fabian HFO Instructions for Use Sw Ver 5.1.x Feb 2021.pdf
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Ventilation Beyond Limits
fabian HFO and Auxiliary Systems
Instructions for Use, Software Version 5.1.x
fabian HFO ] SW V5.1.x Ret: 113003.EN / Date : 09Feb2021
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Disclaimer
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Disclaimer
ACUTRONIC Medical Systems, assumes no responsibility for the use or reliability of its software on equipment that is not furnished by ACUTRONIC Medical Systems
ACUTRONIC Medical Systems makes no warranty of any kind regarding software applications that are created by the user.
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. This document cannot be copied, reproduced, translated, stored in a retrieval system, transmitted in any form, or reduced to any electronic medium or machine-readable form, in whole or in part, without the written permission of ACUTRONIC Medical Systems.
Manufacturer
ACUTRONIC Medical Systems AG Fabrik im Schiffli 8816 Hirzel / Switzerland Tel: +41 44 729 70 80 Fax: +41 44 729 70 81 e-mail: info@acutronic-medical.ch
www.acutronic-medical.ch
For any additional parts and accessories, contact your local distributor for available items and price list.
fabian HFO | SW V5.1.x REF 113003.EN / Date : 09Feb2021
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Table of Contents
Table of Contents
Disclaimer ............................................................................................ i
Table of Contents..................................................................................ii
1 Introduction ...................................................................................1
1.1 Working with the instructions ...........................................................................1 1.2 Notices and warnings ........................................................................................1 1.3 Applicable product versions..............................................................................1 1.4 Symbols ............................................................................................................2
2 Warnings cautions and notices ........................................................5
2.1 Always observe (fabian) ....................................................................................5 2.2 Maintenance .....................................................................................................8 2.3 Liability for functionality / damages .................................................................8 2.4 Intended use .....................................................................................................9
3 System overview........................................................................... 10
3.1 Scope of delivery.............................................................................................10 3.2 Contraindications ...........................................................................................10 3.3 fabian Front connections ................................................................................11
3.3.1 Devices with serial number prefix AI / AL........................................................................ 11 3.3.2 Devices with serial number prefix 20 /AK/AH ................................................................. 11 3.4 Rear panel .......................................................................................................12 3.4.1 Hardware with HDMI output (SN AI-01500 and AL-00400 or higher) ............................ 12 3.4.2 Hardware with Video input .............................................................................................. 13 3.4.3 Initial hardware model ..................................................................................................... 14 3.4.4 General hardware characteristics.................................................................................... 15
4 System functions and displays....................................................... 16
4.1 Control panel options .....................................................................................16 4.1.1 Function buttons .............................................................................................................. 16 4.1.2 Rotary pulse encoder........................................................................................................ 17
4.2 Display concept structure ...............................................................................18 4.2.1 Display areas ..................................................................................................................... 18 4.2.2 Display screen ................................................................................................................... 18 4.2.3 Information bar ................................................................................................................. 19 4.2.4 Numeric field / alarm limits ............................................................................................. 20 4.2.5 Graphics display................................................................................................................ 22 4.2.6 LED indicators ................................................................................................................... 22
4.3 Ventilation menu.............................................................................................23 4.3.1 Operation – general .......................................................................................................... 23 4.3.2 Operation – settings ......................................................................................................... 24 4.3.3 Ventilation parameter dependency ................................................................................ 25
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4.3.4 Locking ventilator parameters .........................................................................................25 4.4 Graphics menu................................................................................................ 27
4.4.1 Curves .................................................................................................................................28 4.4.2 Loops ..................................................................................................................................30 4.4.3 Trend menu........................................................................................................................31
5 System operation ......................................................................... 35
5.1 Preparing for operation .................................................................................. 35 5.1.1 Connect the power supply................................................................................................35 5.1.2 Connect the gas supply.....................................................................................................36 5.1.3 Connect the tubing set......................................................................................................37 5.1.4 Connect Nitric Oxide (NO) tubing sets .............................................................................38 5.1.5 Bias flow selection for NO system usage in HFO mode .................................................41
5.2 Patient circuit assembly ................................................................................. 42 5.2.1 Recommended positioning of temperature probe for humidifier ................................43 5.2.2 Use of reusable patient circuit .........................................................................................44 5.2.3 Connect nCPAP tubing set................................................................................................47 5.2.4 Connect flow sensor in NIV trigger (optional) .................................................................48
