ACUTRONIC fabian +nCPAP evolution Instructions For Use Manual
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ACUTRONIC fabian +nCPAP evolution Instructions For Use Manual

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Ventilation Beyond Limits
fabian +nCPAP evolution
and Auxiliary Systems
Instructions for Use, Software Version 5.1.x
Warning
Carefully read the instructions of use
before using the ventilator to
familiarise yourself with the function of
the equipment
fabian +nCPAP evolution | SW 5.1.x
Ref: 122003.EN / Date 2019-11-22
i

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  • Page 1 Auxiliary Systems Instructions for Use, Software Version 5.1.x Warning Carefully read the instructions of use before using the ventilator to familiarise yourself with the function of the equipment fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • 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

    System operation ......................34 Preparing for operation ....................34 5.1.1 Connect the power supply ....................34 5.1.2 Connect the gas supply ......................34 5.1.3 Connect the tubing set ......................35 fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 4 Operating on external power source (devices with SN till AN-03999) ......78 10 Ventilation parameters ....................79 11 Ventilation modes ......................83 11.1 IPPV .......................... 84 11.2 SIPPV ........................85 11.3 SIMV ......................... 86 fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 5 Disassembly ........................114 16 Setting ranges and parameters ..................117 17 Guide to volume guarantee ................... 121 17.1 fabian volume guarantee (VG) operation ..............121 17.2 Initial settings ......................122 fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 6 19.12 Acoustic Energy....................... 132 19.13 Essential Performance..................... 133 20 Electromagnetic compatibility statement ..............134 20.1 Devices with SN from AN-04000 ................135 20.2 Devices with SN till AN-03999 ................. 139 fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 7: Introduction

    Notes provide additional information to clarify an explanation or instruction. 1.3 Applicable product versions This Instructions for Use is applicable for fabian +nCPAP evolution devices running software version 5.1.x, where (x) can be any number. fabian +nCPAP evolution | 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. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • 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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 10 Symbol Description Humidity Limitation fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • 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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 12 WARNING: DO NOT modify the equipment. WARNING: Before applying non-original accessories, ensure that they are biocompatible. All accessories supplied by ACUTRONIC Medical Systems for use on fabian ventilators are biocompatible. WARNING: When connected to a patient DO NOT simultaneously touch the external power supply cord and the flow sensor connector cable.

  • 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

    2.3 Liability for functionality ∕ damages In the event of improper equipment maintenance or repair by any person not associated with ACUTRONIC Medical Systems AG Service or improper use, any and all liability for the functionality is transferred to the owner or operator.

  • Page 15: System Overview

    3 System overview 3.1 Scope of delivery The fabian +nCPAP evolution product includes the following items: • One fabian +nCPAP evolution Ventilator • One Accessory kit: • One Flow Sensor (reusable) • One Flow Sensor Cable • One Test Lung •...

  • Page 16: Rear Panel

    Connection for compressed air supply 2.0 – 6.0 bar / max 40 l/min Connector for Masimo SpO module Oxygen sensor access cover Connection for oxygen “O2” supply 2.0 – 6.0 bar / max 40 l/min fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 17: Rear Panel Of Devices With Dc Connector (Till Sn An-03999)

    Connection for future use, covered with a faceplate Oxygen sensor Connection for future use, covered with a faceplate Connection for oxygen “O2” supply 2.0 – 6.5 bar / max 40 l/min fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 18: General Hardware Characteristics

    Isolated Ethernet: N/A (disabled) Flow Sensor: Maximum load is one Flow sensor (Only ACUTRONIC Medical Systems Flow sensors can connect) Max. Voltage: 5 V Max operating current: 300 mA per hotwire -> 600 mA total. SpO2: Max Voltage: 3.3 V Max operating Current: 200 mA fabian +nCPAP evolution | SW 5.1.x...

