Vivo 55 Clinician’s Manual Issue U-3

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Cleaning and Maintenance ... 163 7.1 Cleaning the Vivo 55 ... 164 7.2 Cleaning and Replacing the Patient Air Filters... 166 7.3 Change of Patient ... 167 7.4 Regular Maintenance Control ... 167 7.5 Service and Repair... 167 7.6 Storage ... 168 7.7 Disposal ... 168

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Technical Specifications ... 169 8.1 System Description ... 169 8.2 Data Parameters ... 173 8.3 Emission and Immunity Declaration... 186 8.4 Default Settings... 191

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Accessories... 194 9.1 Breas Accessories List... 194

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Patient Settings... 200

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FAA Compliance ... 201

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Index ... 202

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1

Introduction WARNING!

Vivo 55 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 55 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 55? The Vivo 55 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 55 can be operated in 13 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 55 clinician’s 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 • PCV-SIMV – Pressure Controlled Ventilation with Synchronized Intermittent Mandatory Ventilation • PCV-MPV – Pressure Controlled Ventilation with MouthPiece Ventilation • VCV – Volume Controlled Ventilation • VCV(A) – Assisted Volume Controlled Ventilation • VCV-SIMV – Volume Controlled Ventilation with Synchronized Intermittent Mandatory Ventilation • VCV-MPV – Volume Controlled Ventilation with MouthPiece Ventilation • CPAP – Continuous Positive Airway Pressure The Vivo 55 can be used with a leakage circuit, circuit with active exhalation valve or a circuit with mouthpiece interface. The internal memory data of the Vivo 55 can be downloaded to a PC, printed out, and analyzed via the Vivo 55 PC software. For more information about the Vivo 55 PC software, please contact your Breas representative.

1.2 Intended Use The Vivo 55 (with or without the SpO2 and CO2 sensor) is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for pediatric through adult patients weighing more than 10 kg. The Vivo 55 with the SpO2 sensor is intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate. The Vivo 55 with the CO2 sensor is intended to measure CO2 in the inspiratory and expiratory gas.

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The device is intended to be used in home, institution, hospitals and portable applications such as wheelchairs and gurneys. It may be used for both invasive and non-invasive ventilation.

1.3 Contraindications • The use of the Vivo 55 is contraindicated for patients who need to be ventilated with oxygen concentrations (FiO2) higher than achievable when combining inlet from a low pressure oxygen source at 15 l/min with actual ventilator settings. • Generally, after surgery, the surgeon should be consulted to avoid organ damage and help determine ventilator parameters that do not adversely affect hemodynamics or have a negative impact on the patient’s health status. • In case of facial surgery, make sure to choose a suitable patient interface, in order to avoid discomfort and injury. Undesirable Side Effects The Vivo 55 is not intended to be used as an emergency transport ventilator or critical care ventilator. If the patient experiences chest discomfort, pain, severe headache or shortness of breath while using the Vivo 55, a physician or responsible clinician shall be contacted immediately.

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Introduction 5 Vivo 55 clinician’s manual

1.4 About this Manual Always read this manual before setting up and using the Vivo 55 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 55 system. The manual comprises detailed information on the settings and functions of the Vivo 55, to be handled by trained health care personnel only. • Patients and lay caregivers may read the users manual for reference purposes, after appropriate guidance from the responsible care provider. • Service personnel may order the Vivo 55 Service Manual that contains detailed technical information for maintenance, service and repair.

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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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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. • Always have immediate access to an alternative means of ventilation, which is ready for use, to avoid patient death or serious injury. • Failure to have an alternate means of ventilation can result in serious injury or patient death if ventilator fails. • The Vivo 55 must be turned off and on at least every 90 days. This is necessary in order for the Vivo 55 to perform a complete self-test. The self-test automatically tests the alarm sound and certain components. • 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 55 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 55 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 55 is abnormally hot or emits an odour. In these cases, contact the patient’s responsible care provider for an inspection. • The Vivo 55 may not work properly if any part has been dropped, damaged or submerged in water.

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• Inadequate use of device or accessories may cause loss of treatment or decreased performance. • The Vivo 55 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. • Always perform the procedure “Inspecting the Vivo 55 before Use” on page 33 before use. • The Vivo 55 can be used for life-supporting treatment provided an emergency equipment (e.g. resuscitation bag) is available, and that one of the following means of surveillance of ventilator-dependent patient breathing is used: – Leakage circuit: The Vivo 55’s monitoring of exhaled volume must be supervised. – Exhalation valve circuit: The CO2 sensor or an external EtCO2 monitor (capnometer) must be used. The CO2 sensor must be connected between the patient and the exhalation valve or leakage port to be able to measure exhaled gases. The CO2 monitor shall fulfil the ISO 80601-2-55 standard (Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors).

• Make sure that accessories are compatible with the Vivo 55 before use.

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Safety Information 9 Vivo 55 clinician’s manual

• Clinical personnel must read the manual thoroughly and understand the Vivo 55 operation before setting up and using the machine. • All of the physiological alarms of the Vivo 55 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. • Setting the alarm sound level below that of the ambient sound level can impede recognition of alarm conditions. • Handle the Vivo 55 with care. • Do not use the Vivo 55 while in the carry bag. • Do not use the Vivo 55 with nitric oxide, helium or helium mixtures.

