Instruction for Use
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Instructions for Use
Fabius MRI
WARNING To properly use this medical device, read and comply with these Instructions for Use.
Anesthesia Workstation Software 3.n
Working with These Instructions for Use Header Line The header line on each page contains the title of the chapter. Page Body The page body in these Instructions for Use combines text and illustrations. The information is presented as sequential steps of action, giving the user hands-on experience in learning how to use the Fabius MRI workstation.
Configuration
Left-Hand Column - the Text The text in the left-hand column provides explanations and step-by-step instructions on the practical use of the machine. z Bullet points indicate separate actions. 1 Where several actions are described, numbers are used to refer to relevant details in the illustrations. On each page the numbering restart with “1”. – Dashes indicate the listing of data, options or objects.
z The waveform window is replaced by a confirmation message and the instruction to shut off flow. The LED on the Standby key starts blinking and will remain blinking until Standby is confirmed.
Configuration Functions in Standby Mode The configuration functions available in Standby include calibrations, system tests, and the management of default settings. To access Standby mode: 1
Press the »Standby« key.
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1
522
NOTE: If confirmation does not occur within 15 seconds, the ventilator remains in the previous mode and the waveform window is restored.
501
z Confirm the mode change. The ventilator enters Standby mode, the Standby screen replaces the previous screen, and the Standby LED stops blinking and remains on. The following soft key labels appear at the bottom of the Standby screen: – »Run System Test« – »Calibrate Flow Sensor« – »Calibrate O2 Sensor« – »Leak / Compl Test« – »Access Alarm Log« – »Restore Site Defaults«
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Instructions for Use Fabius MRI SW 3.n
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Right-Hand Column - the Illustrations The illustrations provide visual reference for the text and for locating the various parts of the equipment. Elements mentioned in the text are highlighted. Renderings of screen displays guide the user and provide a way to reconfirm actions performed. Typing Conventions in this Manual – User controls, such as hard keys and soft keys, and screen pages are printed in bold within quotation marks, e.g., »PEEP« or »Volume Settings« – Screen messages are printed in bold within quotation marks, e.g., »Flow Calibration in progress« – Alarm messages are printed in bold within quotation marks, including the exclamation marks that indicate their alarm urgency level, e.g., »APNEA PRESSURE!!!« 2
Instructions for Use Fabius MRI SW 3.n
Trademarks ®
Definition of target groups ®
®
DrägerService , Spirolog , SpiroLife , Drägersorb®, Fabius® MRI, Vapor®, and Vitalink® are registered trademarks of Dräger Medical. All other products or brand names are trademarks of their respective owners.
Definitions WARNING A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION A CAUTION statement provides important information about a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or in damage to the equipment or other property. NOTE A NOTE provides additional information intended to avoid inconvenience during operation.
Abbreviations and Symbols
For this medical device users, service personnel, and experts are defined as target groups. These traget groups have been instructed in the use of the medical device and have the necessary knowledge to use, install, reprocess, maintain or repair the medical device. Dräger emphasizes that the medical device must be used, installed, reprocessed, maintained or repaired exclusively by defined target groups. Users Users are persons who may use the medical device in accordance with its intended use. Service personnel Service personnel are persons who are responsible for the maintenance of the medical device towards the operating organization. Service personnel are persons who may instal, reprocess, or maintain the medical device. Experts Experts are persons who may carry out repair or complex maintenance work on the medical device.
Please refer to “Abbreviations” on page 34 and “Symbol Definition” on page 35 for explanations.
Notice This document is provided for customer information only, and will not be updated or exchanged without customer request. Depending on the configuration of the individual medical device, the images in the Instructions for Use may differ.
Instructions for Use Fabius MRI SW 3.n
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Magnetic Resonance (MR) Definitions Term
Meaning
MR
Magnetic Resonance
MRI
Magnetic Resonance Imaging
MRT
Magnetic Resonance Tomography
MR Safe
An item that poses no known hazards in all MR environments.
