Vivo 3 Clinicians Manual Rev Y-2 Sept 2019

Table of Contents 1

2

Introduction... 9 1.1

Manufacturer Information... 10

1.2

What is the Vivo 3? ... 10 1.2.1 1.2.2

Non Invasive Interfaces ...11 Mobility and Usage Environment ...11

1.2.3

Continuous Operation...11

1.2.4

Service Life ...11

1.3

Intended Use...11

1.4

Intended Users...11 1.4.1

Respiratory health care specialists ...11

1.4.2

Lay Operators ... 12

1.4.3

Service Personnel... 12

1.5

Contraindications ... 13

1.6

About this Manual ... 14 1.6.1

Audience ... 14

1.6.2

Icons in this manual ... 14

Safety Information ... 16 2.1

General Use - Warnings and Precautions ... 16

2.2

Electricity - Warnings and Precautions... 19 2.2.1

2.3

Environment - Warnings and Precautions... 20 2.3.1

3

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Electromagnetic Compatibility and Electrostatic Discharge (EMC and ESD)... 20 Disposal ... 21

2.4

Patient Circuit - Warnings and Precautions... 22

2.5

Filter Usage - Warnings and Precautions... 24

2.6

Invasive Use - Warnings and Precautions ... 25

2.7

Humidification and Heating - Warnings and Precautions... 26

2.8

Cleaning and Maintenance - Warning and Precautions... 27

2.9

Oxygen Usage - Warning and Precautions ... 28

2.10

Mobile Use - Warning and Precautions ... 30

Product Description... 32 3.1

Main Components... 32

3.2

Ventilator Front ... 33

3.3

Ventilator Back ... 35

3.4

Power Management... 36

3.5

Menus... 37 3.5.1

Use the Menu... 37

3.5.2

The Monitor Page ... 40

3.5.3

The Setup Pages ... 41

3.5.4

The Alarm Pages ... 42

3.5.5

The Others Pages... 42

Table of Contents 3 Vivo 3 Clinician’s Manual

4

3.6

Symbols on the Vivo 3 ... 46

3.7

Symbols on the Display... 50

Treatment Functions and Settings ... 51 4.1

4.2

5

6

Treatment Modes ... 51 4.1.1

PCV+A - Pressure Controlled Ventilation (Assisted) ... 51

4.1.2 4.1.3

PSV - Pressure Support Ventilation ... 51 S - Spontaneous... 52

4.1.4

S/T - Spontaneous/Timed ... 52

4.1.5

T - Timed... 52

4.1.6

CPAP - Continuous Positive Airway Pressure ... 53

Treatment Settings... 53 4.2.1

Ventilation mode ... 53

4.2.2

Inspiratory Pressure (IPAP) ... 53

4.2.3

Expiratory Positive Airway Pressure (EPAP)... 54

4.2.4

Continuous Positive Airway Pressure (CPAP)... 54

4.2.5

Breath Rate ... 55

4.2.6

Inspiratory Time (Insp. Time) ... 55

4.2.7

Minimum Inspiratory Time (Min Insp. Time) ... 55

4.2.8

Maximum Inspiratory Time (Max. Insp. Time) ... 56

4.2.9

Inspiratory Trigger (Insp.Trigger) ... 56

4.2.10

Expiratory Trigger (Exp.Trigger) ... 57

4.2.11

Rise Time ... 57

4.2.12

Target Volume ... 58

4.2.13

Max Pressure ... 58

4.2.14

Min Pressure ... 59

4.2.15

Ramp Up ... 59

4.2.16

Ramp Down ... 60

4.2.17 4.2.18

Ramp Pressure ... 60 Humidifier ... 61

4.2.19

Humidifier Level ... 61

4.2.20

Heated Circuit ... 62

4.2.21

Heated Circuit Level... 62

Prepare the Vivo 3 for Use ... 63 5.1

Checking the Vivo 3 before First Use ... 63

5.2

Placing the Vivo 3... 63

5.3

Connecting the Vivo 3 to Power Supply... 64

5.4

Connecting the Patient Circuit ... 65 5.4.1

Connect the Heated Patient Circuit ... 66

5.4.2

Disconnect the Heated Patient Circuit from the Ventilator ... 66

5.5

Power up the Vivo 3 ... 66

5.6

Adjusting the Settings ... 67

How to Use the Vivo 3 ... 69

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6.1

Switch On the Vivo 3 ... 69

6.2

Switch Between Clinical Mode and Home Mode ... 69

6.3

Start the Treatment ... 69

6.4

Stop the Treatment ... 70

6.5

Switch Off the Vivo 3 ... 71

6.6

Monitor Treatment ... 71 6.6.1 Treatment Values Monitored by the Vivo 3 ... 72 6.6.2

