Dräger Fabius OS Instructions For Use Manual
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Dräger Fabius OS Instructions For Use Manual

Anesthesia workstation
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Instructions for Use
Fabius OS
WARNING
For a full understanding of the
performance characteristics of this
medical device, the user should care-
fully read these Instructions for Use
before use of the medical device.
Anesthesia Workstation
Software 3.n

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Summary of Contents for Dräger Fabius OS

  • Page 1 Instructions for Use Fabius OS Anesthesia Workstation WARNING For a full understanding of the Software 3.n performance characteristics of this medical device, the user should care- fully read these Instructions for Use before use of the medical device.

  • Page 2: Working With These Instructions For Use

    – Dashes indicate the listing of data, options or Turn off fresh gas flow. objects. Instructions for Use Fabius OS SW 3.n Right-Hand Column – the Illustrations The illustrations provide visual reference for the text and for locating the various parts of the equip- ment.

  • Page 3: Trademarks

    This document is provided for customer information only, and will not be updated or exchanged without customer request. Depending on the configuration of the individual medical device, the images in the Instructions for Use may differ. Instructions for Use Fabius OS SW 3.n...
  • Page 4 This page intentionally left blank Instructions for Use Fabius OS SW 3.n...

  • Page 5: Table Of Contents

    Connecting the Waste-Gas Outlet Port ..46 Ending Operation ..... . . 90 Instructions for Use Fabius OS SW 3.n...
  • Page 6 Reprocessing Breathing system... . 154 Care List for Fabius OS Components ..156 Reassembling the Breathing System ..158 Reinstalling the Ventilator .

  • Page 7: For Your Safety And That Of Your Patients

    Accessories in sterile packaging ... 10 Software ......11 Instructions for Use Fabius OS SW 3.n...

  • Page 8: Strictly Follow These Instructions For Use

    Follow Assembly Instructions and Instructions for strongly recommended that only these acces- Use. sories be used in conjunction with the specific medical device. Otherwise the correct functio- ning of the medical device may be compro- mised. Instructions for Use Fabius OS SW 3.n...

  • Page 9: Patient Safety

    The responsibility for the selection of the best level of patient monitoring lies solely with the medical device operator. Instructions for Use Fabius OS SW 3.n...

  • Page 10: General Warnings And Cautions

    IEC 60601-1-2: 2001 value which exceeds the permissible value, do Electromedical devices are subject to special pre- not use the auxiliary outlets of the Fabius OS: cautionary measures concerning electromagnetic use a separate wall socket. compatibility (EMC) and must be installed and put...

  • Page 11: Software

    Any person involved with the setup, opera- If these precautions are not followed, the tion, or maintenance of the Fabius OS anes- device may tip over and pose a risk to safety. thesia workstation must be thoroughly familiar with this instruction manual.
  • Page 12 Software must be installed by qualified personnel. CAUTION We recommend to contact DrägerService for soft- ware installation. Do not use Fabius OS during magnetic reso- nance (MRT, NMR, NMI). NOTE: Device operation may be affected, thus placing If the error-free state of the protective earthing con- the patient at risk.

  • Page 13: Intended Use

    MEDIBUS and Vitalink Protocols ... 14 Restriction of Distribution ....14 Instructions for Use Fabius OS SW 3.n...

  • Page 14: Intended Use

    Intended Use Intended Use Fabius OS is an inhalation anesthesia machine for MEDIBUS and Vitalink Protocols use in operating, induction and recovery rooms. MEDIBUS and Vitalink are software protocols for use in transferring data between the Fabius OS It may be used with O...

  • Page 15: System Overview

    Abbreviations ......26 Symbols ......27 Instructions for Use Fabius OS SW 3.n...

  • Page 16: Front View

    12 Compact Breathing System (COSY) 4 Vapor mount 13 Ventilator 5 Fresh gas control 14 Auxiliary oxygen flowmeter 6 Gauges for Pin index O AIR and N O cylin- ders 7 Writing table* 8 Storage drawers optional Instructions for Use Fabius OS SW 3.n...

  • Page 17: Compact Breathing System (Top View)

    9 Fresh gas decoupling valve 10 APL bypass valve connection port 11 Breathing system mount with locking bolt 12 Selecting knob for »MAN« and »SPONT« on pressure limiting (APL) valve 13 Sample gas return port Instructions for Use Fabius OS SW 3.n...

  • Page 18: Rear View (Pin-Index Connector)

    2 Connector for medical gas pipeline supply (cen- tral supply) 3 Power cable connection 4 Interface panel 5 Ventilator hose connection 6 ON/OFF switch 7 Fuse 8 Compact Breathing System (COSY) 9 Potential equalization pin 10 Pin-Index system Instructions for Use Fabius OS SW 3.n...

  • Page 19: Interface Panel

    System Overview Interface Panel 1 COM 1 2 COM 2* 3 APL 4 Oxygen Sensor 5 Breathing Pressure 6 Volume Sensor 7 ON/OFF switch 8 Fuse 9 Power cable connection 10 PEEP optional Instructions for Use Fabius OS SW 3.n...

  • Page 20: Vaporizers

    For complete information, consult the appropriate Instruction for Use provided with the vaporizer. Vaporizer Exclusion Systems The exclusion systems available for the Fabius OS are described below. Dräger Auto Exclusion 2 Vaporizer Mount* This system has an automatic interlock system that ensures only one vaporizer can be used at a time.

  • Page 21: Auxiliary Oxygen Flowmeter

    Only then the oxygen flow is completely off. WARNING Risk of fire Before cauterizing, close the flow meter, remove the mask and wait a few moments to ensure that any oxygen accumulation has dis- sipated. optional ASTM F1850-22(2005) §76 Instructions for Use Fabius OS SW 3.n...

  • Page 22: Apl Valve

    The APL valve is automatically excluded from the breathing circuit whenever an automatic ventila- tion mode is selected. NOTE Even in automatic ventilation, the APL valve must be adjusted to a pressure that is safe for the pati- ent. Instructions for Use Fabius OS SW 3.n...

  • Page 23: Communication Ports

    System Overview Communication Ports 1 The Fabius OS has two ports on the back panel for communication with external devices. The ports are labeled COM 1 and COM and sup- port MEDIBUS and Vitalink communications. WARNING A test for leakage current must be performed...
  • Page 24 – automatic anesthesia record keeper – port COM 2* OXYGEN SENSOR BREATHING PRESSURE VOLUME SENSOR 5 Connect monitor to anesthesia record keeper. 6 Connect anesthesia record keeper to COM 1. 7 Connect monitor to COM 2. optional Instructions for Use Fabius OS SW 3.n...

  • Page 25: Accessory Weight Limits

    Trolley mounted units: The total combined weight of all accessories and monitors mounted on the CAUTION top and sides of the Fabius OS shall not exceed 80 lb (36 kg). Risk of tip-over and personal injury Front GCX rails have a maximum accessories weight load of 5 lb/2.3 kg, extended out at 3 in/...

