Dräger Fabius GS premium Instructions For Use Manual
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Dräger Fabius GS premium Instructions For Use Manual

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Instructions for use
Fabius GS premium
WARNING
To properly use this medical device,
read and comply with these
instructions for use.
Anesthesia workstation
Software 3.n

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Summary of Contents for Dräger Fabius GS premium

  • Page 1 Instructions for use Fabius GS premium Anesthesia workstation WARNING Software 3.n To properly use this medical device, read and comply with these instructions for use.
  • Page 2 Use of terms Consecutive numbers indicate steps of action, with the numbering restarting with "1" for each – The product Fabius GS premium is also new sequence of actions. referred to as Fabius.  Bullet points indicate individual actions or dif- –...
  • Page 3 Users Experts must have the necessary knowledge and experience with complex maintenance work on the Users are persons who use the product in product. accordance with its intended use. Instructions for use Fabius GS premium SW 3.n...
  • Page 4 Abbreviations and symbols Explanations can be found in the sections ''Abbreviations'' and ''Symbols'' in chapter ''Symbols''. Instructions for use Fabius GS premium SW 3.n...

  • Page 5: Table Of Contents

    Ensuring the gas supply ........61 Locating and remedying leakages....151 Assembling the breathing system....62 Power supply failure ........153 Connecting the sensors and measurement Ventilator failure ..........155 lines ..............78 Instructions for use Fabius GS premium SW 3.n...
  • Page 6 Device outlets..........202 Essential performance characteristics..... 203 EMC declaration..........204 Device combinations ........208 Connections to IT networks......209 Illustrations ............210 Annex ............. 211 Form for daily checkout and pre-use checkout 212 Instructions for use Fabius GS premium SW 3.n...
  • Page 7 Safe coupling with electrical equipment ..10 Patient safety........... 10 Patient monitoring..........10 Information on electromagnetic compatibility .. 11 Installing accessories ........11 Keeping the instructions for use ...... 11 Training............11 Product-specific safety information .... 12 Instructions for use Fabius GS premium SW 3.n...

  • Page 8: For Your Safety And That Of Your Patients

    Dräger. If other, incompatible accessories are used, there is a risk of patient injury due to medical device failure. Dräger recommends using the medical device only with accessories from the current list of accessories. Instructions for use Fabius GS premium SW 3.n...

  • Page 9: Connected Devices

    Before using the medical device, refer to and strictly comply with the instructions for use of all connected devices and device combinations. Instructions for use Fabius GS premium SW 3.n...

  • Page 10: Safe Coupling With Electrical Equipment

    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. Instructions for use Fabius GS premium SW 3.n...

  • Page 11: Information On Electromagnetic Compatibility

    Only operate radio frequency devices at a Training sufficient safety clearance of at least 20 cm (7.9 in). User training is offered by the responsible Dräger organization, see www.draeger.com. Instructions for use Fabius GS premium SW 3.n...

  • Page 12: Product-Specific Safety Information

    During operation the medical device can move accidentally. WARNING 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. Instructions for use Fabius GS premium SW 3.n...
  • Page 13 (12 – Do not use cyclopropane or ether. feet). This facilitates fast recognition and response in the event of an alarm. Instructions for use Fabius GS premium SW 3.n...
  • Page 14 Do not use the anesthesia workstation at an inclination angle over 5°. NOTE The device software of Fabius must be installed by experts. Dräger recommends having the software installation performed by DrägerService. Instructions for use Fabius GS premium SW 3.n...

  • Page 15: Application

    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 GS premium SW 3.n...

  • Page 16: Intended Use

    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. optional Instructions for use Fabius GS premium SW 3.n...

  • Page 17: Indications/Contraindications

    Patient status must be continuously monitored for potential changes. NOTE Fabius applies medical gases such as O 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 GS premium SW 3.n...

  • Page 18: Further Information On Application

    Otherwise, there is a risk of CO formation. Do not use Fabius in the following environments: – Outside of massive buildings – In intensive care units – During patient transport – In vehicles, airplanes, or helicopters Instructions for use Fabius GS premium SW 3.n...

  • Page 19: The Medibus And Vitalink Protocols

    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 GS premium SW 3.n...

  • Page 20: Overview

    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 Instructions for use Fabius GS premium SW 3.n...

  • Page 21: Fabius Gs Premium (Front View)

    F Fresh-gas delivery N Compact breathing system (COSY) G Pressure gauges for gas cylinders (O , Air, or flush P Ventilator H Writing tray Q Supplemental O delivery for O insufflation* optional Instructions for use Fabius GS premium SW 3.n...

  • Page 22: Compact Breathing System Cosy (Top View)

    The optional cover for the compact breathing G Connection for breathing bag system is not shown in the graphic. H Inspiratory port Inspiratory valve J Fresh gas decoupling valve K Connection for APL bypass valve optional Instructions for use Fabius GS premium SW 3.n...

  • Page 23: Power Supply Unit For Cosy Heating (Front View)

    Overview Power supply unit for COSY heating (front view) A LED indicator for COSY heating B On/Off switch C Fuse Instructions for use Fabius GS premium SW 3.n...

  • Page 24: Power Supply Unit For Cosy Heating (Rear View)

    Overview Power supply unit for COSY heating (rear view) A Power inlet B LED indicator for power supply C Cable clamp Instructions for use Fabius GS premium SW 3.n...

  • Page 25: Rear View

    J Connections for central supply hoses B Interface panel C Connection for ventilator hose D On/Off switch E Fuse F Compact breathing system (COSY) G Potential equalization pin H Gas cylinder Pin-index connection optional Instructions for use Fabius GS premium SW 3.n...

  • Page 26: Screw Connections

    100 (bar) A Connections for central supply hoses B Connections for compressed gas hoses for gas cylinders with O and N O, or O and Air (screw connections) C Gas cylinders optional Instructions for use Fabius GS premium SW 3.n...

  • Page 27: Interface Panel

    J Connection for PEEP hose C Connection for APL hose D Socket for O sensor E Socket for airway pressure sensor F Socket for flow sensor G On/Off switch H Fuse optional Instructions for use Fabius GS premium SW 3.n...

  • Page 28: Vaporizer

    Dräger recommends using only anesthetic vaporizers that are listed in the list of accessories. More information can be found in the respective instructions for use of the anesthetic vaporizers used. Instructions for use Fabius GS premium SW 3.n...

  • Page 29: Supplemental O

    O delivery must be completely closed:  Turn the flow control valve (A) clockwise to the final position stop. ASTM F1850-22(2005) §76 Instructions for use Fabius GS premium SW 3.n...

  • Page 30: Apl Valve

    ManSpont mode or is bypassed. Different settings can be made on the APL valve adjustment knob: – Change between manual ventilation (Man) and spontaneous breathing (Spont) – Setting of the maximum airway pressure for manual ventilation Instructions for use Fabius GS premium SW 3.n...

  • Page 31: Interfaces

    – Only connect with the approval of the respective device manufacturer. – Have the leakage current checked by service personnel. – If the permissible value is exceeded, disconnect the devices from the MEDIBUS interface. optional Instructions for use Fabius GS premium SW 3.n...

  • Page 32: Recommended Device Configuration

    2 Connect the gas analyzer to connection COM 1 or COM 2 (A). COM 2 (D). Configuration 2 – Fabius – Multiparameter monitor with a COM connection 1 Connect monitor to COM 1 (B). optional Instructions for use Fabius GS premium SW 3.n...
  • Page 33 – Automatic anesthesia protocol system 1 Connect monitor (I) to the anesthesia protocol system. 2 Connect the anesthesia protocol system to COM 1 (J). 3 Connect monitor to COM 2 (K). optional Instructions for use Fabius GS premium SW 3.n...