6.7

6.8

6.9 7

Using Accessories ... 73 6.7.1

Using the Attachable Humidifier ... 74

6.7.2

Using the Heated Circuit ... 79

6.7.3

Using the SpO2 Sensor... 80

6.7.4

Using the Oxygen Supply Adapter... 82

6.7.5

Using the Nurse Call Connection... 83

6.7.6

Using the Remote Alarm Unit ... 84

6.7.7

Using the Protective Cover ... 85

6.7.8

Using the Lightweight Mobility Bag... 85

6.7.9

Using the Y-Cable ... 86

6.7.10

Using the Vivo 3 with the Trolley... 86

Transfer Data between the Vivo 3 and a PC... 87 6.8.1

Log Data... 88

6.8.2

Transfer Data using a Memory Card... 88

6.8.3

Transfer Data using an USB Cable... 89

Basic Troubleshooting ... 89

Alarms ... 90 7.1

Operator’s Position ... 91 7.1.1

7.2

7.3

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Treatment Values Monitored by External Equipment ... 73

Checking the Operator’s Position... 91

Handle Alarms... 91 7.2.1 Identify an Alarm Condition... 91 7.2.2

Pause the Alarm Sound ... 93

7.2.3

Reset an Alarm ... 93

7.2.4

View Historical Alarms ... 93

7.2.5

Adjust the Alarm Sound Level ... 94

Physiological Alarms... 95 7.3.1

High Pressure Alarm ... 95

7.3.2

Low Pressure Alarm ... 96

7.3.3

High Breath Rate Alarm ... 97

7.3.4

Low Breath Rate Alarm... 97

7.3.5

High Minute Volume Alarm ... 98

7.3.6

Low Minute Volume Alarm ... 98

7.3.7

Rebreathing Alarm ... 99

Table of Contents 5 Vivo 3 Clinician’s Manual

7.4

8

7.3.8

Apnea Alarm ... 99

7.3.9

Disconnection Alarm... 100

7.3.10

High EPAP Alarm ... 101

7.3.11

Low EPAP Alarm ... 101

7.3.12

High SpO2 Alarm... 102

7.3.13 7.3.14

Low SpO2 Alarm... 102 High Pulse Rate Alarm... 103

7.3.15

Low Pulse Rate Alarm ... 103

Technical Alarms ... 104 7.4.1

High Pressure Limitation Alarm ... 104

7.4.2

Power Fail Alarm... 104

7.4.3

SpO2 Sensor Failure / Disconnected Alarm ... 104

7.4.4

SpO2 Artifact ... 105

7.4.5

Ambient Pressure Compensation Lost Alarm ... 106

7.4.6

Low Battery Alarm... 106

7.4.7

Critically Low Battery Alarm ... 106

7.4.8

High Patient Air Temp. (High Patient Air Temperature) ... 107

7.4.9

Flow Sensor Failure ... 107

7.4.10

Internal Function Failure ... 108

Cleaning and Maintenance ... 109 8.1

Cleaning the Vivo 3 ... 109 8.1.1

Clean the Main Unit Externally ... 109

8.1.2

Air Pathway Disinfection ...110

8.1.3

Clean the Patient Circuit ...110

8.2

Clean and Replace Patient Air Inlet Filters ...110

8.3

Change of Patients...112

8.4

Alarm Tests ...112 8.4.1 8.4.2

8.5 9

Mandatory Test ...112 Optional Tests ...113

Repair...115

Technical Specifications ...116 9.1

Ventilator Size and Weight...116

9.2

Power Supply ...116

9.3

Environmental Conditions...117

9.4

Pneumatic Diagram ...119

9.5

Technical Data... 120

9.6

Data Accuracy... 122

9.7

Emission and Immunity Declaration ... 123 9.7.1

Guidance and Manufacturer's Declaration – Electromagnetic Immunity... 124

9.7.2

Guidance and Manufacturer's Declaration – Electromagnetic Emission... 126

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9.8 10

9.7.3

Recommended separation distances between portable and mobile RF communications equipment and the Vivo 3 ... 127