MR Environment
This term is used to describe the general environment present in the vicinity of an MRT scanner. In particular, this refers to the area within the 5-gauss line around the scanner. Characteristics of the environment include the following: 1) the static magnetic field (the range of 0.2 to 3 tesla is most common, but it can exceed 4.0 tesla*) and associated spatial gradients; 2) rapidly changing magnetic fields (imaging gradients ~kHz); and 3) radio frequency (RF) magnetic field pulses (on the order of tens to hundreds of MHz, i.e., in the FM radio band). The "MR Environment" includes anywhere in the MR procedure room, including the center of the bore of the MRT scanner. *1 tesla = 10000 gauss
Five-Gauss Line
This line specifies the perimeter around an MRT scanner within which the static magnetic fields are higher than five gauss. Five gauss and below are considered "safe” levels of static magnetic field exposure for the general public. (5 gauss = 0.50 mtesla)
Image Artifact
This is a general term that refers to an inappropriate image signal at a specified spatial location. lt is generally characterized as increased signal intensity in an area which is known to contain no signal producing material or decreased signal intensity (voids) where signal should be produced.
MR Conditional
An item that has been demonstrated to pose no known hazards in a specified MR enviroment with specified conditions of use. Field conditions that define the specified MR enviroment include field strength, spatial gradient, dB/dt (time rate of change of the magnetic field), radio frequency (RF) fields and specific absorption rate (SAR).
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Instructions for Use Fabius MRI SW 3.n
Contents
Contents Working with These Instructions for Use... 2 Trademarks... 3 Definitions... 3 Abbreviations and Symbols... 3 Notice... 3 Definition of target groups... 3 Magnetic Resonance (MR) Definitions... 4 For Your Safety and that of Your Patients... 7 Intended Use... 15 Intended Use... 16 Indications for Use... 16 System Overview... 17 Front View... 18 Compact Breathing System (Top View)... 19 Rear View (Threaded Connectors)... 20 Interface Panel... 21 Vaporizers (Optional)... 22 Vaporizer Exclusion Systems... 22 Auxiliary Oxygen Flowmeter... 24 O2 Flush Button... 25 APL Valve... 26 Writing Table... 28 Communication Port... 28 Teslameter... 29 External fresh-gas outlet with an additional switch... 30 Accessory Mounting... 32 Abbreviations... 34 Symbol Definition... 35 Operation Concept... 37 Control Panel... 38 The Screen Display... 39 Rotary Knob... 40 Fixed Function Keys... 40 Soft Keys... 41 Fresh Gas Control... 45 LED Indicators... 48 Gas System Color Coding... 48 Screen Color Concept... 48 Assembly... 49 Instructions for Use Fabius MRI SW 3.n
Activating the Battery... 50 Fitting the CO2 Absorber on the Compact Breathing System... 51 Inserting the Flow Sensor... 52 Connecting the Compact Breathing System . . . 52 Installing the Drägersorb CLIC Adapter... 54 Connecting the Waste Gas Outlet Port... 55 Installing the Breathing Bag Extension and Bag... 56 Connecting Pipeline Supply of N2O, AIR and O2... 57 Connecting the Reserve Gas Cylinders for N2O, AIR and O2 ( for Pin-Index Mounting) . . . 58 Connecting the Reserve Gas Cylinders for N2O, AIR and O2 (for Cylinders with Threaded Connectors)... 61 Connecting the AGSS Anesthetic Gas Scavenging System... 62 Connecting the Suction System... 64 Connecting the Breathing Hoses and Breathing Bag... 65 Inserting a new O2 Sensor Capsule... 68 Connecting the O2 Sensor... 68 Connecting the Pressure Sensor... 69 Connecting the Breathing Pressure Gauge... 69 Connecting the Flow Sensor... 70 Connecting the APL Bypass and PEEP/PMAX Hoses... 70 Preparing the Ventilator... 71 Ventilator Safety Features... 71 Installing Vaporizers... 72 Connecting Auxiliary Equipment... 74 Auxiliary power outlets... 75 Positioning the Fabius MRI at MRT System . . . 76 Connecting AC Power... 78 Checklist... 79 Daily and Pre-use Checkout... 80 Getting Started... 81 Powering-Up the Machine... 82 Power-Up Standby Screen... 83 Checking Readiness for Operation... 83 Operation... 85 Power-Up Standby Screen... 86 5
