fabian HFO Instructions for Use and Auxiliary Systems sw 5.1.x April 2019

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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 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. 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 5.1.x Ref: 113003.EN / Date 2019-04-24

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Contents 1

Introduction ... 7 1.1 Working with the instructions ... 7 1.2 Notices and warnings... 7 1.3 Applicable product versions ... 7 1.4 Symbols ... 8

2

Warnings cautions and notices ... 10 2.1 Always observe... 10 2.2 Maintenance ... 12 2.3 Liability for functionality ∕ damages ... 12 2.4 Intended use ... 13

3

System overview ... 14 3.1 Scope of delivery ... 14 3.2 Contraindications ... 14 3.3 fabian front connections ... 15 3.3.1 3.3.2

3.4

4

Devices with serial number prefix 20 / AK / AH ...15

Rear panel ... 16

3.4.1

Hardware with video in ...16

3.4.2

Initial hardware model...17

3.4.1

General hardware characteristics ...18

System functions and displays... 19 4.1 Control panel options ... 19 4.1.1

Function buttons ...19

4.1.2

Rotary pulse encoder ...20

4.2

Display concept structure ... 21

4.2.1

Display areas ...21

4.2.2

Display screen ...21

4.2.3

Information bar ...22

4.2.4

Numeric field / alarm limits...23

4.2.5

Graphics display ...25

4.2.6

LED indicators ...25

4.3

Ventilation menu ... 26

4.3.1

Operation – general ...26

4.3.2

Operation – settings ...27

4.3.3

Ventilation parameter dependency ...28

4.3.4

Locking ventilator parameters ...28

4.4

5

Devices with serial number prefix AI / AL ...15

Graphics menu ... 30

4.4.1

Curves...31

4.4.2

Loops ...33

4.4.3

Trend menu ...34

System operation ... 39 5.1 Preparing for operation ... 39 5.1.1

Connect the power supply ...39 fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2019-04-24

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5.1.2

Connect the gas supply ... 39

5.1.3

Connect the tubing set ... 40

5.2

Recommended positioning of temperature probe for humidifier ... 43

5.2.2

Use of reusable patient circuit ... 44

5.2.3

Connect nCPAP tubing ... 47

5.2.4

5.3 5.4 5.5 5.6 5.7 6

Connect flow sensor in DUOPAP mode (optional) ... 47

System start-up ... 48 Device check ... 50 System standby ... 51 System shutdown ... 53 Emergency shutdown ... 54

Configurations menu... 55 6.1 Calibration ... 56 6.1.1 6.1.2

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

6.1.1

etCO2 module ... 61

6.1.2

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

Patient circuit assembly ... 42

5.2.1

Body weight setting ... 61 Display ... 62 Touch screen settings ... 63 Trend ∕ graph display ... 64

Ventilation parameter settings ... 65 Patient data ... 67 Language ... 67 Date ∕ Time ... 67 Tools ... 68 Information ... 68 Service mode ... 69

Alarms ... 71 7.1 Alarm limits menu ... 71 7.1.1

Automatic alarm limits ... 73

7.1.2

Configurable alarms ... 73

7.2 7.3

Alarm log ... 75 Alarm causes and solutions ... 75

7.3.1

Alarms table ... 76

7.3.1

Pressure release behaviour ... 82

7.3.2

Application error ... 83

7.3.3

Watchdog alarms ... 84

8

Battery operation ... 85 8.1 Operating on External Power Source... 87

9

Ventilation parameters ... 89

10 Ventilation modes ... 95 10.1 IPPV ... 96 fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2019-04-24

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10.2 10.3 10.4 10.5 10.6 10.7 10.8

SIPPV ... 97 SIMV... 98 SIMV + PSV... 99 PSV ... 100 CPAP... 100 nCPAP ∕ DUOPAP ... 101 O2 Therapy mode (high and low flow oxygen therapy) HFNC... 101

10.9

HFO ... 102

10.9.1

HFO lung recruitment ...102

10.9.2

Special HFO mode information ...102

10.10 Ventilation Additives ... 104 10.10.1 Volume limit ...104 10.10.2 Volume guarantee ...104

10.11 Special functions... 105 10.11.1 Manual inspiration (manual Breath) ...105 10.11.2 Nebulizing medications (optional) ...105 10.11.3 O2 Flush ∕ preoxygenation ...105

