Breas Vivo 3 User manual

Vivo 3 User Manual
Breas Medical AB, Företagsvägen 1, SE-435 33 Mölnlyc e, Sweden
Phone [phone]
Order [phone] , Technical Support [phone]
Fax [phone],, www.breas.com, Date: 2023-12-07 | 25391
Vivo 3,User’s
ENGLISH (EU)
USER MANUAL
7 321820 072316
Breas Vivo 3
User Manual
007231 F-3 en-EU

Table of Contents 1
Doc. 007231 F-3
Table of Contents
1 Introduction.....................................................................................5
1.1 Manufacturer Information . ........................................................... 5
1.2 What is the Vivo 3?................................................................... 6
1.2.1 Non Invasive Interfaces................................................... 6
1.2.2 Mobility and Usage Environment ........................................ 6
1.2.3 Continuous Operation. . . . . . . . . . . . .. . . .. . ... . ... .... .... ................... 6
1.2.4 Service Life ................................................................6
1.3 Intended Use..........................................................................6
1.4 Operation by Lay Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . .. . .... .... ..... .... . .. . . .. . . . 6
1.5 Contraindications ....................................................................7
1.6 About this Manual ....................................................................8
1.6.1 Audience...................................................................8
1.6.2 Icons in this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . ... . ... .... ..... .... . .. 8
2 Safety Information .............................................................................9
2.1 General Use —Warnings and Precautions.. . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.2 Electricity —Warnings and Precautions . . .. . .. .. . .. . .. . .. . .. . .. . .. . .. . .. . .. . .. . .. 11
2.2.1 Electromagnetic Compatibility and Electrostatic Discharge
(EMC and ESD) ..........................................................12
2.3 Environment —Warnings and Precautions.... ..... . ... . .. . . . . . . . . . . . . . . . . . . . . . . . .12
2.4 Patient Circuit —Warnings and Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
2.5 Filter Usage —Warnings and Precautions . . . . . . . . . . . . . . . . . . .. . . .. . ... . ... .... ....15
2.6 Invasive Use —Warnings and Precautions ..... ... . ... . . . . . . . . . . . . . . . . . . . . . . . . . . .16
2.7 Humidification and Heating —Warnings and Precautions . ... . ..... .... ... . . .. . .16
2.8 Cleaning and Maintenance —Warning and Precautions .. . .. .. .. . .. .. .. .. .. . .. ..17
2.9 Oxygen Usage —Warning and Precautions .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
2.10 Mobile Use —Warning and Precautions . . .. . . .. . ... . ... .... .. .... ... . . .. . . . . . . . . .20
3 Product Description...........................................................................22
3.1 Overview.............................................................................22
3.2 Ventilator Front ......................................................................22
3.3 Ventilator Back ......................................................................23
3.4 Power Management.................................................................23
3.5 Menus................................................................................24
3.5.1 Use the Menu.............................................................24
3.5.2 The Monitor Page . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . ... . ... . ... .... ..... .... . .27
3.5.3 The Setup Pages.........................................................27
3.5.4 The Alarm Pages.........................................................27
3.5.5 The Others Pages . . . . . . . . . . . . . .. . ... . ... .... ..... .... . ... . . . . . . . . . . . . . . . .28
3.6 Symbols on the Vivo 3 . .. . ... . ... .... .... ..... .... . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
3.7 Symbols on the Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . .. . ... . ... .33
4 Treatment Functions and Settings .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . .. . .34
4.1 Treatment Settings ..................................................................34

