Dräger Fabius Tiro Instructions For Use Manual

Dräger Fabius Tiro Instructions For Use Manual

Anesthesia workstation
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Instructions for use
Fabius Tiro
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 Tiro

  • Page 1 Instructions for use Fabius Tiro 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 Tiro is also referred to as new sequence of actions. 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 Tiro 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 Tiro SW 3.n...
  • Page 5: Table Of Contents

    Switching on ............ 83 Checking the readiness for operation....85 Overview............19 Operation ............86 Fabius Tiro as trolley version (front view)..20 Compact breathing system COSY (top view) .. 21 Standby page after start-up......87 Power supply unit for COSY heating (front Setting the fresh-gas flow........
  • Page 6 Device outlets..........199 Essential performance characteristics..... 200 EMC declaration..........200 Device combinations ........206 Connections to IT networks......206 Illustrations ............208 Annex ............. 209 Form for daily checkout and pre-use checkout 210 Instructions for use Fabius Tiro SW 3.n...
  • Page 7 Safe coupling with electrical equipment ..Patient safety........... 10 Patient monitoring..........10 Information on electromagnetic compatibility .. 10 Installing accessories ........11 Keeping the instructions for use ...... 11 Training............11 Product-specific safety information .... 12 Instructions for use Fabius Tiro 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 Tiro SW 3.n...
  • Page 9: Connected Devices

    CAUTION Risk of patient injury Coupling with electrical equipment that is not mentioned in these instructions for use or assembly instructions may only be done with the respective device manufacturer. Instructions for use Fabius Tiro SW 3.n...
  • Page 10: Patient Safety

    Only operate radio frequency devices at a sufficient safety clearance of at least 20 cm (7.9 in). Instructions for use Fabius Tiro SW 3.n...
  • Page 11: Installing Accessories

    Keeping the instructions for use CAUTION Risk of incorrect use The instructions for use must be kept in an accessible location for users. Training User training is offered by the responsible Dräger organization, see www.draeger.com. Instructions for use Fabius Tiro SW 3.n...
  • Page 12: Product-Specific Safety Information

    During operation the medical device can immediately. move accidentally. Activate the castor brakes. WARNING 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 Tiro SW 3.n...
  • Page 13 – Do not use cyclopropane or ether. in the event of an alarm. – During therapy directly in front of the device. – When preparing for therapy within a distance of up to 4 meters (13 feet). Instructions for use Fabius Tiro 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 Tiro SW 3.n...
  • Page 15: Application

    Application Application Intended use ..........16 Indications/Contraindications ...... 17 Indications ............17 Contraindications..........17 Further information on application....17 Environment of use.......... 17 The MEDIBUS and Vitalink protocols ..18 Instructions for use Fabius Tiro SW 3.n...
  • Page 16: Intended Use

    Risk due to the accumulation of acetone in the patient Do not perform low-flow anesthesia on patients with ketoacidosis or patients under the influence of alcohol. The risk of accumulation of acetone in the patient increases in such cases. optional Instructions for use Fabius Tiro SW 3.n...
  • Page 17: Indications/Contraindications

    This medical device is neither approved nor carried out. certified for use in areas where oxygen concentrations greater than 25 Vol%, combustible or explosive gas mixtures are likely to occur. Instructions for use Fabius Tiro SW 3.n...
  • Page 18: The Medibus And Vitalink Protocols

    For the protection of patients and users from electrical risk, it is required that all systems that consist of medical devices and other electrical devices, such as computers, printers, etc., are assembled exclusively by trained personnel. Instructions for use Fabius Tiro SW 3.n...
  • Page 19: Overview

    Overview Overview Fabius Tiro as trolley version (front view) .. 20 Compact breathing system COSY (top view)..............21 Power supply unit for COSY heating (front view)..............22 Power supply unit for COSY heating (rear view)..............23 Rear view (pin-index connection) ....24 Gas connections (side view) ......
  • Page 20: Fabius Tiro As Trolley Version (Front View)

    Overview Fabius Tiro as trolley version (front view) A Ventilator control panel (settings for ventilation H Drawers parameters and airway monitoring) Locking brake B Total flow tube J Power supply unit for COSY breathing system C Screen heating* D Vaporizer mount...
  • Page 21: Compact Breathing System Cosy (Top View)

    E Flow-sensor guard or COSY guard (not illustrated) F Expiratory port G Connection for breathing bag H Inspiratory port Inspiratory valve J Fresh gas decoupling valve K Connection for APL bypass valve optional Instructions for use Fabius Tiro SW 3.n...
  • Page 22: 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 Tiro SW 3.n...
  • Page 23: 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 Tiro SW 3.n...
  • Page 24: Rear View (Pin-Index Connection)