  • Page 19: System Functions And Displays

    Waves ∕ Loops …switches to wave-/loop display. Home … displays the main screen for selecting the respiration mode. mode fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 20: Rotary Push Knob

    Subsequent alarms with higher priority are only displayed optically during muting. 4.1.2 Rotary push knob The Rotary Push knob combines a push button with a rotary knob for executing various settings, selections and confirmation options. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 21: Display Concept Structure

    Selection or display of the Operating mode Numeric field ∕ alarm limits Depending on the Display mode selected, individual fields can be shown ∕ hidden. Display field options will be described later. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 22: Information Bar

    A blinking Information bar also alerts the operator of active alarms. If screen lock is in use, the symbol for Locked Screen is displayed. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 23: Numeric Field / Alarm Limits

    To confirm the setting, either touch the Parameter button again, or push Rotary Push knob again. To automatically set the alarm limits, select parameter and touch the AUTOSET button. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 24 WARNING: The respiratory rate and minute volume monitors are calculated as averages using an update period of 6 seconds. In the event that the monitored breath rate falls below 11 bpm, these values are not reported. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 25: Graphic Field

    This LED illuminates Green in Mains operation and switches OFF in battery operation. When powered by the external 24 VDC connector, the Mains LED and Battery LED will NOT illuminate. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 26 2. Report the incident to your local distributor 3. Do not use the device until it has been checked by suitably trained and qualified personnel. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 27: Ventilation Menu

    Using the push button (2) you may also switch between the pressure-, volume- and flow wave (3). The Information bar (1) indicates current information. The Ventilation mode may be changed in the menu. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 28: 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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 29: Ventilation Parameter Dependency

    < 2 PEEP > 10 > 10 PInsp > 25 > 25 PPSV + PEEP > 25 > 25 Vguarant > 30 > 30 Vlimit > 30 > 30 fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 30: Graphics Menu

    The Graphics menu can be accessed from the Waves button on the Keypad. The Graphics menu The following graphics are available in the Graphics menu: Waves Waves Loops Loops Trends Trends fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 31: Waves

    Press the key again to continue updating the wave data. Depending on the Ventilation mode selected, the numeric block will display the parameters that are relevant in this mode fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 32: Loops

    The loop will be saved until a new loop is saved. Comparing loops: 1. Switch to loops display: Freeze current loop. Current loop is shown in Blue, the saved loop is shown in Black. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 33: Trend Menu

    A confirmation message will always be displayed before trend data is deleted. Parameter selection for graphic waves Graphics Parameter values Timeline Adjust timeline (max. 5 days – min. 30 minutes) Update data (refresh) fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 34: System Operation

    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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 35: Connect The Tubing Set

    Pay attention to the correct installation position of the Expiration Membrane. The labelling a 6-digit serial number (SN) must be legible upon installation. (See illustration). fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 36: 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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 37: Recommended Positioning Of Temperature Probe For Humidifier

    Place temperature probe outside the incubator and use Incubator extension line. If the baby is in the open warmer unit, the following setup must be used: fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 38: Use Of Dual Limb Patient Circuit

    If the Humidifier does NOT feature 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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 39 Ensure that the Flow-sensor IS NOT exposed to excessive Humidification. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 40: 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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 41: 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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 42 For more information on SpO2 module, refer to the following sections in this manual:. : section 12.2 All audible alarms are silenced for 2 Minutes after startup of fabian fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 43: Device Check

    80 mbar manual: Caution 2. Press and hold the Manual Ensure that P and other manual Breath button pressures are reduced to safe levels prior to connecting to patient. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 44 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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 45: System Standby / Pause

    NOTE: The pause time will count down the two minutes and then the ventilator will resume ventilation Standby is only available in these modes: • NCPAP • DUOPAP • Therapy fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 46: System Shutdown

    7. Press the Alarm Silence button to confirm system switch OFF. 8. Hold the button for at least three seconds until the WARNING LED stops. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 47: Emergency Shutdown

    OFF, a notice tone will sound. 6. Press the Alarm Silence button to confirm system switch OFF. 7. Hold the button for at least three seconds until the WARNING LED stops. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 48: Configurations Menu

    “Open menu” push button. 1. Calibration (Flow & O Date / Time Tools Display Information Ventilation PDMS (optional) Patient Data 10. Service Mode Language fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 49: Calibration