2Table of Contents
Doc. 007231 F-3
4.1.1 Ramp Up..................................................................34
4.1.2 Ramp Down ..............................................................34
4.1.3 Humidifier.................................................................34
4.1.4 Humidifier Level . . . . .. . ... . ... . ... .... ..... .... . .. . . . . . . . . . . . . . . . . . . . . . . . .34
4.1.5 Heated Circuit ............................................................35
4.1.6 Heated Circuit Level.. ... . ... . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
5 Prepare the Vivo 3 for Use ...................................................................36
5.1 Checking the Vivo 3 before First Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . .. . .36
5.2 Placing the Vivo 3 ...................................................................36
5.3 Connecting the Vivo 3 to Power Supply. . . . . . . . . . . . . . . . . . .. . . .. . . .. . ... . ..... .... ..36
5.4 Connecting the Patient Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . .. . ... . ... .37
5.4.1 Connect the Heated Patient Circuit ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
5.4.2 Disconnect the Heated Patient Circuit from the Ventilator.. ..... . ... . .38
5.5 Performing Start-up Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
5.6 Performing a Pre-Use Test.. . ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
5.6.1 Actions At Pre-Use Test Failure . .. . . .. . ... . ... .... .... ..... .... . .. . . . . . .39
6 How to Use the Vivo 3 ........................................................................40
6.1 Switch On the Vivo 3 ................................................................40
6.2 Start the Treatment..................................................................40
6.3 Stop the Treatment..................................................................41
6.4 Switch Off the Vivo 3 ................................................................42
6.5 Monitor Treatment ..................................................................42
6.5.1 Treatment Values Monitored by the Vivo 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
6.6 Using Accessories...................................................................43
6.6.1 Using the Attachable Humidifier. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
6.6.2 Using the Heated Circuit . .. .. .. .. .. .. .. .. .. .. .. ... ... .. ... .. .. .. .. .. .. .. .46
6.6.3 Using the SpO2Sensor ..................................................47
6.6.4 Using the Oxygen Supply Adapter .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
6.6.5 Using the Nurse Call Connection. . . . . . .. . . . .. . . . . . .. . . . .. . . . . .. . . . . . .. . .48
6.6.6 Using the Remote Alarm Unit. . . .. . .. . . .. . .. . . .. . .. . . .. . . .. . .. . . .. . .. . . ..49
6.6.7 Using the Protective Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
6.6.8 Using the Lightweight Mobility Bag. . . .. . . .. . . .. . .. . . .. . . .. . . .. . . .. . . .. . .49
6.6.9 Using the Y-Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
6.6.10 Using the Vivo 3 with the Trolley . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
6.7 Basic Troubleshooting .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51
7 Alarms .........................................................................................52
7.1 Operator’s Position..................................................................52
7.1.1 Checking the Operator’s Position.......................................53
7.2 Handle Alarms.......................................................................53
7.2.1 Identify an Alarm Condition . .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .53
7.2.2 Pause the Alarm Sound.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54

