fabian +nCPAP evolution 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 +nCPAP evolution | SW 5.1.x Ref: 122003.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 ... 14 3.4 Rear panel ... 15

4

System functions and displays... 17 4.1 Control panel options ... 17 4.1.1

Function buttons ...17

4.1.2

Rotary pulse knob ...18

4.2 4.2.1

Display areas ...19

4.2.2

Display screen ...19

4.2.3

Information bar ...20

4.2.4

Numeric field / Alarm limits ...21

4.2.5

Graphic field ...23

4.2.6

LED Indicators ...23

4.3

Ventilation menu ... 24

4.3.1

Operation – General ...24

4.3.2

Operation – Settings ...25

4.3.3

Ventilation parameter dependency ...26

4.3.4

Locking ventilator parameters ...26

4.4

5

Display concept structure ... 19

Graphics menu ... 27

4.4.1

Waves ...28

4.4.2

Loops ...29

4.4.3

Trend Menu ...30

System operation ... 31 5.1 Preparing for operation ... 31 5.1.1

Connect the power supply ...31

5.1.2

Connect the gas supply ...31

5.1.3

Connect the tubing set ...32

5.2

Patient circuit assembly ... 33

5.2.1

Recommended positioning of temperature probe for humidifier ...34

5.2.2

Use of reusable patient circuit ...34 fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-04-24

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5.2.3

Connect nCPAP tubing ... 37

5.2.4

Connect flow sensor in DUOPAP mode (optional) ... 37

5.3 5.4 5.5 5.6 5.7 6

Configurations menu... 45 6.1 Calibration ... 46 6.1.1 6.1.2

Flow sensor ... 47 O2 Sensor ... 49

6.1.1

SpO2 module ... 50

6.2 6.3

Body weight setting ... 50 Display ... 50

6.3.1

Touch screen settings ... 51

6.3.2

Trend ∕ graph display ... 52

6.4 6.5 6.6 6.7 6.8 6.9 6.10 7

System start-up ... 38 Device check ... 40 System standby ... 42 System shutdown ... 43 Emergency shutdown ... 44

Ventilation parameter settings ... 53 Patient data ... 55 Language ... 56 Date ∕ Time ... 56 Tools ... 57 Information ... 57 Service mode ... 58

Alarms ... 59 7.1 Alarm limits menu ... 59 7.1.1

Automatic alarm limits ... 61

7.1.2

Configurable alarms ... 61

7.2 7.3 7.4

Alarm log ... 63 Nurse call relay ... 63 Alarm causes and solutions ... 64

7.4.1

Alarms table ... 64

7.4.2

Pressure release behaviour ... 70

7.4.3

Application error ... 71

7.4.4

Watchdog alarms ... 72

8

Battery operation ... 73

9

Operating on external power source ... 74

10 Ventilation parameters ... 75 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 ... 84 fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-04-24

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11.7 11.8

nCPAP ∕ DUOPAP ... 85 O2 Therapy mode (high and low flow oxygen therapy) HFNC... 86

11.9

Ventilation Additives ... 87

11.9.1

Volume limit ...87

11.9.2

Volume guarantee ...87

11.10 Special functions... 88 11.10.1 Manual inspiration (manual Breath) ...88 11.10.2 Nebulizing medications (optional) ...88 11.10.3 O2 Flush ∕ preoxygenation ...88

12 Accessories and options... 89 12.1 Accessories List ... 89 12.2 SpO2 module ... 91 12.2.1

Setting up the Masimo sensor ...91

12.2.2

Sensitivity mode ...92

12.2.3

Fast SAT mode ...92

12.2.4 12.2.5

Alarm delay ...93 SpO2 averaging time ...93

12.3

PRICO ... 94

12.3.1

General information on PRICO ...94

12.3.2

Setting up PRICO ...95

12.3.3

PRICO Ventilation modes ...98

12.3.4

PRICO disabling alarms ...99

12.3.5

PRICO re-enabling cases ...99

12.3.6

PRICO errors ...99

13 Replacing the oxygen sensor ... 101 14 Ventilator service and maintenance intervals ... 102 15 Sterilization ∕ cleaning ∕ disinfection ... 103 16 Setting ranges and parameters... 105 17 Guide to volume guarantee ... 109 17.1 Initial settings ... 110 17.2 How to start the VG function ... 110 17.3 Setting up the ventilator PSV+VG ... 112 18 Special procedures ... 113 18.1 Use of closed suction systems ... 113 18.2 Use of NO (Nitric Oxide) ... 114 19 Technical specifications... 115 19.1 Ambient conditions ... 115 19.2 Monitoring ... 115 19.3 Measuring ... 116 19.4 Resistance values... 117 19.5 Ventilation menu settings ... 117 19.6 Dimensions ∕ weight ... 118 19.7 Ratings ... 118 fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-04-24

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19.8 19.9 19.10 19.11 19.1

Data storage ... 119 Applied parts ... 119 Internal device checks ... 119 Gas blender function ... 119 Acoustic Energy... 121

20 Electromagnetic compatibility statement ... 123

fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-04-24

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 +nCPAP evolution devices running software version 5.1.x, where (x) can be any number.

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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. Connection for external trigger 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.

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Symbol

Description Keep dry. 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.

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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.

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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:

31.

•

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.

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.

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2.2

32.

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

33.

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.

34.

Check alarm limit settings each time the oximeter is used.

35.

An oximeter should NOT be used as an apnea monitor.

36.

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.

37.

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

38.

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

39.

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.

40.

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.

41.