  • Page 26: Abbreviations

    Vacuum (e.g. for secretion suction) Hectopascal Expiratory minute volume in./insp. Inspiratory Tidal volume Insp Flow Inspiratory flow L/min Liters per minute Manual ventilation mbar Millibar MEAN Mean pressure Minute volume Nitrous oxide Oxygen Airway pressure Instructions for Use Fabius OS SW 3.n...

  • Page 27: Symbols

    Use by date, which is the date that The following symbols are used on other locations the device shall be used, expressed of the Fabius OS to provice quick and easy recog- YYYY-MM as year and month. nition of product functions.
  • Page 28 System Overview The following symbols are used on the Fabius OS monitoring user interface. Upper and Lower Alarm Limits Return to Home Screen Suppress Alarm Tone for Two Minu- Standby Mode Available Operating Capacity of XX % Close Menu, Back to Previous...

  • Page 29: Operation Concept

    LED Indicators ......40 Gas System Color Coding ....40 Instructions for Use Fabius OS SW 3.n...

  • Page 30: Control Panel

    Operation Concept Control Panel The control panel on the Fabius OS is character- ized by a small number of elements, clear layout, and ease of operation. Its main elements are: 1 A screen displaying all monitoring and ventila- tion information in numeric and graphic form.

  • Page 31: The Screen Display

    4 Respiratory volume monitoring window which displays the patient’s respiratory rate in breaths per minute (Freq), tidal volume, minute volume, and the minute volume high and low alarm lim- its. Instructions for Use Fabius OS SW 3.n...

  • Page 32: Rotary Knob

    3 The »Lamp« key turns the tabletop light ON and OFF. 4 The »Pressure Support« key is used to select the Pressure Support ventilation mode (optional). 5 The »Pressure Control« key (optional) is used to select the Pressure Control ventilation mode. Instructions for Use Fabius OS SW 3.n...

  • Page 33: Soft Keys

    NOTE: The »Volume Alarms On/Off« soft key label does not appear in ManSpont mode because it is select- able on the ManSpont screen. See "Configuration during Operation" on page 127 for complete information. Instructions for Use Fabius OS SW 3.n...

  • Page 34: Selecting/Setting Monitoring Functions

    »Default Settings« or »Configuration« label. Select and confirm the »Default Settings« label. The Default Settings column is selected. (Selecting and confirming the return arrow will exit the Default Settings column and redisplay the main Setup screen.) Instructions for Use Fabius OS SW 3.n...
  • Page 35 (For example in the illustration on the right, the alarm limit was changed from 20 to 25.) Confirm the new value for the alarm limit. The new alarm limit is saved and cursor moves to the return arrow. Instructions for Use Fabius OS SW 3.n...

  • Page 36: Selecting/Setting Ventilation Parameters

    10 seconds. If the new set- ting is not confirmed within the timeout period, the current ventilation setting remains in effect and the Ventilation Settings window returns to the Wave- form window. Instructions for Use Fabius OS SW 3.n...

  • Page 37: Fresh Gas Control

    O central supply pressure gauge 9 AIR central supply pressure gauge 10 O central supply pressure gauge 11 O cylinder pressure gauge 12 AIR cylinder pressure gauge 13 N O cylinder pressure gauge Instructions for Use Fabius OS SW 3.n...

  • Page 38: Total Flow Meter

    2 L/min. If 1 L/min of N O is needed, open the N O flow con- trol knob until the total flow meter reads plus 1 L/min N 3 L/min: 2 L/min O Instructions for Use Fabius OS SW 3.n...

  • Page 39: Fresh Gas Flow Monitoring Resolution

    Operation Concept Fresh Gas Flow Monitoring Resolution The Fabius OS can be configured by DrägerSer- vice or your local authorized service organization to display fresh gas flow rates either in a standard res- olution mode or in a high resolution mode:...

  • Page 40: Led Indicators

    Gas System Color Coding Each connection, valve, gauge, and flow meter on the Fabius OS is color-coded for the appropriate gas, as shown the table below: Yellow Blue Green Instructions for Use Fabius OS SW 3.n...

  • Page 41: Assembly

    Connecting the Pressure Sensor ..58 Connecting the Pressure Breathing Gauge Connecting the Flow Sensor ... . 59 Instructions for Use Fabius OS SW 3.n...

  • Page 42: Activating The Battery

    Assembly Activating the Battery The Fabius OS anesthesia machine is shipped with the battery fuse disconnected in order to prevent discharge during shipment and storage prior to installation. Remove the battery fuse from the top drawer of the machine. Remove the battery fuse from its packaging.

  • Page 43: Installing The Drägersorb Clic Adapter

    Drägersorb CLIC 800 plus or Infinity ID CLIC Absorber 800+, or Infinity ID CLIC Absorber Free can be used on the Fabius OS by using the Drägersorb CLIC adapter. For information on installing the Drägersorb CLIC adapter, consult its Instructions for Use.

  • Page 44: Connecting The Compact Breathing System

    Release the locking bolt and rotate the Com- pact Breathing System until the locking bolt locks into position. 3 Connect the fresh gas hose from the Fabius OS to the Compact Breathing System. Instructions for Use Fabius OS SW 3.n...

  • Page 45: Inserting The Flow Sensor

    1 Connect the ventilation hose to the ventilator 2 attach it to the conical connector ventilator port on the Compact Breathing System. If the Fabius OS is equipped with a threaded con- nector, the sealing rings on the threaded connector must be undamaged and clean.

  • Page 46: Connecting The Waste-Gas Outlet Port

    Installing the Flexible Bag Arm* or Breathing Bag Extension* and Bag WARNING Risk of use of toxic or incompatible materials Breathing bags used on the Fabius OS must comply with current ANSI standards. CAUTION Risk of unintended perioperative awareness Make sure that during ventilation the bag is tightly connected to the bag arm.

  • Page 47: Connecting Pipeline Supply Of N 2 O, Air And O 2

    50 and 55 psi (3.4 and 3.8 kPa x 100). NOTE: The loss of the pipeline supply could cause the loss of combined devices. Instructions for Use Fabius OS SW 3.n...

  • Page 48: Connecting The Reserve Gas Cylinders For N 2 O, Air And O 2 (For Pin-Index Mounting)

    NOTE: If cylinder valves are leaky or difficult to open or close, they must be repaired in accordance with the manufacturer’s specifications. Instructions for Use Fabius OS SW 3.n...
  • Page 49 Verify that the washer is in place, the index pins are engaged, and the cyl- inder hangs vertically. Tighten the yoke firmly. Instructions for Use Fabius OS SW 3.n...
  • Page 50 (PSI - MIN) should be replaced with new, full cylin- ders. PSI/kPa x 100 - PSI/kPa x 100 - FULL (typical full load) 1900/131 1000/69 745/51 600/42 1900/131 1000/69 Instructions for Use Fabius OS SW 3.n...