Table of Contents 3
Doc. 007231 F-3
7.2.3 Reset an Alarm...........................................................54
7.2.4 View Historical Alarms .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55
7.2.5 Adjust the Alarm Sound Level .. . ... ... ... .. .. ..... .... ..... .. ..... .. ....56
7.3 Physiological Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . ... .... ....56
7.3.1 High Pressure Alarm ... . . .. . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57
7.3.2 Low Pressure Alarm .... .... . ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57
7.3.3 High Breath Rate Alarm.. . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58
7.3.4 Low Breath Rate Alarm . . . . . . . . . . . . . . . . . . . . . . . . .. . . .. . . .. . ... . ... .... ....58
7.3.5 High Minute Volume Alarm . . ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59
7.3.6 Low Minute Volume Alarm .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. ... ... .. .. .59
7.3.7 Rebreathing Alarm ... . .. . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
7.3.8 Apnea Alarm..............................................................60
7.3.9 Disconnection Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
7.3.10 High EPAP Alarm... ..... .... . ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61
7.3.11 Low EPAPAlarm .........................................................61
7.3.12 High SpO2Alarm.........................................................62
7.3.13 Low SpO2Alarm..........................................................62
7.3.14 High Pulse Rate Alarm. . . . . . . . . . . . . . . . . . ... . ... .... .... ..... .... . .. . . . . . .62
7.3.15 Low Pulse Rate Alarm . . . . . . . . . . . .. . . .. . .... ..... .... . ... . .. . . . . . . . . . . . . .63
7.3.16 Circuit Disconnection Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
7.3.17 Blocked Circuit Alarm .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
7.4 Technical Alarms ....................................................................64
7.4.1 High Pressure Limitation Alarm . .. . . .. . ... . ... .... .... ..... .... . .. . . . . . .64
7.4.2 Power Fail Alarm . . . .. . ... . ... . ... .... ..... . ... . .. . . . . . . . . . . . . . . . . . . . . . . . .64
7.4.3 SpO2Sensor Failure / Disconnected Alarm . . ... . ... . ... .... ..... .... . .65
7.4.4 SpO2Artifact..............................................................65
7.4.5 Ambient Pressure Compensation Lost Alarm . . . . . . . . . . . . . . . . . . . . . . . . . .66
7.4.6 Low Battery Alarm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . .. . .66
7.4.7 Critically Low Battery Alarm . . . . . . . . . . . . . . . . . . . .. . . .. . . .. . .... ..... .... ..66
7.4.8 High Patient Air Temp. (High Patient Air Temperature) .. . . . . . . . . . . . . . .67
7.4.9 Flow Sensor Failure .. . ... . ... . ..... .... ... . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . .67
7.4.10 Internal Function Failure .. ... ... ... .. ... .... ..... .. .... ..... .. ... .... .. ..68
8 Cleaning and Maintenance . . . . . . . . . . . . . . . . .. . . .. . . ... .... ..... .... . .. . . .. . . . . . . . . . . . . . . . . . . . .69
8.1 Cleaning the Vivo 3..................................................................69
8.1.1 Clean the Main Unit Externally . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69
8.1.2 Clean the Humidifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .70
8.1.3 Clean the Patient Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .70
8.2 Clean and Replace Patient Air Inlet Filters . . . . . . . . . . . . . . . . . . . . . . . . . .. . . .. . ... . ... .70
8.3 Disposal..............................................................................71
9 Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72
9.1 Ventilator Size and Weight .. . .. . .. .. . .. .. . .. .. . .. .. . .. . .. .. . .. .. . .. .. . .. . .. .. . .. .. . .72

4Table of Contents
Doc. 007231 F-3
9.2 Power Supply........................................................................72
9.3 Operating Conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . .. . . .. . ... . ... .... ....73
Appendices .........................................................................................75
A FAA Compliance ..............................................................................75
Index .................................................................................................77

1 Introduction
WARNING!
Risk of Personal Injury
The Vivo 3 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 compatible accessories.
Every other use may lead to risk of personal injury!
CAUTION!
Read this manual thoroughly so that you completely understand how the Vivo 3 is oper-
ated and maintained before taking it into use, to ensure correct usage, maximum per-
formance 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.
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]
Introduction 5
Doc. 007231 F-3 User Manual

U Sales and Support Information
UK Responsible Person: Breas Medical Ltd
Phone UK Head Office
[phone]
Fax UK Head Office
[phone]
General Enquiries and Ordering
[e-mail]
Tech Support
[e-mail]
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 with-
out obstructive sleep apnea.
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 Operation by Lay Users
Day-to-day caregivers, patients, relatives and other non-professional users may operate the
Vivo 3 with the Home mode activated, after it has been set up according to the prescribed
treatment. In Home mode, some settings and controls are locked or hidden.
6Introduction
User Manual Doc. 007231 F-3

The lay operator may also perform basic maintenance that doesn’t require special equipment
or a service environment.
Training
The lay operator shall be trained to basic knowledge of the Vivo 3 and in the specific opera-
tions they are assigned to perform. The training shall be based on this user manual and the
responsible clinical personnel shall assess the level of training required for each lay operator.
This manual shall be available for training and as reference when operating the Vivo 3.
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.
Adverse Effects
If the patient experiences chest discomfort, pain, severe headache or shortness of breath
while using the Vivo 3, a physician or responsible clinician should be contacted immediately.
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
Introduction 7
Doc. 007231 F-3 User Manual

