fabian HFO Instructions for Use Sw Ver 5.1.x Feb 2021

Disclaimer

i

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: [email protected] 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

ii

Table of Contents

Table of Contents Disclaimer ... i Table of Contents... ii 1

Introduction ... 1 1.1 1.2 1.3 1.4

2

Warnings cautions and notices ... 5 2.1 2.2 2.3 2.4

3

Always observe (fabian) ... 5 Maintenance ... 8 Liability for functionality / damages ... 8 Intended use ... 9

System overview... 10 3.1 3.2 3.3 3.3.1 3.3.2

3.4 3.4.1 3.4.2 3.4.3 3.4.4

4

Working with the instructions ... 1 Notices and warnings ... 1 Applicable product versions ... 1 Symbols ... 2

Scope of delivery ... 10 Contraindications ... 10 fabian Front connections ... 11 Devices with serial number prefix AI / AL ... 11 Devices with serial number prefix 20 /AK/AH ... 11

Rear panel ... 12 Hardware with HDMI output (SN AI-01500 and AL-00400 or higher) ... 12 Hardware with Video input ... 13 Initial hardware model ... 14 General hardware characteristics ... 15

System functions and displays... 16 4.1 4.1.1 4.1.2

4.2 4.2.1 4.2.2 4.2.3 4.2.4 4.2.5 4.2.6

4.3 4.3.1 4.3.2 4.3.3

Control panel options ... 16 Function buttons ... 16 Rotary pulse encoder ... 17

Display concept structure ... 18 Display areas ... 18 Display screen ... 18 Information bar ... 19 Numeric field / alarm limits ... 20 Graphics display ... 22 LED indicators ... 22

Ventilation menu ... 23 Operation – general ... 23 Operation – settings ... 24 Ventilation parameter dependency ... 25 fabian HFO | SW V5.1.x REF 113003.EN / Date : 09Feb2021

Table of Contents 4.3.4

4.4 4.4.1 4.4.2 4.4.3

5

5.1.1 5.1.2 5.1.3 5.1.4 5.1.5

5.2 5.2.1 5.2.2 5.2.3 5.2.4

5.3 5.3.1

5.4 5.5 5.5.1

5.6 5.6.1

5.7

Graphics menu ... 27 Curves ... 28 Loops ... 30 Trend menu ... 31

Preparing for operation ... 35 Connect the power supply ... 35 Connect the gas supply ... 36 Connect the tubing set... 37 Connect Nitric Oxide (NO) tubing sets ... 38 Bias flow selection for NO system usage in HFO mode ... 41

Patient circuit assembly ... 42 Recommended positioning of temperature probe for humidifier ... 43 Use of reusable patient circuit ... 44 Connect nCPAP tubing set ... 47 Connect flow sensor in NIV trigger (optional) ... 48

System start-up ... 48 Switching ON the ventilator ... 48

Device check ... 50 System standby / pause ... 52 Standby – stopping / pausing mechanical ventilation ... 52

System shutdown ... 53 Switching OFF the fabian ... 53

Emergency shutdown ... 54

Configurations menu ... 55 6.1

Calibration ... 56

6.1.1 6.1.2

Flow sensor calibration ... 57 O2 Sensor calibration... 60

6.1.3

etCO2 module ... 60

6.1.4

SpO2 module ... 61

6.2 6.3 6.3.1 6.3.2

6.4 6.5 6.6 6.7 6.8 6.9 6.10

7

Locking ventilator parameters ... 25

System operation ... 35 5.1

6

iii

Body weight ... 61 Display ... 61 Touch screen settings ... 62 Trend / graph display ... 63

Ventilation parameter settings ... 64 Patient data ... 66 Language ... 67 Date / Time ... 67 Tools ... 68 Information ... 68 Service mode ... 69

Alarms ... 70

fabian HFO | SW V5.1.x REF 113003.EN / Date : 09Feb2021

iv

Table of Contents

7.1

Alarm limits menu ... 70

7.1.1 7.1.2

7.2 7.3

Automatic alarm limits ... 72 Configurable alarms ... 73

Alarm log ... 74 Alarm causes and solutions ... 74

7.3.1 7.3.2 7.3.3 7.3.4

8

Battery operation ... 85 8.1

9

Alarms table... 75 Pressure release behavior ... 82 Application error ... 82 Watchdog alarms ... 83

Power failure ... 86

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 11.2 11.3 11.4 11.5 11.6 11.7 11.8

IPPV ... 93 SIPPV ... 94 SIMV ... 95 SIMV + PSV... 96 PSV ... 97 CPAP ... 97 NCPAP / DUOPAP ... 98 O2 Therapy mode ... 99

11.8.1

11.9

(high and low flow oxygen therapy) HFNC ... 99

HFO ... 99

11.9.1 11.9.2

HFO lung recruitment ... 100 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 12.2 12.3