5.3 System start-up .............................................................................................. 48 5.3.1 Switching ON the ventilator .............................................................................................48
5.4 Device check ................................................................................................... 50 5.5 System standby / pause .................................................................................. 52
5.5.1 Standby – stopping / pausing mechanical ventilation ..................................................52 5.6 System shutdown ........................................................................................... 53
5.6.1 Switching OFF the fabian..................................................................................................53 5.7 Emergency shutdown ..................................................................................... 54
6 Configurations menu .................................................................... 55
6.1 Calibration...................................................................................................... 56 6.1.1 Flow sensor calibration.....................................................................................................57 6.1.2 O2 Sensor calibration........................................................................................................60 6.1.3 etCO2 module....................................................................................................................60 6.1.4 SpO2 module .....................................................................................................................61
6.2 Body weight .................................................................................................... 61 6.3 Display............................................................................................................ 61
6.3.1 Touch screen settings .......................................................................................................62 6.3.2 Trend / graph display ........................................................................................................63 6.4 Ventilation parameter settings ....................................................................... 64 6.5 Patient data .................................................................................................... 66 6.6 Language ........................................................................................................ 67 6.7 Date / Time ..................................................................................................... 67 6.8 Tools............................................................................................................... 68 6.9 Information .................................................................................................... 68 6.10 Service mode .................................................................................................. 69
7 Alarms ......................................................................................... 70
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7.1 Alarm limits menu ...........................................................................................70 7.1.1 Automatic alarm limits ..................................................................................................... 72 7.1.2 Configurable alarms ......................................................................................................... 73
7.2 Alarm log.........................................................................................................74 7.3 Alarm causes and solutions.............................................................................74
7.3.1 Alarms table....................................................................................................................... 75 7.3.2 Pressure release behavior ................................................................................................ 82 7.3.3 Application error ............................................................................................................... 82 7.3.4 Watchdog alarms .............................................................................................................. 83
8 Battery operation ......................................................................... 85
8.1 Power failure...................................................................................................86
9 Operating on External Power Source.............................................. 87
9.1 (Devices with SN till AI-01500 and AL-00400) ...................................................87
10 Ventilation parameters ................................................................. 88
11 Ventilation modes......................................................................... 92
11.1 IPPV ................................................................................................................93 11.2 SIPPV ..............................................................................................................94 11.3 SIMV ................................................................................................................95 11.4 SIMV + PSV.......................................................................................................96 11.5 PSV..................................................................................................................97 11.6 CPAP ...............................................................................................................97 11.7 NCPAP / DUOPAP.............................................................................................98 11.8 O2 Therapy mode............................................................................................99
11.8.1 (high and low flow oxygen therapy) HFNC...................................................................... 99 11.9 HFO .................................................................................................................99
11.9.1 HFO lung recruitment ..................................................................................................... 100 11.9.2 Special HFO mode information ..................................................................................... 100 11.10 Ventilation Additives ..................................................................................... 101 11.10.1 Volume limit .................................................................................................................... 101 11.10.2 Volume Guarantee (VG) .................................................................................................. 101 11.11 Special functions........................................................................................... 102 11.11.1 Manual inspiration (manual Breath) ............................................................................. 102 11.11.2 Nebulizing medications (optional) ................................................................................ 102 11.11.3 O2 Flush / preoxygenation ............................................................................................. 102
12 Accessories and options .............................................................. 103
12.1 Accessories List ............................................................................................. 103 12.2 Spare parts list ............................................................................................. 105 12.3 CO2 monitoring.............................................................................................106
12.3.1 CO2 Sensor module types and selection ...................................................................... 106 12.3.2 Connect the CO2 module to fabian HFO....................................................................... 108 12.3.3 MicroPod® sensor module ............................................................................................. 110 12.3.4 Periodic service ............................................................................................................... 116