  • Page 34: External Fresh-Gas Outlet

    When using the external fresh-gas outlet, change into the Standby mode. Instructions for use Fabius GS premium SW 3.n...

  • Page 35: Using The External Fresh-Gas Outlet As A

    B Long fresh-gas hose (on Fabius) E Sample line C Short fresh-gas hose (on compact breathing F Non-rebreathing system (e.g., Bain) system) D Compact breathing system E Sample line F Non-rebreathing system (e.g., Bain) optional Instructions for use Fabius GS premium SW 3.n...

  • Page 36: Abbreviations

    PLAT Plateau pressure Freq Min Mandatory minimal respiratory rate in Pressure Support mode PMAX Pressure limitation pounds per square inch High-frequency SIMV Synchronized Intermittent Man- Hectopascal datory Ventilation Insp Flow Inspiratory flow Instructions for use Fabius GS premium SW 3.n...
  • Page 37 Trigger UMDNS Universal Medical Device Nomenclature System, nomen- clature for medical devices Universal Serial Bus, computer interface Tidal volume ∆PPS Differential pressure of the pres- sure support in Pressure Sup- port mode Instructions for use Fabius GS premium SW 3.n...

  • Page 38: Symbols

    Read the flow at the center of the float. Serial number Order number Non-rebreathing system Instructions for use Fabius GS premium SW 3.n...
  • Page 39 Socket for O sensor Socket for flow sensor Socket for airway pressure sen- Ventilator connection Fuse Do not oil! Close menu Key for access to alarm limits Key to call up main screen Instructions for use Fabius GS premium SW 3.n...

  • Page 40: Product Labels

    Transport instructions, see ''Preparing for storage or transport'' on page 114 Trolley version: Observe the weight of the nominal nom. 134 kg configuration and the total permissible weight, see ''Technical data''. max. 300 kg Instructions for use Fabius GS premium SW 3.n...

  • Page 41: Operating Concept

    Monitoring resolutions for fresh-gas flow..49 LED indicators ..........50 LEDs for operating status ........ 50 LEDs for alarm status ........50 Color coding for anesthetic agents and medical gases ..........51 Screen colors (optional) ....... 51 Instructions for use Fabius GS premium SW 3.n...

  • Page 42: Control Panel

    The alarm tone of all active alarms is sup- Opens the window with alarm limits. pressed for 2 minutes. Switches to Standby mode. Monitoring is switched off and the ventilator stops. optional Instructions for use Fabius GS premium SW 3.n...

  • Page 43: Softkeys

    Example for Volume Control mode: – PMAX – VT – Freq – TI:TE – TIP:TI – PEEP More information can be found in chapter ''Configuration in standby mode'' on page 128. Instructions for use Fabius GS premium SW 3.n...

  • Page 44: Screen Display

    – Status of the desflurane compensation percent (%) as well as the upper and lower alarm limits – Remaining battery charge – Current time for Japan and China maximum 3 alarm messages Instructions for use Fabius GS premium SW 3.n...
  • Page 45 – Mean airway pressure (MEAN) – Plateau pressure (PLAT) – Peak pressure (PEAK) F Pressure waveform for airway pressure G Softkeys (labeling depending on ventilation mode) H Virtual flow tubes for O , Air, N Instructions for use Fabius GS premium SW 3.n...

  • Page 46: Selecting And Setting

    – A message with further instructions (B) is displayed. 2 Confirm the ventilation mode. – The LED in the key is continuously lit up. – The pressure waveform is displayed again. Instructions for use Fabius GS premium SW 3.n...

  • Page 47: Selecting And Setting The Ventilation Parameters

    – The pressure waveform (A) is replaced by a dialog window with ventilation settings (C). – The key (D) is highlighted. Volume Control 2 Select new value and confirm. – The pressure waveform is displayed again. Instructions for use Fabius GS premium SW 3.n...

  • Page 48: Fresh-Gas Delivery (Version For 3 Gases)

    The electronic fresh-gas flow displays have an F Air flow control valve altitude adjustment. flow control valve H Pressure gauge for the central N O supply Use only with Pin-index connections (not with screw connections) Instructions for use Fabius GS premium SW 3.n...

  • Page 49: Total Flow Tube

    Fabius can be configured for the following 9.00 L/min, the high resolution is activated. resolutions of fresh-gas flow by DrägerService or the authorized local service partner: – Standard resolution (A) – High resolution (B) Instructions for use Fabius GS premium SW 3.n...

  • Page 50: Led Indicators

    (C) have small LEDs that – Yellow LED (B) flashing: signals caution light up when the respective mode is active. – Yellow LED (B) is lighted continuously: signals a note Instructions for use Fabius GS premium SW 3.n...

  • Page 51: Color Coding For Anesthetic Agents And Medical Gases

    – Virtual flow tubes (setting according to country- specific gas color codes) – Screen background (bright/dark) The screen elements are only displayed in color if the option "Color display" is activated. Instructions for use Fabius GS premium SW 3.n...

  • Page 52: Assembly And Preparation

    Connection of the pressure gauge for measurement of the airway pressure (optional) ................ 79 Connecting the flow sensor ......79 Connecting the APL bypass hose and PEEP/P hose ..........80 Fastening the manual resuscitator ....81 Instructions for use Fabius GS premium SW 3.n...

  • Page 53: Before First Operation

    1 Remove the packaging of the battery fuse. 2 Remove the fuse holder. 3 Insert fuse (A) in the fuse holder. 4 Screw the fuse holder in securely with a quarter turn clockwise. Instructions for use Fabius GS premium SW 3.n...

  • Page 54: Connecting The Mains Power Supply

    The mains plug must be freely accessible so that the power supply to Fabius can be quickly interrupted in the event of device failure. 1 Connect the power cable with the device. Instructions for use Fabius GS premium SW 3.n...

  • Page 55: Auxiliary Power Sockets

    If the good condition of the protective ground or its correct connection with the medical device cannot be ensured, the device must be operated via the internal power supply (battery). Instructions for use Fabius GS premium SW 3.n...

  • Page 56: Connecting The Gas Supply

    (A) on the device side. 2 Plug the probes of the central gas supply hoses in the appropriate wall terminal units (B). 3 Check if all central gas supply hoses are correctly connected. Instructions for use Fabius GS premium SW 3.n...

  • Page 57: Gas Cylinders With Pin-Index System (Optional)

    Leave gas cylinders as a backup at the anesthesia workstation, even if there is a connection to the central gas supply. NOTE Leaky and stiff gas cylinder valves must be repaired according to manufacturer's specifications. Instructions for use Fabius GS premium SW 3.n...
  • Page 58 In this case, the connection is leaking. The gas cylinder must be mounted again. If the gas cylinder is removed, insert the plug (H) in 2 Close the cylinder valves again. the mounted gas cylinder holder and tighten. Instructions for use Fabius GS premium SW 3.n...

  • Page 59: Gas Cylinders With Screw Connections (Optional)

    Have service personnel repair any leaky or stiff gas cylinder valves. NOTE Keep gas cylinders closed as long as they are not being used. There is the risk of accidental emptying of the gas cylinders. Instructions for use Fabius GS premium SW 3.n...

  • Page 60: Mounting The Anesthetic Vaporizers

    – Make sure that the vaporizers are mounted levelly. – When using D-Vapor vaporizers, make sure that the power cable is not pinched. – After mounting the vaporizers, perform a leakage test. Instructions for use Fabius GS premium SW 3.n...