  • Page 51: Connecting The Ags Anesthetic Gas Receiving System

    Assembly Connecting the AGS Anesthetic Gas Receiving System* Every Anesthetic Gas Scavenging System (AGSS) used on the Fabius OS must follow ISO standard 8835-3. The scavenging system is used with vacuum waste-gas disposal systems. The AGS is not applied as an independent system.
  • Page 52 Blocking the openings could result in a shortage of fresh gas in the breath- ing system. For detailed information on the AGS scavenger system, refer to the specific Instructions for Use provided with the scavenger. Instructions for Use Fabius OS SW 3.n...

  • Page 53: Connecting The Passive Scavenger

    Connect the other end of the hose to the hospi- tal waste-gas disposal system. For detailed information on the passive scavenger system, refer to separate Instructions for Use. optional Instructions for Use Fabius OS SW 3.n...

  • Page 54: Connecting The Suction System

    Assembly Connecting the Suction System* The optional suction system for the Fabius OS con- sists of a suction regulator and a bracket that attaches to the side of the anesthesia workstation. The bracket is used to hold the regulator and a suc- tion bottle assembly of the customer’s choice.

  • Page 55: Connecting The Breathing Hoses

    Before each use, check the breathing hoses for damage. WARNING Risk of use of toxic or incompatible materials Breathing hoses used on the Fabius OS must comply with current ANSI standards. WARNING Do not use antistatic or conductive breathing hoses. There is a risk of burns when using high frequency electrosurgical equipment.

  • Page 56: Instructions For Use Of Bacterial Filters, Endotra

    When using coaxial hoses, leaks between the inner and outer hoses cannot be detected during the self test/leak test. Instructions for Use Fabius OS SW 3.n...

  • Page 57: Inserting A New O 2 Sensor Capsule

    3 Push the O sensor into the port opening of the inspiratory port dome, and 4 plug the connector into the fitting labeled OXYGEN SENSOR on the connector panel on the back of the machine. Instructions for Use Fabius OS SW 3.n...

  • Page 58: Connecting The Pressure Sensor

    (3), the breathing pressure gauge port (4) to the pressure gauge connector, and then to the bacterial filter and onto the port labeled BREATHING PRESSURE on the connector panel on the back of the machine (5). optional Instructions for Use Fabius OS SW 3.n...

  • Page 59: Connecting The Flow Sensor

    4 Plug the control hose to the connection port on the APL Bypass valve and to the connection port marked APL on the connection panel. NOTE: The APL bypass hose is larger than the PEEP/P hose. Instructions for Use Fabius OS SW 3.n...

  • Page 60: Attaching The Manual Ventilation Bag

    Assembly Attaching the Manual Ventilation Bag 1 Hang the fully prepared and tested bag on the rail at the right. Instructions for Use Fabius OS SW 3.n...

  • Page 61: Preparing The Ventilator

    1 Close the ventilator door with the attached ven- tilator unit. Ventilator Safety Features – High pressure safety relief valve (A). – Negative pressure safety relief valve (B). – Ventilator chamber pressure sensor. Instructions for Use Fabius OS SW 3.n...

  • Page 62: Installing Vaporizers

    CAUTION Risk of tip-over and personal injury If monitors and other equipment are placed on top of the Fabius OS, the risk of tipping over the unit is increased, especially when rolling over thres- holds etc. Remove all monitors and other equipment from the top of the Fabius OS before moving the unit.

  • Page 63: Equipotential Bonding

    Connect equipotential bonding to the auxiliary equipment. Connecting AC Power Fabius OS can be operated at mains voltages from 100 V to 240 V. Push power plug into supply mains socket. 2 Switch on the machine by using the ON/OFF switch on the rear of the machine.

  • Page 64: Auxiliary Power Outlets

    Daily and Pre-use Checkout At the completion of the assembly of the Fabius OS, perform the Daily and Pre-use Check- out procedure provided in the Appendix of this manual to ensure that the machine is ready for operation.

  • Page 65: Getting Started

    Powering-Up the Machine ....66 Power-Up Standby Screen ....67 Checking Readiness for Operation ..67 Instructions for Use Fabius OS SW 3.n...

  • Page 66: Powering-Up The Machine

    1 Turn the ON/OFF switch to the ON position. When the ON/OFF switch is turned to the ON position, the Fabius OS performs extensive self-tests on its internal hardware. As these diagnostics are per- formed, each test and its result appear on the screen.

  • Page 67: Power-Up Standby Screen

    WARNING The power-on self-test should be carried out once a day. Switch Fabius OS off and on or start the self- test by pressing the soft key »Run System Test«. Power-Up Standby Screen Following a successful power-up, the Standby screen appears and provides instructions on star- ting the operation of the Fabius OS.
  • Page 68 This page intentionally left blank Instructions for Use Fabius OS SW 3.n...

  • Page 69: Operation

    Ending Operation ..... 90 When Fabius OS is not in use ... . . 90 Preparing for Storage or Transport .

  • Page 70: Power-Up Standby Screen

    Power-Up Standby Screen Following a successful power-up, the Standby screen appears and provides instructions on start- ing the operation of the Fabius OS. Setting Fresh Gas Flow Set the fresh gas flow to the desired concentration using the flow control knobs on the front of the machine.
  • Page 71 A vaporizer must never be left switched on without a fresh-gas flow, because high-concentration anesthetic vapor may leak into machine lines and ambi- ent air, causing damage to materials and health risks. Instructions for Use Fabius OS SW 3.n...

  • Page 72: Setting Vaporizer Concentration

    When actuated, the valve delivers an unmetered flow of at least 35 L/min to the breathing system and breathing bag while bypassing the ventilator. The Fabius OS does not need to be switched on in order to use the O flush.

  • Page 73: Low Flow Anesthesia

    Drägersorb 800 Plus or Drägersorb FREE. The color change indicates that the CO absorbent can no longer absorb CO (Drägersorb 800 Plus and Drägersorb FREE change from white to violet). Instructions for Use Fabius OS SW 3.n...
  • Page 74 – Powdered soda lime on the skin must be washed off immediately, because it may irri- tate the skin. NOTE: Please refer to the specific Instructions for Use for "Drägersorb 800 Plus or Drägersorb FREE". Instructions for Use Fabius OS SW 3.n...

  • Page 75: Clic Adapter

    Make sure that during ventilation the absorber canister is tightly connected to the COSY. CLIC Adapter* The disposable CLIC adapter absorber can also be used on the Fabius OS. For information on installing the CLIC adapter, consult its Instructions for Use. optional...

