Breas Vivo 45 User manual

DOC. 006149 EN-EU D-3
2020-10-05
User manual
Vivo 45

Table of Contents 3
Doc. 006149 D-3 Vivo 45
Table of Contents
1 Introduction........................................................................................................................ 9
1.1 What is the Vivo 45? ........................................................................................... 9
1.2 Intended Use......................................................................................................11
1.3 Contraindications ..............................................................................................11
1.4 Intended Environment....................................................................................... 12
1.5 Intended Users.................................................................................................. 12
1.5.1 Respiratory Health Care Specialists................................................. 12
1.5.2 Lay Operators .................................................................................. 12
1.5.3 Service Personnel............................................................................. 13
1.6 About this Manual ............................................................................................. 13
1.6.1 Audience ........................................................................................... 13
1.6.2 Icons in this Manual .......................................................................... 14
1.7 Manufacturer Information.................................................................................. 15
2 Safety Information ........................................................................................................... 16
2.1 General User Precautions................................................................................. 16
2.2 Electrical Safety ................................................................................................ 19
2.3 Environmental Conditions................................................................................. 20
2.4 Usage of Patient Circuit .................................................................................... 21
2.5 Usage of Filters ................................................................................................. 23
2.6 Humidification ................................................................................................... 24
2.7 Cleaning and Maintenance ............................................................................... 26
2.8 Usage of Oxygen .............................................................................................. 26
3 Product Description......................................................................................................... 29
3.1 Main Components............................................................................................. 29
3.2 Front View ......................................................................................................... 31
3.3 Side Views......................................................................................................... 32
3.3.1 Detaching and Reattaching the Side Panels .................................... 33
3.4 Equipment Designation..................................................................................... 35
3.4.1 Additional Symbols ........................................................................... 36
4 Preparing the Vivo 45 for Use ........................................................................................ 38
4.1 Checking the Vivo 45 before First Use ............................................................. 38
4.2 Placing the Vivo 45 ........................................................................................... 38
4.3 Connecting the Vivo 45 to Mains ...................................................................... 40
4.4 Connecting the Patient Circuit .......................................................................... 41
4.5 Inspecting the Vivo 45 before Use ................................................................... 42
4.6 Adjusting the Vivo 45 Patient Settings .............................................................. 43
4.7 Performing the Pre-use Test ............................................................................. 43
5 How to Use the Vivo 45 ................................................................................................... 45
5.1 Switch the Vivo 45 On and Off .......................................................................... 45
5.2 Using the Menu ................................................................................................. 47

4 Table of Contents
Vivo 45 Doc. 006149 D-3
5.2.1 Navigating with the Buttons .............................................................. 47
5.2.2 Symbols Used in the Menu ............................................................... 49
5.2.3 Menu Overview ................................................................................. 51
5.2.4 Display Overview .............................................................................. 52
5.2.5 The Main Display, Home Mode......................................................... 53
5.2.6 The Setup Section, Home Mode....................................................... 54
5.2.7 The Alarm Section ............................................................................ 55
5.2.8 The Monitor Section.......................................................................... 56
5.2.9 The Others Section .......................................................................... 56
5.3 Monitored Values in the Vivo 45........................................................................ 57
5.3.1 Ppeak ................................................................................................ 58
5.3.2 PEEP................................................................................................. 58
5.3.3 Pmean............................................................................................... 58
5.3.4 Leakage ............................................................................................ 59
5.3.5 MVe ................................................................................................... 59
5.3.6 MVi .................................................................................................... 59
5.3.7 Vte..................................................................................................... 59
5.3.8 Vti ...................................................................................................... 59
5.3.9 FiO2................................................................................................... 59
5.3.10 % in TgV............................................................................................ 59
5.3.11 Total Rate .......................................................................................... 59
5.3.12 Spont Rate ........................................................................................ 59
5.3.13 % Spont............................................................................................. 60
5.3.14 SpO2(Oxygen Saturation) ................................................................ 60
5.3.15 Pulse Rate......................................................................................... 60
5.3.16 I:E...................................................................................................... 60
5.3.17 Insp. Time ......................................................................................... 60
5.3.18 Rise Time .......................................................................................... 60
5.3.19 EtCO2................................................................................................ 61
5.3.20 InspCO2............................................................................................. 61
5.3.21 PtcCO2.............................................................................................. 61
5.4 Modes in the Vivo 45......................................................................................... 61
5.4.1 Standby and Operating Mode........................................................... 61
5.4.2 Device Mode ..................................................................................... 61
5.4.3 Patient Mode..................................................................................... 62
5.4.4 Ventilation and Breath Modes........................................................... 62
5.5 Functions and Parameters in the Vivo 45 ......................................................... 64
5.5.1 Parameters’Availability in Different Modes...................................... 65
5.5.2 Insp. Pressure .................................................................................. 67
5.5.3 PEEP................................................................................................. 67
5.5.4 Breath Rate ....................................................................................... 67

