fabius_gs_operating_instructions_sw_3-n.pdf
Page 1
Fabius® GS
WARNING:
For a full understanding of the performance
characteristics of this equipment, the user
should carefully read this manual before
operating.
Inhalation Anesthesia Machine
Software 3.n
Operating Instructions
Emergency Care · Perioperative Care · Critical Care · Perinatal Care · Home Care
Because you care
Page 3
Contents
Chapter 1. Introduction
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Operator’s Responsibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Medibus and Vitalink Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Safety Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Copyright, Trademark, and Limitation of Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Symbol Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Abbreviations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
General Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Chapter 2. Configurations and Components
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Typical Fabius GS Configuration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Chapter 3. Operating Concept
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Standard Function Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cross-Functional Controls and Displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fresh Gas Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fresh Gas Flow Monitoring Resolutions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
APL Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
23
25
25
26
28
32
46
47
48
Chapter 4. Preparation
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Activating the Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Gas Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Medical Gas Pipeline Supply of O2, N2O, and AIR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cylinders with Pin-index Mounting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Electrical Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Attaching Manual (Ambu) Ventilation Bag. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Preparing the Ventilator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ventilator Safety Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Attaching the CO2 Absorber onto the Compact Breathing System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Attaching the Inspiratory Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Attaching the Expiratory Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Attaching the Adjustable Pressure Limiting (APL) Valve. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inserting the Flow Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Attaching the Waste Gas Outlet Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connecting the Compact Breathing System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Installation of HBSPS (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connecting the Breathing Hoses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inserting A New O2 Sensor Capsule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connecting the O2 Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connecting the Pressure Sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
49
51
51
51
52
53
53
54
54
54
55
55
55
56
56
56
57
58
59
60
60
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Contents
Connecting the Breathing Pressure Gauge. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connecting the APL Bypass and Peep/PMAX Hoses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connecting the Flow Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Installing Anesthetic Gas
Scavenging Hose to the Compact Breathing System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Scavenger System for Fabius GS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Additional Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Daily and Preuse Checkout Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
61
61
62
62
63
63
63
Chapter 5. Operation and Shut-down
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Preparation for Transport or Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Chapter 6. Monitoring
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Oxygen Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Respiratory Volume Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Breathing Pressure Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
79
81
81
82
88
93
Chapter 7. Setup Window (Used During Operation)
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Setup Window Access. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Volume Alarms On/Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Auto Set. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Calibrate O2 Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Activate Desflurane Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Automatic Desflurane Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Access Alarm Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Access Alarm Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Window Deactivation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Chapter 8. Standby Mode Functions
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Standby Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Standby Setup Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
107
109
109
113
Chapter 9. Routine Maintenance and Cleaning
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Routine Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Disassembling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Disinfecting/Cleaning/Autoclaving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Maintenance Intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Checking Readiness for Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ii
125
127
127
129
131
131
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Contents
Chapter 10. Troubleshooting
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Chapter 11. Components
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Compact Breathing System (Top View) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rear View (3-Gas Supply Connections) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
139
141
142
143
Chapter 12. Technical Data
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
Technical Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Diagrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Appendix. Daily and Preuse Checkout Form
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Chapter 1 - Introduction
Contents
Introduction
Contents
Overview ................................................................................................................... 3
Recommendations .................................................................................................. 3
Not for Use in Areas of Explosion Hazard .............................................................. 3
Safe Connection with Other Electrical Equipment .................................................. 3
Operator’s Responsibility .......................................................................................... 3
Intended Use ............................................................................................................. 4
Medibus and Vitalink Protocols ................................................................................. 4
Safety Features ......................................................................................................... 4
Copyright, Trademark, and Limitation of Liability ...................................................... 5
Copyright ................................................................................................................ 5
Trademark Notices ................................................................................................. 5
Limitation of Liability ............................................................................................... 5
Symbol Definition ...................................................................................................... 6
Abbreviations ........................................................................................................... 10
Part Number: 4117102-009
Rev. -
General Warnings and Cautions ............................................................................. 11
Fabius GS Operator’s Manual
1
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Overview
Chapter 1 - Introduction
Overview
Caution: For your safety and that of your patients,
strictly follow this instruction manual.
