Vivo 40 Clinician’s Manual Issue E-1

6

Preparing the Vivo 40 for Use ... 54

7

6.1 Installing the Vivo 40 ... 54 6.2 Placing the Vivo 40 ... 55 6.3 Connecting the Vivo 40 to the Mains Supply ... 55 6.4 Connecting the Patient Circuit... 56 Setting Up the Vivo 40 ... 58

8

7.1 Settings Applicable for the Different Modes ... 59 7.2 Selecting the Mode ... 60 7.3 Setting the Parameters ... 61 Alarms ... 66

9

8.1 Alarm Function ... 66 8.2 Physiological Alarm... 69 8.3 Technical Alarm... 76 Complete Function Check... 79

10

9.1 Pre-use Check ... 79 9.2 Alarm Check ... 80 Cleaning the Vivo 40 and Replacement of Accessories ... 83

11

10.1 Cleaning the Vivo 40 ... 83 10.2 Cleaning and Replacing the Patient Air Filters... 86 10.3 Change of Patient ... 87 Maintenance ... 88

12

11.1 Regular Maintenance Control ... 88 11.2 Service and Repair... 89 11.3 Storage... 89 11.4 Disposal ... 89 Technical Specifications ... 90

13

12.1 System Description ... 90 12.2 Data ... 91 12.3 Compliance of Standards ... 97 12.4 Delivery Settings ... 98 Accessories... 100 13.1

Breas Accessories List... 100

2 Table of Contents Vivo 40 clinician’s manual

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1

Introduction WARNING!

Vivo 40 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 40 is operated and maintained before taking it into use, to ensure correct usage, maximum performance and serviceability. WARNING!

Do not use the Vivo 40 for any kind of life support treatment. Breas Medical AB reserves the right to make changes to this product without any prior notification.

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Introduction 3 Vivo 40 clinician’s manual

1.1 What is the Vivo 40? The Vivo 40 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 40 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 40 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 40 is not intended for life support or life-sustaining applications or for transport of critical care patients. The Vivo 40 shall only be used by patients with spontaneous breathing. The Vivo 40 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.

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The Vivo 40 is intended for non-invasive use, or invasive use with appropriate patients. The Vivo 40 is intended for use in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments. The Vivo 40 must always be prescribed by a licensed physician. The Vivo 40 is intended for treatment of both adult and paediatric (who weigh more than 10 kg) patients. The Vivo 40 is intended to be operated by qualified and trained personnel, or by personnel who have been taught using the clinician’s manual.

1.3 Contraindications The use of the Vivo 40 is contraindicated on patients with severe respiratory failure without a spontaneous respiratory drive. Therapy with the Vivo 40 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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Introduction 5 Vivo 40 clinician’s manual

1.4 About this Manual Always read this manual before setting up and using the Vivo 40 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 40 system. The manual comprises detailed information on the settings and functions of the Vivo 40 to be handled by trained health care personnel only. • Patients and other lay users operating the Vivo 40 will find all the information they need in the User Manual. • Service personnel may order the Vivo 40 Service Manual that contains detailed technical information for maintenance, service and repair. 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.

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2

Safety Information

2.1 General User Precautions • The Vivo 40 must be switched off and on at least once a day. This is necessary in order for the Vivo 40 to perform a self test. • The Vivo 40 should not be used for total life support treatment. • The Vivo 40 shall only be used by patients with spontaneous breathing. • 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 40 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 40 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 40 is abnormally hot or emits an odour. Contact your responsible care provider for an inspection. • Inadequate use of device or accessories may cause loss of treatment or decreased performance. • The Vivo 40 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 40 Before Use” on page 35 before using the Vivo 40. • Only use accessories recommended by Breas Medical AB.

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Safety Information 7 Vivo 40 clinician’s manual

• Clinical personnel must read the Clinician’s manual thoroughly and understand the Vivo 40 operation before setting up and using the machine. • The user must read the user manual thoroughly and understand the Vivo 40 operation before using the machine. • All the physiological alarms of the Vivo 40 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 40 with care. • Make sure to place and pack the device in a way that prevents unintentional start of the machine. Due to the internal battery, the Vivo 40 may start if the Start/Stop button is pressed even without the mains being connected. • Do not use the Vivo 40 while in a carry bag. Attach the rear lid and place the swivel in a down position when placing the Vivo 40 in the bag. • If using the Vivo 40 for a short intra hospital or vehicle transportation, the following cautions need to be observed: – Do not mount the Vivo 40 on a wheelchair or in a vehicle. – Make sure that the Vivo 40 stands securely in a upright position and cannot tilt or fall. – Do not use the Vivo 40 outdoors during rain or snowfall. – If the HA 20 is attached, make sure that it is not in use and that the water chamber is empty.

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2.2 Electrical Safety • Do not operate the Vivo 40 if it has a damaged power cord or casing. • The Vivo 40 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 40 before cleaning. Do not immerse the Vivo 40 into any fluids. • The operator shall not touch accessible contacts of connectors and the patient simultaneously. • When handling the HA 20 heating unit, always turn off the Vivo 40 and disconnect the Vivo 40 from the mains supply. • Before detaching or attaching the HA 20 water chamber, always turn off the Vivo 40. • If an external battery is used, always disconnect it when the Vivo 40 is switched off. Otherwise there is a risk that the battery will discharge. • If the mains power source fails and the internal or the 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 40 to the iCom or a PC.

