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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: 2001
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 187.
Portable and mobile RF communications equip-
ment can affect medical electrical equipment.
WARNING
Connector pins with an ESD warn-
ing sign should not be touched
and no connections should be
made between these connectors
without implementing ESD protec-
tive measures. Such precautionary proce-
dures may include antistatic clothing and
shoes, the touch of a ground stud before and
during connecting the pins or the use of elec-
trically isolating and antistatic gloves. All staff
involved in the above shall receive instruction
in these ESD precautionary procedures.
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
accessories is not permitted.
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 mea-
sured values or monitoring parameters.
10
Software
The device's software has been developed and
tested carefully in accordance with Dräger's high
quality standards. It is therefore highly improbable
that software errors can become a hazard to the
patient.
Additionally, independent protective functions are
extensively implemented in the software, as well as
in electronics and mechanics, for all safety-related
functions of the device.
Through this, the probability that an error in the soft-
ware or other functions can be detected before it
affects the patient's safety is very high. Regular
automated or manual tests ensure the effective-
ness of all protective measures.
WARNING!
Do not use conductive breathing hoses or
face masks.
They may cause burns during HF surgery.
WARNING!
Any person involved with the setup, opera-
tion, or maintenance of the
Fabius GS premium anesthesia system must
be thoroughly familiar with this instruction
manual.
WARNING!
This anesthesia system will not respond auto-
matically to certain changes in patient condi-
tion, operator error, or failure of components.
The system has to be operated under the con-
stant supervision and control of a qualified
operator in order to provide immediate correc-
tive action.
WARNING!
No third-party components shall be attached
to the anesthesia machine, ventilator, or
breathing system (except for certain approved
components), otherwise the correct function-
ing of the device may be compromised. For
more information, contact DrägerService or
your local authorized service organization.
Instructions for Use Fabius GS premium SW 3.n
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