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
fabian +nCPAP evolution | SW V5.1.x
Ref: 122003.EN / Date : 26Jan2021

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Summary of Contents for ACUTRONIC fabian +nCPAP evolution

  • Page 1 Ventilation Beyond Limits fabian +nCPAP evolution and Auxiliary Systems Instructions for Use, Software Version 5.1.x fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 3 Disclaimer 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 4: Table Of Contents

    Ventilation menu ....................21 4.3.1 Operation – General ........................21 4.3.2 Operation – Settings .......................22 4.3.3 Ventilation parameter dependency ..................23 4.3.4 Locking ventilator parameters ....................23 Graphics menu ....................25 4.4.1 Waves ............................26 fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 5 Configurable alarms ....................... 60 Alarm log ......................60 Nurse call relay ....................60 Alarm causes and solutions ................61 7.4.1 Alarms table ..........................61 7.4.2 Pressure release behaviour ....................68 fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 6 Setting up PRICO ........................94 12.4.3 PRICO Ventilation modes .......................96 12.4.4 PRICO disabling alarms ......................97 12.4.5 PRICO re-enabling cases ......................97 12.4.6 PRICO errors ..........................97 12.5 External communication, PDMS ................. 99 fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 7 20 Electromagnetic compatibility statement ........129 20.1 Devices with SN from AN-04000 ................ 129 20.2 Devices with SN up to AN-03999 ............... 133 Appendix A: Glossary.................... 137 Appendix B: Index ....................139 fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 9: 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 V5.1.x...

  • Page 10: Symbols

    DO NOT use when patient is connected to the device Expiration date Explosion Hazard warning External power supply input Flammability / Fire hazard warning. Flow sensor connection Sensor Flow sensor connection. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 11 Non-Sterile NOTE symbol Nurse Call signal output. Nurse Call signal output. Potential equalisation connection. Protective Earth ground. Single use. Storage Temperature This way UP. Type BF applied part. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 12 1 Introduction Symbol Description Type B applied part Unplug power before opening housing. Video Output USB connection. Warning regarding operation in explosive areas. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 13: 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 V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 14 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 15 WARNING: DO NOT use the ventilator in association with HF (High Frequency) electrosurgical equipment. WARNING: Connect SpO and etCO sensor cables to the machine before the patient is connected. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 16: Maintenance

    2 Warnings, cautions and notices 2.2 Maintenance The fabian +nCPAP evolution device is a ventilator classified as Class IIb (for prolonged use more than 24 hours and less than 30 days) according to the European Medical Device Directive, as such: •...

  • Page 17: Intended Use

    2 Warnings, cautions and notices 2.4 Intended use The fabian +nCPAP evolution is intended for premature infants, new-borns as well as children weighing up to 30 kg. The fabian +nCPAP evolution is intended for “in-patient use” in professional healthcare environment including intra-hospital patient transport.

  • Page 18: System Overview

    3 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 •...

  • Page 19: 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 “O ” supply 2.0 – 6.0 bar / max 40 L/min fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 20: Devices With Dc Connector (Up To Sn An-03999)

    Connection for future use, covered with a faceplate Oxygen sensor Connection for future use, covered with a faceplate Connection for oxygen “O ” supply 2.0 – 6.5 bar / max 40 L/min fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 21: General Hardware Characteristics

    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. Max Voltage: 3.3 V...

  • Page 22: System Functions And Displays

    Waves / Loops …switches to wave-/loop display. Home … displays the main screen for selecting the respiration mode. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 23: 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 V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 24: Display Concept Structure

    Selection or display of the Operating mode Depending on the Display mode selected, individual fields can be shown / hidden. Display field options will be described later in section “4.3: Ventilation menu”. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 25: 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 V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 26: 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 V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 27 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 V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 28: 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 V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 29: Ventilation Menu

    Ventilation menu indicates the configuration parameters (4) and measurements (5) relevant in the mode. The Ventilation mode may be Figure 4-8: Operation screen changed in the menu. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 30: 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 V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 31: Ventilation Parameter Dependency