  • Page 61: Ensuring The Gas Supply

    6 Connect the probe of the scavenging hose (C) to the terminal unit of the anesthetic gas scavenging system. Observe the associated instructions for use of the AGSS terminal unit. Instructions for use Fabius GS premium SW 3.n...

  • Page 62: Assembling The Breathing System

    – Pressure sensor in the ventilator chamber Only disinfected and sterilized components must be used. 1 Open the ventilator door (A) with the attached ventilator unit. 2 Release the 3 clamps (B). 3 Remove the cover (D). Instructions for use Fabius GS premium SW 3.n...

  • Page 63: Mounting The Co 2 Absorber To The Compact Breathing System

    Otherwise, there is a risk of CO formation. 1 Turn the CO absorber (A) clockwise and remove it from below. 2 Remove and dispose of the soda lime dust filter (B). optional Instructions for use Fabius GS premium SW 3.n...
  • Page 64 Dräger recommends the use of 4 Place the CO absorber (F) below the compact Drägersorb 800 Plus or Drägersorb FREE. breathing system in position and turn counterclockwise to the final position stop. optional Instructions for use Fabius GS premium SW 3.n...
  • Page 65 Fabius is switched on. This ensures that the absorber is included into the leakage test and compliance test of the device. After mounting and replacing, make sure the absorber is firmly locked into place. Instructions for use Fabius GS premium SW 3.n...

  • Page 66: Mounting The Cosy Heating And The Power Supply Unit (Optional)

    When doing so align the red mark of the plug to the red mark of the socket.  After installation of the breathing system heating, perform the leakage test on Fabius. Instructions for use Fabius GS premium SW 3.n...

  • Page 67: Connecting The Compact Breathing System

    Only hand-tighten the screw connection. Do not use tools. 4 Connect the fresh-gas hose (C) to the corresponding connection of the compact breathing system. Instructions for use Fabius GS premium SW 3.n...

  • Page 68: Inserting The Flow Sensor

    1 Screw out the expiratory port (A). 2 Remove the flow-sensor guard (B). 3 Insert the flow sensor (C). 4 Replace the flow-sensor guard* (B). 5 Screw the expiratory port (C) back on. optional Instructions for use Fabius GS premium SW 3.n...

  • Page 69: Connecting The Breathing Bag

    4 Fasten the breathing bag (C) on the other end breathing system with the following variants: of the elbow. – On a flexible arm – On a rigid arm – On the bag elbow directly on the compact breathing system Instructions for use Fabius GS premium SW 3.n...
  • Page 70 2 Tighten the knurled screws (B). Check that the arm is fixed securely. 3 Fasten the breathing bag (C) at the other end of the rigid arm. Instructions for use Fabius GS premium SW 3.n...

  • Page 71: Connecting The Endotracheal Suction System (Optional)

    2 The suction bottle (D) is attached to a separate holder. WARNING Risk of patient injury Only use the suction system if the ventilation mode ManSpont is active or the patient is disconnected from the Y-piece. Instructions for use Fabius GS premium SW 3.n...

  • Page 72: Connecting The Breathing Hoses And The Filters

    Check the breathing hoses If no microbial filter is used, the breathing for damage before each use. system may become contaminated with disease-causing germs. In this case, hygienically reprocess the breathing system after each patient. Instructions for use Fabius GS premium SW 3.n...
  • Page 73 NOTE When applying tidal volumes in the range of the maximum or minimum values indicated for each patient category, use the smaller breathing bag and the smaller breathing circuit. Instructions for use Fabius GS premium SW 3.n...
  • Page 74 Y-piece (B) and to the connector of the water trap (E) on the patient-gas measurement module. 5 Connect the breathing bag hose (C) with the breathing bag to the corresponding connector. Instructions for use Fabius GS premium SW 3.n...
  • Page 75 CO measure- line at Y-piece: ment and help to flush the dead- space between Y-piece and hose adapter. The resistance of the breathing system and connected accessories must be observed. Instructions for use Fabius GS premium SW 3.n...
  • Page 76 If necessary, take additional parts such as water traps or additional hoses in consideration. Instructions for use Fabius GS premium SW 3.n...

  • Page 77: Inserting A New O 2 Sensor Capsule

    22. If the O sensor is replaced during operation, it can lead to transferring of leakage current. Do not touch the patient. Instructions for use Fabius GS premium SW 3.n...

  • Page 78: Connecting The Sensors And Measurement Lines

    2 Connect the other end of the pressure measurement hose to the bacterial filter (B). 3 Plug in the bacterial filter into the connection (C) marked with on the rear of the device. Instructions for use Fabius GS premium SW 3.n...

  • Page 79: Connection Of The Pressure Gauge For Measurement Of The Airway Pressure (Optional)

    2 Plug in the other end of the flow sensor cable (D) marked with on the rear of the device. into the connection (B) marked with on the rear of the device. Instructions for use Fabius GS premium SW 3.n...

  • Page 80: Connecting The Apl Bypass Hose And Peep/Pmax Hose

    4 Connect the other end of the hose on the connection marked with PEEP (B) to the rear of the device. NOTE The APL bypass hose is thicker than the PEEP/P hose. Instructions for use Fabius GS premium SW 3.n...

  • Page 81: Fastening The Manual Resuscitator

    Fastening the manual resuscitator 1 Hang the completely prepared and functionally checked manual resuscitator (A) to the right on the transport rail. For wall-mounted devices, the transport rail is located on the holder. Instructions for use Fabius GS premium SW 3.n...

  • Page 82: Fitting The Cosy Cover

    Assembly and preparation Fitting the COSY cover 1 Fit the COSY cover to the breathing system, taking care that all cables are passed through the openings provided. optional Instructions for use Fabius GS premium SW 3.n...

  • Page 83: Instructions For Mounting The Accessories

     Dismount any additional devices mounted to the swivel arms or the top of the device (e.g., patient monitors, data management systems, syringe pumps).  Clear the writing tray and slide it completely into the device. Instructions for use Fabius GS premium SW 3.n...

  • Page 84: Getting Started

    Getting started Getting started Daily checkout and pre-use checkout ..85 Switching on ..........86 Checking the readiness for operation ..87 FUNCTIONAL ..........87 CONDITIONALLY FUNCTIONAL ....87 NON-FUNCTIONAL ........87 Instructions for use Fabius GS premium SW 3.n...

  • Page 85: Daily Checkout And Pre-Use Checkout

    Risk of device malfunction Some safety systems are only checked during start-up. – A selftest should be performed once daily. – Switch the Fabius on and off or press the softkey Run System Test. Instructions for use Fabius GS premium SW 3.n...

  • Page 86: Switching On

    Activate the castor brakes. If no tone or only one tone is sounded, the device is only conditionally ready for operation. Contact DrägerService.  Set On/Off switch (A) to the position. Instructions for use Fabius GS premium SW 3.n...

  • Page 87: Checking The Readiness For Operation

    – To open the page Standby, press the rotary knob. – Check if an alarm message is displayed. – Contact DrägerService or the authorized local service partner. Instructions for use Fabius GS premium SW 3.n...

  • Page 88: Operation

    Using the external fresh-gas outlet with an auxiliary switch (optional) ......111 Preparation............111 Operation with non-rebreathing system ..112 Operation with the compact breathing system (COSY)............112 Ending operation ..........112 Ending operation........... 113 Instructions for use Fabius GS premium SW 3.n...

