Fabius plus Instructions for Use Sw 3.n Edition 1 June 2014

Typographical conventions 1

Consecutive numbers indicate steps of action, with the numbering restarting with "1" for each new sequence of actions.



Bullet points indicate individual actions or different options for action.

–

Dashes indicate the listing of data, options, or objects.

Use of terms –

The product Fabius plus is also referred to as Fabius.

–

Dräger uses the term "Accessory" not only for accessories in the sense of IEC 60601-1, but also for consumable parts, removable parts, and attached parts.

(A) Letters in parentheses refer to elements in the related illustration. A

Letters in illustrations denote elements referred to in the text.

Any text shown on the screen and any labeling on the device are printed in bold and italics, e.g., PEEP or Man/Spon.

Screen layouts and illustrations of the device The actual screen layout or the device may differ in appearance or in configuration from the illustrations.

Trademarks Trademark Fabius

Trademark owner

®plus ®

Trademark

Trademark owner

Incidin®

Ecolab

Incidur®

DrägerService Spirolog® SpiroLife® D-Vapor®

Dräger

Drägersorb® MEDIBUS® Vitalink® Vapor® Selectatec®

Datex-Ohmeda

Korsolex®

BODE Chemie

Neodisher Mediclean®

Dr. Weigert

Gigasept FF®

Schülke & Mayr

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Instructions for use Fabius plus SW 3.n

Safety information definitions WARNING

CAUTION

A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury.

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 medical device or other property. NOTE A NOTE provides additional information intended to avoid inconvenience during operation.

Definition of target groups For this product, users, service personnel, and experts are defined as target groups.

Service personnel

These target groups must have received instruction in the use of the product and must have the necessary training and knowledge to use, install, reprocess, maintain, or repair the product. The target groups must understand the language of the present document.

Service personnel are persons who are responsible for the maintenance of the product.

The product must be used, installed, reprocessed, maintained, or repaired exclusively by defined target groups.

Users Users are persons who use the product in accordance with its intended use.

Instructions for use Fabius plus SW 3.n

Service personnel must be trained in the maintenance of medical devices and install, reprocess, and maintain the product.

Experts Experts are persons who perform repair or complex maintenance work on the product. Experts must have the necessary knowledge and experience with complex maintenance work on the product.

3

Abbreviations and symbols Explanations can be found in the sections ''Abbreviations'' and ''Symbols'' in chapter ''Symbols''.

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Instructions for use Fabius plus SW 3.n

Contents

Contents For your safety and that of your patients...

7

Connecting the sensors and measurement lines ... Fastening the manual resuscitator ... Instructions for mounting the accessories ...

79 82 82

16 17 18 19

Getting started...

85

Overview... 20

Operation ...

Fabius plus as trolley version (front view) ... Compact breathing system COSY (top view) .. Power supply unit for COSY heating (front view) ... Power supply unit for COSY heating (rear view) ... Rear view... Interface panel... Vaporizer ... Ceiling-mounted version (optional)... Wall-mounted version (optional)... Supplemental O2 delivery (optional)... APL valve ... Interfaces... External fresh-gas outlet... Abbreviations... Symbols... Product labels...

Standby page after start-up... 90 Setting the fresh-gas flow... 90 Setting the anesthetic gas concentration ... 92 O2 flush ... 93 Low-flow anesthesia... 94 Nitrogen rinsing (as needed) ... 94 Replacing the soda lime ... 95 Ventilation... 96 Safety functions of the ventilator ... 108 Patient change ... 109 Using the external fresh-gas outlet as a common gas outlet (optional) ... 110 Using the external fresh-gas outlet with an auxiliary switch (optional) ... 112 Ending operation ... 114 Preparing for storage or transport ... 115

General safety information ... 8 Product-specific safety information... 12 Application ... 15 Intended use... Indications/Contraindications... Further information on application ... The MEDIBUS and Vitalink protocols...