    “Notice signal” will sound. Figure 4-11: Parameter locked The high value must be confirmed by pressing the Rotary push knob again. (see the following table) fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 32 PInsp [mbar] > 25 > 25 PPSV + PEEP [mbar] > 25 > 25 V guarant [mL] > 30 > 30 V limit [mL] > 30 > 30 fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 33: 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 Figure 4-12: Waves Loops Figure 4-13: Loops Trends Figure 4-14: Trends fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 34: Waves

    Press the key again to continue updating the wave data. Figure 4-16: Freeze Waves Depending on the Ventilation mode selected, the numeric block will display the parameters that are relevant in this mode fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 35: Loops

    Switch to loops display: Freeze current loop. Current loop is shown in Blue, the saved loop is shown in Black. Figure 4-19: Compare saved Loops & current loops fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 36: Trend Menu

    A confirmation message will always be displayed before Trend Data is deleted. Figure 4-20: Trends screen Parameter selection for graphic waves Graphics Parameter values Timeline Adjust timeline (max. 5 days – min. 30 minutes) Update data (refresh) fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 37: System Operation

    CGA/ISO standards, including fill indicators. The inputs are coded to prevent wrong connection. Medical grade oxygen and medical grade AIR (dust-free, oil-free and dry, 2.0 bar to 6.0 bar) are required. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 38: Connect The Tubing Set

    Figure 5-2: Membrane holder Pay attention to the correct installation position of the Expiration Membrane. The labeling must be legible upon installation. (See illustration). Figure 5-3: Expiration membrane fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 39: 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 V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 40: Recommended Positioning Of Temperature Probe For Humidifier

    Place temperature probe outside the incubator and use Incubator extension line. If the patient is in the open warmer unit, the following setup must be used: fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 41: 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. Figure 5-5: Dual limb circuit with 2 water traps fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 42 When using an Inspiratory heater, a Water Trap must be installed at the Expiratory end. Figure 5-6: Single heated limb circuit with 1 water trap Ensure that the Flow-sensor IS NOT exposed to excessive Humidification. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 43: Connect Ncpap Tubing

    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 V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 44: System Start-Up

    The O will automatically be calibrated after leaving the Calibration menu and repeated once every 24 hours. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 45 For more information on SpO module, refer to the following sections in this manual: section 12.3: “SpO2 module” All audible alarms are silenced for 2 Minutes after startup of fabian fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 46: Device Check

    Confirm that the audible tone can be test. heard Self-test successful. Calibration Calibrate Flow sensor. Calibration successful Calibrate O sensor (occurs automatically after leaving Calibration menu). fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 47 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 V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 48: 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 +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 49: System Shutdown

    OFF, a notice tone will sound. Press the Alarm Silence button to confirm system switch OFF. Hold the button for at least three seconds until the WARNING LED stops. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 50: Emergency Shutdown

    After the device has powered OFF, a notice tone will sound. Press the Alarm Silence button to confirm system switch OFF. Hold the button for at least three seconds until the WARNING LED stops. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 51: Configurations Menu

    “Open menu” push button. Figure 6-1: Configurations menu Calibration (Flow & O2) Date / Time Display Tools Ventilation Information Patient Data PDMS (optional) Language Service Mode fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 52: Calibration

    Calibration menu is displayed as follows. Figure 6-2: Calibration menu From the Calibration screen, you can calibrate the following Sensors: • Flow sensors: Neonatal and Pediatric • sensor • module fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 53: Flow Sensor

    When centered, these lines will turn Green. Following successful Calibration, the Date of the last calibration will be displayed in the corresponding area. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 54 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 V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 55: 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 V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 56: 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. Autoscale ON / OFF fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 57: Touch Screen Settings

    Return button and the chosen time will be displayed. Figure 6-6: Lock screen time settings The touch screen can also be locked by holding the Rotary push knob for 3 seconds fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 58: Trend / Graph Display

