Breas Vivo 2 User manual

Vivo 2 User manual
Breas Medical AB, Företagsvägen 1, SE-43 33 Mölnlycke, Sweden
Phone [phone] Order [phone] Technical Support [phone]
Fax [phone] www.breas.com, Date: 2020-11-16
Vivo 2,User’s
ENGLISH (EU)
UUSSEERR MMAANNUUAALL
007229 EN-EU D-3
7 321820 072293

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Table of Contents
1 Introduction..................................................................................... 9
1.1 Manufacturer Information . ... . .. . .. . .. . .. . . .. . .. . .. . .. . ... ... . .. . .. . ... .. . . .. . .. . .. .10
1.2 What is the Vivo 2?..................................................................10
1.2.1 Non Invasive Interfaces .. . ... .. .. ... . ... .. .. .. ... .. .. .. .. ... .. .. .. .. ... .. 11
1.2.2 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 ......................................................................12
1.4.1 Respiratory Health Care Specialists . .. . .. . ... ... . .. . .. . ... .. . . .. . .. . .. .12
1.4.2 Lay Operators ............................................................12
1.4.3 Service Personnel. .. . .. . .. . .. . ... . .. . .. . .. . ... . .. . .. . .. . .. . . .. ... . .. . .. . .13
1.5 Contraindications ...................................................................13
1.6 About this Manual ...................................................................14
1.6.1 Audience..................................................................14
1.6.2 Icons in this Manual . . .. . .. . .. . ... ... . .. . .. . ... ... . .. . .. . .. . .. . ... ... . .. . .14
2 Safety Information ............................................................................16
2.1 General Use — Warnings and Precautions... . .. . .. . .. . ... . .. . .. . .. . .. . ... ... . .. . .16
2.2 Electricity — Warnings and Precautions .. . .. . .. . .. . ... . .. . .. . .. . .. . . .. ... . .. . .. . .18
2.2.1 Electromagnetic Compatibility and Electrostatic Discharge
(EMC and ESD) ..........................................................19
2.3 Environment — Warnings and Precautions.. .. . . .. . .. . .. . .. . ... ... . .. . .. . ... .. . . ..20
2.4 Patient Circuit — Warnings and Precautions . . .. . ... ... . .. . .. . .. . .. . . .. ... . .. . .. . .21
2.5 Filter Usage — Warnings and Precautions . . .. . .. . .. . ... ... . .. . .. . ... .. . . .. . .. . .. .23
2.6 Humidification and Heating — Warnings and Precautions .. . .. . .. . .. . ... . .. . .. . .24
2.7 Cleaning and Maintenance — Warning and Precautions . . .. . .. . .. . .. . ... ... . .. . .26
2.8 Oxygen Usage — Warning and Precautions . ... ... . .. . .. . .. . .. . ... . .. . .. . .. . ... . .27
2.9 Mobile Use — Warning and Precautions . . ... ... . .. . .. . ... .. . . .. ... . .. . .. . ... ... . .28
3 Product Description...........................................................................30
3.1 Main Components...................................................................30
3.2 Ventilator Front ......................................................................31
3.3 Ventilator Back ......................................................................33
3.4 Power Management.................................................................34

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3.5 Menus..................................................................35
3.5.1 Use the Menu . . .. . .. . ... ... . .. . .. . ... .. . . .. . .. . .. . .. . ... ...35
3.5.2 The Monitor Page .. . .... .. .... . ... . .. ... . .... . .... . .... ....38
3.5.3 The Setup Pages .. . .. . ... .. . . .. . .. . .. . .. . ... . .. . .. . ... .. . .39
3.5.4 The Alarm Pages .. . .. . ... .. . . .. ... . .. . .. . ... ... . .. . .. . .. . .41
3.5.5 The Others Pages .. . .. . .. . ... . .. . .. . .. . .. . . .. ... . .. . .. . ...41
3.6 Symbols on the Vivo 2 . . ... ... . .. . .. . .. . .. . ... ... . .. . .. . ... ... . .. . .. . .45
3.7 Symbols on the Display . . . . . .. . . . . . .. . . . . . .. .. .. . .. . .. . . . . . .. . . . . . .. . .48
4 Treatment Functions and Settings. .. . .. . ... ... . .. . .. . ... .. . . .. . .. . .. . .. . ... . ..49
4.1 Treatment Modes . . .. . . .. ... . .. . .. . ... ... . .. . .. . .. . .. . . .. ... . .. . .. . ...51
4.1.1 PCV+A — Pressure Controlled Ventilation
(Assisted)...................................................51
4.1.2 PSV — Pressure Support Ventilation . . . . .. . . . . . .. . . . . . .. .51