    K 2 open connections for central supply hoses, 1 C Connection for ventilator hose sealed connection without function D On/Off switch E Fuse F Fresh-gas outlet G Potential equalization pin H Compact breathing system (COSY) Pin-index connection optional Instructions for use Fabius Tiro SW 3.n...
  • Page 25: Gas Connections (Side View)

    280 - 600 kPa 280 - 600 kPa A Vaporizer mount B Connections for central supply hoses C Connections for gas cylinders with O O, or O and Air (screw connections) D Gas cylinders optional Instructions for use Fabius Tiro SW 3.n...
  • Page 26: Interface Panel

    B COM 2 port 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 Tiro SW 3.n...
  • Page 27: Vaporizer

    There are various connector systems with which vaporizes can be connected to an anesthesia workstation. Dräger recommends using only vaporizers that are listed in the list of accessories. Instructions for use Fabius Tiro SW 3.n...
  • Page 28: Ceiling-Mounted Version (Optional)

    In this case, the comprised. anesthesia workstation is not placed on a trolley, (see chapter ''Fabius Tiro as trolley version (front Do not use the anesthesia workstation at an view)'' on page 20), but rather on the mount of a inclination angle over 5°.
  • Page 29: Wall-Mounted Version (Optional)

    (see chapter ''Fabius Tiro as trolley version the cables and hoses may be damaged and (front view)'' on page 20), but rather on a mount on personal damage may occur.
  • Page 30: Supplemental O 2 Delivery (Optional)

    After the O insufflation is ended, the flow control valve of the supplementary 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 Tiro SW 3.n...
  • Page 31: 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 Tiro SW 3.n...
  • Page 32: 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 Tiro SW 3.n...
  • Page 33: 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 Tiro SW 3.n...
  • Page 34 – Multiparameter monitor with 2 COM interfaces – 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 Tiro SW 3.n...
  • Page 35: External Fresh-Gas Outlet

    Fabius do not correspond to the values for the patient connected to external fresh-gas outlet as they are based on measurements taken at the compact breathing system. When using the external fresh-gas outlet, change into the Standby mode. Instructions for use Fabius Tiro SW 3.n...
  • Page 36: Using The External Fresh-Gas Outlet As A Common Gas Outlet

    F Non-rebreathing system (e.g., Bain) Use of the external fresh-gas outlet with an additional switch The switch enables the simple switching of the fresh-gas supply from the compact breathing system to the non-rebreathing system. optional Instructions for use Fabius Tiro SW 3.n...
  • Page 37: Abbreviations

    Respiratory rate 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 Tiro SW 3.n...
  • Page 38 Trigger 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 Tiro SW 3.n...
  • Page 39: Symbols

    Read the flow at the center of the float. Serial number Order number Non-rebreathing system Instructions for use Fabius Tiro SW 3.n...
  • Page 40 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 Tiro SW 3.n...
  • Page 41: Product Labels

    ''Technical data''. max. 235 kg Wall-mounted version, ceiling-mounted version: nom. 48 kg Observe the weight of the nominal configuration and the permissible total weight, see ''Technical max. 105 kg data''. Instructions for use Fabius Tiro SW 3.n...
  • Page 42: 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 Tiro SW 3.n...
  • Page 43: 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 Tiro SW 3.n...
  • Page 44: 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 125. Instructions for use Fabius Tiro SW 3.n...
  • Page 45: Screen Display

    Display of the inspiratory oxygen concentration in – 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 Tiro 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 Tiro 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 Tiro SW 3.n...
  • Page 48: Fresh-Gas Delivery (Version For 3 Gases)

    H Pressure gauge for the central N O supply Pressure gauge for the central Air supply Use only with pin-index connections (not with screwed J Pressure gauge for the central O supply connections) Instructions for use Fabius Tiro 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 Tiro SW 3.n...
  • Page 50: Led Indicators

    (C) have small LEDs that light up when the respective mode is active. LEDs for alarm status Fabius has alarm LEDs that signal alarms and indicate the alarm priority. For additional information, see chapter ''Alarms''. Instructions for use Fabius Tiro SW 3.n...
  • Page 51: Color Coding For Anesthetic Agents And Medical Gases

    – Alarm messages (see chapter ''Alarm priorities''). – 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 Tiro SW 3.n...
  • Page 52: Assembly And Preparation

    Connection of the pressure gauge for measurement of the airway pressure (optional) ................ 77 Connecting the flow sensor ......77 Connecting the APL bypass hose and PEEP/P hose ..........78 Fastening the manual resuscitator ....79 Instructions for use Fabius Tiro SW 3.n...
  • Page 53: Before First Operation

    ''Technical data''. 2 Remove the fuse holder. 3 Insert the fuse (A) in the fuse holder. 4 Screw the fuse holder back in again with a quarter turn clockwise. Instructions for use Fabius Tiro SW 3.n...
  • Page 54: Auxiliary Power Sockets

