ACUTRONIC fabian HFO Instructions For Use Manual
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ACUTRONIC fabian HFO Instructions For Use Manual

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Ventilation Beyond Limits
fabian HFO and Auxiliary Systems
Instructions for Use, Software Version 5.1.x
Warning
Carefully read the instructions for use
before using the ventilator to
familiarise yourself with the function of
the equipment
fabian HFO | SW 5.1.x
Ref: 113003.EN / Date 2020-02-10

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Summary of Contents for ACUTRONIC fabian HFO

  • Page 1 Ventilation Beyond Limits fabian HFO and Auxiliary Systems Instructions for Use, Software Version 5.1.x Warning Carefully read the instructions for use before using the ventilator to familiarise yourself with the function of the equipment fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 2 DISCLAIMER ACUTRONIC Medical Systems assumes no responsibility for the use or reliability of its software on equipment that is not furnished by ACUTRONIC Medical Systems. ACUTRONIC Medical Systems makes no warranty of any kind with regard to software applications that are created by the user.

  • Page 3: Table Of Contents

    Intended use ......................14 System overview ......................15 Scope of delivery ....................... 15 Contraindications ....................... 15 fabian HFO front connections ..................15 3.3.1 Devices with serial number prefix AI / AL ................15 3.3.2 Devices with serial number prefix 20 / AK / AH ..............16 3.3.3...
  • Page 4 Watchdog alarms ......................... 84 Battery operation ......................85 Power failure ......................86 Operating on External Power Source (devices with SN till AI-01500 and AL-00400) .. 87 10 Ventilation parameters ....................88 fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 5 PRICO errors ........................127 12.5 External communication, PDMS ................129 12.6 FOT ......................... 129 12.6.1 Forced Oscillation Technique (FOT) at fabian HFO ............129 12.6.2 FOT general layout ......................131 12.6.3 Erasing the FOT graph ....................... 132 12.6.4 FOT disabling conditions ....................132 fabian HFO | SW 5.1.x...
  • Page 6 19 Electromagnetic compatibility statement ..............164 19.1 Devices from SN AI-01500 and AL-00400 ............... 164 19.2 Devices till SN AI-01500 and AL-00400 ..............168 Appendix A Glossary ......................172 Appendix B Index ......................... 174 fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 7: Introduction

    NOTE: Notes provide additional information to clarify an explanation or instruction. 1.3 Applicable product versions This Instruction for Use is applicable for fabian HFO devices running software version 5.1.x, where (x) can be any number. fabian HFO | SW 5.1.x...

  • Page 8: Symbols

    Potential equalisation connection Flammability/Fire hazard warning Flow sensor connection Sensor Flow sensor connection External power supply input Fragile, Handle with care High Frequency interference warning Keep away from heat Keep dry fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 9 Type B applied part Unplug power before opening housing Video output USB connection Warning regarding operation in explosive areas Do not use if package is damaged Expiration date Storage temperature fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 10 Introduction Symbol Description Humidity limitation Medical device Do not use when patient is connected. For training purpose only fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 11: Warnings Cautions And Notices

    WARNING: Connect only electrical devices which are IEC60601-1 approved. WARNING: NEVER operate the ventilator while covered or set up in a way to negatively impact the operation or function. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 12 WARNING: Always unplug the ventilator from the power source before opening the housing. WARNING: NEVER use anti-static or electrically conductive tubing. NOTE: To support patient and operator safety, the fabian HFO does not contain VOCs, CO, CO , and particulates emitted above hazardous thresholds.

  • Page 13: Maintenance

    Inspection according to manufacturer specifications is required every 12 months. • Maintenance must be performed by ACUTRONIC Medical Systems trained personnel with access to appropriate test and measuring equipment. We strongly recommend ACUTRONIC Medical Systems AG exclusive representatives for service agreements and repairs.

  • Page 14: Liability For Functionality / Damages

    ACUTRONIC Medical Systems AG sales terms and delivery conditions. 2.4 Intended use The fabian HFO is intended for premature infants, new-borns as well as children weighing up to 30 kg. The fabian HFO evolution is intended for “in-patient use” in professional healthcare environment including intra-hospital patient transport.

  • Page 15: System Overview

    Severe airflow obstruction, and intracranial hypertension, would contraindicate the use of the fabian HFO neonatal and infant ventilator. fabian HFO should not be used in association with HF electrosurgical equipment. In the event of ventilation for several hours or more, care must be taken for optimal conditioning of the respiratory gases (warmth, humidification) to optimize secretion mobilization and prevent damage to mucous membranes.