4.1.3 S — Spontaneous . .. . .. . . .. ... . .. . .. . ... ... . .. . .. . .. . .. . ..52
4.1.4 S/T — Spontaneous/Timed . .. . ... ... . .. . .. . ... ... . .. . .. . .52
4.1.5 T — Timed. . . .. . .. . .. . .. . ... . .. . .. . .. . .. . . .. . .. . .. . .. . ... ...53
4.1.6 CPAP — Continuous Positive Airway
Pressure....................................................53
4.2 Treatment Settings . ... ... .. ... ... .... .... ... .... ... .. .. .. .. .... .... ...53
4.2.1 Auto-EPAP . .. . .. . .. . ... . .. . .. . .. . .. . . .. ... . .. . .. . ... ... . .. .53
4.2.2 Ramp Up ...................................................56
4.2.3 Ramp Down .. . .. . .. . .. . ... . .. . .. . .. . .. . ... ... . .. . .. . ... .. . .56
4.2.4 Ramp Pressure .. . .. . .. . ... ... . .. . .. . .. . .. . . .. ... . .. . .. . ...57
4.2.5 Humidifier.. . .. . ... ... . .. . .. . ... .. . . .. . .. . .. . .. . ... ... . .. . .. .57
4.2.6 Humidifier Level . . .. . ... ... .. .. . ... ... .. .. . .. .. . .. .. . ... .. ..57
4.2.7 Heated Circuit . ... ... . .. . .. . ... .. . . .. . .. . .. . .. . ... ... . .. . .. .57
4.2.8 Heated Circuit Level . .. . .. . ... .. . . .. . .. . .. . .. . ... ... . .. . .. .58
4.2.9 Patient Circuit . .. . ... ... . .. . .. . .. . .. . . .. ... . .. . .. . ... ... . .. .58
5 Prepare the Vivo 2 for Use . .. . .. . ... . .. . .. . .. . .. . . .. ... . .. . .. . ... ... . .. . .. . .. . .59
5.1 Checking the Vivo 2 before First Use ... . .. . .. . .. . .. . . .. ... . .. . .. . ...59
5.2 Placing the Vivo 2 .. . ... .. . . .. . .. . .. . .. . ... ... . .. . .. . ... .. . . .. . .. . .. . ..59
5.3 Connecting the Vivo 2 to Power Supply . . .. . .. . ... ... . .. . .. . .. . .. . ..60
5.4 Connecting the Patient Circuit. ... . .. . .. . .. . .. . . .. . .. . .. . .. . ... . .. . .. .61
5.4.1 Connect the Heated Patient Circuit . .. . .. . .. . .. . ... . .. . .. .62

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5.4.2 Disconnect the Heated Patient Circuit from the Ventilator. . ... ... . .. . .62
5.5 Power up the Vivo 2 .................................................................62
6 How to Use the Vivo 2 ........................................................................64
6.1 Switch On the Vivo 2 ................................................................64
6.2 Start the Treatment..................................................................64
6.3 Stop the Treatment..................................................................65
6.4 Switch Off the Vivo 2 ................................................................66
6.5 Monitor Treatment ..................................................................67
6.5.1 Treatment Values Monitored by the Vivo 2 .. . ... ... . .. . .. . .. . .. . . .. . .. .68
6.5.2 Treatment Values Monitored by External Equipment . .. . .. . ... . .. . .. . .69
6.6 Using Accessories...................................................................70
6.6.1 Using the Attachable Humidifier. . .. . ... ... . .. . .. . ... .. . . .. . .. . .. . . . . ... .70
6.6.2 Using the Heated Circuit . ... ... .... .. .. .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. .. . .76
6.6.3 Using the SpO2Sensor ..................................................77
6.6.4 Using the Oxygen Supply Adapter .. . .. . . .. . .. . .. . .. . ... . .. . .. . .. . .. . . ..79
6.6.5 Using the Remote Alarm Unit. . . .. .. .. .. .. .. .. . .. . . . .. . .. . . . .. .. . .. . . . .. .80
6.6.6 Using the Protective Cover . .. . .. . . .. ... . .. . .. . ... ... . .. . .. . .. . .. . . .. . .. .81
6.6.7 Using the Lightweight Mobility Bag. . . .. .. . .. .. . . . . .. .. .. . .. . . . . .. .. . .. . .82
6.6.8 Using the Y-Cable . ... . .. . .. . .. . .. . . .. ... . .. . .. . ... ... . .. . .. . .. . .. . . .. ... .82
6.6.9 Using the Vivo 2 with the Trolley . . .. . .. . .. . ... . .. . .. . .. . ... . .. . .. . .. . .. .82
6.7 Basic Troubleshooting . .. . .. . ... . .. . .. . .. . .. . . .. ... . .. . .. . ... ... . .. . .. . .. . .. . . .. ... .84
7 Alarms .........................................................................................85
7.1 Operator’s Position .. . ... . ... .. ... .. .. .. ... .... .... .... .... .... .... ... . ... . .... .... ..85
7.1.1 Checking the Operator’s Position . .. . . .. . .. . .. . .. . ... . .. . .. . .. . ... . .. . ..85
7.2 Handle Alarms.......................................................................86