    Upon ventilator startup, you will be automatically directed to the Calibration menu. The Calibration menu menu is displayed as follows. From the Calibration screen, you can calibrate the following Sensors: • Flow sensors: Neonatal and Pediatric • sensor • module fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 50: Flow Sensor

    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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 51 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) fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 52: O 2 Sensor

    After a successful calibration, the Date of the last calibration is displayed in the corresponding area. Automatic Sensor Calibration runs every time the equipment Restarts and every 24 hours. The gas concentration to patient is not altered during this calibration procedures. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 53: Spo 2 Module

    Rotary Push knob is pressed. Automatic lock activated / deactivated. Touchscreen automatically locks after a set time. Display Graphs and trends as filled or regular lines. Auto scale ON / OFF fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 54: Touch Screen Settings

    The touch screen can also be locked by holding the Rotary push knob for 3 seconds Lock is automatically cancelled in the event of an alarm or by pressing the Rotary push knob. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 55: Trend ∕ Graph Display

    ∕ ) keys Scaling can be performed manually with the ( on the keypad for the timeline. For Wave height, use the Manual inspiration and Flush keys on the keypad fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 56: Ventilation Parameter Settings

    Maximum Inspiration time for Manual breath (2 to 30 seconds). for Manual breath optional: The “Hospital Settings” button is only active if it is enabled Hospital Settings in service mode. Resets the device to the hospital defaults. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 57 Use BTB for Vt Select if tidal volume measurement should be updated for every breath. WARNING: Only Reset to hospital and factory settings when the device is NOT connected to patients. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 58: 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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 59: 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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 60: 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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 61: Service Mode

    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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 62: Alarms

    7 Alarms 7.1 Alarm limits menu Automatically sets individual alarm limits. Push button underneath. Alarm volume (3 levels). Push button underneath. Open log file. Push button underneath. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 63 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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 64: Automatic Alarm Limits

    CPAP [NCPAP-mode] lower limit: 2 mbar below set CPAP value • Pduo [DUOPAP-mode] upper limit: 5 mbar above set Pduo value • CPAP [DUOPAP-mode] lower limit: 2 mbar below set CPAP value fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 65: Configurable Alarms

    High Pulse Rate alarm: 35 to 235 bpm, off • Low Pulse Rate alarm: off, 30 to 230 bpm • Low Perfusion Index alarm: off, 0.03 to 19% • Low SIQ Alarm: off, 5 to 100%. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 66: Alarm Log

    In case alarm list or alarm log files reach their limit (100 / ca. 70000 entries respectively), the oldest entries are deleted first. 7.3 Nurse call relay The delay from the nurse call relay is < 1 second. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 67: Alarm Causes And Solutions

    Acutronic Medical Systems Distributor Disconnect the device from AC power and 6. parallel System System error contact your local interface failure Acutronic Medical Systems Distributor fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 68 System error contact your local monitoring failure Acutronic Medical Systems Distributor • Change battery, Electrical No power or too less 16. Battery defect • Check fuse. power power from battery. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 69 Check flow sensor and connected. 27. Flow sensor Sensor sensor cable • not connected alarms Defective sensor connection. cable. sensor Sensor Error occurred during Repeat calibration. calibration alarms calibration. failed fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 70 • Check tubing system Patient 39. Low Pmean Leak or disconnection. alarms for leaks. • Check setting of Pmean. Patient Pressure rise in tubing • Check patient, 40. High Pmean alarms system. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 71 47. Low Perfusion Patient for correct contact Index alarms index with patient • Adjust settings • Check patient, Patient 48. Low PIP • Check patient Leak or disconnection. alarms connection. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 72 • Increase flow. set too low. • Check patient, VTe not Inspiratory pressure • Adjust inspiratory reached / System limits default is reached check settings prematurely. pressure setting. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 73 Alarm is operating on battery Slience button. power. • The device continues in battery mode without interruption. 59. Tidal Volume Upper alarm limit System limits Adjust settings. limited exceeded fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 74: Pressure Release Behaviour

