NORTH AMERICAN DRÄGER Fabius User manual

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Operator’s Instruction
Manual
Part Number: 4117102-007
Fabius GS Software Version 2.1n
Date: 16 January 2004
© 2004 Draeger Medical, Inc.
Rev: —
Fabius GS
®
the user should carefully read this manual before operating.
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Contents
Chapter 1. Introduction
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Operator’s Responsibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Safety Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Copyright, Trademark, and Limitation of Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Symbol Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Abbreviations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
General Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Chapter 2. Configurations and Components
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Typical Fabius GS Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Chapter 3. Operating Concept
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Standard Function Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Cross-Functional Controls and Displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Fresh Gas Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Fresh Gas Flow Monitoring Resolutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
APL Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Chapter 4. Preparation
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Activating the Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Gas Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Medical Gas Pipeline Supply of O2, N2O, and AIR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Cylinders with Pin-index Mounting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Electrical Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Attaching Manual (Ambu) Ventilation Bag. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Preparing the Ventilator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Ventilator Safety Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Attaching the CO
Attaching the Inspiratory Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Attaching the Expiratory Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Attaching the Adjustable Pressure Limiting (APL) Valve. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Inserting the Flow Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Attaching the Waste Gas Outlet Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Connecting the Compact Breathing System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Connecting the Breathing Hoses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Inserting A New O
Connecting the O2 Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Connecting the Pressure Sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Connecting the Breathing Pressure Gauge. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Connecting the APL Bypass and Peep/PMAX Hoses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
2 Absorber onto the Compact Breathing System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
2 Sensor Capsule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
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Contents
Connecting the Flow Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Installing Anesthetic Gas Scavenging Hose to the Compact Breathing System . . . . . . . . . . . . . . . . . . . . 52
Scavenger System for Fabius GS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Additional Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Daily and Preuse Checkout Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Chapter 5. Operation and Shut-down
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Preparation for Transport or Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Chapter 6. Monitoring
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Oxygen Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Respiratory Volume Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Breathing Pressure Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Chapter 7. Setup Window (Used During Operation)
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Setup Window Access. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Volume Alarms On/Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Auto Set. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Calibrate O2 Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Activate Desflurane Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Access Alarm Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Access Alarm Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Window Deactivation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Chapter 8. Standby Mode Functions
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Standby Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Standby Setup Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
Chapter 9. Routine Maintenance and Cleaning
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Routine Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Disassembling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Disinfecting/Cleaning/Autoclaving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Maintenance Intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Checking Readiness for Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Chapter 10. Troubleshooting
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
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Chapter 11. Components
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Compact Breathing System (Top View) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
Rear View (3-Gas Supply Connections) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
Chapter 12. Technical Data
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Technical Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
Diagrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
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
Safety Features ......................................................................................................... 4
Copyright, Trademark, and Limitation of Liability ...................................................... 4
Rev: —
Copyright ................................................................................................................ 4
Trademark Notices ................................................................................................. 4
Limitation of Liability ............................................................................................... 4
Symbol Definition ...................................................................................................... 5
Abbreviations ............................................................................................................. 8
General Warnings and Cautions ............................................................................... 9
Part Number: 4117102-007
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 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.
®
requires full understanding
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.
Rev: —
Part Number: 4117102-007
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
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.
Fabius GS Operator’s Manual 3
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Chapter 1 - Introduction Intended Use
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
Fabius GS is an inhalation anesthesia machine for use in operating, induction and recovery rooms.
It may be used with O 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.
The following ventilation options are available:
Volume Controlled Ventilation
Pressure Controlled Ventilation (Optional)
Pressure Support (Optional)
Manual Ventilation
Spontaneous Breathing
Fabius GS is equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO
As per EN740 (Anesthetic Workstations and their Modules- Particular Requirements), additional monitoring of the concentrations of CO agent is required when the machine is in use.
Do not use readily flammable anesthetic agents such as ether, cyclopropane, etc.
2, N2O, and AIR supplied by a
2).
2 and anesthetic
Safety Features
• Monitoring of P, V, FiO2
•O2 SUPPLY LOW alarm
• Integrated S-ORC = Sensitive Oxygen Ratio Controller (control device to ensure minimum O
2 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.
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
Copyright
Copyright 2004 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 114 and “Daily and Preuse Checkout Form” in Appendix A.
Trademark Notices
DrägerService, Fabius GS, and Vitalink are registered trademarks of Draeger Medical, Inc. Fabius and Vapor are registered trademarks of Dräger. All other products or name brands 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).
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
Part Number: 4117102-007
Rev: —
4 Fabius GS Operator’s Manual
CUS
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Symbol Definition Chapter 1 - Introduction
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.
