bellavista 1000, neo and 1000e User Manual Nov 2019

User Manual bellavista Ventilator Thank you very much for choosing bellavista. You have purchased a top-quality ventilator that meets the highest standards.

imtmedical ag Gewerbestrasse 8 9470 Buchs (SG) Switzerland [email protected]

Table of Contents 1

2

3

4

Introduction

7

1.1 1.2 1.3 1.4

Intended use Supported ventilation modes Validity of this User Manual Technical support

7 7 8 8

Important safety instructions

9

2.1 Legend 2.2 Liability 2.3 Introduction 2.4 Storing the documentation 2.5 Training documentation 2.6 Staff qualification 2.7 Correct User Manual 2.8 Use of a functional bellavista 2.9 Working safely with bellavista 2.10 Contraindications 2.11 Note about potential errors 2.12 Start-up 2.13 Setting up ventilation 2.14 Stopping ventilation, shutdown 2.15 Servicing and maintenance 2.16 Transport

9 9 9 9 9 9 9 9 10 10 10 11 15 16 16 16

Description of the device

17

3.1 3.2 3.3 3.4 3.5

17 18 19 20 20

Overview of bellavista 1000 Overview of bellavista neo Overview of bellavista 1000 e System overview Air and oxygen supply

Preparing for ventilation

21

4.1 Checking delivery 4.2 First steps 4.3 Connecting supply lines 4.4 Battery operation 4.5 Oxygen connector 4.6 Inlet filter 4.7 Switching on bellavista 4.8 Start screen 4.9 Selecting the breathing circuit 4.10 Selecting the patient type 4.11 Safety instructions about breathing circuits 4.12 Connecting the breathing circuit 4.13 Connecting the humidifier 4.14 Connecting the patient 4.15 Flow sensor 4.16 Connecting the nebuliser 4.17 Dual limb adapter 4.18 Integrated expiratory valve 4.19 Capnography CO2 respiratory gas sensors 4.20 SpO2 pulse oximeter

21 21 22 23 24 25 26 26 28 28 28 29 30 31 31 32 34 34 35 36

5

NIV, non-invasive ventilation

39

6

Ventilation of neonates

41

7

Operation

43

7.1 Index of applications 7.2 Changing the monitoring settings 7.3 Changing the curve display 7.4 Zooming gestures 7.5 Safety-protected settings 7.6 Login, user level 7.7 Configuration Assist 7.8 Data Assist 7.9 iVista

44 46 47 48 48 49 50 51 52

8

9

Setting up ventilation

53

8.1 Making ventilation settings 8.2 beMode Assist 8.3 Starting ventilation (ventilation menu) 8.4 Introduction to the ventilation modes 8.5 ATC Automatic Tube Compensation 8.6 PLV Pressure Limited Ventilation 8.7 Sigh 8.8 Ramp 8.9 CPAP 8.10 nCPAP 8.11 nIPPV 8.12 PCV 8.13 P-A/C 8.14 T 8.15 PC-SIMV 8.16 PSV 8.17 S 8.18 S/T 8.19 beLevel 8.20 APRV 8.21 VCV 8.22 V-A/C 8.23 VC-SIMV 8.24 AVM 8.25 HFOT

53 54 59 60 64 64 65 66 67 68 69 70 70 70 71 72 72 72 73 74 75 75 76 77 78

During ventilation

81

9.1 Monitoring 9.2 Cockpit 9.3 Lung Recruitment Tool 9.4 Hold manoeuvre 9.5 Esophageal pressure monitoring 9.6 Chameleon 9.7 Trending 9.8 Alarms

81 81 82 87 87 88 89 89

10 Stopping ventilation, shutdown 10.1

bellavista shutdown

11 Servicing and maintenance 11.1 Factory repair 11.2 Changing fuses 11.3 Batteries 11.4 Disposal 11.5 Reprocessing, cleaning, disinfection 11.6 Calibration Assist