  • Page 16: Devices With Serial Number Prefix 20 / Ak / Ah

    Inspiratory limb port/ center port for connecting nCPAP system based on flow generators (single limb systems) Expiratory limb port Proximal Pressure port HFO Port (optional) 3.3.3 Rear panel of device from SN AI-01500 and AL-00400 fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 17: Hardware With Video Input

    Connection for compressed air supply 2.0 – 6.0 bar / max 40 l/min Connection for oxygen “O ” supply 2.0 – 6.0 bar / max 40 l/min 3.3.4 Hardware with video input fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 18: Initial Hardware Model

    2.0 – 6.5 bar / 40 l/min Pressurised air connector 2.0 – 6.5 bar / 40 l/min Power Connector (fuse 1.25 AT) Equipotential connection 3.3.5 Initial hardware model fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 19: General Hardware Characteristics

    Max contact load: 30 VDC @ 1A USB: 5V @ 150 mA max RS-232: Signal Levels: EIA/TIA-232 Standard Pin 9 Power: 5V @ 500 mA max (models without DC input) Isolated fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 20 Ethernet: N/A (disabled) Flow Sensor: Maximum load is one Flow sensor (Only ACUTRONIC Medical Systems Flow sensors can be connected) Max. Voltage: 5 V Max. operating current: 300 mA per hotwire -> 600 mA total. SpO2: Max. Voltage: 3.3 V Max.

  • Page 21: System Functions And Displays

    Switches to the Alarm Limits Configuration. Alarm Silence For acknowledging and audibly silencing alarms for a maximum duration of 120 seconds. Subsequent alarms with higher priority are visually displayed during periods of alarm silence. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 22: Rotary Push Knob

    The Rotary Push knob combines a push button with a rotary knob for executing various settings, selections and confirmation options. 4.2 Display concept structure 4.2.1 Display areas The information system features two key display areas 1. The Touch screen 2. LED indicators fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 23: Display Screen

    • Nurse Call Active / Inactive • Battery Charge Status 2. Ventilation mode, information and alarm message display 3. Alarm mute (time remaining until audible alarm reactivates) Time / Date. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 24: Numeric Field / Alarm Limits

    To go to the next page, press the button (1) below the Numeric area. Depending on the Ventilation mode the data is updated as average / minute or by breath. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 25 (in IPPV, SIPPV, SIMV, SIMV+PSV, PSV modes) OFF, ‒5 to 29 Lower limit ‒10 to 89 PEEP [mbar] Lower limit (in IPPV, SIPPV, SIMV, SIMV+PSV, PSV modes) [mbar] Upper limit 1 to 55 mean fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 26: Graphics Display

    You can also switch to Loop Display view. In this view two loops and one of three waves are displayed. LOOP Display: • Pressure / Volume • Volume / Flow fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 27: Led Indicators

    2. Report the incident to your local distributor Do not use the device until it has been checked by suitably trained and qualified personnel. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 28: Ventilation Menu

    Using the push button, you can also switch between the Pressure-, Volume- and Flow curve (3). The Information bar (1) indicates current information. The ventilation mode can be changed in the menu (5). fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 29: Operation - Settings

    Press any blank area or another parameter to NOT accept the parameter and keep the previous value. Alternating alarms active at the time the mode is switched will automatically be reset. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 30: Ventilation Parameter Dependency

    When this value is reached, a key symbol appears and a “Notice Signal” will sound. The high value must be confirmed by pressing the rotary push knob again. (see the following table) fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 31 >30 >30 guarantee I-flow >20 Not locked >25 >25 Backup P PSV >25 >25 PEEP <2 <2 PEEP >10 >10 > 25 >25 Insp >30 >30 guarantee >30 >30 limit fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 32: Graphics Menu

    The Graphics menu The following graphics are available in the Graphics menu: 1. Curves 2. Loops Curves 3. Trends Loops Trends will be loaded when pressing the Trends button Trends fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 33: Curves

    2 to 300 (PED) Flow [l/min ] 2 to 80* 2 to 80 2 to 80 Pressure [mbar] 10 to 20 10 to 20 10 to 100 0 to 200 fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 34 Press the Freeze key again to continue updating the Curve data. Depending on the Ventilation mode selected, the numeric block will display the parameters that are relevant in this mode fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 35: Loops

    3. The Loop will be saved until a new Loop is saved. Comparing loops: 1. Switch to Loops Display: 2. Freeze current Loop. 3. Current Loop is shown in Blue, the Saved Loop is shown in Black. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 36: Trend Menu

    1. Parameter / Selection 2. Graphics 3. Parameter values 4. Timeline 5. Adjust Timeline (minimum 30 minutes to a maximum of five days) 6. Shift Timeline 7. Update Data (refresh) fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 37 System functions and displays Trend menu 1. Press Graphics (1) key 2. Press Trends key Loading Trend data Loading Trend Data fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 38 HF Amplitude • • Leak • Shifting the Timeline. The Timeline can be shifted for all three parameters simultaneously. 1. Change timeline from the Rotary Pulse encoder or soft keys. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 39 10 to100 [mbar] insp 10 to100 [mbar] mean Resistance 10 to1000 [mbar /Lps] RSBI 5 to 250 [l/m] 10 to120 [%] 5 to 20 10 to 250 [bpm] 10 to 600 [mL] fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 40: System Operation

    If the packaging of the ventilator is damaged use the device only if the startup device check is performed successfully. For initial installation and when lifting the fabian HFO, disconnect all cables and circuits from the ventilator, grab the ventilator with both hands from each lateral side, see arrows indicating on the left side in the figure below, and lift the ventilator carefully.