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12.3.5 Limited Operating life .....................................................................................................116 12.3.6 Respironics® etCO2 sensors ............................................................................................117 12.4 SpO2 module ................................................................................................ 121 12.4.1 Setting up the Masimo sensor ........................................................................................121 12.4.2 Sensitivity mode ..............................................................................................................122 12.4.3 Fast SAT mode .................................................................................................................122 12.4.4 Alarm delay ......................................................................................................................123 12.4.5 SpO2 averaging time .......................................................................................................123 12.5 PRICO ........................................................................................................... 124 12.5.1 General information on PRICO .......................................................................................124 12.5.2 Setting up PRICO .............................................................................................................126 12.5.3 PRICO Ventilation modes................................................................................................129 12.5.4 PRICO disabling alarms...................................................................................................130 12.5.5 PRICO re-enabling cases.................................................................................................130 12.5.6 PRICO errors.....................................................................................................................130 12.6 FOT ............................................................................................................... 132 12.6.1 Forced Oscillation Technique (FOT) at fabian HFO ......................................................132 12.6.2 FOT general layout ..........................................................................................................133 12.6.3 Erasing the FOT graph.....................................................................................................134 12.6.4 FOT disabling conditions................................................................................................134 12.6.5 FOT procedure .................................................................................................................135 12.6.6 FOT post data analysis:...................................................................................................138 12.6.7 FOT specifications ...........................................................................................................139
13 Ventilator service and maintenance intervals............................... 140
14 Sterilization / cleaning / disinfection ........................................... 141
14.1 Fabian HFO ................................................................................................... 141 14.1.1 Preparation for disinfection ...........................................................................................141 14.1.2 Manual disinfection options ...........................................................................................141
14.2 Accessories ................................................................................................... 142 14.2.1 Flow sensor cable............................................................................................................142 14.2.2 Flow sensor ......................................................................................................................143 14.2.3 Exhalation membrane and membrane holder..............................................................146
15 Setting ranges and parameters ................................................... 149
16 Guide to Volume Guarantee (VG) ................................................. 153
16.1 fabian (VG) operation (Conventional ventilation) ......................................... 153 16.2 How to start the VG function ......................................................................... 154 16.3 Setting up the ventilator PSV+VG .................................................................. 157 16.4 fabian VG operation (HFO ventilation) .......................................................... 158
17 Special procedures ..................................................................... 160
17.1 Use of closed suction systems ...................................................................... 160
18 Technical specifications.............................................................. 161
18.1 Ambient conditions ...................................................................................... 161
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18.2 Monitoring .................................................................................................... 161 18.3 Measuring ..................................................................................................... 162 18.4 Resistance values .......................................................................................... 163 18.5 Ventilation menu settings ............................................................................. 163 18.6 Dimensions / weight......................................................................................163 18.7 Ratings .......................................................................................................... 164 18.8 Data storage..................................................................................................165 18.9 Applied parts.................................................................................................165 18.10 Internal device checks...................................................................................165 18.11 Gas blender function ..................................................................................... 165 18.12 Essential Performance .................................................................................. 167
19 Electromagnetic compatibility statement .................................... 169
19.1 Devices with serial numbers from SN AI-01500 and AL-00400........................169 19.2 Devices with serial numbers up to SN AI-01500 and AL-00400 .......................173
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1 Introduction
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1 Introduction
1.1 Working with the instructions
These instructions for use describe equipment components and their operation. These instructions are structured so that you can step your way through the procedures and become familiar with the operation of the ventilator.
WARNING Carefully read the instructions for use before using the ventilator.
After you are familiar with the basic construction and operation of the ventilator you can use this manual as a reference.
1.2 Notices and warnings
This document features three categories of notices and warnings.
WARNING: Warnings identify conditions or practices that could result in serious adverse reactions or potential safety hazards.
! CAUTION:
Cautions identify conditions or practices that could result in damage to the ventilator or other equipment.
NOTE: Notes provide additional information to clarify an explanation or instruction.
1.3 Applicable product versions
This Instructions for Use is applicable for fabian HFO devices running software version 5.1. x, where (x) can be any number.
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1 Introduction
1.4 Symbols
The symbols defined in this section may appear in this document and on the equipment label or labels.