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Safety Information 9 Vivo 40 clinician’s manual

2.3 Environmental Conditions • Do not use the Vivo 40 in any toxic environment. • Do not use the Vivo 40 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 40. • The performance of the Vivo 40 may deteriorate at ambient temperatures below 5°C (41°F) and above 38°C (100°F). • Do not use the Vivo 40 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 97. 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 40. 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 40. Examples include: radio emitting devices such as cellular or cordless telephones, microwave ovens and high-frequency surgery apparatus.

• The Vivo 40, 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 40 and treatment of the patient may deteriorate if the operation conditions in “Technical Specifications” on page 90 are not fulfilled. Do not use the Vivo 40 immediately after storage or transport outside the recommended operating conditions.

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2.4 Usage of Patient Circuit • Only use the Vivo 40 with a mask, patient tube and leakage port recommended by Breas Medical AB and your health care professional. • The Vivo 40 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 40 causes a continuous flow of air to exhaust from the leak ports, flushing exhaled gas from the circuit. The Vivo 40 should be turned on and the leak ports should be checked before application. • Do not breathe in the connected patient circuit unless the Vivo 40 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 40 is to be used by a new patient. • Patient connected parts and filter must be replaced regularly to ensure correct function of the Vivo 40. 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 40 to ensure no water will flow back into the Vivo 40. 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 needs assistance to take off the patient interface, the patient shall not be left alone. This is to avoid the risk of re-breathing of CO2 in case of accidental ventilator failure. • If the patient is using a full face mask (covering mouth and nose), the mask must be equipped with a safety entrainment valve.

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Safety Information 11 Vivo 40 clinician’s manual

• 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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2.5 Invasive Use • For invasive applications, assure that an intentional leakage port is present in the patient circuit. Install the leakage port as close as possible to the patient connection, to reduce the risk of rebreathing CO2. • When using the Vivo 40 invasively the low volume alarm and the low breath rate alarm must be carefully set, to ensure safe use. • The highest output from the HA 20 humidifier is 30 mgH2O/litre, which means that it does not fulfill the humidifier standard for invasive use. • The Vivo 40 is equipped with a low leakage alarm. The low leakage alarm is not a substitute for operator vigilance in ensuring that the leakage ports remains clear at all times. Periodically check the leakage ports during therapy. • In general as pressure decreases the potential of rebreathing increases. Lower pressures produce less flow through the leakage ports which may not clear all CO2 from the circuit to prevent rebreathing. • In general as inspiratory time increases the potential of CO2 rebreathing increases. A higher inspiratory time decreases the expiratory time allowing less CO2 to be cleared from the circuit before the next breath. I:E (inspiration time : expiration time) ratios close to 1:1 increase the potential of CO2 rebreathing. • Endotracheal tubes, oral/nasal tubes etc with small inner diameters increase the resistance in the breathing circuit. • An external heated humidifier approved for invasive use or an appropriate HME (Heat and Moisture Exchanger, artificial nose)/HCH (Hygroscopic Condenser Humidifier) is recommended.

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Safety Information 13 Vivo 40 clinician’s manual

2.6 Usage of Filters • Always use the Vivo 40 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 40, especially when changing patient. Failure to replace or clean a dirty filter may cause the Vivo 40 to operate at higher temperatures than intended. • When operating the Vivo 40, make sure that the air inlet and filters are not obstructed or occluded. • If the Vivo 40 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 100. 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 20 humidifier.

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2.7 Humidification • The HA 20 humidifier is intended for non-invasive use only. • Before transportation of the Vivo 40 with the installed HA 20 humidifier, always disconnect the water chamber from the heating unit. • Do not place the Vivo 40 with the HA 20 humidifier in a bag when the water chamber is attached. • When the HA 20 humidifier is installed, the Vivo 40 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 40 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 40’s low-pressure alarm. • Certain HME’s and HCH’s (Hygroscopic Condenser Humidifiers) are sufficient to provide humidification when the Vivo 40 is used invasively. Check specific suppliers recommended use.

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Safety Information 15 Vivo 40 clinician’s manual

2.8 Cleaning and Maintenance • The Vivo 40 should be cleaned and maintained in accordance with this operating manual. • Do not attempt to autoclave or sterilise the Vivo 40. • Vivo 40 should be subjected to maintenance, service and control and any applicable upgrades, in accordance with Breas service instructions. • Vivo 40 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 40 yourself. If you do so, the manufacturer will no longer be responsible for the performance and safety of the Vivo 40. Furthermore, no warranty will be valid.

2.9 Adverse Patient Symptoms If the patient experiences discomfort or any of the following symptoms while using the Vivo 40, 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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2.10 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 40, the oxygen flow must be turned off when the Vivo 40 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 40 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 litre/min. • Supplemental oxygen affects the accuracy of the volume and flow measurements. It is not recommended to use supplemental oxygen when target volume is active.

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Safety Information 17 Vivo 40 clinician’s manual

3

Product Description

3.1 Main Components The Vivo 40 system contains the following components:

3 2

4

1

5 6

7 8

18 Product Description Vivo 40 clinician’s manual

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NO.

COMPONENT

FUNCTION

PART NO.

1

Carry bag

Storage for transportation

003519

2

User manual

Product and usage information 003821

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

003591

8

Vivo 40 main unit

For usage without the HA 20 humidifier

Product Description 19 Vivo 40 clinician’s manual

3.2 Accessories

9

11

10

13

12

14

16

20

17

15

18

21

19

22

NO.

COMPONENT

FUNCTION

PART NO.

9

HA 20 Humidifier

Humidifies patient air

2230 XX

10

Trach elbow

Trach connection

004810

11

Hygroscopic Con- Humidifier denser Humidifier (HCH)

20 Product Description Vivo 40 clinician’s manual

003974

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