10 Instructions for Use Fabius MRI SW 3.n
For Your Safety and that of Your Patients
General WARNINGS and CAUTIONS
The following WARNINGS and CAUTIONS apply to
general operation of the device. WARNINGS and
CAUTIONS specific to subsystems or particular
features appear with those topics in later sections
of these Instructions for Use or in the device-spe-
cific Instructions for Use.
Note on EMC/ESD risk for the device function
General information on electromagnetic compatibil-
ity (EMC) pursuant to international EMC standard
IEC 60601-1-2
Electromedical devices are subject to special pre-
cautionary measures concerning electromagnetic
compatibility (EMC) and must be installed and put
into operation in accordance with the EMC informa-
tion included, see page 199.
Portable and mobile RF communications equip-
ment can affect medical electrical equipment.
Accessories in sterile packaging
Do not use accessories in sterile packaging if the
packaging has been opened, damaged or if there
are other signs that the accessories are not sterile.
Reprocessing and resterilization of single-use
accessoriesis not permitted.
WARNING
Connector pins with an ESD war-
ning sign should not be touched
and no connections should be
made between these connectors
without implementing ESD protec-
tive measures. Such precautionary procedu-
res may include antistatic clothing and shoes,
the touch of a ground stud before and during
connecting the pins or the use of electrically
isolating and antistatic gloves. All staff invol-
ved in the above shall receive instruction in
these ESD precautionary procedures.
WARNING
Risk of electric shock.
Connecting devices to the
Medical Power Outlet Strip can
cause an increase in leakage
current beyond permissible
values if the protective conduc-
tor of a device fails. Check the leakage current
when connecting devices to the Medical
Power Outlet Strip. If connecting a device (or
devices) increases the leakage current to a
value which exceeds the permissible value, do
not use the auxiliary outlets of the Fabius MRI:
use a separate wall socket.
The system must meet the requirements for
medical equipment in accordance with
IEC/EN 60601-1-1 and IEC/EN 60601-1-2 and
the particular standards of the connected
devices.
CAUTION
Risk of patient injury
An incorrect diagnosis or misinterpretation of
measured values, or other parameters, may
endanger the patient.
Do not base therapy decision on individual
measured values or monitoring parameters.
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