Symbol Description
Article No.
Batch code
!
CAUTION, refer to operator’s manual for important safety information and precautions.
Dangerous voltage warning.
Data input / output RS232. Data input / output RS232. Disposal information.
DO NOT cover.
DO NOT stack no more than 2 on top
2
DO NOT use hooks.
DO NOT use if package is damaged
DO NOT use when patient is connected to the device
Expiration date
Explosion Hazard warning
External power supply Input Flammability Fire hazard warning.
!
Sensor
Flow sensor connection. Flow sensor connection.
Fragile, Handle with care.
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1 Introduction
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Symbol
Description GHS Chemical Hazard warning.
High Frequency interference warning. Humidity Limitation
Keep away from heat. Keep dry.
Manufactured without the use of natural latex or derivatives. Manufacturer Marking per Medical Devices Directive 93/42/EEC. Medical device Nebulizer (Obsolete) Network Ethernet connection Non-Sterile
NOTE symbol Nurse Call signal output. Nurse Call signal output. Potential equalization connection.
Protective Earth ground. Single use. Storage Temperature
This way UP. Type BF application applied part. Type B application part
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4 Symbol
Description Unplug power before opening housing.
Video Output USB connection. Warning regarding operation in explosive areas.
1 Introduction
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2 Warnings cautions and notices
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2 Warnings cautions and notices
2.1 Always observe (fabian)
# Symbol Description
NOTE: The use of the ventilator requires detailed knowledge and the understanding of this operator’s manual. This device is only intended for the described use.
WARNING: Only use this ventilator in combination with an external monitoring device (for example: SpO2). WARNING: Only operate the ventilator with accessories recommended by ACUTRONIC Medical Systems AG.
WARNING: The ventilator must be operated by qualified technical staff to ensure immediate remedial action in the event of malfunction.
WARNING: The fabian system and associated auxiliary systems must NEVER be used in MRI scanning events.
WARNING: An alternate ventilation method (for example. resuscitation) must always be available when using the ventilator.
WARNING: DO NOT use the ventilator in combination with flammable gases or narcotic agents to prevent the risk of fire or explosion.
WARNING: NEVER use the ventilator in explosive environments.
WARNING: An audible signal indicates a system or patient alarm and always requires action by a trained medical professional.
WARNING: If an alarm condition (other than the exceptions listed within this manual) occurs while the audible alarm Silence function is engaged, only the visual alarm indications are displayed.
WARNING: DO NOT silence an audible alarm, engage the audible Alarm Silence function, or decrease the audible alarm volume if patient safety could be compromised.
WARNING: DO NOT obstruct the speaker. Blocking the speaker can result in an inaudible alarm tone.
WARNING: Carefully route patient cabling to reduce the risk of patient entanglement or strangulation.
WARNING: NEVER connect the ventilator to patients if an error or malfunction is detected during equipment check.
WARNING: NEVER connect to electrical devices not mentioned in this operator’s manual without first consulting the manufacturer.
WARNING: Connect only electrical devices which are IEC60601-1 approved.
WARNING: NEVER operate the ventilator while covered or set up in a way to negatively impact the operation or function.
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2 Warnings cautions and notices
# Symbol Description
WARNING: Always unplug the ventilator from the power source before opening the housing.
WARNING: NEVER use anti-static or electrically conductive tubing.
NOTE: To support patient and operator safety, the fabian HFO does not contain VOCs, CO, CO2, O3, and particulates emitted above hazardous thresholds. Acute, subacute/subchronic, and chronic toxicity from the exposure to these compounds from the intended use of this device are not expected.
WARNING: The device can only be isolated from the main power supply by removing the power cord completely. • Ensure the power socket is always accessible for disconnection. • DO NOT disconnect the power cable unless for Service purposes or
transport.
WARNING: DO NOT modify the equipment.
WARNING: Before applying non-original accessories, ensure that they are biocompatible. All accessories supplied by ACUTRONIC Medical Systems for use on fabian ventilators are biocompatible.
WARNING: When connected to a patient DO NOT simultaneously touch the external power supply cord and the flow sensor connector cable.
