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Appendix
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Instruction manual - MULTILINE NEXT DC
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9.6
Glossary
The following groups of persons and terms are defined in this glossary.
Operator
Under the German Medical Device Operator Ordinance (also abbreviated as MPBetreibV), the operator of a medi-
cal device is any natural or legal person who is responsible for the operation of the health facility in which the
medical device is operated or used by its employees.
An operator (e.g. hospital, dialysis centre, hospital, hospital management, medical practice, company doctor etc.)
can be the legal owner of the MULTILINE NEXT DC couch, as well as have actual control over it. The operator is
responsible for the safe operation of this medical device.
User
Under the MPBetreibV, the user is the person who uses a medical device on the patient.
Users (e.g. medical specialists, nurses, doctors, assistants, nursing staff, caregivers etc.) are persons who are au-
thorised by their training, experience or instruction to operate the couch independently or to carry out their work
with it, or who have been instructed in the handling of the couch. Furthermore, they can recognise and avoid
possible dangers and assess the clinical condition of the patient.
Patient
A patient is a person who is ill, in need of care or handicapped and who is placed on this couch.
Service personnel
Service personnel (e.g. service technicians, specially trained employees of a service support point, customer ser-
vice employees of GREINER GmbH etc.) are persons who are authorised to carry out maintenance or repair work
beyond that performed by the user. They are entitled to carry out the necessary maintenance or repair work on
their own responsibility on the basis of their training, experience or through further instruction. They can identify
and avoid any hazards that may occur during maintenance or repair work.
Healthcare facility
Under the MPBetreibV a health facility is any facility, body or institution, including rehabilitation and care facilities,
in which medical devices are professionally operated or used by medical personnel, persons in the nursing profes-
sion or other authorised persons.