  • Page 41: Connect The Gas Supply

    CGA/ISO standards, including fill indicators. The inputs are coded to prevent wrong connection. Input pressure (2.0 to 6.0 bar) for medical grade oxygen and medical grade AIR (dust-free, oil-free and dry). fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 42: Connect The Tubing Set

    Pay attention to the correct installation position of the Expiration Membrane. The label, a 6-digit serial number (SN), must be legible upon installation. (See illustration). fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 43 Bias Flow intern: Use when there is no External NO Flow sensor. Bias Flow extern: Usage of a NO device needs to measure the Bias Flow with an External Flow sensor. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 44: Patient Circuit Assembly

    Connect the machine end of the Proximal Pressure tubing to the Proximal Pressure port (Prox) on the ventilator. Connect the Inspiratory and Expiratory limb heater connectors with the corresponding connectors on the humidifier chamber heater base. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 45: Recommended Positioning Of Temperature Probe For Humidifier

    We recommend carefully following the manufacturer’s instructions for use of the Humidifier to minimize the risk of rainout in the Patient Circuit. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 46: Use Of Dual Limb Patient Circuit

    Use of dual limb patient circuit If Reusable patient circuits are used, they should be used with inspiratory and expiratory limb heater wire or alternatively, a water trap in the expiratory limb: fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 47 If the humidifier does not have an inspiratory line heater, water traps must be installed in the inspiratory and expiratory limbs. When using an inspiratory heater, a water trap must be installed at the expiratory end. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 48 System operation Ensure that the Flow-sensor IS NOT exposed to excessive Humidification. We strongly suggest using an Inspiratory and Expiratory Heated Circuit System in HFO mode. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 49: Connect Ncpap Tubing

    Triggering in DUOPAP mode with flow sensor (optional) Preparing the nCPAP InfantFlow/InfantFlowLP/Inspire Tubing System • Connect Flow sensor to exhalation tube as shown in the picture. Recommendation: • Make the Exhalation tube as short as possible. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 50: System Start-Up

    5. In order to proceed, you must acknowledge that the alarm is audible, continue using the ventilator without audio alarm or shut down the ventilator. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 51: Device Check

    Expiration membrane holder and expiration installed. membrane • Patient breathing circuit tubes Patient circuit assembled • Water traps (if needed) correctly according to • Respiratory humidifier and tube heating manufacturer’s instructions • Flow sensor fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 52 Alarm: Tube Occlusion Fill level Water fill level sufficient. Humidifier Function Function OK CAUTION: Ensure that Pmanual and other pressures are reduced to safe levels prior to connecting to patient. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 53: System Standby / Pause

    When the ventilation has stopped, the Information bar will display the following message: “Ventilation stopped”. NOTE: The pause time will count down the two minutes and then the ventilator will resume ventilation fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 54: System Shutdown

    7. After the device has powered OFF, a notice tone will sound. 8. Press the Alarm Silence button to confirm system switch OFF. 9. Hold the button for at least three seconds until the WARNING LED stops. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 55: Emergency Shutdown

    OFF, a notice tone will sound. 5. Press the Alarm Silence button to confirm system switch OFF. 6. Hold the button for at least three seconds until the WARNING LED stops. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 56: Configurations Menu

    7. Tools 2. Display 8. Information 3. Ventilation 9. PDMS (optional) 4. Patient Data 10. Service mode 5. Language 11. Close menu (return to previous menu) 6. Date / Time fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 57: Calibration

    Upon ventilator startup, you will be automatically directed to the Calibration menu. The Calibration menu is displayed as follows. From the Calibration screen, you can calibrate the following Sensors: • Flow sensors: Neonatal and Pediatric • sensor • etCO module • module fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 58: Flow Sensor

    Flow sensor during Calibration. The sensor can be held occluding either one or both ends with a sterile glove to ensure zero gas flow. 1. Press the Flow Cal button. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 59 When centered, these lines will turn Green. 4. Following successful Calibration, the Date of the last calibration will be displayed in the corresponding area. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 60: O Sensor

    • Flow Sensor Leakage (loose flow insert or leak) • Flow Sensor Contamination (single-use sensor recommended) • Rain-out (contact ACUTRONIC Medical Systems sales for recommended Patient Circuits and Humidifier to prevent Rain-out) 6.1.2 Sensor The O sensor calibration can be accessed in the Configurations menu, by pushing the O button.

  • Page 61: Etco 2 Module

    24 hours. The gas concentration to patient is not altered during this calibration procedure. 6.1.3 etCO module Please refer to chapter “etCO monitoring” 6.1.4 module Please refer to chapter “SpO module” fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 62: Body Weight Setting

    2. Lock Touch screen. The screen will automatically be unlocked if an alarm is triggered or the rotary push knob is pressed. The Touch screen automatically locks after a set time. 3. Display Graphs as filled or regular lines. Auto scale ON / OFF fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 63: Touch Screen Settings

    Rotary push knob. 6.3.2 Trend / graph display Auto-scaling graphs: Curve plotting in Graphics is automatically adjusted. • • Graphs display: • filled • not filled Filled fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 64: Ventilation Parameter Settings

    Configurations menu Not Filled Auto-scaling trends: Trend patterns are automatically scaled. • • Trends display: • filled • not filled Filled Not Filled 6.4 Ventilation parameter settings fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 65 Length and Pressure level are adjustable. Trigger Flow Trigger / Volume Trigger / Pressure Trigger. Trigger mode (conventional) Configuration for assisted breathing E-flow E-flow parameter setting fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 66 The “factory defaults” button is only active if it is enabled in Factory Defaults service mode. Resets the device to the factory defaults. WARNING: Only reset to hospital and factory settings when the device is NOT connected to patients. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 67: Patient Data