    – Do not connect any life-supporting devices to the auxiliary power sockets of the anesthesia workstation. – Ensure an alternative power supply for connected devices. Instructions for use Fabius Tiro SW 3.n...
  • Page 55: Connecting The Gas Supply

    – Use an anesthetic gas scavenging correct function. system. – Even when the anesthesia machine is connected to the central gas supply, the gas cylinders should remain at the device with valves closed as backup. Instructions for use Fabius Tiro SW 3.n...
  • Page 56: Central 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 Tiro SW 3.n...
  • Page 57: Gas Cylinders With Pin-Index System (Optional)

    If required, the gas cylinder valve (C) can be repaired according to manufacturer's opened with the supplied wrench (G). specifications. If the gas cylinder is removed, insert the plug (H) in the mounted gas cylinder holder and tighten. Instructions for use Fabius Tiro SW 3.n...
  • Page 58 No hissing must sound when opening the cylinder valves. In this case, the connection is leaking. The gas cylinder must be mounted again. 2 Close the cylinder valves again. Instructions for use Fabius Tiro 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 Tiro SW 3.n...
  • Page 60: Mounting The Anesthetic Vaporizers

    Patient and user can be endangered. – 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 Tiro 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 Tiro SW 3.n...
  • Page 62: Assembling The Breathing System

    Replace if necessary. 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 Tiro SW 3.n...
  • Page 63 (C), remove the absorber insert from the eyes, skin, and airway. absorber container. Leave the inner and outer sealing rings on the absorber insert. Handle the soda lime carefully and do not spill it. optional Instructions for use Fabius Tiro SW 3.n...
  • Page 64 Make sure that the absorber container is between the seals and the seal surfaces. This connected tightly to the compact breathing type of residue can cause system leakages. system during the ventilation. optional Instructions for use Fabius Tiro SW 3.n...
  • Page 65: Mounting The Cosy Heating And The Power Supply Unit (Optional)

    (fresh-gas flow less than 1 L/min).  Before installation of the COSY heating, the leakage test must be performed, see chapter ''Leakage test'' on page 128. Follow the assembly instructions for breathing system heating (9038262 and 8605899). Instructions for use Fabius Tiro SW 3.n...
  • Page 66: Connecting The Compact Breathing System

    – 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 Tiro SW 3.n...
  • Page 67: Inserting The Flow Sensor

    1 Screw out the expiratory port (A). use tools. 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 Tiro SW 3.n...
  • Page 68: Connecting The Exhaust Port

    The breathing bag can be mounted to the compact breathing system with the following variants: – On a flexible arm – On a rigid arm – On the bag elbow directly on the compact breathing system Instructions for use Fabius Tiro SW 3.n...
  • Page 69 3 Fasten the elbow (D) at the end of the flexible 3 Fasten the breathing bag (C) at the other end arm. of the rigid arm. 4 Fasten the breathing bag (C) on the other end of the elbow. Instructions for use Fabius Tiro SW 3.n...
  • Page 70: 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 Tiro SW 3.n...
  • Page 71: 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 Tiro SW 3.n...
  • Page 72 4 Connect the sample line (D) to the connector of the 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 Tiro SW 3.n...
  • Page 73 HMEF or other filters at the Y-piece in connection with a hose adapter that have a patient-side connection for a sample line. The resistance of the breathing system and connected accessories must be observed. Instructions for use Fabius Tiro SW 3.n...
  • Page 74 – Perform a leakage test and compliance test after changing the length of extendable hoses. If necessary, take additional parts such as water traps or additional hoses in consideration. Instructions for use Fabius Tiro SW 3.n...
  • Page 75: Inserting A New O 2 Sensor Capsule

    Make sure that the O sensor is inserted correctly in the inspiratory valve, see page 21. 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 Tiro SW 3.n...
  • Page 76: 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 Tiro SW 3.n...
  • Page 77: Connection Of The Pressure Gauge For Measurement Of The Airway Pressure (Optional)

    4 Plug in the bacterial filter into the connection 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 Tiro SW 3.n...
  • Page 78: 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 Tiro SW 3.n...
  • Page 79: Fastening The Manual Resuscitator

    Especially if the medical device is rolled over door thresholds and similar obstacles. Before moving the device, remove the monitors and other additional devices. Instructions for use Fabius Tiro SW 3.n...
  • Page 80 10 cm tance of max. 10 cm Other accessory parts must be fastened on wall (4"). (4"). rails if necessary. Instructions for use Fabius Tiro SW 3.n...
  • Page 81  Clear the writing tray and slide it completely into the device.  Position the optional flexible arm for breathing bag close to the device. Prepare additional components as described in the respective instructions for use. Instructions for use Fabius Tiro SW 3.n...
  • Page 82: Getting Started