7.2.1 Identify an Alarm Condition . .. ... .. . .. .. ... ... .. .. ... ... .. .. ... ... ... .. . .86
7.2.2 Pause the Alarm Sound... . .. . .. . ... ... . .. . .. . ... .. . . .. ... . .. . .. . ... ... . .88
7.2.3 Reset an Alarm .. . .. . .. . . .... . .... ... . .. .... ... . .. .... .. . . .... ... . .. .... ..88
7.2.4 View Historical Alarms .. . ... .. . . .. . .. . .. . .. . ... . .. . .. . .. . ... . .. . .. . .. . .. .88
7.2.5 Adjust the Alarm Sound Level .. . .. . ... ... . .... . .. . ... ... . .. .. . .. . .. . ... .89
7.3 Physiological Alarms . .. . . .. . .. . .. . .. . ... ... . .. . .. . ... .. . . .. . .. . .. . .. . ... . .. . .. . ... ..92
7.3.1 High Pressure Alarm .. . .. . .. . .. . ... . .. . .. . .. . ... . .. . .. . .. . .. . ... ... . .. . .92
7.3.2 Low Pressure Alarm . .. . .. . .. . .. . ... ... . .. . .. . ... .. . . .. ... . .. . .. . ... ... . .93
7.3.3 High Breath Rate Alarm... ... . .. . .. . ... ... . .. . .. . .. . .. . ... ... . .. . .. . ... ..94

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7.3.4 Low Breath Rate Alarm . . .. . ... ... ... .. .. . ... ... ... .. .. . ...95
7.3.5 High Minute Volume Alarm ... .. . . .. . .. . .. . .. . ... ... . .. . .. .96
7.3.6 Low Minute Volume Alarm.. . .. . .. . ... ... . .. . .. . ... .. . . .. ..97
7.3.7 Rebreathing Alarm . . . .. . . .. .. . . ... .. .. ... .. .. ... .. .. . . .. ...98
7.3.8 Apnea Alarm .. . .. . . .. ... . .. . .. . ... ... . .. . .. . .. . . . . . .. . .. . ..99
7.3.9 Disconnection Alarm... . .. . .. . .. . .. . . .. ... . .. . .. . ... ... . .. .99
7.3.10 High EPAP Alarm . . .. ... . .. . .. . ... ... . .. . .. . .. . .. . . .. ... . 100
7.3.11 Low EPAP Alarm ... . .. . .. . .. . . .. ... . .. . .. . ... ... . .. . .. . .. 101
7.3.12 High SpO2Alarm......................................... 101
7.3.13 Low SpO2Alarm ......................................... 102
7.3.14 High Pulse Rate Alarm . . . .. ... . .. . .. . ... ... . .. . .. . .. . .. . 103
7.3.15 Low Pulse Rate Alarm . ... . .. . .. . .. . .. . ... ... . .. . .. . ... .. 104
7.4 Technical Alarms . . ... ... . .. . .. . ... ... . .. . .. . .. . .. . ... ... . .. . .. . ... .. 105
7.4.1 High Pressure Limitation Alarm . .. . . .. . .. . .. . .. . ... . .. . . 105
7.4.2 Power Fail Alarm. . .. . .. . ... ... . .. . .. . .. . .. . . .. ... . .. . .. . . 105
7.4.3 SpO2Sensor Failure / Disconnected Alarm .. . .... .... . 106
7.4.4 SpO2Artifact ............................................. 106
7.4.5 Ambient Pressure Compensation Lost
Alarm ..................................................... 107
7.4.6 High Patient Air Temp. (High Patient Air
Temperature) . ... .... .. ... . ... . ... . .... .... .. .. . .... .. ... . 107
7.4.7 Flow Sensor Failure.. ... . .. . .. . ... ... . .. . .. . .. . .. . . .. ... . 108
7.4.8 Internal Function Failure. . .. . .. . .. . ... . .. . .. . .. . ... . .. . .. 108
8 Cleaning and Maintenance .. . .. . .. . ... .. . . .. . .. . .. . .. . ... . .. . .. . .. . ... . .. . .. 109
8.1 Cleaning the Vivo 2 .. . .. . .. . ... . .. . .. . .. . .. . . .. . .. . .. . .. . ... ... . .. . . 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 Disposal.............................................................. 112
9 Technical Specifications. . .. . .. . . .. ... . .. . .. . ... ... . .. . .. . .. . .. . . .. ... . .. . .. . . 113
9.1 Ventilator Size and Weight. . .. . . .. .. .. ... . .. . . .. .. .. .. .. . . .. .. .. .. .. 113
9.2 Power Supply........................................................ 113
9.3 Environmental Conditions . . .. . .. . ... .. . . .. ... . .. . .. . ... ... . .. . .. . .. 114
9.4 Pneumatic Diagram . .. .... . .... . .. .... . .. .... ... . .... . .... . .... . .. .. 115

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9.5 Technical Data..................................................................... 117
10 Accessories ................................................................................. 121
10.1 Accessories/Consumables . . .. . ... .. . . .. . .. . .. . .. . ... . .. . .. . .. . .. . . .. . .. . .. . .. . .. 121
10.2 Accessories........................................................................ 124
Appendices ............................................................................... 131
A Patient Settings Record .. ... . .. . .. . ... ... . .. . .. . .. . .. . . .. ... . .. . .. . ... ... . .. . .. . .. . .. . . .. . . 132