Any use of the Fabius GS® requires full understanding
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) 7215402.
Part Number: 4117102-009
Rev. -
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.
Note: Systems must meet the requirements in
accordance with IEC/EN 60601-1-1 and
IEC/EN 60601-1-2.
Fabius GS Operator’s Manual
General information on electromagnetic
compatibility (EMC) according to the international
EMC standard IEC 60601-1-2: 2001
Medical electrical equipment needs special
precautions regarding electromagnetic compatibility
(EMC) and needs to be installed and put into service
according to the EMC information provided in the
technical documentation available from DrägerService
upon request.
Portable and mobile RF communications equipment
can affect medical electrical equipment.
Pins of connectors identified with the ESD
warning symbol shall not be touched and not
be connected unless ESD precautionary
procedures are used. Such precautionary
procedures may include anti-static clothing and shoes,
the touch of a ground stud before and during
connecting the pins, or the use of electrically isolating
and anti-static gloves. All staff involved in the above
shall receive instruction in these procedures.
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
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
3
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Chapter 1 - Introduction
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.
Restriction
Caution: Federal law and regulations in the United
States restrict this device to sale by, or on
the order of, a physician.
Intended Use
It may be used with O2, N2O, and AIR supplied by a
medical gas pipeline system or by externally mounted
gas cylinders.
Fabius GS is equipped with a compact breathing
system, providing fresh gas decoupling, PEEP, and
pressure limitation.
•
•
•
•
•
•
4
Volume Controlled Ventilation
Pressure Controlled Ventilation (Optional)
Pressure Support (Optional)
SIMV/PS (Optional)
Manual Ventilation
Spontaneous Breathing
As per EN740 (Anesthetic Workstations and their
Modules- Particular Requirements), additional
monitoring of the concentrations of CO2 and anesthetic
agent is required when the machine is in use.
Do not use readily flammable anesthetic agents
such as ether, cyclopropane, etc.
Medibus and Vitalink Protocols
Medibus and Vitalink are software protocols for use in
transferring data between the Fabius GS and an
external medical or non-medical device (e.g.,
hemodynamic monitors, data management systems, or
a Windows-based computer) via the RS-232 interface .
WARNING !
Data transferred via Medibus and Vitalink interfaces
are for information only and are not intended as a
basis for diagnosis or therapy decisions.
WARNING !
In order to protect patients and users from electrical
hazards, is it imperative that all systems consisting of
electrical medical devices and other electrical
devices, such as but not limited to PCs, printers, etc.,
be mounted exclusively by trained personnel.
The system must meet the requirements about medical
electrical equipment in accordance to IEC/EN
60601-1-1 and IEC/EN 60601-1-2.
Safety Features
• Monitoring of P, V, FiO2
• O2 SUPPLY LOW alarm
• Integrated S-ORC = Sensitive Oxygen Ratio
Controller (control device to ensure minimum
O2 concentration of 23 Vol.%).
Per EN740, burns may occur if antistatic or electrically
conductive ventilation tubes are used in combination
with high-frequency electrical surgery equipment.
Therefore, per EN740, these types of breathing tubes
are not recommended.
Fabius GS Operator’s Manual
Rev. -
The following ventilation options are available:
Fabius GS is equipped with an electrically driven and
electronically controlled ventilator and monitors for
airway pressure (P), volume (V), and inspiratory
oxygen concentration (FiO2).
Part Number: 4117102-009
Fabius GS is an inhalation anesthesia machine for
use in operating, induction and recovery rooms.
Intended Use
Page 11
Copyright, Trademark, and Limitation of Liability
Caution: Do not use Fabius GS in the environment
of NMR tomography equipment.
Malfunctions may result, thereby
endangering the patient.
Caution: Do not use mobile phones within a distance
of 10 meters from the machine. Mobile
phones can cause malfunctions in electrical
medical equipment, thereby endangering
the patient and the operator.
