Vivo 50 Operating Manual Issue L-2

Table of Contents 1

Introduction ... 3 1.1 What is the Vivo 50?... 3 1.2 Intended Use... 4 1.3 Contraindications ... 4 1.4 About this Manual ... 5

2

Safety Information ... 7 2.1 General User Precautions... 7 2.2 Electrical Safety ... 9 2.3 Environmental Conditions ... 10 2.4 Usage of Patient Circuit... 12 2.5 Usage of Filters ... 14 2.6 Humidification... 15 2.7 Cleaning and Maintenance ... 16 2.8 Usage of Oxygen ... 16

3

Product Description... 18 3.1 Main Components ... 18 3.2 The Vivo 50's Front Panel... 20 3.3 The Vivo 50's Side Panels ... 21 3.4 Equipment Designation and Safety Label ... 23

4

Preparing the Vivo 50 for Use ... 27 4.1 Checking the Vivo 50 before First Use ... 27 4.2 Placing the Vivo 50 ... 28 4.3 Connecting the Vivo 50 to Mains... 29 4.4 Connecting the Patient Circuit ... 30 4.5 Inspecting the Vivo 50 before Use... 31 4.6 Adjusting the Vivo 50’s Patient Settings ... 32 4.7 Performing the Pre-use Test... 33

5

How to Use the Vivo 50... 35 5.1 Switch the Vivo 50 On and Off ... 35 5.2 Using the Menu ... 37 5.3 Monitored Values in the Vivo 50 ... 51 5.4 Functions and Parameters in the Vivo 50... 55 5.5 Modes in the Vivo 50... 74 5.6 Transferring Data between the Vivo 50 and a PC... 79 5.7 Using Batteries... 81 5.8 Using Accessories... 88

6

Alarms... 100 6.1 Alarm Function ... 100 6.2 Operator’s Position ... 102 6.3 Physiological Alarms ... 103 6.4 Technical Alarms ... 126 6.5 Alarm Test ... 141

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Table of Contents 1 Vivo 50 Operating manual

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Cleaning and Maintenance ... 143 7.1 Cleaning the Vivo 50 ... 144 7.2 Cleaning and Replacing the Patient Air Filters... 145 7.3 Change of Patient... 146 7.4 Regular Maintenance Control ... 146 7.5 Service and Repair ... 147 7.6 Storage... 147 7.7 Disposal ... 147

8

Technical Specifications ... 148 8.1 System Description ... 148 8.2 Data... 150 8.3 Compliance of Standards... 161 8.4 Delivery Settings ... 163

9

Accessories... 166 9.1 Breas Accessories List... 166

10

Patient Settings ... 172

11

Index ... 174

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1

Introduction WARNING!

Vivo 50 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 50 is operated and maintained before taking it into use, to ensure correct usage, maximum performance and serviceability. Breas Medical AB reserves the right to make changes to this product without any prior notification.

1.1 What is the Vivo 50? The Vivo 50 is a pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation. The Vivo 50 can be operated in 9 different combinations of ventilation and breath modes: • PSV – Pressure Support Ventilation • PSV(TgV) – Pressure Support Ventilation with Target Volume • PCV – Pressure Controlled Ventilation

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Introduction 3 Vivo 50 Operating manual

• PCV(TgV) – Pressure Controlled Ventilation with Target Volume • PCV(A) – Assisted Pressure Controlled Ventilation • PCV(A+TgV) – Assisted Pressure Controlled Ventilation with Target Volume • VCV – Volume Controlled Ventilation • VCV(A) – Assisted Volume Controlled Ventilation • CPAP – Continuous Positive Airway Pressure The Vivo 50 can be used with a leakage circuit or a circuit with active exhalation valve. The internal memory data of the Vivo 50 can be downloaded to a PC, printed out, and analysed via the Vivo 50 PC Software. For more information about the Vivo 50 PC Software, please contact your Breas representative.

1.2 Intended Use The Vivo 50 is intended for ventilation treatment: • in hospitals, alternate care settings, patients’ homes, transport settings such as wheelchairs, personal family vehicles, intra hospitals, ground ambulances and civil aircraft. • under the direction of a physician, by qualified personnel that is trained in ventilation therapy. • of adult and paediatric (>10 kg) patients with reduced lung function who are dependent on ventilatory support, such as acute respiratory failure, acute or chronic respiratory insufficiency. • either invasively or non-invasively. • that may be life-supporting, provided that emergency equipment (resuscitation bag) is available.