    Getting started Getting started Daily checkout and pre-use checkout ..83 Switching on ..........83 Checking the readiness for operation ..85 FUNCTIONAL ..........85 CONDITIONALLY FUNCTIONAL ....85 NON-FUNCTIONAL ........85 Instructions for use Fabius Tiro SW 3.n...
  • Page 83: Daily Checkout And Pre-Use Checkout

    Do not set the device into operation if oxygen leakage is suspected in the medical device or its vicinity. Stop oxygen supply and contact service personnel.  Set On/Off switch (A) to the position. Instructions for use Fabius Tiro SW 3.n...
  • Page 84 If no tone or only one tone is sounded, the device is only conditionally ready for operation. Contact DrägerService. Instructions for use Fabius Tiro SW 3.n...
  • Page 85: Checking The Readiness For Operation

    A non-critical malfunction was found. The anesthesia workstation can be used. – 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 Tiro SW 3.n...
  • Page 86: Operation

    Using the external fresh-gas outlet with an auxiliary switch (optional) ......108 Preparation............108 Operation with non-rebreathing system ..109 Operation with the compact breathing system (COSY)............109 Ending operation ..........109 Ending operation........... 110 Instructions for use Fabius Tiro SW 3.n...
  • Page 87: Standby Page After Start-Up

    23 Vol%. S-ORC inhibits the N O flow under the following conditions: – N O flow control valve is open, even though the O flow control valve is closed. Instructions for use Fabius Tiro SW 3.n...
  • Page 88: Setting The Anesthetic Gas Concentration

    The following section describes the operation of Vapor 2000.  Set the fresh-gas flow on the anesthesia workstation. Prerequisite: The vaporizer is mounted in accordance with the instructions for use of the respective vaporizer. Instructions for use Fabius Tiro SW 3.n...
  • Page 89: O 2 Flush

    During this an unmetered flow of at least 35 L/min is given to the breathing system and the breathing bag.  Press the (A) key. O flows for as long as the key is held down. Instructions for use Fabius Tiro SW 3.n...
  • Page 90: 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 Tiro SW 3.n...
  • Page 91: 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 Tiro SW 3.n...
  • Page 92: Ventilation

    4 Confirm the new mode. patient must be ventilated manually. In the following examples and illustrations, the change from Volume Control mode to ManSpont mode is described: Instructions for use Fabius Tiro SW 3.n...
  • Page 93 Changing to manual ventilation NOTE In ManSpont mode, the apnea alarm time for triggering apnea volume alarms is extended from 15 seconds to 30 seconds (Caution category) and from 30 seconds to 60 seconds (Warning category). Instructions for use Fabius Tiro SW 3.n...
  • Page 94 6 Start manual ventilation with the breathing bag. The pressure is limited to the value that is set on the APL valve. Pressure release In the ManSpont mode, lifting the valve head relieves pressure from the breathing system. Instructions for use Fabius Tiro SW 3.n...
  • Page 95: 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 Tiro SW 3.n...
  • Page 96 (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 Tiro SW 3.n...
  • Page 97: Ventilation Mode Pressure Control (Optional)

    Freq Min in Pressure Control mode might not exactly be applied. Pressure Control In the following table, all parameters (B) in Pressure Control mode, together with the corresponding setting ranges and factory settings, are listed. Instructions for use Fabius Tiro SW 3.n...
  • Page 98 (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 Tiro SW 3.n...
  • Page 99: Ventilation Mode Pressure Support (Optional)

    The alarm message is deleted as soon as a spontaneous breath is detected. Changing to Pressure Support mode In the following examples and illustrations, the change from Volume Control mode to Pressure Support mode is described: Instructions for use Fabius Tiro SW 3.n...
  • Page 100 ∆PPS Insp Flow Freq Min Freq Min If the inspiratory flow (Insp Flow) during inspiratory effort is greater than the set trigger flow (Trigger), the device supports the patient with the setting ∆PPS. Instructions for use Fabius Tiro SW 3.n...
  • Page 101: Ventilation Mode Simv/Ps (Optional)

    Pressure Support (optional)'' on page 99. Changing to SIMV mode In the following examples and illustrations, the change from Volume Control mode to SIMV/PS mode is described: Volume Control 1 Press the SIMV/PS (A) key. Instructions for use Fabius Tiro SW 3.n...
  • Page 102 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 Tiro SW 3.n...
  • Page 103: 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 Tiro SW 3.n...
  • Page 104: 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 Tiro SW 3.n...
  • Page 105: 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 131. Instructions for use Fabius Tiro SW 3.n...
  • Page 106: Using The External Fresh-Gas Outlet As A Common Gas Outlet (Optional)

    Vamos). 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 Tiro SW 3.n...
  • Page 107: 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 Tiro SW 3.n...
  • Page 108: 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 Tiro SW 3.n...
  • Page 109: 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 Tiro SW 3.n...
  • Page 110: Ending Operation