21 22 23 24 25 27 28 29 30 31 32 33 34 36 38 40

Operating concept... 41 Control panel ... Screen display ... Selecting and setting ... Fresh-gas delivery (version for 3 gases) ... LED indicators ... Color coding for anesthetic agents and medical gases ... Screen colors (optional)...

42 44 45 47 48 49 49

Assembly and preparation ... 50 Before first operation ... Connecting the gas supply ... Ensuring the gas supply ... Assembling the breathing system... Instructions for use Fabius plus SW 3.n

51 54 60 61

Daily checkout and pre-use checkout ... 86 Switching on ... 86 Checking the readiness for operation... 88 89

Alarms ... 117 Alarm signaling... 118 Monitoring... 121 Main screen... 122 O2 monitoring ... 122 Breathing volume monitoring... 126 Airway pressure monitoring... 128 Configuration... 130 Configuration in standby mode... 131 Page Standby Set-up ... 139 Configuration during operation ... 147 Troubleshooting ... 153 Locating and remedying leakages... 154 Power supply failure ... 156 5

Contents

Ventilator failure ... 158 Failure of the O2 sensor ... 159 Low O2 supply ... 159 Alarm – Cause – Remedy ... 160

Password ... 227 Configuration password for Fabius plus Software 3.n ... 227

Cleaning, disinfection and sterilization... 169 Disassembly ... 170 Removing the compact breathing system ... 172 Reprocessing procedures ... 174 Reprocessing list ... 178 Before using on patients again... 181 Maintenance... 182 Overview ... 183 Inspection ... 184 Preventive maintenance... 185 Repair... 186 Disposal ... 187 Disposing of the medical device... 188 Disposal of accessories... 188 Disposal of non-rechargeable batteries... 189 Technical data ... 190 General information... 191 Ambient conditions ... 191 Device data ... 192 Fuses... 195 External fresh-gas outlet ... 195 Electrical safety ... 195 General safety standards for anesthesia workstations ... 196 Ventilator ... 198 Anesthetic gas supply module... 200 Vaporizer interface ... 201 Breathing system... 203 Alarm for low oxygen supply pressure ... 206 Alarm tone sequence IEC ... 206 Characteristics of additional acoustic signals.. 206 S-ORC (Sensitive Oxygen Ratio Controller) ... 207 Device outlets... 207 Essential performance characteristics... 208 EMC declaration... 209 Device combinations ... 214 Connections to IT networks... 215 Illustrations ... 216 Annex ... 218 Form for daily checkout and pre-use checkout 219 6

Instructions for use Fabius plus SW 3.n

For your safety and that of your patients

For your safety and that of your patients General safety information ...

8

Strictly follow these instructions for use... Maintenance ... Safety checks ... Accessories ... Connected devices ... No operation in potentially explosive areas ... Safe coupling with electrical equipment ... Patient safety... Patient monitoring... Information on electromagnetic compatibility .. Installing accessories ... Keeping the instructions for use ... Training...

8 8 8 9 9 9 10 10 10 11 11 11 11

Product-specific safety information ... 12

Instructions for use Fabius plus SW 3.n

7

For your safety and that of your patients

General safety information The following WARNING and CAUTION statements apply to general operation of the medical device. WARNING and CAUTION statements specific to its subsystems or particular features appear in the respective sections of these instructions for use or in the instructions for use of any other product being used with this device.

Strictly follow these instructions for use WARNING Risk of incorrect operation and incorrect use Any use of the medical device requires full understanding and strict observation of all sections of these instructions for use. The medical device must only be used for the purpose specified under ''Intended use'' on page 16 and in conjunction with an appropriate patient monitoring system (see page 10). Strictly observe all WARNING and CAUTION statements throughout these instructions for use and all statements on medical device labels.

Maintenance WARNING Risk of medical device failure and patient injury The medical device must be inspected and serviced regularly by service personnel. Repair and complex maintenance carried out on the medical device must be performed by experts. If the above is not complied with, medical device failure and patient injury may occur. Observe chapter ''Maintenance''. Dräger recommends DrägerService for a service contract and for repairs. Dräger also recommends using original Dräger parts for maintenance.