    – the exhalation valve pressure control is reduced to PEEP, and the outlet gas flow is switched from I-Flow to E-Flow. Only if this subsequently transitions to a tube obstruction alarm, the outlet flow is switched off and exhalation valve opened as above. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 75: Application Error

    Prepare an alternative treatment for the patient while the device is kept under supervision Start ventilation of patient with an Alternative Ventilation Method Shut down the device. Report the incident to your local distributor Use the device only if it is unavoidable fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 76: Watchdog Alarms

    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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 77: Battery Operation

    Additional messages will be triggered at a remaining Run Time of: • 15 minutes • 30 minutes • 60 minutes, only if the remaining run time is less than 60 minutes during a Power Failure fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 78: Operating On External Power Source (Devices With Sn Till An-03999)

    External power connection on the back panel. 1/2 minus 3/4 plus • NO charging when connected to 12VDC external power supply • NO monitoring of remaining time on external power supply fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 79: Ventilation Parameters

    This corresponds to 10% - 25% of the exhaled tidal volume( Vte ) with • volume trigger and 0.12–1.2 l/min in 10 steps (neonatal mode) / 0.6-6.0 • duoPAP l/min in 10 steps (pediatric mode) with flow trigger. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 80 The lower pressure level is selected in duoPAP mode via the CPAP parameter. • CPAP duoPAP Continuous Positive Airway Pressure • CPAP The ventilator provides continuous flow for producing airway pressure • nCPAP at the set CPAP level fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 81 This ensures the patient receives a guaranteed volume with each • breath. In SIMV +PSV, the VG is only applied for SIMV breath but not for the PSV breath. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 82 • SIMV+PSV Termination Criteria PSV* Criteria PSV • Flow setting (relative to peak flow) for termination of a PSV breath. Adjustable between 1 – 85 %. *In Settings menu fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 83: Ventilation Modes

    Pressure Support Ventilation • CPAP Continuous positive airway pressure • NCPAP NIV ventilation (Optional) • duoPAP NIV ventilation (Optional) • Therapy High and Low Flow Oxygen Therapy HFNC (Optional) fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 84: 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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 85: 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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 86: Simv

    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 Function areas and ventilation parameters. Ventilation additives. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 87: Simv + Psv

    SIMV+PSV, the ventilation mode is automatically changed to SIMV and can be switched back only manually after the activation of the flow sensor. Function areas and ventilation parameters. Ventilation additives. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 88: Psv

    OFF the ventilator and remove the flow sensor from the Y-piece of the dual limbed breathing circuit and connect the proper interface with a 15-millimeter adaptor. Function areas and ventilation parameters. Ventilation additives. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 89: Ncpap ∕ Duopap

    Function areas and ventilation parameters. Ventilation additives. 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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 90: O 2 Therapy Mode (High And Low Flow Oxygen Therapy) Hfnc

    LPM, the Humidifier dual servo temperature controls remain active, so there is no need to switch it OFF in case of short-term Standby mode. There are no patient alarms active in this mode. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 91: Ventilation Additives

    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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 92: 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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 93: Accessories And Options

    12.1 Accessories List WARNING: The items shown in this list have been approved for use with fabian +nCPAP evolution ventilator. Use of non-approved items are NOT recommended and will NOT be recognized or supported by the manufacturer. If a system malfunctions with non-approved parts and ∕...
  • Page 94 Breathing circuit set – Altera 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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 95 Description NIV generator – Inspire InfantFlow NIV generator – Vyaire InfantFlow LP NIV generator – Medin Medijet fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 96: Spo 2 Module

    Here is also displayed information on the sensor state and software release of the connected module. You can select the sensitivity mode, enable or disable Fast SAT mode, and set the Alarm Delay and the SpO Averaging Time. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 97: 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. Fast SAT fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 98: Alarm Delay

    There are different averaging times that can be selected (2 to 4, 4 to 6, 8, 10, 12, 14, 16). averaging time fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 99: 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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 100 7-pin LEMO connector at the opposite end so that it is compatible with the 7-pin LEMO device port on the rear panel of the fabian ventilator. The total length of the LEMO HPLPM, patient cable, and sensor cannot exceed 5 meters. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 101: Setting Up Prico