Contents
Setting Fresh Gas Flow... 86 Setting Vaporizer Concentration... 88 O2 Flush... 89 Low Flow Anesthesia... 90 Nitrogen Wash-Out (If Required)... 90 Replacing CO2 Absorbent... 90 Ventilation... 94 Ventilator Safety Features... 110 Changing Patients... 111 Ending Operation... 112 End of Vaporizer Use... 113 Using the external fresh-gas outlet with an additional switch... 114 Preparing for Storage or Transport... 119 Monitoring... 123 Main Screen... 124 Alarms... 124 Oxygen Monitoring... 128 O2 Monitoring Disabled... 132 Respiratory Volume Monitoring... 133 Breathing Pressure Monitoring... 135 Configuration... 137 Configuration Functions in Standby Mode... 138 Configuration during Operation... 159 Fault-Cause-Remedy... 165
Reinstalling the Suction System... 191 Checking Readiness for Operation... 192 Maintenance... 193 Overview... 194 Routine Maintenance... 197 Checking Readiness for Operation... 199 Disposal... 201 Disposal of the Medical Device... 202 Technical Data... 203 MRI Use... 204 Ambient Conditions... 204 Machine Data... 204 Tesla Sensor... 206 Electromagnetic Compatibility (EMC)... 207 Electrical Safety Conformance... 212 General Safety Standards for Anesthesia... 212 Freedom from latex... 212 Ventilator... 212 Anesthesia Gas Supply Module... 215 Anesthetic Agent Vaporizer Interface... 216 Breathing System... 218 Low Oxygen Supply Pressure Alarm... 220 S-ORC (Sensitive Oxygen Ratio Controller) . . 221 Serial Interface... 221 Diagram... 222
Power Failure Backup... 166 Ventilator Fail State... 168 Overriding the Ventilator... 168 Fault-Cause-Remedy... 170
Appendix 1 - Daily and Pre-use Checkout Form... 225
Cleaning... 175
Imaging Test Protocol (ITP) Overview:... 233
Safety information on reprocessing... 176 Pre-cleaning... 176 Reprocessing methods... 176 Removing the Compact Breathing System... 179 Removing Parts of the Ventilator... 181 Removing anesthetic gas scavenging system (AGSS)... 182 Removing the Suction System... 182 Reprocessing Breathing system... 182 Care List for Fabius MRI Components... 184 Reassembling the Breathing System... 186 Reinstalling the Ventilator... 188 Reinstalling the Scavenger System... 189 6
Appendix 2 - Imaging Test Protocol... 233
Appendix 3 - Record of Transfer and Equipment Installation Drawing... 235 Index... 237
Instructions for Use Fabius MRI SW 3.n
For Your Safety and that of Your Patients
For Your Safety and that of Your Patients Strictly follow these Instructions for Use... 8 Maintenance... 8 Accessories... 8 Not for use in areas of explosion hazard... 8 Safe connection with other electrical equipment... 8 Safe networking of computers... 8 Patient safety... 9 Patient monitoring... 9 General WARNINGS and CAUTIONS... 10 Note on EMC/ESD risk for the device function 10 Accessories in sterile packaging... 10 Software... 11
Instructions for Use Fabius MRI SW 3.n
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For Your Safety and that of Your Patients
Strictly follow these Instructions for Use
Not for use in areas of explosion hazard
WARNING Strictly follow these Instructions for Use. Any use of the medical device requires full understanding and strict observation of all portions of these instructions. The medical device is only to be used for the purpose specified under “Intended Use” on page 16 and in conjunction with appropriate patient monitoring (see page 9). Strictly observe all WARNING and CAUTION statements throughout this Instruction for Use and all statements on medical device labels.