9.7.4

Recommended separation distances between external power conductors and the Vivo 3 ... 128

Delivery Settings ... 128

Accessories ... 130 10.1

Accessories/Consumables ... 130

10.2

Accessories... 132

Appendices ... 137 A

Patient Settings Record ... 138

B

FAA Compliance... 139

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Table of Contents 7 Vivo 3 Clinician’s Manual

1

Introduction WARNING! Risk of Personal Injury The Vivo 3 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. Every other use may lead to risk of personal injury!

CAUTION! Read this Clinician’s manual thoroughly so that you completely understand how the Vivo 3 is operated and maintained before taking it into use, to ensure correct usage, maximum performance and serviceability. Non-professional caregivers (e.g. family members) should consult the medical equipment provider’s respiratory therapist if they have any questions about the function, proper use, operation, service or maintenance of the Vivo 3.

WARNING! The Vivo 3 is not designed for life support treatment: • The Vivo 3 should not be used for life support treatment. • The Vivo 3 shall only be used by patients with spontaneous breathing. • The Vivo 3 should not be used for ventilator dependent patients.

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Introduction 9 Vivo 3 Clinician’s Manual

1.1

Manufacturer Information

Address Breas Medical AB Företagsvägen 1 SE-435 33 Mölnlycke Sweden Web Address www.breas.com E-mail address [email protected] Phone +46 31 868800, Order: +46 31 868820, Technical support: +46 31 868860 Fax +46 31 868810 Local Representatives Information www.breas.com/contact-us/

1.2

What is the Vivo 3? The Vivo 3 is an internally powered pressure ventilator capable of delivering invasive or non-invasive ventilatory support for the care of individuals who require long-term support from mechanical ventilation for respiratory insufficiency or respiratory failure, with or without obstructive sleep apnea. The Vivo 3 can be operated in the following modes: • PCV+A (Assisted Pressure Controlled Ventilation). See page 51. • PSV (Pressure Support Ventilation). See page 51. • S (Spontaneous). See page 52. • S/T (Spontaneous/Timed). See page 52. • T (Timed). See page 52. • CPAP (Continuous Positive Airway Pressure). See page 53. The following modes can be combined with the Target Volume setting: • PCV+A • PSV • S/T • T

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1.2.1

Non Invasive Interfaces The ventilator system can be used non-invasively with nasal mask, full/total face mask, and nasal pillow interfaces.

1.2.2

Mobility and Usage Environment The ventilator system is classified as transit-operable and is intended to be used in homes, public spaces, institutions and hospitals. The ventilator system is intended to be used together with portable applications such as wheelchairs, personal family vehicles, ground ambulances and civil aircraft (not helicopter). It is not intended for use during emergency transports.

1.2.3

Continuous Operation The ventilator can be used for continuous operation up to 24 hours/day at least for 90 days without restarting.

1.2.4

Service Life The expected service life of the Vivo 3 is 5 years or 20,000 hours.

1.3

Intended Use Vivo 3 is intended to provide non-invasive or invasive ventilation for patients weighing over 10 kg (22 lbs) who require long-term support or mechanical ventilation for respiratory insufficiency or respiratory failure, with or without obstructive sleep apnea. Vivo 3 is intended for spontaneously breathing patients.

1.4

Intended Users This section describes the intended users of the Vivo 3, their qualifications and their related documents.

1.4.1

Respiratory health care specialists Health care professionals such as physicians and respiratory therapists, assigned to form the clinical authority when it comes to operating mechanical ventilators. They have a good understanding of the human respiratory system and a general understanding of mechanical ventilators. They are allowed to change the clinical settings of a ventilator and prescribe new settings. They may also operate software applications for follow-up on patient’s ventilator treatment.

