Table of Contents
Related Manuals for ACUTRONIC fabian Therapy evolution
Summary of Contents for ACUTRONIC fabian Therapy evolution
- Page 1 Ventilation Beyond Limits fabian Therapy evolution SW 5.0 Instructions for use Warning Carefully read the instructions of use before using the ventilator to familiarise yourself with the function of the equipment Ref: 121003.EN / Date: 2018-06-18...
- 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.
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Page 3: Table Of Contents
Connect flow sensor in NIV trigger (optional) ..........29 Switching On the device .................. 29 Switching Off the device .................. 30 Device Check ..............31 Configurations Menu ............32 fabian Therapy evolution | SW 5.0 3 / 72 Ref: 121003.EN / Date: 2018-06-18... - Page 4 Service and Maintenance Intervals ........59 Sterilisation / Cleaning / Disinfection ....... 60 Setting Ranges and Parameters ........61 Standard Accessories ............62 Technical Specifications ..........63 4 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18...
- Page 5 18.8 Applied Parts ..................... 66 18.9 Device Checks ....................66 18.10 Gas blender function ..................67 18.11 Acoustic Energy ....................68 Electromagnetic Compatibility Statement ....... 69 fabian Therapy evolution | SW 5.0 5 / 72 Ref: 121003.EN / Date: 2018-06-18...
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Page 6: Working With The Instructions
DANGER indicates a not directly imminent but latent hazard which may result in death or bodily injury unless prevented. Danger ATTENTION indicates a risk which may result in equipment damage when not avoided. 6 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... -
Page 7: Hardware Version Identification
Caution, refer to operator’s manual for important safety information / precautions Flow sensor connection Potential equalisation connection Marking per Medical Devices Directive 93/42/EEC Manufacturer / Date of manufacture Disposal information Type B application part fabian Therapy evolution | SW 5.0 7 / 72 Ref: 121003.EN / Date: 2018-06-18... - Page 8 Single use Article No. Non-sterile Latex free Fragile, handle with care Keep away from heat Keep dry This way up Do not use hooks Do not stack 8 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18...
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Page 9: General Notices
The use of the ventilator requires detailed knowledge and the observation of this operator’s manual. This device is only intended for the described use. Only operate the ventilator with accessories recommended by ACUTRONIC Medical Systems AG. The ventilator must be operated by qualified technical staff or staff supervised by such to ensure immediate remedial action in the event of malfunction. - Page 10 Do not remove the power cable unless for service purposes or transport. Warning: modification of this equipment is not allowed. Note: accessories supplied by ACUTRONIC Medical Systems AG for use on fabian ventilators are biocompatible. Please ensure before applying non-original accessories that they are biocompatible.
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Page 11: Maintenance
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 support or improper use, any and all liability for the functionality is transferred to the owner or operator. -
Page 12: Scope Of Delivery
1 x Operating manual (# country specific) 2.6 Contra-indications No contra-indications for the use of the fabian Therapy evolution neonatal and infant ventilator in an intensive care unit are known. In the event of ventilation for more than several hours, care must be taken for optimal conditioning of the respiratory gases (warmth, moisture) to guarantee secretion mobilization and prevent damage to mucous membranes. -
Page 13: System Overview
3 System overview 3.1 Front Connections Connection for fresh gas Pressure measuring tube port fabian Therapy evolution | SW 5.0 13 / 72 Ref: 121003.EN / Date: 2018-06-18... -
Page 14: Rear Panel
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 / 40 l/min 14 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... - Page 15 Maximum Connected Loads: Nurse call: Galvanically isolated relay output. max Load: 30 V / 1 A DC or AC USB: 5 V/150 mA RS232: 3.3 V/100 mA fabian Therapy evolution | SW 5.0 15 / 72 Ref: 121003.EN / Date: 2018-06-18...