Safety checks The medical device must be subject to regular safety checks. See chapter ''Maintenance''.

Failure to observe these safety information statements constitutes a use of the medical device that is inconsistent with its intended use.

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Instructions for use Fabius plus SW 3.n

For your safety and that of your patients

Accessories

Connected devices

WARNING

WARNING

Risk due to incompatible accessories

Risk of electric shock and device malfunction

Dräger has only tested the compatibility of accessories that appear in the current list of accessories or in separate declarations by Dräger. If other, incompatible accessories are used, there is a risk of patient injury due to medical device failure.

Any connected devices or device combinations not complying with the requirements in these instructions for use may compromise correct functioning of the medical device.

Dräger recommends using the medical device only with accessories from the current list of accessories.

Before using the medical device, refer to and strictly comply with the instructions for use of all connected devices and device combinations.

WARNING

WARNING

Risk of operating errors and incorrect use

Risk of device malfunction

Strictly observe the instructions for use of all accessory parts, e.g.,: – Water traps – Flow sensors – CLIC adapter – CLIC absorber – Soda lime – Breathing hoses – Masks – Filter – Endotracheal suction – Vaporizer – Manual resuscitator – AGSS terminal unit

This medical device can be operated in combination with other Dräger devices or with devices from other manufacturers. If a device combination is not approved by Dräger, the safety and the functional state of the individual devices can be compromised. – The operating organization must ensure that the device combination complies with the applicable editions of the relevant standards for medical devices. – Strictly observe the assembly instructions and instructions for use of each connected device.

No operation in potentially explosive areas WARNING Risk of explosion and fire This medical device is neither approved nor certified for use in areas where oxygen concentrations greater than 25 Vol%, combustible or explosive gas mixtures are likely to occur.

Instructions for use Fabius plus SW 3.n

9

For your safety and that of your patients

Safe coupling with electrical equipment CAUTION Risk of patient injury Coupling with electrical equipment that is not mentioned in these instructions for use or assembly instructions may only be done with the respective device manufacturer.

Patient safety The design of the medical device, the accompanying documentation, and the labeling on the medical device are based on the assumption that the purchase and the use of the medical device are restricted to users, and that certain inherent characteristics of the medical device are known to the user. Instructions and WARNING and CAUTION statements are therefore largely limited to the specifics of the Dräger medical device.

Patient monitoring The user of the medical device is responsible for choosing suitable monitoring that provides appropriate information about medical device performance and the patient's condition. Patient safety may be achieved by a wide variety of means ranging from electronic surveillance of medical device performance and patient condition to simple, direct observation of clinical signs. The responsibility for selecting the best level of patient monitoring lies solely with the user of the medical device.

These instructions for use do not contain references to various hazards which are obvious to users who operate this medical device as well as references to the consequences of medical device misuse, and to potentially adverse effects in patients with different underlying diseases. Medical device modification or misuse can be dangerous. CAUTION Risk of patient injury Do not make therapeutic decisions based solely on individual measured values and monitoring parameters.

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Instructions for use Fabius plus SW 3.n

For your safety and that of your patients

Information on electromagnetic compatibility General information on electromagnetic compatibility (EMC) according to the international EMC standard IEC 60601-1-2: Medical electric equipment is subject to special precautionary measures concerning electromagnetic compatibility (EMC) and must be installed and put into operation in accordance with the EMC information provided (see page 190). Portable and mobile RF communications equipment can affect medical electrical equipment. WARNING Risk of electric shock Do not connect connectors with an ESD warning symbol and do not touch the pins of such connectors without implementing ESD protective measures. Such protective measures may include antistatic clothing and shoes, touching a potential equalization pin before and during connection of the pins, or using electrically insulating and antistatic gloves. All relevant users must be instructed in these ESD protective measures.