B FAA Compliance ............................................................................ 134

1 Introduction
WARNING!
The Vivo 2 must only be used:
• For the intended treatment in accordance with this manual and with the instruc-
tions given by the responsible clinical personnel.
• In accordance with the operating conditions specified in this 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 user manual manual thoroughly so that you completely understand how
the Vivo 2 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 equip-
ment provider’s respiratory therapist if they have any questions about the function,
proper use, operation, service or maintenance of the Vivo 2.
WARNING!
The Vivo 2 is not designed for life support treatment:
• The Vivo 2 should not be used for life support treatment.
• The Vivo 2 shall only be used by patients with spontaneous breathing.
• The Vivo 2 should not be used for ventilator dependent patients.
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1.1 Manufacturer Information
Legal Manufacturer
Postal Address
Breas Medical AB
Företagsvägen 1
SE-435 33 Mölnlycke Sweden
Web Address
www.breas.com
Email address
[e-mail]
Phone
[phone], Order: [phone], Technical support: [phone]
Fax
[phone]
Local Representatives Information
www.breas.com/contact-us/
1.2 What is the Vivo 2?
The Vivo 2 is a pressure ventilator capable of delivering 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 2 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 53.
• CPAP (Continuous Positive Airway Pressure). See page 53.
The following modes can be combined with the Target Volume setting:
• PCV+A
• PSV
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• S
• S/T
• T
The following modes can be combined with the Auto-EPAP setting:
• PCV+A
• PSV
• S
• S/T
• T
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 helicop-
ter). 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 2 is 5 years or 20,000 hours.
1.3 Intended Use
Vivo 2 is intended to provide non-invasive ventilation for patients weighing over 10 kg
(22 lbs) who require long-term support or mechanical ventilation for respiratory impair-
ment, with or without obstructive sleep apnea.
Vivo 2 is intended for spontaneously breathing patients.
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1.4 Intended Users
This section describes the intended users of the Vivo 2, 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 under-
standing 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.
Training
The respiratory health care specialists shall be trained to a good knowledge of the Vivo 2,
its capabilities and the settings that can be made. This training consists of reading the
Clinician’s manual in full and it shall be conducted before operating the Vivo 2.
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 2.
1.4.2 Lay Operators
Day-to-day caregivers, patients, relatives and other non-professional users that operate
the Vivo 2 within the prescribed settings.
They are allowed to operate the Vivo 2 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 fea-
tures/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 2 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.
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Related Documents
The User manual is intended for lay operator. It shall be available for the training and as
reference when operating the Vivo 2.
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 author-
ization 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 soft-
ware applications for follow-up on ventilators usage and for troubleshooting.
Training and Certification
Service personnel shall be trained on the Vivo 2 and certified by Breas for being allowed
to perform any service, repairs or other operations on the Vivo 2. The training consists
of reading the services manual in full.
Related Documents
• The Service Manual.
• The Clinician’s Manual.
• Service bulletins, available for certified service personnel on the Breas extranet.
1.5 Contraindications
The Vivo 2 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 ventila-
tory 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
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• Pathologically low blood pressure, especially if associated with intravascular volume
depletion
• Cerebrospinal fluid leak, recent cranial surgery or trauma
The use of the Vivo 2 is contraindicated in an MRI environment.