  • Page 89: Standby Page After Start-Up

    0% and 75%. When a lack of O is present, the S-ORC limits the O concentration in the fresh gas so that the O concentration will not fall below 23 Vol%. Instructions for use Fabius GS premium SW 3.n...
  • Page 90 This can lead to material damage and contamination of the ambient air with anesthetic gases. Never cut off the fresh-gas flow before the vaporizer is switched off. Instructions for use Fabius GS premium SW 3.n...

  • Page 91: Setting The Anesthetic Gas Concentration

    After connecting the vaporizer to the anesthesia workstation, always turn the control dial of the vaporizer to position 0 and wait at least 15 seconds to enable a pressure equalization. Instructions for use Fabius GS premium SW 3.n...

  • Page 92: O 2 Flush

    Use of the O flush can increase airway pressure very quickly and abruptly change the gas concentration. NOTE In ManSpont mode, the pressure can increase quickly and thus trigger the APL valve. Instructions for use Fabius GS premium SW 3.n...

  • Page 93: Low-Flow Anesthesia

    There is still air in the lungs of the patient and the breathing system during anesthesia introduction, which contains a fraction of approx. 77 % nitrogen. If the device is used for a low-flow anesthesia, press the key. This removes the nitrogen. Instructions for use Fabius GS premium SW 3.n...

  • Page 94: Replacing The Soda Lime

    – Do not use unnecessarily high fresh-gas flows. – Only use the supplemental O delivery if necessary. – Do not leave the flow control valves open unnecessarily long. Instructions for use Fabius GS premium SW 3.n...

  • Page 95: Ventilation

    3 Press the ManSpont (A) key. 4 Confirm the new mode. Instructions for use Fabius GS premium SW 3.n...
  • Page 96 – Volume Alarms (see chapter ''Volume alarms'' Settings between the grid marks are also on page 124) possible. Volume Control 2 Press the ManSpont (A) key. 3 Confirm the new mode. Instructions for use Fabius GS premium SW 3.n...
  • Page 97 4 To refill the breathing bag, press the key. 5 Set suitable fresh-gas flow. 6 Start manual ventilation with the breathing bag. The pressure is limited to the value that is set on the APL valve. Instructions for use Fabius GS premium SW 3.n...

  • Page 98: Ventilation Mode Volume Control

    Inspiratory 0 to 50 pause time:inspira- tory time TIP:TI PEEP [cmH 0 to 20 ([hPa]) 1 Press the Volume Control (A) key. 2 Adjust ventilation settings (B). 3 Confirm the new mode. Instructions for use Fabius GS premium SW 3.n...
  • Page 99 (disconnection) and continuous pressure. If the pressure waveform does not cross the pressure threshold either from above or below, an alarm is sounded. Instructions for use Fabius GS premium SW 3.n...

  • Page 100: Ventilation Mode Pressure Control (Optional)

    3 Confirm the new mode. PEEP [cmH 0 to 20 ([hPa]) Due to the influence of compliance and resistance, the set value for Freq Min in Pressure Control mode might not exactly be applied. Pressure Control Instructions for use Fabius GS premium SW 3.n...
  • Page 101 (disconnection) and continuous pressure. If the pressure waveform does not cross the pressure threshold either from above or below, an alarm is sounded. Instructions for use Fabius GS premium SW 3.n...

  • Page 102: Ventilation Mode Pressure Support (Optional)

    If 2 successive mechanical breaths occur with apnea ventilation, the alarm message APNOEA VENTILATION !! is displayed in the alarm message field. The alarm message is deleted as soon as a spontaneous breath is detected. Instructions for use Fabius GS premium SW 3.n...
  • Page 103 10 to 85 pressure threshold either from above or below, an Insp Flow alarm is sounded. [L/min] PEEP [cmH 0 to 20 ([hPa]) Trigger Trigger ∆PPS Insp Flow Freq Min Freq Min Instructions for use Fabius GS premium SW 3.n...

  • Page 104: Ventilation Mode Simv/Ps (Optional)

    OFF activates the mode – Insp Flow Pressure Support, see chapter ''Ventilation mode – TINSP Pressure Support (optional)'' on page 102. – TIP:TI 3 Confirm the new mode. SIMV/PS Instructions for use Fabius GS premium SW 3.n...
  • Page 105 TIP:TI [%] detect apnea (disconnection) and continuous pressure. If the pressure waveform does not cross the pressure threshold either from above or below, an alarm is sounded. Instructions for use Fabius GS premium SW 3.n...

  • Page 106: Adopting Ventilation Settings During Mode Change

    – TIP:TI is set to the last used value or the factory setting. – PMAX is set to a value that lies 10 cmH (hPa) above the plateau pressure (PLAT) that occurred in Pressure Control. Instructions for use Fabius GS premium SW 3.n...

  • Page 107: Safety Functions Of The Ventilator

    VT even with extremely low fresh-gas supply. gradual emptying of the breathing bag. There will be no sudden switch-off of the ventilator. NOTE To remedy this, the user must take actions, e.g., increasing the fresh-gas flow. Instructions for use Fabius GS premium SW 3.n...

  • Page 108: Patient Change

    – The current settings remain the same. – The Standby screen is active. – Default settings are activated. 2 Press the Restore Site Defaults key, see chapter ''Restoring the default settings'' on page 135. Instructions for use Fabius GS premium SW 3.n...

  • Page 109: Using The External Fresh-Gas Outlet As A Common Gas Outlet (Optional)

    3 Screw on the sample line (C) to the Luer Lock connector of the ventilation mask or of the breathing system filter and to the water trap on the patient-gas measurement module. Instructions for use Fabius GS premium SW 3.n...

  • Page 110: Operation

    1 Change to Standby mode. 2 Set the fresh-gas flow. To prevent rebreathing, the fresh-gas supply must be at least double the minute volume. 3 Operate the non-rebreathing system according to the corresponding instructions for use. Instructions for use Fabius GS premium SW 3.n...

  • Page 111: Using The External Fresh-Gas Outlet With An Auxiliary Switch (Optional)

    3 If necessary, connect the non-rebreathing system scavenging hose to the second connection (D) of the anesthetic gas receiving system. Observe the instructions for use of the non- rebreathing system and the anesthetic gas receiving system. Instructions for use Fabius GS premium SW 3.n...

  • Page 112: Operation With Non-Rebreathing System

    3 Operate the non-rebreathing system according to the corresponding instructions for use. 1 Close all flow control valves on the device. 2 Screw the sample line back to the Y-piece on the breathing circuit. Instructions for use Fabius GS premium SW 3.n...

  • Page 113: Ending Operation

    4 Close the cylinder valves. NOTE Leave Fabius connected to the mains power supply so that the battery is not discharged 2 Set the control dial (B) of the vaporizer until it engages on 0. Instructions for use Fabius GS premium SW 3.n...

  • Page 114: Preparing For Storage Or Transport

    1 Press the button (A) and confirm. press the key. Monitoring and alarm monitoring are switched off. The ventilator stops. 2 Set the control dial (B) of the vaporizer until it engages on 0. Instructions for use Fabius GS premium SW 3.n...

  • Page 115: Alarms

    Alarms Alarms Alarm signaling..........116 Display of alarms ..........116 Acoustic signal..........116 Alarm priorities..........117 Suppressing the alarm tone......118 Adjusting the alarm limits......... 118 Instructions for use Fabius GS premium SW 3.n...