WARNING Risk of electric shock The connection of devices to auxiliary power sockets can lead to an increased leakage current. If the protective ground of one of these devices fails, the leakage current may rise above the permissible values. – Only connect with the approval of the respective device manufacturer. – Have the leakage current checked by service personnel. – If the permissible value is exceeded, use a mains power socket on a wall instead of the auxiliary power socket of the device.

Installing accessories CAUTION Risk of device failure Install the accessory on the basic device in accordance with the instructions of the basic device. Check for secure connection to the basic device. Stricly observe the instructions for use and assembly instructions.

WARNING Risk of device failure Electromagnetic fields, e.g., those generated by radio frequency communication equipment such as mobile phones, highfrequency electrical surgery equipment, defibrillators or shortwave therapy devices can disrupt the function of the medical device. Only operate radio frequency devices at a sufficient safety clearance of at least 20 cm (7.9 in).

Keeping the instructions for use CAUTION Risk of incorrect use The instructions for use must be kept in an accessible location for users.

Training User training is offered by the responsible Dräger organization, see www.draeger.com.

Instructions for use Fabius plus SW 3.n

11

For your safety and that of your patients

Product-specific safety information WARNING

WARNING

Risk of misinterpretation

Risk of patient injury

Misinterpretation of measured values or other parameters or misdiagnosis can endanger the patient.

Conductive breathing hoses or face masks can cause burns during HF surgery.

Every user has the obligation to assess independently which components are required corresponding to the specific prerequisites for the anesthesia workstation. In accordance with the general safety standards for anesthesia systems, additional monitoring of the concentrations of CO2 and anesthetic agent is required when operating the device. To guarantee patient safety, however, the following components must always be used: – O2 monitor – Pressure monitor – Volume monitor

Do not use this type of hose and mask combined with HF surgery.

WARNING

Do not make therapeutic decisions based solely on individual measured values and monitoring parameters. Therapeutic decisions must be made solely by the user. WARNING Risk of burns

WARNING Risk of malfunction Device failure or user error can compromise the correct functioning of the device. The medical device does not react automatically to certain changes in the patient condition, operating errors, or failure of components. Continuously monitor the medical device so that corrective measures can be initiated immediately. WARNING

Risk of malfunction Unallowed modifications to the medical device lead to malfunctions. This medical device may not be changed without permission from Dräger. WARNING Risk of accidental movement of the medical device During operation the medical device can move accidentally. Activate the castor brakes.

Risk of device failure The device can fail if the power supply is interrupted. Always connect the device on an uninterruptible power supply.

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Instructions for use Fabius plus SW 3.n

For your safety and that of your patients

WARNING

WARNING

Risk of tipping over during transport

Risk due to failure of flow measurement

The medical device may tip over if handled incorrectly. Observe the following points when transporting medical devices: – The medical device may only be moved by people who have the physical ability to do so. – To improve the maneuverability, transport the device with 2 persons. – When transporting over inclines, around corners, or over thresholds (e.g., through doors or in elevators), make sure that the medical device does not bump against anything. – Remove any devices mounted to the holding arms or the top of the device. – Clear the writing tray and fold it down completely or slide it into the device. – Do not pull the medical device over hoses, cables, or other obstacles lying on the floor. – Do not activate the brake while the medical device is being moved. – Always use the handles on the device to push or pull it.

Deposits that were not removed during reprocessing can damage the measuring wires in the flow sensor or cause a fire. – Before inserting the flow sensor check for visible damage, soiling, and particles. Repeat this check regularly. – Replace flow sensors when damaged, soiled, or not particle-free.

WARNING

Risk of injury to the lungs

Risk of fire

Endotracheal suction can cause negative pressure in the lungs. This pressure can injure the lungs.

The flow sensor can ignite medications or other substances that are easily flammable. – Do not nebulize medications or other substances that are easily flammable or spray them into the device. – Do not use substances containing alcohol. – Do not allow combustible or explosive substances to enter the breathing system or breathing circuit. – Do not use cyclopropane or ether.

