Fabius OS Instructions for Use Sw 3.n Edition 4 Jan 2015

Working with these Instructions for Use

The configuration functions available in Standby include calibrations, system tests, and the management of default settings. To access Standby mode: 1

Press the »

« key (Standby).

566

1 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. NOTE: If confirmation does not occur within 15 seconds, the ventilator remains in the previous mode and the waveform window is restored.

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« z Turn off fresh gas flow.

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Instructions for Use Fabius OS SW 3.n

305

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.

Configuration Functions in Standby Mode

522

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 OS machine.

Configuration

501

Header Line The header line on each page contains the title of the chapter.

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!!!«.

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Instructions for Use Fabius OS SW 3.n

Trademarks ®

Definition of the Target Group ®

®

DrägerService , Spirolog , SpiroLife , Drägersorb®, D-Vapor®, Fabius® OS, Vapor® 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.

The following group of users is defined with respect to the use of the medical device: Professionals These users are persons – who have been instructed on the medical device, and – who are medical professionals, or have received technical training, and – who are authorized to use and reprocess or to instal and maintain the medical device in accordance with the intended use. Dräger recommends that the medical device is used exclusively by professionals.

NOTE A NOTE provides additional information intended to avoid inconvenience during operation.

Abbreviations and Symbols Please refer to "Abbreviations" on page 26 and "Symbols" on page 27 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 OS SW 3.n

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Instructions for Use Fabius OS SW 3.n

Contents

Contents Working with these Instructions for Use... 2 Trademarks... 3 Definitions... 3 Abbreviations and Symbols... 3 Notice... 3 Definition of the Target Group... 3 For Your Safety and that of Your Patients... 7 Intended Use... 13 Intended Use... 14 System Overview... 15 Front View... 16 Compact Breathing System (Top View)... 17 Rear View (Pin-Index Connector)... 18 Interface Panel... 19 Vaporizers... 20 Vaporizer Exclusion Systems... 20 Auxiliary Oxygen Flowmeter... 21 APL Valve... 22 Communication Ports... 23 Accessory Weight Limits... 25 Abbreviations... 26 Symbols... 27 Operation Concept... 29 Control Panel... 30 The Screen Display... 31 Rotary Knob... 32 Fixed Function Keys... 32 Soft Keys... 33 Fresh Gas Control... 37 LED Indicators... 40 Gas System Color Coding... 40 Assembly... 41 Activating the Battery... 42 Fitting the CO2 Absorber on the Compact Breathing System... 42 Installing the Drägersorb CLIC Adapter... 43 Connecting the Compact Breathing System... 44 Inserting the Flow Sensor... 45 Connecting the Waste-Gas Outlet Port... 46 Instructions for Use Fabius OS SW 3.n

Installing the Flexible Bag Arm or Breathing Bag Extension* and Bag... 46 Connecting Pipeline Supply of N2O, AIR and O2... 47 Connecting the Reserve Gas Cylinders for N2O, AIR and O2 (for Pin-Index Mounting)... 48 Connecting the AGS Anesthetic Gas Receiving System... 51 Connecting the Passive Scavenger... 53 Connecting the Suction System... 54 Connecting the Breathing Hoses... 55 Inserting a new O2 Sensor Capsule... 57 Connecting the O2 Sensor... 57 Connecting the Pressure Sensor... 58 Connecting the Pressure Breathing Gauge... 58 Connecting the Flow Sensor... 59 Connecting the APL Bypass and PEEP/PMAX Hoses... 59 Attaching the Manual Ventilation Bag... 60 Preparing the Ventilator... 61 Ventilator Safety Features... 61 Installing Vaporizers... 62 Additional Equipment... 62 Equipotential Bonding... 63 Connecting AC Power... 63 Auxiliary power outlets... 64 Daily and Pre-use Checkout... 64 Getting Started... 65 Powering-Up the Machine... 66 Power-Up Standby Screen... 67 Checking Readiness for Operation... 67 Operation... 69 Power-Up Standby Screen... 70 Setting Fresh Gas Flow... 70 Setting Vaporizer Concentration... 72 O2 Flush... 72 Low Flow Anesthesia... 73 Nitrogen Wash-Out (If Required)... 73 Replacing CO2 Absorbent... 73 Ventilation... 76 Ventilator Safety Features... 88 Changing Patients... 89 Ending Operation... 90 5

