BREAS Vivo 30 Ventilator Clinician’s manual

Table of Contents

1

2

3

4

5

6

Introduction ..................................................................................................................... 3

1.1

1.2

1.3

1.4

What is the Vivo 30? ......................................................................................... 4

Intended Use..................................................................................................... 4

Contraindications .............................................................................................. 5

About this Manual .......................................................................................... 6

Safety Information........................................................................................................... 8

2.5

2.6

2.7

2.8

2.1

2.2

2.3

2.4

General User Precautions ............................................................................... 8

Electrical Safety ............................................................................................ 10

Environmental Conditions ............................................................................. 11

Usage of Patient Circuit ............................................................................... 12

Usage of Filters ............................................................................................... 13

Humidification ............................................................................................... 14

Cleaning and Maintenance ............................................................................. 14

Adverse Patient Symptoms............................................................................. 15

2.9

Usage of Oxygen .......................................................................................... 16

Product Description....................................................................................................... 18

3.1

3.2

3.3

Main Components ........................................................................................... 18

Accessories ........................................................................................ 20

The Vivo 30’s Front Panel .......................................................................... 22

3.4

3.5

The Vivo 30's Back and Side Panels ........................................................... 23

Equipment Designation and Safety Label .................................................. 24

Functions and Parameters of the Vivo 30..................................................................... 25

4.5

4.6

4.7

4.8

4.9

4.1

4.2

4.3

4.4

Ventilation Mode.............................................................................................. 25

Device Mode ................................................................................................... 25

Settings ........................................................................................................... 25

The PCV Mode (Pressure Control Ventilation)................................................ 28

The PSV Mode (Pressure Support Ventilation)............................................... 29

The Difference between PCV and PSV Mode ................................................ 30

The CPAP Mode ............................................................................................. 30

Standby and Operating Mode ......................................................................... 31

Low Leakage Detection................................................................................... 31

4.10

Humidifier (optional) ........................................................................................ 31

Using the Vivo 30.......................................................................................................... 32

5.1

5.2

5.3

5.4

5.5

5.6

5.7

Set up the Vivo 30 Before Use........................................................................ 32

Switching the Vivo 30 On and Off ................................................................... 33

Using the Menu............................................................................................... 34

Monitoring Section .......................................................................................... 40

Transferring Data between the Vivo 30 and a PC ......................................... 41

Using the HA 01 Humidifier ....................................................................... 45

Using Batteries................................................................................................ 45

5.8

Vivo 30 Operating Time................................................................................... 47

Preparing the Vivo 30 for Use ....................................................................................... 48

6.1

6.2

Installing the Vivo 30 ....................................................................................... 48

Placing the Vivo 30 ....................................................................................... 49

Doc. 003887 En-Us A-1e

Table of Contents

BREAS Vivo 30 clinician’s manual

1

7

8

6.3

Connecting the Vivo 30 to the AC Power Source .......................................... 49

6.4

Connecting the Patient Circuit......................................................................... 50

Setting Up the Vivo 30 ................................................................................................ 51

7.1

7.2

7.3

Settings Applicable for the Different Modes ................................................... 52

Selecting the Mode ......................................................................................... 53

Setting the Parameters ................................................................................. 54

Alarms .......................................................................................................................... 58

9

8.1

8.2

Alarm Function ................................................................................................ 58

Physiological Alarm......................................................................................... 61

8.3

Technical Alarm............................................................................................... 66

Complete Function Check............................................................................................. 69

9.1

Pre-use Check ................................................................................................ 69

9.2

Alarm Check ................................................................................................... 70

10 Cleaning the Vivo 30 and Replacement of Accessories ............................................... 72

10.1

Cleaning the Vivo 30 ...................................................................................... 72

10.2

Cleaning and Replacing the Patient Air Filters................................................ 74

10.3

Change of Patient ........................................................................................... 75

11 Maintenance ................................................................................................................. 76

11.1

11.2

11.3

11.4

Regular Maintenance Control ......................................................................... 76

Service and Repair.......................................................................................... 77

Storage............................................................................................................ 77

Disposal .......................................................................................................... 77

12 Technical Specifications ................................................................................................ 78

12.1

System Description ...................................................................................... 78

12.2

Data ................................................................................................. 79

12.3

Compliance of Standards ............................................................................. 83

12.4

Delivery Settings ...................................................................................... 85

13 Accessories................................................................................................................... 87

13.1

Breas Accessories List.................................................................................... 87

2 Table of Contents

BREAS Vivo 30 clinician’s manual


1 Introduction

WARNING!

Vivo 30 must only be used:

• For the intended treatment in accordance with this operating manual and with the instructions given by the responsible clinical personnel.

• In accordance with the operating conditions specified in this operating manual.

• In original and unmodified shape and only with accessories specified or approved by Breas Medical AB.

Every other use may lead to risk of personal injury!

CAUTION!

Read this operating manual thoroughly so that you completely understand how the Vivo 30 is operated and maintained before taking it into use, to ensure correct usage, maximum performance and serviceability.

WARNING!

Do not use the Vivo 30 for any kind of life support treatment.

Breas Medical AB reserves the right to make changes to this product without any prior notification.


Introduction

Vivo 30 clinician’s manual

3

1.1 What is the Vivo 30?

The Vivo 30 is a pressure-supported and pressure-controlled ventilator.

It has three modes of operation: PCV

(Pressure Control Ventilation)

, PSV

(Pressure Support Ventilation)

and CPAP

(Continuous Positive Airway Pressure)

. The

PCV and PSV modes have an adjustable inspiratory trigger sensitivity setting which allows the patient to initiate ventilator-assisted breaths.

• In the PCV mode (Pressure Control Ventilation), the ventilator provides assisted or controlled pressure-regulated breathing. In PCV mode, the clinician sets an inspiration time. The inspiratory pressure is set by the IPAP

(Inspiratory Positive Airway Pressure) setting. The end-expiratory pressure is set by the EPAP (Expiratory Positive Airway Pressure) setting.

• In the PSV mode (Pressure Support Ventilation), the ventilator’s expiratory trigger can also be adjusted allowing the ventilator to more easily match each patient’s needs. The inspiratory pressure is set by the IPAP setting. The end-expiratory pressure is set by the EPAP setting.

• In the CPAP mode (Continuous Positive Airway Pressure), the ventilator provides a continuous positive airway pressure.

The Vivo 30 has a pressure sensor that continuously monitors output pressure to the patient and reference ambient pressure, so that the device automatically will compensate for altitude changes.

The internal memory of the Vivo 30 can be downloaded to a PC where you can view the patient compliance data in the Breas Vivo PC Software.

For more information about the Breas Vivo PC Software, please contact your

Breas representative.

1.2 Intended Use

The Vivo 30 is not intended for life support or life-sustaining applications or for transport of critical care patients.

The Vivo 30 shall only be used by patients with spontaneous breathing.

The Vivo 30 is designed for patients who require long-term support by mechanical ventilation during night and part of the day, up to a maximum of

20 hours of use per day.

The Vivo 30 is intended for non-invasive use.

4 Introduction



The Vivo 30 is intended for use in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments. The Vivo 30 must always be prescribed by a licensed physician.

The Vivo 30 is intended for treatment of adult patients only.

The Vivo 30 is intended to be operated by qualified and trained personnel, or by personnel who have been taught using the clinician’s manual.

The CPAP function is intended to deliver continuous positive airway pressure therapy for the treatment of obstructive sleep apnea, via non-invasive nasal or full-face masks.

1.3 Contraindications

The use of the Vivo 30 is contraindicated on patients with severe respiratory failure without a spontaneous respiratory drive.

The use of the Vivo 30 for positive pressure therapy may be contraindicated on patients:

• Incapable of maintaining life- sustaining ventilation in the event of a brief circuit disconnection or loss of therapy.

• Unable to maintain a patent airway or adequately clear secretions.

• At risk for aspiration of gastric contents.

• With a history of allergy or hypersensitivity to the mask materials where the risk from allergic reaction outweighs the benefit of ventilatory assistance.

Therapy with the Vivo 30 should not be prescribed when the following specific diseases or conditions are present:

• Bullous lung disease

• Pathologically low blood pressure

• Severe cardiac arrhythmias

• Coronary artery disease

• Unstable angina pectoris

• Decompensated cardiac failure or hypotension, particularly if associated with intravascular volume depletion

• Recent thoracic surgery

• Pneumothorax


Introduction


5

• Pneumomediastinum

• Massive epistaxis or previous history of massive epistaxis

(risk of recurrence)

• Pneumoencephalus, recent trauma or surgery that may have produced cranio-nasopharyngeal fistula

• Cerebral spinal fluid (CSF) leaks

• Acute or unstable respiratory failure or insufficiency

Caution should be used when prescribing positive airway pressure therapy for susceptible patients, such as patients with abnormalities of the cribriform plate, or prior history of head trauma.

The use of CPAP therapy may be temporarily contraindicated if the patient exhibits signs of a sinus or middle ear infection.

1.4 About this Manual

Always read this manual before setting up and using the Vivo 30 or performing maintenance on the machine, to ensure correct usage, maximum performance and serviceability.

Breas Medical AB reserves the right to make changes to the contents of this manual without any prior notification.

Audience

This manual is primarily intended for care providers, clinical personnel, physicians and others who require a working knowledge of the Breas Vivo 30 system.

The manual comprises detailed information on the settings and functions of the

Vivo 30 to be handled by trained health care personnel only.

• Patients and other lay users operating the Vivo 30 will find all the information they need in the User Manual.

• Service personnel may order the Vivo 30 Service Manual that contains detailed technical information for maintenance, service and repair.