Instructions for use Fabius plus SW 3.n

WARNING Risk of insufficient ventilation Device failure or operating errors can lead to ventilation failure. – To ensure immediate remedial action in case of device failure, only operate the device under permanent supervision of users. – The general safety standards for anesthesia systems require that a manual resuscitator be kept at the ready for emergency ventilation. WARNING

Be careful during suction. WARNING Risk of not hearing the alarm tone Dräger recommends that the user remain in the vicinity of the anesthesia machine, i.e., within a distance of up to four meters (12 feet). This facilitates fast recognition and response in the event of an alarm.

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For your safety and that of your patients

WARNING

WARNING

Risk of crushing

Risk of electric shock

If the writing tray is not correctly locked in place, objects can fall down or fingers and breathing hoses, for example, can be pinched.

This device is only intended for use in rooms in which the power lines correspond to the national applicable safety standards for patient's rooms in hospitals. Observe the following points to avoid electric shock: – The covers of the components must not be removed. – Maintenance work must only be performed by DrägerService. Use only grounded electrical connections and power cables that meet hospital standards. – Before connecting the medical device, make sure that external devices are grounded to meet the hospital standard (in accordance with national applicable regulations). – Before cleaning work or maintenance work is performed, disconnect all plugs for the power supply. – If the medical device has come in contact with liquids, let it dry completely before it is reconnected to the power supply. – Check that the power cable is securely clamped to the power inlet. – Only connect additional devices if they have been approved by Dräger.

Make sure that the writing tray is correctly locked when folding down or sliding into the device. WARNING Risk of crushing Movable device parts or attached components may cause crushing due to clamping. Pay special attention to edges, movable parts, and corners when working with the following components: – Breathing system cover – Drawers – Extensible writing tray – Swivel arms for mounted devices – Accessories such as gas cylinders, vaporizers, CLIC absorber, and CLIC adapter

WARNING Risk of device failures If the anesthesia workstation is used in a tipped position, parts can be damaged or their function can be comprised. Do not use the anesthesia workstation at an inclination over 1°. NOTE The device software of Fabius must be installed by experts. Dräger recommends having the software installation performed by DrägerService.

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Instructions for use Fabius plus SW 3.n

Application

Application Intended use ... 16 Indications/Contraindications ... 17 Indications ... 17 Contraindications... 17 Further information on application... 18 Environment of use... 18 The MEDIBUS and Vitalink protocols ... 19

Instructions for use Fabius plus SW 3.n

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Application

Intended use The Fabius anesthesia workstation for inhalational anesthesia is appropriate for use in operating rooms, induction rooms, and recovery rooms. Fabius is equipped with an electrically driven and electronically controlled ventilator. The following parameters are monitored: –

Airway pressure (PAW),

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Tidal volume (VT)

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Inspiratory oxygen concentration (FiO2)

Anesthesia is achieved through a mixture of pure oxygen and Air (medical compressed air) or pure oxygen and nitrous oxide, with the addition of volatile anesthetic agents. A Dräger anesthetic vaporizer is used to enrich the fresh gas with volatile anesthetic agents. The gas supply is done via a central gas supply system or via externally connected gas cylinders. Fabius is equipped with a compact breathing system that offers fresh gas decoupling, PEEP, and pressure limitation.

WARNING Risk of patient injury In accordance with the general safety standards for anesthesia systems, additional monitoring of the concentrations of CO2 and anesthetic agent is required. WARNING Risk of insufficient ventilation Device failure or operating errors can lead to ventilation failure. – To ensure immediate remedial action in case of device failure, only operate the device under permanent supervision of users. – The general safety standards for anesthesia systems require that a manual resuscitator be kept at the ready for emergency ventilation.

The following ventilation modes are available:

WARNING

–

Volume Control (volume-controlled ventilation)

Risk due to malignant hyperthermia

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Pressure Control* (pressure-controlled ventilation)

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Pressure Support* (pressure-supported ventilation)

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SIMV/PS* (synchronized intermittent ventilation with pressure support)

For patients suspected of suffering from malignant hyperthermia: Do not use any volatile anesthetic agent or Fabius with residual concentrations of these gases above 5 ppm.