  • Page 76: Ventilation

    It remains blinking until the selected mode of operation is confirmed. 2 The Waveform window is replaced by the ManSpont window and a message that pro- vides instructions to confirm the mode change. Instructions for Use Fabius OS SW 3.n...
  • Page 77 30 seconds, and for warning alarms from 30 seconds to 60 seconds. Rotate the APL valve adjustment knob to the desired pressure. Clockwise rotation increases the pressure, and counterclockwise rotation decreases the pressure. Instructions for Use Fabius OS SW 3.n...
  • Page 78 Start manual ventilation. The pressure will be limited to the value set on the APL valve. Start manual ventilation by hand via the brea- thing bag. To temporarily relieve pressure: Pull up on the APL valve knob. Instructions for Use Fabius OS SW 3.n...

  • Page 79: Volume Control Ventilation

    When the ventilator settings for Volume Control cause the ventilator to operate at its limits of perfor- mance, it is not possible for the Fabius OS to apply compliance compensation. If the ventilator's perfor- mance limit is reached, it is not possible to incre-...
  • Page 80 20 to 1400 [mL] Frequency 4 to 60 Freq [bpm] ([1/min]) Insp time: 4:1 to 1:4 Exp time Insp pause time: 0 to 50 Insp time PEEP [cmH O] ([hPa]) 0 to 20 Instructions for Use Fabius OS SW 3.n...
  • Page 81 (disconnection) and continuous pressure. An alarm is generated when the pressure curve does not cross the pres- sure threshold either from above or below. Instructions for Use Fabius OS SW 3.n...

  • Page 82: Pressure Control Ventilation

    Freq Min might not be applied accu- Freq [bpm] ([1/min]) rately in the Pressure Control Mode. Insp time: 4:1 to 1:4 Exp time Inspiratory Flow 10 to 75 Insp Flow [L/min] PEEP [cmH O] ([hPa]) 0 to 20 optional Instructions for Use Fabius OS SW 3.n...
  • Page 83 Flow sure monitoring to detect apneas (disconnection) Freq. and continuous pressure. An alarm is generated when the pressure curve does not cross the pres- sure threshold either from above or below. Time Instructions for Use Fabius OS SW 3.n...

  • Page 84: Pressure Support Ventilation

    It is not intended as a primary mode of ventilation. When delivering Apnea Ventilation, the Fabius OS Δ uses the Pressure Support settings for Freq Min, Insp Flow, and PEEP.

  • Page 85: Starting Pressure Support Ventilation

    3 to 20, OFF 3 apnea ventilation Freq Min [bpm] ([1/min]) Trigger Sensitivity 2 to 15 Trigger [L/min] Inspiratory Flow 10 to 85 Insp Flow [L/min] PEEP [cmH O] ([hPa]) 0 to 20 Instructions for Use Fabius OS SW 3.n...
  • Page 86 (disconnection) and continuous pressure. An alarm is generated when the pressure curve does not cross the pres- sure threshold either from above or below. Instructions for Use Fabius OS SW 3.n...

  • Page 87: When Changing Between Ventilation Modes

    When changing from Volume Control or Pressure Control to Pressure Support, the suggested value for Trigger is either the last used value or the site default value. Instructions for Use Fabius OS SW 3.n...

  • Page 88: Ventilator Safety Features

    NOTE: The user should then take action to resolve this, for example by increasing the fresh-gas flow. Fabius OS behaviour in case of no action taken by the user – breathing bag gradually empties completely – after two more strokes the alarm »FRESH GAS LOW«...

  • Page 89: Changing Patients

    Operation Changing Patients WARNING Risk of inappropriate alarm settings As it is possible that Fabius OS devices within a care area have different site default alarm limit configurations, check whether the pre- set alarm limits are appropriate to the new patient.

  • Page 90: Ending Operation

    When Fabius OS is not in use If Fabius OS is not used for an extended period: Unplug the medical gas hoses from the wall supply points of the central gas supply.

  • Page 91: Preparing For Storage Or Transport

    This precau- tion prolongs the service life of the sensor. 2 Switch off system power using the switch on the back of the machine, and disconnect the power plug. Disconnect the scavenger hoses. Instructions for Use Fabius OS SW 3.n...
  • Page 92 Operation 1 Remove the pipeline supply hoses from the central supply. Press the O flush to depressurize the entire system. Instructions for Use Fabius OS SW 3.n...

  • Page 93: Monitoring

    Limits ....... 106 Instructions for Use Fabius OS SW 3.n...

  • Page 94: Main Screen

    Alarms Alarm Indication Fabius OS alarms are organized into three catego- Warning – warning message appears in red in ries based on urgency: alarm window, followed by three excla- – Warning: highest priority alarm, requiring...

  • Page 95: Sorting Of Displayed Alarms

    If an alarm with the category Caution is active and an alarm with the category Warning is generated, the alarm sequence is started for the warning because the warning is assigned the highest prio- rity. Instructions for Use Fabius OS SW 3.n...

  • Page 96: Silencing Alarms

    « key (Silence), the yellow LED turns off. Disabling Volume Alarms Visual and audible volume alarms can be turned on or off during operation using the » « key (Setup). See "Volume Alarms On/Off" on page 128. Instructions for Use Fabius OS SW 3.n...

  • Page 97: Setting Alarm Limits

    Confirm the new value for the alarm limit. The new alarm limit is saved and the cursor moves to the return arrow. The adjustment range and factory default values for all alarms on the Fabius OS are shown in the follo- wing table. Alarm Adjustment...

  • Page 98: Oxygen Monitoring

    2 high oxygen concentration alarm limit 3 low oxygen concentration alarm limit Setting Oxygen Monitoring Alarm Limits Follow the procedure "Setting Alarm Limits" on page 97 to change the high or low alarm limit. Instructions for Use Fabius OS SW 3.n...

  • Page 99: Calibrating The Oxygen Sensor

    « key (Setup) on the front panel. The Setup window appears at the bottom of the screen. 2 Press the »Calibrate O2 Sensor« soft key. 3 The calibration instruction window replaces the Setup window. Follow the directions provided. Instructions for Use Fabius OS SW 3.n...
  • Page 100 »O2 SENSOR FAIL!« appears in the Alarm window. If this happens, ensure that the sensor is correctly assembled and recalibrate the oxygen sensor. Instructions for Use Fabius OS SW 3.n...

  • Page 101: Consequences Of Incorrect O 2 Calibration

    Fabius OS will not complete an attempted calibration; however, if the calibration gas is rich or lean but is within certain limits, the Fabius OS will complete the calibration. As a result, when dis- playing sensor measurements, the Fabius OS dis- plays an oxygen percentage either higher or lower than the actual oxygen percentage.

  • Page 102: O 2 Low Supply Alarm

    »O2 SUPPLY LOW« alarm is generated and the LED (1) starts blinking. If the alarm occurs in Standby mode and the user changes to a ventilation mode, a continuous alarm tone sounds for seven seconds. Instructions for Use Fabius OS SW 3.n...