12 Specifications 12.1 Standards 12.2 Classification 12.3 Device data 12.4 Ambient conditions 12.5 Units and languages 12.6 Pressure, flow 12.7 Connection data 12.8 Trending 12.9 SpO2 pulse oximeter (optional) 12.10 CO2 respiratory gas sensor (optional) 12.11 Breathing circuit and flow sensor 12.12 Drug nebuliser (optional) 12.13 Noise generation 12.14 Supported ventilation modes 12.15 Ventilation settings 12.16 Curves and loops 12.17 Monitoring parameters 12.18 Alarm limits 12.19 Pneumatic block diagram 12.20 Models accessories, consumables, spare parts 12.21 Symbols on device and packaging

13 Appendix 13.1 Network / data sharing 13.2 Start screen settings 13.3 List of alarms 13.4 Manufacturer's EMC declaration in accordance with EN60601-1-2:2007 13.5 ESD safety measures 13.6 bellavista training certificate 13.7 Servicing and maintenance checklist for bellavista 13.8 bellavista quick check

14 Index Passwords for bellavista ventilator

91 92

93 93 93 93 93 94 95

97 97 97 98 99 99 99 100 101 101 101 102 104 105 106 107 111 113 119 120 121 124

127 127 131 135 143 147 148 151 153

155 159

Introduction

1

Introduction

1 Welcome to bellavista. This User Manual will show you how to put your bellavista ventilator into operation and use all its functions.

1.1

Intended use

The bellavista ventilator was developed for ventilating adult and paediatric patients and, optionally, neonatal patients as of a tidal volume of ≥ 2 mL 1. The device is intended for use in clinics and institutional facilities where medically trained professionals are available for attending to the patient. The device can be used at the bedside, as well as for transferral within a facility, when a patient is in need of oxygen. bellavista is only intended for use by trained personnel under the supervision of a licensed doctor.

Carefully read the instruction for use before using bellavista. Use bellavista only if you are a trained professional. This instruction for use only applies to the ventilator type and software version specified.

1.2

Supported ventilation modes

1

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Abbreviation

Description

CPAP

Continuous Positive Airway Pressure

nCPAP

Nasal Continuous Positive Airway Pressure

nIPPV

Nasal Intermittent Positive Pressure Ventilation

PCV

Pressure Controlled Ventilation

P-A/C

Pressure Assist / Control Ventilation

PC-SIMV

Pressure Controlled Synchronised Intermittent Mandatory Ventilation

PSV

Pressure Support Ventilation, Spontaneous

S

Spontaneous without backup rate

S/T

Spontaneous/timed with backup rate

T

Timed

beLevel

Biphasic ventilation at two pressure levels and additional pressure support

APRV

Airway Pressure Release Ventilation

VCV

Volume Controlled Ventilation

V-A/C

Volume Assist / Control Ventilation

VC-SIMV

Volume Controlled Synchronised Intermittent Mandatory Ventilation

AVM

Adaptive Ventilation Mode

HFOT

High Flow Oxygen Therapy

beModes

Special modes for Day / Night, DualVent, MaskFit, TargetVent, Apnea Backup ventilation

TargetVent

Pressure-regulated, volume-controlled ventilation mode

Neonatal option not available in all countries.

7

Introduction

1

1.3

Validity of this User Manual

This User Manual applies to • bellavista 1000 (G6) SN: MB200000 and higher Software version 6.0 • bellavista 1000 neo (G6) SN: MB160000 and higher Software version 6.0 In the following document the device “bellavista 1000 neo” will be described with the following name: “bellavista neo”. • b  ellavista 1000 e (G6) SN: MB170000 and higher Software version 6.0

Where necessary, distinctions are made accordingly in this User Manual. 1.4

Technical support

Should you encounter any unexpected problems with bellavista, please notify your local distributor or contact imtmedical ag directly: Technical support • [email protected] • https://www.imtmedical.com/Support/OpenTicket

8

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Important safety instructions

2

Important safety instructions

2.1

Legend

Indicates a potential danger to life and limb. Or indicates a hazard that can cause damage to bellavista.

2

Notes and measures with which operation of bellavista can be made easier and more efficient.