Copyright, Trademark, and
Limitation of Liability
Chapter 1 - Introduction
Draeger Medical, Inc. shall in no event be liable for any
special, incidental, or consequential damages
(including loss of profits) whether or not foreseeable
and even if Draeger Medical, Inc. has been advised of
the possibility of such loss or damage. Draeger
Medical, Inc. disclaims any liability arising from a
combination of its product with products from another
manufacturer if the combination has not been
endorsed by Draeger Medical, Inc. Buyer understands
that the remedies noted in Draeger Medical Inc.'s
limited warranty are its sole and exclusive remedies.
Furthermore, buyer acknowledges that the
consideration for the products, equipment, and parts
sold reflects the allocation of risk and the limitations of
liability referenced herein.
Copyright
Copyright 2005 by Draeger Medical, Inc. All rights
reserved. No part of this publication may be
reproduced, transmitted, transcribed, or stored in a
retrieval system in any form or by any means,
electronic or mechanical, including photocopying and
recording, without written permission of Draeger
Medical, Inc. The exceptions to this are
“Recommendations for Typical Cleaning and
Disinfection After Use” on page 130 and “Daily and
Preuse Checkout Form” in Appendix A.
Part Number: 4117102-009
Rev. -
Trademark Notices
DrägerService, Fabius GS, and Vitalink are registered
trademarks of Draeger Medical, Inc. Drägersorb,
D-Vapor, Vamos, and Vapor are registered trademarks
of Dräger. Selectatec is a registered trademark of
Datex-Ohmeda. All other products or brand names are
trademarks of their respective owners.
Limitation of Liability
Draeger Medical, Inc.'s liability, whether arising from or
related to the manufacture and sale of the products,
their installation, demonstration, sales representation,
use, performance, or otherwise, including any liability
based upon Draeger Medical, Inc.'s product warranty,
is subject to and limited to the exclusive terms of
Draeger Medical, Inc.'s limited warranty, whether
based upon breach of warranty or any other cause of
action whatsoever, regardless of any fault attributable
to Draeger Medical, Inc. and regardless of the form of
action (including, without limitation, breach of warranty,
negligence, strict liability, or otherwise).
Fabius GS Operator’s Manual
5
Page 12
Chapter 1 - Introduction
Symbol Definition
Symbol Definition
The following symbols appear on the labels on the
back of the Fabius GS and are defined below.
Caution: Refer to accompanying documents
before operating equipment.
!
Caution: Risk of electric shock, do not remove
cover. Refer servicing to a
DrägerService representative.
Degree of protection against electric shock: Type B.
Registration Mark
C
US
Year Manufactured
The following symbols appear on the shipping
container of the Fabius GS.
This end up.
Part Number: 4117102-009
Handle with care.
REV
_
DESCRIPTION
DATE
APPROVED
Keep dry.
BY
ECN/DCN
00-0922
Rev. -
Minimum and maximum storage temperatures.
APVD
11-28-00 SAG DLB
60°c
-10°c
DRAGER
MEDICAL,
INC
Quarry Road
Telford, PA 18969
TITLE
AW - LOGO - PACKAG
DRAWN BY
SAG
6
Fabius GS Operator’s Manual
APPROVED BY ARTWORK NO
DLB
DATE 11-28-00 DATE 12-05-00
AW41150
Page 13
Symbol Definition
Chapter 1 - Introduction
The following symbols are used on other locations of
the Fabius GS to provide quick and easy recognition
of product functions.
Oxygen Concentration Sensor Port
Breathing Pressure Sensor Port
Breathing Volume Sensor Port
Ventilator Port
Pipeline, Gauge, Pipeline Inlet
Breathing Bag
Part Number: 4117102-009
Rev. -
Flowmeter Level Indicator
Indicates Direction
Total Power Applied
Partial Power Applied
Fabius GS Operator’s Manual
7
Page 14
Chapter 1 - Introduction
Symbol Definition
Cylinder Gauge, Remote Cylinder Inlet
Do Not Oil
The following symbols are used on the Fabius GS
monitoring user interface.