WARNING This medical device is neither approved nor certified for use in areas where combustible or explosive gas mixtures are likely to occur.
Maintenance WARNING The medical device must be inspected and serviced regularly by trained service personnel. Repair of the medical device may also only be carried out by trained service personnel. Dräger recommends that a service contract be obtained with DrägerService and that all repairs also be carried out by them. Dräger recommends that only authentic Dräger repair parts be used for maintenance. Otherwise the correct functioning of the medical device may be compromised. See chapter "Maintenance". Accessories WARNING Only the accessories indicated on the list of accessories 9052103 en (1st edition or higher) have been tested and approved to be used with the medical device. Accordingly it is strongly recommended that only these accessories be used in conjunction with the specific medical device. Otherwise the correct functioning of the medical device may be compromised.
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Safe connection with other electrical equipment WARNING Electrical connections to equipment which is not listed in these Instructions for Use should only be made following consultation with the respective manufacturers. Safe networking of computers When networking with electrical devices, the operator is responsible for ensuring that the resulting system meets the requirements set forth by the following standards: – EN 60601-1 (IEC 60601-1) Medical electrical equipment Part 1: General requirements for safety – EN 60601-1-1 (IEC 60601-1-1) Medical electrical equipment Part 1-1: General requirements for safety Collateral standard: Safety requirements for medical electrical systems – EN 60601-1-2 (IEC 60601-1-2) Medical electrical equipment Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility; Requirements and tests – EN 60601-1-4 (IEC 60601-1-4) Medical electrical equipment Part 1-4: General requirements for safety Collateral standard: Programmable electrical medical systems Follow associated Assembly Instructions and Instructions for Use.
Instructions for Use Fabius MRI SW 3.n
For Your Safety and that of Your Patients
Patient safety The design of the medical device, the accompanying literature, and the labeling on the medical device take into consideration that the purchase and use of the medical device are restricted to trained professionals, and that certain inherent characteristics of the medical device are known to the trained operator. Instructions, warnings, and caution statements are limited, therefore, largely to the specifics of the Dräger design. This publication excludes references to various hazards which are obvious to a medical professional and operator of this medical device, to the consequences of medical device misuse, and to potentially adverse effects in patients with abnormal conditions. Medical device modification or misuse can be dangerous. Patient monitoring The operators of the medical device must recognize their responsibility for choosing appropriate safety monitoring that supplies adequate information on medical device performance and patient condition. Patient safety may be achieved through a wide variety of different means ranging from electronic surveillance of medical device performance and patient condition to simple, direct observation of clinical signs. The responsibility for the selection of the best level of patient monitoring lies solely with the medical device operator.
Instructions for Use Fabius MRI SW 3.n
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For Your Safety and that of Your Patients
General WARNINGS and CAUTIONS The following WARNINGS and CAUTIONS apply to general operation of the device. WARNINGS and CAUTIONS specific to subsystems or particular features appear with those topics in later sections of these Instructions for Use or in the device-specific Instructions for Use. Note on EMC/ESD risk for the device function General information on electromagnetic compatibility (EMC) pursuant to international EMC standard IEC 60601-1-2 Electromedical devices are subject to special precautionary measures concerning electromagnetic compatibility (EMC) and must be installed and put into operation in accordance with the EMC information included, see page 207. Portable and mobile RF communications equipment can affect medical electrical equipment. WARNING Connector pins with an ESD warning sign should not be touched and no connections should be made between these connectors without implementing ESD protective measures. Such precautionary procedures may include antistatic clothing and shoes, the touch of a ground stud before and during connecting the pins or the use of electrically isolating and antistatic gloves. All staff involved in the above shall receive instruction in these ESD precautionary procedures.