1.3 Contraindications • The use of the Vivo 50 is contraindicated for patients who need to be ventilated with oxygen concentrations (FiO2) higher than

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achievable when combining inlet from a low pressure oxygen source at 15 l/min with actual ventilator settings. • Generally after surgery, the surgeon has to be consulted to avoid organ damage and care should be taken to choose ventilator parameters that do not adversely affect haemodynamics or have a negative impact on the patients health status. • In case of facial surgery, make sure to choose a suitable patient interface, in order to avoid discomfort and injury. The Vivo 50 is not intended to be used as an emergency transport ventilator or critical care ventilator. Undesirable Side Effects If the patient experiences chest discomfort, pain, severe headache or shortness of breath while using the Vivo 50, a physician or responsible clinician shall be contacted immediately.

1.4 About this Manual Always read this manual before setting up and using the Vivo 50 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 Vivo 50 system. The manual comprises detailed information on the settings and functions of the Vivo 50, to be handled by trained health care personnel only. Patients and lay caregivers may read the operating manual for reference purposes, after appropriate guidance from the responsible care provider. Service personnel may order the Vivo 50 Service Manual that contains detailed technical information for maintenance, service and repair.

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Introduction 5 Vivo 50 Operating 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.

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2

Safety Information

2.1 General User Precautions • When a patient is treated, there must be a supervising person present during the treatment in order to take care of alarms and conditions that the patient cannot solve on their own. • The Vivo 50 must be switched off and on at least once a week. This is necessary in order for the Vivo 50 to perform a complete self-test. • 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 50 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 form and only with accessories specified or approved by Breas Medical AB.

• Do not use the Vivo 50 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 50 is abnormally hot or emits an odour. In these cases, contact the patient’s responsible care provider for an inspection. • The Vivo 50 may not work properly if any part has been dropped, damaged or submerged in water. • Inadequate use of device or accessories may cause loss of treatment or decreased performance. • The Vivo 50 therapy settings must always be based on medical advice and must be carried out by authorised clinical personnel only. Blood gas measurement shall be performed when changing treatment settings or changing to another device.

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Safety Information 7 Vivo 50 Operating manual

• Always perform the procedure “Inspecting the Vivo 50 before Use” on page 31 before use. • The Vivo 50 can be used for life-supporting treatment in accordance with the ISO 10651-2 standard (Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients.), provided that the CO2 sensor or an external EtCO2 monitor (capnometer) is used for surveillance of ventilator-dependent patient breathing. The CO2 sensor must be connected between the patient and the external exhalation valve or leakage port to be able to measure exhaled gases. The CO2 monitor shall fulfil the ISO 21647:2004 standard (Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors). • Clinical personnel must read the manual thoroughly and understand the Vivo 50 operation before setting up and using the machine. • All the physiological alarms of the Vivo 50 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 50 with care. • Do not use the Vivo 50 while in the carry bag.

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2.2 Electrical Safety • Do not operate the Vivo 50 if it has a damaged power cord or casing. • To avoid electrical shock, disconnect the electrical supply to the Vivo 50 before cleaning. Do not immerse the Vivo 50 into any fluids. • If a multiple portable socket-outlet is used, it must not be placed on the floor. • Do not use more than one multiple portable socket-outlet or extension cord. • The operator must not touch accessible contacts of connectors and the patient simultaneously. • Nurse Call must only be connected to a safety extra low voltage system with an isolation from mains voltage which complies with the requirements of IEC 60601-1. • The aspects of electromagnetic compatibility must be considered. The Vivo 50 should not be used adjacent to or stacked with other equipment; if adjacent or stacked use is necessary, the Vivo 50 should be observed to verify normal operation in that configuration. Mobile or transportable radio transmitters may interfere with the Vivo 50. Guidance for safe installation of the Vivo 50 can be found in the service manual. • If a portable AC power supply is used, make sure that the voltage variations are within the operating limits of the Vivo 50. See “Power Supply” on page 157 for AC operating limits.

