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Overview
Overview
Caution:
For your safety and that of your patients,
strictly follow this instruction manual.
Any use of the Fabius GS
and strict observation of these instructions. The unit is
only to be used for purposes specified here.
Recommendations
Because of the sophisticated nature of Draeger
Medical anesthesia equipment and its critical
importance in the operating room setting, it is highly
recommended that only appropriately trained and
experienced professionals, using authentic Draeger
Medical spare parts, be permitted to service and
maintain this equipment. Please contact DrägerService
at (800) 543-5047 or (215) 721-5402 for service of this
equipment.
Draeger Medical also recommends that its anesthesia
equipment be serviced at six-month intervals. Periodic
Manufacturer's Certification Agreements are available
for equipment manufactured by Draeger Medical. For
further information concerning these agreements,
contact DrägerService at (800) 543-5047 or (215) 721-
5402.
Not for Use in Areas of Explosion Hazard
The Fabius GS is neither approved nor certified for use
in areas where combustible or explosive gas mixtures
are likely to occur. To avoid explosion hazards,
flammable anaesthetic agents such as ether and
cyclopropane or other flammable substances must not
be used in this machine. Only anaesthetic agents that
comply with the requirements on non-flammable
anaesthetic agents in the IEC Standard, Particular
requirements for the safety of anaesthetic machine,
are suitable for use in this machine.
Safe Connection with Other Electrical
Equipment
Electrical connections to equipment which are not
listed in these Instructions for Use should only be
made following consultations with the respective
manufacturers or an expert and shall be in compliance
with national medical device regulations.
Operator's Responsibility
The equipment design, the accompanying literature,
and the labeling on the equipment take into
consideration that the purchase and use of the
equipment are restricted to trained professionals, and
that certain inherent characteristics of the equipment
Fabius GS Operator's Manual
®
requires full understanding
Chapter 1 - Introduction
are known to the trained operator. Instructions,
warnings, and caution statements are limited,
therefore, to the specifics of the Draeger Medical, Inc.
design. This publication excludes references to
hazards which are obvious to a medical professional,
to the consequences of product misuse, and to
potentially adverse effects in patients with abnormal
conditions. Product modification or misuse can be
dangerous. Draeger Medical, Inc. disclaims all liability
for the consequences of product alterations or
modifications, as well as for the consequences which
might result from the combination of Draeger Medical,
Inc. products with products supplied by other
manufacturers if such a combination is not endorsed
by Draeger Medical, Inc.
The operator of the anesthesia system must recognize
that the means of monitoring and discovering
hazardous conditions are specific to the composition of
the system and the various components of the system.
It is the operator, and not the various manufacturers or
suppliers of components, who has control over the final
composition and arrangement of the anesthesia
system used in the operating room. Therefore, the
responsibility for choosing the appropriate safety
monitoring devices rests with the operator and user of
the equipment.
The Fabius GS is equipped to monitor breathing circuit
pressure, exhaled volume and inspired oxygen, and to
sound an alarm when any of these parameters violates
a preset limit. The Fabius GS should not be used if any
of these monitors are not functioning properly. Draeger
Medical, Inc. also recommends that the Fabius GS
only be used to deliver anesthesia and/or mechanical
ventilation in accordance with the guidelines for patient
monitoring published by the American Society of
Anesthesiologists. In addition to volume, pressure, and
oxygen monitoring, these guidelines require the use of
a capnometer to monitor inspired and expired carbon
dioxide as well as other patient monitors including
continuous electrocardiography, pulse oximetry, and
arterial blood pressure monitoring. Anesthetic agent
monitoring and temperature monitoring are also
strongly recommended. The responsibility for the
selection of the best level of patient monitoring belongs
solely to the equipment operator. To this extent, the
manufacturer, Draeger Medical, Inc., disclaims
responsibility for the adequacy of the monitoring
package selected for use with the anesthesia system.
However, Draeger Medical, Inc. is available for
consultation to discuss monitoring options for different
applications.
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