Adverse Effects
If the patient experiences chest discomfort, pain, severe headache or shortness of breath
while using the Vivo 2, a physician or responsible clinician should be contacted
immediately.
The following side effects may occur during the course of therapy with the Vivo 2,
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 intended for patients and other lay users operating the Vivo 2.
• Care providers, clinical personnel, physicians and others who require a working
knowledge of the Vivo 2 will find additional information on settings and functions
in the Clinician’s Manual.
• Service personnel may order the Service Manual that contains detailed technical
information for maintenance, service, repair and disposal procedure.
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.
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Icon Explanation
Warning!
Risk of death or personal injury.
Warning!
Risk of Cross-contamination.
Warning!
Risk of electric shock.
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.
MR Unsafe. The device should not enter a magnetic resonance (MR)
environment, such as an MRI scanner room.
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 Use — Warnings and Precautions
WARNING!
Risk of Personal Injury
The Vivo 2 is not designed for life support treatment:
• The Vivo 2 shall only be used by patients with spontaneous breathing.
• The Vivo 2 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 ventila-
tion treatment.
Risk of Insufficient Ventilation
Usage outside the specified operating conditions may cause reduced performance.
The Vivo 2 must only be used in accordance with the operating conditions specified
in this manual.
Risk of Faulty Treatment
Do not use the Vivo 2 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 2 as described in this manual before use.
Risk of Unnoticed Critical Conditions
• 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 Reduced Safety and Performance
Accessories that have not been tested with the Vivo 2 might affect safety features
and performance negatively. Only use the Vivo 2 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 2.
The responsible organization is responsible for ensuring the compatibility of the ven-
tilator 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 2 must only be used in original and unmodified shape and only with acces-
sories specified or approved by Breas Medical.
Inadequate use of device or accessories may cause loss of treatment or decreased
performance.
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 user manual manual thoroughly and understand the operation of the Vivo 2
before operating or using the machine.
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Always use the therapeutic pressure setting, as individually determined with the con-
figuration 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 2 with care.
Make sure to place and pack the device in a way that prevents unintentional start of
the machine.
Do not use the Vivo 2 with nitric oxide, helium or helium mixtures. This may affect
patient air flow and volume measurements.
NOTE
Any serious incident that has occurred in relation to this device should be reported
to the competent authority and the manufacturer.
2.2 Electricity — Warnings and Precautions
WARNING!
Risk of Electric Shock
High voltage contact may cause cardiac arrhythmia.
• Do not operate the Vivo 2 if it has a damaged power cord, power supply or casing.
• To avoid electrical shock, only clean the Vivo 2 according to instructions in this
manual. Do not soak or immerse the Vivo 2 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
60601-1.
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WARNING!
Risk of Faulty Treatment
Electromagnetic Interference may cause electrical equipment to malfunction.
• The aspects of electromagnetic compatibility must be considered.
• The Vivo 2 should not be used adjacent to or stacked with other
equipment; if adjacent or stacked use is necessary, the Vivo 2 should
be observed to verify normal operation in that configuration.
• Mobile or transportable radio transmitters may interfere with the
Vivo 2.
• 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 2.
• 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 2, including specified cables. Otherwise, degradation of the
performance of this equipment could result.
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 2. The
electromagnetic field levels at the Vivo 2 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 2.
• Avoiding the use of known sources of Electromagnetic Interference, (e.g. RFID, dia-
thermy equipment), in the presence of the Vivo 2.
Please note some of these RF emitters may not be visible and the Vivo 2 can poten-
tially be exposed to fields from these RF emitters without the user’s awareness. If
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abnormal performance of the Vivo 2 is observed, and the RF emitters cannot be
identified and removed, the Vivo 2 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 2 in a toxic environment.
Risk of Faulty Treatment
If a room humidifier is used, place it at least 2 meters away from the Vivo 2.
Risk of Faulty Treatment
Do not use or store the Vivo 2 in a magnetic resonance (MR) environment.
Use of the Vivo 2 in an MR environment may result in malfunction of the Vivo 2
and pose unacceptable risk to the patient, medical staff or other persons.
Risk of faulty Treatment
The performance of the Vivo 2 may deteriorate at altitudes or ambient temperatures
outside the operation conditions specified in the chapter Technical Specifications.
• 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 ambi-
ent pressure outside the specifications.
• Do not use the ventilator immediately after storage or transport outside the rec-
ommended operating conditions.
WARNING!
Risk of Fire
Do not use the Vivo 2 in environments where explosive gases or flammable anes-
thetic agents present.
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User manual Doc. 007229 D-3