WARNING: if the strength of the auditory alarms is less than the ambient sound this might impede an operator to recognize alarm conditions.
WARNING: NEVER cover the ventilator when in use.
WARNING: DO NOT position the ventilator in such a way that adversely affects its performance or makes it difficult to disconnect the ventilator from the mains supply. In case of emergency, removal of the mains plug from the wall outlet disconnects the ventilator from mains power.
WARNING: in case of ventilator failure, the lack of immediate access to appropriate alternative means of ventilation can result in patient death.
WARNING: Ensure that alarms are appropriately set before use of ventilator on a patient.
WARNING: In case portions of the gas pathways through the VENTILATOR become contaminated with body fluids or expired gases during NORMAL CONDITION or SINGLE FAULT CONDITION, immediately contact ACUTRONIC Medical Systems
WARNING: • When selecting the neonatal patient size, a Neonatal Flow sensor must
be used. • When selecting the pediatric patient size, a Pediatric Flow sensor must
be used.
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2 Warnings cautions and notices
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# Symbol Description
NOTE: In general, it should be noted that ventilation of children should only be carried out by clinically trained specialists who have sufficient knowledge of ventilation of patients of specified age.
WARNING: DO NOT use the etCO2 module in the presence of flammable anesthetics or other flammable substances in combination with air, oxygen-enriched environments, or nitrous oxide.
WARNING: Check alarm limit settings each time the etCO2 module is used.
WARNING: The etCO2 module is intended only as an adjunct in patient assessment. It must be used in conjunction with assessment of clinical signs and symptoms.
Before use, carefully read the following literature: • Oximetry Sensor Directions for Use • PC-Series Patient Cable Directions for Use
EXPLOSION HAZARD: DO NOT use the oximeter in the presence of flammable anesthetics or other flammable substances in combination with air, oxygen-enriched environments, or nitrous oxide.
Check alarm limit settings each time the oximeter is used.
A pulse oximeter should NOT be used as an Apnea monitor.
A pulse oximeter should be considered an early warning device. As a trend towards patient deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter to completely understand the patient's condition.
Always remove the sensor from the patient and completely disconnect the patient from the oximeter before bathing the patient.
DO NOT use malfunctioning equipment. Have the unit repaired by Masimo or a qualified service person.
ELECTRIC SHOCK HAZARD: Do not remove the pulse oximeter cover. There are no user-serviceable items inside the oximeter. • An operator may only perform maintenance procedures specifically
described in this manual. • ONLY connect IEC 60601-1 or IEC 60950-1 compliant devices to
Ethernet, Nurse call, and RS232 ports.
If the accuracy of any measurement by the oximeter does NOT seem reasonable, first check the patient's vital signs by alternate means, and then check the oximeter for proper functioning.
WARNING: DO NOT use the ventilator in association with HF (High Frequency) electrosurgical equipment.
WARNING: Connect SpO2 and etCO2 sensor cables to the machine before the patient is connected.
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2 Warnings cautions and notices
2.2 Maintenance
The fabian HFO device is a ventilator classified as Class IIb (for prolonged use more than 24 hours and less than 30 days) according to the European Medical Devices Directive, as such: • Inspection according to manufacturer specifications is required every 12 months. • Maintenance must be performed by ACUTRONIC Medical Systems trained personnel with
access to appropriate test and measuring equipment.
ACUTRONIC Medical Systems AG representatives are strongly recommend for service agreements and repairs. Only use original ACUTRONIC Medical Systems parts for repairs. Note chapter “13: Ventilator service and maintenance intervals”.
2.3 Liability for functionality / damages
In the event of improper equipment maintenance or repairs by any persons not associated with ACUTRONIC Medical Systems AG, Service or improper use, all liability for the functionality is transferred to the owner or operator.
ACUTRONIC Medical Systems AG, assumes no liability for damages caused by the nonobservance 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.
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2.4 Intended use
The fabian HFO is intended for premature infants, new-borns as well as children weighing up to 30 kg. The fabian HFO is intended for “in-patient use” in hospitals, medically used rooms and intrahospital patient transport.
The fabian HFO is an electronically microprocessor-controlled ventilator.