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Safety Information 9 Vivo 50 Operating manual

2.3 Environmental Conditions • Do not use the Vivo 50 in any toxic environment. • Do not use the Vivo 50 in environments where there are explosive gases or other flammable anesthetic agents present. • The air flow for breathing produced by the Vivo 50 can be as much as 4°C (7°F) higher than room temperature. Caution should be exercised if the room temperature is greater that 36°C (97°F). • If a room humidifier is used, place it at least 2 metres away from the Vivo 50. • The performance of the Vivo 50 may deteriorate at ambient temperatures below -20°C (-4°F) and above 40°C (104°F). However, the treatment shall always be started in an ambient temperature warmer than 5°C (41°F). • Do not use the Vivo 50 system in an MR environment. • Do not expose the Vivo 50 to rain or snowfall.

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• Do not use the Vivo 50 while positioned in a warm place, such as direct sunlight or close to a radiator. • The device complies with the EMC requirements of standards listed in “Compliance of Standards” on page 161. Necessary measures should be taken in order to assure field levels exceeding 20 V/m are avoided, since this may impair the safety and performance of the Vivo 50. 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 50. Radio emitting devices are e.g cellular or cordless telephones, microwave ovens and high-frequency surgery apparatus.

• The Vivo 50, 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 50 and treatment of the patient may deteriorate if the operation conditions in “Technical Specifications” on page 148 are not fulfilled. Do not use the Vivo 50 immediately after storage or transport outside the recommended operating conditions.

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Safety Information 11 Vivo 50 Operating manual

2.4 Usage of Patient Circuit • The Vivo 50 supports both leakage circuits and circuits with an active exhalation valve. • For the Vivo 50 to deliver treatment according to settings, it is important that the selection of the patient circuit type is correctly set. • Only use the Vivo 50 with accessories recommended by Breas Medical AB. • The pressurized air from the Vivo 50 causes a continuous flow of air to exhaust from the leakage ports or exhalation valve, flushing exhaled gas from the circuit. The Vivo 50 should be turned on and the function of the leakage port or exhalation valve should be checked before use. • Do not breathe in the connected patient circuit unless the Vivo 50 is turned on and operating properly. • Do not use patient hoses or tubes made of static or electrically conductive material. • Always use a cleaned or new patient circuit when the Vivo 50 is to be used by a new patient. • Always make sure that the patient circuit and joined parts are undamaged and correctly connected, in order to avoid unwanted leakage. • Always perform a pre-use test when the patient circuit is replaced or modified. • Patient connected parts and all filters must be replaced regularly to ensure correct function of the Vivo 50. 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 50 to ensure no water flows back into the Vivo 50. 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.

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• When using the Vivo 50 invasively, the low volume alarm and the low breath rate alarm must be carefully set, to ensure safe use. • The use of equipment such as endotracheal tubes, oral/nasal tubes, adaptors etc. with small inner diameters or high resistance filters, humidifiers etc. increase the resistance in the patient circuit which may interfere with the operation of the patient disconnect function. It may also interfere with the device trigger function. The impact can be reduced by conducting a pre-use test properly (see “Performing the Pre-use Test” on page 33). • In case of invasive application, the use of an appropriate external heated humidifier or HME (Heat and Moisture Exchanger, artificial nose)/HCH (Hygroscopic Condenser Humidifier, part no. 003974) is recommended. • Make sure that the exhalation valve or the leakage port is never blocked or obstructed. • 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. • The Vivo 50 is equipped with a rebreathing alarm. The alarm is not a substitute for operator vigilance in ensuring that the leakage port or exhalation valve remains clear at all times. Periodically check the patient circuit during therapy. • In general, as pressure decreases the potential of rebreathing increases. Lower pressures produce less flow through the leakage port which may not clear all CO2 from the circuit to prevent rebreathing. • To reduce the risk of rebreathing CO2: – Single limb circuit use, make sure that the leakage port or active exhalation valve is present as close as possible to the patient connection. – Dual limb circuit with exhalation valve use, make sure that the Ypiece is present as close as possible to the patient connection.

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Safety Information 13 Vivo 50 Operating manual

2.5 Usage of Filters • Always use the Vivo 50 with patient air inlet filters installed. Only use the Vivo 50 with accessories recommended by Breas Medical AB. • Replace or clean the filters regularly to ensure correct function of the Vivo 50, especially when changing patient. Failure to replace or clean a dirty filter may cause the Vivo 50 to operate at higher temperatures than intended. • When operating the Vivo 50, make sure that the air inlet and filters are not obstructed or occluded. • If the Vivo 50 is used in a clinic by several patients, a low resistance bacterial filter is recommended between the air outlet and the patient circuit to prevent patient cross-contamination (Breas Medical AB recommends the low resistance bacterial filter part no. 004185). Reuse of mask or bacterial filter may expose patients to contagious agents. • The use of a high resistance bacterial 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. The impact can be reduced by conducting a pre-use test properly (see “Performing the Pre-use Test” on page 33). • When adding or removing any kind of filter, always perform a preuse test.