1.6 About this Manual
1.6.1 Audience
This manual is intended for patients and other lay users operating the Vivo 3.
• Care providers, clinical personnel, physicians and others who require a working
knowledge of the Vivo 3 will find additional information on settings and functions
in the Clinician’s Manual. The Clinician’s manual should be of the same revision as
the User’s Manual.
• Service personnel may order the Service Manual that contains detailed technical
information for maintenance, service, repair and disposal procedure. The Service
manual’s revision is independent of the User’s Manual revision.
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.
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) envi-
ronment, 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.
8Introduction
User Manual Doc. 007231 F-3

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 treat-
ment, always inform the medical staff that the patient is on mechanical ventilation
treatment.
The Vivo 3 shall not be used with nebulizers.
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 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 prescription. Changes to settings
must be made by authorized clinical personnel only.
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.
Safety Information 9
Doc. 007231 F-3 User Manual

Risk of Unnoticed Critical Conditions
• All the physiological alarms of the Vivo 3 must be set at safe levels that will effec-
tively 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 sys-
tem 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 verified to be compatible with the Vivo 3 might affect
safety features and performance negatively.
Only use the Vivo with accessories that are compatible with the ventilator. Use of incom-
patible parts to connect the ventilator to the patient can result in degraded performance
and change of pressure gradient.
Breas Medical has verified the compatibility between the Vivo 3 and the accessories listed
in the Clinician's manual.
The responsible organization must ensure the compatibility of the ventilator with all
parts used to connect to the patient before starting the intended treatment. If incompati-
ble accessories are used, Breas Medical AB has no responsibility for the safe and effective
use of the Vivo 3.
WARNING!
Risk of Electric Shock
Modifying or using the ventilator with incompatible accessories may cause cardiac
arrhythmia.
The Vivo 3 must only be used in original and unmodified shape and only with compati-
ble accessories.
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!
Proper placement and positioning of the patient interface is critical to the consistent
operation of this equipment.
Handle the Vivo 3 with care.
Always use the therapeutic pressure setting, as individually determined with the configu-
ration of the equipment and accessories.
Make sure to place and pack the device in a way that prevents unintentional start of the
machine.
10 Safety Information
User Manual Doc. 007231 F-3

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.
If you suspect that the device has been mistreated, perform a functional check before
taking it to use. A basic functional check can be performed as described in 5.5 Performing
Start-up Checks, page 38. A complete functional check can be performed by an authorized
service technician.
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 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 iso-
lation from AC power (Mains) voltage which complies with the requirements of
IEC 60601-1.
Safety Information 11
Doc. 007231 F-3 User Manual

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 nor-
mal 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 chap-
ter 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. 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 3. The elec-
tromagnetic 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 elec-
tromagnetic 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, micro-
wave 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, dia-
thermy 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.
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.
12 Safety Information
User Manual Doc. 007231 F-3

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 out-
side 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 ambient
pressure outside the specifications.
• Do not use the ventilator immediately after storage or transport outside the recom-
mended 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.
CAUTION!
The ventilator, 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.
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 per-
mits spontaneous breathing can cause asphyxiation.
Risk of Abnormal Exhalation Volume Measurement
Non-invasive ventilation: The exhaled volume of the patient can differ from the meas-
ured 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.
Safety Information 13
Doc. 007231 F-3 User Manual