Contents

Preparing for Storage or Transport... 91 Monitoring... 93 Main Screen... 94 Alarms... 94 Oxygen Monitoring... 98 O2 Low Supply Alarm... 102 Respiratory Volume Monitoring... 103 Breathing Pressure Monitoring... 105 Configuration... 107 Configuration Functions in Standby Mode... 108 Configuration during Operation... 127 Fault-Cause-Remedy... 135 Power Failure Backup... 136 Ventilator Fail State... 138 Overriding the Ventilator... 138 Fault-Cause-Remedy... 140 Cleaning, Disinfection and Sterilization... 147

Ambient Conditions... 176 Machine Data... 176 Fuses... 178 Electromagnetic Compatibility (EMC) Declaration... 179 Electrical Safety Conformance... 184 General Safety Standards for Anesthesia... 184 Freedom from Latex... 184 Ventilator... 184 Anesthesia Gas Supply Module... 187 Anesthetic Agent Vaporizer Interface... 188 Breathing System... 190 Low Oxygen Supply Pressure Alarm... 192 S-ORC (Sensitive Oxygen Ratio Controller) . . 192 Serial Interface... 193 Diagram... 194 Appendix – Daily and Pre-use Checkout Form... 195 Index... 203

Safety information on reprocessing... 148 Pre-cleaning... 148 Reprocessing methods... 148 Removing the Compact Breathing System... 151 Removing Parts of the Ventilator... 153 Removing anesthetic gas scavenging system (AGSS)... 154 Removing the Suction System... 154 Reprocessing Breathing system... 154 Care List for Fabius OS Components... 156 Reassembling the Breathing System... 158 Reinstalling the Ventilator... 160 Reinstalling the Scavenger System... 161 Reinstalling the Suction System... 163 Checking Readiness for Operation... 164 Maintenance... 165 Overview... 166 Routine Maintenance... 169 Checking Readiness for Operation... 171 Disposal... 173 Disposing of the medical device... 174 Technical Data... 175 6

Instructions for Use Fabius OS 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 OS SW 3.n

7

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 14 and in conjunction with appropriate patient monitoring (see page 9). Strictly observe all WARNING and CAUTION statements throughout these Instructions 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 90 52 154 (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.

8

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 Assembly Instructions and Instructions for Use.

Instructions for Use Fabius OS 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 OS 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: 2001 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 179. 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.

10

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 OS: 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 OS 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 OS anesthesia workstation must be thoroughly familiar with this instruction manual. 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 workstation, 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.

Instructions for Use Fabius OS SW 3.n

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 Risk of unintentional movement of the anesthesia machine Apply the caster brakes when the anesthesia machine is in use. 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 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 inflammable substances are used for disinfection. WARNING Explosive anesthetics, such as ether or cyclopropane, must not be used due to the risk of fire. 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.

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For Your Safety and that of Your Patients

WARNING Do not apply unregulated suction to the patient circuit when using this device. 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 electric 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 hospital-grade 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. CAUTION Communications with external equipment may be temporarily affected by electromagnetic interference due to the use of electrosurgical equipment. CAUTION Do not use Fabius OS during magnetic resonance (MRT, NMR, NMI). Device operation may be affected, thus placing the patient at risk.

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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. 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 Risk of device failure If the anesthesia workstation is operated when tilted, components maybe damaged or may function improperly. Do not operate the anesthesia workstation if it is tilted more than 5°. NOTE: Software must be installed by qualified personnel. We recommend to contact DrägerService for software installation. NOTE: If the error-free state of the protective earthing conductor or its connection to the medical device is doubtful, the device must be operated using the internal power supply (battery).

