Related Manuals for ACUTRONIC fabian
Summary of Contents for ACUTRONIC fabian
- Page 1 Ventilation Beyond Limits fabian Therapy evolution and Auxiliary Systems Instructions for Use, Software Version 5.1.x fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021...
- Page 2 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 regarding software applications that are created by the user.
-
Page 3: Table Of Contents
Operation – Settings ......................20 4.3.3 Ventilation parameter dependency ..................21 4.3.4 Locking ventilator parameters....................21 Graphics menu ....................22 4.4.1 Trend Menu ..........................23 5 System operation ................24 fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... - Page 4 7.4.4 Watchdog alarms ........................59 8 Battery operation ................60 Power Failure ..................... 61 9 Operating on External power source..........62 (Devices with SN up to AT-03999) ............... 62 fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021...
- Page 5 15.2.1 Flow sensor cable ........................85 15.2.2 Flow sensor ..........................87 16 Setting ranges and parameters ............89 17 Technical specifications ..............90 Ambient conditions..................... 90 Monitoring ......................90 fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021...
- Page 6 18 Electromagnetic compatibility statement ......... 98 Device with SN from AT-04000................98 Device with SN up to AT-04000 ................. 102 Appendix A: Glossary .................... 105 Appendix B: Index ....................107 fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021...
-
Page 7: Introduction
Notes provide additional information to clarify an explanation or instruction. Applicable hardware versions This Instructions for Use is applicable for fabian Therapy evolution devices running software version 5.1: x, where (x) can be any number. fabian Therapy evolution | SW V5.1.x... -
Page 8: Symbols
Expiration date External power supply input Flammability warning Flow sensor connection. Sensor Flow sensor connection Fragile, handle with care GHS Chemical Hazard warning High Frequency interference warning. Humidity Limitation fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... - Page 9 Storage Temperature This way up Type B application part Type BF application applied part. Unplug power before opening housing Video Output USB connection Warning regarding operation in explosive areas fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021...
-
Page 10: Warnings Cautions And Notices
: The ventilator must be operated by qualified technical staff to ensure immediate remedial action in the event of malfunction. WARNING : The fabian system and associated auxiliary systems must NEVER be used in MRI scanning facilities. WARNING for example... - Page 11 : 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 12: Maintenance
: DO NOT use the ventilator in association with HF (High Frequency) electrosurgical equipment. Maintenance The fabian Therapy 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 13: Liability For Functionality / Damages
ACUTRONIC Medical Systems AG, sales terms and delivery conditions. Intended use The fabian Therapy evolution is intended for premature infants, newborns as well as children weighting up to 30 kg. The fabian Therapy evolution is intended for “in-patient use” in professional healthcare environment including intra-hospital patient transport. -
Page 14: System Overview
3 System overview 3 System overview Scope of Delivery The fabian Therapy product includes the following items: • One - fabian Therapy evolution ventilator • Two - Infant Flow Ventilator Tubes country specific • One - Power cable (# country specific •... -
Page 15: Rear Panel
Connection for compressed Air supply 2.0 to 6.0 bar/40 L/min Connection for future use, covered with a faceplate Oxygen Sensor Connection for oxygen “O ” supply 2.0 to 6.0 bar /40 L/min fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 16: Devices With Dc Connector (Up To Sn At-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 Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 17: 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 Max operating Current: 200 mA fabian Therapy evolution | SW V5.1.x... -
Page 18: System Functions And Displays
Used to access the Configurations and Calibration menus. Pressing once will open the calibration menu; pressing again will open the configuration menu. Waves Switches to Waves display and values are shown in big letters fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 19: Rotary Pulse Knob
Subsequent alarms with higher priority are only displayed optically during silencing. 4.1.2 Rotary pulse knob The Rotary Pulse knob combines a push button with a rotary knob for executing various settings, selections and confirmation options. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 20: Display Concept Structure
Numeric field / Alarm Limits Figure 4-3: Display screen 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 Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 21: 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 Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 22: Numeric Field/Alarm Limits
Figure 4-5: Alarm limits touch the Parameter button again or push Rotary Pulse knob again. To automatically set the Alarm limits, select parameter and touch the AUTOSET button (3). fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 23: Graphic Field
The Graphics button enlarges the measured values Displays the current values in large letters and the actual Wave. Use the Graphics button to access the Waves menu. Figure 4-6: Graphics display fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 24: Led Indicators
Report the incident to your local distributor DO NOT use the device until it has been checked by suitably trained and qualified personnel. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 25: Ventilation Menu
Depending on the Ventilation mode, the Respiration menu indicates the Configuration parameters (2) and Measurements (3) relevant in this mode. The Ventilation parameters can be changed in the menu. Figure 4-7: Operation screen fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 26: 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 Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 27: Ventilation Parameter Dependency
List of locked values: Parameter Locking at Modes CPAP >10 mbar DUOPAP/NCPAP Flow >5 L/min Therapy Frequency I : E >1 DUOPAP I-Time I : E >1 DUOPAP fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 28: Graphics Menu