The fabian HFO 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: • Continuous Positive Airway Pressure (CPAP) • High and Low flow oxygen therapy (HFNC: O2 Therapy) • High Frequency Oscillation (HFO)
(membrane principle) • Intermittent Positive Pressure Ventilation (IPPV) • Pressure Support Ventilation (PSV) • Synchronized Intermittent Mandatory Ventilation (SIMV) • Synchronized Intermittent Mandatory Ventilation combined with PSV (SIMV + PSV) • Synchronized Intermittent Positive Pressure Ventilation (SIPPV) • Ventilation nCPAP / DUOPAP with variable flow generators (NIV)
(Infant Flow™, Infant Flow™ LP, Inspire™, Medijet®)
The equipment is operated by a physician or by a physician’s orders by a professional with technical training in this task, any operator must be trained on this equipment, be familiar with the operator’s manual and have knowledgeable use of the equipment.
fabian HFO is NOT approved for use in a homecare environment.
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3 System overview
3 System overview
3.1 Scope of delivery
The fabian HFO product includes the following items: • One fabian HFO Ventilator • One Accessory kit
One Flow Sensor (reusable) One Flow Sensor Cable One Test Lung Two Infant Flow Ventilator Tubes • One Power Cable (# country specific) • One Operating Manual (# country specific) • NOTE: The duration of indirect patient contact is defined as prolonged (i.e. more than 24 hours and less than 30 days)
3.2 Contraindications
Severe airflow obstruction and intracranial-hypertension would contraindicate the use of the fabian HFO neonatal and infant ventilator.
In the event of ventilation for several hours or more, care must be taken for optimal conditioning of the respiratory gases (warmth, humidification) to optimize secretion mobilization and prevent damage to mucous membranes.
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3.3 fabian Front connections
3.3.1 Devices with serial number prefix AI / AL
2
3
4
1
External Bias Flow (FG - Fresh Gas) port and port for nCPAP system based on flow generators (single limb systems) Expiratory limb port Proximal Pressure port Inspiratory limb port/ HFO port
3.3.2 Devices with serial number prefix 20 /AK/AH
3 4
2
1
Inspiratory Limb port/ center port for connecting nCPAP system based on flow generators (single limb systems) Expiratory limb port Proximal Pressure port HFO Port
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3 System overview
3.4 Rear panel
3.4.1 Hardware with HDMI output (SN AI-01500 and AL00400 or higher)
1 2 3
4
5
6 7
9
8
10
11 12
13
14
# Description Video Out HDMI connection USB connection for connection of a USB powered nebulizer. Also available when not in clinical use for data output and software update. Network jack for data management (DISABLED) RS232 interface, service, PDMS Flow Sensor Connector Nurse Call Connector, max switching voltage 30V DC Loudspeaker (Audio) Fan Connector for etCO2 module (optional) Connector for SpO2 module Connection for Oxygen “O2” supply 2.0 to 6.0 bar / max. 40 L / min Connection for pressurized Air supply 2.0 to 6.0 bar / max. 40 L / min Main Power Connector with fuse holder
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# Description Terminal stud for potential equalization
3.4.2 Hardware with Video input
# Description Connector for 24V DC external power supply (No charging) Network jack for data management, PDMS (For connection to network with minimum 3 KV galvanic isolation) (DISABLED) USB port for data output, Software update and connection for Masimo SpO2 module. DB9 RS-232 port for PDMS Flow Sensor 7-pin Connector Nurse Call 3-pin Connector Video In, VGA (NOT USED) Loudspeaker (Audio) Fan CO2 sensor (Optional) Nebulizer (Not used) O2 supply connector 2.0 to 6.5 bar/ 40 L/min Pressurised air connector 2.0 to 6.5 bar /40 L/min Power Connector (fuse 1.25 AT) Equipotential connection
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3.4.3 Initial hardware model
3 System overview
# Description Connector for 24VDC external power supply (does not charge internal battery) Network jack for data management, PDMS (for connection to network within minimum 3KV galvanic isolation) (DISABLED) USB port for data output and Software update, Connection for Masimo SpO2 module DB9 RS-232 port for Service, CO2 option or PDMS Flow Sensor 7-pin Connector Nurse Call 3-pin Connector Loudspeaker (Audio) Fan Optional Ports Power Connector (Fuse 1 AT) Equipotential connection O2 Supply Connector 2.0 to 6.5 bar /max. 40 L/min Pressurized Air Connector 2.0 to 6.5 bar /max. 40 L/min
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3.4.4 General hardware characteristics
WARNING: • DO NOT connect Ethernet, Nurse call, USB, RS-232 (CO2), Flow Sensor port to
anything other than specified devices.