Table of Contents 5
Doc. 006149 D-3 Vivo 45
5.5.5 Backup Rate...................................................................................... 67
5.5.6 Insp. Time (Inspiratory Time) ............................................................ 68
5.5.7 Backup Insp. Time (Backup Inspiratory Time).................................. 68
5.5.8 Rise Time .......................................................................................... 68
5.5.9 Insp. Trigger (Inspiratory Trigger) ..................................................... 69
5.5.10 Exp. Trigger (Expiratory Trigger) ...................................................... 69
5.5.11 Max Insp. Time (Maximum Inspiratory Time) ................................... 69
5.5.12 Min Insp. Time (Minimum Inspiratory Time) ..................................... 69
5.5.13 Target Volume ................................................................................... 70
5.5.14 CPAP................................................................................................. 70
5.5.15 Ramp Time........................................................................................ 71
5.5.16 Start Pressure ................................................................................... 71
5.5.17 Always Start Ramp ........................................................................... 71
5.5.18 Humidifier.......................................................................................... 71
5.5.19 Humidifier Setting.............................................................................. 71
5.5.20 Heated Circuit Temp ......................................................................... 72
5.5.21 Circuit Heating .................................................................................. 72
5.6 Using Batteries.................................................................................................. 72
5.6.1 Power Source Priority ....................................................................... 72
5.6.2 Power Switchover Tests.................................................................... 72
5.6.3 Charging the Batteries ...................................................................... 74
5.6.4 Battery Icons .................................................................................... 74
5.6.5 Internal Battery.................................................................................. 75
5.6.6 Click-in Battery.................................................................................. 76
5.6.7 Battery Operating Time (Internal and Click-in) ................................. 77
5.6.8 Storing the Internal Battery and the Click-in Battery......................... 78
5.6.9 External DC....................................................................................... 78
5.7 Using Accessories ............................................................................................ 79
5.7.1 Connecting and Disconnecting the Cables....................................... 79
5.7.2 Using the ventilator with a Nurse Call System.................................. 79
5.7.3 Using the ventilator with the FiO2Sensor ......................................... 80
5.7.4 Using the ventilator with the Remote Alarm...................................... 81
5.7.5 Using the ventilator with the EtCO2Sensor ...................................... 82
5.7.6 Using the ventilator with the PtcCO2Cable ...................................... 86
5.7.7 Using the Ventilator with the SpO2module....................................... 87
5.7.8 Using the Ventilator with the Effort Belts........................................... 87
5.7.9 Using the ventilator with the Remote Start/Stop............................... 89
5.7.10 Using the ventilator with the Protective Cover.................................. 90
5.7.11 Using the Vivo 45 with the Trolley..................................................... 91
5.7.12 Using the Click-in Humidifier............................................................. 92
5.7.13 Installing the Water Chamber ........................................................... 92