Definition: The operator is the facility which, after purchase of the medical device, holds responsibility for operation of that device.

2.2

Liability

The manufacturer does not assume liability for any damage that occurs owing to non-compliance with this User Manual. The terms of warranty and liability contained in the manufacturer's terms and conditions of sale and delivery are not extended by the following provisions. If the device is not used as intended, liability for the performance of bellavista shall always pass to the owner or operator. Modifications to the device are prohibited.

2.3

Introduction

Read through the User Manual carefully before you put bellavista into operation. This User Manual only applies to the device types and software version referred to on the first pages.

2.4

Storing the documentation

Always keep the documentation in a readily accessible place near bellavista.

2.5

Training documentation

This User Manual serves as training documentation for teaching the main user control functions.

2.6

Staff qualification

bellavista is designed to be operated by qualified medical and technical personnel. After suitable instruction, the patient cockpit can be operated by persons without a medical qualification, e.g. patients and nursing staff. Liability for the performance of bellavista shall pass to the owner or operator if bellavista is improperly serviced or repaired by persons who are not authorised to do so by the manufacturer.

2.7

Correct User Manual

2.8 Use of a functional bellavista

Make sure you have the appropriate User Manual that belongs with the device and the software to avoid any risk to the user, patient or device. If a defective bellavista is used, malfunctions may directly or indirectly endanger the patient's health. Before putting bellavista into operation, always check to make sure it is functioning properly. Never use bellavista if it has been found to be faulty. Have any defects repaired without delay.

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9

Important safety instructions

2.9

Working safely with bellavista

22

Before each use of bellavista, perform a quick check. bellavista has to be reprocessed after each use on a patient. Check the ventilation settings before connecting the patient up to bellavista. Check apnea backup settings carefully before activating backups. Adjust the alarm volume so that the alarm can be heard. Nurse call is only designed as an additional alarm. Check that it is working after installation. The patient monitoring system is also active when on standby so pneumatograms and measurements displayed are no indication of active ventilation by the device. Check the oxygen saturation and CO2 concentration in the blood regularly using pulse oximetry and capnography or blood gas analysis. Before using a defibrillator, remove the SpO2 pulse oximeter and CO2 capnography sensor from the patient or disconnect from the device. In non-invasive ventilation (NIV) the ventilator is intended to support a patient breathing spontaneously. It is not intended to ensure complete ventilation of a patient. A change in the patient's position may make it necessary to adjust the ventilator settings. Make sure the patient is properly supplied at all times and that lung damage and mistriggering are avoided. • • • • • •

Check tidal volume and minute volume. Check the ventilation pressures. Adjust the ventilation pressure if necessary. Check the trigger reaction. Adjust the trigger settings. Always adapt the alarm limits to any new ventilation settings.

Only use your fingers to operate the touch screen. Pointed objects can damage the touch screen. 2.10

Contraindications

2.11

Note about potential errors

10

• • • • • • • •

Complications with airway intubation Complications from positive pressure ventilation Barotrauma Oxygen toxicity Cardiovascular complications Breathing effort and patient-respirator asynchrony Adverse effects of sedation and paralysis Other disease-related complications

If you have any concerns about the performance or the behaviour of bellavista, you should take it out of service without delay. Please report your observations with respect to potential errors or ambiguities in bellavista or the accompanying documentation. The safety of the patient being ventilated is the responsibility of the attending physician or nursing staff. Their judgement takes priority over the content of this User Manual. Always ensure that appropriate measures are taken to adequately monitor the patient.