• DO NOT connect anything to Ethernet, Nurse call, and RS232, while operating on battery power.
• ONLY connect IEC 60601-1 or IEC 60950-1 compliant devices to Ethernet, Nurse call, and RS232 ports.
The Potential Equalization Pin is for additional safety and can be connected to an equipotential zone. Adhere to local guidelines when using this PIN. The guidelines may vary between countries, localities and power companies. Always keep the PIN for Potential equalization accessible.
Maximum Connected Loads:
Nurse call :
Isolated relay output. Max contact load: 30 VDC @ 1A
USB :
5V @ 150 mA max.
RS-232 :
Signal Levels: EIA/TIA-232 Standard Pin 9 Power: 5V @ 500 mA max (models without DC input) Isolated
Ethernet :
N/A (Disabled)
Flow Sensor :
Maximum load is one Flow sensor. (Only ACUTRONIC Medical Systems Flow sensors can connect) Max. Voltage: 5 V Max operating current: 300 mA per hotwire -> 600 mA total.
SpO2 :
Max. Voltage: 3.3 V Max. operating current: 200 mA
etCO2 :
Max Voltage: 5 V max operating Current: 700 mA
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4 System functions and displays
4 System functions and displays
4.1 Control panel options
The Control Panel features two key elements: The Display (Touch screen)
The Touch screen (1) allows the direct
control of the ventilator parameters by
pressing defined buttons on the
Graphic User Interface (GUI).
1
Access to Quick Launch settings is on the left side of the touch screen.
The Key / Control Panel (2) with Rotary Pulse encoder (combines a key and a rotary encoder).
2
Figure 4-1: Display
4.1.1 Function buttons
The keypad features two rows of buttons with various functions. Home Displays the Main Screen for selecting the Respiration mode.
Graphics Switches to Curve / loop display.
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. Alarm limits Switches to the Alarm Limits Configuration.
Alarm Silence For acknowledging and audibly silencing alarms for a maximum duration of 120 seconds. Subsequent alarms with higher priority are visually displayed during periods of alarm silence.
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The keypad features two rows of buttons with various functions.
menu / Calibration Used to access the Configuration and Calibration menus.
Press once to open the Configuration menu; Press again to open the Calibration menu.
Nebulizer Obsolete function.
O2 Flush Used to start O2 Flush. Flush concentration and time can be preset.
Start / Stop Used to temporarily stop or commence respiration. During mechanical ventilation this provides a two-minute pause in ventilation. In nCPAP, DUOPAP and O2 Therapy modes this acts as a Standby mode (therapy is disabled until re-enabled by the operator).
ON / OFF Used to switch the device ON or OFF.
4.1.2 Rotary pulse encoder
The Rotary Pulse encoder combines a push button with a rotary encoder for executing various settings, selections and confirmation options.
fabian HFO | SW V5.1.x REF 113003.EN / Date : 09Feb2021
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4 System functions and displays
4.2 Display concept structure
4.2.1 Display areas
The information system features two key display areas
The Touch screen LED indicators
1
2
2
Figure 4-2: Functional & Information areas
4.2.2 Display screen
The display screen shows various information, setting and display areas depending on the display settings or menu.
Information bar indicating:
1
• Battery status,
• Time / Date,
2
• Status information,
• System and Alarm
information.
Graphic area (single graph or
multigraph with loops or curves).
3
Parameter settings and controls
area. Operating mode selection
5 4
Numeric area / alarm limits.
Figure 4-3: Display screen
Depending on the display mode selected, individual areas can be shown / hidden.
Display area options are described in section “4.3: Ventilation menu”.
fabian HFO | SW V5.1.x REF 113003.EN / Date : 09Feb2021