    Deleting all stored data from the “old” patient For data input just touch the Change data and choose the field for input For capital letters touch Accepting data with “Apply” fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 68: Language

    1. Use the Up and Down arrows to set the date and time. 2. After the time or date has been changed, the confirmation check mark changes colors. 3. The new information is applied after confirmation. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 69: Tools

    Alarm and System log. Device Information SW and HW Configuration with licenses. Only allowed when patient is NOT connected. 6.9 Information Displays the Information screen (System Information) containing Equipment data. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 70: Service Mode

    This section is described in the Service Manual and is only for trained Service technicians. After using service mode and before connecting fabian to a patient, restart the device. Only allowed when patient is NOT connected. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 71: Alarms

    Alarms 7 Alarms 7.1 Alarm limits menu 1. Automatically sets individual alarm limits. 2. Alarm volume (three levels). 3. Open Log file. 4. Display measurements with alarm limits. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 72 Once the alarm limit has been adjusted or there are no more active alarms, the bell symbol will turn grey. The visual alarm message must be reset by pressing the “Alarm silence” button fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 73: Automatic Alarm Limits

    CPAP [NCPAP-mode] upper limit: 5 mbar above set CPAP value • CPAP [NCPAP-mode] lower limit: 2 mbar below set CPAP value • Pduo [DUOPAP-mode] upper limit: 5 mbar above set Pduo value fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 74: Configurable Alarms

    Low Perfusion Index alarm: off, 0.03 to 19% • Low SIQ Alarm: off, 5 to 100%. 7.2 Alarm log Switch to Alarm Limit menu. Press the button underneath Show Log to access the alarm overview. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 75: Nurse Call Relay

    In the event there are two alarm conditions with the same priority at the same time, the first alarm condition triggered is active and displayed. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 76: Alarms Table

    PIC Acutronic Medical Systems Distributor Disconnect the device from AC power and checksum System failure System error contact your local monitor PIC Acutronic Medical Systems Distributor fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 77 Mains supply or Flat battery! Electrical power can no longer continue access alternative on battery power ventilation Change exhalation Exhalation Exhalation calibration System alarms membrane holder or calibration failed membrane. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 78 • Repeat Calibration and/or Replace O sensor. • Disconnect the value out of sensor or mixer Sensor alarms device from AC range defective. power and contact your local Acutronic Medical Systems Distributor fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 79 Adjust settings minimum FiO than set for PRICO • Check patient connection. • Check tubing Low Pmean Patient alarms Leak or disconnection. system for leaks. • Check setting of Pmean. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 80 Pulse rate measured Patient alarms for correct contact Rate above set limit with patient • Adjust settings Low Pulse Pulse rate measured • Check patient, Patient alarms Rate below set limit fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 81 Patient alarms alarm limit • Check tubing system. • Check patient, • Check tubing Upper alarm limit High tube leak Patient alarms system for leaks, exceeded • Adjust limit value. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 82: Pressure Release Behaviour

    Slience button. power. • The device continues in battery mode without interruption. Tidal Volume Upper alarm limit System limits Adjust settings. limited exceeded 7.4.2 Pressure release behaviour fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 83: Application Error

    English: “Application fabianHFO.exe encountered a serious Error and must shut down.” If there is an audible alarm, follow these steps: 1. Immediately start ventilation of patient with an Alternative Ventilation method 2. Shut down the device. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 84: Watchdog Alarms

    4. Use the device only if it is unavoidable In case a WDST 4/16/32/64 error is resolved (only a temporary error) WDST#8 will be triggered and displayed and the device can continue to be used. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 85: Battery Operation

    60 mbar. When the main power supply is reconnected, the amplitude remains at 60 mbar. When storing the ventilator for long term storage, please remove the battery pack. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 86: Power Failure

    – Connect to Main – – Charge battery for approx. 5 hours – After reconnecting the fabian HFO to the mains power, the fabian HFO is running on mains power and the internal battery is charged. fabian HFO | SW 5.1.x...

  • Page 87: Operating On External Power Source (Devices With Sn Till Ai-01500 And Al-00400)

    24 Volt DC, 1.5 A External power connection on the back panel. NO charging when connected to 24V DC external power supply NO monitoring of remaining time on external power supply fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 88: Ventilation Parameters

    This corresponds to 10% - 25% of the exhaled tidal • duoPAP volume( Vte ) with volume trigger and 0.12–1.2 l/min in 10 steps (neonatal mode) / 0.6-6.0 l/min in 10 steps (pediatric mode) with flow trigger. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 89 CPAP level • P manual CPAP Manual Inspiratory pressure • nCPAP Applying a manual breath • Next breath is possible after a block period of 200 ms. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 90 PSV breath. Max. time • All modes Maximum time manual breath* manual breath Maximum duration allowed for manual breaths. Adjustable from 2 – 30s. *In Settings menu fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 91 Inspiration to Expiration Ratio Adjustable 1:3 / 1:2 / 1:1. I-time Inspiratory Time Lung Recruitment* Adjustable 2 to 13 seconds *Optional. Mean Pressure mean Continuous positive Airway Pressure. Pmean Lung Recruitment* meanrec *Optional. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 92: Ventilation Modes

