Transcript
Ventilation Beyond Limits
fabian HFOi Instructions for Use
SW 3.4
Warning Carefully read the instructions of use before using the ventilator to familiarise yourself with the function of the equipment
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. This document contains confidential and proprietary information that is protected by copyright. All rights are reserved. Any unauthorized copying, storage, reproduction or translation of this document in any form is strictly prohibited.
Manufacturer: ACUTRONIC Medical Systems AG Fabrik im Schiffli 8816 Hirzel / Switzerland
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Table of Contents 1.
Working with the instructions ................................................................. 8
1.1 Document Structure .................................................................................................................................................. 8 1.2 Notices and Warnings................................................................................................................................................ 8 1.3 Hardware Version Identification .............................................................................................................................. 9 1.4 Symbols ....................................................................................................................................................................... 9
2.
General Notices ..................................................................................... 11
2.1 Always Observe ........................................................................................................................................................ 11 2.2 Maintenance ............................................................................................................................................................. 12 2.3 Liability for Functionality / Damages .................................................................................................................... 13 2.4 Intended use ............................................................................................................................................................. 13 2.5 Scope of Delivery...................................................................................................................................................... 13 2.6 Contra-indications ................................................................................................................................................... 14
3.
System overview ................................................................................... 15
3.1 Front Connections ................................................................................................................................................... 15 3.2 Rear Panel ................................................................................................................................................................. 15
4.
Operation and Display ........................................................................... 17
4.1 Control options ........................................................................................................................................................ 17 4.1.1 Buttons ................................................................................................................................................................................................. 17 4.1.1 Rotary pulse encoder ........................................................................................................................................................................ 18
4.2 Display concept structure ....................................................................................................................................... 18 4.2.1 Display areas ....................................................................................................................................................................................... 18 4.2.2 Display screen ..................................................................................................................................................................................... 19 4.2.3 Info bar ................................................................................................................................................................................................. 19 4.2.4 Numeric field / Alarm limits ............................................................................................................................................................. 20 4.2.5 Graphic field ........................................................................................................................................................................................ 21 4.2.6 LED Indicators ..................................................................................................................................................................................... 22
4.3 Ventilation Menu ...................................................................................................................................................... 23 4.3.1 Operation – General .......................................................................................................................................................................... 23 4.3.2 Operation – Settings - ....................................................................................................................................................................... 24
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4.3.3 Ventilation parameter dependency .............................................................................................................................................. 25 4.3.4 Locking ventilator parameters........................................................................................................................................................ 25
4.4 Graphics Menu.......................................................................................................................................................... 26 4.4.1 Curves ................................................................................................................................................................................................... 27 4.4.2 Loops .................................................................................................................................................................................................... 28 4.4.3 Trend Menu ......................................................................................................................................................................................... 29
5.
Preparing for Operation ........................................................................ 31
5.1 Establish Power Supply........................................................................................................................................... 31 5.2 Establish Gas Supply ............................................................................................................................................... 31 5.3 Connect tube set ...................................................................................................................................................... 32 5.4 Patient circuit assembly .......................................................................................................................................... 33 5.4.1 Connect NO tube set and flow sensor........................................................................................................................................... 33 5.4.2 Patient circuit assembly ................................................................................................................................................................... 34 5.4.3 Recommended positioning of temperature probe of humidifier ........................................................................................... 35 5.4.4 Use of reusable patient circuit ........................................................................................................................................................ 36
5.5 Connect nCPAP Tubing ........................................................................................................................................... 37 5.6 Switching On the device.......................................................................................................................................... 38 5.7 Switching Off the device.......................................................................................................................................... 38
6.
Device Check fabian HFOi ...................................................................... 39
7.
Configurations Menu ............................................................................. 40
7.1 Calibration ................................................................................................................................................................ 41 7.1.1 Flow Sensor Calibration ................................................................................................................................................................... 42 7.1.2 O2 Sensor.............................................................................................................................................................................................. 43
7.2 Display ....................................................................................................................................................................... 44 7.2.1 Touch Screen Settings ...................................................................................................................................................................... 44 7.2.2 Trend / Graph Display ....................................................................................................................................................................... 45
7.3 Ventilation parameter settings............................................................................................................................... 46 7.3.1 Standard Hospital Settings.............................................................................................................................................................. 48
7.4 Patient Data .............................................................................................................................................................. 48 7.5 Language................................................................................................................................................................... 49 7.6 Date / Time ............................................................................................................................................................... 49 7.7 Tools ......................................................................................................................................................................... 50 7.8 Info
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7.9 Service Mode ............................................................................................................................................................ 51
8.
Alarm Limits Menu ................................................................................ 52
8.1 Automatic Alarm Limits ........................................................................................................................................... 54 8.1.1 Alarm Conditions ............................................................................................................................................................................... 54 8.1.2 Automatic Alarm Presets.................................................................................................................................................................. 54
8.2 Alarm Log .................................................................................................................................................................. 55 8.3 Nurse call relay ......................................................................................................................................................... 55
9.
Battery Operation ................................................................................. 56
9.1 Power Failure ............................................................................................................................................................ 57 9.2 Operating on External Power Source .................................................................................................................... 57
10.
Function Fields – Ventilation Parameters .............................................. 58
10.1 Special Parameters in HFO Mode ........................................................................................................................ 61
11.
Ventilation Modes ................................................................................. 62
11.1 IPPV ......................................................................................................................................................................... 63 11.2 SIPPV........................................................................................................................................................................ 63 11.3 SIMV ......................................................................................................................................................................... 64 11.4 SIMV + PSV ............................................................................................................................................................... 65 11.5 PSV ......................................................................................................................................................................... 66 11.6 CPAP ........................................................................................................................................................................ 66 11.7 nCPAP / duoPAP .................................................................................................................................................... 67 11.8 O2 Therapy mode (High and Low flow oxygen therapy) HFNC ........................................................................ 67 11.9 HFO ......................................................................................................................................................................... 68 11.9.1 HFO Lung Recruitment ................................................................................................................................................................... 68 11.9.2 Special HFO Mode Information .................................................................................................................................................... 68
11.10 Ventilation Additives............................................................................................................................................ 69 11.10.1 Volume limit .................................................................................................................................................................................... 69 11.10.2 Volume guarantee ......................................................................................................................................................................... 69
11.11 Special Functions ................................................................................................................................................ 70 11.11.1 Manual inspiration ( man. Breath) ............................................................................................................................................. 70 11.11.2 O2 Flush / Preoxygenation ........................................................................................................................................................... 70 11.11.3 Standby – stopping / pausing mechanical ventilation ......................................................................................................... 70
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12.
Error – Cause – Solution – Alarms .......................................................... 71
12.1 Technical Alarm ..................................................................................................................................................... 71 12.2 Physiological Alarm ............................................................................................................................................... 73 12.3 Other Alarm............................................................................................................................................................. 74
13.
Replacing the Oxygen Sensor ................................................................ 75
14.
Service and Maintenance Intervals ........................................................ 76
15.
Sterilisation/Cleaning/Disinfection ....................................................... 77
16.
Setting Ranges and Parameters ............................................................ 78
17.
Standard Accessories ............................................................................ 82
18.
Guide to Volume Guarantee................................................................... 83
18.1 How Does Volume Guarantee (VG) on fabian Work?......................................................................................... 83 18.2 Settings to start with ............................................................................................................................................. 84 18.3 How to start VG function ....................................................................................................................................... 84 18.4 Setting up the ventilator PSV+VG......................................................................................................................... 87
19.
Special Procedures................................................................................ 88
19.1 Use of closed suction systems ............................................................................................................................. 88
20.
Technical Specifications ........................................................................ 89
20.1 Ambient Conditions ............................................................................................................................................... 89 20.2 Monitoring............................................................................................................................................................... 89 20.3 Measuring................................................................................................................................................................ 90 20.4 Resistance Values .................................................................................................................................................. 91 20.5 Parameter Defaults in Configurations Menu ...................................................................................................... 91 20.6 Dimensions / Weight ............................................................................................................................................. 91 20.7 Ratings ..................................................................................................................................................................... 92 20.8 Data storage ........................................................................................................................................................... 92 20.9 Applied Parts .......................................................................................................................................................... 93 20.10 Device Checks....................................................................................................................................................... 93
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20.11 Gas blender function ........................................................................................................................................... 94 20.12 Acoustic Energy .................................................................................................................................................... 94
21.
Electromagnetic Compatibility Statement ............................................ 95
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1. Working with the instructions 1.1 Document Structure The left side of the page … … displays explanations, instructions and detailed description on the topic or procedure. The right side of the page … … displays the graphic representations, operating elements and displays belonging to the description and guides the user through any handling steps. These instructions for use describe equipment components and their operation. It is laid out such that you can step by step become familiar with operation of the ventilator.
Please carefully read the instructions for use before using the ventilator.
Once you are familiar with the basic construction and operation of the ventilator you may use the instructions for use as a reference. The table of contents will assist you in quickly locating the respective topic.
1.2 Notices and Warnings This document features 3 categories of notices and warnings.
NOTICES are supplements to instructions
Danger
DANGER indicates a not directly imminent but latent hazard which may result in death or bodily injury unless prevented.
ATTENTION indicates a risk which may result in equipment damage when not avoided.
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1.3 Hardware Version Identification The hardware version can be identified from the fabian HFO serial number. Serial number: xxyyxx-nnnn, yy = Hardware version From the 1st January 2016 the serial numbering has changed to AI-xxxxx
1.4 Symbols Symbol
Description External power supply input (24V - 5A) USB connection Network connection RJ45 Connection for external trigger Nebulizer Connection
Data input / Data output RS232
Nurse call signal output
Caution, refer to operator’s manual for important safety information and 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
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Symbol
Description Unplug power before opening housing Flammability warning Warning regarding operation in explosive areas Dangerous voltage warning Do not cover Protect from moisture Chemical burn warning Chargen code 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
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2. General Notices 2.1 Always Observe 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. An alternate ventilation method (e.g. Resuscitator) must be available at all times when using the ventilator. If the life-support function is no longer warranted due to a noticeable ventilator defect, the patient must immediately be artificially ventilated using a stand-alone ventilator (e.g. Resuscitator). The ventilator may not be used in combination with inflammable gases or narcotic agents – there is otherwise an acute risk of fire and explosion! Never use the ventilator in explosive environments! An audible signal indicates a system or patient alarm and always requires action by a medical professional. Never connect the ventilator to patients if an error or malfunction is detected during equipment check! Never connect to electrical devices not mentioned in this operator’s manual without first consulting the manufacturer or an expert. Never operate the ventilator while covered or set up in a way so as to negatively impact the operation or function. Always unplug before opening the housing! Never use anti-static or electrically conductive tubes. Note: the safety and health of the users is guaranteed by the fact that the products for example do not contain any allergenic or mutagenic materials such as phthalates. The device can only be separated from the main power supply by removing the power cord completely. Please ensure the power socket is freely accessible at all times for disconnection. Do not remove the power cable unless for Service purposes or transport.
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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. Warning: When connected to a patient do not simultaneously touch the external power supply and the flow sensor connector cable. Warning: if the strength of the auditory alarms are less than the ambient sound this might impede an operator to recognize alarm conditions. Warning: please ensure that the ventilator is never covered. Warning: please ensure that the ventilator is never positioned in such a way that the performance of the ventilator is adversely affected. Warning: in case of ventilator failure, the lack of immediate access to appropriate alternative means of ventilation can result in patient death. Warning: please ensure that Alarms are set appropriately prior to use of ventilator on patient. Warning: Do not use the fabian in an oxygen-rich environment Warning: In case portions of the gas pathways through the VENTILATOR can become contaminated with body fluids or expired gases during NORMAL CONDITION or SINGLE FAULT CONDITION, please contact Acutronic Medical Systems.
2.2 Maintenance This device is a ventilator classified as Class IIb according to the European directive, as such: • Inspection as per manufacturer specifications is required every 12 months. • Maintenance must be performed by Acutronic trained experts with access to appropriate test and measuring equipment. We strongly recommend ACUTRONIC Medical Systems AG exclusive representatives for service agreements and repairs. Only use original ACUTRONIC parts for repairs. Note chapter “Maintenance Intervals”.