6 Table of Contents
Vivo 45 Doc. 006149 D-3
5.7.14 Detaching the Water Chamber ......................................................... 94
5.7.15 Using the Patient Circuit with Heated Wire....................................... 97
6 Alarms ............................................................................................................................ 99
6.1 Alarm Function .................................................................................................. 99
6.1.1 Alarm Indication ................................................................................ 99
6.1.2 Audible Signal Pause...................................................................... 100
6.1.3 Audible Signal Presilence ............................................................... 101
6.1.4 Alarm Reset .................................................................................... 101
6.2 Operator’s Position ......................................................................................... 101
6.3 Physiological Alarms....................................................................................... 102
6.3.1 High Pressure Alarm ...................................................................... 102
6.3.2 Low Pressure Alarm ....................................................................... 103
6.3.3 High PEEP Alarm ............................................................................ 104
6.3.4 Low PEEP Alarm............................................................................. 104
6.3.5 High Vti(High Inspired Tidal Volume Alarm) .................................. 105
6.3.6 Low Vti Alarm (Low Inspired Tidal Volume) .................................... 105
6.3.7 High MViAlarm (High Inspired Minute Volume Alarm) ................... 106
6.3.8 Low MVi(Low Inspired Minute Volume Alarm) ............................... 106
6.3.9 High VteAlarm (High Expired Tidal Volume) .................................. 107
6.3.10 Low VteAlarm (Low Expired Tidal Volume) .................................... 107
6.3.11 High MVe(High Expired Minute Volume Alarm) ............................. 108
6.3.12 Low MVeAlarm (Low Expired Minute Volume) ............................... 108
6.3.13 High Breath Rate Alarm .................................................................. 109
6.3.14 Low Breath Rate Alarm....................................................................110
6.3.15 Apnea Alarm .................................................................................... 111
6.3.16 Disconnection Alarm........................................................................111
6.3.17 Rebreathing Alarm ...........................................................................112
6.3.18 Obstruction Alarm ............................................................................113
6.3.19 High FiO2Alarm ...............................................................................113
6.3.20 Low FiO2Alarm ................................................................................114
6.3.21 High SpO2Alarm..............................................................................114
6.3.22 Low SpO2Alarm...............................................................................115
6.3.23 High EtCO2Alarm ............................................................................115
6.3.24 Low EtCO2Alarm.............................................................................116
6.3.25 High InspCO2Alarm (High Inspired CO2)........................................116
6.3.26 High Pulse Rate Alarm.....................................................................117
6.3.27 Low Pulse Rate Alarm .....................................................................117
6.3.28 PtcCO2Alarm...................................................................................118
6.4 Technical Alarms..............................................................................................119
6.4.1 Power Fail Alarm..............................................................................119
6.4.2 High Patient Air Temp. (High Patient Air Temperature) ...................119

Table of Contents 7
Doc. 006149 D-3 Vivo 45
6.4.3 Low Patient Air Temp. (Low Patient Air Temperature
Alarm).............................................................................................. 120
6.4.4 Low Last Power Source Alarm ....................................................... 120
6.4.5 Crit. Low Last Power Source Alarm................................................ 120
6.4.6 Lost Mains Power Alarm ................................................................. 121
6.4.7 SpO2Disconnected (SpO2Sensor Failure/Disconnection
Alarm).............................................................................................. 121
6.4.8 SpO2Signal Lost Alarm .................................................................. 121
6.4.9 Poor SpO2Signal............................................................................ 122
6.4.10 CO2Disconnected (CO2Sensor Failure/Disconnection
Alarm).............................................................................................. 122
6.4.11 CO2Accuracy Error Alarm .............................................................. 122
6.4.12 Check CO2Adapter Alarm .............................................................. 123
6.4.13 CO2Sensor Error Alarm ................................................................. 123
6.4.14 FiO2Disconnected (FiO2Sensor Failure/Disconnection
Alarm).............................................................................................. 123
6.4.15 Ambient Pressure Compensation Lost Alarm ................................ 124
6.4.16 Temperature Comp. Lost (Ambient Temperature Compensation
Lost Alarm)...................................................................................... 124
6.4.17 Humidity Comp. Lost (Humidity Compensation Lost
Alarm).............................................................................................. 125
6.4.18 LED Failure Alarm........................................................................... 125
6.4.19 Low Alarm Battery Alarm ................................................................ 125
6.4.20 Alarm Battery Error Alarm............................................................... 126
6.4.21 Internal/Click-In Battery Hot Alarm ................................................. 126
6.4.22 Heated Circuit Temp. Alarm............................................................ 126
6.4.23 High Humidifier Temp. Alarm .......................................................... 127
6.4.24 Humidifier Fault Alarm .................................................................... 127
6.4.25 Heated Circuit Fault Alarm.............................................................. 128
6.4.26 Internal Function Failure ................................................................. 128
6.4.27 Air Temp. Sensor Fail Alarm ........................................................... 128
6.4.28 Internal Error Alarm......................................................................... 129
6.4.29 Database Integrity Fail Alarm ......................................................... 129
6.4.30 Cooling Fan Error Alarm ................................................................. 129
6.4.31 Clock Failure Alarm......................................................................... 130
6.4.32 Internal Temp High Alarm ............................................................... 130
6.4.33 Humidifier/Bypass Loose Alarm ..................................................... 130
6.5 Alarm Test ....................................................................................................... 131
6.5.1 Alarm Signal Test ............................................................................ 131
6.5.2 Mandatory Alarm Tests ................................................................... 131
6.5.3 Optional Alarm Tests....................................................................... 134
7 Cleaning and Maintenance ........................................................................................... 136
7.1 Cleaning the Vivo 45 ...................................................................................... 136