    • CPAP Continuous positive airway pressure • NCPAP NIV ventilation (Optional) • duoPAP NIV ventilation (Optional) • High-frequency oscillation (Optional) • Therapy High and Low Flow Oxygen Therapy HFNC (Optional) fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 93: Ippv

    Y-piece of the dual limbed breathing circuit and connect the proper interface. A higher I-flow can be requested during NIPPV mode, because of potential higher leakages. Function areas and ventilation parameters. Ventilation additives. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 94: Sippv

    • Pinsp • Trigger Sensitivity To prevent Auto-Triggering, another breath cannot be triggered for 180 ms following the end of the preceding breath. Function areas and ventilation parameters. Ventilation additives. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 95: Simv

    For weaning from ventilation. If Apnea is detected, ventilation will commence with the specified TI and TE frequency. The synchronization window for the next mechanical breath is maximum ½ T fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 96: Simv + Psv

    PSV breath is only available with active flow sensor measurement. As a result, in case flow sensor is deactivated in SIMV+PSV, the ventilation mode is automatically changed to SIMV and can be switched back only manually after the activation of the flow sensor. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 97: Psv

    In nCPAP / DUOPAP mode the patient breathes spontaneously from a mask or nasal prongs. A NIV Trigger option can be enabled to provide these modes with breath detection (Apnea fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 98 If Inspiratory Time is set lower than 1 second; the maximum pressure may NOT be reached. Depending on the tubing set, nCPAP generator and humidifier. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 99: O 2 Therapy Mode (High And Low Flow Oxygen Therapy) Hfnc

    The repetition frequency is selectable from one cycle / hour to four cycles / minute. • The Inspiratory Time can be set from 2 to 60 seconds if the Expiratory Time is ≥2 seconds. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 100: Special Hfo Mode Information

    In the event of Flow Measurement Outage (for example: changing the sensor) “V Guarant” will automatically be deactivated. After Flow Measurement is available again “V-guarant” will automatically be reactivated. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 101: Special Functions

    Flush button in a Ventilation mode to initiate the O Flush. 4. The Flush Concentration can now be set with the rotary push knob.. 5. Pressing the O Flush button again will end the Flush immediately. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 102: Accessories And Options

    12.1 Accessories List WARNING: The items shown in this list have been approved for use with fabian HFO ventilator. Use of non-approved items is NOT recommended and will NOT be recognized or supported by the manufacturer. If a system malfunctions with non-approved parts and / or accessories, the user is responsible and liable for any and all issues associated with the system malfunction.
  • Page 103 Accessories and options Description Picture Adapter NIST– DISS Air Water trap / Filterset Masimo SpO module Microstream MicroPod etCO Sensor Capnostat® 5 Mainstream etCO Sensor LoFlo Sidestream etCO Sensor fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 104 NIV generator – Medin Medijet Altera breathing circuits (REF 154308), InfantFLow, Medijet and InfantFlow LP generators are validated, all other circuits can be used but need to be validated by the user itself. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 105: Etco 2 Monitoring

    NOTE: Only one module at a time can be connected and used with the ventilator. The module can be activated in the etCO submenu of Calibration view of fabian HFO (Figure 1 / Figure 2). Figure 2 - etCO Sensor submenu Figure 1 - fabian HFO Calibration menu fabian HFO | SW 5.1.x...
  • Page 106 Alarm Limit view (Figure 6), which can be reached by pressing the Alarm Limits button (Figure 5). • etCO high • etCO • FiCO high • FiCO Alarm Limits Button Figure 5 - Hard key buttons Figure 6 - Alarm limits fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 107: Connect The Etco 2 Module To Fabian Hfo

    3. Fasten the connection by turning the Binder connector ring clockwise. Figure 7 - Rear View of fabian HFO (main board 3.x and higher). Arrow points towards CO2 port. Figure 8 - Male connector Figure 9 - Female connector fabian HFO | SW 5.1.x...
  • Page 108 1. Attach the 9-pin RS-232 Connector from the CO2 module (Figure 11) to the Receptacle RS-232 Connector at the back of the fabian HFO labelled with Data input / output symbol (Figure 12). 2. Fasten the connection by turning the screws on either side of the pinned connector clockwise.

  • Page 109: Micropod Sensor Module

    (EtCO ) and the respiratory rate. The respiration rate is referred on the fabian HFO as Freq etCO . Infrared spectroscopy is used to measure the concentration of molecules that absorb infrared light. Because the absorption is proportional to the concentration of the absorbing molecule, the concentration can be determined by comparing its absorption to that of a known standard.
  • Page 110 • "SFM in progress" • "standby" • "Temperature out of range" The messages are displayed on the information line of the CO Monitoring screen or in the CO Settings menu. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 111 MicroPod calibration Oridion supplies a Calibration kit (including a Calibration software CD and Calibration accessories) that enables calibration of the module on a PC. The fabian HFO displays a Calibration message that indicates on the host monitor CO screen that calibration is required at the designated interval (Figure 15).
  • Page 112 The displayed data includes: • Real time “etCO ” values along with selected unit “mmHg”, “kPa” or “Vol%”. • Respiration rate (RR) named “Freq” in breaths-per-minute (bpm). • etCO Waveform. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 113 The initialization time includes module initialization and self-tests. • Power-up time: Maximum 10 seconds • Initialization time: Typically, 30 seconds, maximum 180 seconds fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 114 Accessories and options 12.2.3.9 System response time The system response time of the microMediCO and fabian HFO together is typically 3.1 seconds. This includes the following timing sequences: • 2.7 seconds delay time • 0.2 seconds rise time from the microMediCO •...