    Scaling can be performed manually with the (− / ) keys on the keypad for the timeline. For Wave height, use the Manual inspiration and Flush keys on the keypad fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 59: Ventilation Parameter Settings

    Factory Settings optional: The “factory defaults” button is only active if it is enabled in service mode. Resets the device to the factory defaults. Pressure Rise I-Flow or Rise-Time fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 60 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 V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 61: Patient Data

    For data input, just push Change data and choose the field for input For capital letters, push Accepting data with “Apply” Figure 6-11: Data entry keyboard fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 62: Language

    After the time or date has been changed, the confirmation check mark changes colors. Figure 6-13: Change Date & time screen The new information is applied after confirmation. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 63: Tools

    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. Figure 6-15: Information screen fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 64: Service Mode

    After using service mode and before connecting fabian to a patient, restart Figure 6-16: Service mode password screen the device. Only allowed when patient is NOT connected. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 65: Alarms

    7.1 Alarm limits menu Figure 7-1: Alarm limits menu Alarm volume (3 levels). Push button underneath Automatically sets individual alarm limits. Push button underneath. Open log file. Push button underneath. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 66 After 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 V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 67: Automatic Alarm Limits

    Lower limit: 2 mbar below set CPAP value CPAP [NCPAP-mode] : • Upper limit: 5 mbar above set Pduo value Pduo [DUOPAP-mode] : • CPAP [DUOPAP-mode] : Lower limit: 2 mbar below set CPAP value fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 68: Configurable Alarms

    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 V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 69: Alarm Causes And Solutions

    Contact your local checksum System failure System error ACUTRONIC Medical conductor PIC Systems Distributor Contact your local checksum System failure System error ACUTRONIC Medical monitor PIC Systems Distributor fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 70 Remaining battery Immediately switch to time < 1 min. Depleted Electrical Mains supply or Ventilation can no battery! power Access alternative longer continue on ventilation battery power fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 71 Oxygen sensor sensor defective. Replace O sensor. Sensor alarms defect Replace O sensor as Oxygen sensor quickly as possible. sensor worn. Sensor alarms used up Calibration still available. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 72 • Check setting of Pmean. • Check patient, • Check tubing system, Pressure rise in tubing High Pmean Patient alarms • Check exhalation system. valve. • Replace patient system. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 73 • Adjust settings • Check patient, • Check SpO sensor Low SpO perfusion Low Perfusion Patient alarms for correct contact Index index with patient • Adjust settings fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 74 • Check tubing • Resistance has system for Low minute increased. Patient alarms obstructions, volume • Spontaneous • Check ventilation breathing has settings stopped or is declining fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 75 Alarm Slience and is operating on button. battery power. • The device continues in battery mode without interruption. Tidal Volume Upper alarm limit System limits Adjust settings. limited exceeded fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 76: Pressure Release Behaviour

    If the device software encounters an unexpected ERROR, a window appears in the middle of the screen with the following text in English: “Application fabian.exe encountered a serious Error and must shut down.” Figure 7-4: Application error displayed fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 77: Watchdog Alarms

    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. NOTE: WDST#8 is not an alarm and only shows that all watchdogs are working correctly. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 78: Battery Operation

    When storing the ventilator for long term storage, please remove the Battery pack. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 79: Power Failure

    After 60 minutes on Battery power, the Battery is drained, and fabian will power OFF. Depleted Battery – Connect to Main – – Charge battery for approx. 5 hours – fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 80: Operating On External Power Source

    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 V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 81: Ventilation Parameters

    SIPPV Adjustable flow during inspiration • SIMV • SIMV + PSV • I-time • IPPV Inspiratory Time • SIPPV • SIMV • SIMV + PSV • • duoPAP fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 82 I-Flow or Rise Time • SIPPV Control Will allow for use of either I-flow or Rise time based pressure • SIMV rise control during inspiration • SIMV + PSV • fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 83 Volume Guarantee/ Volume Limit Guarantee/ • SIPPV Volume Limit • SIMV Will allow either volume guarantee or volume limit to be • SIMV + PSV enabled in the user interface. • fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 84: 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 V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 85: Ippv

