fabian HFO Instructions for Use ver 3.0.1 sw 3.3 Edition April 2014

DISCLAIMER The information contained in this document is subject to change without notice. Acutronic Medical Systems makes no warranty or representation of any kind with regard to this material. Acutronic Medical Systems specifically disclaims all warranties, including but not limited to the implied warranties of merchantability and fitness for a particular purpose. Acutronic Medical Systems shall not be liable for errors, omissions or misstatements contained in this document. In no event shall Acutronic Medical Systems be liable for any damages, including, but not limited to loss of data, lost profits or any other incidental, special or consequential damages in connection with the furnishing, performance, or use of this material. 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 reserves the right to change the protocol described in this document without prior notice. 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 ... 7 1.1 Document Structure ...7 1.2 Notices and Warnings ...7 1.3 Hardware Version Identification ...8 1.4 Symbols...8 2 General Notices ... 11 2.1 Always Observe ... 11 2.2 Maintenance... 13 2.3 Liability for Functionality / Damages ... 13 2.4 Intended use ... 13 2.5 Scope of Delivery ... 14 2.6 Contra-indications ... 15 3 System overview ... 16 3.1 Front Connections ... 16 3.2 Rear Panel ( HW rev. ≤ 1.7 ) ... 17 3.3 Rear Panel ( HW rev. ≥ 1.8 ) ... 19 4 Operation and Display ... 21 4.1 Control options... 21 4.1.1 Buttons ... 22 4.1.1 Rotary pulse encoder ... 22 4.2 Display concept structure ... 23 4.2.1 Display areas ... 23 4.2.2 Display screen ... 23 4.2.3 Info bar... 23 4.2.4 Numeric field / Alarm limits... 25 4.2.5 Graphic field ... 26 4.2.6 LED Indicators ... 27 4.3 Ventilation Menu ... 28 4.3.1 Operation – General... 28 4.3.2 Operation – Settings - ... 29 4.3.3 Ventilation parameter dependency ... 30 4.3.4 Locking ventilator parameters ... 31 4.4 Graphics Menu ... 32 4.4.1 Curves ... 33 4.4.2 Loops ... 34 4.4.3 Trend Menu... 36

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5 Preparing for Operation ... 39 5.1 Establish Power Supply ... 39 5.2 Establish Gas Supply ... 39 5.3 Connect tube set ... 40 5.3.1 HFO Tube Set ... 41 5.3.2 Patient circuit assembly... 42 5.3.3 Recommended positioning of temperature probe of humidifier ... 43 5.3.4 Use of reusable patient circuit ... 45 5.4 Connect nCPAP Tubing... 46 5.5 Switching On the device ... 47 5.6 Switching Off the device ... 48 6 Device Check fabian HFO ... 49 7 Configurations Menu ... 51 7.1 Calibration ... 52 7.1.1 O2 Sensor Calibration ... Fehler! Textmarke nicht definiert. 7.1.2 Flow Sensor Calibration ... 53 7.2 Display ... 56 7.2.1 Touch Screen Settings ... 57 7.2.2 Trend / Graph Display... 58 7.3 Ventilation parameter settings... 59 7.3.1 Standard Hospital Settings ... 61 7.4 Patient Data... 62 7.5 Language ... 63 7.6 Date / Time ... 63 7.7 Tools ... 64 7.8 Info ... 64 7.9 Service Mode ... 65 7.10 CO2 and SpO2 Modes ... Fehler! Textmarke nicht definiert. 8 Alarm Limits Menu... 66 8.1 Automatic Alarm Limits ... 68 8.1.1 Alarm Conditions ... 68 8.1.2 Automatic Alarm Presets ... 68 8.2 Alarm Log ... 69 9 Battery Operation ... 70 9.1 Power Failure ... 71 9.2 Operating on External Power Source... 72 10 Function Fields – Ventilation Parameters ... 73 10.1 Special Parameters in HFO Mode ... 78

