2
Safety
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Instruction manual - MULTILINE NEXT DC
© 2019 GREINER GmbH
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2.2.1
Safety inspection
Legal foundations
Operators of electrically driven couches for medical use are, in accordance with
EC Medical Device Directive 93/42 EEC (MDD)
and the resulting national laws/regulations (e.g. in Germany)
German Medical Device Operator Ordinance (MPBetreibV) § 4 (repair)
DGUV Information 203-071 (periodic inspections of mobile electrical work equipment).
DGUV Regulation 3 Accident Prevention Regulation (electrical systems and equipment).
obliged to maintain the safe condition of medical devices throughout the entire period of use. This also includes
regular professional maintenance and regular safety checks.
In other countries, outside Germany or the EU, the applicable national regulations must be observed.
GREINER GmbH generally recommends an annual maintenance according to the maintenance table as well as a
safety inspection with simultaneous electrical inspection according to IEC 62353 (see service manual).
2.3
Personal safety
To avoid errors and to ensure trouble-free operation of the couch, the safety instructions in this instruction man-
ual must have been read and understood completely and must always be made available to the user at all times
(in printed or electronic form).
Basic instruction for the user can be given by GREINER GmbH or its authorised specialist distributor at the re-
quest of the operator.
Participation in such a training will be certified in a special form with name, date and signature (see 9.5 Proof of
instruction).
Patients must be instructed in the use of the couch before activating the hand control.
For the definition or delineation of the groups of persons in this Instruction manual see under 9.6 Glossary.
In other countries, outside Germany or the EU, the applicable national regulations and laws must be observed. In
Germany, the provisions of the Medical Devices Act (MPG), the Medical Devices Operator Ordinance (MPBetreibV)
and the relevant statutory regulations must be observed.
Notes to the operator
This couch meets all requirements of the EC directive 93/42 EEC for medical devices. It is classified,
designed and manufactured as an active class I medical device in accordance with the Medical De-
vices Act (MPG).
Observe your obligations as operator according to the Medical Device Operator Ordinance
(MPBetreibV) to ensure a permanently safe operation of this medical device without endangering
patients, users and third parties.
Notes to the user
In accordance with MPBetreibV, the user must ensure that the couch is functional and in proper
condition before using it in medical areas and must observe the Instruction manual.
The same applies to any accessories that have been attached to the couch.
Notes to the patients
With each new assignment, the patient must be instructed in the important functions of the couch.
Instruction is usually given by the user.