    PRICO can only be “ON” when the measured SIQ (Signal Quality) is higher than the SIQ alarm limit. Due to the dependencies of the PRICO alarm limits it is critical that you first select the appropriate alarm limits for the patient, before switching on PRICO. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 102 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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 103: 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. PRICO “ON” fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 104: Prico Disabling Alarms

    Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line. • Significant levels of dysfunctional hemoglobins (for example: carboxyhemoglobin or methemoglobin) • Venous pulsation fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 105 High SpO 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. Alarm limits fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 106: External Communication, Pdms

    PDMS interface is called acuLink. A license is needed to activate this feature, which can be ordered through your local distributor. fabian supports acuLink with three different protocols: 1. Acutronic proprietary RS232 protocol without wave data 2. Acutronic proprietary RS232 protocol with wave data 3. IVOI protocol from Philips for Intellibridge/Vuelink via RS232 There are two major version of our acuLink protocol available: version 3 and version 4.

  • Page 107: Replacing The Oxygen Sensor

    When installing a brand new sensor a second calibration can be necessary after about 30 minutes. If possible, expose the new sensor for about 30 minutes to the ambient air BEFORE installing fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 108: Ventilator Service And Maintenance Intervals

    • Exhalation membrane • 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 109: Sterilization ∕ Cleaning ∕ Disinfection

    Use more dampened cloths if necessary to keep the surface moist for five minutes. 3. Wipe the enclosure with a clean lint-free cloth dampened with purified water for one minute. 4. Allow to dry in the air. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 110: Accessories

    1. Remove the flow sensor from the flow sensor cable. 2. Remove any visible soiling on the flow sensor cable with the cleaning agent using a manual disinfection option listed in section 0. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 111 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. 4. Allow to dry in the air. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 112: Flow Sensor

    Note: Articles must be individually single pouched in a qualified pouch (e.g. Cardinal Health self- sealing pouch CAT# 92713). Each of the non-critical devices in-scope are thermostable and have been validated for steam sterilization. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 113 3. Autoclave the cassette articles using the cycle parameters in Step 1 15.2.2.4 Duration of use The flow sensor must be replaced after 30 sterilization cycles and also in case of any detected defect that is affecting the accessory performance. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 114: Exhalation Membrane And Membrane Holder

    3. Transfer the cassette items on to the 4-Level manifold rack accessory (or other appropriate rack system) contained inside the washer for processing. 4. Select the appropriate cycle as listed below: fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 115 Dry cycle for 30 minutes 2. Individually single pouch the exhalation membrane and membrane holder separately. 3. Autoclave the exhalation membrane and membrane holder using the cycle parameters in Step 1 above. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 116 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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 117: 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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 118 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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 119 [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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 120 I-time [sec] 0.15 E-time [sec] Frequency [1/min] O2 [%] Flush [%] Flush Time [s] Man Breath Time [s] Flowmin [l/min] CPAP [mbar] Pmanual [mbar] PDUO [mbar] fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 121: 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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 122: Initial Settings

    Do not set the inspiratory time to a value too short to allow the plateau pressure to be reached. Step 3 Set in the Pmax area, the maximal pressure value to which the VG function can regulate. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 123 In case the flow sensor is deactivated, the VG will be shut off and the pre-set Pinsp will be used to ventilate. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 124: 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 patients breathing pattern. The Apnea Backup breaths are Volume Guaranteed breaths. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 125: Special Procedures

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

  • Page 126: 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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 127: 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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 128: Resistance Values

    Set as Frequency ∕ I–time Ratio of I-time • Set as I–time ∕ E-time • Pressure Rise I-flow • RiseTime • Termination criteria PSV 1 to 85% • Trigger (Conventional) Volume trigger fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 129: Dimensions ∕ Weight

    2.0 to 6.5 bar ∕ max. 40 Lpm Connection thread: NIST NOTE: Medical grade Oxygen Power rating IPPV mode: max. 70 W Standby, fabian connected to Mains: 35 W (Battery charging) fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 130: Data Storage

    Communication between GUI and Parallel Interface • Relias: Relay Check from the SPI • SPI: Communication between GUI and Monitor PIC. • SPICks: SPI Checksum • Voltage: Voltage Error Check from the SPI fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 131: Gas Blender Function

    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. Internal Gas Blending function of the fabian +nCPAP evolution Oxygen 2.0 to 6.0 bar Air 2.0 to 6.0 bar...