  • Page 116: Alarm Signaling

    – The yellow LED lights continu- ously, accompanied by a singe alarm tone sequence of 2 alarm tones: E-E" – with internal priority ≥6: alarm tone sequence of 2 tones – with internal priority <6: no tone Instructions for use Fabius GS premium SW 3.n...

  • Page 117: Alarm Priorities

    Alarm messages with low priority are only displayed if the cause for a high-priority alarm is remedied. optional 3 alarm messages for Japan and China Instructions for use Fabius GS premium SW 3.n...

  • Page 118: Suppressing The Alarm Tone

    During the alarm tone suppression, only the new alarms are acoustically signaled whose alarm priority or internal priority number is higher than the suppressed alarm, see chapter ''Alarm – Cause – Remedy'' on page 157. Instructions for use Fabius GS premium SW 3.n...

  • Page 119: Monitoring

    Setting the minute volume alarm limits.... 124 Deactivating the volume alarms ...... 124 Airway pressure monitoring......125 Parameter field and waveform window for airway pressure ..........125 Setting the upper alarm limit and the pressure threshold............126 Instructions for use Fabius GS premium SW 3.n...

  • Page 120: Main Screen

    A Numerical value for the inspiratory O concentration in percent (%) in the range from 10 % to 100 % B Upper alarm limit for the O concentration in C Lower alarm limit for the O concentration in Instructions for use Fabius GS premium SW 3.n...

  • Page 121: Setting The O 2 Alarm Limits

    2 Adjust the upper and lower alarm limit values of the O concentration (C), see setting ranges of alarm parameters in chapter ''Changing the alarm limits'' on page 138. 3 Confirm new values. Instructions for use Fabius GS premium SW 3.n...

  • Page 122: Deactivating The O 2 Monitoring

    E During calibration, the sensor was exposed to ambient air with >21 % O . Therefore, the displayed O percentage is lower than the actual O percentage. Instructions for use Fabius GS premium SW 3.n...

  • Page 123: Breathing Volume Monitoring

    (L/min). The display range is between 0.0 L/min and 99.9 L/min. D Upper alarm limit of the minute volume in L/min E Lower alarm limit of the minute volume in L/min Instructions for use Fabius GS premium SW 3.n...

  • Page 124: Volume Alarms

    The volume alarms can be switched on and off during operation by pressing the key (A), see chapter ''Switching the volume alarms on and off'' on page 145. 1 Press the (A) key. Instructions for use Fabius GS premium SW 3.n...

  • Page 125: Airway Pressure Monitoring

    O (0 and 50 hPa). NOTE Fabius can be configured by DrägerService or an authorized local service partner so that the mean airway pressure (MEAN) is displayed instead of the plateau pressure (PLAT). Instructions for use Fabius GS premium SW 3.n...

  • Page 126: Setting The Upper Alarm Limit And The Pressure Threshold

    The dialog window (B) with the alarm limits opens. 2 Adjust upper alarm limit and pressure threshold of the peak pressure (PEAK) (C), see chapter ''Changing the alarm limits'' on page 138. 3 Confirm new values. Instructions for use Fabius GS premium SW 3.n...

  • Page 127: Configuration

    Switching the desflurane compensation on and off ..............147 Automatic desflurane compensation ....147 Accessing the alarm logbook......148 Clearing the alarm logbook......148 Closing the alarm logbook ....... 148 Changing the alarm volume......149 Instructions for use Fabius GS premium SW 3.n...

  • Page 128: Configuration In Standby Mode

    (A) starts flashing. It flashes until the Standby mode is confirmed. NOTE If the confirmation is not done within 15 seconds, the ventilator remains in the previous mode and the pressure waveform window is restored. Instructions for use Fabius GS premium SW 3.n...

  • Page 129: Power-Saving Mode

    When Fabius is in Standby mode and there is no user input for 2.5 minutes, the power-saving mode is activated. The screen is then replaced by the screensaver. Press any key to end the screensaver. Instructions for use Fabius GS premium SW 3.n...

  • Page 130: Calibrating The Flow Sensor

    If the calibration continues to fail, contact activated. DrägerService or the authorized local service partner. Calibrating the flow sensor Standby 1 Press the Calibrate Flow Sensor softkey (A). 2 Follow the instructions on the screen. Instructions for use Fabius GS premium SW 3.n...

  • Page 131: Calibrating The O 2 Sensor

    (B): Calibration in progress After the calibration, one of the following two messages are displayed above the standby softkeys (B): Sensor Calibration completed - reinsert O sensor Sensor Calibration Failed Instructions for use Fabius GS premium SW 3.n...

  • Page 132: Leakage Test

    Measured value and FAILED Standby >250 >250 and FAILED After completion of the tests, the results (B) are displayed on the screen. 3 To return to the start screen, press the rotary knob. Instructions for use Fabius GS premium SW 3.n...
  • Page 133 Test of the overpressure safety valve This test checks the functionality of the overpressure safety valve. The test results are displayed on the screen with the leakage test results (B). Instructions for use Fabius GS premium SW 3.n...

  • Page 134: Accessing The Alarm Logbook

    1 Press the Access Alarm Log softkey (A). Standby 2 To scroll through the alarm logbook (B), turn the rotary knob. Clearing the alarm logbook  Select Clear Alarm Log (C) and confirm Instructions for use Fabius GS premium SW 3.n...

  • Page 135: Restoring The Default Settings

    Standby Set-up screen. Adjustment of the default settings is password-protected. WARNING Risk due to unsuitable ventilation settings After the default settings are restored, check whether the settings for the ventilation and monitoring are suitable for the patient. Instructions for use Fabius GS premium SW 3.n...

  • Page 136: Page Standby Set-Up

    2 In the displayed row, select the digits in sequence and confirm. 2 Select Default Settings (B) or Configuration (C) with the cursor. By selecting and confirming with the input arrow (D), the screen changes back to the Standby screen. Instructions for use Fabius GS premium SW 3.n...
  • Page 137 (C) and confirm. Default settings for Pressure Control, Pressure Support, and SIMV/PS  Change the parameters (see description in section ''Default settings for Volume Control'' on page 137). optional Instructions for use Fabius GS premium SW 3.n...
  • Page 138 Fabius. Alarm parame- Setting range Factory setting 19 to 100 18 to 99 0.1 to 20.0 12.0 [L/min] 0.0 to 19.9 Pressure 10 to 70 [[cmH 5 to 30 (hPa)] Instructions for use Fabius GS premium SW 3.n...
  • Page 139 Lower value = 8 PEAK Freq= 12 Minimum Alarm Vol- Volume = 5 TI:TE= 1:2.0 TIP:TI= 10 PEEP= 0 Pressure Control PINSP= 15 Freq= 12 TI:TE= 1:2.0 Insp Flow= 30 PEEP= 0 Instructions for use Fabius GS premium SW 3.n...

  • Page 140: Changing The Configurations

    – Date Format – Language – Pressure Unit – Acoustic Confirmation – Waveform Display – Display Background  To return to the Standby Set-up screen, select the input arrow (A) and confirm. Instructions for use Fabius GS premium SW 3.n...
  • Page 141 1 Select Language (F) and confirm. 1 Select Date Set (D) and confirm. 2 Select language and confirm. 2 Select new value and confirm. The window is closed. The window is closed. Instructions for use Fabius GS premium SW 3.n...
  • Page 142 1 Select Acoustic Confirmation (H) and – cmH confirm. – mbar 2 Select On or Off and confirm. – kPa The window is closed. 2 Select new unit and confirm. The window is closed. Instructions for use Fabius GS premium SW 3.n...
  • Page 143 The window is closed. Standby Set-up When the setting Normal is selected, the pressure waveform (J) is not shown as a filled area, but as a line. available only with optional color screen Instructions for use Fabius GS premium SW 3.n...