6 Introduction



Icons

In this manual, icons are used to highlight specific information. The meaning of each icon is explained in the table below.

I

CON

E

XPLANATION

Warning!

Risk of death and serious personal injury.

Caution!

Risk of minor or moderate injury. Risk of equipment damage, loss of data, extra work, or unexpected results.

Note

Information that may be valuable but is not of critical importance, tips.

Reference

Reference to other manuals with additional information on a specific topic.


Introduction


7

2 Safety Information

2.1 General User Precautions

• U.S. Federal law restricts this device for sale by or on order of a physician.

• The Vivo 30 should not be used for any kind of life support treatment.

• The Vivo 30 shall only be used by patients with spontaneous breathing.

• Advice contained in this manual should not supersede instructions given by the prescribing physician.

• If the patient is admitted to a hospital or is prescribed any other form of medical treatment, always inform the medical staff that the patient is on mechanical ventilation treatment.

• Vivo 30 must only be used:

– for the intended treatment in accordance with this operating manual and with the instructions given by the responsible clinical personnel;

– in accordance with the operating conditions specified in this operating manual;

– in original and unmodified shape and only with accessories specified or approved by Breas Medical AB.

• Do not use the Vivo 30 in the event of suspected damage to the device, unexplainable or sudden pressure, performance or sound changes during operation, or if the delivered air from the Vivo 30 is abnormally hot or emits an odor. Contact your responsible care provider for an inspection.

• Inadequate use of device or accessories may cause loss of treatment or decreased performance.

• The Vivo 30 therapy settings must always be based on medical supervision and must be changed by authorized clinical personnel only. Blood gas measurement should be performed when changing settings or changing to another device.

• Always perform the procedure “Set up the Vivo 30 Before Use” on page 32 before using the Vivo 30.

• Only use accessories recommended by Breas Medical AB.




• Clinical personnel must read the Clinician’s manual thoroughly and understand the Vivo 30 operation before setting up and using the machine.

• The user must read the user manual thoroughly and understand the

Vivo 30 operation before using the machine.

• All the physiological alarms of the Vivo 30 must be set at safe levels that will effectively warn the user of any risk. The alarm levels should be assessed considering the patient settings. Any change of settings or components may require the readjustment of the alarm levels.

• Handle the Vivo 30 with care.

• Do not use the Vivo 30 while in a carry bag. Attach the rear lid and place the swivel in a down position when placing the Vivo 30 in the bag.

• If using the Vivo 30 for a short intra hospital or vehicle transportation, the following cautions need to be observed:

– Do not mount the Vivo 30 on a wheelchair or in a vehicle.

– Make sure that the Vivo 30 stands securely in a upright position and cannot tilt or fall.

– Do not use the Vivo 30 outdoors during rain or snowfall.

– If the HA 01 humidifier is attached, make sure that it is not in use and that it is empty.


Safety Information


9

2.2 Electrical Safety

• Do not operate the Vivo 30 if it has a damaged power cord or casing.

• The Vivo 30 may not work properly if any part has been dropped, damaged or submerged in water.

• To avoid electrical shock, disconnect the electrical supply to the Vivo 30 before cleaning. Do not immerse the Vivo 30 into any fluids.

• The operator shall not touch accessible contacts of connectors and the patient simultaneously.

• When handling the HA 01 humidifier, always turn off the Vivo 30 and disconnect the Vivo 30 from the AC power supply.

• Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (e.g. IEC 60950 for data processing equipment and IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the valid version of the system standard IEC 60601-1-1. Therefore, everyone who connects additional equipment to the signal input part or signal output part configures a medical system is responsible that the system complies with the requirements of the valid version of the system standard IEC 60601-1-1. If in doubt, consult the technical service department or your local representative.

• If an external battery is used, always disconnect it when the Vivo 30 is switched off. Otherwise there is a risk that the battery will discharge.

• If the AC power source fails and an external battery activates, the

HA 20 humidifier will be turned off automatically. It must be activated again manually, if humidification during battery use is necessary.

• Only use the data connection to connect the Vivo 30 to the iCom or a PC.




2.3 Environmental Conditions

• Do not use the Vivo 30 in any toxic environment.

• Do not use the Vivo 30 in environments where there are explosive gases or other flammable anesthetic agents present.

• The air flow for breathing produced by the Vivo 30 can be as much as 10°F

(5°C) higher than room temperature. Caution should be exercised if the room temperature is greater that 95°F (35°C).

• If a room humidifier is used, place it at least 6 feet (2 meters) away from the

Vivo 30.

• The performance of the Vivo 30 may deteriorate at ambient temperatures below 41°F (5°C) and above 100°F (38°C).

• Do not use the Vivo 30 while positioned in a warm place, such as direct sunlight.

• The device complies with the EMC requirements of standards listed in

“Compliance of Standards” on page 83. Necessary measures should be

taken in order to assure that field levels exceeding 10 V/m are avoided, since this may impair the safety and performance of the Vivo 30. Measures should include but not be limited to:

– normal precautions with regard to relative humidity and conductive characteristics of clothing in order to minimize the build-up of electrostatic charges.

– avoiding the use of radio emitting devices closer than 1 m to the Vivo 30.

Examples include: radio emitting devices such as cellular or cordless telephones, microwave ovens and high-frequency surgery apparatus.

• The Vivo 30, all accessories and replacement parts must be disposed of in accordance with the local environmental regulations regarding the disposal of used equipment and waste.

• The performance of the Vivo 30 and treatment of the patient may deterio-

rate if the operation conditions in “Technical Specifications” on page 78

are not fulfilled. Do not use the Vivo 30 immediately after storage or transport outside the recommended operating conditions.




11

2.4 Usage of Patient Circuit

• Only use the Vivo 30 with a mask, patient tube and leakage port recommended by Breas Medical AB and your health care professional.

• The Vivo 30 requires an intentional leak port instead of an actively controlled exhalation valve to remove exhaled gases from the patient circuit.

Therefore, specific masks and patient circuits using an intentional leakage are required for normal operation. The pressurized air from the Vivo 30 causes a continuous flow of air to exhaust from the leak ports, flushing exhaled gas from the circuit. The Vivo 30 should be turned on and the intentional leak ports should be checked before application.

• Do not breathe in the connected patient circuit unless the Vivo 30 is turned on and operating properly.

• Do not use patient hoses or tubes made of static or electrically conductive material.

• Always use a new mask, tube and leakage port when the Vivo 30 is to be used by a new patient.

• Patient connected parts and filter must be replaced regularly to ensure correct function of the Vivo 30. All replaced parts must be disposed of according to local environmental regulations regarding the disposal of used equipment and parts.

• Periodically check for moisture in the patient circuit. When present, remove the moisture. Before attempting to dry the circuit, disconnect it from the Vivo 30 to ensure no water will flow back into the Vivo 30. The frequency at which these checks must be performed will depend on the patient’s own condition and the device used. You should assess this on an individual basis in accordance with the patient’s needs.

• If the patient is using a full face mask (covering mouth and nose), the mask must be equipped with a safety entrainment valve.




• Make sure that the ventilation holes in the mask or the leakage ports are never blocked or obstructed. These ports are used to prevent re-breathing of exhaled air. Re-breathing of exhaled gases for longer than several minutes can, in some circumstances, lead to suffocation.

• At low CPAP pressures, the air flow through the ventilation holes in the mask or the leakage ports may be inadequate to clear all exhaled gases.

Some re-breathing may occur.

• Do not leave long lengths of air tubing around the top of the bed. It could twist around the patient’s head or neck while sleeping.

• Always follow the instructions of the mask manufacturer.

2.5 Usage of Filters

• Always use the Vivo 30 with patient air inlet filters installed. Only use filters that are specified in this manual.

• Replace or clean the filters regularly to ensure correct function of the

Vivo 30, especially when changing patient. Failure to replace or clean a dirty filter may cause the Vivo 30 to operate at higher temperatures than intended.

• When operating the Vivo 30, make sure that the air inlet and filters are not obstructed or occluded.

• If the Vivo 30 is used in a clinic by several patients, a low resistance bacteria filter is recommended between the air outlet and the patient circuit to prevent patient cross-contamination. Breas Medical AB recommends the

usage of the Breas filter 004185, see “Breas Accessories List” on page 87.

Reuse of mask or bacteria filter may expose patients to contagious agents.

• The use of a high resistance bacteria filter on the output of the device may interfere with the operation of the patient disconnect function. It may also interfere with the device trigger function.

• Do not connect any filter to the HA 01 humidifier.




13

2.6 Humidification

• The HA 01 humidifier is intended for non-invasive use only.

• Do not place the Vivo 30 with the HA 01 humidifier in a bag.

• When the HA 01 humidifier is installed, the Vivo 30 must be located below the patient and on a flat surface. This is to prevent personal injury from accidental spillage or from excess water or condensation flowing down the patient tube and into the patient’s mask. Extra cautions should be taken for patients who are unable to guard their airways or cannot pull off the mask.

• When using an external heated humidifier, it should be located below the

Vivo 30 and the patient to prevent injury from accidental spillage.

• If the condensation in the patient circuit is excessive, the use of a heated humidifier may require the installation of a water trap in the circuit. The water trap prevents any condensated water in the patient circuit from running into the patient airways and causing personal injury.

The use of an HME (Heat and Moisture Exchanger, artificial nose) or an external humidifier may require readjustment of the Vivo 30’s low-pressure alarm.

2.7 Cleaning and Maintenance

• The Vivo 30 should be cleaned and maintained in accordance with this operating manual.

• Do not attempt to autoclave or sterilize the Vivo 30.

• Vivo 30 should be subjected to maintenance, service and control and any applicable upgrades, in accordance with Breas service instructions.