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.
Rev: —
Degree of protection against electric shock: Type B.
Registration Mark
Year Manufactured
The following symbols appear on the shipping container of the Fabius GS.
This end up.
Handle with care.
Part Number: 4117102-007
Keep dry.
Fabius GS Operator’s Manual 5
REV DESCRIPTION DATE BY ECN/DCNAPVD
11-28-00
SAG DLB
00-0922
_
APPROVED
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Chapter 1 - Introduction Symbol Definition
Minimum and maximum storage temperatures.
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
60°c
-10°c
Ventilator Port
Pipeline, Gauge, Pipeline Inlet
Breathing Bag
Flowmeter Level Indicator
Indicates Direction
Total Power Applied
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Symbol Definition Chapter 1 - Introduction
Partial Power Applied
Cylinder Gauge, Remote Cylinder Inlet
Do Not Oil
The following symbols are used on the Fabius GS monitoring user interface.
Table Top Light
Rev: —
Part Number: 4117102-007
Upper and Lower Alarm Limits
Return to Home Screen
Suppress Alarm Tone for Two Minutes
Standby Mode
Available Operating Capacity of UPS
Close Menu, Back to Previous Menu
Upper Alarm Limit
Lower Alarm Limit
Fabius GS Operator’s Manual 7
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Chapter 1 - Introduction Abbreviations
Mains Applied/Mains Power
Alarm Off
Setup Screen
Abbreviations
Abbreviation Meaning
FLOW Expiratory flow
FiO
2
Freq Ventilation frequency
Freq Min Minimum ventilation frequency setting for Pressure Support Apnea Ventilation
MAN Manual ventilation
MEAN Mean (airway) pressure
N
O Nitrous Oxide
2
O
2
PAW Airway pressure
PEAK Peak (airway) pressure
PEEP Positive end-expiratory pressure
PINSP Pressure setting in Pressure Control mode or the sum of PSUP and PEEP
PLAT Plateau airway pressure
Pmax Maximum (airway) pressure setting
PSUP Pressure Support
SPONT Spontaneous breathing
TI : TE Ratio of inspiratory to expiratory time
Inspiratory O2 concentration
Oxygen
settings in Pressure Support mode
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Tip : Ti Ratio of inspiratory pause time to inspiratory time
UPS Uninterruptible power supply
VAC Vacuum (e.g., for secretion aspiration)
VT Tidal volume
8 Fabius GS Operator’s Manual
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General Warnings and Cautions Chapter 1 - Introduction
Rev: —
Part Number: 4117102-007
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.
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: 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: Apply the caster brakes when the
anesthesia machine is in use.
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.
Caution: Pressure Support ventilation is triggered
by the patient's spontaneous effort to breath. 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.
Fabius GS Operator’s Manual 9
Weight
r
Approved
Option
Possible Tip Over
T
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Chapter 1 - Introduction General Warnings and Cautions
Fabius GS Back Left Side Accessory Option with Breathing System
Mounted on Left Side
Caution: Possible Tip Ove Hazard If Mounting Accessories Exceed Approved Limits.
Mounting Limits
15.0 in.
38.1 cm
10.0 in.
25.4 cm
Mount Arm Length
5.0 in.
12.7 cm
Weight
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
18 lb. / 8.2 kg
Option
16 lb. / 7.3 kg
14 lb. / 6.4 kg
12 lb. / 5.4 kg
10 lb. / 4.5 kg
Option Weight
60 lb. / 27.2 kg
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
15 lb. / 6.8 kg
10 lb. / 4.5 kg
Approved
Mounting Limits
MAXIMUM WEIGH PER ARM 30 lb. COMBINED MULTIPLE ARM WEIGHTS NOT
TO EXCEED 60 lb. MAX.
5.0 in.
12.7 cm
10.0 in.
25.4 cm
Mount Arm Length
15.0 in.
38.1 cm
Fabius GS Back Right Side Accessory Option with Breathing System
Mounted on Left Side
Caution: Hazard If Mounting Accessories
Exceed Approved Limits.
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10 Fabius GS Operator’s Manual
n
10.0 in.
r
A
Caution:
r
T
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General Warnings and Cautions Chapter 1 - Introduction
Fabius GS Back Left Side Accessory Option with Breathing System Mounted on Right Side
Caution: Possible Tip Ove Hazard If Mounting Accessories Exceed Approved Limits.
pproved
Mounting Limits
15.0 in.
38.1 cm
25.4 cm
Mount Arm Length
5.0 in.