The key will turn Green. The measured parameters in the Display field continue being updated. Press the Freeze key again to continue updating the Waves data. Figure 4-12: Freeze Waves fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 29: Trend Menu
A confirmation message will always be displayed before trend data is deleted. Figure 4-13: Trends screen Parameter selection for graphic waves Graphics Parameter values Timeline Adjust timeline (minimum 30 minutes to a maximum of five days) Update data (refresh) fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 30: System Operation
The device can be operated with 100 to 240 VAC, 50 or 60 Hz and automatically adjusts to voltage and frequency without manual switch-over being necessary. WARNING The use of fuses must correspond with the value and type approved for the fabian. • The fuse type and value is printed on the back of the fabian. -
Page 31: Connect The Tubing Set
WARNING: ELECTRICAL HAZARD NEVER use anti-static or electrically conductive tubes. WARNING: The pressure gradient on the fabian ventilator system is measured at the patient connection port and can increase when accessories or other components are attached to the system. Change in pressure gradient can adversely affect the performance of the fabian system. -
Page 32: Connect Flow Sensor In Niv Trigger ( Optional )
Figure 5-1: Infant Flow LP tubing system CAUTION: Always follow the manufactures instructions to ensure the correct connections for the nCPAP and Infant Flow LP systems. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... - Page 33 5 System operation Infant Flow ® LP patient breathing circuit fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021...
-
Page 34: System Start-Up
The O will automatically be calibrated after leaving the Calibration menu once every 24 hours. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 35: Device Checks
Always perform a Device Check before each ventilator use or after changing the patient circuit. The fabian ventilator does not automatically compensate gas fraction measurements for changes in barometric pressure during use. The oxygen sensor is calibrated in the hospital prior to use and this calibration remains in effect. This calibration process is part of the normal pre-use checks for the ventilator. - Page 36 Unplug power cord switch to Battery mode. Reconnect power cord CAUTION: Ensure that Pmanual and other pressures are reduced to safe levels prior to connecting to patient. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021...
-
Page 37: System Standby
If the device is ready to resume operation before the 2 minute standby, press the Start/Stop button at any time to interrupt the Standby cycle and return the ventilator to operation. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 38: System Shutdown
Press the Alarm Silence button to confirm system switch OFF. Hold the button for at least three seconds until the WARNING LED and audio alarm stops. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 39: 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 Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 40: Configurations Menu
Figure 6-1: Configurations menu in Therapy WITH flow sensor connector Calibration menu Date / Time Display Tools Ventilation Information Patient Data PDMS (optional) Language Service Mode fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... - Page 41 6 Configurations menu Figure 6-2: Configurations menu in Therapy WITHOUT flow sensor connector Calibration O Tools Information Display PDMS (optional) Ventilation sensor Patient Data Language Service Mode Date / Time fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021...
-
Page 42: Calibration
Calibration Menu at Therapy (only with flow sensor connector) Figure 6-3: Calibration menu From the Calibration screen, you can calibrate the following sensors: • Flow sensors: Neonatal and Pediatric • sensor • module fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 43: Flow Sensor
If Flow measurements are not regained. Consider the following: • 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 Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 44: O 2 Sensor
After a successful calibration, the Date of the last calibration is displayed in the corresponding field. Automatic sensor calibration runs every time the equipment restarts and every 24h. The gas concentration to patient is not altered during this calibration procedure. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 45: Spo 2 Module
Lock Touch screen. The screen will automatically be unlocked if an alarm is triggered or the Rotary Pulse knob is pressed. Automatic lock activated/deactivated. Touchscreen automatically locks after a set time. Display graphs as filled or regular lines. Autoscale ON / OFF fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 46: Touch Screen Settings
Return button and the chosen time will be displayed. Figure 6-7: Lock screen time settings The touch screen can also be locked by holding the Rotary Pulse knob for 3 seconds. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 47: Trend/Graph Display
Scaling can be performed manually • with the (−/) keys on the keypad for the timeline. For Wave height, use the Manual Breath and O Flush keys on the keypad. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 48: Ventilation Parameter Settings
: The “Hospital Settings” button is only active if special Settings settings were previously saved in the device. Hospital Settings can be accessed, loaded from the Service menu or copied in Service mode. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 49: Patient Data
Accepting data by pressing the Apply button. NOTE : For Capital letters, touch the Up-arrow key. Figure 6-12: Data entry keyboard fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 50: Language
Danish • German • Polish • Swedish • Dutch • Hungarian • Portuguese • Turkish Only select a new language when the device is NOT connected to a patient. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 51: Date / Time
Log files Alarm and System log Figure 6-15: Download to USB stick screen Device Information SW and HW configuration with licenses Only allowed when patient is NOT connected. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 52: Information
This section is described in the Service Manual and is only for trained Service technicians. Figure 6-17: Service mode password screen Only allowed if patient is not connected! fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 53: Alarms
Figure 7-1: Alarm limits menu Automatically sets individual Alarm Limits. Push button underneath Autoset. Alarm volume (3 levels). Push button underneath Bell symbol. Open Log File. Push button underneath Show Log. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... - Page 54 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 Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021...