8 Table of Contents
Vivo 45 Doc. 006149 D-3
7.1.1 Main Unit ........................................................................................ 137
7.1.2 Air Pathway Disinfection ................................................................. 137
7.1.3 Patient Circuit.................................................................................. 137
7.2 Cleaning and Replacing the Air Filters ........................................................... 138
7.2.1 Coarse Filter (Grey, Washable) ...................................................... 139
7.2.2 Fine Filter (White, Disposable) ....................................................... 139
7.3 Change of Patients.......................................................................................... 139
7.4 Service and Repair.......................................................................................... 139
7.5 Storage............................................................................................................ 140
7.6 Disposal .......................................................................................................... 140
8 Technical Specifications ................................................................................................ 142
8.1 System Description ......................................................................................... 142
8.1.1 Pneumatic Diagram for the ventilator ............................................ 142
8.2 Data................................................................................................................. 143
8.2.1 Worst Case Accuracy ..................................................................... 143
8.2.2 Modes Specifications...................................................................... 143
8.2.3 Parameter Specifications................................................................ 143
8.2.4 Monitored Values Specifications..................................................... 148
8.2.5 Power Supply.................................................................................. 150
8.2.6 Environmental Conditions............................................................... 150
8.2.7 Other ............................................................................................... 151
8.3 Emission and Immunity Declaration ............................................................... 152
8.3.1 Vivo 45 Essential Performance....................................................... 152
8.3.2 Guidance and Manufacturer's Declaration –Electromagnetic
Immunity.......................................................................................... 153
8.3.3 Guidance and Manufacturer's Declaration –Electromagnetic
Emission.......................................................................................... 155
8.3.4 Recommended separation distances between portable and
mobile RF communications equipment and the ventilator ............. 156
8.3.5 Recommended separation distances between external power
conductors and the ventilator.......................................................... 156
8.3.6 Recommended separation distances between external power
conductors and the ventilator.......................................................... 157
8.4 Delivery Settings ............................................................................................. 157
9 Accessories and Parts .................................................................................................. 160
9.1 Patient Circuits and Air Delivery Accessories................................................. 160
9.2 Power Accessories ......................................................................................... 164
9.3 Monitoring Accessories................................................................................... 166
9.4 Ventilator Filters and Detachable Parts .......................................................... 170
9.5 Other Accessories........................................................................................... 171
10 Patient Settings ............................................................................................................. 175
11 FAA Compliance............................................................................................................ 177

1 Introduction
WARNING!
Risk of Personal Injury
The Vivo 45 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 manual thoroughly so that you completely understand how the Vivo 45 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 45.
Breas Medical reserves the right to make changes to this product without any prior
notification.
1.1 What is the Vivo 45?
The Vivo 45 is a pressure ventilator capable of delivering continuous or intermittent
ventilatory support for patients who require invasive or non-invasive mechanical ventila-
tion. The Vivo 45 is capable of running 24 hours/day.
The Vivo 45 can be operated in the following ventilation modes:
•PSV (Pressure Support Ventilation). May be combined with:
–TgV (Target Volume)
–AE (Auto-EPAP)
•PCV (Pressure Controlled Ventilation). May be combined with:
–A (Assist function —inpiration trigger)
–TgV (Target Volume)
–AE (Auto-EPAP)
–MPV (Mouthpiece Ventilation)
Introduction 9
Doc. 006149 D-3 Vivo 45 User manual

