Electrical Warnings - Fresenius Medical Care multiFiltrate Instructions For Use Manual

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Chapter 2: Important information

2.12.4 Electrical warnings

2-14
Warning
The "type of protection against electric shock" for this device is
"Protection class I". To avoid the risk of electric shock, this device may
only be connected to a power supply network with a protective earth
conductor.
It must be taken into consideration that, in many countries, specific
regulations of the national authorities are in force.
Warning
Danger to life due to electric shock
If treatments are carried out using central venous catheters positioned
in the atrium, please observe the following points:
 Connect the device (multiFiltrate) to the equipotential bonding of the
installation.
 Remove all other non-medical electrical devices and medical
electrical devices with a touch current or patient leakage current
greater than the corresponding alarm limits for type CF applied parts
from the patient environment (1.5 m in all directions).
The touch current or the patient leakage current from another
non-medical electrical device or medical electrical device in the patient
environment can flow to the earth via the central venous catheter and
via the type B or BF applied part of the device (multiFiltrate).
multiFiltrate
(medical electrical
device)
The patient is
connected
electrically to the
earth potential via
his or her blood and
the dialysate (type B
direct, type BF
capacitive).
Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015
Central venous catheter
positioned in the atrium
Other electrical
device
(medical electrical
device or non-medical
electrical device)

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