Stiegelmeyer Deka - Target User Groups and Responsibilities

Target Groups, Qualifications and Duties
Operator
10
Instruction Manual
3 Target Groups, Qualifications and Duties
Important: This instruction manual was compiled for a complete range of hospital beds.
Hospital beds in the Deka range can be supplied in a mechanical or electric version with
a greater or lesser number of functions. Please note that functions or equipment that your
bed does not incorporate may be described in this instruction manual.
3.1 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
device.
3.2 Operator Responsibilities
Please observe your obligations as the operator in accordance with the Medical Devices Operator
Ordinance (Medizinprodukte-Betreiberverordnung, German abbreviation: MPBetreibV), in order to
ensure the permanently safe operation of this medical product with no risk of danger to patients,
users or third parties. In other countries the relevant national regulations concerning the duties of
the operator must be followed!
Only allow this bed to be used by persons who have been instructed in its safe operation!
x In Europe: Ensure that users know where this instruction manual is kept, in accordance with
the Medical Devices Directive 93/42 EEC!
x In other countries, the relevant national regulations must be complied with!
x Using this instruction manual, which is provided with this hospital bed, ensure that every user is
instructed in the safe operation of this bed before using it for the first time!
x Draw every user’s attention to the possible hazards that can arise if the hospital bed is improp-
erly used. This applies in particular to the use of electrical actuators and safety sides!
x Make sure that substitute staff are also sufficiently well instructed in the safe operation of the
hospital bed!
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 must be handed over with the
bed.
If any other equipment is attached to the bed, (e.g. compressors for positioning systems, etc.), en-
sure that this is securely fastened and is functioning properly.
Consult the manufacturer of these devices, or Stiegelmeyer, if there are any uncertainties.