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Introduction 11 Vivo 3 Clinician’s Manual

Training The respiratory health care specialists shall be trained to a good knowledge of the Vivo 3, its capabilities and the settings that can be made. This training consists of reading the Clinician’s manual in complete and it shall be conducted before operating the Vivo 3. Related Documents The Clinician’s manual is intended for the respiratory health care specialists. It shall be available for training of new personnel and as reference when operating the Vivo 3. 1.4.2

Lay Operators Day-to-day caregivers, patients, relatives and other non-professional users that operate the Vivo 3 within the prescribed settings. They are allowed to operate the Vivo 3 with the Home mode activated. The lay operator may also perform basic maintenance that doesn’t require special equipment or a service environment. In Home mode, the device is locked in order to limit settings accessibility and hide features/controls. The User Manual contains the information intended for patients and lay operators. Training The lay operator shall be trained to basic knowledge of the Vivo 3 and in the specific operations they are assigned to perform. The training shall be based on the user manual and the responsible clinical personnel shall assess the level of training required for each lay operator. Related Documents The User manual is intended for lay operator. It shall be available for the training and as reference when operating the Vivo 3.

1.4.3

Service Personnel Certified service personnel with responsibility to maintain the equipment in proper working order. They have a technical education and/or relevant experience of technical work on electrical equipment. If local or national regulations requests additional authorization or competence, these shall be complied to. Certified service personnel may perform any repairs, upgrades or service operations that they have been certified to perform, as long as they have the required equipment and the operation is performed in an appropriate environment. They may also operate software applications for follow-up on ventilators usage and for troubleshooting.

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Training and Certification Service personnel shall be trained on the Vivo 3 and certified by Breas for being allowed to perform any service, repairs or other operations on the Vivo 3. The training consists of reading the services manual in complete. After completed training the certification test may be performed. Related Documents • The Service Manual. • The User Manual. • Service bulletins, available for certified service personnel on the Breas extranet.

1.5

Contraindications The Vivo 3 is not a life-support ventilator and is contraindicated in patients who are unable to tolerate more than brief interruptions in ventilation. If a patient has any of the following conditions, therapy with positive airway pressure may be contraindicated and the prescribing clinician shall decide if the benefit of ventilatory assistance overweighs the risks: • Untreated pneumothorax • Pneumomediastinum • Inability to maintain a patent airway or adequately clear excessive respiratory secretions • Severe acute systemic complications (shock, unstable arrhythmias, myocardial ischemia) • Severe bullous lung disease • Risk of vomiting • Pathologically low blood pressure, especially if associated with intravascular volume depletion • Cerebrospinal fluid leak, recent cranial surgery or trauma The use of the Vivo 3 is contraindicated in an MRI environment.

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Introduction 13 Vivo 3 Clinician’s Manual

Adverse Effects Patients should report any unusual chest pain, severe headache or increased breathlessness. The following side effects may occur during the course of therapy with the Vivo 3, patients are advised to report any new or changing adverse effects to their physician: • Nasal, mouth or throat dryness • Nosebleeds • Abdominal bloating • Ear or sinus discomfort • Eye irritation • Skin rashes

1.6

About this Manual

1.6.1

Audience This manual is primarily intended for care providers, clinical personnel, physicians and others who require a working knowledge of the Vivo 3 system. The manual comprises detailed information of the settings and functions of the Vivo 3, to be handled by trained health care personnel only.

• Patients and lay caregivers may read the user manual for reference purposes, after appropriate guidance from the responsible care provider. • Service personnel may order the Vivo 3 Service Manual that contains detailed technical information for maintenance, service and repair.

1.6.2

Icons in this manual 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 or personal injury. Warning! Risk of Cross-contamination. Warning! Risk of electric shock.

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Icon

Explanation Warning! Hot surface, risk of burns. Warning! Flammable material, risk of fire. Caution! 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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Introduction 15 Vivo 3 Clinician’s Manual

2

Safety Information

2.1

General Use - Warnings and Precautions WARNING! Risk of Personal Injury The Vivo 3 is not designed for life support treatment: • The Vivo 3 shall only be used by patients with spontaneous breathing. • The Vivo 3 should not be used for ventilator dependent patients. Risk of Faulty Treatment 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. Risk of Insufficient Ventilation Usage outside the specified operating conditions may cause reduced performance. The Vivo 3 must only be used in accordance with the operating conditions specified in this operating manual Risk of Faulty Treatment Do not use the Vivo 3 in the event of • Suspected damage to the device, including the occurrence of Internal Functional Failure alarms. • Unexpected patient symptoms during treatment. • Unexplainable or sudden changes of pressure, performance or sound during operation. • Delivered air being abnormally hot or emitting an odor. Contact your responsible care provider for an inspection. Risk of Suffocation Do not remove the protection for the heated patient circuit connector, the connector can be fitted with the protection in place. If removed, children can choke or suffocate if swallowing it. Risk of Asphyxia or Personal Injury Using incorrect settings may cause personal injury or severe medical conditions, such as hypercarbia, producing arterial acidemia. The therapy settings shall be based on a physician’s description. Changes to settings must be made by authorized clinical personnel only.