Table Top Light
Upper and Lower Alarm Limits
Return to Home Screen
Suppress Alarm Tone for Two Minutes
Standby Mode
Part Number: 4117102-009
Available Operating Capacity of UPS
Close Menu, Back to Previous Menu
Rev. -
Upper Alarm Limit
Lower Alarm Limit
Mains Applied/Mains Power
8
Fabius GS Operator’s Manual
Page 15
Symbol Definition
Chapter 1 - Introduction
Alarm Off
Setup Screen
In addition to symbols already described, the
following symbols appear on the optional Heated
Breathing System Power Supply (HBSPS).
Fuse
Heater Power
DC Voltage
Part Number: 4117102-009
Rev. -
AC Voltage
Fabius GS Operator’s Manual
9
Page 16
Chapter 1 - Introduction
Abbreviations
Abbreviations
Meaning
COSY
Compact Breathing System
FLOW
Expiratory flow
FiO2
Inspiratory O2 concentration
Freq
Ventilation frequency
Freq Min
Minimum ventilation frequency setting for Pressure Support Apnea Ventilation
MAN
Manual ventilation
MEAN
Mean (airway) pressure
N2O
Nitrous Oxide
O2
Oxygen
PAW
Airway pressure
PEAK
Peak (airway) pressure
PEEP
Positive end-expiratory pressure
PINSP
Pressure setting in Pressure Control mode or the sum of ∆ PPS and PEEP
settings in Pressure Support mode
PLAT
Plateau airway pressure
Pmax
Maximum (airway) pressure setting
∆ PPS
Pressure support setting in Pressure Support mode or SIMV/PS mode
SIMV
Synchronized Intermittent Mandatory Ventilation
SPONT
Spontaneous breathing
TI : TE
Ratio of inspiratory to expiratory time
Tip : Ti
Ratio of inspiratory pause time to inspiratory time
UPS
Uninterruptible power supply
VAC
Vacuum (e.g., for secretion aspiration)
VT
Tidal volume
Part Number: 4117102-009
Abbreviation
Rev. -
10
Fabius GS Operator’s Manual
Page 17
General Warnings and Cautions
General Warnings and Cautions
The following list of warnings and cautions apply to
general operation and maintenance of the
Fabius GS. Warnings and cautions about installing and
operating specific parts appear with those topics.
•
•
A Warning statement gives important information
that, if ignored, could lead directly to personal
injury.
A Caution statement gives important information
that, if ignored, could lead directly to equipment
damage and indirectly to personal injury.
Warning: Any person involved with the setup,
operation, or maintenance of the
Fabius GS anesthesia system must be
thoroughly familiar with this instruction
manual.
Warning: This anesthesia system will not respond
automatically to certain changes in patient
condition, operator error, or failure of
components. The system is designed to be
operated under the constant surveillance
and control of a qualified operator.
Part Number: 4117102-009
Rev. -
Warning: No third-party components shall be
attached to the anesthesia machine,
ventilator, or breathing system (except for
certain approved exceptions). For more
information, contact your local Authorized
Service Organization or DrägerService at:
DrägerService
Draeger Medical, Inc.
3122 Commerce Drive
Telford, PA 18969
Tel: (215) 721-5402
(800) 543-5047
Fax: (215) 721-5784
Warning: Each institution and user has a duty to
independently assess, based on its, his, or
her unique circumstances, what
components to include in an anesthesia
system. However, Draeger Medical, in the
interest of patient safety, strongly
recommends the use of an oxygen
analyzer, pressure monitor, volume
monitor, and end-tidal CO2 monitor in the
breathing circuit at all times.
Warning: Apply the caster brakes when the
anesthesia machine is in use.
Fabius GS Operator’s Manual
Chapter 1 - Introduction
Warning: When moving the anesthesia machine,
remove all monitors and equipment from
the top shelf and use only the machine
handles or push/pull bars. The anesthesia
machine should only be moved by people
who are physically capable of handling its
weight. Draeger Medical recommends that
two people move the anesthesia machine
to aid in maneuverability. Exercise special
care so that the machine does not tip
when moving up or down inclines, around
corners, and across thresholds (for
example, in door frames and elevators).