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Important safety instructions

2.12

Start-up

Only use earthed cables in order to avoid the risk of an electric shock. Do not use: • • • • •

2

a power cord set longer than 3 m a defective power cord set a power cord set that is not earthed extension cables double plugs or adapters

Keep the power cord set away from the patient to avoid strangulation. Keep the power supply accessible to make it possible to disconnect the device from the mains if necessary. The absence of a ventilation alternative such as a self-priming, user-operated resuscitator with a breathing mask (ventilation bag as specified in ISO 10651-4) can lead to the patient's death if the ventilator fails. If there are concerns about the condition or set-up of the earth wire, bellavista may only be operated in battery mode. Earthing is only reliable if the device is plugged into a socket marked as being suitable for medical equipment. Breathing circuit C must not be used for life-supporting ventilation owing to the absence of expiratory volume monitoring. Avoid occlusion of the expiratory valve. Omitting a bacterial filter or using an incorrect bacterial filter can bring about transmission of pathogens to the patient and contamination of bellavista. Change the bacterial filter according to the manufacturer’s instructions and before each new patient. Used filters must be disposed of as medical waste. To avoid electric shocks to the patient and/or user, refrain from using antistatic or electrically conductive tubes or lines. Additional accessories in the breathing circuit can significantly increase the flow resistance or dead space volume and, as a result, negatively impact ventilation performance. Comply with the instructions provided by the manufacturer of the humidifier in order to prevent exposure of the patient to a hazard and damage to bellavista. Place the humidifier at a lower level than bellavista and the patient in order to prevent aspiration of water and flooding of bellavista. Calibrate flow sensor in the event of • a new patient • a new flow sensor • “Calibrate flow sensor” alarm In the case of non-invasive ventilation, the expiratory measurements of volumes and capnography values can differ considerably from the actual expiration on account of leakage. imtmedical ag

11

Important safety instructions

2.12.1 Installation and ambient conditions The installations for supplying power to bellavista must be earthed and must comply with the applicable standards.

22

Any external DC power supply must comply with IEC 60601-1 or IEC 60950-1 providing 2 MOOP between primary and secondary circuit and be of class II without functional earth. Use oxygen only in well ventilated rooms. Not in hazardous areas or near/with combustible materials or gases. bellavista batteries and accessories must not be operated in an explosive environment or in the vicinity of combustible materials or gases. bellavista must not be used for combustible mixtures of anaesthetic gases or anaesthetic agents with air or oxygen and/or nitrous oxide. bellavista must never be operated in areas subject to splashing (e.g. near bath tubs, showers) or in the vicinity of an open flame (e.g. candle). Do not cover bellavista and do not position it such that the openings for suctioning patient air or the device fan are covered or blocked (risk of overheating, inadequate supply to the patient). Do not place vessels filled with liquid or any other objects on top of bellavista. In order to avoid accidental excessive supply of oxygen to the patient, do not use bellavista in the vicinity of free-flowing oxygen. Place bellavista in an upright position so that it cannot tip over. bellavista has been tested for electromagnetic interference in accordance with the EN 60601-1-2 standard. Operation of bellavista can be influenced by electromagnetic interference. bellavista must therefore not be operated in the vicinity of magnetic resonance imaging scanners, mobile phones or any other potentially disruptive devices or systems, for example. To avoid interference with bellavista, please refer to the tables in the appendix: Manufacturer's EMC declaration in accordance with EN 60601-1-2. Do not position bellavista too close to other equipment or place it on top of other equipment. Do not expose bellavista to ionising radiation. It must therefore not be used in the vicinity of devices that generate diagnostic or therapeutic radiation (X-ray equipment, radiotherapy devices). bellavista must not be used in the vicinity of devices that generate diagnostic or therapeutic sound pressure. bellavista is not a portable device and must not be used while being carried. Do not use bellavista in a hyperbaric chamber (pressurised chamber).

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Important safety instructions

2.12.2 Connecting up to oxygen Use medical oxygen only. Do not connect nitrogen oxide, helium, heliox or other gases. To avoid inadequate or excessive supply of oxygen, use the bellavista oxygen monitoring system and alarm options. The use of oxygen can lead to serious complications. The impact on the processes of peripheral and cerebral respiratory control can cause respiratory pauses. Use clean, intact oxygen tubing. Open the flow valve of the oxygen cylinder slowly and only when you have connected up the oxygen cylinder. An oxygen leak in the O2 supply or in bellavista can lead to a fire risk or an inadequate supply of oxygen to the patient. Check the system regularly for leaks. In the event of a leak, turn off the oxygen source immediately. Use oxygen only in well ventilated rooms. Do not use bellavista in the MR environment.