    A higher I-flow can be requested during NIPPV mode, because of potential higher leakages. See Section 10: “Ventilation parameters” See Section 11.9 : “Ventilation Additives” fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 86: Sippv

    To prevent Auto-Triggering, another breath cannot be triggered for 180 ms following the end of the preceding breath. See Section 10: “Ventilation parameters” See Section 11.9: “Ventilation Additives” fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 87: Simv

    TI and TE frequency. The synchronization window for the next mechanical breath is maximum ½ See Section 10: “Ventilation parameters” See Section 11.9: “Ventilation Additives” fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 88: Simv + Psv

    SIMV+PSV, the ventilation mode is automatically ch anged to SIMV and can be switched back only manually after the activation of the flow sensor. See Section 10: “Ventilation parameters” See Section 11.9: “Ventilation Additives” fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 89: 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. See Section 10: “Ventilation parameters” See Section 11.9: “Ventilation Additives” fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 90: Ncpap / Duopap

    11.9: “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 V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 91: O 2 Therapy Mode

    The display will show the message: “Volume Limited”. In the event of Flow Measurement Outage (for example: changing the sensor) “V-limit” will automatically be deactivated. After Flow Measurement is available again “V-limit” is automatically reactivated. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 92: Volume Guarantee

    NOTE: Manual Breath is NOT available in O Therapy mode. A Manual breath however can lead to lung over distension. If activated, some clinicians use this for a manual sustained lung inflation after suctioning. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 93: Nebulizing Medications (Optional)

    Flush button in a Ventilation mode to initiate the O Flush. The Flush Concentration can now be set with the Rotary push knob. Pressing the O Flush button again will end the Flush immediately. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 94: Accessories And Options

    12.1 Accessories List WARNING: The items shown in this list have been approved for use with the fabian +nCPAP evolution 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 95 NIV generator – Vyaire InfantFlow LP For Invasive modalities, only Altera breathing circuits (REF 154308) are validated, for nCPAP modalities only Medijet, InfantFlow, InfantFlow generators and associated sets are validated. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 96: Spare Parts List

    12.2 Spare parts list Description Membrane holder, 22mm OD / 15mm ID IMPORTANT: There is a risk of damage due to nebulizing dugs or aggressive cleaning solutions. Membrane, expiration Oxygen sensor fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 97: Spo 2 Module

    In addition, the following general messages for the sensor state can appear in the information bar in the Configurations menu: • "checking " • "processing active " fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 98: Sensitivity Mode

    This mode is clinically applicable during procedures when detecting rapid changes in oxygen saturation is paramount such as induction, intubation, and sleep studies. Figure 12-4: Fast SAT fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 99: Alarm Delay

    There are different averaging times that can be selected (2 to 4, 4 to 6, 8, 10, 12, 14, 16). Figure 12-6: SpO averaging time fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 100: Prico

    USB device port on the rear panel of the fabian ventilator. The total length of the USB HPL/MIN, patient cable, and sensor cannot exceed 5 meters. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 101 7-pin LEMO device port on the rear panel of the fabian ventilator. The total length of the LEMO HPL/MIN, patient cable, and sensor cannot exceed 5 meters. Figure 12-9: LEMO HPL/MIN module fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 102: Setting Up Prico

    Graphics menu. PRICO will adjust the FiO , to try to keep the SpO within the selected range. Figure 12-10: PRICO in fabian Therapy & fabian +nCPAP evolution devices PRICO has the following parameters: PRICO Parameters Min FiO...
  • Page 103 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 V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 104: 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 12-12: PRICO “ON” fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 105: Prico Disabling Alarms

    • There is arterial occlusion proximal to the sensor • There is excessive illumination from light sources such as a surgical lamp, a bilirubin lamp, or direct sunlight fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 106 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 12-14: Alarm limits fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 107: 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: Acutronic proprietary RS232 protocol without wave data Acutronic proprietary RS232 protocol with wave data 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 108: 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 V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 109: Ventilator Service And Maintenance Intervals

    WARNING: The user of the device is responsible for performing routine maintenance when scheduled, and is also responsible for notifying ACUTRONIC Medical Systems in a timely basis when service needs to be performed. Maintenance Interval Indicator. The symbol will appear in the Information bar 30 days before the next maintenance has to be performed.

