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11 Technical Safety Checks / maintenance
procedures
11.1 Important information on the Technical Safety Checks /
maintenance procedures
Technical Safety Checks
(TSC)
Maintenance procedures
(MA)
Qualification requirements
of testers
Specifications
Documentation
Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015
Chapter 11: Technical Safety Checks / maintenance procedures
The first TSC are required before the end of the 24th month following
initial start-up after delivery from the factory. All additional TSC are
required before the end of the 24th month following the last TSC
performed.
The maintenance procedures (MA) are a recommendation of the
manufacturer. The maintenance procedures help ensure trouble-free
operation, and must be carried out for the first time before the end of the
24th month following initial start-up after delivery from the factory. All
additional maintenance procedures are required before the end of the
24th month following the last maintenance procedure performed.
The checks must only be performed by the manufacturer's service
support organisation or a person authorised by it.
The checks may only be performed by personnel qualified to perform
them correctly based on their education, training, knowledge, and
experience. Furthermore, the personnel performing the checks must be
permitted to do so independently and without outside interference.
Any information on the specifications must be observed.
The Technical Safety Checks, the maintenance points, and further
procedural information are described in the Service Manual.
Reports are available on request.
The completion of the Technical Safety Checks must be entered in the
Medical Device Register.
11-1
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