•CPAP (Continuous Positive Airway Pressure)
Compatible Patient Circuits
The Vivo 45 should be used with a leakage circuit and a suitable patient interface or an
MPV circuit. See 9 Accessories and Parts, page 160 for detailed information about
approved patient circuits.
The patient circuit shall comply to ISO 17510. The leakage should be at least 12 l/min
at 4 cmH2O, to prevent rebreathing of exhaled air. The recommended leakage is 20 to
50 l/min at 10 cmH2O pressure.
Compatible Patient Interfaces
For invasive use, the patient interface may be a tracheostomy tube (cuffed or uncuffed).
For non-invasive use it may be a mask, mouthpiece or pillow interface. See the patient
interface’s instructions for use when selecting the interface to use.
Data Log
The Vivo 45 has an internal memory with a data log that holds the following data:
•Running hours
•Technical alarms
•Settings
•Asset data
•Treatment hours
•Treatment settings
•Device serial number
•Physiological alarms
•Detailed log, containing at least 24 h data of clinical data (monitored values)
•Breath log, containing at least 30 day data of (monitored values)
•Usage log (containing at least 1 year data of non-clinical events, alarms and settings)
The internal memory data is maintained also during power failure. The data can be
transferred to a computer, printed out, and analysed via Breas software products.
For more information about Breas software products, please contact your Breas
representative.
Expected Service Life
The expected service life of the Vivo 45 is 8 years.
10 Introduction
Vivo 45 User manual Doc. 006149 D-3

1.2 Intended Use
Vivo 45 is intended to provide non-invasive or invasive ventilation for adult or paediat-
ric patients weighing over 10 kg (22 lbs) who require long-term support or mechanical
ventilation for respiratory insufficiency or respiratory failure, with or without obstruc-
tive sleep apnea.
Vivo 45 is intended for spontaneously breathing patients.
1.3 Contraindications
The Vivo 45 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
•Pathologically low blood pressure, especially if associated with intravascular volume
depletion
•Cerebrospinal fluid leak, recent cranial surgery or trauma
The use of the Vivo 45 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 45, a physician or responsible clinician should be contacted
immediately.
The following side effects may occur during the course of therapy with the Vivo 45,
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 11
Doc. 006149 D-3 Vivo 45 User manual

1.4 Intended Environment
The Vivo 45 is intended to be used in clinical settings (e.g. hospitals, sub-acute care insti-
tutions), public spaces and home environments as well as during portable applications
such as wheelchairs, personal family vehicles, ground ambulances and civil aircraft,
excluding helicopters.
It is not intended for use during emergency transportation.
1.5 Intended Users
This section describes the intended users of the Vivo 45, their qualifications and their
related documents.
1.5.1 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 set-
tings. 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 45, its capabilities and the settings that can be made. This training consists of read-
ing the Clinician’s manual in full and it shall be conducted before operating the Vivo 45.
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 45.
1.5.2 Lay Operators
Day-to-day caregivers, patients, relatives and other non-professional users that operate
the Vivo 45 within the prescribed settings.
They are allowed to operate the Vivo 45 with the Home mode activated. The lay opera-
tor 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.
12 Introduction
Vivo 45 User manual Doc. 006149 D-3

Training
The lay operator shall be trained to basic knowledge of the Vivo 45 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 45.
1.5.3 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
software applications for follow-up on ventilators usage and for troubleshooting.
Training and Certification
Service personnel shall be trained on the Vivo 45 and certified by Breas for being
allowed to perform any service, repairs or other operations on the Vivo 45. The training
consists of reading the services manual in full. After training is completed, the certifica-
tion test may be performed.
Related Documents
•The Service Manual.
•The Clinician’s Manual.
•Service bulletins, available for certified service personnel on the Breas extranet.
1.6 About this Manual
CAUTION!
Always read this manual before setting up and using the Vivo 45 or performing main-
tenance on the machine, to ensure correct usage, maximum performance and
serviceability.
1.6.1 Audience
This manual is intended for patients and other lay users operating the Vivo 45.
Introduction 13
Doc. 006149 D-3 Vivo 45 User manual

•Care providers, clinical personnel, physicians and others who require a working
knowledge of the Vivo 45 will find additional information on settings and func-
tions 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.
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.
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.
14 Introduction
Vivo 45 User manual Doc. 006149 D-3

1.7 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/
Introduction 15
Doc. 006149 D-3 Vivo 45 User manual