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Risk of Faulty Treatment The responsible organization should periodically reassess the settings of the therapy for effectiveness. Risk of Faulty Treatment Always prepare the Vivo 3 as described in this manual before use. Risk of Unnoticed Critical Conditions • All the physiological alarms of the Vivo 3 must be set at safe levels that will effectively warn the user of any risk. The alarm levels should be assessed considering the patient’s treatment settings. • Any change of treatment settings or change of components in the ventilation system may require readjustment of the alarm levels. • The alarm sound level should be set to a clearly audible level. Setting the alarm sound level below that of the ambient sound level can impede recognition of alarm conditions. Risk of Unnoticed Critical Conditions When using the Vivo 3 invasively, physiological alarms, such as the low volume alarm and the low breath rate alarm, must be carefully set, to ensure safe use. Risk of Reduced Safety and Performance Accessories that have not been tested with the Vivo 3 might affect safety features and performance negatively. Only use the Vivo 3 with accessories approved by Breas Medical. Incompatible parts can result in degraded performance and change of pressure gradient. If unapproved accessories are used, Breas Medical has no responsibility for the safe and effective use of the Vivo 3. The responsible organization is responsible for ensuring the compatibility of the ventilator and all parts used to connect to the patient before use.

WARNING! Risk of Electric Shock Modifying or using the ventilator with accessories that are not specified or approved by Breas may cause cardiac arrhythmia. The Vivo 3 must only be used in original and unmodified shape and only with accessories specified or approved by Breas Medical. Inadequate use of device or accessories may cause loss of treatment or decreased performance.

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Safety Information 17 Vivo 3 Clinician’s Manual

WARNING! Risk of Burns Covering breathing tubes with a blanket or heating them with an overhead heater can affect the quality of the therapy or injure the patient.

CAUTION! Read the Clinician’s manual thoroughly and understand the operation of the Vivo 3 before operating or using the machine. Always use the therapeutic pressure setting, as individually determined with the configuration of the equipment and accessories. Proper placement and positioning of the patient interface is critical to the consistent operation of this equipment. Handle the Vivo 3 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 3 may start if the Start/Stop button is pressed even without the mains being connected. Do not use the Vivo 3 with nitric oxide, helium or helium mixtures. This may affect patient air flow and volume measurements.

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2.2

Electricity - Warnings and Precautions WARNING! Risk of Electric Shock High voltage contact may cause cardiac arrhythmia. • Do not operate the Vivo 3 if it has a damaged power cord, power supply or casing. • To avoid electrical shock, only clean the Vivo 3 according to instructions in this manual. Do not soak or immerse the Vivo 3 into any fluids. • Use the approved power supply units only. Use of unapproved power supply units may compromise the electrical isolation and lead to risk of electric shock. • Do not use more than one multiple portable socket-outlet or extension cord. If a multiple portable socket-outlet is used, it must not be placed on the floor. • 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 606011.

WARNING! Risk of Faulty Treatment Electromagnetic Interference may cause electrical equipment to malfunction. • The aspects of electromagnetic compatibility must be considered. – The Vivo 3 should not be used adjacent to or stacked with other equipment; if adjacent or stacked use is necessary, the Vivo 3 should be observed to verify normal operation in that configuration. – Mobile or transportable radio transmitters may interfere with the Vivo 3. – Further guidance for safe installation of the ventilator can be found in the chapter about emission and immunity declaration. • If a portable AC power supply is used, make sure that the voltage variations are within the operating limits of the Vivo 3. • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Vivo 3, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

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Safety Information 19 Vivo 3 Clinician’s Manual