    3 Close the flow control valves. Power-saving mode is activated after 2.5 minutes. 4 Close the cylinder valves. NOTE Leave Fabius connected to the mains power supply so that the battery is not discharged Instructions for use Fabius Tiro SW 3.n...
  • Page 111: Preparing For Storage Or Transport

    1 Press the key (A) and confirm. 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 Tiro SW 3.n...
  • Page 112: Alarms

    Alarms Alarms Alarm signaling ..........113 Display of alarms ..........113 Acoustic signal ..........113 Alarm priorities ..........114 Suppressing the alarm tone ......115 Adjusting the alarm limits ........ 115 Instructions for use Fabius Tiro SW 3.n...
  • Page 113: Alarm Signaling

    (!!!) is displayed in the alarm message field (A). – The red LED (B) flashes, accom- panied by a repeating alarm tone sequence: E-E-E--E-Bb-----E-E-E--E-Bb – The alarm tone sequence (2x5 alarm tones) sounds every 10 seconds. Instructions for use Fabius Tiro SW 3.n...
  • Page 114: 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 Tiro SW 3.n...
  • Page 115: 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 152. Instructions for use Fabius Tiro SW 3.n...
  • Page 116: Monitoring

    Setting the minute volume alarm limits.... 121 Deactivating the volume alarms ...... 121 Airway pressure monitoring......122 Parameter field and waveform window for airway pressure ..........122 Setting the upper alarm limit and the pressure threshold............123 Instructions for use Fabius Tiro SW 3.n...
  • Page 117: Main Screen

    (%) 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 Tiro SW 3.n...
  • Page 118: 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 134. 3 Confirm new values. Instructions for use Fabius Tiro SW 3.n...
  • Page 119: Consequences Of Incorrect O Calibration

    . Therefore, the If the internal FiO monitoring is deactivated, an displayed O percentage is higher than the external FiO monitoring must be available in actual O percentage. accordance with general safety standards. Instructions for use Fabius Tiro SW 3.n...
  • Page 120: Breathing Volume Monitoring

    D Upper alarm limit of the minute volume in L/min display again, wait at least one minute. E Lower alarm limit of the minute volume in L/min Parameter field for breathing volume Volume Control Instructions for use Fabius Tiro SW 3.n...
  • Page 121: 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 140. 1 Press the (A) key. Instructions for use Fabius Tiro SW 3.n...
  • Page 122: 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 Tiro SW 3.n...
  • Page 123: 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 134. 3 Confirm new values. Instructions for use Fabius Tiro SW 3.n...
  • Page 124: Configuration

    Switching the desflurane compensation on and off ..............142 Automatic desflurane compensation ....142 Accessing the alarm logbook ......143 Clearing the alarm logbook ......143 Closing the alarm logbook....... 143 Changing the alarm volume ......144 Instructions for use Fabius Tiro SW 3.n...
  • Page 125: Configuration In Standby Mode

    If the flow control valves are not closed before the ventilator remains in the previous mode and accessing Standby mode, the following message the pressure waveform window is restored. (D) is shown on the start screen: Instructions for use Fabius Tiro SW 3.n...
  • Page 126: Power-Saving Mode

    Standby mode is Risk of patient injury activated. During the system test, the system is pressurized. To prevent patient injury, do not perform the system test on the medical device if a patient is connected. Instructions for use Fabius Tiro SW 3.n...
  • Page 127: Calibrating The Flow Sensor

    Sensor Calibration completed - reinsert O sensor  Repeat the calibration.  Replace the flow sensor. If the calibration continues to fail, contact Sensor Calibration Failed DrägerService or the authorized local service partner. Instructions for use Fabius Tiro SW 3.n...
  • Page 128: Leakage Test

    System compliance Displayed result [mL/cmH [mL/cmH ≤6.5 Measured value and PASSED 1 Press the Leak /ComplTest softkey (A). The value of the compliance is displayed on the Standby screen. Instructions for use Fabius Tiro SW 3.n...
  • Page 129 >350 and FAILED 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 Tiro SW 3.n...
  • Page 130: 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 Tiro SW 3.n...
  • Page 131: Restoring The Default Settings

    The default settings are restored in the following cases: – Switching Fabius on and off – Performing the system test – Pressing the softkey Restore Site Defaults Standby 1 Press the Restore Site Defaults softkey (A). Instructions for use Fabius Tiro SW 3.n...
  • Page 132: 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 Tiro SW 3.n...
  • Page 133  To return to the Standby Set-up screen, select the input arrow (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 133). optional Instructions for use Fabius Tiro SW 3.n...
  • Page 134 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 Tiro SW 3.n...
  • Page 135 VT= 600 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 Tiro SW 3.n...
  • Page 136: Changing The Configurations