  • Page 115: Etco 2 Sensors

    "Sensor state: ok" • • "CO out of Range" "Sensor Warm Up" • • "No Message" "Standby" • • "Sensor Faulty" "Zero in Progress" • • "Zero Required” "Sensor off" fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 116 Respironics module settings and information Figure 21 – Respironics CO module In addition, the following information on the module is displayed: • The sensor state • Last service date • Sensor type fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 117 Care should be taken to ensure that the airway adapter is clear of any residual CO gas. • The maximum elapsed time for a zero is 30 seconds. The typical time for a zero is 15 to 20 seconds. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 118 Capnostat 5 Mainstream CO2 sensor is initially connected to the host. • The data rate for the continuous waveform modes is 100 Hz, therefore the host can expect a new waveform packet approximately every 10 milliseconds fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 119: Spo 2 Module

    This can be done in the menu of the SpO module. Figure 24 Enable SpO You can choose from the SpO menu, different module settings described in the following sections. Figure 25 SpO Settings and Information fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 120: Sensitivity Mode

    Fast SAT enables rapid tracking of arterial oxygen saturation changes by minimizing the averaging. This mode is clinically applicable during procedures when detecting rapid changes in oxygen saturation is paramount such as induction, intubation, and sleep studies. Figure 27 Fast SAT fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 121: Alarm Delay

    There are different averaging times that can be selected (2 to 4, 4 to 6, 8, 10, 12, 14, 16). Figure 29 SpO averaging time fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 122: Prico

    USB Type A connector at the opposite end so that it is compatible with the USB device port on the rear panel of the fabian ventilator. The total length of the USB HPLPM, patient cable, and sensor cannot exceed 5 meters. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 123 Masimo Pulse Oximetry sensors and provides functional oxygen saturation (SpO ), pulse rate (PR), perfusion index (PI), Plethysmograph Waveforms, and other information through a serial digital interface. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 124: Setting Up Prico

    PRICO can be activated in the SpO section of the Graphics menu. PRICO will adjust the FiO , to try to keep the SpO within the selected range. Figure 32 PRICO in fabian HFO PRICO has the following parameters: PRICO Parameters Min FiO Minimum allowed FiO .
  • Page 125 +1%, if FiO is in lower half. If FiO is in upper half decrease FiO by 1%. • adjustments are made up to the pre-set FiO limits (min FiO to max FiO fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 126: Prico Ventilation Modes

    When PRICO is ON, this is indicated by the PRICO icon in the Status bar and the green field with the current FiO labelled PRICO above the O parameter. Figure 34 PRICO “ON” fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 127: Prico Disabling Alarms

    Significant levels of dysfunctional hemoglobins (for example: carboxyhemoglobin or methemoglobin) • Venous pulsation Loss of pulse signal can occur in any of the following situations: • The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 128 Alarm The actual alarm limits and state (OFF) are also displayed in the graphical view next to the numeric values with the high/low alarm limit symbol. Figure 36 Alarm limits fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 129: External Communication, Pdms

    Mindray • METAVISION iMDSoft 12.6 FOT 12.6.1 Forced Oscillation Technique (FOT) at fabian HFO FOT is available as a submenu under Waves / loops in fabian HFO ventilators in the following modes: • CPAP - Continuous Positive Airway Pressure •...
  • Page 130 Accessories and options There are two types of FOT distinguished in fabian HFO: • FOT-HFO: The forced oscillation is created by the HFO module. The measurement does not change the ventilation mode as it is available only in HFOV. •...

  • Page 131: Fot General Layout

    9. Information field: Depending on the status of FOT it displays the current and next PEEP/ Pmean and PIP values; the date and time of last recruitment / derecruitment maneuver; feedback information of unsuccessful measurements. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 132: Erasing The Fot Graph

    • Low physical memory • parallel interface • Safety relay defect • SPI interface • Voltage monitoring Alarm actions: • Applying Manual breath • Applying or preset another ventilation mode fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 133: Fot Procedure

    When all FOT parameters are set appropriately for the patient’s respiratory system, FOT is ready to be initiated by pressing the ON / OFF button, which will turn Green and a confirmation message will appear on the display. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 134 FOT Conventional mode with the following settings and how the results are displayed: IPPV settings FOT settings PEEP Pinsp PEEPlow PEEPhigh FOTsteps Step 6 mbar 14 mbar 4 mbar 10 mbar 2 mbar fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 135 The following graph illustrates how a complete FOT maneuver looks in real time regarding pressure levels in HFO mode with the following settings: HFO settings FOT settings PEEP PEEP PEEP step insp high steps 10 mbar 15 mbar 5 mbar 14 mbar 3 mbar fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 136: Fot Post Data Analysis