• Vivo 30 shall only be repaired or modified in accordance with Breas service manuals, technical bulletins, and any special service instructions, by service technicians authorized by Breas Medical AB.

• Do not under any circumstances attempt to service or repair the Vivo 30 yourself. If you do so, the manufacturer will no longer be responsible for the performance and safety of the Vivo 30. Furthermore, no warranty will be valid.




2.8 Adverse Patient Symptoms

If the patient experiences discomfort or any of the following symptoms while using the Vivo 30, a physician or responsible clinician shall be contacted immediately:

• Bloated feeling from excessive swallowing of air while awake

• Air continually leaking from the mouth while sleeping

• Dryness of air passages or nose

• Ear pain, runny nose or sinus discomfort

• Day time sleepiness

• Disorientation or memory lapse

• Mood change or irritability

• Skin sensitivity

• Severe headache

• Chest discomfort

• Shortness of breath

The following are potential side effects of non-invasive positive pressure therapy:

• Ear discomfort

• Conjunctivitis

• Skin abrasions due to non-invasive interfaces

• Aero phagia (gastric distension)




15

2.9 Usage of Oxygen

• The presence of oxygen can speed up combustion of inflammable materials.

• If oxygen has been prescribed, connect the oxygen supply tube to the appropriate oxygen port of the nasal mask or breathing system connector.

• At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen concentration will vary, depending on the pressure delivered, patient’s breathing pattern, mask selection, and leak rate.

• When oxygen is used with the Vivo 30, the oxygen flow must be turned off when the Vivo 30 is not operating.

• Ventilate the room adequately.

• Do not smoke in a room where oxygen is being used.

• Naked light bulbs and other sources of ignition must be kept a minimum of

6 feet (2 meters) away from the oxygen cylinder or any part of the patient circuit.

• Do not use aerosols or solvents close to the oxygen supply, even when the oxygen supply is shut off.

• When the Vivo 30 is not in operation, and the oxygen flow is left on, oxygen delivered into the patient tubing may accumulate within the machine enclosure. Oxygen accumulated in the machine enclosure will create a risk of fire.

• Supplemental oxygen may trigger the low leakage alarm prematurely.

• Supplemental oxygen flow may not exceed 15 liter/min.

• Supplemental oxygen affects the accuracy of the volume and flow measurements.







17

3 Product Description

3.1 Main Components

The Vivo 30 system contains the following components:

3

2

4

1



8

7

6

5


6

7

3

4

5

N

O

.

C

OMPONENT

1 Carry bag

2 User manual

Patient tube

Power cord

Filter (white, disposable)

8

F

UNCTION

Storage for transportation

Product and usage information 003820

Inlet air filtration

Filter (grey, washable) Inlet air filtration

Rear lid For usage without the HA 01 humidifier

Vivo 30 main unit

P

ART NO

.

003519

004465

003522

003526

003527

003591


Product Description


19

3.2 Accessories

9

10

11

12 13 14 15

16

17

18

N

O

.

C

OMPONENT

F

UNCTION

9 HA 01 Humidifier Humidifies patient air

10 Battery cable 12/24 V

DC

11 iCom kit Includes:

• Isolated communication interface: PC and Vivo

• Vivo-iCom data cable

• iCom-PC data cable (D-sub)

• iCom-PC data cable (USB)

• iCom User manual

• iCom PC drivers

P

ART NO

.

003530

004258

004143




N

O

.

C

OMPONENT

F

UNCTION

12 Vivo-PC data cable Data cable: PC and Vivo 30

(RJ45 to D-sub)

13 Vivo-iCom data cable

Data cable: Vivo 30 and iCom

(RJ45 to D-sub)

14 iCom-PC data cable

D-sub

Data cable: iCom and PC

(D-sub to D-sub)

15 iCom-PC data cable

USB

16 Memory card

Data cable: iCom and PC

(USB to USB)

Vivo 30 settings, patient data and usage data

17 Memory card reader

/ writer

Read/write memory card

18 Vivo PC software kit Data monitoring software

P

ART NO

.

003588

003574

003721

003722

003619

002185

004145




21

3.3 The Vivo 30’s Front Panel

1

2

3

4

5

6

7, 8, 9, 10

17

18

11

12

13

14

15

16

N

O

.

U

SER

B

UTTONS

1 Start/Stop

F

UNCTION

Start/Stop ventilation treatment

6 Audio pause Pause the alarm sound

7-10 Function/Navigation Function according to display

13-16 Navigation/Setting Navigation in current menu selection/

Define settings

5

11

12

N

O

.

L

ED

F

UNCTION

2 Trigger Patient breath trigger indication

3-4 Alarm (red & yellow) Alarm indication

Audio pause

AC power

External DC

Paused alarm sound indication

Power source: AC power

Power source: External DC

N

O

.

D

ISPLAY

W

INDOW

17

18

Monitoring section

Active section

F

UNCTION

Current treatment data

Adjustable settings




3.4 The Vivo 30's Back and Side Panels

4

5

1

2

3


6

7

8

9

7

8

9

5

6

3

4

N

O

.

I

TEM

1

2

Air inlet

Locking mechanism

Air outlet

Memory card slot

HA 01 humidifier

AC power inlet

On/Off

External DC inlet

Data connection

F

UNCTION

Air path in, replaceable filters

Release and lock the HA 01 humidifier or rear lid

Air path out to the patient

Read and write memory card

Patient air humidification

Connection for an external AC power source

AC power on and off

External DC power source connection

Data cable connection

(iCom/PC and the Vivo 30)



23

3.5 Equipment Designation and Safety Label

1, 2

3, 4

5, 6, 7, 8, 9

7

8

5

6

9

3

4

N

O

.

S

YMBOL

1

2

E

XPLANATION

Model designation

Serial number (last seven alphanumeric characters)

Data connection port (for iCom or PC)

Before using the data connection port, read

“Transferring Data between the Vivo 30 and a

PC” on page 41 carefully.

Class II electrical equipment; double insulation

Body floating (IEC 60601-1 Type BF, Isolated

Applied Part)

Read the clinician’s manual thoroughly before connecting the Vivo 30 to the patient.

CE marking applies in accordance with the directive MDD 93/42/EEC.

Read “Disposal” on page 77 for information

about recycling and disposal.




4 Functions and Parameters of the Vivo 30

This chapter includes descriptions of the modes and parameters used for controlling the ventilation of the Vivo 30.

4.1 Ventilation Mode

The following modes can be selected for the Vivo 30:

• PCV mode (Pressure Control Ventilation)

• PSV mode (Pressure Support Ventilation)

• CPAP mode (Continuous Positive Airway Pressure)

4.2 Device Mode

• Clinical

• Home

In order to prevent the patient from changing the settings, the home mode should be activated before giving the Vivo 30 to the user. The home mode hides treatment settings, alarm limits and other selected information.

The clinical mode is used by the clinician to control all mode choices, settings and limits.

4.3 Settings

All the parameters that are used for controlling the breathing by the Vivo 30 are listed below.

Read the chapter “Settings Applicable for the Different Modes” on page 52 for

information about the modes and ranges the different settings work with.

IPAP (PSV & PCV only, mandatory)

The IPAP setting is used for defining the patient’s airway pressure during the inspiration phase.

EPAP (PSV & PCV only, mandatory)

The EPAP setting is used for controlling the patient’s airway pressure during the expiration phase.


Functions and Parameters of the Vivo 30


25

Breath Rate (PSV & PCV only, mandatory)

The breath rate defines the minimum number of breaths the Vivo 30 will deliver. If the number of spontaneous patient breaths per minute is less than this number, Vivo 30 will uphold this rate.

In PSV mode the expiratory trigger is inactive during the non-patient triggered breaths, and these breaths are delivered with an I:E ratio of 1:2 (up to maximum inspiration time of 3 seconds). In PCV mode, non-patient triggered breaths are delivered according to settings.

Rise Time (PSV & PCV only, mandatory)

The rise time setting controls the pressure increase to the desired IPAP value. A high setting will give a slow increase and therefore a shorter plateau. A low setting will give a faster increase and therefore a longer plateau.

Min and Max Inspiration Time (PSV only, optional)

If set, the min and max inspiration time setting defines a minimum and maximum length of each inspiration. If the min and max inspiration time are set off, the length of each inspiration is dependent on the set expiratory trigger.

Inspiration Time (PCV only, mandatory)

The inspiration time setting controls the length of each inspiration.

Inspiratory Trigger (PSV mandatory, PCV optional)

The inspiratory trigger setting defines the patient’s effort required to initiate a ventilator assisted breath.

When the patient starts a breath, an increasing flow is created in the patient circuit. If the patient reaches the set inspiratory trigger level, the increasing flow is registered by the ventilator, and that immediately starts an inspiration. If the patient cannot trigger a breath, the ventilator will deliver breaths according to the set breath rate.

Expiratory Trigger (PSV only, mandatory)

The expiratory setting defines the patient's effort required to terminate an inspiration at IPAP pressure level. To increase or to decrease the set patient effort requirement the expiration trigger level can be set to a number between 1 and 9 where 1 is the lowest patient effort level setting and 9 is the highest effort level.




CPAP (CPAP only, mandatory)

The CPAP setting sets the pressure for the CPAP (Continuous Positive Airway

Pressure) mode.

The Ramp Function (optional)

The ramp function is used for increasing the EPAP and IPAP pressure during a set time, the IPAP pressure starts at 2 cmH

2

O above the ramp start pressure.

Ramp start pressure = EPAP

Ramp start pressure < EPAP

Pressure

IPAP

Pressure

IPAP

EPAP

Ramp start pressure

Set ramp time

Time

EPAP

Ramp start pressure

Set ramp time

Time

During CPAP mode the ramp function provides a pressure increase from the ramp start pressure to the set CPAP pressure during a set time.