  • Page 103: Respiratory Volume Monitoring

    3 Minute Volume Measurement (MV) conti- nuously displays the volume of exhaled gas accumulated during the previous minute of respiration in units of liters/minute (L/min). The display range is from 0.0 L/min to 99.9 L/min. Instructions for Use Fabius OS SW 3.n...

  • Page 104: Volume Monitoring Alarms

    While the ventilator is off and the system is in ManSpont mode, these alarms are generated at 30 seconds (Caution) and 60 seconds (Warning). The Fabius OS's volume alarms are automatically enabled when the ventilator is switched from Standby to a ventilation mode.

  • Page 105: Breathing Pressure Monitoring

    The breathing pressure monitoring windows show the following breathing pressure information in numeric and graphic form: NOTE: The Fabius OS can be configured by DrägerService or your local authorized service organization to display mean pressure (MEAN) instead of plateau pressure (PLAT).

  • Page 106: Breathing Pressure Monitoring Alarms

    97 to change the breathing pressure high or threshold alarm limit. NOTE: The pressure threshold alarm limit should be as close as possible to the sensed plateau pressure without exceeding it, approximately 4 cmH (hPa) below the plateau pressure. Instructions for Use Fabius OS SW 3.n...

  • Page 107: Configuration

    Access Alarm Log ..... 133 Access Alarm Volume ....133 Instructions for Use Fabius OS SW 3.n...

  • Page 108: Configuration Functions In Standby Mode

    Standby screen: – »Run System Test« – »Calibrate Flow Sensor« – »Calibrate O2 Sensor« – »Leak/Compl Test« – »Access Alarm Log« – »Restore Site Defaults« Turn off fresh gas flow. Instructions for Use Fabius OS SW 3.n...

  • Page 109: Sleep Mode

    "Power-Up Standby Screen" on page 70). Pressing this key restores the site defaults. The test results are posted on the screen. Following successful completion, the system returns to the Standby screen. Instructions for Use Fabius OS SW 3.n...

  • Page 110: Calibrate Flow Sensor

    »Flow Calibration Failed«. Troubleshooting Flow Calibration Failure If the flow sensor cannot be calibrated, retry the calibration. If the flow sensor still cannot be calibrated, call DrägerService or your local authorized service organization. Instructions for Use Fabius OS SW 3.n...

  • Page 111: Calibrate O 2 Sensor

    If the O sensor cannot be calibrated, replace the capsule in the O sensor housing (see page 169). If the O sensor still cannot be calibrated, call DrägerService or your local authorized service organization. Instructions for Use Fabius OS SW 3.n...

  • Page 112: Leak/Compliance Test

    15 to 30. Upon completion of the test, the results are pos- ted on the screen. Press the rotary knob to return to the Standby screen. Instructions for Use Fabius OS SW 3.n...
  • Page 113 Displayed result Setting Fresh-gas [mL/min] [mL/min] Ventilator Decoupling PEEP measured value and ≤250 PASSED Vaporizer Bypass Valve 251 to 350 measured value and Absorber Flow Tube FAILED >350 >350 and FAILED Oxygen Flush Scavenging Instructions for Use Fabius OS SW 3.n...
  • Page 114 – absorber canister not firmly mounted in place – flow sensor not installed properly – breathing system not assembled and installed correctly – microbial filters not connected securely – breathing bag arm not tight or defective Instructions for Use Fabius OS SW 3.n...

  • Page 115: Access Alarm Log

    To exit the alarm log and return to the Standby screen, select and confirm the return arrow. CAUTION Alarm log data is deleted if Fabius OS is switched off or a total loss of electrical power supply occurs. Restore Site Defaults 2 Press the »Restore Site Defaults«...

  • Page 116: Standby Setup Screen

    »Default Settings« (see below) or »Configuration« (see page 122). (Selecting and confirming the return arrow on the right of the Setup screen will exit the Standby Setup screen and redisplay the Standby screen.) Instructions for Use Fabius OS SW 3.n...

  • Page 117: Default Settings In Standby Setup

    – »Alarm Volume« – »Restore Factory Defaults« Volume Settings Select and confirm the »Volume Settings« label on the Standby Setup screen. The Default Volume Settings window appears at the bottom of the screen. Instructions for Use Fabius OS SW 3.n...
  • Page 118 Pressure Settings and Pressure Support Set- tings Use the procedure described in “Volume Settings” to change the parameters associated with these ventilator modes. Instructions for Use Fabius OS SW 3.n...
  • Page 119 Confirm the new value for the O alarm limit. The new alarm limit is saved and cursor moves to the return arrow. If necessary, repeat the process for the other parameter alarm limits. Instructions for Use Fabius OS SW 3.n...
  • Page 120 Configuration The adjustment range and factory default values for all alarms on the Fabius OS are shown in the follo- wing table. Alarm Adjustment Factory Parameter Range Default Value 19 to 100 18 to 99 0.1 to 20.0 12.0 L/min 0.0 to 19.9...
  • Page 121 Select and confirm »Yes« or »No«. When is selected, the factory defaults are restored and replace the current default settings. The factory defaults for the Fabius OS are shown in the table below: Parameter Factory Default Settings...

  • Page 122: Configuration In Standby Setup

    The following settings are available under Configu- ration: – »Time Set« – »Time Format« – »Date Set« – »Date Format« – »Acoustic Confirmation« – »Alarm Tone Sequence« – »Waveform Display« – »Display Background« Instructions for Use Fabius OS SW 3.n...
  • Page 123 »15« to »30«). The new time values are saved, the Time Set win- dow is removed from the screen, and the cursor returns to the Time Set label. Instructions for Use Fabius OS SW 3.n...
  • Page 124 »Time Format« label. Date Set The values that can be selected are two-digit numerical values for day, month, and year. Use the procedure described in "Time Set" on page 123 to change the date parameter. Instructions for Use Fabius OS SW 3.n...
  • Page 125 The values that can be selected for the alarm tone sequence are »Standard« or »Dräger«. Use the procedure described in "Time Format" on page 124 to change the alarm tone sequence para- meter. Instructions for Use Fabius OS SW 3.n...
  • Page 126 Display Background The values that can be selected for the display background are »Dark« or »Light«. Use the procedure described in "Time Format" on page 124 to change the display background para- meter. Instructions for Use Fabius OS SW 3.n...

  • Page 127: Configuration During Operation

    Setup functions during operation. If no rotary knob activity occurs within 15 seconds, the Setup win- dow is removed and the waveform window is redis- played. The waveform window can be also displayed by pressing the » « key (Home). Instructions for Use Fabius OS SW 3.n...

  • Page 128: Volume Alarms On/Off

    The threshold setting may not be less than 5 cmH O (5 hPa) or greater than 30 cmH (30 hPa). NOTE: In the absence of a current plateau pressure data value, pressing the soft key will have no effect. Instructions for Use Fabius OS SW 3.n...

