Vivo 30 Users Manual Rev Z-1

8

7.3 Technical Alarm... 44 Cleaning the Vivo 30 and Replacement of Accessories ... 47

9

8.1 Cleaning the Vivo 30 ... 47 8.2 Cleaning and Replacing the Patient Air Filters... 50 Maintenance ... 51

10

9.1 Regular Maintenance Control ... 51 9.2 Service and Repair... 52 9.3 Storage... 52 9.4 Disposal ... 52 Technical Specifications ... 53

11

10.1 Data... 53 Accessories... 58

12

11.1 Breas Accessories List... 58 Patient Settings ... 60

2 Table of Contents BREAS Vivo 30 users manual

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1

Intended Use of the Vivo 30 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.

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

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Intended Use of the Vivo 30 3 Vivo 30 users manual

• 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 setting. The end-expiratory pressure is set by the EPAP 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.

1.2 Indications for 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. The Vivo 30 can be used in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments. It 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.

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1.3 Contraindications The use of the Vivo 30 is contraindicated on patients with severe respiratory failure without a spontaneous respiratory drive. Therapy with the Vivo 30 may be contraindicated when the following specific diseases or conditions are present: • Pathologically low blood pressure • Severe cardiac arrhythmias • Unstable angina pectoris • Decompensated cardiac failure or hypotension, particularly if associated with intravascular volume depletion • Untreated Pneumothorax • Pneumomediastinum • Massive epistaxis or previous history of massive epistaxis (risk of recurrence) • Pneumoencephalus, recent trauma or surgery that may have produced cranio-nasopharyngeal fistula

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.

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Intended Use of the Vivo 30 5 Vivo 30 users manual

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 intended for patients and other lay users operating the Vivo 30. Care providers, clinical personnel, physicians and others who require a working knowledge of the Vivo 30 will find additional information on settings and functions in the Clinician’s Manual. Icons

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

EXPLANATION

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.

6 Intended Use of the Vivo 30 Vivo 30 users manual

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Safety Information

2.1 General User Precautions • The Vivo 30 must be switched off and on at least once a day. This is necessary in order for the Vivo 30 to perform a self test. • The Vivo 30 should not be used for total life support treatment. • The Vivo 30 shall only be used by patients with spontaneous breathing. • If you are admitted to a hospital or are prescribed any other form of medical treatment, always inform the medical staff that you are 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 and contact your responsible care provider for an inspection 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 odour. • 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 advice and must be carried out 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 24 before use. • Only use accessories recommended by Breas Medical AB.

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Safety Information 7 Vivo 30 users manual

• Clinical personnel and the patient must read the manual thoroughly and understand the Vivo 30 operation before setting up and 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. • Make sure to place and pack the device in a way that prevents unintentional start of the machine. Attach the rear lid and place the swivel in a down position when placing the Vivo 30 in the carry bag. • Handle the Vivo 30 with care. • Do not use the Vivo 30 while in the carry 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 snow fall.

• Do not use the HA 01 humidifier.

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 mains. • Before a filled HA 01 humidifier is attached, connect all cables to the Vivo 30 but not to the mains.

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• 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 external power source fail and an external battery activates, the HA 01 humidifier will be turned off automatically. It needs to be activated again manually if needed. • Only use the data connection to connect the Vivo 30 to the iCom or a PC.

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Safety Information 9 Vivo 30 users manual

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. • If a room humidifier is used, place it at least 2 metres away from the Vivo 30. • The performance of the Vivo 30 may deteriorate at ambient temperatures below 5°C (41°F) and above 38°C (100°F). • 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. 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. Radio emitting devices are e.g cellular or cordless telephones, microwave ovens and high-frequency surgery apparatus.

• The Vivo 30, any accessories and all replaced 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 deteriorate if the operation conditions in “Technical Specifications” on page 53 are not fulfilled. Do not use the Vivo 30 immediately after storage or transport outside the recommended operating conditions.

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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 a leak port instead of an actively controlled exhalation valve to remove exhaled gases from the patient circuit. Therefore, specific masks and patient circuits using a 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 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. • 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. • 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 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 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.

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Safety Information 11 Vivo 30 users manual

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. • 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.

2.6 Humidification • The HA 01 humidifier is intended for non-invasive use only. • Humidification must only be used if this has been prescribed by your physician. The Vivo 30 therapy settings must always be prescribed by a physician or other licensed health care professional, and be carried out by authorized clinical personnel. • The humidifier shall be disconnected from the Vivo 30 during transportation. The Vivo 30 shall not be placed in the bag with the HA 01 humidifier attached. • 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.

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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 sterilise 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 guarantees 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

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Safety Information 13 Vivo 30 users manual

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 2 metres 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 l/min. • Supplemental oxygen affects the accuracy of the volume and flow measurements.

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Safety Information 15 Vivo 30 users manual

3

Product Description

3.1 Main Components The Vivo 30 system contains the following components:

3 2 4

1

6

5

7 8

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NO.

COMPONENT

FUNCTION

PART NO.

1

Carry bag

Storage for transportation

003519

2

User manual

Product and usage information 003822

3

Patient tube

004465

4

Power cord

003521 (EU: 003520)

5

Filter (white, disposa- Inlet air filtration ble)

003526

6

Filter (grey, washable) Inlet air filtration

003527

7

Rear lid

8

Vivo 30 main unit

For usage without HA 01 humidifier

the 003591

Product Description 17 Vivo 30 users manual

3.2 Accessories

11

10 9

13

12 NO.

COMPONENT

FUNCTION

PART NO.

9

HA 01 Humidifier

Humidifies patient air

003530

10

iMask 100

003971

11

iMask 200

003972

12

Battery cable 12/24 V DC

004258

13

EB 2 Battery kit

Includes:

004128

• Charger • Trafobox • Isolation • Battery pack • Carry bag • Power cord 24 V AC • Power cord 24 V DC • Power cord mains • EB 2 User manual

18 Product Description Vivo 30 users manual

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3.3 The Vivo 30's Front Panel

11 12

2 17

13

3 4

14 18

1

5

15

6

16

7, 8, 9, 10

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NO.

USER BUTTONS

FUNCTION

1

Start/Stop

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

NO.

LED

FUNCTION

2

Trigger

Patient breath trigger indication

3-4

Alarm (red & yellow)

Alarm indication

5

Audio pause

Paused alarm sound indication

11

Mains

Power source: Mains

12

External DC

Power source: External DC

NO.

DISPLAY WINDOW

FUNCTION

17

Monitoring section

Current treatment data

18

Active section

Adjustable settings

Product Description 19 Vivo 30 users manual

3.4 The Vivo 30's Back and Side Panels 1 2 3 4 5

6 7 8 9

NO.

ITEM

FUNCTION

1

Air inlet

Air path in, replaceable filters

2

Locking mechanism

Release and lock the HA 01 humidifier or rear lid

3

Air outlet

Air path out to the patient

4

Memory card slot

Read and write memory card

5

HA 01 humidifier

Patient air humidification

6

Mains inlet

Connection for an external mains power source

7

On/Off

Mains power on and off

8

External DC inlet

External DC power source connection

9

Data connection

Data cable connection (iCom/PC and the Vivo 30)

20 Product Description Vivo 30 users manual

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