  • Page 132: Acoustic Energy

    Lin ∕ A weighted (dB) Calculated average Supplementary information: LpA: A weighted sound pressure level in 1m distance: 46dB 1) Highest Level at Pos 2 2) Highest Level at Pos 4 etc. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 133: Essential Performance

    • error of Delivered Volume (V ) of individual breaths greater than 35% and error of the DELIVERED VOLUME averaged over a one minute interval greater than 25%. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

  • Page 134: Electromagnetic Compatibility Statement

    Portable medical HF communication devices could impact fabian +nCPAP evolution . WARNING: NEVER use fabian +nCPAP evolution directly adjacent to, or stack with other equipments. If unavoidable, be sure to monitor the equipment for proper operation with this set-up. WARNING:...

  • Page 135: Devices With Sn From An-04000

    Guideline and Manufacturer Declaration – Electromagnetic Emissions The device fabian +nCPAP evolution is intended for operation in the environment described below. The customer or operator of the fabian +nCPAP evolution apparatus should ensure it is operated in this type of environment.
  • Page 136 Guideline and Manufacturer Declaration – Electromagnetic Immunity The device fabian +nCPAP evolution is intended for operation in the environment described below. The customer or operator of the fabian +nCPAP evolution apparatus should ensure it is operated in this type of environment.
  • Page 137 Guideline and Manufacturer Declaration – Electromagnetic Immunity The device fabian +nCPAP evolution is intended for operation in the environment described below. The customer or operator of the fabian +nCPAP evolution apparatus should ensure it is operated in this type of environment.
  • Page 138 The operator of the fabian +nCPAP evolution can help avoid electromagnetic interference by maintaining the minimum distance between portable and mobile HF telecommunication devices (transmitters) and the device fabian +nCPAP evolution – depending on the output rating of the communication device, as listed below.

  • Page 139: Devices With Sn Till An-03999

    The device " fabian +nCPAP evolution " is intended for operation in the environment described below. The customer or user of the " fabian +nCPAP evolution " apparatus should ensure it is operated in this type of environment. EMI measurement Compliance Electromagnetic environment –...
  • Page 140 Guideline and manufacturer declaration – electromagnetic immunity The device "fabian +nCPAP evolution" is intended for operation in the environment described below. The customer or user of the " fabian +nCPAP evolution " apparatus should ensure it is operated in this type of environment. Immunity testing...
  • Page 141 Guideline and manufacturer declaration – electromagnetic immunity The device "fabian +nCPAP evolution" is intended for operation in the environment described below. The customer or user of the " fabian +nCPAP evolution " apparatus should ensure it is operated in this type of environment. Immunity...
  • Page 142 The operator of the " fabian +nCPAP evolution " can help avoid electromagnetic interference by maintaining the minimum distance between portable and mobile HF telecommunication devices (transmitters) and the device " fabian +nCPAP evolution " – depending on the output rating of the communication device, as listed below. Maximum transmitter...
  • Page 143 Non-Volatile Random-Access Memory. Flush Delivers oxygen directly into the common gas outlet without passing through a flowmeter or vaporizer. PACU Post-anesthesia care Unit sometimes referred to as Post-Anesthesia Recovery (PAR). fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 144 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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 145 Device checks, 130 Start ∕ Stop, 45, 103 Dimensions, 129 Disconnection, 51 Display, 53, 57 Language, 59 Leaks, 51, 121, 143 Liability, 14 Electromagnetic compatibility, 134 environments, 11, 136 fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...
  • Page 146 Pulse oximetry, 99 Warning, 11, 12, 13, 34, 46, 47, 77, 92, 134 Chemical burn, 8 Rain-out, 51 Dangerous voltage, 8 Ratings, 129 Fire hazard, 8 Resistance values, 128 warnings, 7 fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-11-22...

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