-
Page 55: Automatic Alarm Limits
Lower limit: 2 mbar below set CPAP value CPAP [NCPAP-Mode] : • Pduo [DUOPAP-Mode] : Upper limit: 5 mbar above set PDUO value • Pduo [DUOPAP-Mode] : Lower limit: 2 mbar above PEEP lower limit fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 56: Configurable Alarms
The Alarm Log files capable of export from the submenu (Tools) will not be deleted. In case alarm list or alarm log files reach their limit (100 / ca. 70000 entries respectively), the oldest entries are deleted first. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 57: Nurse Call Relay
Systems Distributor Contact your local SPI interface System failure System error ACUTRONIC Medical Systems Distributor Contact your local checksum System failure System error ACUTRONIC Medical conductor PIC Systems Distributor fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... - Page 58 Charge mains supply. Electrical without battery power • Remaining interruption. (<15min) battery time <15 • Alarm may be min. silenced with Alarm Silence button. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021...
- Page 59 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 Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021...
- Page 60 • Check tubing system. High Pressure Patient alarms system. NOTE : High PIP alarm • Replace patient should be set to at system. least +2mbar above Pmax. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021...
- Page 61 • Adjust settings • Check patient, • Check patient connection. Leak or Low PIP Patient alarms • Check tubing disconnection. system for leaks. • Check setting of Pinsp. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021...
- Page 62 Check patient, • Leak or • Check tubing disconnection. Low PEEP Patient alarms system for tight • Insp. flow or exp. connection. flow set too low. • Increase flow. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021...
- Page 63 Electrical unplugged from silenced with Power failure power mains power supply Alarm Silence and is operating on button. battery power. • The device continues in battery mode without interruption. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021...
-
Page 64: Pressure Release Behaviour
Application error 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 7-3: Application error displayed... -
Page 65: Watchdog Alarms
In case a WDST 4/16/32/64 error is resolved (was only a temporary error) WDST#8 will be triggered and displayed and the device can be further used. NOTE : WDST#8 is not an alarm and only shows that all watchdogs are working correctly. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 66: Battery Operation
When storing the ventilator for long term storage, please remove the Battery pack. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 67: Power Failure
Primary Power Source. After 60 minutes on Battery power, the battery is drained and fabian will power OFF. Depleted Battery! – Connect to Mains – – Charge battery for approx. 5 hours –... -
Page 68: 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 Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 69: Ventilation Parameters
Next breath possible after a Block period of 200 milliseconds. Trigger Trigger • DUOPAP The trigger sensitivity can be adjusted from level 1 to 10 and can be turned OFF. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 70: Ventilation Modes
A NIV Trigger option can be additionally implemented in order to provide those modes with Breath detection (Apnea monitoring with alarms) and triggered supported breaths (or synchronized transition from low to high CPAP levels) in DUOPAP. Depending on the generator in use, fabian will then automatically select the proper NIV trigger sensor: •... -
Page 71: O 2 Therapy Mode
L/min, the humidifier dual servo temperature controls remain active, so no need to switch it OFF in case of short-term Standby mode. There are no patient alarms active in this mode fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 72: Special Functions
Flush button in a ventilation mode to initiate the O Flush. The flush concentration can now be set with the Rotary Pulse knob. Pressing the O Flush button again will prematurely end the Flush. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 73: Connect Nitric Oxide (No) Tubing Sets
11 Ventilation modes 11.3.4 Connect Nitric Oxide (NO) tubing sets IMPORTANT: Only INOmax and INOvent NO systems are approved by ACUTRONIC Medical Systems. If other manufacturers’ NO systems are used, they must be validated first before use with the fabian. 11.3.4.1... -
Page 74: Accessories And Options
Accessories List WARNING The items shown in this list have been approved for use with fabian Therapy 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/or accessories, the user is responsible and liable for any and all issues associated with the system malfunction. - Page 75 NIV generator – Vyaire InfantFlow LP NIV generator – Medin Medijet Humidifier – WILAmed; AIRcon For nCPAP modalities only Medijet, InfantFlow, InfantFlow generators and associated sets are validated. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021...