2.12.3 Accessories, combination with other devices The operator is responsible for ensuring that bellavista is only operated with accessories approved for it. The use of non-approved accessories or cables can: • jeopardise the safety of the patient and/or user • have a negative impact on the proper functioning of bellavista • reduce performance • have a negative impact on EMC protection • lead to non-compliance with legal regulations. Combination with devices that are not mentioned in this User Manual is only permissible in agreement with the manufacturers. Ventilation modes nCPAP and nIPPV may only be used with a compatible nasal interface, in order to ensure correct alarms. Do not reuse single-use accessories because this can lead to a detrimental effect on sterility, functionality and general performance. Do not use antistatic breathing circuits!

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13

2

Important safety instructions

2.12.4 Nebulisation Do not use a nebuliser together with the capnography sensor (risk of incorrect measurements). During nebulisation do not use any expiratory or HME filters.

22

Installation of a nebuliser between the Y-piece (or expiratory valve) and the patient increases dead space ventilation. Only nebulise medicinal products approved for nebulisation. Check and clean, or replace the expiratory valve on a regular basis. Nebulisation can affect expiratory valve performance. Also bear in mind that nebulisation has an impact on the concentration of oxygen administered.

2.12.5 External sensors (SpO2 and CO2) According to EN/ISO 80601-2-12 bellavista must be provided, before start-up, with a monitoring device for measuring the expiratory carbon dioxide concentration in compliance with ISO 80601-2-55, e.g. in the expiratory section of the breathing circuit or at the patient port. Only use the sensor in combination with other methods when monitoring the vital functions of a patient. Only use the sensor on a patient if you have the necessary expertise. Always bear in mind the dead space volume of the capnography airway adapter. Do not use the sensor in conjunction with flammable anaesthetic gases. • Do not autoclave the sensor or immerse it in a liquid. • Do not pull on the sensor cable. • Comply with the operating temperature range.

2.12.6 Communication interface The data supplied via a network / data sharing system is provided for reference purposes only. Decisions on patient treatment should be made by the clinician on the basis of patient observation. In the event of an alarm, check the patient and bellavista on the spot immediately because not all alarms are displayed in detail in the network / data sharing system. Only use recommended connecting cables. The devices connected must be approved medical devices conforming to EN 60601-1. Connecting bellavista to a network / data sharing system that contains other devices can lead to previously unknown risks for the patient, user or third parties. The following changes to the network / data sharing system can lead to risks and thus require additional analyses. Changes to the network / data sharing system particularly include the following: • Changes in configuration • Connection of additional elements • Update or upgrade of connected devices

14

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Important safety instructions

2.13

Setting up ventilation

Ventilation does not start automatically but has to be started by the user pressing the button. Before connecting a patient:

2

• Perform a quick check. • Using the start screen select the breathing circuit and the correct patient category. • Adjust the ventilation settings. • Adjust the alarm settings to meet the specific requirements Minimise rebreathing of CO2 by carefully selecting the settings for PEEP and expiration time. Monitor the patient carefully if his/her condition changes. Monitor the patient carefully at the start of ventilation and when changing the settings or the breathing circuit. Check the oxygen saturation and CO2 concentration regularly using pulse oximetry and capnography or blood gas analysis. Only use the Alarm Autoset function if the current ventilation situation is safe and stable. Do not use any unadjusted alarm settings since this could prevent activation of the alarm in an emergency. Connectors and pins that bear the ESD warning symbol must not be touched with the hand or a hand tool before the necessary safety measures have been taken. Otherwise the device may be damaged.

2.13.1 HFOT High Flow Oxygen Therapy Only use for patients breathing spontaneously. Only use with a special interface for oxygen therapy (e.g. nasal cannula). Do not use nasal CPAP masks or prongs! Only use with actively humidified breathing tubes. Always use an SpO2 monitoring.