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2.6 Humidification • Humidification must only be used if this has been prescribed by a physician. • When using an external heated humidifier, it should be located below the Vivo 50 and the patient to prevent injury from accidental spillage. • During transportation of the Vivo 50, the humidifier must be disconnected. • 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. • When adding or removing a HME (Heat and Moisture Exchanger, artificial nose) or HCH ((Hygroscopic Condenser Humidifier), always perform a pre-use test. • Any humidifier connected to the Vivo 50 must comply with ISO 8185. • Any HME connected to the Vivo 50 must comply with ISO 9360. • The use of an HME or an external humidifier may require readjustment of the Vivo 50 low-pressure alarm. • Certain HME’s and HCH’s are sufficient to provide humidification when the Vivo 50 is used invasively. Check specific suppliers’ recommended use.

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Safety Information 15 Vivo 50 Operating manual

2.7 Cleaning and Maintenance • The Vivo 50 should be cleaned and maintained in accordance with this operating manual, see “Cleaning and Maintenance” on page 143. • Do not attempt to autoclave or sterilise the Vivo 50 main unit. • Vivo 50 should be subjected to maintenance, service and control and any applicable upgrades, in accordance with Breas service instructions. • Vivo 50 shall only be repaired or modified in accordance with Breas service manuals, technical bulletins, and any special service instructions, by service technicians authorised by Breas Medical AB. • Do not under any circumstances attempt to open, service or repair the Vivo 50 yourself. If you do so, the manufacturer will no longer be responsible for the performance and safety of the Vivo 50. Furthermore, no guarantees will be valid.

2.8 Usage of Oxygen • Always follow the oxygen provider’s instructions. • The presence of oxygen can speed up combustion of inflammable materials. • At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen concentration will vary, depending on the pressure delivered, the patient’s breathing pattern, mask selection and leak rate. To monitor the oxygen concentration the FiO2 sensor (part no. 004888) is recommended. • When oxygen is used with the Vivo 50, the oxygen flow must be turned off when the Vivo 50 is not operating. Oxygen delivered into the patient tubing may accumulate within the machine enclosure. Oxygen accumulated in the machine enclosure will increase the risk of fire.

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• Do not use a humidifier between the oxygen source and the ventilator, in order to humidify the oxygen flow. • 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. • Supplemental oxygen with a flow up to 15 l/min can be added by an oxygen source with rotameter such as oxygen cylinder, central oxygen supply system or an oxygen concentrator. • Supplemental oxygen flow must not exceed 15 l/min. • The oxygen concentration in the delivered air has influence on the volume measurement of the Vivo 50. This measurement is based on a normal oxygen concentration of 21%. If the oxygen concentration is higher, the monitored inspired volume will deviate from the actual volume as follows: – 40% oxygen concentration: -2.5% deviation – 60% oxygen concentration: - 5% deviation – 80% oxygen concentration: -7.5% deviation

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Safety Information 17 Vivo 50 Operating manual

3

Product Description

3.1 Main Components The Vivo 50 system contains the following components:

4

3

2

5 1 6

7

10 9

18 Product Description Vivo 50 Operating manual

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NO.

COMPONENT

FUNCTION

PART NO.

1

Carry bag

Storage for transportation

004939

2

Operating manual

Product and usage information

005003

3

Circuit: Dual limb with active exhalation valve

Deliver air to the patient

005114 (reusable) 005118 (disposable)

4

Circuit: Single limb with leakage port

Deliver air to the patient

005065 (reusable) 005060 (disposable)

5

Circuit: Single limb with active exhalation valve

Deliver air to the patient

005055 (reusable) 005050 (disposable)

6

Filter (white, disposable)

Inlet air filtration

004910

7

Filter (grey, washable)

Inlet air filtration

004909

8

Power cord

EU: 005336 UK: 005337 AU/NZ: 005049

9*

Click-on battery

004559

10

Vivo 50 main unit

* Optional

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Product Description 19 Vivo 50 Operating manual