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WARNING Risk of electric shock. Connecting devices to the Medical Power Outlet Strip can cause an increase in leakage current beyond permissible values if the protective conductor of a device fails. Check the leakage current when connecting devices to the Medical Power Outlet Strip. If connecting a device (or devices) increases the leakage current to a value which exceeds the permissible value, do not use the auxiliary outlets of the Fabius MRI: use a separate wall socket. The system must meet the requirements for medical equipment in accordance with IEC/EN 60601-1-1 and IEC/EN 60601-1-2 and the particular standards of the connected devices. Accessories in sterile packaging Do not use accessories in sterile packaging if the packaging has been opened, damaged or if there are other signs that the accessories are not sterile. Reprocessing and resterilization of single-use accessories is not permitted. CAUTION Risk of patient injury An incorrect diagnosis or misinterpretation of measured values, or other parameters, may endanger the patient. Do not base therapy decision on individual measured values or monitoring parameters.
Instructions for Use Fabius MRI SW 3.n
For Your Safety and that of Your Patients
Software The device's software has been developed and tested carefully in accordance with Dräger's high quality standards. It is therefore highly improbable that software errors can become a hazard to the patient. Additionally, independent protective functions are extensively implemented in the software, as well as in electronics and mechanics, for all safety-related functions of the device. Through this, the probability that an error in the software or other functions can be detected before it affects the patient's safety is very high. Regular automated or manual tests ensure the effectiveness of all protective measures. WARNING Do not use conductive breathing hoses or face masks. They may cause burns during HF surgery. WARNING Any person involved with the setup, operation, or maintenance of the Fabius MRI anesthesia workstation must be thoroughly familiar with this instruction manual. WARNING Do not use conductive breathing hoses or face masks. They may cause burns during HF surgery. WARNING This MR conditional anesthesia workstation has been tested with magnets with field strengths of 1.5 tesla and 3 tesla by a fringe field strength of 40 mtesla (400 gauss). Use of the machine with higher strengths could result in ventilator and device malfunction. Additionally, unmanageable attractive forces could lead to serious injury.
Instructions for Use Fabius MRI SW 3.n
WARNING This anesthesia workstation will not respond automatically to certain changes in patient condition, operator error, or failure of components. The anesthesia workstation has to be operated under the constant supervision and control of a qualified operator in order to provide immediate corrective action. WARNING No third-party components shall be attached to the anesthesia machine, ventilator, or breathing system (except for certain approved components), otherwise the correct functioning of the medical device may be compromised. For more information, contact DrägerService or your local authorized service organization. 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, Dräger, 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 Always lock the caster brakes after the Fabius MRI has been positioned in the MRI scanner room. Magnetic attractive forces between the magnet and the anesthesia machine may cause unintentional movement of the anesthesia machine if the casters are unlocked. WARNING Risk of fire Drugs or other substances based on inflammable solvents, such as alcohol, must not be introduced into the patient system. Adequate ventilation must be ensured if highly flammable substances are used for disinfection. 11
For Your Safety and that of Your Patients
WARNING Explosive anesthetics, such as ether or cyclopropane, must not be used due to the risk of fire. WARNING Do not use conductive breathing hoses or face masks. They may cause burns during HF surgery. WARNING Do not apply unregulated suction to the patient circuit when using this device. WARNING Always keep a breathing bag at hand. If ventilation of the patient is compromised, the patient must be immediately ventilated with a separate emergency ventilator. WARNING Remove any equipment mounted to the machine before transport. The writing table should also be free of all objects and pushed back in the locked position. If these precautions are not followed, the device may tip over and pose a risk to safety.
WARNING Do not bring any ferromagnetic tools or equipment into the scanning room. Ferromagnetic objects (made of steel, iron, or stainless steel) are strongly attracted to the magnet and can become harmful projectiles. WARNING Be careful in handling the power cord and main power plug. These parts still contain minor magnetic components. The power cord can be attracted to MRI system. WARNING Do not use any type of Desflurane vaporizer in the MR environment. In an MR environment functionality of the Desflurane vaporizer will be compromised. WARNING A pre-use checkout procedure must be performed immediately before each use of the Fabius MRI. A recommended procedure is provided in this Instruction for Use, see “Appendix 1 - Daily and Pre-use Checkout Form” on page 225.