Do not attempt to pull the machine over
any hoses, cords, or other obstacles on
the floor.
Warning: Pressure Support ventilation is triggered
by the patient's spontaneous effort to
breathe. Most anesthetic agents will cause
patients to have reduced ventilatory
responses to carbon dioxide and to
hypoxemia. Therefore, patient triggered
modes of ventilation may not produce
adequate ventilation. Additionally, the use
of neuromuscular blocking agents will
interfere with patient triggering.
Warning: When the moisture content falls below a
specified minimum level, the following
undesirable reactions can occur,
regardless of the type of CO2 absorbent
and the anesthetic agent used, e.g.
Halothane, Enflurane, Isoflurane,
Sevoflurane or Desflurane:
• reduced CO2 absorption,
• formation of CO,
• absorption and/or decomposition of
the inhalation anesthetic agent,
• increased heat generation in the
absorber, leading to higher breathing
gas temperatures.
Additionally, the breakdown products of
anesthetic agents exposed to dry
absorbent are both flammable and toxic,
and fires have been reported in
association with the use of desiccated
absorbent and volatile anesthetics.
These reactions can result in danger to the
patient in the form of CO intoxication,
insufficient depth of anesthesia and airway
burns.
11
Page 18
Chapter 1 - Introduction
General Warnings and Cautions
Warning: Route all lines/cables away from the APL
valve to prevent interference with the APL
valve adjustment knob. Lines/cables
caught underneath the APL valve
adjustment knob could interfere with
proper functioning of this valve.
Caution: Although the Fabius GS is designed to
minimize the effects of ambient radiofrequency interference, machine functions
may be adversely affected by the
operation of electrosurgical equipment or
short wave or microwave diathermy
equipment in the vicinity.
Caution: Communications with external equipment
may be temporarily affected by
electromagnetic interference due to the
use of electrosurgical equipment.
Caution: Do not place more than 40 pounds on top
of the Fabius GS monitor housing.
Caution: Never allow the battery to completely
discharge. If the battery does discharge
completely, recharge immediately.
Caution: Front GCX rails have a maximum
accessories weight load of 5 lb./2.3 kg,
extended out at 3 in./7.6 cm from the rail,
at any position on the rail.
Part Number: 4117102-009
Rev. -
12
Fabius GS Operator’s Manual
Page 19
General Warnings and Cautions
Chapter 1 - Introduction
Option
Weight
Fabius GS
Back Left Side
Accessory Option
with Breathing System
Mounted on Left Side
30 lb. / 13.6 kg
28 lb. / 12.7 kg
26 lb. / 11.8 kg
24 lb. / 10.9 kg
22 lb. / 10.0 kg
20 lb. / 9.1 kg
Caution: Possible Tip Over
Hazard If Mounting Accessories
Exceed Approved Limits.
18 lb. / 8.2 kg
Approved
Mounting Limits
Option
16 lb. / 7.3 kg
Weight
14 lb. / 6.4 kg
12 lb. / 5.4 kg
10 lb. / 4.5 kg
15.0 in.
38.1 cm
10.0 in.
25.4 cm
5.0 in.
12.7 cm
Mount Arm Length
Option
Weight
Fabius GS
Back Right Side
Accessory Option
with Breathing System
Mounted on Left Side
60 lb. / 27.2 kg
Part Number: 4117102-009
Rev. -
55 lb. / 24.9 kg
50 lb. / 22.7 kg
45 lb. / 20.4 kg
40 lb. / 18.1 kg
35 lb. / 15.9 kg
30 lb. / 13.6 kg
25 lb. / 11.3 kg
20 lb. / 9.1 kg
Approved
Mounting Limits
Caution: Possible Tip Over
Hazard If Mounting Accessories
Exceed Approved Limits.
MAXIMUM WEIGHT
PER ARM 30 lb.
COMBINED MULTIPLE
ARM WEIGHTS NOT
TO EXCEED 60 lb. MAX.
15 lb. / 6.8 kg
10 lb. / 4.5 kg
5.0 in.