    180 seconds (can be skipped) Adjustable parameters 1 to 21 (only odd numbers) * steps 5 to 49 mbar mean low 6 to 50 mbar ** mean high PEEP 3 to 29 mbar fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 137 ** The difference between the high and low-pressure parameters can be minimum 1 mbar) or more if the setting of the number of FOT measurements (FOTsteps) is bigger than 3 because of the step size cannot be lower than 1 mbar. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 138: Ventilator Service And Maintenance Intervals

    • sensor • Flow sensor Maintenance and safety inspections must be performed by ACUTRONIC Medical Systems trained personnel with access to suitable testing and measuring equipment. Maintenance Interval Indicator. The symbol will appear in the Information bar 30 days before the next maintenance has to be performed.

  • Page 139: Sterilization / Cleaning / Disinfection

    Remove any heavy soiling with additional dampened cloths if necessary. Note: The surface treated must remain visibly moist for five minutes. Use more dampened cloths if necessary to keep the surface moist for five minutes. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 140: Accessories

    Use more dampened cloths if necessary to keep the surface moist for five minutes. 3. Wipe the cable with a clean lint-free cloth dampened with purified water for one minute. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 141: Flow Sensor

    Tap water Liter (Set Point) Neutralization 02:00 Warm tap water Neodisher Z 1.0 ml per Liter Wash Rinse 1 01:00 Warm tap water Dry Time 7:00 90°C / 194°F (Set Point) fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 142: Exhalation Membrane And Membrane Holder

    The flow sensor must be replaced after 30 sterilization cycles and also in case that any detected defect is affecting the accessory performance. 14.2.3 Exhalation membrane and membrane holder WARNING: Conduct hygienic preparation of exhalation membrane and exhalation membrane holder prior to each use. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 143: Disassembly

    Detergent Type and Concentration (Minutes) (If applicable) Pre-wash 1 02:00 Cold tap water Wash 1 02:00 45°C / 113°F Neodisher Mediclean Forte 10 ml per Tap water Liter (Set Point) fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 144 Duration of use The exhalation membrane and membrane holder must be replaced after 30 sterilization cycles and also in case of any detected defect that is affecting the accessory performance. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 145: Setting Ranges And Parameters

    Rise Time [sec] I–time [sec] E–time [sec] Frequency (Rate) [1 / min] PEEP [mbar] [mbar] insp Trigger [mL] limit [mL] guarant [mbar] Flush [%] Flush Time [sec] Man. Breath Time [sec] fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 146 Frequency (Rate) [1 / min] PEEP [mbar] (backup)[mbar] insp [mbar] Trigger [mL] limit [mL] guarant Pmax [mbar] Flush [%] Flush Time [sec] Man. Breath Time [sec] Termination criteria PSV [%] fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 147 Backup Rate [mbar] [mbar] backup PPSV [mbar] Trigger [mL] limit [mL] guarant Flush [%] Flush Time [sec] Man, Breath Time [sec] Termination critera PSV [%] Flow [Lpm] CPAP [mbar] [mbar] manual Backup fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 148 I-time [sec] 0.15 E-time [sec] Frequency [1/min] O2 [%] Flush [%] Flush Time [sec] Man Breath Time [sec] Flowmin [l/min] CPAP [mbar] Pmanual [mbar] PDUO [mbar] fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 149: Guide To Volume Guarantee

    Inspiratory time and pressure. If the breath was triggered by patient, it is colored Green on the waveform graphics, if none triggered, Grey. The baby controls the rate of ventilation. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 150: Initial Settings

    IMPORTANT: To ensure the VG function works appropriately, a small plateau in the Tidal Volume wave needs to be present. Do not set the inspiratory time to a value too short to allow the plateau pressure to be reached. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 151 Triggered and non-triggered breaths are independently supported based on lung compliance. Normally, a triggered breath has a lower Pinsp than a non-triggered one due to the effort provided by the patient. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 152 VG can now be activated by selecting the ON /OFF button. When VG function is ON, this button will turn Green. A line will appear in the Pressure Wave diagram to mark the Pmax. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 153 ” area to indicate the maximum pressure has been reached. In case the flow sensor is deactivated, the VG will be shut off and the pre-set Pinsp will be used to ventilate. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 154: Setting Up The Ventilator Psv+Vg

    Ventilation immediately after E-time, otherwise after Preset Apnea Time. We recommend using a delay time to prevent the ventilator from starting unnecessarily and interfering with patient’s breathing pattern. The apnea backup breaths are volume guaranteed breaths. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 155: Special Procedures

    It is important to place the flow sensor of the NO delivery system directly at the fresh gas outlet of the fabian HFO. The measuring line must be placed close to patient in Inspiratory Limb.