WARNING: Only use air and O2 hoses which are in accordance to the ISO 5359 standard

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 +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-04-24

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2.4

Intended use The fabian +nCPAP evolution is intended for premature infants, new-borns as well as children weighing up to 30 kg. The fabian +nCPAP evolution is intended for “in-patient use” in hospitals, medically-used rooms, intra-hospital patient transport. The fabian +nCPAP evolution is an electronically microprocessor controlled ventilator. The fabian +nCPAP evolution 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: •

IPPV Intermittent Positive Pressure Ventilation (CMV Controlled Mandatory Ventilation)

•

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

•

SIMV Synchronised Intermittent Mandatory Ventilation

•

SIMV + PSV Synchronised Intermittent Mandatory Ventilation combined with PSV

•

PSV Pressure Support Ventilation

•

CPAP Continuous positive airway pressure

•

NIV ventilation nCPAP/duoPAP with variable flow generators

•

(Infant Flow®, Infant Flow LP®, InspireTM, Medijet®

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 +nCPAP evolution is not approved for use in a homecare environment.

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3 System overview 3.1

Scope of delivery The fabian +nCPAP evolution product includes the following items:

3.2

•

One fabian +nCPAP evolution 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 +nCPAP evolution 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.

3.3

fabian front connections

1.

Inspiratory tube port

2.

Connection for nCPAP system based on flow generators (single limb systems)

3.

Proximal pressure measuring tube port

4.

Expiration port

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3.4

Rear panel

1.

Mains connection with fuse holder

2.

Terminal studs for potential equalization

3.

Connection for external voltage supply 12 – 24V DC With HW Rev. 1.0 use only with connection cable Part. No. 151401

4.

Nurse call, max. Switching voltage 50 VDC

5.

Flow sensor connector

6.

Network connection for data management (disabled)

7.

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

8.

RS232 interface, service, PDMS

9.

Connection for compressed air supply 2.0 – 6.5 bar / 40 l/min

10.

Connection for future use, covered with a faceplate

11.

Oxygen sensor

12.

Connection for future use, covered with a faceplate

13.

Connection for oxygen “O2” supply 2.0 – 6.5 bar / 40 l/min

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For Adapter to DISS see Accessories. WARNING: DO NOT connect Ethernet, Nurse call, USB, R232, Flow Sensor ports to anything other than specified devices.

The PIN for the Equipotential connection 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 Equipotential connection accessible. Maximum Connected Loads: Nurse call:

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

USB:

5V ∕ 150mA

RS232:

±3 to ±15V

Flow Sensor: maximum load is one flow sensor. Only Acutronic Medical flow sensors are allowed to connect. max. Voltage: 5 V max operating current: 300 mA per hotwire -> 600 mA total.

fabian +nCPAP evolution | SW 5.1.x Ref: 122003.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 (1) allows the direct control of the ventilator parameters by tapping defined buttons on the graphic user interface. Fields in the lower section (2) of the touch screen are operated with the buttons underneath. The button /-control panel (3) incremental knob (combined with a push button and selection dial)

1

2 3

4.1.1

Function buttons

The key pad features two rows of buttons with various functions. Manual breath Used to apply a manual breath. Available in all the ventilation modes. O2 Flush Used to start O2 flush. Flush concentration and time can be preset. Cursor buttons These buttons serve as control in several menus

Screen contrast setting Menu ∕ Calibration Used to access the setting and calibration menus. Pressing once will open the configuration menu; pressing again will open the calibration menu.

mode

Waves ∕ Loops …switches to wave-/loop display. Home … displays the main screen for selecting the respiration mode.

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The key pad features two rows of buttons with various functions. Alarm limits Switches to the alarm limits configuration. ON ∕ OFF – Start ∕ Stop For switching the device ON and OFF, stopping and resuming ventilation.

Alarm Silence For acknowledging and muting alarms for a maximum duration of 120 seconds. Subsequent alarms with higher priority are only displayed optically during muting.

4.1.2

Rotary pulse knob

The Rotary Pulse knob combines a push button with a rotary knob for executing various settings, selections and confirmation options.

fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-04-24

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4.2

Display concept structure

4.2.1

Display areas

The information system features two key display areas: 1. The Touch screen 2. LED indicators

2

1

4.2.2

Display screen

The Display screen shows various information, setting and display fields depending on the display settings or menu: 1

1. Information bar indicating: •

Battery status,

•

Time/date,

•

Status information,

2

• System and alarm information 2. Graphics field (single graph or multigraph with loops or waves) 3.

Function field

4.

Selection or display of the Operating mode

5.

Numeric field ∕ alarm limits

3 5

4

Depending on the Display mode selected, individual fields can be shown ∕ hidden. Display field options will be described later.

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4.2.3

Information bar

The Information bar displays from general information to displaying alarms. It is divided into 3 sections.

1

3

2

The Information bar indicates the following among other things:

1 1. Neonatal, Pediatric or Transport mode, Patient data available Nurse call active / inactive Battery charge status 2. Ventilation mode, information and alarm display 3.

Alarm Mute (time remaining until alarm reactivates) Time / Date

Pediatric mode. For patients above 10 kilograms bodyweight, use of Pediatric mode is recommended. Extended range for flow and volume is available. Neonatal mode. Used for patients up to 10 kilograms bodyweight. The Ambulance symbol indicates that the Transport mode is activated, This is limiting Pressure to 60 mbar The Patient symbol indicates patient data associated with the current ventilator operation is saved to the device. The Nurse indicates Nurse Call is activated

Ventilation mode ∕ Info ∕ and Alarm display Displays ventilation mode and, if applicable, additional current information and notices. A RED blinking Information bar also alerts the operator of active alarms. If screen lock is in use, the symbol for Locked Screen is displayed. fabian +nCPAP evolution | SW 5.1.x Ref: 122003.EN / Date 2019-04-24

2

3