-
Page 76: Spare Parts List
12 Accessories and options Description Humidifier – VADI Spare parts list Description Proximal pressure connection sleeve Oxygen sensor fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 77: 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 " • "pulse search " fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 78: 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 12-4: Fast SAT fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 79: 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 Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 80: Prico
The sensor is connected to the fabian with a patient cable. The sensor collects signal data from the patient and sends it to the ventilator. The fabian displays the calculated data additional to the ventilation data in four... - Page 81 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 HPL/MIN, patient cable, and sensor cannot exceed 5 meters.
-
Page 82: Setting Up Prico
Graphics menu. PRICO will adjust the FiO , to keep the SpO within the selected range. Figure 12-10: PRICO in fabian Therapy Alarm Limits menu PRICO has the following parameters: PRICO Parameters Min FiO Minimum allowed FiO... - Page 83 Inside the SpO target range : lower half +1, if FiO is in lower half. Upper half decrease FiO with 1%. • adjustments are made up to the pre-set FiO ranges. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021...
-
Page 84: Prico Ventilation Modes
12 Accessories and options 12.4.3 PRICO Ventilation modes PRICO is available on the fabian ventilators in the following modes: • High and Low Flow Oxygen Therapy HFNC (O Therapy) • NIV Bi-levels positive airway pressure (DUOPAP) • NIV Continuous Positive Airway Pressure NCPAP) The “O... -
Page 85: Prico Disabling Alarms
The sensor is too tight • 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 Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... - Page 86 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 Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021...
-
Page 87: 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 Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 88: Ventilator Service And Maintenance Intervals
Always clean and disinfect equipment or equipment components prior to any maintenance – including when returning the equipment for repair. The expected service life of fabian is 8 years, assuming the servicing operations are performed as specified by the manufacturer. -
Page 89: Disposal
Lithium Battery (real time clock battery) • Sensor Disposal fabian must not be disposed of with household waste but must be handed in for disposal as electrical and electronic equipment, including battery / batteries according to applicable national, regional and local rules, laws and regulations. -
Page 90: Sterilization / Cleaning / Disinfection
The device must NOT be sterilized under any circumstances. 15.1.1 Preparation for disinfection Switch OFF the fabian before cleaning and unplug at the mains in order to prevent damage due to penetration by liquid. Figure 15-1: Unplug mains connection To ensure that no contamination gets into the gas path, make sure all gas connectors (O and Air hoses on the backwall, Insp port and Prox port on frontside) are covered (e.g. -
Page 91: Manual Disinfection Options
Allow to dry in the air. Accessories 15.2.1 Flow sensor cable The flow sensor cable must be prepared after each patient treatment. WARNING: The flow sensor cable must NOT be sterilized under any circumstances. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... - Page 92 15 Sterilization / cleaning / disinfection 15.2.1.1 Preparation for disinfection 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.
-
Page 93: Flow Sensor
: Articles must be individually single pouched in a qualified pouch ( 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 Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... - Page 94 Steam cycle at 134°C / 273°F for 5 minutes 1.3. Dry cycle for 30 minutes Individually single pouch the cassette articles Autoclave the cassette articles using the cycle parameters in Step 1 fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021...