  • Page 129: Calibrate O 2 Sensor

    Sensor and expose to room air for 2 minutes. – To start O calibration press rotary knob. – Observe Calibration status in O data window. – Reinsert O Sensor after successful Calibra- tion. Instructions for Use Fabius OS SW 3.n...

  • Page 130: Des Comp On/Off

    This parameter is used to activate or deactivate desflurane compensation. 2 Press the »Des Comp Off« soft key in the Setup window. The key label changes from »Des Comp Off« to »Des Comp On«, and des- flurane compensation is activated. Instructions for Use Fabius OS SW 3.n...
  • Page 131 CAUTION Desflurane has characteristics that affect the sen- sitivity of the Fabius OS flow sensor. To help assure that the volume measurements from the monitor are accurate, activate Desflurane com- pensation when Desflurane is used in the brea- thing circuit.

  • Page 132: Automatic Desflurane Compensation

    Configuration Automatic Desflurane Compensation If Desflurane concentration data is communicated to the Fabius OS by an external agent analyzer, the following occurs: 1 »Des auto« appears in the status bar at the top of the screen. 2 The »Des Comp On/Off« soft key label is removed.

  • Page 133: Access Alarm Log

    Select and confirm a new alarm volume value in the range of 1 (minimum) to 10 (maximum). The value is saved and the Alarm Volume Setting window is replaced by the Setup window. Instructions for Use Fabius OS SW 3.n...
  • Page 134 This page intentionally left blank Instructions for Use Fabius OS SW 3.n...

  • Page 135: Fault-Cause-Remedy

    Overriding the Ventilator ....138 Fault-Cause-Remedy ....140 Instructions for Use Fabius OS SW 3.n...

  • Page 136: Power Failure Backup

    Fault-Cause-Remedy Power Failure Backup When AC power is interrupted from the Fabius OS, the internal battery backup will provide full opera- tion of the ventilator and internal monitors for up to two hours after the power interruption. The battery depletion rate depends upon ventilator settings and...
  • Page 137 When the battery is completely discharged Fabius OS switches off. As a consequence all indi- vidual settings including alarm limits, which are not saved in the default settings, will be lost.

  • Page 138: Ventilator Fail State

    Fault-Cause-Remedy Ventilator Fail State If the Fabius OS does not recover from a »VENTILATOR FAIL!!!« condition: Switch to ManSpont mode by pressing the ManSpont key and confirming the mode change by pressing the rotary knob. Set the APL valve to MAN position.
  • Page 139 If the diagnostic tests result in FUNCTIONAL, the Fabius OS will automatically switch to ManSpont mode if a fresh-gas flow is detected. Fabius OS respiratory monitoring is available. If the diagnostic tests result in NON-FUNCTIONAL, manual venti- lation is still possible but Fabius OS respiratory monitoring is not available.

  • Page 140: Fault-Cause-Remedy

    Fault-Cause-Remedy Fault-Cause-Remedy The Fabius OS divides alarm messages into three categories based on priority. Exclamation marks indicate the priority. Warning high priority Caution medium priority Advisory low priority Internal priority numbers, see page 95, for the ran- king within an alarm category are written below in brackets, e.g.
  • Page 141 Volume Control, Check tubing of expiration Pressure Control, or Pressure control line. Support mode. Check flow sensor. Follow the procedure to calib- rate flow sensor. Call DrägerService or your local authorized service orga- nization. Instructions for Use Fabius OS SW 3.n...
  • Page 142 Plateau pressure is more than Check ventilator, patient cir- (11) 3 cmH O (hPa) below the cuit, and P settings. INSP setting and the expec- INSP ted Plat while ventilating in Pressure Control or Pressure Support mode. Instructions for Use Fabius OS SW 3.n...
  • Page 143 Follow the procedure to calib- sensor replaced and/or not rate O sensor. calibrated. Replace sensor capsule and sensor used up. calibrate. Connect O sensor assembly. sensor disconnected. Replace O sensor housing Faulty sensor cable. assembly. Instructions for Use Fabius OS SW 3.n...
  • Page 144 External monitor cable discon- Check monitor interface nected from External Commu- cable. nication Port 1. RS232 COM2 FAIL External monitor cable discon- Check monitor interface nected from External Commu- cable. nication Port 2. Instructions for Use Fabius OS SW 3.n...
  • Page 145 Check diaphragm and close (28) correctly. cover. Check PEEP/P line for disconnect or leak. Select Standby Mode and switch back to the previous ventilation mode. VOLUME ALARMS OFF Volume alarms disabled by operator. Instructions for Use Fabius OS SW 3.n...
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  • Page 147: Cleaning, Disinfection And Sterilization

    Sensor ......155 Care List for Fabius OS Components ..156 Reassembling the Breathing System .

  • Page 148: Safety Information On Reprocessing

    Affected parts: compact breathing system, valve cover, expiration nozzle, absorber and APL valve – Afterwards rinse all parts thoroughly under run- ning water until no residue of the cleaning agents is detected (approx. 5 min). Instructions for Use Fabius OS SW 3.n...

  • Page 149: Manual Cleaning

    Remove disinfectant residues. Observe the relevant Instructions for Use. Rinse parts under running water until no clea- ning agent residues are discernible. Check parts for visible soiling and damage. Repeat manual cleaning if necessary. Instructions for Use Fabius OS SW 3.n...

  • Page 150: Visual Inspection

    CAUTION There is a risk of damage to the medical device. CAUTION The surfaces of Fabius OS, the pressure gas Even accessories designed to be reused (e.g. hoses and cables must not be treated with alcohol after reprocessing) have a limited service life. Due...

  • Page 151: Removing The Compact Breathing System

    5 Remove the gasket on top of the valve disc. Removing the Expiratory Valve 6 Unscrew the retaining nut. 7 Remove the inspection cap. 8 Extract the valve disc. 9 Remove the gasket on top of the valve disc. Instructions for Use Fabius OS SW 3.n...

  • Page 152: Removing The Waste Gas Port

    Disinfect and clean the flow sensor as described in the Instructions for Use of the Spirolog, Infinity ID flow sensor and SpiroLife flow sensors. Instructions for Use Fabius OS SW 3.n...

  • Page 153: Removing Parts Of The Ventilator

    1 Open the ventilator door. 2 Disconnect the pressure sensor line of the ven- tilator chamber from the respective connector. 3 Unlock the three clasps. 4 Remove the cover. 5 Remove the ventilator diaphragm. Instructions for Use Fabius OS SW 3.n...

  • Page 154: Removing Anesthetic Gas Scavenging System

    Observe the hospital hygiene regulations. NOTE: Reprocessing/disinfection instructions for the reusable suction bottle and the suction regulator, refer to their respective Instructions for Use. Instructions for Use Fabius OS SW 3.n...