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Page 16: Operation And Display
2. Fields in the lower section of the touch screen are operated with the buttons underneath. 3. The button /-control panel incremental knob (combined with a push button and selection dial) 16 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... -
Page 17: Buttons
Subsequent alarms with higher priority are only displayed optically during muting. 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 5.0 17 / 72 Ref: 121003.EN / Date: 2018-06-18... -
Page 18: Display Concept Structure
4. Selection or display of operating mode 5. Numeric field / alarm limits Depending on the display mode selected, individual fields may be shown/hidden. Display field options will be described later. 18 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... -
Page 19: Information Bar
A red blinking info bar also alerts the user to active alarms. If screen lock is in use, the symbol for locked screen is displayed. fabian Therapy evolution | SW 5.0 19 / 72 Ref: 121003.EN / Date: 2018-06-18... -
Page 20: Numeric Field / Alarm Limits
AUTOSET button. 4.2.5 Graphic field The button Waves enlarges the measured values Displays the current values in big letters and also the actual Wave 20 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... -
Page 21: Led Indicators
During voltage supply via the external 12 - 24 VDC connection the mains LED are not illuminated. Battery LED flashes in green when the battery is being charged. fabian Therapy evolution | SW 5.0 21 / 72 Ref: 121003.EN / Date: 2018-06-18... -
Page 22: Ventilation Menu
(4) and measurements (5) relevant in this mode. The Info bar (1) indicates current information. The ventilation parameters may be changed in the menu (5). 22 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... -
Page 23: Operation - Settings
Press any blank area or another parameter to not accept the parameter and keep the previous value Old active alarms at the time the mode is switched will automatically be reset. fabian Therapy evolution | SW 5.0 23 / 72 Ref: 121003.EN / Date: 2018-06-18... -
Page 24: Ventilation Parameter Dependency
I-Time I : E > 1 DUOPAP Frequenz I : E > 1 DUOPAP Flow > 5 l/min Therapy CPAP > 10 mbar DUOPAP / NCPAP 24 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... -
Page 25: Graphics Menu
The key will turn green. The measured parameters in the display field continue being updated. Press the key again to continue updating the Waves data. fabian Therapy evolution | SW 5.0 25 / 72 Ref: 121003.EN / Date: 2018-06-18... -
Page 26: Trend Menu
1. Parameter selection for graphic waves 2. Graphics 3. Parameter values 4. Timeline 5. Adjust timeline (max. 5 days – min. 30 minutes) 6. Update data (refresh) 26 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... -
Page 27: Preparing For Operation
If there is no central gas supply, gas supply from cylinders is also possible. The inputs are coded to prevent wrong connection. Input pressure 2 – 6.5 bar for Oxygen and Medical grade AIR (dust-free, oil-free and dry). fabian Therapy evolution | SW 5.0 27 / 72 Ref: 121003.EN / Date: 2018-06-18... -
Page 28: Connect Tube Set
• Apply nCPAP system to patient per manufacturer specifications. For details of using nCPAP systems, refer to the operators manual of the supplier of the consumables. 28 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... -
Page 29: Connect Flow Sensor In Niv Trigger (Optional)
After that every 24 hours. Can be also done manually after opening O sensor menu. All audible alarms are silenced for 2 Minutes after startup of fabian. fabian Therapy evolution | SW 5.0 29 / 72 Ref: 121003.EN / Date: 2018-06-18... -
Page 30: Switching Off The Device
Once the device has powered off a notice tone will sound. Press the “Alarm Mute” button to confirm system switch off. Hold the button for at least 3 seconds until the WARNING LED stops. 30 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... -
Page 31: Device Check
Warning: disconnected will appear Disconnection the device after the set delay. alarm Reconnect the tube. fabian will automatically switch to Unplug power cord Battery battery mode Reconnect power cord fabian Therapy evolution | SW 5.0 31 / 72 Ref: 121003.EN / Date: 2018-06-18... -
Page 32: Configurations Menu
6. Date / Time 2. Display 7. Tools 3. Ventilation 8. Info (System Information) 4. Patient Data 9. PDMS network settings 5. Language 10. Service Mode 32 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... - Page 33 6. Date / Time 2. Display 7. Tools 3. Ventilation 8. Info (System Information) 4. Patient Data 9. PDMS network settings 5. Language 10. SpO sensor 11. Service Mode fabian Therapy evolution | SW 5.0 33 / 72 Ref: 121003.EN / Date: 2018-06-18...
