
•
Ensure that users know where this instruction manual is kept!
Check to ensure that the safety instructions are adhered to!
If the hospital bed is in long-term use, test the functions and check for any visible damage
after a reasonable period of time (at least once a year)!
If the owner of the hospital bed changes, the instruction manual should be handed over with
the bed.
If any other equipment is attached to the bed, (e.g. compressors for positioning systems,
etc.), ensure that this is securely fastened and is functioning properly.
If you have any queries or concerns, consult the manufacturer of the equipment or Stiegel-
meyer.
3 Instruction Manual