27

4.4 The PCV Mode (Pressure Control Ventilation)

In the PCV mode, the ventilation is controlled by the Vivo 30. This is done by the pressure, rate, inspiration time, and rise time settings.

Inspiration is started either when the ventilator initiates a breath, or when the patient triggers a breath (if the trigger function is activated). The ventilator tries to reach and maintain the set pressure until the expiration starts.

The inspiration stops and an exhalation starts in two cases:

• The inspiration time expires.

• The limit for the high-pressure alarm is reached.

The figure below shows how the pressure and the inspiration time settings control the ventilator’s function in the PCV mode.

The following settings have been used: Pressure 20 cmH

2

O, insp. time 1.8 sec.

Pressure cmH

2

O

IPAP

Pressure setting

Patient exhales

Start of breath

Patient flow

Insp. time PCV

EPAP

Max flow and set pressure is reached seconds

Patient exhales seconds




4.5 The PSV Mode (Pressure Support Ventilation)

In the PSV mode, the patient normally controls both the inspiration through the inspiratory trigger, and the exhalation by the expiratory trigger.

Inspiration is started when either the patient triggers a breath (if the trigger is activated), or when the breath rate setting initiates an inspiration. The ventilator tries to reach and maintain the set pressure until the expiration starts.

Inspiration stops and an exhalation starts in three cases:

• The inspiration flow has dropped to the value set for expiratory trigger.

• The limit for the high-pressure alarm is reached.

• The inspiration time is longer than the limit for maximal inspiration time or when inspiration time reaches 3 seconds.

The set IPAP pressure is used as a target pressure. If the flow is decreased to the expiratory trigger level before the set IPAP is reached the expiration starts.

The figure below shows how the pressure and the expiratory trigger settings control the ventilator’s function in the PSV mode.

The following settings have been used: Pressure 20 cmH

2

O, exp. trigger 8.

Pressure cmH

2

O

Pressure setting

IPAP

Max. delivered pressure

Flow

Insp. time PSV

Max. flow

EPAP

Exp. Trig.

setting

Patient exhales

Flow has dropped to set Exp. Trig.

New breath is triggered seconds seconds




29

4.6 The Difference between PCV and PSV Mode

The figure below shows the previous two examples superimposed to illustrate how the PCV and PSV modes differ.

Pressure cmH

2

O

PSV

PCV

IPAP

EPAP seconds

Flow

Insp. time PSV

Insp. time PCV seconds

4.7 The CPAP Mode

In CPAP mode, the device delivers a continuous positive airway pressure during operation.

The flow is automatically adjusted to maintain the set CPAP level, within the limitations of the devices flow compensation.




4.8 Standby and Operating Mode

Standby mode is defined as the state of the Vivo 30 when AC power is connected and the On/Off switch is on, but without starting the Vivo 30 with the

Start/Stop button.

Operating mode is defined as the state of the Vivo 30 when the fan is operating and producing an air flow.

Enter operating mode by switching the Vivo 30 on (see “Switching the Vivo 30

On and Off ” on page 33). Enter standby mode by switching the Vivo 30 off

again.

Some operations such as accessing the memory card and setting time and date are only available in standby mode.

4.9 Low Leakage Detection

The Vivo 30 automatically detects if the mask and tubing fitted to the device has sufficient leakage. If the leakage measured is below the recommended level it will generate a Low Leakage Alarm. The Vivo 30 will continue to deliver breaths during the alarm.

Check mask and tubing and if necessary clean ventilation holes if clogged.

4.10 Humidifier (optional)

The humidifier function is adjustable to provide additional humidity to the patient air.




31

5 Using the Vivo 30

5.1 Set up the Vivo 30 Before Use

Always perform the following checks before using the Vivo 30:

1

2

Connect a cleaned or new patient circuit to the Vivo 30.

Connect the Vivo 30 to the AC power source.

3

Switch on the Vivo 30 main power using the On/Off switch on the side panel.

4

Press the Start/Stop button on the front panel. Check that a short sound signal is heard. If there is no signal, do not use the Vivo 30 and contact your service provider.

5

Disconnect the power cord for more than 5 seconds. Check that the audible alarm for power failure sounds. If the power failure alarm is not heard, do not use the Vivo 30 and contact your service provider.

6

7

8

Reconnect the power cord. The alarm shall silence.

Put on the mask and adjust its fit.

Ensure that the settings are adjusted as prescribed.

The Vivo 30 is ready for use.




5.2 Switching the Vivo 30 On and Off

Switching On

1

Make sure the AC power source is connected and the

On/Off switch is switched on.

2

Turn on the Vivo 30 by pressing the Start/Stop button on the front panel for 2 seconds. A short sound signal is heard.

Switching Off

1

Press the Start/Stop button on the front panel for 2 seconds (max

4 seconds).

2

Release the Start/Stop button when the message is shown in the display window.

3

Turn off the Vivo 30 by pressing the Start/Stop button again.


Using the Vivo 30


33

5.3 Using the Menu

Use the four navigation buttons and the up, down, “+” and “-” buttons on the front panel to navigate the

Vivo 30 menu.

Read chapter “The Vivo 30’s Front Panel” on page 22 for exact position of the

buttons.

The navigation buttons are used to view the different sections defined above each navigation button. The same navigation button can also be used to view additional information in some sections.

Use the up or down button to enter the menu list.

During operation and when no button has been pressed for 20 seconds, the menu will automatically switch to the clock in home mode and to the simple setup in clinical mode.

The up and down buttons are used to select values in a section. The plus and minus buttons are used to alter a value.




Symbols Used in the Menu

S

YMBOL

D

ESCRIPTION

Alarm time active

HA 01 humidifier active

Ramp active

Panel locked

U

NIT

Hour : Minute

1 to 9, Off

Minute

On, Off

Panel locked by the Breas

Vivo PC software

Rise time

Inspiratory trigger

Expiratory trigger

On, Off

1 to 9

1 to 9, Off

1 to 9




35

Overview

The Vivo 30 menu has the following section layout in the clinic mode:

Mode Basic Setup

More Settings

Alarm Limits

Alarm History

Others

Humidity (if used)

Ramp

PCV PSV

CPAP

Wake Up Alarm

Adjust

Parameters

Adjust

Parameters

Adjust

Parameters

Device Settings

Alarm Limits Alarm Limits

Device Information

Alarm Limits

Memory Card

(standby only)

Home

Time and Date

(standby only)

The Vivo 30 menu has the following section layout in the home mode:

Main

Clinic

Others

Wake Up Alarm

Device Settings

Device Information

Memory Card

(standby only)

Time and Date

(standby only)

Humidity (if used) Ramp (if active)





The Others Menu

The menu list for “Others” in standby mode (with HA 01 humidifier connected).

The menu list for “Others” in operating mode.

Wake up Alarm

Navigate to the section “Others” and select “Wake up Alarm” to reach the

“Wake up Alarm” page.

Device Settings

Navigate to the section “Others” and select “Device Settings” to reach the

“Device Settings” page.



37

Device Information

Navigate to the section “Others” and select “Device Information” to reach the “Device Information” page.

Time and Date

Navigate to the section “Others” and select “Time and Date” to reach the

“Time and Date” page.

Switching between Clinical and Home Mode

1

Navigate to the “Mode” section.

2

Use the down arrow to navigate to the “Device Mode” setting. Select the required mode with the “+” and

“-” buttons.





3

Press “Go to home” to change to home mode.

4

In home mode, navigate to the

“Main” section and change the

“Device Mode” setting back to

“Clinical” if wanted.

When handing out the Vivo 30 to a patient, the panel should always be locked.

Locking and Unlocking the Panel

The panel can be locked in order to prevent an accidental change of settings. The panel is locked by pressing the “+” and “-” buttons simultaneously for 5 seconds. When locked, the Vivo 30 enters the home mode. It cannot be switched back to clinical mode by using the menu.

The Vivo 30 is unlocked from the home mode by pressing the “+” and “-” buttons again simultaneously for 5 seconds.



39

5.4 Monitoring Section

The monitoring section provides a display of the current treatment data. The monitoring section is located in the top of the display window:

Clinical Mode

The monitoring section contains a bargraph to display current pressure, information about max and min pressure, mode, estimated tidal volume, leakage, HA 01 humidifier, remaining ramp time, total rate and the I:E ratio.

In some screens, the information will adapt in size and amount depending on the page layout.

Home Mode

The monitoring section contains a bargraph, information about the alarm time, HA 20 humidifier, remaining ramp time and the panel lock is shown.

Settings in Home Mode

To show settings in home mode:

Enter the main screen and press up button for 3 seconds.




To show alarm history and alarm settings in home mode: Enter main screen and press down button for

3 seconds.

5.5 Transferring Data between the Vivo 30 and a PC

Read the chapter “Electrical Safety” on page 10 carefully to make sure all

conditions are fulfilled and considered.

In order to view and present patient data correctly, the Breas Vivo PC Software must be installed on the PC.

Instructions on how to manage data in the Breas Vivo PC Software can be found in the software help.

Data can be transferred in three ways:

• Memory card

• iCom communication unit

• Vivo-PC data cable




41

Memory Card

The Vivo 30 can only copy and transfer data to the memory card in standby mode (not operating).

The memory card is used for copying and transferring settings, detail logs, usage logs and breath logs.

1

Insert the memory card in the memory card slot on the side of the

Vivo 30. Make sure the memory card is properly inserted.

2

In clinical mode, navigate to the

“Memory Card” page under the

“Others” section.