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Page 34: Calibration
7.1 Calibration 7.1.1 Calibration Menu at Therapy (only with flow sensor connector) 34 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... -
Page 35: O 2 Sensor Calibration
Automatic sensor calibration runs every time the equipment restarts and every 24h. The gas concentration to patient however is not altered during this calibration procedure. fabian Therapy evolution | SW 5.0 35 / 72 Ref: 121003.EN / Date: 2018-06-18... -
Page 36: Flow Sensor Calibration
Flow sensor calibration is available only with InfantFlow and InfantFlow LP generator selected and in ventilation mode NCPAP and DUOPAP. 7.1.4 Module For more information on the SpO configurations please refer to the separate available manuals. 36 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... -
Page 37: Display
2. Automatic lock activated / deactivated. Touchscreen automatically locks after a set time. 3. Display graphs as filled or regular lines. 4. Auto scale ON / OFF fabian Therapy evolution | SW 5.0 37 / 72 Ref: 121003.EN / Date: 2018-06-18... -
Page 38: Touch Screen Settings
Auto-scaling trends: Trend patterns are automatically scaled. • Scaling is done manually with for the timeline • and with for the waves height 38 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... -
Page 39: Ventilation Parameter Settings
Selection of the nCPAP system used. Infant Flow®, Infant Flow LP® (Inspire ), Medijet® Maximum time for manual Maximum inspiration time for a manual breath breath (2 – 30 sec.) fabian Therapy evolution | SW 5.0 39 / 72 Ref: 121003.EN / Date: 2018-06-18... -
Page 40: Standard Hospital Settings
The “Hospital Settings” button (reset) is only active if specific settings were saved in the device. Access hospital settings from “Service Mode” menu This menu is also where the nurse call can be activated and deactivated. 40 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... -
Page 41: Patient Data
Japanese Slovensko • • • • Czech French Norwegian Spanish • • • • Danish German Polish Swedish • • • • Dutch Hungarian Portuguese Turkish fabian Therapy evolution | SW 5.0 41 / 72 Ref: 121003.EN / Date: 2018-06-18... -
Page 42: Date / Time
Save of: Trends Trend data will be output in CSV format. Log files Alarm and System log Device Info SW and HW configuration with licenses 42 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... -
Page 43: Info
This section is described in the Service Manual and is only for trained Service technicians. Only allowed if patient is not connected! fabian Therapy evolution | SW 5.0 43 / 72 Ref: 121003.EN / Date: 2018-06-18... -
Page 44: Alarm Limits Menu
8 Alarm Limits Menu 1. Automatically sets individual alarm limits. Push button underneath. 2. Alarm volume (3 levels). Push button underneath. 3. Open log file. Push button underneath. 44 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... - Page 45 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 Mute” button fabian Therapy evolution | SW 5.0 45 / 72 Ref: 121003.EN / Date: 2018-06-18...
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Page 46: Automatic Alarm Limits
Upper limit: 5 mbar above set P value • PEEP [DUOPAP-Mode]: Lower limit: 2 mbar below set PEEP pressure • Freq: Upper limit: 150% of the measured frequency 46 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... -
Page 47: Alarm Log
Switching the device off will erase the alarm log. The alarmlog files from the submenu (Tools) will not be deleted. 8.3 Nurse call relay The delay from the nurse call relay is < 1 second. fabian Therapy evolution | SW 5.0 47 / 72 Ref: 121003.EN / Date: 2018-06-18... -
Page 48: Battery Operation
In the event of power failure the pneumatic system will automatically open against atmospheric pressure so that pressure can’t build in the breathing system, allowing spontaneous patient breathing. When long term storing please remove the batteries. 48 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... -
Page 49: Power Failure
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 5.0 49 / 72 Ref: 121003.EN / Date: 2018-06-18... -
Page 50: Function Fields - Ventilation Parameters
Duration of O Flush* • All modes Adjustable from 0 – 120s. *In Ventilation menu Flow Flow setting • Therapy Adjustable from 0 – 19 l/min 50 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... -
Page 51: Ventilation Modes
The following systems are currently can be used: • Infant Flow ® • Infant Flow LP ® • MediJet ® Inspire • Function fields and ventilation parameters Ventilation additives fabian Therapy evolution | SW 5.0 51 / 72 Ref: 121003.EN / Date: 2018-06-18... -
Page 52: Therapy Mode (High And Low Flow Oxygen Therapy) Hfnc
Flush” button in a ventilation mode to initiate the O -Flush. The flush concentration may now be set with the rotary pulse knob. Pressing the O button again will end the flush prematurely. 52 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... -
Page 53: Standby - Stopping / Pausing Mechanical Ventilation
In both cases the built-in gas mixer delivers a minimal flow to prevent heat build- up inside the ventilatory gas moistener. Risk of oxygen undersupply! The standby function is not intended for siphoning. A disconnection or reconnection is not recognised. fabian Therapy evolution | SW 5.0 53 / 72 Ref: 121003.EN / Date: 2018-06-18... -
Page 54: Error - Cause - Solution - Alarms
Contact your local checksum System failure System error ACUTRONIC monitor PIC Distributor Low physical Contact your local memory - please System failure System error ACUTRONIC reboot! Distributor 54 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... - Page 55 Contact value out of sensor or mixer Sensor alarms your local range defective. ACUTRONIC Distributor. Spontaneous Switch to Apnea alarm Patient alarms patient breathing controlled fabian Therapy evolution | SW 5.0 55 / 72 Ref: 121003.EN / Date: 2018-06-18...
