Responsibility Of The Manufacturer; Quality Management; Checks And Repair; Notes On Esd - Braun Infusomat Space Service Manual

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Important Preliminary Remarks

Responsibility of the Manufacturer

Quality Management

Checks and Repair

Notes on ESD

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The manufacturer, person who assembles, installs or imports the
device can only be held responsible for safety, reliability and per-
formance if
- mounting, enhancements, new settings, changes or repairs
are carried out by duly authorized persons,
- the electrical installation in the corresponding room meets
the requirements of the VDE 0107, VDE 0100 part 710 or
IEC 60364-7-710 and the national standards,
- the device is used in accordance with the instructions for use
and the Service Manual,
- the Technical Safety Checks are performed at regular inter-
vals in the case of devices for which TSC checks are manda-
tory,
- a current manual which corresponds to the revision state is
used when carrying out maintenance, repair and service,
- the service technician takes part in the revision service,
- the technician has participated in a technical training course
for the specific B. Braun unit.
B. Braun is certified in accordance with DIN EN ISO 9001 and
ISO 13485. This certification also includes maintenance and serv-
ice.
The unit has the CE label. The CE label confirms that the device
corresponds to the "Directive of the Council for Medical Products
93/42/EC" of June 14, 1993.
Training may only be performed by B. Braun. The possession of the
manual does not authorize the performance of repairs. The in-
structions on electrostatic sensitive components (ESD standards)
must be observed.
After repair a device check or diagnosis is to be carried out.
Semiconductors can be destroyed by electrostatic discharge. Es-
pecially MOS components can be damaged by interference from
electrostatic fields, even without discharge via contact. This type
of damage is not immediately recognizable. Unit malfunctions
can even occur after a longer period of operation.
Infusomat® Space 6.0 EN