-
Page 95: Setting Ranges And Parameters
DUOPAP Neonatal Neonatal Neonatal Parameters CPAP [mbar] E-time [sec] Flowmin [L∕ min] Flush Time [sec] Frequency [1/min] I-time [sec] 0.15 Man. Breath Time [sec] flush PDUO [mbar] Pmanual [mbar] fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 96: Technical Specifications
IMPORTANT: When moving the device between ambient and controlled temperatures, removing the device from storage, and before use; acclimate the fabian device for 12 hours. The Minimum and Maximum ambient temperatures in the clinical area will NOT affect the accuracy of the Flow, Pressure or Oxygen measurement. -
Page 97: 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 Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 98: Dimensions / Weight
L/min Connection thread: NIST NOTE : Medical grade Oxygen DUOPAP mode: max. 70 W Power Rating Standby, fabian connected to mains: 35 W (Battery charging) 100 to 240 VAC 0.4 to 0.8 A Power Supply 50 / 60Hz Till SN AT-03999: External 12 to 24 VDC 3 AT (Charging only when more than 12.5V) -
Page 99: Data Storage
• Relias Check via SPI Relias : • SPI : Communication between GUI and Monitor PIC. • SPICks : SPI Checksum • Voltage Error Check via SPI Voltage : fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 100: Gas Blender Function
The proportional valves, which also act as return valves, prevent the return flow of a gas into the supply cable of the other gas. An Oxygen sensor measures the Inspiratory Oxygen Concentration. Figure 17-1: Internal Gas Blending function of the fabian Therapy evolution Air 2.0 to 6.5 bar Proportional valve Oxygen 2.0 to 6.5 bar... -
Page 101: Acoustic Energy
51.0/47.1 Lin/A weighted (dB) Supplementary information: LpA: A weighted sound pressure level in 1m distance: 40dB 1) Highest Level at Pos 2 2) Highest Level at Pos 4 etc. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... -
Page 102: 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 Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... - Page 103 • ± 5 bpm (motion conditions); ISO 80601-2-61: 2017 201.11.8.101.1 Low and High Pulse Rate alarm conditions shall occur, 201.12.4 as appropriate; 201.13.101 a technical alarm condition shall occur. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021...
-
Page 104: Electromagnetic Compatibility Statement
Guideline and Manufacturer Declaration – Electromagnetic Emission The "fabian Therapy evolution" device is intended for operation in the environment described below. The customer or user of the "fabian Therapy evolution" apparatus should ensure it is operated in this type of environment. - Page 105 Guideline and Manufacturer Declaration – Electromagnetic Immunity The fabian Therapy evolution device is intended for operation in the environment described below. The customer or operator of the fabian Therapy evolution apparatus should ensure it is operated in this type of environment.
- Page 106 Guideline and Manufacturer Declaration – Electromagnetic Immunity The fabian Therapy evolution device is intended for operation in the environment described below. The customer or operator of the fabian Therapy evolution apparatus should ensure it is operated in this type of environment.
- Page 107 If the area intensity at the location where the fabian Therapy evolution is used exceeds the above compliance levels, fabian Therapy evolution should be monitored for proper function. If unusual pe rformance characteristics are observed, additional measures could be required, as for example: changing the direction or location of the fabian Therapy evolution.
-
Page 108: Device With Sn Up To At-04000
Guideline and manufacturer declaration – electromagnetic emission The device "fabian Therapy evolution" is intended for operation in the environment described below. The customer or user of the "fabian Therapy evolution" apparatus should ensure it is operated in this type of environment. - Page 109 Guideline and manufacturer declaration – electromagnetic immunity The device fabian Therapy evolution is intended for operation in the environment described below. The customer or user of the fabian Therapy evolution apparatus should ensure it is operated in this type of environment.
- Page 110 Therapy evolution is used exceeds the above compliance levels, fabian Therapy evolution should be monitored for proper function. If unusual performance characteristics are observed, additional measures may be required, as e.g. changing the direction or location of the fabian Therapy evolution.
-
Page 111: Appendix A: Glossary
700 nanometres Infrared radiation [ (nm)]. Leaks Leakage from patient or system tubings ∕ connections. Light Emitting Diode. LNCS Low Noise Cable Sensors. Magnetic Resonance Imaging. Magnetic Resonance Therapy. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... - Page 112 Used for testing Ventilator equipment. Trend A general direction in which something is developing or changing. Universal Serial Bus, communication cables and connections. USB HPL/MIN Link Power Management. Video Graphics Array. fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021...
-
Page 113: Appendix B: Index
7, 25, 26, 31, 42, 63, 64, 65, 78, 91 Neonatal, 89 Note, 4, 5, 92, 98 Fast SAT mode, 71, 72 Over-breathing, 37 Gas blender, 94 Oxygen sensor, 79 Gas Supply, 24 fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021... - Page 114 1, 4, 5, 6, 24, 29, 60, 74, 75, 98 Voltage, 98, 99 Rain-out, 37 Warning, 4, 5, 6, 24, 32, 33, 60, 66, 98 Chemical burn, 2 Sensitivity mode, 72 warnings, 1 sensor, 37, 66, 91 fabian Therapy evolution | SW V5.1.x Ref: 121003.EN / Date: 26Jan2021...
Need help?
Do you have a question about the fabian and is the answer not in the manual?
Questions and answers