11 Accessories and options... 107 11.1 Accessories List ... 107 11.2 CO2 monitoring... 109 11.2.1

CO2 Sensor module types and selection ...109

11.2.2

Connect the CO2 module to fabian HFO...111

11.2.3 11.2.4

MicroPod® sensor module ...113 Respironics® CO2 sensors ...119

11.3

SpO2 module ... 123

11.3.1

Setting up the Masimo sensor ...123

11.3.2

Sensitivity mode ...124

11.3.3

Fast SAT mode ...124

11.3.4 11.3.5

Alarm delay ...125 SpO2 averaging time ...125

11.4

PRICO ... 126

11.4.1

General information on PRICO ...126

11.4.2

Setting up PRICO ...127

11.4.3

PRICO Ventilation modes ...130

11.4.4

PRICO disabling alarms ...131

11.4.5

PRICO re-enabling cases ...131

11.4.6

PRICO errors ...131

11.5

FOT ... 133

11.5.1

Forced Oscillation Technique (FOT) at fabian HFO ...133

11.5.2

FOT general layout ...134

11.5.3

Erasing the FOT graph ...135

11.5.4

FOT disabling conditions ...135

11.5.5

FOT procedure ...136

11.5.6

FOT specifications ...140

12 Ventilator service and maintenance intervals ... 141 fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2019-04-24

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13 Sterilization ∕ cleaning ∕ disinfection ... 142 14 Setting ranges and parameters ... 144 15 Guide to volume guarantee ... 148 15.1 Initial settings... 149 15.2 How to start the VG function ... 149 15.3 Setting up the ventilator PSV+VG ... 153 16 Special procedures... 155 16.1 Use of closed suction systems... 155 17 Technical specifications ... 156 17.1 Ambient conditions ... 156 17.2 Monitoring... 156 17.3 Measuring... 157 17.4 Resistance values ... 158 17.5 Ventilation menu settings... 158 17.6 Dimensions ∕ weight ... 159 17.7 Ratings ... 159 17.8 Data storage ... 160 17.9 Applied parts ... 160 17.10 Internal device checks ... 160 17.11 Gas blender function ... 160 17.12 Acoustic Energy... 162 18 Electromagnetic compatibility statement ... 163

fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2019-04-24

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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.

fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2019-04-24

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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. Chemical burn warning. Dangerous voltage warning. Data input / output RS-232. Data input / output RS-232. Disposal information. DO NOT cover. DO NOT stack no more than 2 on top.

2

DO NOT use hooks.

Potential equalisation connection. Flammability Fire hazard warning.

Flow sensor connection Sensor Flow sensor connection.

External power supply input Fragile, Handle with care. High Frequency interference warning. Keep away from heat. Keep dry.

fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2019-04-24

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Symbol

Description Manufactured withut the use of natural latex or derivatives. Manufacturer Marking per Medical Devices Directive 93/42/EEC Nebulizer (obsolete) Network Ethernet connection (disabled) Non-Sterile NOTE symbol

Nurse Call signal output. Nurse Call signal output. Protective Earth ground. Single use. This way UP.

Type BF application applied part.

Type B application part Unplug power before opening housing. Video Output USB connection. Warning regarding operation in explosive areas.

fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2019-04-24

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2 Warnings cautions and notices 2.1

Always observe #

Symbol

Description

1.

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.

2.

WARNING: Only use this ventilator in combination with an external monitoring device (for example: SpO2).

3.

WARNING: Only operate the ventilator with accessories recommended by ACUTRONIC Medical Systems AG.

4.

WARNING: The ventilator must be operated by qualified technical staff to ensure immediate remedial action in the event of malfunction.

5.

WARNING: The fabian system and associated auxiliary systems must NEVER be used in MRI scanning events.

6.

WARNING: An alternate ventilation method (for example. resuscitation) must always be available when using the ventilator.

7.

WARNING: DO NOT use the ventilator in combination with flammable gases or narcotic agents or in an oxygen-rich environment to prevent the risk of fire or explosion.

8.

WARNING: NEVER use the ventilator in explosive environments.

9.

WARNING: An audible signal indicates a system or patient alarm and always requires action by a trained medical professional.

10.

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.

11.

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.

12.

WARNING: DO NOT obstruct the speaker. Blocking the speaker can result in an inaudible alarm tone.

13.

WARNING: Carefully route patient cabling to reduce the risk of patient entanglement or strangulation.

14.

WARNING: NEVER connect the ventilator to patients if an error or malfunction is detected during equipment check.

15.

WARNING: NEVER connect to electrical devices not mentioned in this operator’s manual without first consulting the manufacturer or an expert.

16.

WARNING: NEVER operate the ventilator while covered or set up in a way to negatively impact the operation or function.

17.

WARNING: Always unplug the ventilator from the power source before opening the housing.

fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2019-04-24

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#

Symbol

Description

18.

WARNING: NEVER use anti-static or electrically conductive tubing.

19.

NOTE: The safety and health of the operators are guaranteed by the fact that the products for example: DO NOT contain any allergenic or mutagenic materials such as phthalates.

20.

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.

21.

WARNING: DO NOT modify the equipment.

22.

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.

23.

WARNING: When connected to a patient DO NOT simultaneously touch the external power supply cord and the flow sensor connector cable.

24.

WARNING: if the strength of the auditory alarms is less than the ambient sound this might impede an operator to recognize alarm conditions.

25.

WARNING: NEVER cover the ventilator.

26.

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 on all poles simultaneously.

27.

WARNING: in case of ventilator failure, the lack of immediate access to appropriate alternative means of ventilation can result in patient death.

28.

WARNING: Ensure that alarms are appropriately set before use of ventilator on a patient.

29.

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.

30.

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.

31.

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.

32.

WARNING: DO NOT use the etCO2 module in the presence of flammable anesthetics or other flammable substances in combination with air, oxygenenriched environments, or nitrous oxide.

33.