    – Display Background  To return to the Standby Set-up screen, select the input arrow (A) and confirm. 1 Select Time Format (C) and confirm. 2 Select new format and confirm. The window is closed. Instructions for use Fabius Tiro SW 3.n...
  • Page 137 2 Select new format and confirm. The following units can be selected: – hPa The window is closed. – cmH – mbar – kPa 2 Select new unit and confirm. The window is closed. Instructions for use Fabius Tiro SW 3.n...
  • Page 138 2 Select Light or Dark screen brightness and confirm. The window is closed. 1 Select Waveform Display (I) and confirm. 2 Select Normal or Filled curve display and confirm. The window is closed. available only with optional color screen Instructions for use Fabius Tiro SW 3.n...
  • Page 139: Configuration During Operation

    If no change is made within 15 seconds, the pressure waveform is displayed again. Pressing the key (B) will also cause the pressure waveform window to be displayed again. 1 Press the (A) key. Volume Control Instructions for use Fabius Tiro SW 3.n...
  • Page 140: 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 Tiro SW 3.n...
  • Page 141: 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 75. Instructions for use Fabius Tiro SW 3.n...
  • Page 142: 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 Tiro SW 3.n...
  • Page 143: Accessing The Alarm Logbook

    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 softkeys are displayed again. Instructions for use Fabius Tiro SW 3.n...
  • Page 144: 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 Tiro SW 3.n...
  • Page 145: Troubleshooting

    Mains power supply failure ......148 Ventilator failure ..........150 Alarm VENTILATOR FAIL !!! ......150 Failure of the O sensor........ 151 Causes for faulty calibration ......151 Alarm – Cause – Remedy......152 Instructions for use Fabius Tiro SW 3.n...
  • Page 146: 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 Tiro SW 3.n...
  • Page 147: Systematic Localization Of Leakages

    Vaporizers Remove the vaporizers. 1 Perform the leakage test, see chapter ''Leakage test'' on page 128. 2 Contact service personnel if the leakages cannot be localized. Instructions for use Fabius Tiro SW 3.n...
  • Page 148: 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 Tiro SW 3.n...
  • Page 149 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 Tiro SW 3.n...
  • Page 150: 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 Tiro SW 3.n...
  • Page 151: Failure Of The O 2 Sensor

    Replace the O 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 Tiro SW 3.n...
  • Page 152: Alarm - Cause - Remedy

    (31) AIRWAY PRESSURE HIGH !!! The alarm limit was set too Check the breathing sys- low. tem or the alarm limit. Instructions for use Fabius Tiro SW 3.n...
  • Page 153 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 Tiro SW 3.n...
  • Page 154 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 Tiro SW 3.n...
  • Page 155 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 Tiro SW 3.n...
  • Page 156 Pressure Support are not correct. 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 Tiro SW 3.n...
  • Page 157 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 127). removed and reconnected. Instructions for use Fabius Tiro SW 3.n...
  • Page 158 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 127). Sensor error. If necessary, replace the flow sensor. Instructions for use Fabius Tiro SW 3.n...
  • Page 159 (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 Tiro SW 3.n...
  • Page 160 Check whether the 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 Tiro SW 3.n...
  • Page 161: Cleaning, Disinfection And Sterilization

    Non-critical medical devices ......167 Semi-critical medical devices ......167 Visual inspection..........168 Sterilization ............169 Reprocessing list........... 170 Non-critical medical devices ......170 Semi-critical medical devices ......172 Before using on patients again ....173 Instructions for use Fabius Tiro SW 3.n...
  • Page 162: 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 Tiro SW 3.n...
  • Page 163: Information Concerning Dismounted Accessory Parts And Attached Devices

    – Soda lime dust filter (optional) – 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 Tiro SW 3.n...
  • Page 164: 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 Tiro SW 3.n...
  • Page 165: 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 Tiro SW 3.n...
  • Page 166: 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 Tiro SW 3.n...
  • Page 167: 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 Tiro SW 3.n...
  • Page 168: Visual Inspection

    After cleaning, the breathing system must be sterilized with steam until it is completely dry. Instructions for use Fabius Tiro SW 3.n...
  • Page 169: 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 Tiro SW 3.n...
  • Page 170: 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 Tiro SW 3.n...
  • Page 171 – 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 Tiro SW 3.n...
  • Page 172: Semi-Critical Medical Devices

    – When the sample 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 Ventilator membrane After each patient Instructions for use Fabius Tiro SW 3.n...
  • Page 173: 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 162. 3 Check readiness for operation, see ''Checking the readiness for operation'' on page 85. Instructions for use Fabius Tiro SW 3.n...
  • Page 174: Maintenance

    Maintenance Maintenance Overview ............175 Inspection ............176 Safety checks ..........176 Service............177 Repair ............. 178 Instructions for use Fabius Tiro SW 3.n...
  • Page 175: 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 Tiro SW 3.n...
  • Page 176: Inspection