- Page 56 Increase flow. Switch to mains supply. Alarm may be silenced with Mute Alarm. Power failure Electrical power Power failure The device continues in battery mode without interruption. 56 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18...
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Page 57: Application Error
4. Shut down the device by holding the on/off button till it turns off 5. Report the incident to your local distributor 6. Use the device only if it is inevitable fabian Therapy evolution | SW 5.0 57 / 72 Ref: 121003.EN / Date: 2018-06-18... -
Page 58: 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 58 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... -
Page 59: Service And Maintenance Intervals
Calibration valves • Lithium battery • Flow Sensor Maintenance and safety inspections must be performed by ACUTRONIC trained experts with access to suitable testing and measuring equipment. fabian Therapy evolution | SW 5.0 59 / 72 Ref: 121003.EN / Date: 2018-06-18... -
Page 60: Sterilisation / Cleaning / Disinfection
Ventilation tubes Preparation according to manufacturer information Heating wire Preparation according to manufacturer information Temperature probe Preparation according to manufacturer information 60 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... -
Page 61: Setting Ranges And Parameters
0.15 15 E-time [sec] Frequency [1/min] 21 100 flush [%] 23 100 Flush Time [s] Man Breath Time [s] Flowmin [l/min] CPAP [mbar] Pmanual [mbar] PDUO [mbar] fabian Therapy evolution | SW 5.0 61 / 72 Ref: 121003.EN / Date: 2018-06-18... -
Page 62: Standard Accessories
151111 Flow sensor, single use 151120 Flow sensor, reusable You can obtain a complete accessories catalogue from your distributor or direct from ACUTRONIC Medical System AG. 62 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... -
Page 63: Technical Specifications
Set value ± 5 Vol% for > 1 minute at 21 Vol% below threshold value 18 Vol% Breath frequency Alarm: If alarm limit exceeded Apnoea alarm Alarm: If no breathing activity is recognized fabian Therapy evolution | SW 5.0 63 / 72 Ref: 121003.EN / Date: 2018-06-18... -
Page 64: Measuring
2 – 30 seconds Max time manual breath 18.5 Dimensions / Weight W x H x D 24 cm x 27 cm x 35 cm Weight Approx. 9 kg 64 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... -
Page 65: Ratings
IP Protection IPX1, Protected against falling water Equivalent to 1- 1.5mm rainfall per minute for duration of 10 minutes. Unit is placed in its normal operating position. fabian Therapy evolution | SW 5.0 65 / 72 Ref: 121003.EN / Date: 2018-06-18... -
Page 66: Data Storage
In addition an audible alarm can be heard on start-up. The user must check if this alarm can be heard to verify that the speaker is functioning. 66 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... -
Page 67: Gas Blender Function
The minimum base flow is 4 l/min in all modes except in O Therapy. For more information, please refer to the “Service Manual for fabian evolution” fabian Therapy evolution | SW 5.0 67 / 72 Ref: 121003.EN / Date: 2018-06-18... -
Page 68: Acoustic Energy
Lin / A weighted (dB) Supplementary information: LpA: A weighted sound pressure level in 1m distance : 40dB Highest Level at Pos 2 Highest Level at Pos 4 etc. 68 / 72 fabian Therapy evolution | SW 5.0 Ref: 121003.EN / Date: 2018-06-18... -
Page 69: Electromagnetic Compatibility Statement
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 70 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 71 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 72 HF communication devices and the device " fabian Therapy evolution " fabian Therapy evolution is intended to be operated in an electromagnetic environment with controlled HF interferences. The operator of the fabian Therapy evolution can help avoid electromagnetic interference by maintaining the minimum distance between portable and mobile HF telecommunication devices (transmitters) and the device fabian Therapy evolution –...
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