Important Preliminary Remarks
0 - 6 Infusomat® Space 6.0
EN
Responsibility of the Manufacturer 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 re
pairs
are carried out by duly authorized persons,
- the electrical installation in the corresponding room meets
th
e 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 revisio
n 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 c
ourse
for the specific B. Braun unit.
Quality Management B. Braun is certified in accordance with DIN EN ISO 900
1 and
ISO 13485. This certification also includes maintena
nce 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.
Checks and Repair 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 (ES
D standards)
must be observed.
After repair a device check or diagnosis is to be carried out.
Notes on ESD Semiconductors can be destroyed by electrosta
tic 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.
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