In home mode, navigate to the

“Memory card” page under the

“Others” section

3

Select the desired operation and wait while the ventilator load or save to the memory card.

4

Connect the memory card reader/writer to the PC and insert the memory card. The Breas logo should be facing down.




Vivo-PC Data Cable

• The Vivo-PC data cable shall not be used for data transfer while the patient is connected to the Vivo 30. Only a PC that complies to the

IEC 60601-1 standards can be used for copying and transferring data during treatment of a patient.

• Never connect the Vivo 30 directly to a network port.

The Vivo-PC data cable can copy and transfer the same data as the memory card. However, the Vivo-PC data cable is considerably slower than the memory card. With the Vivo-PC data cable, real-time data can also be received and sent between the

Vivo 30 and a PC.

1

Connect the Vivo-PC data cable to the Vivo 30. Make sure it is fitted correctly.

2

Connect the other end of the

Vivo-PC data cable to the PC.


iCom Communication Unit

The iCom is an accessory which electrically isolates the Vivo 30 from a PC and other devices (i.e. plotters, printers etc). A common PC, which does not comply with IEC 60601-1, must comply with IEC 60950 and be placed outside the patient area (i.e. more than 2 meters from the patient).

The iCom can copy and transfer the same data as the memory card and the data cable. However, the iCom is considerably slower than the memory card.

With the iCom, real-time data can also be received and sent between the

Vivo 30 and a PC.



43

1

Connect the Vivo-iCom data cable to the Vivo 30. Make sure it is fitted correctly.

2

Connect the other end of the Vivo-iCom data cable to the iCom.

3

Connect the iCom-PC data cable between the iCom and a PC. Do only use either the D-sub cable or the USB cable.




5.6 Using the HA 01 Humidifier

Information about safety, warnings, product description, installation, usage, cleaning, maintenance and technical specifications can be found in the Breas

HA 01 Humidifier User manual.

Read the chapter “Humidification” on page 14 carefully to make sure all


If the AC power source fails and an external battery activates, the

HA 20 humidifier will be turned off automatically. It must be activated again manually, if humidification during battery use is necessary.

The HA 01 humidifier is intended to humidify the patient air. The

HA 01 humidifier must be installed in order to access and navigate to the humidifier setting on the Vivo 30 menu, both in clinical and home mode. The

HA 01 humidifier can only be activated if the Vivo 30 is operating.

If the HA 01 humidifier is disconnected and reconnected after usage according to the instructions in the HA 01 Humidifier User manual, the Vivo 30 will remember the humidity setting used.

5.7 Using Batteries

A battery is intended as a backup power source if the primary AC power source fails.

Power Source Priority

1

2

AC power

External DC

When the AC power supply fails, the Vivo 30 will switch to the external battery if installed and show a message in the display window.

Using the HA 01 humidifier while operating on a battery significantly decreases the battery operation time.




45

External Battery

The Vivo 30 can be operated from a 12 V or a 24 V DC external battery.

• Use the battery cable 12/24 V DC and check carefully that the voltage is

12 V or 24 V.

• Check the polarity of the external battery before connecting it to the

Vivo 30.

With an external battery connected, the Vivo 30 will automatically switch over to the external battery source if the AC power cord is removed or if the AC power supply fails. The external DC level is shown under “Others, Device information” in the menu.

1

Connect the external DC cable to the Vivo 30. Make sure that it is fitted correctly.

2

Connect the other end of the cable to the battery source.

• Only use a Breas external DC cable to connect the Vivo 30 to the external battery.

• An external battery must be disconnected when the Vivo 30 is switched off, otherwise the battery can be discharged.

External Battery Operation Time

The operation time is dependent on the battery condition, its capacity, the ambient air temperature and the Vivo 30 settings.




5.8 Vivo 30 Operating Time

The Vivo 30 records two types of operating times. They can be viewed on the page “Device Information” in the “Others” section.

Total Operating Time

Shows the total number of hours the Vivo 30 have been operating.

Patient Operating Time

Shows the total number of hours a patient have been using the Vivo 30 for breathing therapy.




47

6 Preparing the Vivo 30 for Use

Read the chapter “Safety Information” on page 8 before setting up and

using the Vivo 30.

6.1 Installing the Vivo 30

When using the Vivo 30 for the first time, follow the instructions below:

1

Check that all main components and ordered accessories have been delivered (refer to the packing note or the invoice, if available).

2

Ensure that the equipment is in good condition.

3

If stored more than 1 month, connect the Vivo 30 to the AC power supply and switch on the On/Off switch to recharge the alarm battery in standby mode.

4

Check that the air filters are installed.




6.2 Placing the Vivo 30

Read the chapter “Environmental Conditions” on page 11 carefully to

make sure all conditions are fulfilled and considered.

1

Place the Vivo 30 on a solid, flat surface facing towards the patient.

The Vivo 30 should be placed lower than the patient in order to prevent the device from falling on the patient, as well as preventing condensated water to reach the patient.

2

Make sure that nothing can block the patient air inlet at the rear of the

Vivo 30.

6.3 Connecting the Vivo 30 to the AC Power Source

Read the chapter “Electrical Safety” on page 10 carefully to make sure all


To connect the Vivo 30 to the AC Power Source:

1

Plug the power cord into the power inlet of the Vivo 30.

2

Create a small loop on the cable in order to prevent stretching. Secure the power cord using the cable holder.


Preparing the Vivo 30 for Use


49

3

Connect the power cord to the

AC power source.

6.4 Connecting the Patient Circuit

Read the chapter “Usage of Patient Circuit” on page 12 carefully to make

sure all conditions are fulfilled and considered.

1

Connect the patient tube to the air outlet.

2

Connect the other end of the patient tube to the mask and the leakage port, if applicable.

Intentional Leakage

The leakage from the mask or leakage/exhalation port should be at least

12 liter/min at 4 cmH

2

O, to prevent re-breathing of exhaled air. The recommended mask leakage is 20 to 40 liter/min at 10 cmH

2

O pressure.

This leakage may be achieved by:

• integrated leakage in the mask

• an adjoining leakage port




7 Setting Up the Vivo 30

Read the chapter “Safety Information” on page 8 before setting up and

using the Vivo 30.

The configuration of the Vivo 30 therapy settings must always be prescribed by a licensed physician and carried out by an authorized health care professional.

This chapter describes how to set the different parameters that are used for controlling the ventilation of the Vivo 30.

Follow the Instructions below when Setting Up the Vivo 30

• Adjust the settings to find the best possible breathing comfort for each patient.

• You must confirm all applicable settings for each of the PSV, PCV, or CPAP modes that are to be used by the patient. See the table matrix in the following section.

• If you have changed the ventilation mode, always consider the settings before pressing “Confirm”.

• Always document the set values before the patient returns home.


Setting Up the Vivo 30


51

7.1 Settings Applicable for the Different Modes

S

ETTING

EPAP

R

ANGE

2 cmH

-2 cmH

2

O to

20 cmH

2

2

O or IPAP

O.

PCV PSV CPAP

CPAP

Breath rate

4 to 20 cmH

2

O

4 to 40 BPM (Breaths

Per Minute)

0.3 to 5 sec Inspiration time

Min inspiration time Off, 0.3 to 3 sec

Max inspiration time 0.3 to 3 sec, Off

Rise time 1 to 9

Insp. trigger (PCV) 1 to 9, Off

Insp. trigger (PSV) 1 to 9

Exp. trigger 1 to 9

Ramp time (PSV,

PCV, CPAP)

10 to 60 min

Ramp start pressure 2 cmH

2

O to EPAP

Ramp start pressure 3 cmH

2

O to CPAP

HA 01 humidifier 1 to 9, Off

The ventilation modes and setting parameters are described in detail in the chapter

“Functions and Parameters of the Vivo 30” on page 25.




7.2 Selecting the Mode

Navigate to the section “Mode” and then to “Ventilation Mode”. Use the

“+” and “-” buttons to select the desired mode.

Follow the on-screen instructions and adjust the parameters according to the prescribed treatment.

The ventilator always starts in the mode and with the settings that were active when it was switched off.




53

7.3 Setting the Parameters

If the set values are outside the Vivo 30’s working range and cannot be achieved, the lines for these settings will flash. Adjust the settings so that the flashing ceases.

For more information about how to use the menu, please read the chapter “Using the Menu” on page 34.

Study the “Overview” on page 36 if a page or section cannot be found.

IPAP (PSV & PCV only, mandatory)

Setting range: 4 to 30 cmH

2

O.

Navigate to the section “Setup”.

EPAP (PSV & PCV only, mandatory)

Setting range: 2 cmH

2

20 cmH

2

O or IPAP -2 cmH

2

O.


O to

Breath Rate (PSV & PCV only, mandatory)

Setting range: 4 to 40 BPM.






Inspiration Time (PCV only, mandatory)

Setting range: 0.3 to 5 seconds.

Navigate to the section “Setup” and press “Setup” one more time to reach the “More Settings” page.

Rise Time (PSV & PCV only, mandatory)

Setting range: 1 to 9.


In PSV mode, Rise Time is limited by

Min Inspiration Time.

Inspiratory Trigger (in PSV mandatory, in PCV optional)

Setting range: 1 to 9, Off (where 1 is the most sensitive).


Expiratory Trigger (PSV only, mandatory)

Setting range: 1 to 9 (where 1 is the most sensitive).




55

Min and Max Inspiration Time (PSV only, optional)

Setting range: Off, 0.3 sec [min] and

3 sec [max].


CPAP (CPAP only, mandatory)

Setting range: 4 to 20 cmH

2

O.


The Ramp Function (optional)

Ramp function: On, Off or Disabled

(where On and Off turns on and off the ramp function in operating mode.