  • Page 144: Configuration During Operation

    Pressing the key (B) will also cause the pressure waveform window to be displayed again. 1 Press the (A) key. Volume Control The pressure waveform is no longer displayed. Instructions for use Fabius GS premium SW 3.n...

  • Page 145: Switching The Volume Alarms On And Off

    (PLAT), pressing the softkey mode, the softkey Volume Alarms ON /OFF is has no effect. not displayed. NOTE In SIMV/PS mode, the pressure threshold depends on the pressure of the mandatory breaths. Instructions for use Fabius GS premium SW 3.n...

  • Page 146: Calibrating The O 2 Sensor

     If the calibration was not successful, replace the O sensor capsule in the O sensor housing, see chapter ''Inserting a new O sensor capsule'' on page 77. Instructions for use Fabius GS premium SW 3.n...

  • Page 147: Switching The Desflurane Compensation On And Off

    Make sure that the anesthetic gas monitor gas analyzer, Fabius compensates desflurane functions correctly. automatically. In this case, the transmitted data cancel the function of the softkey for desflurane compensation. Instructions for use Fabius GS premium SW 3.n...

  • Page 148: Accessing The Alarm Logbook

     Select Clear Alarm Log (C) and confirm. Volume Control Closing the alarm logbook  Select the input arrow (B) and confirm. The pressure waveform and the softkeys are displayed again. 1 Press the AccessAlarm Log softkey (A). Instructions for use Fabius GS premium SW 3.n...

  • Page 149: Changing The Alarm Volume

    Always set the alarm tone to a sufficient volume. Volume Control 1 Press the AccessAlarm Volume softkey (A). Volume Control 2 Set the new alarm volume to a value between 1 (minimum) and 10 (maximum) and confirm. Instructions for use Fabius GS premium SW 3.n...

  • Page 150: Troubleshooting

    Mains power supply failure......153 Ventilator failure ..........155 Alarm VENTILATOR FAIL !!!......155 Failure of the O sensor........ 156 Causes for faulty calibration ......156 Alarm – Cause – Remedy ......157 Instructions for use Fabius GS premium SW 3.n...

  • Page 151: Locating And Remedying Leakages

    – The filling or emptying connections on the vaporizer are leaking or are open. The vaporizer is incorrectly fitted. The O-ring is missing or damaged. The control dial is not in the 0 position. Instructions for use Fabius GS premium SW 3.n...

  • Page 152: Systematic Localization Of Leakages

    Vaporizers Remove the vaporizers. 1 Perform the leakage test, see chapter ''Leakage test'' on page 132. 2 Contact service personnel if the leakages cannot be localized. Instructions for use Fabius GS premium SW 3.n...

  • Page 153: Power Supply Failure

    The device must not be used until the battery – If no manual ventilation follows, the following is completely charged again. alarm messages are displayed: – APNOEA PRESSURE !!! – APNOEA FLOW !!! – MINUTE VOLUME LOW !! Instructions for use Fabius GS premium SW 3.n...
  • Page 154 When the power supply is restored and Fabius is restarted, all ventilation and alarm settings are reset to default settings. After the restart of Fabius, check all settings and adjust to the patient if necessary. Instructions for use Fabius GS premium SW 3.n...

  • Page 155: Ventilator Failure

    – The spontaneous breathing mode cannot be activated. To bypass the ventilator, proceed as follows: 1 Set the On/Off switch on the rear of Fabius to (off). 2 Set the On/Off switch back to (on). Instructions for use Fabius GS premium SW 3.n...

  • Page 156: Failure Of The O 2 Sensor

    Expose the new O sensor elapsed. to ambient air 15 minutes before calibration. The O sensor is not connected. Check the O sensor. Connect the O sensor cor- rectly and recalibrate. Instructions for use Fabius GS premium SW 3.n...

  • Page 157: Alarm - Cause - Remedy

    The alarm messages are listed in alphabetical order. Some alarms appear in this table several times with different alarm priorities because their priority can change under certain conditions. Instructions for use Fabius GS premium SW 3.n...
  • Page 158 Freq < 6 or in Pressure Support mode with apnea ventilation acti- vated: Caution = VT <20 mL for >30 seconds Breathing/ventilation Check ventilator. stopped. Leakage or disconnection in Check breathing system. the breathing system. Instructions for use Fabius GS premium SW 3.n...
  • Page 159 Freq < 6 or in Pressure Support mode with apnea ventilation acti- vated: Warning = VT <20 mL for >60 seconds Breathing/ventilation Check ventilator. stopped. Leakage or disconnection in Check breathing system. the breathing system. Instructions for use Fabius GS premium SW 3.n...
  • Page 160 Caution = PAW did not exceed the pressure thresh- old value for a duration of >30 seconds. Breathing/ventilation Check ventilator. stopped. Leakage or disconnection in Check breathing system. the breathing system. Instructions for use Fabius GS premium SW 3.n...
  • Page 161 BATTERY LOW ! No mains power and battery Restore mains power sup- <20 % ply. (17) BATTERY LOW !! No mains power and battery Restore mains power sup- <10 % ply. Instructions for use Fabius GS premium SW 3.n...
  • Page 162 FLOW SENSOR CAL DUE ! More than 18 hours have Perform the procedure for passed since the last sensor calibration of the flow sen- calibration. The cable was sor (see page 130). removed and reconnected. Instructions for use Fabius GS premium SW 3.n...
  • Page 163 MINUTE VOLUME HIGH !! The minute volume has exceeded the upper alarm limit. The flow sensor was not cali- Calibrate the flow sensor brated. (see page 130). Sensor error. If necessary, replace the flow sensor. Instructions for use Fabius GS premium SW 3.n...
  • Page 164 (approx. 20 psi) (approx. 1.4 kPa x 100). PEEP HIGH ! In ManSpont mode, PEEP is Check APL valve setting above 8 cmH O (hPa). and/or fresh-gas flow. Instructions for use Fabius GS premium SW 3.n...
  • Page 165 PEEP/PMAX line is connected and without leakage. Select Standby mode and then switch to the previous ventilation mode. VOLUME ALARMS OFF ! Volume alarms deactivated Reactivate the volume by user. alarms. Instructions for use Fabius GS premium SW 3.n...

  • Page 166: Cleaning, Disinfection And Sterilization

    Non-critical medical devices......172 Semi-critical medical devices ......172 Visual inspection ..........173 Sterilization............174 Reprocessing list .......... 175 Non-critical medical devices......175 Semi-critical medical devices ......177 Before using on patients again ....178 Instructions for use Fabius GS premium SW 3.n...

  • Page 167: Disassembly

    NOTE 10 Unscrew the holder for the breathing bag. To prevent accidental penetration of soda lime into the breathing system, do not transport the breathing system with a filled reusable CO absorber. Instructions for use Fabius GS premium SW 3.n...

  • Page 168: Information Concerning Dismounted Accessory Parts And Attached Devices

    – Sample line WARNING Risk of infection Used sample lines may be infectious due to the breathing gases that passed through them. Replace the sample lines regularly, see table ''Semi-critical medical devices''. Instructions for use Fabius GS premium SW 3.n...

  • Page 169: Removing The Compact Breathing System

     Screw off the exhaust port (A). 2 Screw off the cap nut (A). 3 Remove the dome (C). 4 Take out the valve plate (D). 5 Remove the sealing ring (E) from the socket (F). Instructions for use Fabius GS premium SW 3.n...