12.7 cm
10.0 in.
25.4 cm
15.0 in.
38.1 cm
Mount Arm Length
Fabius GS Operator’s Manual
13
Page 20
General Warnings and Cautions
Chapter 1 - Introduction
Option
Weight
Fabius GS
Back Left Side
Accessory Option
with Breathing System
Mounted on Right Side
60 lb. / 27.2 kg
55 lb. / 24.9 kg
50 lb. / 22.6 kg
45 lb. / 20.4 kg
40 lb. / 18.1 kg
35 lb. / 15.8 kg
Caution: Possible Tip Over
Hazard If Mounting Accessories
Exceed Approved Limits.
30 lb. / 13.6 kg
Approved
Mounting Limits
Option
25 lb. / 11.3 kg
Weight
20 lb. / 9 kg
15 lb. / 6.8 kg
10 lb. / 4.5 kg
15.0 in.
38.1 cm
10.0 in.
25.4 cm
5.0 in.
12.7 cm
Mount Arm Length
Option
Weight
Fabius GS
Back Right Side
Accessory Option
with Breathing System
Mounted on Right Side
30 lb. / 13.6 kg
Part Number: 4117102-009
Rev. -
28 lb. / 12.7 kg
26 lb. / 11.7 kg
24 lb. / 10.8 kg
22 lb. / 9.9 kg
20 lb. / 9.0 kg
18 lb. / 8.1 kg
16 lb. / 7.2 kg
14 lb. / 6.3 kg
Approved
Mounting Limits
Caution: Possible Tip Over
Hazard If Mounting Accessories
Exceed Approved Limits.
MAXIMUM WEIGHT
PER ARM 30 lb.
COMBINED MULTIPLE
ARM WEIGHTS NOT
TO EXCEED 60 lb. MAX.
12 lb. / 5.4 kg
10 lb. / 4.5 kg
5.0 in.
12.7 cm
10.0 in.
25.4 cm
15.0 in.
38.1 cm
Mount Arm Length
Fabius GS Operator’s Manual
14
Page 21
Chapter 2 - Configurations and Components
Contents
Configurations and Components
Contents
Typical Fabius GS Configuration ............................................................................. 17
Components ............................................................................................................ 17
Vaporizers (Optional) ............................................................................................ 17
Dräger Vapor Interlock System (Optional) ............................................................ 18
Selectatec® (Optional) ......................................................................................... 18
Heated Breathing System (Optional) .................................................................... 18
Auxiliary Oxygen Flowmeter (Optional) ................................................................ 18
Part Number: 4117102-009
Rev. -
Second Communications Port (Optional) ............................................................. 19
Fabius GS Operator’s Manual
15
Page 23
Typical Fabius GS Configuration
Chapter 2 - Configurations and Components
Typical Fabius GS Configuration
The Fabius GS Inhalation Anesthesia Machine is a
modular system consisting of a basic gas-delivery
module with a variety of components and
configuration designs to meet the requirements of
various anesthesia delivery applications.
•
•
•
Figure 1. Fabius GS Anesthesia Machine
2-gas version (O2 and Air)
3-gas version (O2, N2O, and Air)
pin index cylinder yokes and pressure gauges
Components
Vaporizers (Optional)
Figure 2. Dräger Vapor System
®
The Dräger Vapor anesthetic agent vaporizers (1 in
Figure 2) are used to enrich the fresh gas with a
precisely metered quantity of vapor from the liquid
anesthetic agent being used, i.e. Isoflurane,
Halothane, Enflurane, or Sevoflurane.
When using a Desflurane vaporizer:
220 V Mains
Devapor*
110 V Mains
D-Tec*
230 V Mains
D-Vapor
1
1
Part Number: 4117102-009
Rev. -
* Devapor and D-Tec are available through your local Desflurane
representative.
Note: The Fabius GS may be equipped with the
Vapor Park option which provides a place to
store a spare vaporizer on the side or back of
the machine. Do not attempt to use the
parked vaporizer for clinical use; it is not
connected to the gas flow and is not
functional in the parked position.