2.13.2 Lung Recruitment Tool Do not perform the lung recruitment and assessment manoeuvre with patients breathing spontaneously. Always take into account the duration of manoeuvres for lung recruitment and assessment in the context of the patient's condition. In the event of a leak during manoeuvres the accuracy of measurements (parameters and loops) is reduced. Bear in mind that ventilation after the recruitment manoeuvre will continue with PEEPEnd.

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Important safety instructions

22

2.14

Stopping ventilation, shutdown

Disconnect the patient from the bellavista before switching off the ventilator.

2.15

Servicing and maintenance

Only trained professionals authorised by the manufacturer may perform maintenance and repair work. Appropriate measuring equipment and testing devices must be available. Before subjecting bellavista to any maintenance work • Switch off and unplug at the mains. • Clean and disinfect it. • Please return bellavista in a disinfected and cleaned condition. If an error message appears during the self-test or the quick check, do not put bellavista into operation. For servicing, maintenance, cleaning and disposal refer to the instruction leaflet and/ or the operating instructions of the relevant accessory. Calibrate the O2 sensor regularly. An uncalibrated O2 sensor can lead to incorrect measurement and inadequate alarm signals. Subject the external CO2 sensor (optional) to zero-point calibration if necessary. An incorrectly calibrated CO2 sensor may lead to incorrect CO2 respiratory gas measurement. A patient air filter that is soiled or inappropriate can cause inadequate supply to the patient. Missing, incorrect or soiled air filters can cause bellavista to become contaminated or overheated. Only use original spare parts.

2.15.1 bellavista quick check prior to start-up Always perform the quick check in full. After the quick check, return the settings to the correct values.

2.16

16

Transport

bellavista is a medical device and should be transported carefully. bellavista and accessories must be shipped in their original packaging. Keep the original packaging in a dry place.

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Description of the device

3

Description of the device

3.1

Overview of bellavista 1000 1

4

2

No.

Description

1

Alarm lights

2

Screen with touch-screen function

3

Speaker

4

Attachment of expiratory valve or dual limb adapter

5

Handle

6

Cover for cooling air filter

7

Cover for patient air filter

8

Connection Assist button

9

External device interface (blue)

3 30

•

Connector for SpO2 sensor

•

Data Communication Interface

10

External device interface (yellow)

11

Expiratory valve or, alternatively, dual limb adapter

12

Inspiration patient connector

13

Cover for O2 sensor

14

Connector for bedside pressure measurement

15

Connector for flow sensor

16

Connector for expiratory valve

17

Nebuliser pressure connector (optional)

18

PAux additional pressure measurement connector (optional)

19

bellavista bus

20

Nurse call

21

2 × USB 2.0 *

22

100 Mbit Ethernet

23

On/Off

24

Power cord set strain relief

25

Oxygen connector

26

External 24 VDC power supply

27

Power indicator (green LED = battery charging)

28

Power plug

29

Device fuse 2 × T 6.3 AH, 250 V

30

Display Port (for servicing purposes)

•

5

3 7

6

9 12

8

10

14

15 11

13

17 18

16

3

Connector for CO2 sensor

* It is recommended not to plug in or unplug any USB devices when ventilation is taking place.

19

21 20

22 8

28

29

23

26

27

25

24

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Description of the device

3.2

Overview of bellavista neo 1

3

4

2

5

3 7 9 12

8

10

14

15 11

13

17 18

19

Description

1

Alarm lights

2

Screen with touch-screen function

3

Speaker

4

Attachment of expiratory valve or dual limb adapter

5

Handle

6

Cover for cooling air filter

7

Cover for patient air filter

8

Connection Assist button

9

External device interface (blue)

3

30

6

No.