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11 Ventilation Modes ... 79 11.1 IPPV ... 80 11.2 SIPPV... 81 11.3 SIMV ... 82 11.4 SIMV + PSV ... 83 11.5 PSV ... 84 11.6 CPAP ... 85 11.7 nCPAP / duoPAP ... 86 11.8 HFO ... 87 11.8.1 HFO Lung Recruitment... 87 11.8.2 Special HFO Mode Information ... 87 11.9 O2 Therapy mode (High and Low flow oxygen therapy) HFNC... 88 11.10 Ventilation Additives ... 89 11.1 Volume limit ... 89 11.2 Volume guarantee ... 90 11.11 Special Functions ... 91 11.11.1 Manual inspiration ( man. Breath)... 91 11.11.2 Nebulising medications (option) ... 91 11.11.3 O2 Flush / Preoxygenation ... 92 11.11.4 Standby – stopping / pausing mechanical ventilation ... 92 12 Error – Cause – Solution – Alarms ... 93 12.1 Technical Alarm... 93 12.2 Physiological Alarm ... 95 12.3 Other Alarm ... 96 13 Replacing the Oxygen Sensor ... 97 14 Service and Maintenance Intervals ... 98 15 Sterilisation/Cleaning/Disinfection... 99 16 Setting Ranges and Parameters ... 101 17 Standard Accessories ... 106 18 Guide to Volume Guarantee ... 108 18.1 How Does Volume Guarantee (VG) on fabian Work? ... 108 18.2 Settings to start with ... 109 18.3 How to start VG function ... 110 18.4 Setting up the ventilator PSV+VG ... 114 18.5 Settings to start with ... 114 19 Special Procedures ... 116 19.1 Use of closed suction systems ... 116 19.2 Use of NO (Nitric Oxide) ... 117

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20 Technical Specifications ... 118 20.1 Ambient Conditions... 118 20.2 Monitoring ... 118 20.3 Measuring ... 119 20.4 Resistance Values ... 120 20.5 Parameter Defaults in Configurations Menu ... 121 20.6 Dimensions / Weight ... 121 20.7 Ratings... 122 20.8 Data storage ... 123 20.9 Applied Parts ... 123 20.10 Device Checks ... 123 20.11 Gas blender function... 124 20.12 Acoustic Energy ... 125 21 Electromagnetic Compatibility Statement ... 126

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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

1.4 Symbols Symbol

Description External power supply input 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

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Symbol

Description Disposal information

Type B application part

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

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Symbol

Description 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.

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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. 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.

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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”.

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 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 intra-hospital 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: • 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

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• 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 HFO is not approved for use in a homecare environment.

2.5 Scope of Delivery This product includes the following items: • 1 x fabian HFO 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 HFO 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, centre port for connecting the nCPAP system based on flow generators (single limb systems)

2

Expiratory tube port

3

Pressure measuring tube port

4

HFO port

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3.2 Rear Panel ( HW rev. ≤ 1.7 )

1

Connector for 24V DC external power supply (no charging!)

2

Network jack for data management , PDMS (For connection to network with minimum 3 KV galvanic isolation)

3

USB port for data output and Software update. Connection for Masimo SpO2 module.

4

RS232 port for Service, CO2 Option or PDMS

5

Flow sensor connector

6

Nurse call connector ( max. switching Voltage 50 VDC )

7

Loudspeaker

8

Fan

9

Optional ports

10

Power Connector ( fuse 1 AT )

11

Pin for potential equalization

12

O2 supply connector 2.0 – 6.5 bar / 40 l/min

13

Compressed air connector 2.0 – 6.5 bar / 40 l/min

For Adapter to DISS see Accessories.

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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:

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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.

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3.3 Rear Panel ( HW rev. ≥ 1.8 )

1

Connector for 24V DC external power supply (no battery charging!)

2

Network jack for data management , PDMS ( For connection to network with minimum 3 KV galvanic isolation )

3

USB port for data output, Software update. Connection for Masimo SpO2 module.

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.

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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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