Fabius GS Operator’s Manual
17
Page 24
Chapter 2 - Configurations and Components
Dräger Vapor Interlock System (Optional)
Components
Figure 3. Dräger Vapor Interlock System
The Fabius GS is configured for two vaporizers. An
interlock system is used to ensure only one vaporizer
can be used at a time.
OP00520
Note that the selector lever (1 in Figure 3) is shown in
the center position. This ensures that both vaporizers
are in the locked position. Also, this is the
recommended position for the selector lever when
moving the Fabius GS.
1
Moving the selector lever away from the desired
vaporizer allows that vaporizer to be utilized and the
other to be locked out of use.
Selectatec® (Optional)
The interlock system for the Selectatec is built into
the vaporizers. When a vaporizer is selected for use,
the interlocking index pins will protrude from the
sides of the vaporizer thereby not allowing the
neighboring vaporizer to be opened. For more
specific information on the Selectatec, refer to the
Selectatec Vaporizer’s instruction manual.
Heated Breathing System (Optional)
The Fabius GS can be configured with an optional
heated breathing system to reduce condensation of
moisture in the system. See “Installation of HBSPS
(Optional)” on page 57 for installation instructions.
For the delivery of a metered flow of pure oxygen (for
example, delivery of oxygen through a nasal
cannula), an optional auxiliary oxygen flowmeter
(1 in Figure 4) can be mounted on the left side of the
flowmeter bank. This flowmeter can be used when
the machine is turned off. A zero stop prevents
damage to the flow control valve seat.
Figure 4. Auxiliary Oxygen Flowmeter
1
Part Number: 4117102-009
Auxiliary Oxygen Flowmeter (Optional)
Rev. -
18
Fabius GS Operator’s Manual
Page 25
Components
Chapter 2 - Configurations and Components
Second Communications Port (Optional)
Figure 5. Second Communications Port
The Fabius GS can be configured with a second
communications port that, like the standard
communications port, supports Vitalink and Medibus
communications (1 in Figure 5).
1
OXYGEN
SENSOR
BREATHING
PRESSURE
VOLUME
SENSOR
Recommended Device Configurations
Fabius GS with One COM Port
Gas Analyzer with One COM Port
2
1
Rev. -
Connect gas analyzer (1 in Figure 6) to
Fabius GS COM1 (2 in Figure 6).
Figure 6. Recommended Device Configuration 1
Part Number: 4117102-009
OP00528
Fabius GS Operator’s Manual
19
Page 26
Chapter 2 - Configurations and Components
Fabius GS with One COM Port
Gas Analyzer with One COM Port
Automatic Anesthesia Record Keeper
1. Connect gas analyzer (1 in Figure 7) to
anesthesia record keeper (2 in Figure 7).
Components
Figure 7. Recommended Device Configuration 2
3
2
1
2. Connect anesthesia record keeper to
Fabius GS COM1 (3 in Figure 7).
OP00529
Fabius GS with Two COM Ports
Gas Analyzer with One COM Port
Figure 8. Recommended Device Configuration 3
Connect gas analyzer (1 in Figure 8) to
Fabius GS COM2 (2 in Figure 8).
2
1
Note: Data Pass Through (gas analysis data) must
be enabled by your local Authorized Service
Organization or DrägerService.
1. Connect gas analyzer (1 in Figure 9) to
Fabius GS COM2 (2 in Figure 9).
Figure 9. Recommended Device Configuration 4
3
4
2
1
2. Connect anesthesia record keeper (3 in Figure 9)
to Fabius GS COM1 (4 in Figure 9).
Note: Data Pass Through (gas analysis data) must
OP00531
20
Rev. -
be enabled by your local Authorized Service
Organization or DrägerService.
Part Number: 4117102-009
Fabius GS with Two COM Ports
Gas Analyzer with One COM Port
Automatic Anesthesia Record Keeper
OP00530
Fabius GS Operator’s Manual
Page 27
Components
Chapter 2 - Configurations and Components
Fabius GS with One or Two COM Ports
Multi Parameter Monitor with One COM Port
Automatic Anesthesia Record Keeper
Figure 10. Recommended Device Configuration 5
1. Connect monitor (1 in Figure 10) to
anesthesia record keeper (2 in Figure 10).