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2.3 Liability for Functionality / Damages In the event of improper equipment maintenance or repair by any person not associated with ACUTRONIC Medical Systems AG Service or improper use, any and all liability for the functionality is transferred to the owner or operator. ACUTRONIC Medical Systems AG assumes no liability for damages caused by the non-observance of preceding notices. The preceding notices do not extend the warranty and liability terms of the ACUTRONIC Medical Systems AG sales terms and delivery conditions.
2.4 Intended use The fabian HFOi is intended for premature infants, new-borns as well as children weighing up to 30 kg. The fabian HFOi is intended for “in-patient use” in hospitals, medically-used rooms and intra-hospital patient transport. The fabian HFOi is an electronically microprocessor controlled ventilator. The fabian HFOi ventilates with excess pressure based on the continuous-flow principle. (Time cycled, pressure / volume limited or volume guaranteed) Oxygen is metered by the integrated Air/O2 blender. The oxygen concentration is measured internally with a galvanic oxygen sensor. The ventilator is intended for the following ventilation methods: • HFO High frequency oscillation ( membrane principle ) • IPPV Intermittent Positive Pressure Ventilation (CMV Controlled Mandatory Ventilation) • SIMV Synchronised Intermittent Mandatory Ventilation • SIPPV Synchronised Intermittent Positive Pressure Ventilation (A/C, Assist Controlled) • CPAP Continuous positive airway pressure • PSV Pressure Support Ventilation • SIMV + PSV Synchronised Intermittent Mandatory Ventilation combined with PSV • NIV ventilation nCPAP/duoPAP with variable flow generators (Infant Flow®, Infant Flow LP®, InspireTM, Medijet®, • HFNC O2 Therapy, (High and Low flow oxygen therapy) The equipment is operated by a physician or at his orders by a professional with technical training in this task, whereupon any user must be trained on this equipment and familiar with the operator’s manual and the use of the equipment. fabian HFOii is not approved for use in a homecare environment.
2.5 Scope of Delivery This product includes the following items: • • • • • •
1 x fabian HFOi ventilator ( # 7200 ) 1 x flow sensor ( reusable ) ( # 1031 ) 1 x flow sensor cable ( # 1016 ) 1 x test lung ( # 1116 ) 1 x Power cable ( # country specific ) 1 x Operating manual ( # country specific )
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2.6 Contra-indications No contra-indications for the use of the fabian HFOi 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. In general, it should be noted with regard to contra-indications that ventilation of children should only be carried out by clinically trained specialists who have sufficient knowledge of ventilation aof patients of specified age. Detailed studies and experience can be requested from the following address: ACUTRONIC Medical Systems AG Fabrik im Schiffli 8816 Hirzel / Switzerland Tel: +41 44 729 70 80 Fax: +41 44 729 70 81 Email:
[email protected]
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3. System overview 3.1 Front Connections
1
Inspiratory tube port/ HFO port
2
Expiratory tube port
3
Pressure measuring tube port
4
External bias flow port and port for nCPAP system based on flow generators (single limb systems)
3.2 Rear Panel
1
Connector for 24VDC (5A) external power supply (no charging!)
2
Network jack for data management , PDMS (To network with minimum 3 KV galvanic isolation)
3
USB port for data output, Software update. Connection for Masimo SpO2 module.
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4
RS232 port for PDMS
5
Flow sensor connector
6
Nurse call connector ( max. switching Voltage 50 VDC )
7
Video In , VGA ( option )
8
Loudspeaker
9
Fan
10
CO2 sensor ( option )
11
Nebulizer, ultrasonic ( option )
12
O2 supply connector 2.0 – 6.5 bar / 40 l/min
13
Pressurised air connector 2.0 – 6.5 bar / 40 l/min
14
Power Connector ( fuse 1.25 AT )
15
Pin for potential equalisation
For Adapter to DISS see Accessories. Warning: Do not connect Ethernet, Nurse call, USB, R232 (CO2), Flow Sensor port to anything other than specified devices. The PIN for the Potential Equalisation is there for additional safety and can be connected to an equipotential zone. Please adhere to local guidelines when using this PIN. The guidelines may vary between countries, localities and power companies. Always keep the PIN for Potential equalisation accessible. Maximum Connected Loads: Nurse call: USB: RS232: Flow Sensor:
Video IN: CO2:
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Galvanically isolated relay output. max Load: 30V / 1 A DC or AC 5V/150mA 3.3V/100mA maximum load is one flow sensor. Only ACUTRONIC flow sensors are allowed to connect. max. Voltage: 5 V max operating current: 300 mA per hotwire -> 600 mA total. max voltage: 5 V max operating current: 300 mA max voltage: 5 V max operating current: 700 mA
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4. Operation and Display 4.1 Control options The control panel features 2 key elements: 1. The display (Touch Screen) The touch screen allows the direct control of the ventilator parameters by tapping defined buttons on the graphic user interface.
1
Access to “quick launch“ settings on the left side of the touch screen. 2. The key/control panel with rotary pulse encoder (combines a key and a rotary encoder)
4.1.1 Buttons The key pad features 2 rows of buttons with various functions. Manual breath … used to apply a manual breath. Available in all the ventilation modes. In HFO mode, it can be disabled in the ventilation menu. O2 Flush … used to start O2 flush. Flush concentration and time can be preset. Menu / Calibration … used to access the setting and calibration menus. Pressing once will open the configuration menu; pressing again will open the calibration menu. Nebuliser … switches the optional medication nebuliser on and off. The flow sensor is switched off during medication nebulisation. Waves / Loops …switches to ^wave-/loop display. Home … displays the main screen for selecting the respiration mode.
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Alarm limits … switches to the alarm limits configuration. On/Off … used to switch the device on or off. Mute alarm … for acknowledging and muting alarms for a maximum duration of 120 seconds. Subsequent alarms with higher priority are only displayed optically during muting. Start/Stop … used to halt or commence respiration. In ventilation mode, the stop is for 2 minutes, in nCPAP and DUOPAP mode acts as standby mode.
4.1.1 Rotary pulse encoder The rotary pulse encoder combines a push button with a rotary encoder for executing various settings, selections and confirmation options.
4.2 Display concept structure 4.2.1 Display areas The information system features 2 key display areas 1. The touch screen 2. LED indicators
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4.2.2 Display screen Shows various information, setting and display fields depending on the display settings or menu 1. Info bar indicating battery status, time/date, status information, system and alarm information 2. Numeric field / alarm limits 3. Graphic field (single graph or multigraph with loops or curves) 4. Function field 5. Operating mode selection Depending on the display mode selected, individual fields may be shown/hidden. Display field options will be described later.
4.2.3 Info bar The Info bar displays from general information to displaying alarms. It is divided into 3 sections.
The Info bar indicates the following among other things: 1. Neonatal or paediatric mode Patient data available Manual breath in HFO mode ON/OFF Nurse call active / inactive Battery charge status 2. Ventilation mode, info and alarm display 3. Mute alarm (time remaining until alarm reactivates) Time / date Paediatric mode. For patients above 10kg bodyweight, use of paediatric mode is recommended. Extended range for settings. Neonatal mode. Used for patients up to approx. 10kg bodyweight. The patient symbol indicates patient data associated with the current ventilator operation is saved to the device. Displays ventilation mode and, if applicable, additional current information or notices. A red blinking info bar alerts the user to active alarms. If screen lock is in use, the symbol for locked screen is displayed.
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4.2.4 Numeric field / Alarm limits … in the numeric field all measured values are displayed together with the set limits relevant in the selected Ventilation mode. There can be multiple pages of numeric fields. To go to the next page, press the button below the numeric field. Depending on the Ventilation mode the data is updated as average/minute or by breath.
The upper and lower limits can be manually or automatically adjusted in the alarm limits menu.
Numeric field
To adjust the alarm limit manually: • press the alarm limits button • touch the parameter you wish to change • the button turns from dark blue to green • with rotary pulse encoder, change the value • to confirm the setting, either touch parameter button again, or push rotary pulse encoder again. To automatically set the alarm limits, select parameter and touch AUTOSET button.
Alarm limits
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4.2.5 Graphic field The button waves/loops changes the screen … displays the current pressure-, volume- or flow measurements as a diagram. Use “Waves/loops” to access the graphics menu. Three waveforms are displayed simultaneously
Display with 3 curves You may also switch to loop display view. In this view two loops and one of 3 waves are displayed. LOOP display: • •
Pressure / Volume Volume / Flow
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4.2.6 LED Indicators The LED Indicators
Warning LED This LED will light or blink red when a system alarm is triggered. Battery LED This LED will light yellow in battery operation and green when the battery is fully charged. The LED will blink green when the battery is charging. Mains LED This LED will light green in mains operation, and will switch off in battery operation.
When powered via the external 24 VDC connector the mains and battery LED will not light up.
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4.3 Ventilation Menu 4.3.1 Operation – General Push buttons and their statuses are indicated by various colours:
1 light blue: Push button 2 dark blue: focused push button 3 yellow (in functions menu): parameters metered 4 green: selected push button, if the push button features a parameter for setting a value it may now be changed. 5 orange: parameter is automatically adjusted by fabian HFOi. The value set by the user indicates the maximum value and will not be exceeded.
Depending on the Ventilation mode, the respiration menu indicates the configuration parameters (4) and measurements (2) relevant in the mode. Using the push button you may also switch between the pressure-, volume- and flow curve (3). The Info bar (1) indicates current information. The Ventilation mode may be changed in the menu (5).
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4.3.2 Operation – Settings The ventilation parameters may be set before starting/activating ventilation mode: 1 Desired ventilation mode tap 1x: key will turn yellow 2 The configuration parameters for the preselected ventilation mode may now be adjusted 3 Tap ventilation mode again: key will turn green, ventilation will start with the parameter settings. The selected parameter may also be confirmed by pressing the rotary encoder. If the setting is active (yellow button) and no action is taken for 15 seconds, or the preselected mode is not confirmed by tapping again, the device will continue in the previous mode, any settings are deleted.
After confirming a parameter the audible alarm is automatically suppressed for 15 seconds. The audible alarm may be immediately activated by pressing the Mute Alarm key. 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.
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4.3.3 Ventilation parameter dependency If parameters are mutually regulating, an arrow will appear on the parameter requiring modification indication the required direction. List of dependencies: • O2 Flush min. 2 Vol.% above O2 setting, max. 100 Vol.% • P insp min. 2 mbar above PEEP • Ppsv min. 2 mbar above PEEP • Pmax min. 2 mbar above PEEP • Pduo min. 2 mbar above PEEP • P manual min. 2 mbar above CPAP • Ppsv ≤ Pinsp • Rise-Time ≤ I-Time
4.3.4 Locking ventilator parameters Some ventilator parameters are “locked” to prevent unusual high values. When this value is reached a key symbol will appear and a notice signal will sound. The high value must be confirmed by pressing the rotary knob again. (see table below) List of locked values Parameter
Neonatal
Pediatrics
I:E Ratio
I:E>1
I:E>1
HFO V guarantee
> 30
HFO Pmean
> 20
> 20
HFO amplitude
> 40
> 40
HFO Pmanual
> 25
> 25
PInsp
> 25
> 25
CPAP
> 10
> 10
PEEP
<2
<2
PEEP
> 10
> 10
V guarantee
> 30
> 30
V limit
> 30
> 30
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4.4 Graphics Menu The graphics menu may be accessed via the curve key
on the keypad.
The following graphics are available in the graphics menu: 1. Curves
2. Loops
3. Trends
Curves
Loops Trends will be loaded when pressing the trends key
Trends
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4.4.1 Curves The curves menu shows the following curves: • Pressure • Flow • Volume When auto-scaling of graphics is switched off the graph may be adjusted manually: 1. Select desired graph 2. Tap graph 3. The selected graph is marked with the cursor symbol and the scaling cursor is displayed 4. Use the cursor to scale the graph in the X and Y direction. The cursor disappears if not used within 5 seconds, or by tapping the selected graph again.