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.
• The leakage port of the patient circuit or patient interface prevents rebreathing by
flushing the exhaled air. It should be located as near the patient interface as possi-
ble (this is even more important for treatments with low pressure). Make sure that
it is not blocked or obstructed.
• The Vivo 3 should be turned on and the function of the leakage port should be
checked before use:
Risk of Insufficient Ventilation
Incompatible patient circuits may come loose.
To prevent disconnection of the patient circuit or patient circuit system during use, espe-
cially during ambulatory use, only patient circuits in compliance with ISO 5367 or ISO
80601-2-74.
Risk of Suffocation
Periodically check for moisture in the patient circuit.
When present, remove the moisture. Before attempting to dry the circuit, disconnect it
from the Vivo 3 to ensure no water flows back into the Vivo 3.
The frequency at which these checks must be performed will depend on the patient’s
condition and the device used. The responsible caregiver should assess this on an indi-
vidual basis in accordance with the patient’s needs.
Risk of Suffocation
If the patient needs assistance to remove the patient interface, the patient shall not be
left alone. This is to avoid the risk of re-breathing of CO2in case of accidental ventilator
failure.
Do not breathe through the connected patient circuit unless the ventilator is turned on
and operating properly.
Risk of Suffocation
If the patient is using a full face mask (covering mouth and nose), the mask must be
equipped with a safety entrainment valve.
Risk of Suffocation or Barotrauma
In HFNT mode, do not use a sealed patient interface.
Risk of Constriction
Entanglement with cables or tubing constricting airways may cause asphyxiation.
Do not leave long lengths of air tubing or cables around the top of the bed. They could
twist around the patient’s head or neck while sleeping.
Risk of Insufficient Ventilation
Insufficient ventilation may cause transient hypoxia.
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 func-
tion. It may also interfere with the device trigger function.
14 Safety Information
User Manual Doc. 007231 F-3

WARNING!
Risk of Electric Shock
Do not use antistatic or electrically conductive hoses or tubing with the ventilator breath-
ing system. This could result in electrical shock.
WARNING!
Risk of Cross-Contamination
Patient circuits might get contaminated by exhaled gases. To avoid cross-contamination,
always use a new patient circuit when the Vivo 3 is to be used by a new patient.
NOTE
For masks and accessories, always follow the manufacturer’s instructions.
2.5 Filter Usage —Warnings and Precautions
Low resistance bacteria filter, if used, should be replaced every 24 hours.
WARNING!
Risk of Overheating
Replace or clean the air inlet filters as specified in the Maintenance chapter.
Using old or clogged filters may cause the Vivo 3 to operate at higher temperatures than
intended.
When operating the Vivo 3, make sure that the air inlet and filters are not obstructed or
occluded.
Risk of Insufficient Ventilation
Insufficient ventilation may cause transient hypoxia.
Do not use high resistance bacteria filter at the air outlet of the Vivo 3. High resistance
bacteria filters placed between the air outlet and the patient interface may interfere with
the operation of the patient disconnect function. It may also interfere with the device
trigger function.
Risk of Insufficient Ventilation
Humidification can increase the resistance of breathing system filters and the operator
must monitor the breathing system filter frequently for increased resistance and blockage
to ensure the delivery of the therapeutic pressure.
Increased resistance may interfere with the operation of the patient disconnected
function.
WARNING!
Risk of Cross-Contamination
Deep tissue or mucosal contact with infectious agents may cause infections:
• If assigning the Vivo 3 to a new patient, always replace the filters.
• Always use the Vivo 3 with patient air inlet filters installed.
Risk of Cross-Contamination
Deep tissue or mucosal contact with infectious agents may cause infections.
If the Vivo 3 is used by several patients, a low resistance bacteria filter shall be used
between the air outlet and the patient circuit, for preventing patient cross-contamination.
Reuse of bacteria filter, patient circuit or mask may expose patients to contagious agents.
Safety Information 15
Doc. 007231 F-3 User Manual