  • Page 170: Removing The Flow Sensor

    To disassemble, follow the steps in reverse order as listed in chapter ''Connecting the anesthetic gas receiving system (optional)'' on page 61. 1 Loosen the knurled nut (A). 2 Remove the valve. Instructions for use Fabius GS premium SW 3.n...

  • Page 171: Reprocessing Procedures

    – Hot steam, 134 °C (273.2 °F) for 5 minutes procedures and agents. The following agents showed good material compatibility and effectiveness at the time of the test: Instructions for use Fabius GS premium SW 3.n...

  • Page 172: Non-Critical Medical Devices

    3 Inspect components for visible soiling and damage. Repeat manual disinfection if necessary. 4 Shake off all excess water. Allow components to dry thoroughly. Instructions for use Fabius GS premium SW 3.n...

  • Page 173: Visual Inspection

    After cleaning, the breathing system must be sterilized with steam until it is completely dry. Instructions for use Fabius GS premium SW 3.n...

  • Page 174: Sterilization

     Sterilize only components that have been cleaned and disinfected. For sterilization, use a vacuum steam sterilizer (in accordance with DIN EN 285), preferably with fractional vacuum. Instructions for use Fabius GS premium SW 3.n...

  • Page 175: Reprocessing List

    – O flush key – Flow control valves – APL valve – Writing tray – Grip bar on trolley – Drawer handles – Standard rails on both sides – Clic adapter, Clic absorber Instructions for use Fabius GS premium SW 3.n...
  • Page 176 – Network cables and data cables – Compressed gas hoses – Pressure reducers – Gas cylinders – Drawer surfaces, outside and inside – Anesthetic gas receiving sys- – Lamp – Holder for sample line Instructions for use Fabius GS premium SW 3.n...

  • Page 177: Semi-Critical Medical Devices

    After each patient line is fitted directly to the Y-piece and the filters are fit- ted on the breath- ing system Ventilator lid After each patient Yes Ventilator membrane After each patient Yes Instructions for use Fabius GS premium SW 3.n...

  • Page 178: Before Using On Patients Again

    ''Assembly and preparation'' on page 52. 2 Mount the parts in the reverse oder of the disassembly, see ''Disassembly'' on page 167. 3 Check readiness for operation, see ''Checking the readiness for operation'' on page 87. Instructions for use Fabius GS premium SW 3.n...

  • Page 179: Maintenance

    Maintenance Maintenance Overview............180 Inspection............181 Safety checks ..........181 Preventive maintenance ....... 182 Repair ............. 182 Instructions for use Fabius GS premium SW 3.n...

  • Page 180: Overview

    Measures intended to determine and assess the actual state of a medical device Service Recurrent specified measures intended to maintain the functional condition of a medical device Repair Measures intended to restore the functional condition of a medical device after a device malfunction Instructions for use Fabius GS premium SW 3.n...

  • Page 181: Inspection

    – Check the function of the anesthetic – Check S-ORC functionality. vaporizer according to the associated instructions for use. – Check the function of the O flush. Instructions for use Fabius GS premium SW 3.n...

  • Page 182: Preventive Maintenance

    After 6 years Basic overhauling Experts high-pressure cylinders Pressure reducer for PIN After 6 years Replace Experts index 1) optional Repair For repairs, Dräger recommends DrägerService and the use of original Dräger parts. Instructions for use Fabius GS premium SW 3.n...

  • Page 183: Disposal

    Disposal Disposal Disposing of the medical device....184 For countries subject to the EU Directive 2002/96/EC............184 Disposal of accessories........ 184 Disposal of non-rechargeable batteries ..185 Instructions for use Fabius GS premium SW 3.n...

  • Page 184: Disposing Of The Medical Device

    – CLIC absorber, Infinity ID CLIC absorber – Soda lime Dispose on the following articles according to hospital hygiene regulations: – Sample line – Soda lime dust filter – Anesthetic gas receiving system Instructions for use Fabius GS premium SW 3.n...

  • Page 185: Disposal Of Non-Rechargeable Batteries

    The battery used in this device must therefore be removed by experts prior to disposal of the device. In countries other than Germany the respective national regulations must be complied with. Instructions for use Fabius GS premium SW 3.n...

  • Page 186: Technical Data

    General information......... 204 Electromagnetic emissions......204 Electromagnetic immunity ....... 205 Recommended safety clearance for portable and mobile high-frequency communication equipment............207 Reduced safety clearance for portable and mobile high-frequency communication equipment............207 Instructions for use Fabius GS premium SW 3.n...

  • Page 187: General Information

    Vaporizers and anesthetic agents can limit the use of an anesthesia workstation with regard to its temperature range and maximum fresh-gas flow. Therefore when using additional devices, follow the associated instructions for use. Instructions for use Fabius GS premium SW 3.n...

  • Page 188: Device Data

    0 to 3000 psi (206.8 kPa x 100) Medical gas supply at device inlet Dew point >5 °C (41 °F) at ambient temperature Oil content <0.1 mg/m Particles Dust-free air (filtered with pore size < 1 µm) Instructions for use Fabius GS premium SW 3.n...
  • Page 189 16 hours on mains power for full operating time Backup time with fully charged battery Minimum 45 minutes Weight Basic device with compact breathing system, no gas 134.2 kg (296 lb) cylinders or vaporizers Instructions for use Fabius GS premium SW 3.n...

  • Page 190: Fuses

    22 mm outer taper / 15 mm inner taper (ISO) Pressure limitation Max. 80 cmH O (hPa) at 18 L/min Fresh-gas flow 0 and 0.2 to 18 L/min Electrical safety In compliance with UL 60601-1 IEC 60601-1 CAN/CSA C22.2 No. 601.1-M90 Instructions for use Fabius GS premium SW 3.n...

  • Page 191: General Safety Standards For Anesthesia Workstations

    Transfer and receiving systems of active anesthetic gas scavenging systems ISO 8835-4 Part 4: Systems for inhalational anesthesia Anesthetic vapor delivery devices ISO 8835-5 Part 5: Systems for inhalational anesthesia Anesthetic ventilators Instructions for use Fabius GS premium SW 3.n...
  • Page 192 Medical electrical equipment Particular requirements for basic safety and essen- tial performance of an anaesthetic workstation ISO 80601-2-55 Part 2-55: Particular requirements for basic safety and essen- tial performance of respiratory gas monitors Instructions for use Fabius GS premium SW 3.n...

  • Page 193: Ventilator

    3 to 20 bpm (resolution: 1 bpm) and OFF Min) (3 to 20 1/min (resolution: 1/min) and OFF) Trigger value (Trigger) 2 to 15 L/min (resolution: 1 L/min) Inspiratory time (TINSP) 0.3 bis 4.0 sec. Instructions for use Fabius GS premium SW 3.n...
  • Page 194 O (-9 hPa) Measuring the system compliance 0.2 to 6.0 mL/cmH O (0.2 to 6.0 mL/hPa) ±0.2 mL/cmH O (±0.2 mL/hPa) or ±10 % of the actual compliance depending which value is higher Instructions for use Fabius GS premium SW 3.n...

  • Page 195: Anesthetic Gas Supply Module

    Flow tube for O supplemental delivery (optional) Connection Stepped connection for use with hoses of different diameters Flow 0 to 10 L/min Accuracy ±5 % of the measurement range Resolution 0.5 L/min Instructions for use Fabius GS premium SW 3.n...