12.7 cm
Option Weight
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
30 lb. / 13.6 kg
Optio
25 lb. / 11.3 kg
Weight
20 lb. / 9 kg
15 lb. / 6.8 kg
10 lb. / 4.5 kg
Rev: —
Part Number: 4117102-007
Option Weight
30 lb. / 13.6 kg
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
12 lb. / 5.4 kg
10 lb. / 4.5 kg
Approved
Mounting Limits
MAXIMUM WEIGH PER ARM 30 lb. COMBINED MULTIPLE ARM WEIGHTS NOT
TO EXCEED 60 lb. MAX.
5.0 in.
12.7 cm
10.0 in.
25.4 cm
Mount Arm Length
Fabius GS Back Right Side Accessory Option with Breathing System
Mounted on Right Side
Possible Tip Ove
Hazard If Mounting Accessories Exceed Approved Limits.
15.0 in.
38.1 cm
Fabius GS Operator’s Manual 11
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Chapter 2 - Configurations and Components Contents
Configurations and Components
Contents
Typical Fabius GS Configuration ............................................................................. 15
Components ............................................................................................................ 15
Vaporizers (Optional) ............................................................................................ 15
Dräger Vapor® Interlock System (Optional) ......................................................... 15
Selectatec™* (Optional) ....................................................................................... 16
Auxiliary Oxygen Flowmeter (Optional) ................................................................ 16
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Typical Fabius GS Configuration Chapter 2 - Configurations and Components
Typical Fabius GS Configuration
Figure 1. Fabius GS Anesthesia Machine 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.
2-gas version (O2 and Air)
3-gas version (O2, N2O, and Air)
pin index cylinder yokes and pressure gauges
Components
Figure 2. Dräger Vapor SystemVaporizers (Optional)
Rev: —
Part Number: 4117102-007
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 third-party Desflurane vaporizer:
220 V Mains Devapor*
110 V Mains D-Tec*
* Devapor and D-Tec are available through your local Desflurane representative.
®
Interlock System
(Optional)
The Fabius GS is configured for two vaporizers. An interlock system is used to ensure only one vaporizer can be used at a time.
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.
Moving the selector lever away from the desired vaporizer allows that vaporizer to be utilized and the other to be locked out of use.
1 1
Figure 3. Dräger Vapor Interlock SystemDräger Vapor
OP00520
1
Fabius GS Operator’s Manual 15
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Chapter 2 - Configurations and Components Components
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.
*Selectatec™ is a registered trademark of Datex-Ohmeda.
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 FlowmeterAuxiliary Oxygen Flowmeter (Optional)
1
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Chapter 3 - Operating Concept Contents
Operating Concept
Contents
Overview ................................................................................................................. 19
Standard Function Controls ..................................................................................... 19
Home Key ............................................................................................................. 19
Mains Power Applied LED .................................................................................... 19
Selecting and Confirming ..................................................................................... 19
Tabletop Light Key ................................................................................................ 19
Cross-Functional Controls and Displays ................................................................. 20
Key LED Indicators ............................................................................................... 20
Rev: —
Setup Key ............................................................................................................. 20
Status Bar ............................................................................................................. 21
Monitoring ................................................................................................................ 22
Monitoring Controls .............................................................................................. 22
Monitoring Windows ............................................................................................. 23
Selecting/Setting Monitoring Functions ................................................................ 24
Ventilation ................................................................................................................ 26
Ventilation Controls ............................................................................................... 26
Ventilator Compliance Compensation .................................................................. 26
Ventilation Screens ............................................................................................... 27
Changing Ventilation Modes ................................................................................. 31
Selecting/Setting Ventilation Parameters ............................................................. 35
Fresh Gas Control ................................................................................................... 37
Fresh Gas Flow Monitoring Resolutions ................................................................. 38
Standard Resolution ............................................................................................. 38
High Resolution .................................................................................................... 38
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Fabius GS Operator’s Manual 17
APL Valve ................................................................................................................ 39
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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 67 for more information.
Figure 5. Ventilation Monitor Screen and System ControlsStandard Function Controls
Home Key
The Home key (1 in Figure 5) displays the main screen (the screen in Figure 5) from anywhere in the system.
Rev: —
Mains Power Applied LED
The Mains Power Applied LED (2 in Figure 5), when illuminated, indicates that the machine is connected to a Mains power source.
Selecting and Confirming
The rotary knob (3 in Figure 5) is used to select and confirm functions by:
Turning (Select)
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
1
4
2
3
confirms the system operating parameter to be adjusted or
confirms the change to the selected
Part Number: 4117102-007
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 5) turns on the tabletop light.