Instructions for Use Fabius OS SW 3.n

Intended Use

Intended Use Intended Use... 14 MEDIBUS and Vitalink Protocols... 14 Restriction of Distribution... 14

Instructions for Use Fabius OS SW 3.n

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Intended Use

Intended Use Fabius OS is an inhalation anesthesia machine for use in operating, induction and recovery rooms. It may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius OS 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) Manual Ventilation Spontaneous Breathing

Fabius OS 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. 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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MEDIBUS and Vitalink Protocols MEDIBUS and Vitalink are software protocols for use in transferring data between the Fabius OS 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 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. Restriction of Distribution CAUTION Device for use in health care facilities only and exclusively by persons with specific training and experience in its use.

Instructions for Use Fabius OS SW 3.n

System Overview

System Overview Front View... 16 Compact Breathing System (Top View)... 17 Rear View (Pin-Index Connector)... 18 Interface Panel... 19 Vaporizers... 20 Vaporizer Exclusion Systems... 20 Dräger Auto Exclusion 2 Vaporizer Mount* . . . 20 Auxiliary Oxygen Flowmeter... 21 APL Valve... 22 Communication Ports... 23 Recommended Device Configuration... 23 Accessory Weight Limits... 25 Abbreviations... 26 Symbols... 27

Instructions for Use Fabius OS SW 3.n

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System Overview

Front View

1 23

4

O

14 13 12 11

5 6 7

10

8

073

9

1

7 8

Ventilator control panel (settings for ventilation parameters and airway monitoring) Total fresh gas flowmeter Display screen Vapor mount Fresh gas control Gauges for Pin index O2, AIR and N2O cylinders Writing table* Storage drawers

*

optional

2 3 4 5 6

16

9 Brake 10 Absorber 11 Oxygen Flush 12 Compact Breathing System (COSY) 13 Ventilator 14 Auxiliary oxygen flowmeter

Instructions for Use Fabius OS SW 3.n

System Overview

Compact Breathing System (Top View)

1

2

3

4

13 5

12 11

6 7

9

8 090

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 OS SW 3.n

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System Overview

Rear View (Pin-Index Connector)

1 2

3 4

5 6 7 8

10

066

9

1 2

Sealed connector Connector for medical gas pipeline supply (central supply) 3 Power cable connection 4 Interface panel 5 Ventilator hose connection 6 ON/OFF switch 7 Fuse 8 Compact Breathing System (COSY) 9 Potential equalization pin 10 Pin-Index system

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Instructions for Use Fabius OS SW 3.n

System Overview

Interface Panel

10

9

1 2 3 4 5 6

7

002

8 1 COM 1 2 COM 2* 3 APL 4 Oxygen Sensor 5 Breathing Pressure 6 Volume Sensor 7 ON/OFF switch 8 Fuse 9 Power cable connection 10 PEEP

*

optional

Instructions for Use Fabius OS SW 3.n

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System Overview

Vaporizers* The Dräger Vapor anesthetic agent vaporizers 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, Sevoflurane, or Desflurane.

When using a Desflurane vaporizer, it must be connected to mains power.

When using a Desflurane vaporizer, it must be connected to mains power. For complete information, consult the appropriate Instruction for Use provided with the vaporizer.

Vaporizer Exclusion Systems The exclusion systems available for the Fabius OS are described below. Dräger Auto Exclusion 2 Vaporizer Mount* This system has an automatic interlock system that ensures only one vaporizer can be used at a time. When one of the two vaporizers is selected for use (opened), the interlock mechanism within that vaporizer’s mounting system is activated automatically, preventing the other vaporizer from being used. NOTE Only Dräger vaporizers labeled as "AUTO EXCLUSION" vaporizers are compatible with the Dräger Auto Exclusion 2-Vaporizer Mount. See table for the Auto Exclusion Vaporizer technical data. Normal Operating Range

Extended Operating Range

*

20

≤10 L/min Dräger Vapor 2000

Instruction for Use Manual’s delivered concentration accuracy values apply.

>10 to

Dräger auto exclusion

≤15 L/min vaporizer concentration output accuracy may be reduced.

optional

Instructions for Use Fabius OS SW 3.n