  • Page 155: O 2 Sensor

    All components with the suitable reprocessing opti- in the flow sensor may be destroyed. The Spirolog ons are listed in the maintenance list for Fabius OS and Infinity ID flow sensors must not be sterilized components page 156. Follow the hygiene regula- in hot steam.

  • Page 156: Care List For Fabius Os Components

    The list is only intended as a rough guideline. The CAUTION instructions of the hospital´s hygiene officer shall prevail and must be observed! Fabius OS and its components must not be trea- ted with formaldehyde vapors or ethylene oxide. Fabius OS Recommen-...
  • Page 157 7) Remove any water which may have accumulated in the ventilator diaphragm. Large quantities of condensed water can negatively effect the operation of the device and lead to failure of the medical device! Instructions for Use Fabius OS SW 3.n...

  • Page 158: Reassembling The Breathing System

    Lines/cables caught underneath the APL valve adjustment knob could interfere with proper functioning of this valve. 10 Position the APL valve in the valve seat, and tighten securely with the retaining nut. Instructions for Use Fabius OS SW 3.n...

  • Page 159: Screw The Waste Gas Port

    – breathing bag extension* and bag – flow sensor and breathing pressure cables – APL bypass and PEEP/P cables – O sensor cable – breathing system hoses Follow instructions on page 169 to reinstall the absorber system optional Instructions for Use Fabius OS SW 3.n...

  • Page 160: Reinstalling The Ventilator

    4 Insert the diaphragm. Fit the cover and lock the three clasps. 5 Connect pressure sensor line to the ventilator chamber to the respective connector. Close the ventilator door with the attached ven- tilator unit. Instructions for Use Fabius OS SW 3.n...

  • Page 161: Reinstalling The Scavenger System

    Reinstalling the Scavenger System Reconnecting the Anesthetic Gas Receiving System (AGS) Every Anesthetic Gas Scavenging System (AGSS) used on the Fabius OS must follow ISO standard 8835-3. The scavenging system is used with vacuum waste-gas disposal systems. The AGS is not applied as an independent system.
  • Page 162 Otherwise there may be a shor- tage of fresh gas in the breathing system. For detailed information on the AGS, refer to the specific Instructions for Use provided with the anesthetic gas receiving system AGS (9038579). Instructions for Use Fabius OS SW 3.n...

  • Page 163: Reinstalling The Suction System

    Cleaning, Disinfection and Sterilization Reinstalling the Suction System Reconnecting the Suction System The optional aspiration system for the Fabius OS consists of an suction regulator and a suction bottle. The suction regulator is attached to a holder, which is fastened on the side channel of the anes- thesia device.

  • Page 164: Checking Readiness For Operation

    Cleaning, Disinfection and Sterilization Checking Readiness for Operation At the completion of the reassembly of the Fabius OS, perform the Daily and Pre-use Check- out procedure provided in the Appendix of this manual to ensure that the machine is ready for ope- ration.

  • Page 165: Maintenance

    CLIC Adapter ......171 Checking Readiness for Operation ..171 Instructions for Use Fabius OS SW 3.n...

  • Page 166: Overview

    Measures intended to restore a medical device to operating condition, not including enhancement. Inspection Inspections must be carried out regularly according to the following specifications and in the specified intervals. Check Interval Personnel responsible Inspection and Safety Checks every 12 months professionals Instructions for Use Fabius OS SW 3.n...

  • Page 167: Safety Checks

    – Check correct functioning of Vaporizer Interlock function. – Check correct functioning of auxillary air supply and safety valves of ventilator. – Check correct functioning of S-ORC. – Check correct functioning of vaporizers accor- ding the IfU of vaporizers. Instructions for Use Fabius OS SW 3.n...

  • Page 168: Preventive Maintenance

    NOTE If desired, the customer may receive a list of those parts and their assembly instructions to be replaced in the event of repairs being necessary. Instructions for Use Fabius OS SW 3.n...

  • Page 169: Routine Maintenance

    CO (Drägersorb 800 Plus and Drägersorb FREE change from white to violet). NOTE: Please refer to the specific Instructions for Use for "Drägersorb 800 Plus or Drägersorb FREE". Instructions for Use Fabius OS SW 3.n...
  • Page 170 – Powdered soda lime on the skin must be washed off immediately, because it may irri- tate the skin. Instructions for Use Fabius OS SW 3.n...

  • Page 171: Checking Readiness For Operation

    CLIC Adapter* The disposable CLIC adapter absorber can also be used on the Fabius OS. For information on installing the CLIC adapter, consult its Instructions for Use. Checking Readiness for Operation...
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  • Page 173: Disposal

    Disposal Disposal Disposing of the medical device ..174 Disposing of non-rechargeable batteries ..174 Instructions for Use Fabius GS premium SW 3.n...

  • Page 174: Disposing Of The Medical Device

    Disposal Disposing of the medical device At the end of its service life: Have the medical device appropriately dis- posed of in accordance with applicable laws and regulations. Disposing of non-rechargeable batteries WARNING Risk of explosion and of chemical burns Improper handling of batteries can result in explosions and chemical burns.

  • Page 175: Technical Data

    Diagram ......194 Gas flow diagram ..... . 194 Instructions for Use Fabius OS SW 3.n...

  • Page 176: Ambient Conditions

    Conform to ASME B40.1 Grade B Cylinder Gauge Range 0 to 3000 psi (206.8 kPa x 100) 0 to 3000 psi (206.8 kPa x 100) 0 to 3000 psi (206.8 kPa x 100) Instructions for Use Fabius OS SW 3.n...
  • Page 177 100 to 240 VAC, 50/60 Hz, 2.3 Amax Rating non-configurable, with optional Dräger mul- tiple socket outlet (see instructions for use for Mul- tiple socket outlet for medical devices, 9039553) 1) Width may vary with COSY arm position Instructions for Use Fabius OS SW 3.n...

  • Page 178: Fuses

    Operation time with fully charged batteries: 45 minutes, minimum Fuses Mains fuses For 100 to 240 V supply voltage: 2x T2.5AH 250 V IEC 60127-2/V Battery fuse 1x T3.15AH 250 V IEC 60127-2/V Instructions for Use Fabius OS SW 3.n...

  • Page 179: Electromagnetic Compatibility (Emc)

    The non-observance may result in increased emissions or decreased immunity of Fabius OS. The Fabius OS should not be used adjacent to or stacked with other equipment; if adjacent or sta- cked use is inevitable, Fabius OS should be obser- ved to verify normal operation in the configuration in which it will be used.