  • Page 196: Vaporizer Interface

    ISO 80601-2-55 1) Max. ±4 % of the measured value or ±2 cmH O (±2 hPa), depending on which value is higher. 2) With standard test conditions in accordance with ISO 80601-2-13. Instructions for use Fabius GS premium SW 3.n...
  • Page 197 Maximum period of use of O >12 months at 25 °C (77 °F), 50 % relative humidity, 50 % O in fresh sensor cell gas (or >5000 hours at 100 Vol% O Instructions for use Fabius GS premium SW 3.n...

  • Page 198: Breathing System

    M30146 tory: 4.4 cmH O (4.4 hPa) In accordance with ISO 80601-2-13, dry, without hos- Inspiratory: Expira- -3.7 cmH O (-3.7 hPa) tory: 3.7 cmH O (3.7 hPa) Typical leakage <50 mL/min Instructions for use Fabius GS premium SW 3.n...
  • Page 199 Pressure drop at 30 L/min 3.4 cmH O (hPa) (wet and dry) 1) Depending on the current ventilation settings, the indicated values may deviate by ±0.3 cmH O (0.3 hPa) Instructions for use Fabius GS premium SW 3.n...
  • Page 200 Technical data Instructions for use Fabius GS premium SW 3.n...

  • Page 201: Alarm For Low Oxygen Supply Pressure

    (approx. 51 dB(A) at max. alarm tone volume) Time exceeded when changing ventilation mode 3 tones adjustable from 46 dB(A) to approx. 56 dB(A) Selection of alarm volume Single tone per level (corresponds to volume of alarm tone) Instructions for use Fabius GS premium SW 3.n...

  • Page 202: S-Orc (Sensitive Oxygen Ratio Controller)

    9-pole Sub-D, galvanically isolated with 1.5 kV against internal electronics, 0.5 kV against housing Baud rate 1200, 2400, 4800, 9600, 19200, 38400 baud Data bits 7 or 8 Parity Uneven, even, none Startbit Stopbit 1 or 2 Instructions for use Fabius GS premium SW 3.n...

  • Page 203: Essential Performance Characteristics

    Alarms are issued depending on the set alarm limits. If the O sensor fails, an alarm is issued. NOTE In accordance with general safety standards, additional components are required for a complete anesthesia workstation. Instructions for use Fabius GS premium SW 3.n...

  • Page 204: Emc Declaration

    – the ‘quieter‘ the electrical environment the better.In general, increasing the distance between electrical devices decreases the likelihood of interference. Instructions for use Fabius GS premium SW 3.n...

  • Page 205: Electromagnetic Immunity

    25 periods power supply interruptions, it is recommended that the Voltage dip >95 %, >95 %, medical device is powered 5 seconds 5 seconds from an uninterruptible power supply or a battery. Instructions for use Fabius GS premium SW 3.n...
  • Page 206 150 kHz to 2.5 GHz and less than 1 V/m above 2.5 GHz. 2) ISM bands in this frequency range are: 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; 40.66 MHz to 40.70 MHz. Instructions for use Fabius GS premium SW 3.n...

  • Page 207: Recommended Safety Clearance For Portable And Mobile High-Frequency Communication Equipment

    GSM 1800, GSM 1900 (limited to 1 W ERP) 0.30 m (12 in) UMTS, DECT (limited to 0.25 W ERP) 0.15 m (6 in) Bluetooth, WLAN 2450, RFID 2450 (limited to 0.1 W ERP) 0.30 m (12 in) Instructions for use Fabius GS premium SW 3.n...

  • Page 208: Device Combinations

    – IEC 60601-1-8 (alarm systems) – IEC 60601-1, 2nd edition (general requirements for safety) – IEC 60601-1-1 (device combinations) – IEC 60601-1-2 (electromagnetic compatibility) – IEC 60601-1-4 (software-controlled functions) – IEC 60601-1-8 (alarm systems) Instructions for use Fabius GS premium SW 3.n...

  • Page 209: Connections To It Networks

    Serial interfaces The following interfaces are supported: – RS232 interfaces complying with EIA RS--232 (CCITT V.24/V.28) for the following applications: – MEDIBUS, MEDIBUS.X – Connections to medical devices from other manufacturers Instructions for use Fabius GS premium SW 3.n...

  • Page 210: Illustrations

    Technical data Illustrations Gas flow plan of the breathing system Instructions for use Fabius GS premium SW 3.n...

  • Page 211: Annex

    Annex Annex Form for daily checkout and pre-use checkout............212 Checklist ............213 Instructions for use Fabius GS premium SW 3.n...

  • Page 212: Form For Daily Checkout And Pre-Use Checkout

    If one of the checks does not pass, the device must not be used. Contact DrägerService or the responsible service partner. NOTE The following applies to this section: cmH mbar = hPa. Instructions for use Fabius GS premium SW 3.n...
  • Page 213 The sample line for gas monitoring (if gas flow stops. present) is connected to the Luer Lock connection on the Y-piece. An appropriate anesthetic agent was selected. D-Vapor (if present) is switched on. Instructions for use Fabius GS premium SW 3.n...
  • Page 214 Operation LED is lit. Expose the O sensor to ambient air for 2 minutes. Start the calibration. Reinsert the O sensor housing to the cover of the inspiratory valve. Instructions for use Fabius GS premium SW 3.n...
  • Page 215 The valve plates in the inspiratory valve Leak / Compl Test softkey. Follow the and expiratory valve move. instructions on the screen. The breathing bag fills and empties. If the system has leakage (the pressure drops): Instructions for use Fabius GS premium SW 3.n...
  • Page 216 Set the flow control valve on the anes- thetic gas receiving system so that the float is located between the "Min." and "Max." marks. Occlude the Y-piece. Close all flow control valves. Instructions for use Fabius GS premium SW 3.n...
  • Page 217 – The breathing system is ready for opera- tion (the breathing bag is correctly posi- tioned and all hoses are correctly connected). – CO absorber is attached to the device and sufficiently filled. Instructions for use Fabius GS premium SW 3.n...
  • Page 218 Name Date Signature for pre-use checkout Name Signature for pre-use checkout Date Name Date Signature for pre-use checkout Name Signature for pre-use checkout Date Name Date Signature for pre-use checkout Name Date Instructions for use Fabius GS premium SW 3.n...
  • Page 219 Signature for pre-use checkout Name Name Date Date Signature for pre-use checkout Signature for pre-use checkout Name Name Date Date Signature for pre-use checkout Signature for pre-use checkout Name Name Date Date Instructions for use Fabius GS premium SW 3.n...

  • Page 220: Password

    8088 Information for the configuration password To prevent unauthorized alteration, the default settings of Fabius GS premium are protected by a 4-digit password. For information on the start settings, see page 136. The configuration password appears on this page of the instructions for use. Cut out the area with the password and keep in a place which is safe from access by unauthorized persons.
  • Page 221 This page intentionally left blank. Instructions for use Fabius GS premium SW 3.n...
  • Page 222 Assembling ......62 Breathing volume monitoring ....123 Instructions for use Fabius GS premium SW 3.n...
  • Page 223 Gas supply ......56 Instructions for use Fabius GS premium SW 3.n...
  • Page 224 Vaporizer interface ..... . 196 Ventilation......95 Instructions for use Fabius GS premium SW 3.n...
  • Page 225 This page intentionally left blank. Instructions for use Fabius GS premium SW 3.n...
  • Page 226 These instructions for use only apply to Fabius GS premium SW 3.n with the Serial No.: If no serial number has been filled in by Dräger, these instructions for use are provided for general information only and are not intended for use with any specific medical device.

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