Fabius GS Operator’s Manual 19
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Chapter 3 - Operating Concept Cross-Functional Controls and Displays
Figure 6. Ventilation Monitor Screen and System ControlsCross-Functional Controls and
Displays
Cross-functional controls and displays are used for both monitoring and ventilation functions.
Key LED Indicators
LED indicators (1 in Figure 6) within keys (Volume Control, Pressure Control, Pressure Support, Man/ Spont, Alarm Silence, and Standby) illuminate when that mode or function is selected and operating.
The Setup key is 2 in Figure 6.
1
2
3
Figure 7. Setup WindowSetup Key
Pressed During A Ventilation Mode
The Setup window (1 in Figure 7) replaces the Waveform area (3 in Figure 6).
The Setup window enables you to
perform ventilation functions and
view and change monitoring settings.
Note: The Volume Alarms On/Off soft key label
does not appear in ManSpont mode because it is selectable on the ManSpont screen (Figure 24 on page 30).
The Standby Setup screen (Figure 8) appears. The Standby Setup screen enables you to define site defaults and configuration.
1
Figure 8. Standby Setup ScreenPressed During Standby Mode
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Cross-Functional Controls and Displays Chapter 3 - Operating Concept
Figure 9. Status BarStatus Bar
The following numbers in parenthesis refer to
Figure 9.
Mode Display (1)
Displays the active ventilator mode.
Alarm Silence Status (2)
Displays the time remaining for alarm silence when the Silence Alarms key is pressed.
Battery Power Level (3)
Displays the status of the reserve power.
Time (4)
Displays the time.
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Chapter 3 - Operating Concept Monitoring
Figure 10. Ventilation Monitor Screen and System ControlsMonitoring
Monitoring Controls
LED Indicators
LED lamps (1 in Figure 10) in the upper right corner of the control panel indicate the degree of urgency of currently active alarms.
Warning — Red Blinking
Caution — Yellow Blinking
Advisory — Yellow Continuous
Silence Alarms Key
The Silence Alarms key (2 in Figure 10) silences all active alarm tones for 2 minutes. It resets the silence time for two minutes each time the key is pressed.
The Alarm Limit key (3 in Figure 10) displays the Alarm Limits window (1 in Figure 11), which appears in the same location on all mode screens.
Setup Key
The Setup key (4 in Figure 10) is a cross-functional control. See “Setup Key” on page 20.
1
3
2
4
Figure 11. Alarm Limit Configure WindowAlarm Limit Key
1
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Monitoring Chapter 3 - Operating Concept
Figure 12. Monitor ScreenMonitoring Windows
The following numbers in boldface refer to
Figure 12.
Alarm Window
The Alarm window (1) displays up to four of the highest priority alarms.
1
2
3
Oxygen Monitor Window
The Oxygen Monitor window (2) displays the inspiratory oxygen concentration in units of percent (%). It also displays the oxygen alarm limits in the far­right section of this window.
Respiratory Volume Monitor Window
The Respiratory Volume Monitor window (3) displays the patient's frequency (breaths per minute) or respiratory rate, tidal volume, minute volume, the minute volume high alarm limit, and the minute volume low alarm limit.
Breathing Pressure Monitor Window
The Breathing Pressure Monitor window (4) displays the patient's positive end expiratory pressure (PEEP), mean airway pressure (MEAN) or plateau airway pressure (PLAT), and peak airway pressure (PEAK).
Breathing Pressure Trace Window
The Breathing Pressure Trace window (5) displays a trace, or waveform, of the patient's breathing pressure.
4
5
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Chapter 3 - Operating Concept Monitoring
Figure 13. Standby ScreenSelecting/Setting Monitoring Functions
The following example describes changing alarm limits on the Standby Setup Screen.
Example
1. Press the Setup key while the Standby Screen (Figure 13) is active. The Standby Setup screen (Figure 14) replaces the Standby Screen.
2. The rotary knob enables you to select the “Default Settings” or “Configuration” label. Select and confirm the “Default Settings” label.
The Default Settings column is selected (Figure 15).
Note: Selecting and confirming the return arrow
(1 in Figure 14) will deactivate the Standby Setup screen and activate the Standby screen (Figure 13).
Figure 14. Standby Setup ScreenNote: Selecting and confirming the return arrow
(1 in Figure 15) will deselect the Default Settings column and reselect the Default Settings label as in Figure 14.
1
Figure 15. Standby Setup Screen Default Settings Selected
1
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