With the ramp function Disabled, it cannot be activated in operating mode).

Ramp time setting range: 10 to

60 min.

Start pressure setting range: 2 cmH

2

CPAP (CPAP).

O to EPAP (PSV & PCV), 3 cmH

2

O to

“Always start with ramp” setting range: On or Off or Disabled.

Navigate to the section “Others” and select “Ramp” to reach the “Ramp” page.

In home mode the ramp can be activated by pressing the ramp soft key for more than 1 second.




Humidifier (optional)

Setting range: 1 to 9 (where 9 is the maximum humidity), Off.

Navigate to the section “Others” and select “Humidity” to reach the

“Humidity” page.

In home mode the HA 01 humidifier can be activated by pressing the humidity soft key for more than

1 second.




57

8 Alarms

The adjustable alarm settings should be re-evaluated whenever a change in settings is made on the Vivo 30.

This chapter describes the alarm functions used for the Vivo 30, and how to adjust the alarm levels for each ventilation mode.

8.1 Alarm Function

The alarm function of the Vivo 30 consists of the alarm LEDs on the front

panel, an audible alarm, and messages on the LCD display (see “The Vivo 30’s

Front Panel” on page 22 for an overview of the position of the LEDs and the

LCD display).

Alarm Indication

As soon as an alarm condition is set, the Vivo 30 will alarm without delay.

When an alarm condition arises the alarm is indicated in three ways:

• Color LED on the panel: indicates the priority of the active alarm condition.

– High priority: Red color, flashing twice per second.

– Medium priority: Yellow color, flashing every 2 seconds.

• Alarm text in display: displays the name of the active alarm condition.

58 Alarms




• Audible signals: indicates the priority of the active alarm condition.

– High priority: 3 signals followed by 2 more. The signal sequence is repeated after a 0.5 seconds pause.

– Medium priority: 3 signals only, with a lower frequency than the high priority alarm. The signal sequence is repeated after a 6 seconds pause.

– Function failure. Same signal as the high priority alarm or a constant signal, depending on the kind of function failure.

Audible Signal Pause and Reactivation

The audible signal can be paused by pressing the Audio Pause button. If the ventilator still registers the same alarm after 60 seconds, and the Audio

Pause button was pressed, the audible signal will sound again.

Once the audible signal has been paused, it can be reactivated by pressing the

Audio Pause button again for 2 seconds.

If a new alarm condition occur during the silence period, the audible signal will be reactivated.

To ensure the timely detection of any new alarm condition, never leave a patient unattended while the audible signal is paused.

Alarm Reset

An alarm will automatically be reset once the cause of the alarm has been corrected.

If an alarm condition cannot be corrected, discontinue use and refer the

Vivo 30 for service.

Alarms


59

Alarm History Screen

Alarm History will display the 6 last alarms, when the alarm occurred and what type of alarm it was. The latest alarm will be placed in top of the list.

The Alarm History is maintained when the Vivo 30 is powered down.

The last set alarm settings are retrieved after power has been off.

60 Alarms



8.2 Physiological Alarm

Low Pressure Alarm

I

TEM

Definition

D

ESCRIPTION

A low pressure alarm will be given when the

Vivo 30’s pressure fails to reach the low pressure alarm limit for 15 seconds.

Possible cause

• Disconnection of patient circuit.

• Setting is higher than IPAP.

• Leakage from the mask or other components of the patient circuit.

Setting

Parameter: Low pressure

Min: Max: Resolution:

2 cmH

2

O IPAP 1.0 cmH

2

O

Ventilator action The Vivo 30 will continue to give breaths with the same settings.

Indication

The alarm is given audibly with a tone and visibly by the red alarm LED and a display message.


Alarms


61

High Pressure Alarm

I

TEM

D

ESCRIPTION

Definition

A high pressure alarm will be given when the

Vivo 30’s pressure exceeds 10 cmH

2

IPAP, for 3 consecutive breaths.

O more than

Possible cause

Only activated under exceptional conditions, such as a strong cough during the ventilator’s inspiration phase.

Setting

Self adjusting

Ventilator action The Vivo 30 will terminate inspiration from the first high pressure breath. The Vivo 30 will then continue to give breaths with same settings.

Indication

The alarm is given audibly and visibly by the red alarm LED and a display message.

62 Alarms




Low Volume Alarm

I

TEM

D

ESCRIPTION

Definition

A low volume alarm will be given when the

Vivo 30’s volume fails to reach the low volume alarm limit for 15 seconds (45 seconds after startup and after cancelling a high leakage alarm).

Possible cause

• Restrictions in airways.

• Obstructed or occluded patient circuit.

Setting

Parameter: Low volume

Min: Max:

Off, 0.03 l 2.0 l

Resolution:

0.05 l


Indication


Alarms


63

Low Leakage Alarm

I

TEM

D

ESCRIPTION

Definition

A low leakage alarm will be given when the measured flow is lower than the expected leakage flow at set pressure.

Possible cause

• Incorrect patient circuit leakage.

• Obstructed or occluded patient circuit.

Setting

Self adjusting

Ventilator action The Vivo 30 tries to continue delivering breaths according to settings.

Indication

The alarm is given audibly with a tone and visibly by the yellow alarm LED and a display message.

64 Alarms



High Leakage Alarm

I

TEM

D

ESCRIPTION

Definition

A high leakage alarm will be given when the measured flow exceeds the expected leakage flow at set pressure during more than 15 seconds.

Possible cause

• Leakage in patient circuit.

• The patient has removed the mask.

Setting

Self adjusting

Ventilator action The Vivo 30 tries to continue delivering breaths according to settings.

Indication



Alarms


65

8.3 Technical Alarm

Low External DC Warning

I

TEM

Definition

D

ESCRIPTION

A low external DC warning will be given when the external DC is the last power source and it falls below the voltage warning limit.

Possible cause

A discharged external battery.

Warning limits

These limits are only applicable on a power source specified by Breas Medical AB.

12 V source:

11.3 V

24 V source:

22.7 V


Indication

The warning is given audibly with a tone and visibly by the yellow alarm LED and a display message.

66 Alarms




Low Power Alarm

I

TEM

D

ESCRIPTION

Definition

A low power alarm will be given when the last power source has fallen lower than its voltage alarm limit.

Possible cause

• Lost connection to AC power.

• Discharged batteries.

Alarm limits

These limits are only applicable on a power source specified by Breas Medical AB.

AC power: External DC:

65 ±15 V 12 V:

10.0 ±0.5 V

24 V:

20.0 ±0.5 V

Ventilator action The Vivo 30 stops giving breaths and gives an alarm for 2 minutes.

If connected to AC power with a too low voltage, the Vivo 30 will enter standby mode.

Indication


Alarms


67

Internal Function Failure Alarms

I

TEM

D

ESCRIPTION

Definition

An internal function failure alarm will be given when the Vivo 30 has an internal function failure.

Ventilator action The Vivo 30 will continue or stop the treatment depending on the type and priority of the alarm.

Indication

The alarm is given audibly with a tone and visible by a display message at least for 120 seconds.

Ventilator reset

In order to stop the alarm the ventilator must be switched off by the On/Off switch on the side panel.

68 Alarms



9 Complete Function Check

This chapter describes the complete function check of the Vivo 30. This function check should be performed after changing the ventilation mode, or if the ventilator function needs to be checked for any other reason.

For information on the short function check, which should be performed once

a day, see “Set up the Vivo 30 Before Use” on page 32.

To perform a complete function check, all tasks in this chapter needs to be completed in the written number order.

9.1 Pre-use Check

Inspection of the HA 01 humidifier, if used

1

2

3

Remove and open HA 01 humidifier.

Check that there is no visible damage.

Check that the water container is clean.

Inspection of device

• Check that there is no visible damage.

• Check that the surface is clean.

• Check that the rear lid (or the HA 01 humidifier if applicable) is connected properly.

Inspection of cables

• Check that they are Breas cables.

• Check that the cables are undamaged.

• Check that the cables are properly connected.

Inspection of placement

• The Vivo 30 shall be placed on solid flat surface below the patient level.

• Make sure that nothing can block the patient air inlet at the rear.


Complete Function Check


69

9.2 Alarm Check

If an alarm check fails, do not use the Vivo 30 and contact your responsible service provider for an inspection of the device.

Chapter “Alarms” on page 58 has a detailed description of the alarm functions

used for the Vivo 30.

Prepare the Vivo 30 for the Alarm Test

1

Connect Vivo 30 to the AC power supply and turn it on.

2

Press the Start/Stop button on the front panel. Check that a short sound signal is heard. Press the Start/Stop button again to switch off the Vivo 30.

3

The Vivo 30 shall be in standby mode (not operating) and the AC LED

(see “The Vivo 30’s Front Panel” on page 22) shall be lit.

4

Adjust the ventilator settings as follows:

S

ETTING

Mode

IPAP

EPAP

Set rate

Inspiration time

Rise time

Inspiration trigger

Low pressure alarm

Low volume alarm

V

ALUE

PCV

14 cmH

2

O

2 cmH

2

O

10 BPM

1.5 sec

4

Off

2 cmH

2

O

0.05 l

Check the Low Leakage Alarm and High Leakage Alarm

5

6

7

Connect the patient circuit to a test lung (<1.5 l) and a leakage connector.

Enter operating mode by starting the treatment.

Block the leakage port.

8

9

The low leakage alarm shall occur within 60 seconds.

Disconnect the patient circuit from the air outlet.

10

The high leakage alarm shall occur within 30 seconds.

70 Complete Function Check




Check the High Pressure Alarm

11

Enter standby mode by stopping the treatment.