  • Page 180: Electromagnetic Emissions

    Technical Data Electromagnetic emissions The Fabius OS is intended for use in the electro- magnetic environment specified below. The user should assure that it is used only in such an envi- ronment. Emissions Compliance Electromagnetic environment according to RF emissions (CISPR 11)

  • Page 181: Electromagnetic Immunity

    Technical Data Electromagnetic immunity The Fabius OS is intended for use in the electro- magnetic environment specified below. The user should assure that it is used only in such an envi- ronment. Immunity against IEC 60601-1-2 test level Compliance Electromagnetic environment...
  • Page 182 Field strengths from fixed, portable or mobile RF transmitters at the location of the Fabius OS should be less than 3 V/m in the frequency range from 150 kHz to 2.5 GHz and less than 1 V/m above 2.5 GHz.

  • Page 183: Recommended Separation Distances

    GSM 900 mobiles 3.000 3.16 9.49 1) 3 V/m distance to transmitters with frequencies from 150 kHz to 2.5 GHz, otherwise 1 V/m distance. Information regarding separation distances (IEC 60601-1-2: 2001, tables 205 and 206) Instructions for Use Fabius OS SW 3.n...

  • Page 184: Electrical Safety Conformance

    (0 to 20 hPa resolution) Inspiratory pressure 5 to 65 cmH O (1 INSP resolution)) (5 to 65 hPa (1 hPa (setting must be at least 5 cmH O (5 hPa) above PEEP) Instructions for Use Fabius OS SW 3.n...
  • Page 185 ±1 bpm (1/min) of setting Inspiration/expiration ratio ±5 % of setting Inspiration pause ±25 % of setting PEEP End-expiratory pressure ±2 cmH O (±2 hPa) or ±20 % of setting, whichever is greater Instructions for Use Fabius OS SW 3.n...
  • Page 186 Minimal Limit Pressure –8.5 cmH O (–8.5 hPa) System Compliance Measurement 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 actual compliance, whichever is greater Instructions for Use Fabius OS SW 3.n...

  • Page 187: Anesthesia Gas Supply Module

    13 psi (0.9 kPa x 100), maximum Auxiliary Oxygen Flowmeter Connection Staged connector for use with different hose diameters Fresh-gas flow 0 to 10 L/min Accuracy ±5 % of full scale Resolution 0.5 L/min Instructions for Use Fabius OS SW 3.n...

  • Page 188: Anesthetic Agent Vaporizer Interface

    ISO 21647 1) Max. ±4 % of the measured value or ±2 cmH O (±2 hPa), whichever is greater. 2) At standard test conditions per IEC 60601-2-13. Instructions for Use Fabius OS SW 3.n...
  • Page 189 ±0.02 % of measured value / % relative humidity Service life of O sensor cell >12 months at 77 °F (25 °C), 50 % relative humidity, 50 % O gas mixture (or >5000 % hours at 100 Vol.% O Instructions for Use Fabius OS SW 3.n...

  • Page 190: Breathing System

    ±6 hPa (±6 cmH2O), with hose (–4.7 hPa) (4.4 hPa) set for adults M30146 As per ISO 8835-2, dry, sole bre- –3.7 cmH 3.7 cmH athing system without (–3.7 hPa) (3.7 hPa) patient hoses Typical leak <50 mL/min Instructions for Use Fabius OS SW 3.n...
  • Page 191 Technical Data ISO 8835-2: Pressure/Flow Characteristics of Breathing System COSY 2.6 (averaged resistances without breathing tubes) Flow [L/min] averaged Pinsp. [hPa] averaged Pexp. [hPa] Instructions for Use Fabius OS SW 3.n...

  • Page 192: Low Oxygen Supply Pressure Alarm

    23 vol.%. O metering valve open S-ORC prevents N O flow and O metering valve closed or O flow less than 0.2 L/min During N O failure may still be administered. No alarm. Instructions for Use Fabius OS SW 3.n...

  • Page 193: Serial Interface

    Pin 5 GND Galvanic Isolation 500 V Baud Rates: 1200, 2400, 4800, 9600, 19200, 38400 Parity: Odd, Even, None Data Bits: 7 or 8 Start Bits: Stop Bits: 1 or 2 Protocol: Vitalink, MEDIBUS Instructions for Use Fabius OS SW 3.n...

  • Page 194: Diagram

    Technical Data Diagram Gas flow diagram Compact Breathing System Ventilator Setting /PEEP Fresh Gas Decoupling Fresh gas Bypass Valve Absorber Scavenging Instructions for Use Fabius OS SW 3.n...

  • Page 195: Form

    Appendix – Daily and Pre-use Checkout Form Appendix – Daily and Pre-use Checkout Form Before operating the Fabius OS, the following checkout verification form must be completed to ensure that the machine is ready for use. Do not insert any additional components into or modify the anesthesia system after the checkout procedure is started.
  • Page 196 This page intentionally left blank Instructions for Use Fabius OS SW 3.n...
  • Page 197 Checking the Medical Gas Connections into consideration all possible configurations of the Visually inspect all gas supplies from the Fabius OS. The clinician need only use those areas medical gas pipeline system and cylinders that apply to their specific Fabius OS configuration.
  • Page 198 Filling level between min. and max. the rear. Interlock; Locking function OK (when present) Key-indexed filling system; Sealing key or pin inserted and closed tight (when pre- sent). Filler opening locked shut. Instructions for Use Fabius OS SW 3.n...
  • Page 199 Press the Standby key and confirm. Breathing Pressure Trace window stabilizes (e.g., a flat line), flip the APL-valve to SPONT to release pressure. Peak pressure display on monitor reads 24 to 36 cmH O (hPa). Instructions for Use Fabius OS SW 3.n...
  • Page 200 Pre-use Checkout Signature recover its original shape. Block off the mask connector (cone) with the Name ball of your thumb: you should only be able to squeeze the bag a little. Date Instructions for Use Fabius OS SW 3.n...
  • Page 201 Name Date Date Pre-use Checkout Signature Pre-use Checkout Signature Name Name Date Date Pre-use Checkout Signature Pre-use Checkout Signature Name Name Date Date Pre-use Checkout Signature Pre-use Checkout Signature Name Name Date Date Instructions for Use Fabius OS SW 3.n...
  • Page 202 Name Date Date Pre-use Checkout Signature Pre-use Checkout Signature Name Name Date Date Pre-use Checkout Signature Pre-use Checkout Signature Name Name Date Date Pre-use Checkout Signature Pre-use Checkout Signature Name Name Date Date Instructions for Use Fabius OS SW 3.n...

  • Page 203: Index

    Maintenance ......165 Control Panel ......30 Instructions for Use Fabius OS SW 3.n...
  • Page 204 Standby ....... 34 Suction System ..... 54, 154 Instructions for Use Fabius OS SW 3.n...
  • Page 205 This page intentionally left blank Instructions for Use Fabius OS SW 3.n...
  • Page 206 These Instructions for Use only apply to Fabius OS SW 3.n with the Serial-Nr.: If no Serial No. has been filled in by Dräger, these Instructions for Use are provided for general information only and are not inten- ded for use with any specific machine or device.

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