2.2.1

Electromagnetic Compatibility and Electrostatic Discharge (EMC and ESD) 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. Electromagnetic disturbance may impair the safety and performance of the Vivo 3. The electromagnetic field levels at the Vivo 3 should not exceed 20 V/m. Unsteady indicated values for delivered volumes or pressures and the occurrence of alarm conditions without apparent cause may be an indication of loss of performance due to electromagnetic disturbances. Measures for keeping electromagnetic field levels low should include but are 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 (e.g. cellular or cordless telephones, microwave ovens and high-frequency surgery apparatus) closer than 1 meter to the Vivo 3. • Avoiding the use of known sources of Electromagnetic Interference, (e.g. RFID, diathermy equipment), in the presence of the Vivo 3. Please note some of these RF emitters may not be visible and the Vivo 3 can potentially be exposed to fields from these RF emitters without the user’s awareness. If abnormal performance of the Vivo 3 is observed, and the RF emitters cannot be identified and removed, the Vivo 3 may need to be reoriented or relocated.

See the section Emission and Immunity Declaration for detailed information and further guidance for mitigating electromagnetic disturbance.

2.3

Environment - Warnings and Precautions WARNING! Risk of Intoxication Do not use the Vivo 3 in a toxic environment. Risk of Faulty Treatment If a room humidifier is used, place it at least 2 meters away from the Vivo 3.

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Risk of Faulty Treatment

Do not use or store the Vivo 3 in a magnetic resonance (MR) environment. Use of the Vivo 3 in an MR environment may result in malfunction of the Vivo 3 and pose unacceptable risk to the patient, medical staff or other persons. Risk of faulty Treatment The performance of the Vivo 3 may deteriorate at altitudes or ambient temperatures outside the operation conditions specified in the section Environmental Conditions. • Do not use the ventilator while positioned in a warm place, such as direct sunlight or close to a radiator as this might lead to temperature outside the specifications. • Do not use the ventilator in an hyperbaric chamber, as this would cause an ambient pressure outside the specifications. • Do not use the ventilator immediately after storage or transport outside the recommended operating conditions.

WARNING! Risk of Fire Do not use the Vivo 3 in environments where explosive gases or flammable anesthetic agents present.

WARNING! Risk of Electric Shock Water on and in the device may cause an electric conductive path. Do not expose the Vivo 3 to rain or snowfall.

2.3.1

Disposal The Vivo 3, any accessories and any replaced parts must be disposed of in accordance with the local environmental regulations regarding the disposal of used equipment and waste.

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Safety Information 21 Vivo 3 Clinician’s Manual

2.4

Patient Circuit - Warnings and Precautions WARNING! Risk of Insufficient Ventilation Insufficient ventilation may cause transient hypoxia. The Vivo 3 ventilator is intended to be used with patient circuits with intentional leakage and compliant to ISO 17510. Recommended leak rate: 20 to 50 liters per minute at 10 cmH2O. Failure to use a mask or accessory that minimizes rebreathing of carbon dioxide or permits spontaneous breathing can cause asphyxiation. Risk of Abnormal Exhalation Volume Measurement Non-invasive ventilation: The exhaled volume of the patient can differ from the measured exhaled volume due to unintentional leaks around the mask. Invasive ventilation: The exhaled volume of the patient can differ from the measured exhaled volume due to unintentional leaks around the cannula. For correct measurements, minimize unintentional leaks. Risk of Reduced Safety and Performance Accessories that have not been tested with the Vivo 3 might affect safety features and performance negatively. Only use the Vivo 3 with accessories approved by Breas Medical. Incompatible parts can result in degraded performance and change of pressure gradient. If unapproved accessories are used, Breas Medical has no responsibility for the safe and effective use of the Vivo 3. The responsible organization is responsible for ensuring the compatibility of the ventilator and all parts used to connect to the patient before use. Risk of Reduced Performance Filters and patient connected parts must be replaced regularly to ensure correct function of the Vivo 3. Risk of Insufficient Ventilation Insufficient ventilation may cause transient hypoxia. Before use: • Make sure that the patient circuit and joined parts are undamaged and correctly connected, in order to avoid unwanted leakage. • Make sure that the leakage port of the circuit or mask is not blocked or obstructed. This port prevents rebreathing by flushing the exhaled air. • For active exhalation valve circuits: Check the function of the exhalation valve and that is not blocked or obstructed. • The Vivo 3 should be turned on and the function of the leakage port should be checked before use: The pressurized air from the Vivo 3 causes a continuous flow of air through the leakage port, enabling flushing of exhaled air.

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