2.6 Invasive Use —Warnings and Precautions
WARNING!
Risk of Faulty Treatment
If using the Vivo 3 for invasive ventilation, humidification is recommended. Make sure
to use an external heated humidifier that complies to invasive use according to ISO
80601-2-74.
The attachable humidifier is not intended for invasive use.
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 Rebreathing
Be aware of risks for rebreathing exhaled gases:
• A blocked, clogged or in other ways occluded leakage port causes exhaled gases to
be rebreathed.
• With low pressures the risk of rebreathing increases.
• I:E (inspiration time : expiration time) ratios close to 1:1 increase the risk of
rebreathing as the expiratory time allowing exhaled gases to be cleared from the
circuit before the next breath is decreased.
The Vivo 3 is equipped with a low leakage alarm. However, the alarm is not a substitute
for operator vigilance for ensuring that the leakage ports remains clear at all times.
Periodically check the leakage ports during therapy.
See the section 2.4 Patient Circuit — Warnings and Precautions, page 13 for mitigating the
risks of rebreathing.
2.7 Humidification and Heating —Warnings and Precautions
WARNING!
Risk of Personal Injury
The attachable humidifier shall not be used with nitric oxide. Such use might cause the
humidifier to not function correctly, causing serious deterioration of health.
Risk of Suffocation
When the attachable humidifier is installed, the Vivo 3 must be located below the patient
and on a flat surface. This is to prevent personal injury from accidental spillage or from
excess water or condensation flowing down the patient tube and into the patient’s mask.
Extra cautions should be taken for patients who are unable to guard their airways or can-
not pull off the mask.
Risk of Suffocation or Loss of Ventilation
Incorrect placing of the ventilator may cause transient hypoxia.
If using an external humidifier, it shall be placed below both the patient and the Vivo 3.
This is to prevent personal injury from accidental spillage or from excess water or con-
densation flowing down to the ventilator or down the patient tube and into the patient’s
mask. Extra cautions should be taken for patients who are unable to guard their airways
or cannot pull off the mask.
Risk of Inflammation
Incorrect connection of the ventilator may cause inflammation.
The attachable humidifier is only enabled when the Vivo 3 is connected to the AC Power
supply.
16 Safety Information
User Manual Doc. 007231 F-3

Risk of Suffocation
Installation of a water trap may be required if the condensation is extensive in the patient
circuit when using a heated humidifier.
The water trap prevents condensed water in the patient circuit from reaching the patient
airways and causing personal injury.
Risk of Suffocation or Electric Shock
Do not use the attachable humidifier during mobile use.
Due to movements, water spillage from the humidifier or condensed water may cause
suffocation or electric shock.
WARNING!
Risk of Electric Shock
Do not transport the ventilator with water in the humidifier.
The attachable humidifier must be detached before filling. Do not fill above the Maxi-
mum Water Level indication on the water chamber.
Electrostatic discharge or contact with leakage current may cause an electric shock.
WARNING!
Risk of Burns
After using the ventilator, wait one minute before you open the water chamber since it
can get hot under certain conditions (for example if the humidifier runs out of water).
CAUTION!
The use of external humidifier may require readjustment of the low-pressure alarm.
2.8 Cleaning and Maintenance —Warning and Precautions
This manual contains instructions for cleaning and maintenance that can be carried out by
the care provider or users with physical ability and working knowledge of the system.
WARNING!
Risk of Faulty Treatment
Service and Maintenance of the Vivo 3 shall not be performed when the Vivo 3 is in use.
WARNING!
Risk of Electric Shock
Cleaning with excessive water or opening the device’s casing without certified training
may cause electric shocks.
The Vivo 3 should be regularly cleaned and maintained in accordance with this operating
manual.
Risk of Electric Shock
High voltage contact may cause cardiac arrhythmia.
Repairs and modifications must be carried out by authorized technicians only and in
accordance with instructions from Breas Medical AB
• The Vivo 3 must not be opened, repaired or modified by unauthorized personnel
or interconnected with incompatible equipment. If subjected to unauthorized
modifications or operations, Breas Medical AB is no longer responsible for the
device’s performance and safety and all warranties will become invalid.
Safety Information 17
Doc. 007231 F-3 User Manual

CAUTION!
Do not attempt to autoclave or sterilize the Vivo 3.
18 Safety Information
User Manual Doc. 007231 F-3