The key “Freeze” stops curve being updated. The configuration parameters and measurements in the display field continue being updated. The key will turn green. Press the key again to continue updating the curve data. Depending on the Ventilation mode selected, the graphics menu will display the configuration parameters and measurements relevant in this mode
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4.4.2 Loops The loops menu features the following loops: • Pressure / Volume (P/V Loop) • Volume / Flow (V/F Loop) The following parameters for the respective curve may be selected in the upper area of the display: • Pressure • Volume • Flow The “Freeze” key is used to pause loop updating. The settings parameters and measurements in the display field will only be shown once a loop has been saved. The key will be displayed green. Press the key again to continue updating the loop data. After “freezing” the loop can be saved to later compare it against reference loop. Save loop: 1. Freeze loop 2. Push “Freeze” key 3. The loop will be saved until a new loop is saved.
Comparing loops: 1 Switch to loops display: 2 Freeze current loop. 3 Current loop is shown in blue, the saved loop black.
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4.4.3 Trend Menu The fabian HFOi trending function automatically saves an average of measurements every 30 seconds. Measurements of up to 5 days can be recorded. Trend data is automatically deleted in the following cases: • Date and / or time is modified • New patient data is entered • Software update A confirmation message will always be displayed before trend data is deleted.
3
1 2
4
5
1. 2. 3. 4. 5. 6. 7.
6
7
Parameter / selection Graphics Parameter values Timeline Adjust timeline (max. 5 days – min. 30 minutes) Shift timeline Update data (refresh)
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Trend Menu 1. Press Curves / loops (1) key 2. Press Trends key
3. Loading trend data
Loading trend data
The trend menu features 3 simultaneous parameters as curves The parameters displayed can be modified by activating the Select list on left side. Available parameters are: • Pinsp. Pmean • Fi O2 Vte • Compliance DCO2 • MV HF Amplitude Shifting the timeline. The timeline can be shift for all 3 parameters simultaneously. 1. Change timeline via rotary pulse encoder or keyboard
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5. Preparing for Operation 5.1 Establish Power Supply Connect the fabian with power cable to a suitable power socket. Do not connect the device to a power outlet strip. Exception: the power outlet strip has been expressly approved by the manufacturer for connection to a ventilator. The device can be operated with 100 VAC to 240 VAC and automatically adjusts to particular voltage without manual switch-over being necessary. The fuses used must correspond with the value and type approved for the fabian. The particular fuse type and value is printed on the back of the fabian. Replacement of the fuses may only be carried out by trained staff. Please replace fuses with identical values, failing to do so, might cause fire hazards. WARNING: To avoid risk of electric shock, this equipment must only be connected to a mains supply with protective earth.
5.2 Establish Gas Supply Connect the compressed air and oxygen supply tube to the back of the device and to the central gas supply. 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 bar, dust-free, oil-free and dry.
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5.3 Connect tube set Never use anti-static or electrically conductive tubes.
The pressure gradient on the Ventilation system of the ventilator measured on the patient connection port may increase when accessories or other components are attached to the Ventilation system. 1. 2. 3. 4.
Connect inspiratory tube to Insp. port. Connect expiratory tube to Exp. port. Connect pressure measuring tube to Prox. port. Use FG connection when connecting to an INoVent Flowsensor.
Always hold tubes by the collar when connecting and disconnecting to prevent damage. The expiration membrane can be easily removed by turning the membrane holder anticlockwise.
Pay attention to the correct installation position of the expiration membrane The labelling TOP must be legible upon installation. See Illustration.
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5.4 Patient circuit assembly 5.4.1 Connect NO tube set and flow sensor
Connect tube „art. No. 7067“ with the NO Flowsensor. Place the NO flow sensor on top of the water chamber of the humidifier with a T-piece connector in between. Select in Quick Launch external Bias Flow. With this setting will only come from the FG port, and will halted at the Insp. Port.
Bias Flow intern: Use when there is no external NO flow sensor. Bias Flow extern: Use an NO needs to measure the bias flow with an external flow sensor.
1. Select the Bias Flow Extern.
2. A warning message appears Select the Confirm Box to switch to external bias flow.
When switching between HFO to a Conventional Ventilation Mode one can leave the external NO flow sensor in this position.
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5.4.2 Patient circuit assembly We recommend the use of single patient circuits to be used on the fabian HFOi. Best performance is achieved with dual limb heated systems. Please refer to following diagram for setup: • Connect fresh gas outlet of ventilator (Insp) with inlet of water chamber • Connect Inspiratory hose with chamber outlet • Plug proximal pressure line into port and other end with proximal pressure port on ventilator marked (Prox) • Connect the inspiratory- and expiratory tube heater connector with corresponding connector on humidifier base. • Connect expiratory hose with exhalation valve
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5.4.3 Recommended positioning of temperature probe of humidifier One of the major sources of problems in neonatal ventilation is, that excessive rainout is affecting accuracy of flow measurement and therefore compromising its use in various modes of ventilation. It is recommended to carefully follow the instructions of use of the manufacturer of the humidifier to minimize the risk of rainout in the patient circuit. If baby is positioned in incubator, the following setup is recommended: Place temperature probe outside the incubator and use incubator extension line.
If baby is in open warmer unit, the following setup shall be used:
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5.4.4 Use of reusable patient circuit If reusable patient circuits are used, they preferably shall be with in- and expiratory tube heater wire or alternatively, a water trap in the expiratory hose: Assemble the tubing as required: Connect in-/expiratory tubes and pressure tube to Y-piece. Connect flow-sensor to Y-piece Connect flow-sensor cable to flow-sensor 1 2 3 4 5
Ventilation tubes Y-piece Flow sensor Flow sensor connection cable Proximal pressure measurement tube
Prepare humidifier according to manufacturer specifications and connect to tubing. If the humidifier does not feature an inspiratory tube heater, water traps must be installed in the inspiratory and expiratory tubes. When using an inspiratory heater a water trap must be installed at the expiratory end. Be sure the flow-sensor is not exposed to excessive humidification.
We strongly suggest using an inspiratory and expiratory heated tube system in HFO mode.
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5.5 Connect nCPAP Tubing Preparing the nCPAP tubing system • • • • •
Connect nCPAP adapter to the fabian nCPAP port. (Item no.: 7057) Connect 22 mm adapter connector to humidifier chamber. Connect nCPAP system pressure measuring tube to fabian port marked prox. Connect nCPAP system to humidifier chamber. 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.
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5.6 Switching On the device Use the ON / OFF button (1) on fabian HFOi to power on the equipment. When the device is powered on the start-up screen will appear and the equipment will perform a selftest. The SOFTWARE REVISION, the CHECK SUMS and the status of the interfaces will be checked. (ok ≙ no error)
Once the system test has completed the Calibration menu will appear. Now, flow sensor calibration must be performed Please select the appropriate flow sensor (neonatal or paediatric). The O2 will automatically be calibrated after leaving the calibration menu. EtCO2 and SpO2 modules can be switched on here as well. For more information on both modules please refer to the “fabian HFO CO2 manual” and the “fabian HFO SpO2 Manual”. All audible alarms are silenced for 2 Minutes
5.7 Switching Off the device Disconnect patient. Use the ON/OFF button (1) on fabian HFOi to switching off the device. Hold ON/OFF button until the equipment is switched off. Once the device has powered off a notice tone will sound. Press the “Mute Alarm” button to confirm system switch off. Hold the button for at least 3 seconds until the WARNING LED stops.
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6. Device Check fabian HFOi Always perform an equipment check before each ventilator use! What
How
Target
Gas supply
Attach high pressure air and oxygen supply hoses on the rear side of the ventilator. Connect with corresponding wall outlets.
Air and oxygen supply hoses are correctly connected
Breathing system
Membrane holder and membrane Tubes Water traps (if needed) Respiratory Humidifier and tube heating Flow sensor Connect test lung
Membrane holder and membrane correctly installed.
Switch on test
switch on fabian Alarm tone (loudspeaker)
Self-test successful Alarm tone audible during switch-on test.
Calibration
Calibrate flow sensor Calibrate O2 sensor (occurs automatically after leaving calibration menu)
Calibration successful
Leakage test
Start CPAP mode CPAP 5 mbar P manual 80 mbar Press button manual insp.
Pressure of 80 ± 4 mbar is achieved
Function test
Ventilation mode: IPPV • I - flow: 10 l/min • E - flow: 8 l/min • PEEP: 5 mbar • Pinsp: 20 mbar • Frequency: 30 1/ min • I-time: 1 sec • Oxygen: 30 vol.%
Ventilation occurs with the set frequency. • P insp.: 20 ±2 mbar • PEEP: 5 ±1 mbar • O2: 30 ±2 vol.%
Alarms
Kink inspiration tube.
Alarm: Tube Occlusion
Kink expiration tube.
Alarm: Tube Occlusion
Kink proximal measurement tube
Alarm: Tube Occlusion
Fill level Function
Water fill level sufficient. Function OK
Humidifier
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Patient circuit assembled correctly as per manufacturer’s instructions
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7. Configurations Menu The configuration menu can be accessed by pressing the Menu / Calibration key and selected the push button “Open menu”.
1. 2. 3. 4. 5. 6.
Calibration Display Ventilation Patient Data Language Data / Time
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on the keypad
7. Tools 8. Info 9. Video ( optional ) 10. PDMS ( optional ) 11. Service Mode 12. Close menu (return to previous menu)
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7.1 Calibration The calibration menu can be accessed through the calibration button in the configurations menu.
The calibration menu can also be accessed via the calibration key.
Finally, upon ventilator start-up it you will be automatically directed to the calibration menu. The calibration menu can be seen below.
From the calibration screen, one can calibrate the following sensors: • Flow sensors: neonatal and pediatric • O2 sensor • etCO2 module • SpO2 Module
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7.1.1 Flow Sensor Calibration Flow sensors can be calibrated in the upper half in the calibration menu.
To calibrate a neonatal flow sensor please select the neonatal button.
To calibrate a pediatric flow sensor please select the pediatric button.
For both types of flow sensors the calibration procedure is identical and described below. Ensure no gas will flow through the flow sensor during calibration. To do so the sensor may be held occluding either one or both ends with a sterile glove.
Press Flow-Cal button IF the ventilator is in a trigger function mode, the function will be deactivated during calibration and respiration will continue in IPPV mode. First “Checking” will appear, then “Calibration running”. The lines in the diagram (see on the right) will move from left to right, until they are centered in this diagram. When centered these lines will turn green. Following successful calibration, the date of the last calibration will be displayed in the corresponding field. The flow sensor calibration needs to be performed each time a new sensor is put in place. Sensor calibration remains valid, even if unit is switched off and after restart of it. We recommend cleaning flow sensor once per day.
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7.1.2 O2 Sensor The O2 sensor cailbration can be accessed in the configurations menu, by pushing the O2 button.
The O2 sensor is automatically calibrated when machine starts up and every 24 hours when in use. During calibration procedure, the FiO2 concentration of the fresh gas to patient is not altered. In case of a supply gas failure, oxygen sensor calibration is disabled automatically to avoid false sensor calibration Manual calibration: Press the “21%” button to perform one point calibration at 21% O2. Press the “21 + 100%” button to perform a two point calibration at respectively 21% and 100% O2.
After one of these buttons has been the Calibration procedure starts. If the procedure has been successful, a green tick will appear.
Following successful calibration, the date of the last calibration will be displayed in the corresponding field. Automatic sensor calibration runs every time the equipment restarts and every 24h. The gas concentration to patient however is not altered during this calibration procedures.
7.1.3 CO2 and SpO2 Modules
For more information on the CO2 and SpO2 configurations please refer to the “fabian HFO CO2 manual” and “fabian HFOi SpO2 Manual”.
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7.2 Display
1. Adjust screen brightness, 4 levels 2. Lock touchscreen. The screen will automatically be unlocked if an alarm is triggered or the rotary encoder is pressed. Touchscreen automatically locks after a set time. 3. Display graphs as filled or regular lines. Auto scale ON / OFF 4. Display trends as filled or regular lines. Auto scale ON / OFF
7.2.1 Touch Screen Settings Lock touchscreen 1. 2.
Manual After default time
Also locks by holding the rotary encoder for 3 seconds. Lock is automatically cancelled in the event of an alarm or by pressing the rotary encoder.