    – Check the proper function of the O – Check S-ORC functionality. measurement – Check the function of the anesthetic vaporizer according to the associated instructions for use. – Check the function of the O flush. Instructions for use Fabius Tiro SW 3.n...
  • Page 177: Service

    Service personnel Lead-gel battery Every 3 years Replace Experts Cylinder pressure reducer for After 6 years Basic overhauling Experts high-pressure cylinders Pressure reducer for PIN After 6 years Replace Experts index 1) optional Instructions for use Fabius Tiro SW 3.n...
  • Page 178: Repair

    Maintenance Repair For repairs, Dräger recommends DrägerService and the use of original Dräger parts. Instructions for use Fabius Tiro SW 3.n...
  • Page 179: Disposal

    Disposal Disposal Disposing of the medical device....180 For countries subject to the EU Directive 2002/96/EC............180 Disposal of accessories........ 180 Disposal of non-rechargeable batteries ..181 Instructions for use Fabius Tiro SW 3.n...
  • Page 180: 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 Tiro SW 3.n...
  • Page 181: 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 Tiro SW 3.n...
  • Page 182: Technical Data

    General information......... 200 Electromagnetic emissions......201 Electromagnetic environment......202 Electromagnetic immunity ....... 203 Recommended safety clearance for portable and mobile high-frequency communication equipment............205 Reduced safety clearance for portable and mobile high-frequency communication equipment............205 Instructions for use Fabius Tiro SW 3.n...
  • Page 183: 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 Tiro SW 3.n...
  • Page 184: 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 Tiro SW 3.n...
  • Page 185 9038776) Internal battery Power rating 24 V; 3.5 Ah Type Closed, lead/acid, gel Charge time 16 hours on mains power for full operating time Backup time with fully charged battery Minimum 45 minutes Instructions for use Fabius Tiro SW 3.n...
  • Page 186: Fuses

    For 100 to 240 V power supply 2x T2.5AH 250 V IEC 60127-2/V Size: Length 20 mm, ø5 mm (glass 4.4 mm) Battery fuse 1x T3.15AH 250 V IEC 60127-2/V Size: Length 20 mm, ø5 mm (glass 4.4 mm) Instructions for use Fabius Tiro SW 3.n...
  • Page 187: External Fresh-Gas Outlet

    General requirements for safety, collateral stan- dard: Programmable electrical medical systems IEC 60601-1-8 Part 1-8: Medical electrical equipment General requirements for safety, collateral stan- dard: General requirements, tests, and guidance for alarm systems in medical electrical systems Instructions for use Fabius Tiro SW 3.n...
  • Page 188 ISO 80601-2-13 Part 2-13: Medical electrical equipment Particular requirements for basic safety and essen- tial performance of an anaesthetic workstation Instructions for use Fabius Tiro SW 3.n...
  • Page 189: Ventilator

    (3 to 20 hPa (resolution: 1 hPa)), in Pressure Support mode Support pressure (∆PPS) 3 to 20 cmH O, OFF (resolution: 1 cmH (3 to 20 hPa OFF (resolution: 1 hPa)), in SIMV/PS mode Instructions for use Fabius Tiro SW 3.n...
  • Page 190 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 Tiro SW 3.n...
  • Page 191: Anesthetic Gas Supply Module

    Maximum 13 psi (0.9 kPa x 100) ±5% 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 Tiro SW 3.n...
  • Page 192: Vaporizer Interface

    (68 °F) Ambient value is higher pressure and satu- rated gas Expiratory tidal 0 to 1500 mL 1 mL ±15 % or ±20 mL, volume depending on which value is higher Instructions for use Fabius Tiro SW 3.n...
  • Page 193 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 Tiro SW 3.n...
  • Page 194: 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 Tiro SW 3.n...
  • Page 195 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 Tiro SW 3.n...
  • Page 196 Technical data Instructions for use Fabius Tiro SW 3.n...
  • Page 197: Alarm For Low Oxygen Supply Pressure

    (approx. 52 dB(A) at max. alarm tone volume) Time exceeded when changing ventilation mode 3 tones adjustable from 50 dB(A) to approx. 61 dB(A) Selection of alarm volume Single tone per level (corresponds to volume of alarm tone) Instructions for use Fabius Tiro SW 3.n...
  • Page 198: S-Orc (Sensitive Oxygen Ratio Controller)

    O flow control valve is open and at the same O flow. time the O flow control valve is closed or set at less than 0.2 L/min. In case of N O failure can continue to be supplied. No alarm. Instructions for use Fabius Tiro SW 3.n...
  • Page 199: Device Outlets

    Data bits 7 or 8 Parity Uneven, even, none Startbit Stopbit 1 or 2 Pin assignment Pin 1 Pin 2 Pin 3 Pin 4 Pin 5 Pin 6 Pin 7 Pin 8 Pin 9 Instructions for use Fabius Tiro SW 3.n...
  • Page 200: Essential Performance Characteristics