  • Page 110: Disposal

    Accessories and consumables must be disposed of in accordance with the relevant instructions for use. For information, contact your local environmental or regulatory agency, or an appropriate waste disposal company. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 111: Sterilization / Cleaning / Disinfection

    Unfold the CaviWipe and wipe the surface of the enclosure completely. NOTE: The surface treated must remain visibly moist for three minutes. Use more wipes if necessary, to keep the surface moist for three minutes. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 112: Accessories

    Switch OFF the fabian before cleaning and unplug at the mains in order to prevent damage due to penetration by liquid. Remove the Flow sensor from the flow sensor cable. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 113: Flow Sensor

    NOTE: Prior to sterilization, ensure that the flow sensor and flow sensor cable have been replaced during the 12 month maintenance or after 30 Sterilization cycles, whichever comes first. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 114 NOTE: Articles must be individually single pouched in a qualified pouch (for example: 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 V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 115: Exhalation Membrane And Membrane Holder

    Disassemble the membrane holder from the expiratory limb port by rotating the holder a quarter of turn in counter-clockwise direction and then pull it out from the port. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 116 Tap water (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 07:00 90°C / 194°F fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 117 Dry cycle for 30 minutes Individually single pouch the exhalation membrane and membrane holder separately. Autoclave the exhalation membrane and membrane holder using the cycle parameters in Step 1 above. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 118 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 V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 119: Setting Ranges And Parameters

    [%] 21 Flush [%] 23 PEEP [mbar] 0 Pinsp [mbar] 4 Pmax [mbar] 4 Rise Time [sec] 0.1 Trigger [Volume] V guarant [mL] 0.8 V limit [mL] 1 fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 120 [mbar] 0 Pinsp (backup) [mbar] 4 Pmax [mbar] 4 Ppsv [mbar] PSV Termination criteria Rise Time [sec] 0.1 Trigger [Volume] 1 V guarant [mL] 0.8 V limit [mL] 1 fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 121 [%] 23 Pbackup [mbar] 4 Pmanual [Volume] PPSV [mbar] 2 Rise Time [sec] 0.1 Termination critera PSV [%] 1 Trigger [Volume] 1 Vguarant [mL] 0.8 Vlimit [mL] 1 fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 122 [sec] Flowmin [L/min] Flush Time [sec] 0 Frequency [1/min] I-time [sec] 0.15 15 Man Breath Time [sec] 2 [%] 21 Flush [%] 23 PDUO [mbar] Pmanual [mbar] 5 fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 123: Guide To Volume Guarantee (Vg)

    If the flow sensor measurements become unavailable, the VG function will be disabled and t he pre-set Pinsp is used for ventilation. VG function will restart once flow sensor measurements become available again. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 124: How To Start The Vg Function

    Select the appropriate VTe to be guaranteed by setting Vguarant to a target volume. A typical infant tidal volume target is 4 to 6mL/kg. Figure 17-1: Set Vguarant parameter fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 125 Pinsp setting and High PIP alarm setting. NOTE: To avoid unintentional breath abortions by reaching / exceeding High PIP, make sure that the High PIP alarm is set to at least +2mbar above Pmax. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 126 VG can now be activated by selecting the ON/OFF button. When VG function is enabled, this button will turn Green. A line will appear in the Pressure Wave diagram to mark the Pmax. Figure 17-4: : Vguarant ON / OFF button fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 127: Setting Up The Ventilator Psv+Vg