•

Connector for SpO2 sensor

•

Data Communication Interface

10

External device interface (yellow)

11

Expiratory valve or, alternatively, dual limb adapter

12

Inspiration patient connector

13

Cover for O2 sensor

14

Connector for bedside pressure measurement

15

Connector for flow sensor

16

Connector for expiratory valve

17

Nebuliser pressure connector

18

PAux additional pressure measurement connector

19

bellavista bus

20

Nurse call

21

2 × USB 2.0 *

22

100 Mbit Ethernet

23

On/Off

24

Power cord set strain relief

25

Oxygen connector

26

External 24 VDC power supply

27

Power indicator (green LED = battery charging)

28

Power plug

29

Device fuse 2 × T 6.3 AH, 250 V

30

Display Port (for servicing purposes)

•

Connector for CO2 sensor

16 * It is recommended not to plug in or unplug any USB devices when ventilation is taking place.

21 20

22 8

28

29

23

26

27

25

24

18

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Description of the device

3.3

Overview of bellavista 1000 e 1

No.

Description

1

Alarm lights

2

Screen with touch-screen function

3

Speaker

4

Display Port (for servicing purposes)

5

Cover for cooling air filter

6

Cover for patient air filter

7

Connection Assist button

8

External device interface (blue) •

9 3

4

30

29 3

6

5

8 11

7

9

13

10

12

14

16 17

Connector for SpO2 sensor

External device interface (yellow) •

2

3

Connector for CO2 sensor (optional)

10

Expiratory valve

11

Inspiration patient connector

12

Cover for O2 sensor

13

Connector for bedside pressure measurement

14

Connector for flow sensor

15

Connector for expiratory valve

16

Nebuliser pressure connector

17

PAux additional pressure measurement connector

18

bellavista bus

19

Nurse call

20

2 × USB 2.0 *

21

100 Mbit Ethernet network

22

On/Off

23

Power cord set strain relief

24

Oxygen connector

25

External 24 VDC power supply

26

Power indicator (green LED = battery charging)

27

Power plug

28

Device fuse 2 × T 6.3 AH, 250 V

29

Data communication interface

30

Handle

* It is recommended not to plug in or unplug any USB devices when ventilation is taking place.

15

20

18 19

21 7

27

28

22

25

26

24

23

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19

Description of the device

3.4

System overview

bellavista is an electronically controlled pneumatic ventilation system. It is powered by AC or DC and also provided with an internal battery set. The bellavista pneumatic system guarantees the supply of respiratory gas whilst the electrical systems control the pneumatics, monitor the alarms and provide the power supply. The user can enter values or parameters in the bellavista microprocessor system via the touch screen. These inputs entail instructions for bellavista’s pneumatic system to ventilate the patient with a precisely controlled gas mixture. bellavista gathers readings from the proximal flow sensor and other sensors within the ventilator. Patient monitoring data can be displayed on the graphical user interface.

3

bellavista has two microprocessor systems, one to control the ventilation and one to control the user interface. The two processor systems cross-check each other and are able to trigger alarms independently of one another. This multiple check helps to prevent simultaneous failure of the main functions. A comprehensive system of visual and audible alarms helps ensure the patient’s safety. Clinical alarms indicate abnormal physiological conditions. Technical alarms triggered by the ventilator’s self-tests, including ongoing background checks, can indicate hardware or software failures. 3.5

Air and oxygen supply

bellavista has several ways of ensuring a safe ventilation pressure. Maximum working pressures are ensured by appropriate alarm limits. If the set upper pressure alarm limit is reached, the expiratory valve opens. bellavista uses ambient air and high-pressure oxygen. Ambient air is drawn in through the fresh air inlet and compressed by a turbine. Oxygen is supplied through a pressure port. An electronic blender mixes the oxygen and air to achieve the concentration entered by the user. The gas is delivered to the patient through a microprocessor-controlled inspiratory valve. bellavista ventilates the patient through the inspiratory limb of the breathing circuit, which may include an inspiratory filter, flexible tubes, the humidifier system, a water trap, the Y-piece, the flow sensor and other components.

You will find the block diagram in the section “Specifications” under “Pneumatic block diagram”.

20

Gas exhaled by the patient is discharged through the flow sensor and the optional expiratory limb of the breathing circuit. Measurements taken by the flow sensor are used to determine the pressure, flow and volume. An oxygen sensor monitors the oxygen concentration of the gas delivered to the patient.

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