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7.2.2 Trend / Graph Display Auto-scaling graphs: • On • Off
Curve plotting in graphics is automatically adjusted.
Graphs display: • Filled • Not filled
filled
not filled Auto-scaling trends: • On • Off
Trend patterns are automatically scaled.
Trends display: • Filled • Not filled filled
not filled
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7.3 Ventilation parameter settings
1. 2. 3. 4. 5. 6. 7.
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Patient range Manual breath HFO Tube set nCPAP Pressure unit Automatic O2 Calibration Ratio of I-Time Maximum time for manual breath
8. 9. 10. 11. 12. 13.
Trigger mode E-Flow Parameter settings Alarm delay Pmin (nCPAP/DUOPAP) Ppsv parameter Hospital settings Factory defaults
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1.
Patient area (neonatal / pediatric))
Before setting of the ventilation parameters can begin, the appropriate area setting must be selected.
2.
Manual breath HFO (ON / OFF)
The manual breath in HFO mode can be used to perform lung recruitment manoeuvre (sustained lung inflation) if clinically accepted by internal guideline. Length and pressure level adjustable.
3.
Tube set Infant Flow®, Infant Flow LP®, Medijet®
Selection of the nCPAP system used.
4.
Unit for pressure (mbar / cmH2O)
Selection of pressure unit.
5.
Automatic oxygen calibration (21 Vol% / 21 and 100 Vol.%)
6.
Setting I time or frequency (Frequency - I-time / I-time / E-time)
I-time display configuration
7.
Maximum time for manual breath (2 – 30 sec.)
Inspiration time for manual breath
8.
Trigger mode (Flow Trigger / Volume Trigger)
Trigger mode configuration for assisted breathing
9.
E-Flow
E-Flow parameter
10.
Alarm delay
After visual reset of alarm, the reactivation of alarm is delayed for the set period. Avoids an immediate re-alarm in case of values have not stabilized yet.
11.
Ppsv Parameter
Select Ppsv parameter to be absolute value or above PEEP parameter
12.
Hospital settings
The “Hospital Settings” button is only active if specific settings were saved in fabian HFO.( see chapter Hospital settings )
13.
Factory defaults
Resetting fabian HFO to the factory defaults
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I cases where oxygen supply source does not provide 100% oxygen, this should be set to 21% only to avoid calibration at false value.
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7.3.1 Standard Hospital Settings Only reset to hospital settings if no patients is connected to fabian HFOi.
The “Hospital Settings” button (1) is only active if specific settings were saved in fabian HFOi.
Access hospital settings from service mode. This menu is also where the nurse call can be activated and deactivated.
7.4 Patient Data
Entering patient data: Note: Entering new patient data will delete all trend data. 1. 2. 3.
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Reset data Accept Change
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7.5 Language
Selecting the user language Available language option see below (SW Version ≥ 3.0.1)
• • • • •
American Chinese Czech Dutch English
• • • • •
French Finnish German Hungarian Italian
• • • • •
Japanese Norwegian Polish Portuguese Russian
• • • •
Slovensko Spanish Swedish Turkish
7.6 Date / Time
Changing the data and time: Once the time or data has been changed the confirmation tick will change colours. The new information will be applied once confirmed. Note: Changing the date or time will delete all trend data.
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7.7 Tools
Only available with USB stick connected. Save of: Trends Trend data will be output in CSV format. Log files Alarm and Error log
7.8 Info
Displays the info screen (System Information) containing equipment data.
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7.9 Service Mode
The service mode is password protected. Service Modus provides access to hospital settings, nurse call activation/deactivation, etc.
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8. Alarm Limits Menu
1. 2. 3. 4.
Automatically sets individual alarm limits. Alarm volume (3 levels) Open log file Display measurements with alarm limits
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Accessing the alarm limits menu by pressing the button: Alarm Limits (1)
The alarm limits menu allows all alarm limits to manually or automatically be adjusted. In the event of an alarm a notice will appear in the info bar and a red bell symbol indicates the alarm cause. In addition an audible alarm will sound which may be silenced for 2 minutes by pressing the mute button. The alarm limit can be adjusted manually. The alarm limits menu automatically focuses on the corresponding parameter. The limit may also automatically be adjusted by pressing Autoset button.
Once the alarm limit has been adjusted or there are no more active alarms, the bell symbol will turn grey. The visual alarm message must be reset by pressing the “Alarm silence” button.
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8.1 Automatic Alarm Limits 8.1.1 Alarm Conditions Each displayed breath data is checked for violations of the current alarm limits. Additionally the measured pressure will be checked against the limit every 20 milliseconds with following conditions: Upper alarm limit of pressure: - A breath in the range of the upper limit will reset the delay of 5 seconds. - CPAP: with a delay of 300 milliseconds in case of a manual or mechanic breath -> pressure will be checked against upper limit, if the pressure is still above the limit after 5 seconds the alarm will be signaled, otherwise it is cleared - nCPAP: with a delay of 3000 milliseconds in case of a manual or mechanic breath -> pressure will be checked against upper limit, if the pressure is still above the limit after 5 seconds the alarm will be signaled, otherwise it is cleared Lower alarm limit of pressure: - A breath in the range of the lower limit will reset the delay set by the user in the ventilation menu - nCPAP: with a delay of 3000 milliseconds in case of a manual or mechanic breath -> pressure will be checked against lower limit, if the pressure is still below the limit after the alarm delay set by the user in the ventilation menu, the alarm will be signaled, otherwise it is cleared - DUOPAP: pressure will be checked against lower limit, if the pressure is still below the limit after the alarm delay set by the user in the ventilation menu, the alarm will be signaled, otherwise it is cleared If an alarm condition has been detected, a dedicated alarm array is written, otherwise it is cleared.
8.1.2 Automatic Alarm Presets The following alarm limits presets are used as defaults. • Minute volume upper limit: 180% of measured minute volume • Minute volume lower limit: 50% of measured minute volume • Leak upper limit: 150% of measured tube leak up to maximum of 50% tube leak • BPM (Breath rate) upper limit: 150% of measured breath rate • APNOE: 10sec • Proximal pressure upper limit: 5 mbar above set inspiratory pressure • HFO: Proximal pressure upper limit: 5 mbar above measured inspiratory pressure • PEEP lower limit: 3 mbar below set exhalatory pressure • DCO2 upper limit: 150% of measured DCO2 value • DCO2 lower limit: 50% of measured DCO2 value • etCO2 upper limit: 150% of measured etCO2 value • etCO2 lower limit: 50% of measured etCO2 value • CPAP [CPAP-Mode] upper limit: 5 mbar above set CPAP value • CPAP [CPAP-Mode] lower limit: 5 mbar below set CPAP value • CPAP [NCPAP-Mode] upper limit: 5 mbar above set CPAP value • CPAP [NCPAP-Mode] lower limit: 2 mbar below set CPAP value • Pduo [DUOPAP-Mode] upper limit: 5 mbar above set Pduo value • CPAP [DUOPAP-Mode] lower limit: 2 mbar below set CPAP value
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8.2 Alarm Log Switch to alarm limit menu Press the “Show Log” key to access the alarm overview
The alarm list is sorted in chronological order. The parameters shown are: • • •
Date / Time Message Priority (highlighted. See: chapter Error – Cause – Alarms)
Press the “Hide Log” key to return to the alarm limits menu.
Switching fabian HFOi off will erase the alarm log.
8.3 Nurse call relay The delay from the nurse call relay is < 1 second
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9. Battery Operation fabian HFOi features an internal battery. Battery run time in HFO mode on full charge: Battery run time in conventional mode on full charge:
approx. 1 hour approx. 2.5 hours
These values may vary depending on the parameter settings. The fabian HFOi will continuously calculate the remaining run time and display it in the info bar. The battery charge is continuously monitored. The internal NIMH Battery is Maintenance free. Reduction in battery life on changing operating mode Automatic shutdown of ventilator! Changing the operating mode can greatly shorten the operating mode! • • •
Monitor the remaining battery life when changing the settings! Never leave the device and patient unattended during battery operation! Establish mains power supply in good time!
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 operating fabian HFOi on the internal battery the HFO amplitude is limited to 60 mbar. When long term storing please remove the batteries.
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9.1 Power Failure In the event of a power failure fabian HFOi will automatically switch to battery power without interruption. A visual and audible message will be triggered. Power failure This message can be confirmed with the Mute Alarm button. fabian HFOi will continuously monitor the battery run time. Additional messages will be triggered at a remaining run time of: • 15 minutes • 30 minutes • 60 minutes, only if the remaining run time is less than 60 minutes during a power failure If the remaining run time is less than 1 minute a warning will appear prompting to immediately switch to a primary power source. After this point the battery is drained and fabian will power off. Battery drained! – Connect to mains – – Charge battery after approx. 5 hours –
9.2 Operating on External Power Source fabian HFOi can also be operated from an external power source. In this case connect the external 24 Volt power source at the back of the equipment. Conventional mode: HFO mode:
24 Volt DC, 1 A 24 Volt DC, 1.5 A
External power connection on the back panel.
NO charging when connected to 24V DC external power supply NO monitoring of remaining time on external power supply
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10. Function Fields – Ventilation Parameters Ventilation Parameters Pressure Rise Control
• • • • •
IPPV SIPPV SIMV SIMV + PSV PSV
I-Flow or Rise Time Will allow for use of either I-flow or Rise time based pressure rise control during inspiration. Pediatric Mode Only.
Rise Time
• • • • •
IPPV SIPPV SIMV SIMV + PSV PSV
Rise Time Adjustable rise time during inspiration. Pediatric Mode Only.
I-Flow
• • • • •
IPPV SIPPV SIMV SIMV + PSV PSV
Inspiratory flow Adjustable flow during inspiration
E-Flow
• • • • •
IPPV SIPPV SIMV SIMV + PSV PSV
Expiratory flow (base flow) The continuous expiratory flow is variable separate from the inspiratory flow. • Flushing dead space in the Y-piece • Maintaining the PEEP
PEEP
• • • • •
IPPV SIPPV SIMV SIMV + PSV PSV
Positive end-expiratory pressure Pressure inside the lung following inspiration.
Trigger
• SIPPV • SIMV • SIMV + PSV • PSV
Trigger The trigger sensitivity can be adjusted from level 1 – 10. This corresponds to 10% - 25% of the exhaled tidal volume( Vte ) with volume trigger and 0.120 – 2.4 l/min with flow trigger. There are 2 trigger functions: • Volume trigger • Flow trigger Which may be selected in the configurations menu Ventilation
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Ventilation Parameters I-time
• • • • •
IPPV SIPPV SIMV SIMV + PSV PSV
Inspiratory Time
Freq
• • • • •
IPPV SIPPV SIMV SIMV + PSV PSV
Frequency (Rate)
P insp.
• • • •
IPPV SIPPV SIMV SIMV + PSV
Inspiratory pressure
P PSV
• SIMV + PSV • PSV
Inspiratory pressure PSV Inspiratory pressure during inspiration in PSV mode.
P Backup
• PSV
Inspiratory pressure Inspiratory pressure during mandatory inspiration in PSV mode.
P DUO
• duoPAP
Upper inspiratory pressure in duoPAP mode. The lower pressure level is selected in duoPAP mode via the CPAP parameter.
CPAP
• duoPAP • CPAP • nCPAP
Continuous Positive Airway Pressure Continuous flow for producing airway pressure at the CPAP level
P manual
• CPAP • nCPAP • HFO
Manual Inspiratory pressure Applying a manual breath Next breath possible after a block period of 200 ms.
O2
• All modes
Oxygen concentration Inspiratory oxygen concentration setting
O2 Flush
• All modes
Oxygen flush Perform O2 flush / oxygen spray (Preoxygenation for max. 2 minutes)
Backup
• CPAP
Backup Frequency In the event of apnoea spontaneous breathing is stimulated after the apnoea duration with a default number of mechanical breaths. Flow sensor must be connected and activated. Backup trigger depends on apnoea period setting.