WARNING: Check alarm limit settings each time the etCO2 module is used.

fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2019-04-24

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2.2

34.

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.

35.

Before use, carefully read the Oximetry Sensor Directions for Use and PCSeries Patient Cable Directions for Use.

36.

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.

37.

Check alarm limit settings each time the oximeter is used.

38.

An oximeter should NOT be used as an apnea monitor.

39.

An 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.

40.

Always remove the sensor from the patient and completely disconnect the patient from the oximeter before bathing the patient.

41.

Do not use malfunctioning equipment. Have the unit repaired by Masimo or a qualified service person.

42.

ELECTRIC SHOCK HAZARD: Do not remove the oximeter cover. There are no user-serviceable items inside the oximeter. An operator may only perform maintenance procedures specifically described in this manual. Measure the leakage current whenever an external device is connected to the serial or analog output ports. Leakage current must not exceed 100 µA.

43.

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.

Maintenance The device is a ventilator classified as Class IIb according to the European 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.

We strongly recommend ACUTRONIC Medical Systems AG exclusive representatives for service agreements and repairs. Only use original ACUTRONIC Medical Systems parts for repairs. Note chapter ”Service and 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.

fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2019-04-24

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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 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 (HFO/Sigh) - High Frequency Oscillation (membrane principle)

•

IPPV - Intermittent Positive Pressure Ventilation (CMV Controlled Mandatory Ventilation)

•

SIMV - Synchronized Intermittent Mandatory Ventilation

•

SIPPV - Synchronized Intermittent Positive Pressure Ventilation (A/C, Assist Controlled)

•

CPAP (Spn-CPAP/PS) - Continuous Positive Airway Pressure

•

PSV - Pressure Support Ventilation

•

SIMV + PSV - Synchronized Intermittent Mandatory Ventilation combined with PSV

•

Non-Invasive Ventilation (NIV) - nCPAP/duoPAP with variable flow generators (Infant Flow®, Infant Flow LP®, Inspire™, 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.

fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2019-04-24

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3 System overview 3.1

Scope of delivery The fabian HFO product includes the following items:

3.2

•

One fabian HFO Ventilator

•

One Accessory kit: •

One Flow Sensor (reusable)

•

One Flow Sensor Cable

•

One Test Lung

•

Two single limb connecting tube

•

One Power Cable (country specific)

•

One Operating Manual (country specific)

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 5.1.x Ref: 113003.EN / Date 2019-04-24

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3.3

fabian front connections

3.3.1

Devices with serial number prefix AI / AL

2

3

4

1

1.

External Bias Flow (FG - Fresh Gas) port and port for nCPAP system based on flow generators (single limb systems)

2.

Expiratory limb port

3.

Proximal Pressure port

4.

Inspiratory limb port/ HFO port

3.3.2

Devices with serial number prefix 20 / AK / AH 3 4

2

1

1.

Inspiratory limb port/ center port for connecting nCPAP system based on flow generators (single limb systems)

2.

Expiratory limb port

3.

Proximal Pressure port

4.

HFO Port (optional)

fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2019-04-24

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3.4

Rear panel

3.4.1

Hardware with video in

#

Description

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) (disabled)

3.

USB port for data output, Software update and connection for Masimo SpO 2 module.

4.

DB9 RS-232 port for PDMS

5.

Flow Sensor 7-pin Connector

6.

Nurse Call Connector

7.

Video In, VGA (not used)

8.

Loudspeaker (Audio)

9.

Fan

10.

CO2 sensor (optional)

11.

Nebulizer (not used)

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.

Equipotential connection

fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2019-04-24

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3.4.2

Initial hardware model

#

Description

1.

Connectior for 24V DC external power supply (Does not charge internal battery!)

2.

Network jack for data management, PDMS (for conection to netwok withi minimum 3KV galvanic isolation) (disabled)

3.

USB port for data output, Software update and connection for Masimo SpO2 module

4.

DB9 RS-232 port for CO2 option and PDMS

5.

Flow Sensor 7-pin Connector

6.

Nurse Call Connector

7.

Loudspeaker (Audio)

8.

Fan

9.

Optional Ports

10.

Power Connector (Fuse 1 AT)

11.

Equipotential connection

12.

O2 Supply Connector 2.0 to 6.5 bar ∕ 40 Lpm

13.

Pressurized Air Connector 2.0 to 6.5 bar ∕ 40 Lpm

fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2019-04-24

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3.4.1 • •

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.

For Adapter to DISS see Accessories. The pin for the Potential Equalization 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:

Galvanically isolated relay output. max Load: 30 V ∕ 1 A DC or AC

USB:

5V ∕ 150 mA

RS-232:

±3 to ±15V

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.

CO2:

max Voltage: 5 V max operating Current: 700 mA

fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2019-04-24

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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). Access to Quick Launch settings is on the left side of the touch screen.

1

The Key ∕ Control Panel (2) with Rotary Pulse encoder (combines a key and a rotary encoder).

2

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.

fabian HFO | SW 5.1.x Ref: 113003.EN / Date 2019-04-24

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4 System functions and displays

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 from the configuration menu. 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 5.1.x Ref: 113003.EN / Date 2019-04-24