Accessories List ... 103 Spare parts list ... 105 CO2 monitoring ... 106

12.3.1

CO2 Sensor module types and selection ... 106

12.3.2

Connect the CO 2 module to fabian HFO ... 108

12.3.3 12.3.4

MicroPod ® sensor module ... 110 Periodic service ... 116 fabian HFO | SW V5.1.x REF 113003.EN / Date : 09Feb2021

Table of Contents 12.3.5 12.3.6

12.4

Setting up the Masimo sensor ... 121 Sensitivity mode ... 122 Fast SAT mode ... 122 Alarm delay ... 123 SpO2 averaging time ... 123

PRICO ... 124

12.5.1 12.5.2 12.5.3 12.5.4 12.5.5 12.5.6

12.6

Limited Operating life ... 116 Respironics ® etCO2 sensors ... 117

SpO2 module ... 121

12.4.1 12.4.2 12.4.3 12.4.4 12.4.5

12.5

v

General information on PRICO ... 124 Setting up PRICO ... 126 PRICO Ventilation modes ... 129 PRICO disabling alarms ... 130 PRICO re-enabling cases ... 130 PRICO errors ... 130

FOT ... 132

12.6.1 12.6.2 12.6.3 12.6.4 12.6.5 12.6.6 12.6.7

Forced Oscillation Technique (FOT) at fabian HFO ... 132 FOT general layout ... 133 Erasing the FOT graph ... 134 FOT disabling conditions ... 134 FOT procedure ... 135 FOT post data analysis: ... 138 FOT specifications ... 139

13 Ventilator service and maintenance intervals... 140 14 Sterilization / cleaning / disinfection ... 141 14.1

Fabian HFO ... 141

14.1.1 14.1.2

14.2

Preparation for disinfection ... 141 Manual disinfection options ... 141

Accessories ... 142

14.2.1 14.2.2 14.2.3

Flow sensor cable ... 142 Flow sensor ... 143 Exhalation membrane and membrane holder ... 146

15 Setting ranges and parameters ... 149 16 Guide to Volume Guarantee (VG) ... 153 16.1 16.2 16.3 16.4

fabian (VG) operation (Conventional ventilation) ... 153 How to start the VG function ... 154 Setting up the ventilator PSV+VG ... 157 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

fabian HFO | SW V5.1.x REF 113003.EN / Date : 09Feb2021

vi

Table of Contents

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 19.2

Devices with serial numbers from SN AI-01500 and AL-00400 ... 169 Devices with serial numbers up to SN AI-01500 and AL-00400 ... 173

fabian HFO | SW V5.1.x REF 113003.EN / Date : 09Feb2021

1 Introduction

1

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.

fabian HFO | SW V5.1.x REF 113003.EN / Date : 09Feb2021

2

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.

2

DO NOT stack no more than 2 on top 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.

!

Flow sensor connection.

Sensor Flow sensor connection. Fragile, Handle with care.

fabian HFO | SW V5.1.x REF 113003.EN / Date : 09Feb2021

1 Introduction

Symbol

3

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

fabian HFO | SW V5.1.x REF 113003.EN / Date : 09Feb2021

4

1 Introduction

Symbol

Description Unplug power before opening housing. Video Output USB connection. Warning regarding operation in explosive areas.

fabian HFO | SW V5.1.x REF 113003.EN / Date : 09Feb2021

2 Warnings cautions and notices

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: SpO 2). 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.

fabian HFO | SW V5.1.x REF 113003.EN / Date : 09Feb2021

5

6

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, CO 2, O 3, 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.

fabian HFO | SW V5.1.x REF 113003.EN / Date : 09Feb2021

2 Warnings cautions and notices

#

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 etCO 2 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 etCO 2 module is used. WARNING: The etCO 2 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 SpO 2 and etCO 2 sensor cables to the machine before the patient is connected.

fabian HFO | SW V5.1.x REF 113003.EN / Date : 09Feb2021

7

8

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.

fabian HFO | SW V5.1.x REF 113003.EN / Date : 09Feb2021

2 Warnings cautions and notices

2.4

9

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: O 2 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.

fabian HFO | SW V5.1.x REF 113003.EN / Date : 09Feb2021

10

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.

fabian HFO | SW V5.1.x REF 113003.EN / Date : 09Feb2021

3 System overview

3.3

11

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

fabian HFO | SW V5.1.x REF 113003.EN / Date : 09Feb2021

12

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

9

6 8

7

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 etCO 2 module (optional) Connector for SpO 2 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 fabian HFO | SW V5.1.x REF 113003.EN / Date : 09Feb2021

3 System overview

#

13

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 SpO 2 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 CO 2 sensor (Optional) Nebulizer (Not used) O 2 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

fabian HFO | SW V5.1.x REF 113003.EN / Date : 09Feb2021