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Ventilation Parameters Volume Guarantee/ Volume Limit
• • • • •
IPPV SIPPV SIMV SIMV + PSV HFO
Volume Guarantee/ Volume Limit
• • • • •
IPPV SIPPV SIMV SIMV + PSV PSV
Volume limit Maximum ventilator volume setting.
Pmax
• • • •
IPPV SIPPV SIMV SIMV + PSV
Max Pressure Maximum inspiratory pressure during volume guarantee.
Vguarant
• • • • •
IPPV SIPPV SIMV SIMV + PSV HFO
Volume guarantee This additional function controls breaths by volume. Changes in the Ventilation system are compensated. This ensures the patient receives a guaranteed volume with each breath. In SIMV +PSV, the VG is only applied for SIMV breath but not for the PSV breath.
Max. time manual breath
• All modes
Vlimit
Will allow either volume guarantee or volume limit to be enabled in the user interface.
When the volume limit is reached inspiration is stopped.
Maximum time manual breath* Maximum duration allowed for manual breaths. Adjustable from 2 – 30s. *In Settings menu
Flush Time
• All modes
Duration of O2 Flush* Adjustable from 20 – 120s. *In Settings menu
Termination Criteria PSV
• SIMV+PSV • PSV
Termination Criteria PSV* Adjustable from 5 – 35 %. *In Settings menu
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10.1 Special Parameters in HFO Mode Special Parameters Flow
• HFO
Constant flow / bias Adjustable from 5 – 20 l/min Default value: 8 l / min
HF amp
• HFO
High-frequency amplitude Maximum pressure amplitude. Peak to peak.
P mean
• HFO
Mean pressure Continuous positive airway pressure.
I:E
• HFO
Inspiration to expiration ratio Adjustable 1:3 / 1:2 / 1:1
HF Freq
• HFO
High-frequency – frequency Adjustable 5 – 20 Hz
I-Timerec
• HFO
Inspiratory time Lung Recruitment* Adjustable 2-13s. *Optional.
Freqrec
• HFO
Frequency Lung Recruitment* Adjustable 5 – 20 Hz *Optional.
Pmeanrec
• HFO
Pmean Lung Recruitment* *Optional.
AMP max
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• HFO
Maximal Amplitude in Volume Guarantee
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11. Ventilation Modes The ventilator is intended for the following ventilation modes: •
IPPV Intermittent Positive Pressure Ventilation
•
SIPPV Synchronised Intermittent Positive Pressure Ventilation
•
SIMV Synchronised Intermittent Mandatory Ventilation
•
SIMV + PSV Synchronised Intermittent Mandatory Ventilation with PSV support
•
PSV Pressure Support Ventilation
•
CPAP Continuous positive airway pressure
•
NCPAP NIV mask ventilation (Optional)
•
duoPAP NIV mask ventilation (Optional)
•
HFO High-frequency oscillation (Optional)
•
O2 Therapy High and Low Flow Oxygen Therapy HFNC (Optional)
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11.1 IPPV In IPPV mode (Intermittent Positive Pressure Ventilation) ventilation is performed at the specified patterns set on the equipment without consideration to possible spontaneous patient respiration. The set rate is the delivered rate. Set following parameters; • I-Flow, E-Flow, PEEP, Pinsp, I-Time, Frequency (Rate) • Here positive pressure is created during inspiration with passive expiration. • This mode should only be used if no spontaneous breathing from patient is expected
Function fields and ventilation parameters Ventilation additives
11.2 SIPPV Assist Controlled Ventilation (Synchronized Intermittent Positive Pressure Ventilation) each spontaneous patient inspiratory effort triggers a mechanical breath of the ventilator according to the ventilator parameters set for inspiratory period and pressure. The number of breaths per minute supported by the ventilator is controlled by the patient. In this mode the patient breathing frequency must be closely monitored to prevent hyperventilation. Set the alarm for Frequency high according clinical guidelines. Set following parameters: • I-Flow, E-Flow, PEEP, Pinsp, Trigger Sensitivity, I-Time, Frequency (Rate) Function fields and ventilation parameters Ventilation additives
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11.3 SIMV Breaths triggered by the patient will be displayed in green (default settings).
Ventilation with specified pattern and frequency synchronous to the patient’s independent breathing. The patient may spontaneously breathe in between breaths but receives no pressure support.
The synchronisation window for the next mechanical breath is ½ Te.
For weaning from ventilation. If apnoea is detected ventilation will commence with the specified TI and TE frequency. To prevent auto-triggering another breath cannot be triggered for 200 ms following a breath.
Function fields and ventilation parameters Ventilation additives
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11.4 SIMV + PSV In SIMV mode + PSV (Synchronized Intermittent Mandatory Ventilation + Pressure Support Ventilation) the patient may initiate a PSV breath in between the mandatory SIMV breaths. The machine breath (SIMV) is synchronised with the patient’s breathing pattern. The amount of mechanical breath per minute is same as the preset frequency. If patient stops spontaneous breathing, the ventilator will deliver the amount of mechanical breath set with the Frequency button. Every spontaneous inspiratory effort of the patient is supported with the preset Ppsv pressure level. It ends when flow termination criteria is met. Each SIMV breath can be triggered by the patient. Between SIMV breaths the patient is able to trigger a supportive PSV breath. The minimum pressure for the Ppsv is 2 mbar ( trigger breath ) / 5 mbar ( untriggered breath ) above PEEP. Maximum PSV level Ppsv = Pinsp Note: The PSV support is shown as absolute pressure A triggered breath is coloured green whereas the non-triggered ones are grey.
The inspiratory pressure for the PSV breath is set using the P psv button. The PSV breath is terminated at one of the following criteria’s: • Airway pressure exceeds a pressure setting PPSV • Inspiratory flow has dropped to 5 - 35 % of the maximum value of inspiratory flow. Function fields and ventilation parameters Ventilation additives
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11.5 PSV The Pressure Support Ventilation option is used to support the pressure of insufficient spontaneous breathing in triggered ventilation modes. The breathing frequency is determined by the spontaneously breathing patient, whereas the ventilator assumes an adjustable portion of the breathing effort. Thus inspiration is controlled by the patient, and occurs according to the parameters set in ventilation type SIMV. However, the ventilator will now control expiration. This will occur when one of the following criteria is met: • •
Airway pressure exceeds a PPSV pressure setting Inspiratory flow has dropped to 5 – 35% of the maximum inspiratory flow setting (indicating a virtually filled lung)
If the patient stops breathing spontaneously the ventilator will assume alternate breathing with the ventilation parameter settings. Apnea backup ventilation will start after preset Apnea time. If this is set to OFF, backup starts after E-Time.
The inspiratory pressure for the PSV breath is set using the P insp. button. Function fields and ventilation parameters Ventilation additives
11.6 CPAP In CPAP ventilation the patient breathes spontaneously, the ventilator does not provide breathing. This mode will merely produce a positive pressure during inspiration and expiration, noticeably reducing the patient’s breathing effort. The maximum automatic leak compensation is 100% of the inspiratory flow. In the event of an interruption in the patient’s breathing, following the default apnoea period the ventilator will perform a default number of mechanical breaths to stimulate spontaneous breathing. Once breathing commences stimulation will abort and will only commence with the next apnea event. Function fields and ventilation parameters Ventilation additives
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11.7 nCPAP / duoPAP In nCPAP / duoPAP mode the patient spontaneously breathes via mask or nasal cannula. Since no flow sensor is connected, an additional apnoea monitoring method should be used, e.g. impedance measurement. Additionally monitoring SpO2 and PCO2 is recommended. nCPAP: Supplies a positive airway pressure with automatic leak compensation. The maximum flow compensation is 40%. duoPAP: Same as nCPAP but with the option of positive pressure ventilation with adjustable frequency and inspiratory period. This mode requires a special nCPAP patient set with nCPAP generator. Before using the nCPAP / duoPAP mode the correct system must be specified in the specifications menu. The following systems are currently can be used: • Infant Flow ® • Infant Flow LP ® • MediJet ® • Inspire Function fields and ventilation parameters Ventilation additives If Insp. time is set lower than 1 sec. the maximum pressure may not be reached. Depending on the tube set, nCPAP generator and humidifier
11.8 O2 Therapy mode (High and Low flow oxygen therapy) HFNC O2 Therapy is an option which allows use of a continuous flow of blended gas, from 1 – 19 LPM. Nasal cannulas of various makes like F&P, Atom or similar can be used. There are no alarm functions active in this mode, except for the set FiO2 Note: This mode can also be used to put the ventilator in standby mode. By setting a flow of 4 LPM, 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.
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11.9 HFO Ventilation with high-frequency pressure oscillations allows a gas exchange inside the lung despite the very small Tidal volumes (often on the scale of the dead space volume). While pressure amplitudes inside the breathing tube system can be quite significant, only minor fluctuations around the mean pressure occur inside the lung. The mechanical strain due to periodic lung expansion and relaxation is minimal. High-frequency ventilation about the PEEP/CPAP level as mean pressure average. The high frequency pulses superimpose the mean pressure at the set frequency.
11.9.1 HFO Lung Recruitment Lung Recruitment is an optional setting in HFO. The Pmean is thereby increased cyclically to an adjustable value “Pmean rec.” The repetition frequency is selectable from 1 cycle/hour to 4 cycles/minute. The inspiratory time can be set from 2 sec to 60 sec if the expiratory time is ≥ 2 seconds.
Function fields and ventilation parameters Ventilation additives
11.9.2 Special HFO Mode Information When operating fabian HFOi via the internal battery HFO amplitude is limited to 60 mbar. During HFO ventilation the distinct recognition of disconnection and measurement of the minute volume is limited. Use of a heated inspiratory and expiratory tubing system is strongly recommended in HFO mode. Function fields and ventilation parameters Ventilation additives
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11.10 Ventilation Additives To optimise ventilation the following additives can be combined with the selected mode.
Function fields and ventilation parameters
11.10.1 Volume limit The volume limit function automatically switches to expiration when the default tidal volume is reached. Changing the ventilation pattern or adjusting the volume limit the tidal volume is automatically limited. The display will show the message: “Volume limited” In the event of flow measurement outage ( e.g. changing the sensor) „V Limit“ will automatically be deactivated. Once flow measurement is available again “V Limit” will automatically be reactivated.
11.10.2 Volume guarantee Volume guarantee is an additional pressure limiting function with controlled or targeted tidal volume application. Select the volume to be applied in the “V Guarant” field. fabian HFOi automatically adjusts the required ventilation pressure Pinsp up to the maximum pressure “Pmax”. “Pmax” can be set before switching on VG. When the presets are ready, please switch on by pushing the “Volume guarantee on” button. Pinsp will be gradually increased breath by breath to achieve preset Vte. The maximum pressure increase breath by breath is limited to 3 mbar. If the Pinsp setting is insufficient for applying the targeted volume, the following message is displayed: “Tidal volume not reached”. An upward arrow in Pinsp field guides user that to achieve preset Vte, the Pinsp must be increased. In the event of flow measurement outage ( e.g. changing the sensor) „V Guarant“ will automatically be deactivated. Once flow measurement is available again “V Guarant” will automatically be reactivated.
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11.11 Special Functions 11.11.1 Manual inspiration ( man. Breath) In virtually all ventilation modes a manual breath (with the ventilation parameters set in the current ventilation mode) can be triggered by pressing the “manual inspiration” button The duration of the manual breath can be set under Configurations Menu > Ventilation. This may last 2-30 seconds, then a termination of the manual breath will be forced. The next manual breath is only allowed after a block period of 200 ms. In HFO mode manual inspiration can be deactivated. If activated, some clinicians use this for a manual sustained lung inflation after suctioning. A manual breath however may lead to lung over distension.
11.11.2 O2 Flush / Preoxygenation Press the “O2 Flush” button to trigger an O2 flush. Short-term oxygen spray (O2-Flush) with an increased O2 concentration is permissible in all ventilation modes. This will automatically be ended after a maximum of 2 minutes. (also see defaults in menu: Configuration -> Ventilation -> Flush Duration) Press the “O2 Flush” button in a ventilation mode to initiate the O2-Flush. The flush concentration may now be set with the rotary pulse encoder. Pressing the O2 button again will end the flush prematurely.