–

ManSpont (manual ventilation/spontaneous breathing)

WARNING

Volatile anesthetic agents may cause malignant hyperthermia.

Risk due to the accumulation of acetone in the patient Do not perform low-flow anesthesia on patients with ketoacidosis or patients under the influence of alcohol. The risk of accumulation of acetone in the patient increases in such cases. *

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optional

Instructions for use Fabius plus SW 3.n

Application

NOTE

NOTE

CO2 values and anesthetic gas values can be monitored if the Fabius is combined with a gas monitor (e.g., Vamos) or a gas analyzer (e.g., Scio with Dräger patient monitor).

O2 monitoring can be deactivated on site by an authorized service partner. More information can be found in chapter ''Deactivating the O2 monitoring'' on page 125. If O2 monitoring is deactivated, use external O2 monitoring.

Indications/Contraindications

Indications Fabius is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions.

Contraindications The device has no product-specific contraindications. It is the responsibility of the user to select the appropriate treatment for the patient's underlying disease. Patient status must be continuously monitored for potential changes. NOTE Fabius applies medical gases such as O2, N2O, or volatile anesthetic agents. For contraindications to the applied medical gases, strictly observe the instructions for use of the medical gas.

Instructions for use Fabius plus SW 3.n

17

Application

Further information on application

Environment of use Fabius is designed for use in rooms in which therapeutic or diagnostic interventions can be carried out. WARNING Risk of explosion This medical device is neither approved nor certified for use in areas where oxygen concentrations greater than 25 Vol%, combustible or explosive gas mixtures are likely to occur. WARNING Risk of device malfunctions and/or patient injury and user injury Magnetic fields can negatively influence the correct functioning of the medical device and therefore endanger the patient or user. Do not use the medical device near magnetic resonance imagers. WARNING Do not use soda lime based on potassium hydroxide. Otherwise, there is a risk of CO formation. Do not use Fabius in the following environments: –

Outside of massive buildings

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In intensive care units

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During patient transport

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In vehicles, airplanes, or helicopters

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Instructions for use Fabius plus SW 3.n

Application

The MEDIBUS and Vitalink protocols MEDIBUS and Vitalink are software protocols for the transfer of data between Fabius and an external medical or non-medical product (e.g., hemodynamic monitors, data management systems, or Windows-based computers) via an RS232 interface (see instructions for use 9038530, 3rd edition or higher). WARNING Risk of patient injury All data transferred via the MEDIBUS interface are for information only and must not be used as the sole basis for diagnostic or therapeutic decisions. The data accessible via this interface are not intended for use with a distributed alarm system in accordance with IEC 60601-1-8:2012 (in the sense of remote monitoring). WARNING For the protection of patients and users from electrical risk, it is required that all systems that consist of medical devices and other electrical devices, such as computers, printers, etc., are assembled exclusively by trained personnel. The system must meet the requirements of standards IEC 60601-1-1 and IEC 60601-1-2, or of IEC 60601-1:2005 for medical electrical equipment.

Instructions for use Fabius plus SW 3.n

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Overview

Overview Fabius plus as trolley version (front view) .

21

Compact breathing system COSY (top view) ...

22

Power supply unit for COSY heating (front view) ...

23

Power supply unit for COSY heating (rear view) ...

24

Rear view...

25

Pin-index connection ... 25 Screw connections ... 26 Interface panel ...

27

Vaporizer ...

28

Ceiling-mounted version (optional)...

29

Wall-mounted version (optional) ...

30

Supplemental O2 delivery (optional) ...

31

Functional check of the supplemental O2 delivery ...

31

APL valve ...

32

Interfaces ...

33

Recommended device configuration ...

33

External fresh-gas outlet ...

34

Using the external fresh-gas outlet as a common gas outlet ... 35 Use of the external fresh-gas outlet with an additional switch ... 35 Abbreviations ...

36

Symbols ...

38

Product labels...

40

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Instructions for use Fabius plus SW 3.n