12

Connect a patient circuit to the Vivo 30.

13


14

Create pressure towards the Vivo 30 by blowing air into the mask or patient tube.

15

The high pressure alarm shall be activated after 3 consecutive high pressure breaths.

Check the Low Pressure Alarm

16

Enter standby mode by stopping the treatment.

17

Connect the patient circuit to a test lung (<1.5 l) and a leakage connector.

18

Adjust the IPAP to 12 cmH

2

O and the low pressure alarm to 10 cmH

2

O.

19


20


2

O.

21

The low pressure alarm shall occur within 30 seconds.

22


2

O.

23

The alarm shall disappear.

Check the Low Volume Alarm

24

Adjust the low volume alarm to 2.0 l.

25

The low volume alarm shall occur within 20 seconds.

26

Adjust the low volume alarm to 0.05 l.

27

The alarm shall disappear in 30 seconds.

Check the Low Power Alarm

28

Disconnect the power cord from the power supply.

29

Treatment stops and the power failure alarm shall occur.

30

Reconnect the power cord to the AC power supply.

31

The ventilator shall start automatically if the power is reconnected within

2 minutes.

Complete Function Check


71

10 Cleaning the Vivo 30 and Replacement of

Accessories

The patient-connected parts and the filter must be cleaned and replaced regularly to ensure correct function of the Vivo 30. All replaced parts must be disposed of in accordance with local environmental regulations regarding the disposal of used equipment and waste.

10.1 Cleaning the Vivo 30

To avoid electrical shock, disconnect the ACpower supply to the Vivo 30 before cleaning. Do not immerse the Vivo 30 into any fluids.

• Always be careful when cleaning to ensure that you do not damage any equipment.

• Fluid must not be allowed to enter into the Vivo 30.

• Do not sterilize the Vivo 30.

Main Unit

1

Switch off the Vivo 30 and disconnect the supply.

2

Remove the patient circuit.

3

At regular cleaning after normal use, keep the rear lid or the HA 20 heating unit attached. If attached, allow the HA 20 humidifier to cool down for ten minutes. Detach only the HA 20 water chamber.

In case a more thorough cleaning is needed, detach the rear lid or the

HA 20 heating unit.

72 Cleaning the Vivo 30 and Replacement of Accessories



4

Disconnect all electric cables.


5

Clean the outside of the Vivo 30 using a lint-free cloth and a mild soap solution. If the surface of the

Vivo 30 needs to be disinfected, this can be done with Virkon

®

or Gigasept

®

.

6

Reconnect the patient circuit. Make sure all parts are dry before the Vivo 30 is put into operation.

HA 01 Humidifier

The HA 01 humidifier should be cleaned, maintained and replaced in accordance with the manufacturer’s instructions.

For more information, see Breas HA 01 Humidifier User Manual.

Patient Circuit

The patient circuit should always be cleaned, disinfected and replaced in accordance with the applicable manufacturer’s instructions.

Always replace the patient circuit with a new one when the Vivo 30 is to be used by a new patient.

2

3

All parts that come into contact with the respiration gas must be cleaned as follows:

1

4

Place the dismantled parts in hot water containing mild detergent.

Remove fouling with a brush.

Rinse parts thoroughly under running hot water.

Shake water out of all parts.

Cleaning the Vivo 30 and Replacement of Accessories


73

5

6

Dry the parts completely.

Store in dust-free location.

Check the patient circuit for damage regularly. In case of damage, replace the circuit.

If the parts need to be disinfected, this can be done in a bath of disinfectant, for instance Virkon

®

or Gigasept

®

. Then rinse the parts well in clear water and dry them thoroughly.

10.2 Cleaning and Replacing the Patient Air Filters

The patient air filters are located in the filter cassette at the rear of the ventilator. There are two types of filters: washable filter and disposable filter.

Washable Filter (gray)

2

3

Replace the washable filter at least once a year. Wash the filter at least once a week.

1

Wash the filter using warm water and a mild soap.

Rinse thoroughly.

Dry the filter by squeezing it out in a towel. Do not wring the filter.

Disposable Filter (white)

Replace the filter at least every 4th week, or more often when used in high pollution or pollen-rich environments.

Do not wash or reuse the disposable filter.

74 Cleaning the Vivo 30 and Replacement of Accessories



10.3 Change of Patient

If the Vivo 30 is used in a clinic by several patients, a low resistance bacteria filter may be used between the air outlet and the patient tube to prevent patient cross-contamination. However, if a HA 01 humidifier is connected to the

Vivo 30, do not use any bacteria filter.

1

5

Follow the instructions in “Cleaning the Vivo 30” on page 72, step 1 to 5.

2

Clean the HA 01 humidifier according to the Breas HA 01 Humidifier

User Manual.

3

Replace the patient filters according to “Cleaning and Replacing the Patient

Air Filters” on page 74.

4

If a low resistance bacteria filter is used, it shall be replaced.

Use a new patient circuit when the Vivo 30 is used by a new patient.


Cleaning the Vivo 30 and Replacement of Accessories


75

11 Maintenance

WARNING!

• Vivo 30 should be subjected to maintenance, service and control and any applicable upgrades, in accordance with Breas service instructions.

• Vivo 30 shall only be repaired or modified in accordance with

Breas service manuals, technical bulletins, and any special service instructions, by service technicians that have been authorized after Breas Vivo 30 service training, or have an equivalent technical knowledge on medical device.

• Do not under any circumstances attempt to service or repair the

Vivo 30 yourself. If you do so, the manufacturer will no longer be responsible for the performance and safety of the Vivo 30.

D

EVIATION FROM THESE SERVICE INSTRUCTIONS MAY LEAD TO RISK OF

PERSONAL INJURY

!

11.1 Regular Maintenance Control

Regular maintenance inspections and controls shall be carried out at least every

12 months. Maintenance control according to the Vivo 30 Service Manual.

Do not use the device and contact your responsible care provider for an inspection of the device in the event of:

• Unexpected patient symptoms during treatment.

• Unexplainable or sudden pressure, performance or sound changes during operation.

• Suspected damage to the device.

76 Maintenance



11.2 Service and Repair

The service and repair of the Vivo 30 must be carried out by authorized service personnel in accordance with Breas service instructions. Service inspections must always be carried out after any repair of the device.

Authorized service workshops can order the Vivo 30 Service Manual that contains all technical documentation required for the maintenance and service of the

Vivo 30.

11.3 Storage

Empty, clean and dry the HA 01 humidifier (if applicable) before storage of the

Vivo 30.

11.4 Disposal

The Vivo 30, any accessories and all replaced parts must be disposed of and recycled in accordance with the local environmental regulations regarding the disposal of used equipment and waste.

Batteries used with the Vivo 30 shall be recycled in accordance with the local environmental regulations.


Maintenance


77

12 Technical Specifications

12.1 System Description

8

1

Blue

2

4

3

5

Yellow

Blue

6

Grey

Pink

7

6

Pink

9

12

10

11

6

7

4

5

2

3

N

O

.

1

8

9

10

11

12

D

ESCRIPTION

Air inlet filter

Blower

Silencer box

Vivo 30 casing

Pressure regulating valve

Pressure sensor

Flow sensor

Ambient

Humidifier (HA 01)

Patient tube

Leak hole

Mask




12.2 Data

S

ETTING

/V

ALUE

R

ANGE

/P

ERFORMANCE

Ventilation modes

• PSV (Pressure Support

Ventilation)

• PCV (Pressure Control

Ventilation)

• CPAP (Continuous Positive Airway Pressure)

Device modes • Clinical

• Home

EPAP 2 cmH

2

O to 20 cmH

2

O

O or

IPAP -2 cmH

2

Tolerance: ±2% of the maximum value and ±10% of the set value.

IPAP 4 to 30 cmH

2

O

R

ESOLUTION

0.5 below 10 cmH

1.0 above 10 cmH

2

2

O

O

CPAP

Breath rate


4 to 20 cmH

2

O.


4 to 40 breaths per minute

(BPM), tolerance: ±10% of set value.

Inspiration time 0.3 to 5 sec, tolerance: ±10% of set value.

Off, 0.3 to 3 sec Min inspiration time

Max inspiration time

0.3 to 3 sec, Off

Rise time 1 to 9

0.5 below 10 cmH

2

1.0 above 10 cmH

2

O

O

0.5 below 10 cmH

2

1.0 above 10 cmH

2

O

O

1 BPM

0.1 sec

0.1 sec

0.1 sec

1


Technical Specifications


79

S

ETTING

/V

ALUE

R

ANGE

/P

ERFORMANCE

Inspiratory trigger effort level

Expiratory trigger effort level

1 to 9, Off.

1 to 9, where 1 is the lowest effort and 9 is the highest effort setting.

Ramp function On, Off, Disabled

HA 01 humidifier

Audible alarm level

Settings: Off, 1 to 9, corresponds to 10 to 30 mgH

2

O/l,

<100% RH. Heat-up time from 73°F (23°C): less than

1 hour. Max gas temperature at patient port: 109°F (43°C).

1 to 9, where 1 is the lowest and 9 is the highest volume setting.

Maximum flow > 200 liter/min

Maximum limited pressure during single fault condition

Maximum steady limiting pressure

PCV, PSV:

60 cmH

2

O

CPAP: 30 cmH

2

O

Set IPAP + 10 cmH ance: ±10%

2

O, toler-

Max flow in

CPAP mode

Breathing resistance under single-fault

Sound level at

10 cmH

2

O

1/3 of max press.: 110 liter/ min

2/3 of max press.: 150 liter/ min

Max pressure: 155 liter/min

4 cmH

2

6 cmH

2

O at 30 liter/min

O at 60 liter/min

Less than 30 dB(A)

R

ESOLUTION

1

1

1

1

Measured at 1 m





I

NDICATOR

Pressure

Estimated tidal volume

Leakage

Total rate

I:E

S

PECIFICATION

0 to 30 cmH

2

O liter (BTPS, Body Temperature and Pressure Saturated) liter/min (BTPS)

BPM (Breath Per Minute)

1:10 to 10:1

R

ESOLUTION

±2% of full scale and

±4% of actual reading

±20% or ±20 ml, whichever is the greatest.