11.11.3 Standby – stopping / pausing mechanical ventilation The “Start / Stop” button may be used to interrupt mechanical ventilation for 2 minutes. In nCPAP and duoPAP mode ventilation may be interrupted indefinitely. In both cases the built-in gas mixer delivers a minimal flow to prevent heat build-up inside the ventilatory gas moistener. Ventilation will resume following the 2 minute pause or the button is pressed again. Risk of oxygen undersupply! The standby function is not intended for siphoning. A disconnection or reconnection is not recognised.
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12. Error – Cause – Solution – Alarms Alarms are categories by 3 priority levels; high, medium and low. They differ visually and acoustically according to priority. I=HIGH II=MEDIUM III=LOW
blinking message highlighted red blinking message highlighted yellow message highlighted yellow
Tone: ♪♪♪-♪♪-♪♪♪-♪♪ Tone: ♪♪♪ Tone: ♪
4 sec. pause 5 sec. pause 15 sec. pause
Messages in this table are listed in alphabetical order. This table is intended to help you determine and resolve the cause of an alarm message.
12.1 Technical Alarm Priority
Description
Cause
Solution
Air supply pressure
Air supply pressure too low.
Ensure pressure above 2 bar.
Blender defect
Proportional mixer or control defective
Contact Acutronic Service
Charge battery (< 15 min)
Remaining battery time < 15 min.
Switch to mains supply. Alarm may be silenced with Mute Alarm. fabian HFOi continues in battery mode without interruption.
I
Charge battery (< 30 min)
Remaining battery time < 30 min.
Switch to mains supply. Alarm may be silenced with Mute Alarm. fabian HFOi continues in battery mode without interruption.
II
Charge battery (< 60 min)
Power failure. Internal battery remaining charge less than 60 minutes.
Switch to mains supply. Alarm may be silenced with Mute Alarm. fabian HFOi continues in battery mode without interruption.
II
Checksum-ERROR
System error
Contact Acutronic Service
I
COM read/write error
System error
Contact Acutronic Service
DIO read/write error
System error
Contact Acutronic Service
Blower defect
Fan not moving
Contact Acutronic Service
Flat battery!
Remaining battery time < 1 min.
Immediately switch to mains supply
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I I I I
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Priority
Description
Cause
Solution
Flow sensor defect
Damaged heating wires inside flow sensor.
Replace flow sensor. Calibrate.
I
Flow sensor not connected
Flow sensor not connected. Defective sensor cable.
Check flow sensor and sensor cable connection.
I
High tube leak
Upper alarm limit exceeded
Adjust limit value. Inspect tubing system.
II
I2C read/write error
System error
Contact Acutronic Service
I
Inspiratory pressure not reached
Leak. Flow too low.
Check tubing system for tight connection. Increase flow.
III
Low RAM memory
System error
Contact Acutronic Service
I
O2-Sensor calibration failed
Error occurred during calibration.
Repeat calibration.
O2 value out of range
O2 sensor or mixer defective.
Replace O2 sensor or contact Acutronic Service.
Oxygen sensor defect
O2 sensor defective.
Replace O2 sensor.
Oxygen sensor used up
O2 sensor worn.
Replace O2 sensor as quickly as possible. Calibration still available.
Oxygen supply pressure
Oxygen supply pressure too low.
Ensure pressure above 2 bar.
PIF read/write error
System error
Contact Acutronic Service
I
Power failure
Power failure
Switch to mains supply. Alarm may be silenced with Mute Alarm. fabian HFOi continues in battery mode without interruption.
III
I I I I I
Safety relay defect
Safety relay defective.
Contact Acutronic Service
I
SPI read/write error
System error
Contact Acutronic Service
I
Voltage control
System error
Contact Acutronic Service
I
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12.2 Physiological Alarm Priority
Description
Cause
Solution
Apnea
Spontaneous patient breathing halted.
Switch to controlled ventilation.
High breath rate
Hyperventilation self-trigger
Adjust frequency Increase trigger threshold
II
High DCO2 alarm
Exceeded upper alarm limit
Adjust limit value. Check tubing system.
II
High minute volume
Lung compliance has increased. Resistance has decreased. Hyperventilation.
Check ventilation settings
Low DCO2 alarm
Value below lower alarm limit
Adjust limit value. Check tubing system.
Low minute volume
Lung compliance has decreased. Resistance has increased. Spontaneous breathing stops or is declining
Check ventilation settings
Upper alarm limit exceeded
Adjust settings.
Volume limited
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II
II
II
II
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12.3 Other Alarm Priority
Description
Cause
Solution
Check ET Tube
Tube snapped or clogged.
Clear passage.
I
Clean flow sensor
Water or secretion in flow sensor
Clean/replace flow sensor. Calibrate.
I
High PEEP alarm
PEEP 6 mbar above set value for at least 15 seconds.
Check tubing. Check patient connection.
Patient disconnected
Leak or disconnection.
Check tubing system for leaks. Check setting of Pinsp.
Pressure too high
Pressure rise in tubing system, mechanical inspiration was reduced to relieve the system.
Check tubing system. Replace patient system.
Leak or disconnection. Insp. flow or exp. flow set too low.
Check tubing system for tight connection. Increase flow.
Tidal volume not reached
Inspiratory pressure default is reached prematurely.
Adjust inspiratory pressure setting. Increase inspiratory period. Adjust volume setting
Tube occlusion
Expiration tube blocked/kinked
Check ventilation tubes.
Tube occlusion
Inspiration tube blocked/kinked
Check ventilation tubes.
Tube occlusion
Excessive deviation between inspiration and expiration pressure sensor.
Check pressure sensor connection (proximal). Contact Acutronic Service
Pressure too low
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I
I
I
I
II
I I
I
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13. Replacing the Oxygen Sensor Switch off fabian HFOi and unplug from power supply. Remove screws (3 x) on fabian housing cover. Lift off housing cover. The oxygen sensor is located at the front right inside the fabian, viewing from the back. Unplug oxygen sensor cable. Unscrew oxygen sensor counter-clockwise. Screw in new sensor and connect sensor cable. Reinstall housing cover. Switch on fabian. Calibrate oxygen sensor at 21 %Vol. and 100 %Vol. Used O2 sensors must be properly disposed of. Please note:
Do not force O2 sensor open – risk of chemical burns!
Dispose of O2 sensors in accordance with local waste management regulations (cf. battery disposal). Please contact local environmental or regulatory agencies and appropriate waste management companies for information. 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
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14. Service and Maintenance Intervals Always clean and disinfect equipment or equipment components prior to any maintenance – including when returning the equipment for repair. Every 6 months Perform the following work: • Clean cooling air filter (casing bottom), replace if necessary Every 12 months Maintenance and safety inspections Perform the following work: • Device check as specified by manufacturer • Check alarm and limit value functions • Check pressure connections • Check electrical connections • Check safety shutdown calibration Replace the following components: • Air and oxygen Input filter • Cooling air filter (casing bottom) • O2 sensor Every 4 years Replace the following components: • Air and oxygen Input filter • Cooling air filter (casing bottom) • O2 sensor • Linear valves pressurised air / oxygen mixer • Input pressure regulator pressurised air / oxygen • Calibration valves • Lithium battery • Accumulator • Membrane HFO module
Maintenance and safety inspections must be performed by Acutronic trained experts with access to suitable testing and measuring equipment.
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15. Sterilisation/Cleaning/Disinfection The device must be prepared after each patient treatment.
Cleaning and disinfection procedures according to country specific regulations
The device may not be sterilized under any circumstances!
Flow Sensor • Do not clean sensor with compressed air or water jet, as the sensor wires could be destroyed. • Never treat sensor in automatic cleaning-/disinfection machine. • Rinse flow sensor element in distilled water. • Thoroughly shake off residual water. Steam sterilization at 132°C for 2 minutes (half cycle). The flow sensor should be changed when it is unable to be calibrated. Replace and clean sensor once a day. It has been shown that this increases the service life of the sensor. Never connect an uncalibrated sensor to a patient. Always calibrate the sensor before connecting to a patient. Membrane holder with membrane Clean and disinfect wet thermally (80 - 95°C / 5 min) in the automatic cleaning/disinfection machine just with detergent. Steam sterilization at 132°C for 2 minutes ( half cycle ) Change the membrane when the unit fails the device check – Function Test. See chapter 6. In general, sterilize the membrane holder to ensure that residual water in the channels and control cables dries out. Ventilation tubes Preparation according to manufacturer information Heating wire Preparation according to manufacturer information Water trap Preparation according to manufacturer information Temperature probe Preparation according to manufacturer information Y-piece Preparation according to manufacturer information
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16. Setting Ranges and Parameters Mode Parameter
IPPV Neonatal
SIPPV Pediatric
Neonatal
Pediatric
min
max
min
max
min
max
min
max
I-Flow [l/min]
1
20
2
32
1
20
2
32
E-Flow [l/min]
3
8
4
20
3
8
4
20
0.3
2
0.3
2
Rise Time [s] I-time [s]
0.1
2
0.3
2
0.1
2
0.3
2
E-time [s]
0.2
30
0.3
30
0.2
30
0.3
30
Frequency[1/min]
2
200
2
100
2
200
2
100
PEEP [mbar]
0
30
0
30
0
30
0
30
Pinsp [mbar]
4
80
4
80
4
80
4
80
1
10
1
10
Trigger* (Volume) Vlimit [ml]
1
150
10
500
1
150
10
500
Vguarant [ml]
0.8
60
10
300
0.8
60
10
300
Pmax [mbar]
4
80
4
80
4
80
4
80
O2 [%]
21
100
21
100
21
100
21
100
O2 Flush [%]
23
100
23
100
23
100
23
100
Flush Time [s]
30
120
30
120
30
120
30
120
Max. Time Man. Breath [mbar]
2
30
2
30
2
30
2
30
*Flow trigger: 0.120 – 2.4 l/min
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Mode Parameter
SIMV Neonatal
SIMV+PSV Pediatric
Neonatal
Pediatric
min
max
min
max
min
max
min
max
I-Flow [l/min]
1
20
2
32
1
20
2
32
E-Flow [l/min]
3
8
4
20
3
8
4
20
0.3
2
0.3
2
Rise Time [s] I-time [s]
0.1
2
0.3
2
0.1
2
0.3
2
E-time [s]
0.5
30
0.5
30
0.5
30
0.5
30
Frequency [1/min]
2
100
2
100
2
100
2
100
PEEP [mbar]
0
30
0
30
0
30
0
30
Pinsp ( backup )[mbar]
4
80
4
80
4
80
4
80
2
80
2
80
PPSV [mbar] Trigger
1
10
1
10
1
10
1
10
Vlimit [ml]
1
150
10
500
1
150
10
500
0.8
60
10
300
1.2
60
10
300
Pmax [mbar]
4
80
4
80
4
80
4
80
O2 [%]
21
100
21
100
21
100
21
100
O2 Flush [%]
23
100
23
100
23
100
23
100
Flush Time [s]
30
120
30
120
30
120
30
120
Max. Time Man. Breath [mbar]
2
30
2
30
2
30
2
30
5
35
5
35
Vguarant [ml]
PSV Termination Criterium [%]
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Mode Parameter
PSV Neonatal
CPAP Pediatric
min
max
min
max
I-Flow [l/min]
1
20
2
32
E-Flow [l/min]
3
8
4
20
0.3
2
I-time [s] E-time [s]
Neonatal
Pediatric
min
max
min
max
0.2
30
0.3
30
Frequency [1/min]
2
200
2
100
PEEP [mbar]
0
30
0
30
PBackup [mbar]
4
80
4
80
PPSV [mbar]
2
80
2
80
Trigger
1
10
1
10
Vlimit [ml]
1
150
10
500
Vguarant [ml]
0.8
60
10
300
O2 [%]
21
100
21
100
21
100
21
100
O2 Flush [%]
23
100
23
100
23
100
23
100
Flush Time [s]
30
120
30
120
30
120
30
120
Max. Time Man. Breath [mbar]
2
30
2
30
2
30
2
30
PSV Termination Criterium [%]
5
35
5
35
Flowmin [l/min]
4
16
4
16
CPAP [mbar]
1
30
1
30
Pmanual [mbar]
4
100
4
100
Backup
0
5
0
5
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Mode
HFO Neonatal
Parameter
Pediatric
min
max
min
max
0.3
30
10
100
AMPmax [mbar]
5
100
5
100
O2 [%]
21
100
21
100
O2 Flush [%]
23
100
23
100
Pmanual [mbar]
4
80
4
80
HFamp [mbar]
5
100
5
100
HFFreq [Hz]
5
20
5
20
Pmean [mbar]
5
50
5
50
1:3
1:1
1:3
1:1
Flow [l/min] (constant / bias)
5
20
5
20
Freqrec [1/hr]
1
240
1
240
Pmean rec [mbar]
7
50
7
50
I-Timerec [s]
2
60
2
60
Flush Time
30
120
30
120
Max. Time Man. Breath
2
30
2
30
Vguarant [ml]
I:E
When powering fabian HFO by internal battery HFO amplitude is limited to 60 mbar. Mode Parameters
NCPAP Neonatal
DUOPAP
Pediatric
Neonatal
O2 Therapy
Pediatric
0.15
15
0.15
15
E-time [sec]
0.2
30
0.2
30
2
60
2
60
Frequency [1/min] O2 [%]
21
100
21
100
21
100
21
100
O2 flush [%]
23
100
23
100
23
100
23
100
Flush Time
30
120
30
120
30
120
30
120
Max. Time Man. Breath
2
30
2
30
2
30
2
30
Flowmin [l/min] CPAP [mbar]
2
13
2
13
Pmanual [mbar]
5
15
5
15
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Pediatric
min max min max min max min max min max min max
I-time [sec]
PDUO [mbar]
Neonatal
2
13
2
13
5
15
5
13
21
100
21
100
30
120
30
120
0
15
0
19
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17. Standard Accessories Item no.