    Dräger is inevitable, verify correct functioning of the medical device in this configuration before it is used. In any case, strictly observe the instructions for use of the other devices. Instructions for use Fabius Tiro SW 3.n...
  • Page 201: Electromagnetic Emissions

    Communication devices in accordance with IEEE 802.15.1: – 2400 to 2485 MHz – FHSS (frequency-hopping spread spectrum) limited to 2.5 mW See the instructions for use of the wireless devices for further details. Instructions for use Fabius Tiro SW 3.n...
  • Page 202: Electromagnetic Environment

    (without transformer) to the public low-voltage power supply net- work that supplies buildings used for domestic purposes. Harmonic emissions (IEC 61000- Not applicable 3-2) Voltage fluctuations/flicker emis- Not applicable sions (IEC 61000-3-3) Instructions for use Fabius Tiro SW 3.n...
  • Page 203: Electromagnetic Immunity

    25 periods 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 Tiro SW 3.n...
  • Page 204 150 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 Tiro SW 3.n...
  • Page 205: 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 Tiro SW 3.n...
  • Page 206: Device Combinations

    The following documents must be followed: – Signaling of alarms – Accompanying documents of this device – Service mode, access to logbooks – Descriptions of the network interface – Description of the network-based alarm systems Instructions for use Fabius Tiro SW 3.n...
  • Page 207 24 V DC and meet the requirements of one of the following standards: – IEC 60950-1: Ungrounded SELV circuits – IEC 60601-1 (2nd edition or later): Exposed secondary electrical circuits Instructions for use Fabius Tiro SW 3.n...
  • Page 208: Illustrations

    Technical data Illustrations Gas flow plan of the breathing system Instructions for use Fabius Tiro SW 3.n...
  • Page 209: Annex

    Annex Annex Form for daily checkout and pre-use checkout............210 Checklist ............211 Instructions for use Fabius Tiro SW 3.n...
  • Page 210: Form For Daily Checkout And Pre-Use Checkout

    CAUTION 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 Tiro SW 3.n...
  • Page 211 Fresh-gas delivery and S-ORC selected. Activate the ManSpont mode. D-Vapor (if present) is switched on. Open the O flow control valve completely. Check whether the electronic O fresh-gas flow display shows at least 10 L/min. Instructions for use Fabius Tiro SW 3.n...
  • Page 212 Control dial is in position 0. Check type of gas Filling level is between the minimum mark and maximum mark. Set the O flow control valve to 3 L/min. Instructions for use Fabius Tiro SW 3.n...
  • Page 213  Check all plug connections and screw con- Press the standby key and confirm. nections for a tight seat.  Replace missing or damaged seals. If nec- essary, contact DrägerService or the authorized local service partner Instructions for use Fabius Tiro SW 3.n...
  • Page 214 – The APL valve is set to the desired pres- Occlude the Y-piece. Close all flow control sure. valves. – All electronic fresh-gas flow displays and Change to the Standby screen. the total flow tube indicate 0. Instructions for use Fabius Tiro SW 3.n...
  • Page 215 Date and sufficiently filled. Signature for pre-use checkout Name Date Signature for pre-use checkout Name Date Signature for pre-use checkout Name Date Signature for pre-use checkout Name Date Instructions for use Fabius Tiro SW 3.n...
  • Page 216 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 Signature for pre-use checkout Signature for pre-use checkout Name Name Date Date Instructions for use Fabius Tiro SW 3.n...
  • Page 217 Signature for pre-use checkout Name Date Signature for pre-use checkout Name Date Signature for pre-use checkout Name Date Signature for pre-use checkout Name Date Signature for pre-use checkout Name Date Signature for pre-use checkout Name Date Instructions for use Fabius Tiro SW 3.n...
  • Page 218 This page intentionally left blank. Instructions for use Fabius Tiro SW 3.n...
  • Page 219 Password Password Configuration password for Fabius Tiro Software 3.n Cut-out from the instructions for use of Fabius Tiro Software 3.n To prevent unauthorized alteration, the start settings for Fabius Tiro are protected by the following configuration password: 8088 Information for the configuration...
  • Page 220 This page intentionally left blank. Instructions for use Fabius Tiro SW 3.n...
  • Page 221 Breathing hose configurations ....73 Breathing hoses and filters ....71 Instructions for use Fabius Tiro SW 3.n...
  • Page 222 Pin-index system ......57 Gas supply ......55 Instructions for use Fabius Tiro SW 3.n...
  • Page 223 Vaporizer interface ..... . 192 Ventilation ......92 Instructions for use Fabius Tiro SW 3.n...
  • Page 224 These instructions for use only apply to Fabius Tiro 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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