2 Safety Information
2.1 General User Precautions
WARNING!
Risk of Personal Injury
The Vivo 45 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!
Risk of Insufficient Ventilation
Usage outside the specified operating conditions may cause reduced performance.
The Vivo 45 must only be used in accordance with the operating conditions specified
in this manual
Risk of Reduced Safety and Performance
Accessories that have not been tested with the Vivo 45 might affect safety features
and performance negatively. Only use the Vivo 45 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 45.
The responsible organization is responsible for ensuring the compatibility of the ven-
tilator and all parts used to connect to the patient before use.
Changes to the patient circuit, like adding or removing accessories or changing type
or length of breathing tube, may affect both circuit compliance and alarm triggering
conditions.
It’s recommended to perform a pre-use test and re-test the alarm function after mak-
ing changes to the patient circuit.
When a patient is treated, there must be a supervising person present during the treat-
ment in order to take care of alarms and conditions that the patient cannot solve on
their own.
If using the ventilator in a transport case, only use the protective cover listed as
approved accessory to prevent adverse ventilator performance, which can conse-
quently result in patient death.
16 Safety Information
Vivo 45 User manual Doc. 006149 D-3

To prevent disconnection of the patient circuit during use, only tubes in compliance
with ISO 5367 or ISO 80601-2-74 should be used.
The ventilator may not work properly if any part has been dropped, damaged or sub-
merged in water.
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.
WARNING!
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 Faulty Treatment
Do not use the Vivo 45 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 Faulty Treatment
The responsible organization should periodically reassess the settings of the therapy
for effectiveness.
Before starting treatment, always perform the procedure 4.5 Inspecting the Vivo 45 before
Use , page 42.
The ventilator is not suitable for a ventilator dependent patient.
Safety Information 17
Doc. 006149 D-3 Vivo 45 User manual

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.
CAUTION!
Clinical personnel must read the Clinician’s manual thoroughly and understand the
ventilator operation before setting up and using the ventilator.
•Handle the ventilator with care.
•Do not use the ventilator while in the carry bag.
•Do not use the ventilator with nitric oxide, helium or helium mixtures.
Contact Injuries: Skin irritation may occur due to prolonged exposure to either a
mask (if used) or the SpO2module.
Ensure that the cooling air intake vents are not blocked. If the vents are blocked,
especially in hot use environments, the surface temperature of the patient circuit may
rise above 41°C (106°F). In a 40°C (104°F) environment and with the cooling air
intake vents blocked, surface temperatures as high as 50°C (122°F) can occur. Before
an unsafe temperature is reached, the “High Patient Air Temp”alarm will occur. If
this alarm occurs, assure that the ventilator cooling air intake path is free of obstruc-
tion and that the patient circuit surface is not heating the patient’s skin.
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 45 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.
NOTE
Any serious incident that has occurred in relation to this device should be reported to
the competent authority and the manufacturer.
18 Safety Information
Vivo 45 User manual Doc. 006149 D-3

2.2 Electrical Safety
WARNING!
Risk of Electric Shock
High voltage contact may cause cardiac arrhythmia.
•Do not operate the Vivo 45 if it has a damaged power cord, power supply or
casing.
•To avoid electrical shock, only clean the Vivo 45 according to instructions in this
manual. Do not soak or immerse the Vivo 45 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.
WARNING!
Risk of Faulty Treatment
Electromagnetic Interference may cause electrical equipment to malfunction.
•The aspects of electromagnetic compatibility must be considered.
–The Vivo 45 should not be used adjacent to or stacked with other equipment;
if adjacent or stacked use is necessary, the Vivo 45 should be observed to ver-
ify normal operation in that configuration.
–Mobile or transportable radio transmitters may interfere with the Vivo 45.
–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 45.
•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 45, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
Safety Information 19
Doc. 006149 D-3 Vivo 45 User manual

WARNING!
Avoid touching the contacts within the ventilator click-in battery compartment.
Under certain circumstances touch current limits per IEC 60601-1 may be exceeded.
2.3 Environmental Conditions
WARNING!
Risk of Intoxication
Do not use the Vivo 45 in a toxic environment.
WARNING!
Risk of Fire
Do not use the Vivo 45 in environments where explosive gases or flammable anes-
thetic agents present.
WARNING!
The delivered patient air can be as much as 4°C (7°F) higher than ambient tempera-
ture. Caution should be exercised if the room temperature is greater that 36°C (97°F).
Risk of Faulty Treatment
If a room humidifier is used, place it at least 2 meters away from the Vivo 45.
Risk of faulty Treatment
The performance of the Vivo 45 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.
20 Safety Information
Vivo 45 User manual Doc. 006149 D-3