Description
7360
Membrane holder, 22mm OD / 15mm ID
7007
Membrane, expiration
7003
Oxygen sensor
1016
Flow sensor connector cable
7058.1
Flow sensor, single use
1031
Flow sensor, reusable
1116
Test lung for neonatal ventilators, with 2 bellows, to simulate ventilation Not autoclavable
5191
Adapter NIST – DISS O2
5192
Adapter NIST DISS Air
18. Guide to Volume Guarantee Mechanical ventilation is required to manage neonates with severe respiratory failure. Pressure-limited ventilation (PLV), delivering a fixed peak inflating pressure (PIP), has traditionally been used to control the arterial carbon dioxide (PaCO2). During PLV the tidal volume (VTe) fluctuates widely due to the baby's breathing, changes in lung mechanics and variable endotracheal tube (ETT) leak. As high VTe (volutrauma), and not pressure per se, causes lung injury, controlling VTe rather than PIP is a logical strategy for ventilating preterm infants. The fabian™ series of Neonatal/Pediatric microprocessor-controlled ventilators allow volume-targeted ventilation (VTV) even in very preterm infants. Measurements are done with the flow sensor placed at the Y-piece. The flow sensor measures inspired and expired VT, and ETT leak is calculated and displayed. The advantage of targeting inspired VTi is that the ventilator controls the VTi as it is delivered. The major disadvantage is that variable ETT leak alters the delivered VTi. The advantage of using the expired VTe is that this most accurately reflects the VT that entered the infant's lung, and is less influenced by ETT leaks unless they are very large. Volume guarantee (VG) ventilation is a VTV-mode controlling the expired VTe.
18.1 How Does Volume Guarantee (VG) on fabian Work? The operator sets a target expired VTe (set VTe). The ventilator measures the expired VTe for each inflation and automatically adjusts the PIP(Ppeak) for the next inflation of the same type, triggered or untriggered, aiming to deliver the VTe around the set level. The detailed guide how to start VG function on the fabian™ ventilators is described on the following pages in detail. The maximum difference in pressure from breath to breath is limited to 3cmH2O to avoid any overdistension due to excessive pressure compensation. The main issue is to choose an appropriate VTe at the start and to give enough pressure to get it in. The following procedure describes the use of VG in SIPPV(A/C) mode, however, the same procedure can be followed in the other modes where VG function is available. IPPV, SIPPV, SIMV+PSV and PSV. Look at what VTe the baby is currently getting on his current ventilation settings. You can get this value from the measured parameters displayed on the right side of the display. The usual VTe to aim for is 4-6ml/kg per breath. Starting with 5ml/kg is usually a safe point but may be a bit high for some babies. Look at the pressure settings. The pressure settings are - in essence - alarm settings. If the ventilator cannot deliver the VTe at the pressures prescribed, it will alarm "Tidal Volume not reached". You may need to increase the PIP(Pinsp) to stop it from alarming. The rate setting is a "back-up" rate if the baby is not breathing. However, it should be set 10-15 breaths below the baby's apparent rate so that the baby has an opportunity to trigger. If VG is added to the SIPPV, each breath is maintained at same exhaled tidal volume. In case of an improvement of lung compliance, the Pinsp is automatically reduced Every single inspiratory effort of the patient is supported with a mechanical breath with fixed inspiratory time and fixed Inspiratory Pressure. If the breath was triggered by patient, it is colored green, if none triggered, grey. The baby controls the rate of ventilation.
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18.2 Settings to start with I-Flow E-Flow Rate Inspiratory time Pinsp PEEP
8 LPM 6 LPM between 35 and 40 BPM between 0.3s and 0.4s between 16 and 18cmH2O 4 - 6 cmH2O
18.3 How to start VG function Step 1 Setup ventilator in SIPPV and start ventilation Step 2 Please select the appropriate Vte to be guaranteed.
Important: To ensure the VG function works appropriately, a small plateau in the tidal volume wave needs to be present.
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Step 3 Please set in the Pmax field the maximal pressure value to which the VG function is allowed to regulate.
Triggered and non-triggered breaths are independently supported based on lung compliance. Normally, a triggered breath has a lower Pinsp than a non-triggered one due to different lung compliance. Step 4 VG can now be activated by selecting the “ON/OFF” button. When VG function is on this button will turn green. Furthermore a red line will appear in the pressure wave diagram to marks the Pmax.
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Note: If the targeted volume cannot be reached with the set Pmax the warning: “Vte not reach, check settings” will appear. An upward pointing arrow will appear in the “Pmax” field to indicate the maximum pressure has been reached.
In case the flow sensor is deactivated, the VG will be shut off and the pre-set Pinsp will be used to ventilate.
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18.4 Setting up the ventilator PSV+VG If Volume Guarantee is added to PSV, the ventilator automatically is adjusting the PPSV level necessary to maintain preset target volume. In case of an apnea, the ventilator will start cycling at preset rate and PBackup. As soon as spontaneous activity restarts, the backup stops. Settings to start with I-Flow 8 LPM E-Flow 8 LPM Rate between 30 to 40 BPM - Safety backup rate in case of apnea Inspiratory time between 0.3s and 0.4s - Used for backup and as max I-Time between 16 – 18cmH2O used during apnea backup ventilation Pbackup PPSV 16 – 18 cmH2O PBackup PEEP 4 - 6 cmH2O The minimum pressure difference between PEEP and PPSV is always 2 cmH2O and PPSV is max same level as Pinsp. PSV breaths as well as apnea backup breaths are volume targeted breath in this mode. The delay to start backup ventilation is set with the Apnea time in alarm limit screen. If Apnea is set to OFF > backup starts after E-Time In PSV+VG mode, the patient controls the onset of inspiration as well as the end of inspiration, offering a total synchrony with patients breathing pattern. If patient lung compliance is improving, the ventilator automatically is using the lowest pressure, necessary to maintain the preset target volume. In case of a respiratory fatigue and a ceasing inspiratory effort, the ventilator automatically will provide an apnea backup ventilation with the preset parameters for I-Time, Frequency and Pbackup. The delay for the onset of the apnea backup ventilation is set in the alarm screen, by setting the apnea delay time. If set to OFF, the ventilator will start apnea backup ventilation immediately after E-Time, otherwise after preset apnea time. It is recommended to use a delay time to avoid the ventilator to kick in unnecessarily and interfering with patients breathing pattern. The apnea backup breaths are Volume guaranteed breaths.
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19. Special Procedures 19.1 Use of closed suction systems Suction can be done in the following ventilation modes: HFO IPPV SIPPV SIMV SIMV+PSV PSV CPAP The suction catheter system has to be placed between the flow sensor and the patient. See picture
1. 2. 3. 4.
Tube set coming from the fabian +nCPAP evolution Flow sensor has to be placed on the device side of the suction system Closed Suction System Patient side
Before suction do a preoxygenation of the patient Choose the right catheter for the suction. Otherwise, a too high vacuum is possible!
Silence the alarms before suction (2 minutes) for not disturbing the suctioning. After the suction reactivate the alarm again.
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20. Technical Specifications 20.1 Ambient Conditions During Ambient Temperature Air Pressure Relative Humidity Non condensing
Operation
Transport
Storage
min
max
min
max
min
max
+10 C +50oF 700hPa
+40 C +104oF 1060hPa
-20 C -4oF 500hPa
+60 C +140oF 1060hPa
o
0C +32oF 700hPa
+40oC +104oF 1060hPa
10%
90%
10%
90%
20%
80%
o
o
o
o
The minimum and maximum ambient temperatures in the clinical area will not affect the accuracy of the flow, pressure or oxygen measurement. Depending to the accessories the environmental conditions can be different. Note Related Manuals.
20.2 Monitoring Acoustic pressure of alarm tones. Alarm tone sequence IEC: High priority: 49 db(A) – 65 db(A) Medium priority: 49 db(A) – 63 db(A) Low priority: 48 db(A) – 63 db(A) A weighted sound pressure level in 1m distance : 46dB Expiratory minute volume Alarm lower threshold value: Alarm upper threshold value: Airway pressure Alarm lower threshold value: Alarm upper threshold value: maximum airway pressure: Inspiratory O2 concentration Alarm: Breath frequency Alarm: Volume monitoring Alarm lower threshold value: Apnoea alarm Alarm:
fabian HFOi | SW 3.4
If lower alarm limit undershot If upper alarm limit exceeded If lower alarm limit undershot If upper alarm limit exceeded 100 mbar
Set value ± 5 Vol.% for > 1 minute at 21 Vol% below threshold value 18 Vol% If alarm limit exceeded If the breath volume set was not supplied If no breathing activity is recognized
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20.3 Measuring Airway measurement Range: Precision: Resolution:
-60 – 130 mbar ± 4% 0.1 – 1 mbar
Breath volume measurement range: Precision: Resolution:
0 – 9.99 l ( BTPS ) (inspiratory and expiratory) ± 8% 0.1 – 100 ml
Volume Controlled Breaths: Max. bias error: Max. linearity error: Max. error delivered vs. set volume: Max. error in delivered vs set PEEP:
0.5 ml 10% (1ml at 10ml) 0.5 ml at 1ml, 1 ml at 10 ml, 8 ml at 100 ml 0.5 mbar < 10 mbar, 1 mbar > 10 mbar
Pressure Controlled Breaths: Max. bias error: Max. linearity error: Max. error of airway pressure (Paw): Max. error in delivered vs set PEEP:
0.5 mbar 3% 1 mbar or 3% 0.5 mbar < 10 mbar, 1 mbar > 10 mbar
Inspiratory Oxygen Concentration: Max. error delivered vs. set FiO2: Response time to change in FiO2:
3% FiO2. Conventional Ventilation: blender delay is 1 breath. HFO mode: blender delay is 500ms. Total Delay = Blender Delay + Pneumatic Delay
Tube leak range: Precision: Resolution: Dynamic compliance Range: Precision: Resolution: Resistance Range: Precision: Resolution:
10 – 50% ± 10% 1% ml 0-500 ml/mbar ± 8% 0.1 – 1 ml/mbar 0 – 5000 mbar/l/s ± 8% 0.1 mbar/l/s
Overdistension index C20 / C Range: Resolution: Inspiratory O2 concentration Range: Precision:
0–5 0.1 18 – 100 Vol% ± 3%
Drift: Pressure influence: Warm-up time:
< 1 Vol% per month. < 15% rel. over entire service life Proportional to change in partial pressure max. 3 minutes (< 30 minutes with new O2 sensor)
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20.4 Resistance Values System resistance at 30 l/min Inspiratory resistance Expiratory resistance
< 20 mbar/l/s < 12 mbar/l/s < 8 mbar/l/s
20.5 Parameter Defaults in Configurations Menu Tubing set nCPAP
• • • •
MediJet ® Infant Flow ® Infantflow LP ® Inspire™
O2 Flush time
• • •
30 seconds 60 seconds 120 seconds
Automatic O2 calibration
• •
21% Vol. 21% Vol. and 100% Vol.