  • Page 156: Technical Specifications

    Breath Frequency Alarm: If Alarm Limit exceeded Volume Monitoring Alarm Lower Threshold Value: If the breath volume set was not supplied Apnea Alarm Alarm: If no breathing activity is recognized fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 157: Measuring

    ± 1.75% of reading or 0.1 mbar (whichever is greater) For volume measurements: ± 1.75% of reading or 0.1 mL (whichever is greater) For oxygen level measurements: ± 1% absolute fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 158: Resistance Values

    Trigger (Conventional) Volume trigger • Flow trigger • Pressure trigger • Unit for Pressure mbar • • Use BTB for Vt Enabled • Disabled • limit guarant limit • guarant fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 159: Dimensions / Weight

    From SN AI-01500 and AL-00400: Type BF Till SN AI-01500 and AL-00400: Type B Electrical Safety Classification Class I (mains power) Internally powered (battery power) Sound Pressure Max. 52 dB (A) fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 160: Data Storage

    The proportional valves, which also act as return valves, prevent the return flow of a gas into the supply line of the other gas.An Oxygen sensor measures the Inspiratory Oxygen Concentration. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 161 Technical specifications Internal Gas Blending function of the fabian HFO 1. Oxygen 2.0 to 6.0 bar 2. Air 2.0 to 6.0 bar 3. Filters 4. Pressure regulators 5. Pressure Sensors 6. Proportional valves 7. To manifold The fraction of oxygen concentration, measured at the patients mouth, does not change immediately when changing the O concentration on the ventilator.

  • Page 162: Essential Performance

    Level alarm conditions 201.12.4 shall occur, as appropriate; 201.13.101 a technical alarm condition shall occur. Measurement accuracy of the pulse rate ISO 80601-2-61: 201.12.1.104 from the SpO monitor is maintained within 2017 fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 163 ± 3 bpm (no motion conditions); or ± 5 bpm (motion conditions); 201.11.8.101.1 Low and High Pulse Rate alarm conditions 201.12.4 shall occur, as appropriate; 201.13.101 a technical alarm condition shall occur. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 164: Electromagnetic Compatibility Statement

    19.1 Devices from SN AI-01500 and AL-00400 Guideline and Manufacturer Declaration – Electromagnetic Emissions The device fabian HFO is intended for operation in the environment described below. The customer or operator of the fabian HFO apparatus should ensure it is operated in this type of environment.
  • Page 165 IEC 61000-3-3 Guideline and Manufacturer Declaration – Electromagnetic Immunity The device fabian HFO is intended for operation in the environment described below. The customer or operator of the fabian HFO apparatus should ensure it is operated in this type of environment.
  • Page 166 Electromagnetic compatibility statement Guideline and Manufacturer Declaration – Electromagnetic Immunity The device fabian HFO is intended for operation in the environment described below. The customer or operator of the fabian HFO apparatus should ensure it is operated in this type of environment.
  • Page 167 If the area intensity at the location where the fabian HFO is used exceeds the above compliance levels, fabian HFO should be monitored for proper function. If unusual performance characteristics are observed, additional measures could be required, as for example: changing the direction or location of the fabian HFO.

  • Page 168: Devices Till Sn Ai-01500 And Al-00400

    19.2 Devices till SN AI-01500 and AL-00400 Guideline and manufacturer declaration – electromagnetic emission The device “fabian HFO” is intended for operation in the environment described below. The customer or user of the "fabian HFO" apparatus should ensure it is operated in this type of environment.
  • Page 169 Electromagnetic compatibility statement Guideline and manufacturer declaration – electromagnetic immunity The device "fabian HFO" is intended for operation in the environment described below. The customer or user of the "fabian HFO" apparatus should ensure it is operated in this type of environment.
  • Page 170 A study of the location should be conducted to determine the electromagnetic environment with regard to stationary transmitters. If the field intensity at the location where the "fabian HFO" is used exceeds the above compliance levels, "fabian HFO" should be monitored for proper function. If unusual performance characteristics are observed, additional measures may be required, as e.g.
  • Page 171 The operator of the "fabian HFO" can help avoid electromagnetic interference by maintaining the minimum distance between portable and mobile HF telecommunication devices (transmitters) and the device "fabian HFO" – depending on the output rating of the communication device, as listed below.

  • Page 172: Appendix A Glossary

    Ingress protection rating. Infrared radiation [wavelength around 700 nanometers (nm)]. Leaks Leakage from patient or system tubings /connections. Light Emitting Diode. LNCS Low Noise Cable Sensors (Masimo trade mark). Magnetic Resonance Imaging. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 173 Link Power Management. Video Graphics Array. Tidal Volume is the lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied. fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

  • Page 174: Appendix B Index

    126, 129, 130, 134, 147, 172 85, 91, 99, 100, 101, 105, 107, 108, 109, 111, 112, 114, 117, 124, 126, 129, 130, 134, 135, 138, 148, 158, 159, 164, 167 fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 175 45, 47, 51, 60, 62, 66, 100, 106, 109, preoxygenation, 101 110, 112, 114, 119, 122, 130, 131, 134, 136, 137, PRICO, 122, 123, 124, 125, 126, 127, 130 PRICO alarms, 127 fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...
  • Page 176 SIMV, 25, 33, 88, 89, 90, 91, 92, 95, 96, 126, 129, Fire hazard, 8 130, 146, 149 warnings, 7 SIMV + PSV, 96, 129 Single Patient Use Circuits, 44 SIPPV, 129 Software, 36, 112 Zeroing, 117, 118 license, 129 fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2020-02-10...

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