2. Connect anesthesia record keeper to
Fabius GS COM1 (3 in Figure 10).
1
2
3
Note: Data Pass Through (gas analysis data) must
be disabled by your local Authorized Service
Organization or DrägerService.
OP00532
Fabius GS with Two COM Ports
Multi Parameter Monitor with Two COM Ports
Automatic Anesthesia Record Keeper
Figure 11. Recommended Device Configuration 6
1. Connect monitor (1 in Figure 11) to
anesthesia record keeper (2 in Figure 11).
2. Connect anesthesia record keeper to
Fabius GS COM1 (3 in Figure 11).
1
2
3
4
3. Connect monitor (1 in Figure 11) to
Fabius GS COM2 (4 in Figure 11).
Note: Data Pass Through (gas analysis data) must
Part Number: 4117102-009
Rev. -
be disabled by your local Authorized Service
Organization or DrägerService.
OP00533
Fabius GS Operator’s Manual
21
Page 29
Chapter 3 - Operating Concept
Contents
Operating Concept
Contents
Overview ................................................................................................................. 25
Standard Function Controls ..................................................................................... 25
Home Key ............................................................................................................. 25
Mains Power Applied LED .................................................................................... 25
Selecting and Confirming ..................................................................................... 25
Tabletop Light Key ................................................................................................ 25
Cross-Functional Controls and Displays ................................................................. 26
Key LED Indicators ............................................................................................... 26
Setup Key ............................................................................................................. 26
Status Bar ............................................................................................................. 27
Monitoring ................................................................................................................ 28
Monitoring Controls .............................................................................................. 28
Monitoring Windows ............................................................................................. 29
Selecting/Setting Monitoring Functions ................................................................ 30
Ventilation ................................................................................................................ 32
Ventilation Controls ............................................................................................... 32
Ventilator Compliance Compensation .................................................................. 32
Part Number: 4117102-009
Rev. -
Ventilation Screens ............................................................................................... 33
Changing Ventilation Modes ................................................................................. 39
Selecting/Setting Ventilation Parameters ............................................................. 43
Fresh Gas Control ................................................................................................... 46
. Flowmeter and Pressure Gauge AssemblyFresh Gas Flow Monitoring ................ 46
Standard Resolution ............................................................................................. 47
High Resolution .................................................................................................... 47
APL Valve ................................................................................................................ 48
Fabius GS Operator’s Manual
23
Page 31
Overview
Chapter 3 - Operating Concept
Overview
This chapter provides an overview of the user
interface, which enables you to set and view
monitoring, ventilation, and status information using
the respective screens, windows, keys, soft keys,
and the rotary knob. See “Monitoring” on page 79 for
more information.
Standard Function Controls
Figure 12. Ventilation Monitor Screen and System Controls
Home Key
The Home key (1 in Figure 12) displays the main
screen (the screen in Figure 12) from anywhere in
the system.
1
Mains Power Applied LED
The Mains Power Applied LED (2 in Figure 12), when
illuminated, indicates that the machine is connected
to a Mains power source.
2
4
3
Selecting and Confirming
The rotary knob (3 in Figure 12) is used to select and
confirm functions by:
•
Turning (Select)
Part Number: 4117102-009
Rev. -
Turning the rotary knob
•
moves the cursor over the system
operating parameters or
•
changes the value of a parameter that has
been confirmed for adjustment.
Note: This function is indicated in the examples
and instructions of this manual by
“select.”
•
Pressing (Confirm)
Pressing the rotary knob either
•
confirms the system operating parameter
to be adjusted or
•
confirms the change to the selected
operating parameter.
Note: This function is indicated in the examples
and instructions of this manual by
“confirm.”
Tabletop Light Key
The Tabletop Light key (4 in Figure 12) turns on the
tabletop light.
Fabius GS Operator’s Manual
25