1 liter/min, ±20%

1

0.1 unit, ±1 unit

A

LARM

Auditory alarm signal pressure

Low pressure alarm

High pressure alarm

Low volume alarm

Low leakage alarm

High leakage alarm

Low External

DC Warning

Low power alarm

S

PECIFICATION

45 to 85 dB(A)

2 cmH

2

O to IPAP resolution 1 cmH

2

O

Self adjusting

Off, 0.03 l to 2.0 l resolution 0.05 l

Self adjusting

Self adjusting

Ext. DC 12 V: 11.3 V

Ext. DC 24 V: 22.7 V

AC power: 65 ±15 V AC

Ext. DC 12 V: 10.0 ±0.5 V

Ext. DC 24 V: 20.0 ±0.5 V

I

NDICATION

±5 dB(A).

Measured at 1 m.

Red LED, audible alarm and a warning message on the display.


Red LED, audible alarm and a warning message on the display. Accuracy:

0.05 l.

Yellow LED, audible alarm and a warning message on the display.


Yellow LED, audible alarm and a warning message on the display.




81

A

LARM

Internal function failure alarms

P

OWER SUPPLIES

AC power supply

External battery

S

PECIFICATION

I

NDICATION

Red or yellow LED, audible alarm and a warning message on the display.

S

PECIFICATION

100 to 240 V AC, tolerance: +10%/-20%, 50 to 60 Hz, max 140 VA

12/24 V DC, tolerance: +20%/-15% (10.5 to

15 V/20.4 to 30 V).

Max 120 W with Breas external battery.

E

NVIRONMENTAL

C

ONDITIONS

Operating temperature range

Storage and transport temperature

Ambient pressure range

Humidity

S

PECIFICATION

41 to 100°F (5 to 38°C)

-4 to +140°F (-20 to +60°C)

600 to 1060 cmH

2

O, corresponding to

~4000 metres above sea level to ~375 metres below sea level, at normal atmospheric pressure.

10% to 95%, non-condensing

O

PERATING

C

ONDITIONS

Recommended leakage

Minimum leakage

D

IMENSIONS

W

×

H

×

D

Weight

Air outlet

S

PECIFICATION

20 to 40 liter/min at 10 cmH

2

O

12 liter/min at 4 cmH

2

O

S

PECIFICATIONS

7.48

×

8.86

×

8.78 inch (with rear lid)

6.8 lbs (with rear lid)

22 mm male conical standard connector




12.3 Compliance of Standards

S

TANDARD

IEC 60601-1 (1988)

A1 (1991)

A2 (1995)

IEC 60601-1-2 (2001)

S

PECIFICATION

Medical electrical equipment - Part 1: General requirements for safety.

IEC 60601-1-4 (2000)

IEC 60601-1-8 (2003)

Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - requirements and tests.

Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems.

Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: Alarm systems - requirements, tests and guidelines.

ISO 10651-6 (2004)

ISO 17510-1 (2002)

ISO 8185 (2007)

CAN/CSA-C22.2

No. 601.1-M90

CAN/CSA-C22.2

No. 601.1S1-94

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home care ventilatory support devices.

Sleep apnea breathing therapy - Part 1: Sleep apnea breathing therapy devices.

Respiratory tract humidifiers for medical use -

Particular requirements for respiratory humidification systems.

Medical electrical equipement Part 1: General requirements for safety.

Supplement no. 1-94 to CAN/CSA-C22.2

No. 601.1-M90--Medical electrical equipement Part 1: General requirements for safety

CSA 601.1 Amendment 2:1998

UL Std No. 60601-1, 1st Ed. Medical electrical equipement Part 1: General requirements for safety.




83

C

LASSIFICATION

Class II (IEC 60601-1)

Class IIb

S

PECIFICATION

Class II, Type BF.

Electrical equipment with dual isolation and body floating (isolated) applied part according to IEC 60601-1.

Classification according to the European

Medical Device Directive 93/42/EEC.

The Vivo 30 and it’s packaging do not contain any natural rubber latex.




12.4 Delivery Settings

M

ODES AND

F

UNCTIONS

PSV

PCV

CPAP

Ramp

Clinical

Home

Humidifier

Wake up

P

ARAMETERS

IPAP

EPAP

CPAP

Breath rate

Inspiration time

Inspiration trigger

Expiration trigger

Rise time

Max inspiration time

Min inspiration time

Ramp time

CPAP ramp start pressure

IPAP ramp start pressure

S

ETTING

10 cmH

2

O

4 cmH

2

O

10 cmH

2

O

10 BPM

1.5 sec

3

3

3

Off

Off

10 min

4 cmH

2

O

4 cmH

2

O

On

Off

Off

Off

S

ETTING

On

Off

Off

Disable




85

A

LARMS

Low pressure

Low volume

O

THERS

Time format

Patient operating time

Pressure unit

Wake up alarm sound

Sound level (alarm)

Display light

Light intensity

Display contrast

Wake up time

Humidity level

S

ETTING

2 cmH

2

O

0.25 l

S

ETTING

12 h AM/PM

0 h cmH

2

O

1

5

Delayed

5

6

07:30, Off

6




13 Accessories

13.1 Breas Accessories List

Only use accessories recommended by Breas Medical AB. Breas Medical

AB cannot guarantee the performance and safety for the use of other accessories with the Vivo 30.

The following Breas accessories are currently available for the Vivo 30:

D

ESCRIPTION

Carry bag

Users manual

Clinician’s manual

Patient tube

P

ART

N

O

.

003519

003820

003887

004465

HA 01 humidifier 003530

Rear lid

Filter (grey, washable)

003591

003563 (5 pcs)

Filter (white, disposable)

Low resistance bacteria filter (303 Respirgard-II

Filter)

Power cord (Vivo)

003564 (5 pcs)

004185

003522

002185 Memory card reader/writer

Memory card

External DC cable iCom

Vivo-PC data cable, RJ45 to D-sub 9F

Vivo-iCom data cable, RJ45 to D-sub 15F

003619

003584

004143

003588

003574 iCom-PC data cable, D-sub 9M to D-sub 9F iCom-PC data cable, USB to USB

Vivo PC Software kit

003721

003722

004145


Accessories


87

Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (e.g. IEC 60950 for data processing equipment and IEC 60601-1 for medical equipment). Furthermore all configurations shall comply with the valid version of the system standard

IEC 60601-1-1. Everybody who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible that the system complies with the requirements of the valid version of the system standard IEC 60601-1-1. If in doubt, consult the technical service department or your local representative.

88 Accessories



BREAS Vivo 30 Ventilator Clinician’s manual

Assistant Bot

Table of Contents

1 Introduction

1.1 What is the Vivo 30?

1.2 Intended Use

1.3 Contraindications

1.4 About this Manual

2 Safety Information

2.1 General User Precautions

2.2 Electrical Safety

2.3 Environmental Conditions

2.4 Usage of Patient Circuit

2.5 Usage of Filters

2.6 Humidification

2.7 Cleaning and Maintenance

2.8 Adverse Patient Symptoms

2.9 Usage of Oxygen

3 Product Description

3.1 Main Components

3.2 Accessories

3.3 The Vivo 30’s Front Panel

3.4 The Vivo 30's Back and Side Panels

3.5 Equipment Designation and Safety Label

4 Functions and Parameters of the Vivo 30

4.1 Ventilation Mode

4.2 Device Mode

4.3 Settings

4.4 The PCV Mode (Pressure Control Ventilation)

4.5 The PSV Mode (Pressure Support Ventilation)

4.6 The Difference between PCV and PSV Mode

4.7 The CPAP Mode

4.8 Standby and Operating Mode

4.9 Low Leakage Detection

4.10 Humidifier (optional)

5 Using the Vivo 30

5.1 Set up the Vivo 30 Before Use

5.2 Switching the Vivo 30 On and Off

5.3 Using the Menu

5.4 Monitoring Section

5.5 Transferring Data between the Vivo 30 and a PC

5.6 Using the HA 01 Humidifier

5.7 Using Batteries

5.8 Vivo 30 Operating Time

6 Preparing the Vivo 30 for Use

6.1 Installing the Vivo 30

6.2 Placing the Vivo 30

6.3 Connecting the Vivo 30 to the AC Power Source

6.4 Connecting the Patient Circuit

7 Setting Up the Vivo 30

7.1 Settings Applicable for the Different Modes

7.2 Selecting the Mode

7.3 Setting the Parameters

8 Alarms

8.1 Alarm Function

8.2 Physiological Alarm

8.3 Technical Alarm

9 Complete Function Check

9.1 Pre-use Check

9.2 Alarm Check

10 Cleaning the Vivo 30 and Replacement of

Accessories

10.1 Cleaning the Vivo 30

10.2 Cleaning and Replacing the Patient Air Filters

10.3 Change of Patient

11 Maintenance

11.1 Regular Maintenance Control

11.2 Service and Repair

11.3 Storage

11.4 Disposal

12 Technical Specifications

12.1 System Description

12.2 Data

12.3 Compliance of Standards

12.4 Delivery Settings

13 Accessories

13.1 Breas Accessories List

Key Features

Frequently Answers and Questions

What is the Vivo 30?