I-time settings
• •
Frequency / I-time I-time / E-time
Manual breath
•
2 – 30 Seconds
Manual breath HFO
• •
ON OFF
Trigger mode
• •
Volume trigger Flow trigger
Triggered breath signal tone
• •
With signal tone Without signal tone
Termination criteria PSV
•
5 – 35%
Alarm delay Pmin. nCPAP
•
1 – 10 seconds
V limit signal tone
• •
ON OFF
20.6 Dimensions / Weight WxHxD
30 cm x 37 cm x 40 cm
Weight
Approx. 20 kg with HFO module Approx. 14 kg without HFO module
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20.7 Ratings Pressurised air supply
2.0-6.5 bar / max. 40 l/ min. Connection thread: NIST
Oxygen supply
2.0-6.5 bar / max. 40 l/min. Connection thread: NIST
Power supply
100-240 VAC 0.9 – 0.5 A 50/60Hz external 24 VDC 4 A (no charging when connected via external battery connector)
Power rating
IPPV mode: max. 70 W HFO mode: max. 100 W Standby , fabian connected to mains: 35 W ( battery charging )
Internal Battery
16.8 V with 4500 mAh max. charging time: 5 hours internal NIMH Battery is Maintenance free battery charge is continuously monitored Battery life in HFO mode: 1 hour Battery life in conventional mode (IPPV): 2.5 hour
Sound pressure
Max. 52 dB (A)
Device fuse
T 1.0 A L / from HW rev. 1.8: T 1.25 A L
Safety class Certification
Type B ≙ EN 60601-1
Classification to EC directive 93/42/EEC
Class II b
IP Protection
IPX1, Protected against falling water Equivalent to 3-5mm rainfall per minute for a duration of 10 minutes. Unit is placed in its normal operating position.
IEC 60601-1; IEC 60601-1-2; IEC 60601-1-8; IEC 6060601-2-12
20.8 Data storage Trend
maximum 5 days storage every 30 seconds
Alarms
maximum 1.000 messages
Log
Maximum 10 Log Files. Log is stored during power failure When Log capacity is reached index is shifted and oldest log file deleted
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20.9 Applied Parts Applied parts for the fabian HFOi are the Tube set and Flow Sensor.
20.10 Device Checks The following internal device checks are performed on start-up: • • • • • • • •
COM: Communication between GUI and Conductor PIC. I2C: Communication between GUI to Acu PIC, FRAM and Multiplexer. PIF: Communication between GUI and Parallel Interface DIO: Communication between GUI and Digital I/O. SPI: Communication between GUI and Monitor PIC. Voltage: Voltage Error Check via SPI Relais: Relais Check via SPI SPICks: SPI Checksum
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.
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20.11 Gas blender function The air/oxygen blender provides a gas blend with adjustable proportions of oxygen and air. Gas from the central gas supply enters the device via the gas input connections. Blending of the gases occurs via two proportional valves. The proportional valves, which also act as return 5 valves, prevent the return flow of a gas into the supply cable of the other gas. An oxygen sensor measures the inspiratory oxygen concentration. 6 4 3 1 7
2
1. 2. 3. 4. 5. 6. 7.
Oxygen 2.0 – 6.5 bar Air 2.0 – 6.5 bar Filter Pressure Regulator P sensor Proportional valve To Manifold
The minimum base flow is 4 l/min in all modes except in O2 Therapy. For more information, please refer to the technical service manual
20.12 Acoustic Energy Acoustic pressure from the alarm sounds at the workstation. The operator position is defined with 1 m distance of the front panel of the device Lowest sound pressure level of alarm 56.6 dB Highest sound pressure Level of alarm: 72.0 dB Weighted sound pressure level in 1m distance: 43dB
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21. Electromagnetic Compatibility Statement Note: "fabian HFOi" is a MEDICAL APPLIANCE subject to specific precautionary measures with regard to EMC and must be installed and started up according to the notices according to the instructions in this manual. Warning:
Portable and medical HF communication devices could impact MEDICAL APPLIANCES!
Warning:
Never use "fabian HFOi" directly adjacent to, or stack with other apparatuses. If unavoidable, be sure to monitor the equipment for proper operation with this set-up.
Warning:
Using other accessories, cables or converters with "fabian HFOi" may result in increased electromagnetic interference and reduce the immunity of "fabian HFOi".
Note:
The key performance characteristics of the "fabian HFOi" ventilator are: • fabian HFOi must operate within the defined specifications and the medical purpose. Failure to meet these specifications will result in respiration being stopped. • For this reason a second, stand-alone ventilation unit must always be available, e.g. resuscitation bag.
Guideline and manufacturer declaration – electromagnetic emission The device "fabian HFOi" is intended for operation in the environment described below. The customer or user of the "fabian HFOi" apparatus should ensure it is operated in this type of environment. EMI measurement
Compliance
Electromagnetic environment – guideline
HF emission CISPR 11
Group 1
The device "fabian HFOi" uses HF energy solely for internal operation. Its HF emission is thus very low and interference with adjacent apparatuses is unlikely.
HF emission CISPR 11
Class A
Emission of harmonics IEC 61000-3-2
Class A
The device "fabian HFOi" is suitable for use in all other areas except residential areas and areas directly connected to a public mains supply which also supplies buildings used for residential purposes.
Emission of voltage fluctuations / flickers IEC 61000-3-3
Met
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Guideline and manufacturer declaration – electromagnetic immunity The device "fabian HFOi" is intended for operation in the environment described below. The customer or user of the "fabian HFOi" apparatus should ensure it is operated in this type of environment. Immunity testing
IEC 60601 test level
Compliance level
Electromagnetic environment – guideline
Electrostatic discharge (ESD)
± 6 kV contact ± 8 kV air
± 6 kV contact ± 8 kV air
Floors should be wooden or concrete or tiled with ceramic tiles. For flooring made from synthetic materials the relative air humidity must be no less than 30%.
Quick electric transients/burst
± 2kV for power cords
± 2kV for power cords
The mains quality should correspond to typical business or hospital environments.
IEC 610004-4
± 1kV for in/output cables
± 1kV for in-/output cables
Surges
± 1 kV lead to lead
± 1 kV lead to lead
IEC 61000-4-2
IEC 61000-4-5 ± 2 kV lead to ground Voltage drops, temporary power failures and fluctuations IEC 61000-4-11
Magnetic field at supply frequency (50/60 Hz) IEC 61000-4-8
The mains quality should correspond to typical business or hospital environments.
± 2 kV lead to ground
<5% UT (>95% drop of UT) for ½ period
<5% UT (>95% drop of UT) for ½ period
40% UT (60% drop of UT) for 5 periods
40% UT (60% drop of UT) for 5 periods
70% UT (30% drop of UT) for 25 periods
70% UT (30% drop of UT) for 25 periods
<5% UT (>95% drop of UT) for 5 seconds
<5% UT (>95% drop of UT) for 5 seconds
3 A/m
3 A/m
The mains quality should correspond to typical business or hospital environments. If the operator of the "fabian HFOi" requires continued use in the event of a power failure we recommend connecting the "fabian HFOi" to an uninterruptible mains supply or a battery.
Magnetic fields at the mains frequency should correspond to typical values in business and hospital environments.
Remark UT is the mains alternating voltage prior to applying the test level.
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Guideline and manufacturer declaration – electromagnetic immunity The device "fabian HFOi" is intended for operation in the environment described below. The customer or user of the "fabian HFOi" apparatus should ensure it is operated in this type of environment.
Immunity testing
IEC 60601 test level
Compliance level
Electromagnetic environment – guideline Never use portable or mobile radio devices closer to the "fabian HFOi", including cables, than the recommended safety distance calculated using the equation applicable to the transmission frequency. Recommended safety distance
HF interference currents IEC 61000-4-6
HF interference radiation IEC 61000-4-3
3 Veff 150 kHz to 80 MHz beyond ISM bands a
10 V
d = 0.35√P
10 Veff 150 kHz to 80 MHz within ISM bands b
10 V
d = 1.2√P
10 V/m 80 MHz to 2.5 GHz
10 V/m
d = 1.2√P 80 MHz to 800 MHz d = 2.3√P 800 MHz to 2.5 GHz P being the transmitter’s nominal rating in Watts (W) per manufacturer specifications and d being the recommended safety distance b in metres (m). The field strength of stationary radio transmitters should be below the compliance level d on all frequencies as tested on site c. Interference may occur in proximity of apparatuses bearing the following symbol:
REMARK 1
At 80 MHz and 800 MHz the higher frequency range applies.
REMARK 2 These guidelines may not apply to all case. The propagation of electromagnetic quantities is influenced by absorption and reflexion of buildings, objects and people. a
The ISM bands (industrial, scientific and medical) between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.7 MHz.
b
The compliance levels in ISM frequency bands between 150 kHz and 80 MHz and between 80 MHz and 2.5 GHz are defined as such so as to decrease the probability of mobile/portable transmitters causing interference in the event they are accidentally brought in to the vicinity of the patient. For this reason an additional factor of 10/3 is used when calculating the recommended safety distance of transmitters in this frequency range.
c
In theory the field intensity of stationary transmitters, as e.g. base units of radio telephones (mobile/cordless) and mobile land radio devices, amateur radio stations, AM and FM radio stations and television stations cannot be predefined precisely. A study of the location should be conducted to determine the electromagnetic environment with regard to stationary transmitters. If the field intensity at the location where the "fabian HFOi" is used exceeds the above compliance levels, "fabian HFOi" 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 HFOi".
d
Above a frequency range of 150kHz to 80MHz the field intensity should be below 10 V/m.
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Recommended safety distances between portable and mobile HF communication devices and the device "fabian HFOi" "fabian HFOi" is intended to be operated in an electromagnetic environment with controlled HF interferences. The operator of the "fabian HFOi" can help avoid electromagnetic interference by maintaining the minimum distance between portable and mobile HF telecommunication devices (transmitters) and the device "fabian HFOi" – depending on the output rating of the communication device, as listed below. Maximum transmitter power output W
Safety distance depending on transmission frequency m 150 kHz to 80 MHz outside ISM bands
150 kHz to 80 MHz 80 MHz to within ISM bands 800 MHz
800 MHz to 2.5 GHz
d = 0.35√P
d = 1.2√P
d = 1.2√P
d = 2.3√P
0.01
0.04
0.12
0.12
0.23
0.1
0.13
0.38
0.38
0.73
1
0.40
1.2
1.2
2.3
10
1.3
3.8
3.8
7.3
100
4.0
12
12
23
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. REMARK 1
At 80 MHz and 800 MHz the safety distance of the higher frequency applies.
REMARK 2 The ISM bands (industrial, scientific and medical) between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.7 MHz. REMARK 3 An additional factor of 10/3 is used when calculating the recommended safety distance for transmitters within the ISM frequency between 150KHz and 80 MHz and between 80MHz and 2.5GHz to reduce the probability of mobile/portable transmitters causing interference if accidentally brought into the vicinity of the patient. REMARK 4 These guidelines may not apply to all case. The propagation of electromagnetic quantities is influenced by absorption and reflexion of buildings, objects and people.
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This manual is only valid for devices with SW Version: 3.4 7. Edition – 3 / 2016
Guideline 93/42/EWG
ACUTRONIC Medical Systems AG Fabrik im Schiffli CH-8816 Hirzel / Switzerland T +41 44 729 70 80 F +41 44 729 70 81
[email protected] www.acutronic-medical.ch
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