WARNING Do not place any object on this machine unless it is specifically labeled to be used in an MR scanning room and on a Fabius MRI anesthesia system. Objects placed on this machine that are not designed for use with this anesthesia system may be strongly attracted to the magnet and may cause serious injury or death when the machine is used in an MR scanning room. WARNING All the procedures described in this manual require that any use of ferromagnetic tools is done only while the Fabius MRI is out of the scanner room.
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Instructions for Use Fabius MRI SW 3.n
For Your Safety and that of Your Patients
WARNING To avoid electrical shock hazard: Due to the risk of electrical shock, do not remove any component cover. Refer any servicing to DrägerService. Use only hospital-grade grounded electrical outlets and power cord. This device is to be used only in rooms with line power installations complying with national safety standards for hospital patient rooms (e.g., IEC 60601-1 "Safety of Medical Electrical Equipment"). Make sure the external equipment is hospitalgrade grounded (regarding national regulations) before connecting the equipment. Disconnect the power supply from the electrical outlet before cleaning or servicing. Let it dry completely before reconnecting it to the electrical outlet. Always ensure that the clamp for the power cord at the power supply end is tight, thus preventing an accidental disconnect from the unit. Do not connect additional external equipment other than equipment specified by Dräger.
WARNING The Fabius MRI and its patient connections must be carefully positioned so that the patient cannot be disconnected when being removed from the MRT system.
WARNING When moving the anesthesia machine, remove all monitors and equipment from the top shelf and hinged arms, remove the absorber system, vaporizers, and reserve gas cylinders, push in the writing tray, and use only the machine handles to push or pull the unit (see “Accessory Mounting” on page 32). The anesthesia machine should only be moved by people who are physically capable of handling its weight. Dräger 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.
CAUTION Do not use the following non-rebreathing systems: Magill, Kuhn or Bain. They are not MR safe or MR conditional. Otherwise the diagnostic quality of the MRT images will be affected.
Instructions for Use Fabius MRI SW 3.n
WARNING To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. WARNING Use only non-rebreathing systems having a reservoir bag in compliance with ISO 5362 and/or a pressure relief valve to ensure correct pressure at the patient connection port. If disregarded, this could lead to personal injury. CAUTION Risk of pinching fingers or breathing hoses and objects falling down If the writing table is not engaged correctly, objects can fall down and fingers or breathing hoses can be pinched.
CAUTION Use MR safe or MR conditional non-rebreathing systems. Otherwise the diagnostic quality of the MRT images will be affected. CAUTION Provide sufficient length of hoses for movement. CAUTION Communications with external equipment may be temporarily affected by electromagnetic interference due to the use of electrosurgical equipment.
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For Your Safety and that of Your Patients
CAUTION Watch hoses connected to the patient while moving the Fabius MRI. CAUTION Only Vapor 2000 vaporizers can by used on the Fabius MRI in MRT scanner rooms. CAUTION Risk of injury and image artifacts The Fabius MRI is designed for use in MR environment only as a system. The user should not assume that individual components of the system can be safely used in MR environment. CAUTION Risk of injury Do not service this device while it is in the MR environment. CAUTION Risk of physical injury To avoid physical injury, pay special attention to edges, moving parts and corners when working with – drawers, – the ventilator module, – the writing tray, – swivel arms for mounted devices, – gas cylinders, – vaporizer units, – CLIC absorbers and CLIC adapters, as well as other accessories. NOTE Software must be installed by qualified personnel. We recommend to contact DrägerService for software installation. NOTE If the correct functionality of the protective earthing conductor or its connection to the device is doubtful, the device must be operated using the internal power supply (battery).