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2.2 Electrical Safety • Do not operate the Vivo 55 if it has a damaged power cord or casing. • To avoid electrical shock, disconnect the electrical supply to the Vivo 55 before cleaning. Do not immerse the Vivo 55 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 55 should not be used adjacent to or stacked with other equipment; if adjacent or stacked use is necessary, the Vivo 55 should be observed to verify normal operation in that configuration. Mobile or transportable radio transmitters may interfere with the Vivo 55. Guidance for safe installation of the Vivo 55 can be found in “Emission and Immunity Declaration” on page 186. • If a portable AC power supply is used, make sure that the voltage variations are within the operating limits of the Vivo 55. See “Power Supply” on page 182 for AC operating limits. • Use of accessories, transducers and cables other than those specified or provided by Breas could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

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Safety Information 11 Vivo 55 clinician’s manual

2.3 Environmental Conditions • Do not use the Vivo 55 in any toxic environment. • Do not use the Vivo 55 in environments where there are explosive gases or other flammable anesthetic agents present. • The air flow for breathing produced by the Vivo 55 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 55. • The performance of the Vivo 55 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). • MR Unsafe. Do not use or store the Vivo 55 in a magnetic resonance (MR) environment. Use of the Vivo 55 in an MR environment may result in malfunction of the Vivo 55 and pose unacceptable risk to the patient, medical staff or other persons. • Do not expose the Vivo 55 to rain or snowfall. • Do not use the Vivo 55 while positioned in a warm place, such as direct sunlight or close to a radiator. • Avoid using RFID devices closer than 1 meter to the Vivo 55. • Avoid using the Vivo 55 within 1 meter of electronic article surveillance (EAS) system antennae.

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• The device complies with the EMC requirements of standards listed in “Emission and Immunity Declaration” on page 186. 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 55. 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 meter to the Vivo 55. Radio emitting devices include cellular or cordless telephones, microwave ovens and high-frequency surgery apparatus. – avoiding the use of the Vivo 55 in the presence of known EMI sources, including RF emitters (e.g., RFID, diathermy equipment). Please note that some of these RF emitters may not be visible and the Vivo 55 can potentially be exposed to fields from these RF emitters without the user’s awareness. If abnormal performance of the Vivo 55 is observed, and the RF emitters cannot be identified and removed, the Vivo 55 may need to be reoriented or relocated.

• Unsteady indicated values for delivered volumes or pressures and the occurrence of alarm conditions without apparent cause may be an indication of a loss of performance due to electromagnetic disturbances. Follow the instructions above and the guidance provided in “Emission and Immunity Declaration” on page 186 to mitigate the effects of electromagnetic disturbances. • The Vivo 55, 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 55 and treatment of the patient may deteriorate if the operation conditions in “Technical Specifications” on page 169 are not fulfilled. Do not use the Vivo 55 immediately after storage or transport outside the recommended operating conditions.

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Safety Information 13 Vivo 55 clinician’s manual

2.4 Usage of Patient Circuit • For the Vivo 55 to deliver treatment according to settings, it is important that the selection of the patient circuit type (see “Select Patient Circuit Type” on page 49) is correctly set. • Only use the Vivo 55 with accessories recommended by Breas Medical AB. • The pressurized air from the Vivo 55 causes a continuous flow of air to exhaust from the leakage ports or exhalation valve, flushing exhaled gas from the circuit. The Vivo 55 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 55 is turned on and operating properly. • Do not use patient hoses or tubes made of static or electrically conductive material. • Always use a new patient circuit when the Vivo 55 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 55. 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 55 to ensure no water flows back into the Vivo 55. 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 55 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 (such as humidifiers) increases 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 35.) • 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) 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 he or she is sleeping. • Always follow the instructions of the mask manufacturer. • The Vivo 55 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, make sure that the leakage port or active exhalation valve is present as close as possible to the patient connection. • Contact Injuries: Skin irritation may occur due to prolonged exposure to either a mask (if used) or the SpO2 module. The Vivo 55 and its packaging do not contain any natural rubber latex.

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Safety Information 15 Vivo 55 clinician’s manual

2.5 Usage of Filters • Always use the Vivo 55 with patient air inlet filters installed. Only use the Vivo 55 with accessories recommended by Breas. • Replace or clean the filters regularly to ensure correct function of the Vivo 55, especially when changing patients. Failure to replace or clean a dirty filter may cause the Vivo 55 to operate at higher temperatures than intended. A dirty filter may be caused by dust or animal hair in the home environment. • When operating the Vivo 55, make sure that the air inlet and filters are not obstructed or occluded. • If the Vivo 55 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 recommends the low resistance bacterial filter part no. 004185.) Reuse of a 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 35.) • 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 55 and the patient to prevent injury from accidental spillage. • When using a humidifier or nebulizer, any patient air filter will need more frequent replacement to prevent increased resistance or blockage. • During transportation of the Vivo 55, 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 55 must comply with ISO 8185. • Any HME connected to the Vivo 55 must comply with ISO 9360. • The use of an HME or an external humidifier may require readjustment of the Vivo 55 low-pressure alarm. • Certain HMEs and HCHs are sufficient to provide humidification when the Vivo 55 is used invasively. Check specific suppliers’ recommended use.

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2.7 Cleaning and Maintenance • The Vivo 55 should be cleaned and maintained in accordance with this operating manual. (See “Cleaning and Maintenance” on page 163.) • Do not attempt to autoclave or sterilize the Vivo 55 main unit. • The Vivo 55 should undergo maintenance, service and control procedures, as well as any applicable upgrades, in accordance with Breas service instructions. • The Vivo 55 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 55 yourself. If you do so, the manufacturer will no longer be responsible for the performance and safety of the Vivo 55. Furthermore, no guarantees will be valid.

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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. 006347) is recommended. • When oxygen is used with the Vivo 55, the oxygen flow must be turned off when the Vivo 55 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. • 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. • 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. • Do not use aerosols or solvents close to the oxygen supply, even when the oxygen supply is shut off.

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• Supplemental oxygen flow must not exceed 15 l/min. or 100 kPa. • The oxygen concentration in the delivered air has influence on the volume measurement of the Vivo 55. 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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