    Ventilation immediately after E-time, otherwise after Preset Apnea Time. Using a delay time will determine the apnea period before backup ventilation begins. The Apnea Backup breaths are Volume Guaranteed breaths. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 128: 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 129: Technical Specifications

    Value 18 Vol% Breath Frequency If Alarm Limit exceeded Alarm: Volume Monitoring If the breath volume set was not supplied Alarm Lower Threshold Value: Apnea Alarm fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 130: 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 V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 131: Resistance Values

    Pressure trigger • enabled / disabled Transport mode • mbar Unit for Pressure • • Enabled Use BTB for Vt • Disabled • Vlimit Vlimit / Vguarant • Vguarant fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 132: Dimensions / Weight

    Safety Classification (Applied Parts) From SN AN-04000: Type BF Till SN AN-03999: Type B Electrical Safety Classification Class I (mains power) Internally powered (battery power) Sound Pressure Max. 68 dB (A) fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 133: 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 +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 134 19 Technical specifications Figure 19-1: Internal Gas Blending function of the fabian +nCPAP evolution Proportional Gas Blending Assembly Ventilator Manifold Air 2.0 to 6.0 bar Sensor Block Manifold Block Oxygen 2.0 to 6.0 bar Manifold PCB Sensor Pressure Regulator Manifold PCB Cover...

  • Page 135: 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 V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 136 ± 3 bpm (no motion conditions); or ± 5 bpm (motion conditions); 201.11.8.101.1 201.12.4 Low and High Pulse Rate alarm conditions shall occur, as appropriate; 201.13.101 a technical alarm condition shall occur. fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 137: Electromagnetic Compatibility Statement

    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 138 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 139 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 140 The operator of the fabian +nCPAP evolution can help avoid electromagnetic interference by maintaining the minimum distance between portable and mobile HF telec ommunication devices (transmitters) and the device fabian +nCPAP evolution – depending on the output rating of the communication device, as listed below.

  • Page 141: Devices With Sn Up To An-03999

    Guideline and manufacturer declaration – electromagnetic emission 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.
  • Page 142 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.
  • Page 143 HF communication devices and the device " fabian +nCPAP evolution " " fabian +nCPAP evolution " is intended to be operated in an electromagnetic environment with controlled HF interferences. 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 "...
  • Page 144 20 Electromagnetic compatibility statement Recommended safety distances between portable and mobile HF communication devices and the device " fabian +nCPAP evolution " For transmitters with a maximum power output not listed in the above table the recommended safety distance d in metres (m) can be determined using the equation from the corresponding column, with P being the transmitter’s maximum power output Watts (W) per the transmitter’s manufacturer specifications.

  • Page 145: Appendix A: Glossary

    Infrared radiation [wavelength greater than 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. Mechanical Ventilation. Non-invasive Ventilation fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 146 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 V5.1.x Ref: 122003.EN / Date : 26Jan2021...

  • Page 147: Appendix B: Index

    IPPV, 74, 75, 76, 77 Data storag, 124 Date ∕ Time, 55 Keypad features Dependencies, 95, 96 Alarm limits, 57 Device checks, 124 Graphics, 20, 95, 137 Dimensions, 123 fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 148 Ventilation, 16, 21, 33, 39, 40, 51, 59, 70, 77, 78, patient circuit, 33, 136 79, 80, 81, 82, 83, 84, 85, 86, 97, 115, 118, Patient data, 53 122, 136 Pediatric, 44, 45, 111, 112, 113, 115 fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...
  • Page 149 79, 81, 82, 93, 94, 115, 118, 128 Dangerous voltage, 2 VG function, 116 Fire hazard, 2 Voltage, 13, 124, 128, 129 warnings, 1 volume guarantee, 115 Volume guarantee, 85 fabian +nCPAP evolution | SW V5.1.x Ref: 122003.EN / Date : 26Jan2021...

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