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Instructions for Use Fabius MRI SW 3.n
Intended Use
Intended Use Intended Use... 16 Indications for Use... 16 MEDIBUS Protocol... 16
Instructions for Use Fabius MRI SW 3.n
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Intended Use
Intended Use
Indications for Use
Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms. It can only be used in MRI scanner rooms with magnets 1.5 tesla and 3 tesla at a fringe field strength of 40 mtesla (400 gauss) or less.
The Fabius MRI is indicated as a continuous flow anesthesia system useable in an MRI environment. The Fabius MRI may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen concentration, breathing pressure and respiratory volume.
It may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius MRI 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 Pressure Support (Optional) SIMV/PS (Optional) Manual Ventilation Spontaneous Breathing
Fabius MRI is equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2). As per IEC 60601-2-13 (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.
MEDIBUS Protocol MEDIBUS is a software protocol for use in transferring data between the Fabius MRI 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 (see 9038530, 3rd edition or higher). WARNING Data transferred via MEDIBUS 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.
NOTE O2 Monitoring Disabled” is a local authorized service organization-configurable option. See “O2 Monitoring Disabled” on page 132 for more information. In this case, external FiO2 monitoring must be available. IEC 60601-2-13 :2003 requires that a manual ventilation bag must be available for emergency use. Fresh gas enrichment is provided by the Dräger Vapor anesthetic vaporizer.
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Instructions for Use Fabius MRI SW 3.n
System Overview
System Overview Front View... 18 Compact Breathing System (Top View)... 19 Rear View (Threaded Connectors)... 20 Interface Panel... 21 Vaporizers (Optional)... 22 Vaporizer Exclusion Systems... 22 Dräger Vapor Interlock 2 System (Optional) . . 22 Dräger Auto Exclusion 2-Vaporizer Mount (Optional)... 23 Auxiliary Oxygen Flowmeter... 24 O2 Flush Button... 25 APL Valve... 26 Writing Table... 28 Communication Port... 28 Teslameter... 29 Location of the Sensors... 29 External fresh-gas outlet with an additional switch... 30 Accessory Mounting... 32 Maximum Weight Loads... 33 Abbreviations... 34 Symbol Definition... 35
Instructions for Use Fabius MRI SW 3.n
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System Overview
Front View
1
23
4
5
5
15 6
14 13
≤ 40 mtesla (400 gauss)
7
12 8 11
9
113
10
1
Ventilator control panel (settings for ventilation parameters and airway monitoring) 2 Total fresh gas flowmeter 3 Display screen 4 Interlock or Auto Exclusion Vapor mount 5 Additional alarm indicators 6 Fresh gas controls 7 Gauges (Pin-Index cylinders) 8 Writing table 9 Storage drawers 10 Central brake 18
11 Absorber 12 Compact Breathing System (COSY) 13 Oxygen flush button 14 Ventilator 15 Auxiliary oxygen flowmeter
Instructions for Use Fabius MRI SW 3.n
System Overview
Compact Breathing System (Top View)
1
2
3 4
13 5
12 11
6 7 9
8 064
10
1 PEEP/PMAX valve connection port 2 Bag holder 3 Expiratory valve 4 Flow-sensor guard (flow-sensor protection) 5 Expiratory port 6 Connector for breathing bag 7 Inspiratory port 8 Inspiratory valve 9 Fresh gas decoupling valve 10 APL bypass valve connection port 11 Breathing system mount with locking bolt 12 Selecting knob for »MAN« and »SPONT« on pressure limiting (APL) valve 13 Sample gas return port
Instructions for Use Fabius MRI SW 3.n
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System Overview
Rear View (Threaded Connectors)
1 2
3
4 5 6 7
11
10 8
103
9
1 2 3 4 5 6 7 20
Connector for medical gas pipeline supply (central supply) Connector for cylinders (threaded connectors) Type plate Ventilator hose connection Interface panel ON/OFF switch Fuse
8 Compact Breathing System (COSY) 9 Power cable connection 10 Potential equalization pin 11 Auxiliary power outlets
Instructions for Use Fabius MRI SW 3.n