Breas Vivo 65 User manual

Vivo 65 User manual
Breas Medical AB, Företagsvägen 1, SE-435 33 Mölnlycke, S eden
Phone [phone] Order [phone] Technical Support [phone]
Fax [phone] .breas.com, Date: 2022-05-16 | 18320
Vivo 65,User’s
ENGLISH (EU)
UUSSEERR MMAANNUUAALL
006150 M-1 EN-EU
7 321820 061501

Table of Contents 1
Doc. 006150 M-1
Table of Contents
1 Introduction..................................................................................... 7
1.1 What is the Vivo 65? .................................................................7
1.1.1 Multiple Use ...............................................................8
1.2 Intended Use.......................................................................... 8
1.3 Contraindications.....................................................................8
1.3.1 Undesirable Side Effects.. .. .. .. . .. .. .. .. .. .. ..... .. .. .. .. .. ..... .. .. .. .. . 8
1.4 About this Manual ....................................................................8
1.4.1 Audience...................................................................9
1.4.2 Icons in this Manual . .. .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. . 9
1.5 Manufacturer Information . .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. ..10
2 Safety Information ............................................................................11
2.1 General User Precautions . .. . .. . .. .. . .. . .. .. . .. .. . .. . .. .. . .. . .. .. . .. .. . . .. .. . .. .. . . 11
2.2 Electrical Safety .....................................................................13
2.3 Environmental Conditions. . . . .. . .. .. . .. . .. . .. . .. .. . .. . .. . .. . .. .. . .. . .. . .. .. . .. . .. . ..13
2.4 Usage of Patient Circuit . .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. ..15
2.5 Usage of Filters......................................................................17
2.6 Humidification........................................................................18
2.7 Cleaning and Maintenance .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .18
2.8 Usage of Oxygen ....................................................................19
3 Product Description...........................................................................21
3.1 Main Components...................................................................21
3.2 The Front Panel .....................................................................24
3.3 The Vivo 65’s Side Panels .. . .. .. .. .. .. .. .. . .. .. .. .. .. ....... .. .. .. .. .. . .. .. .. .. .. ..26
3.4 Equipment Designation and Safety Labels . .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .28
4 Preparing the Vivo 65 for Use . .. .. ... .. ... .. .. ... .. ... .. ... .. .. ... .. ... .. .. ... .. ... .. ... .. .. .31
4.1 Checking the Vivo 65 before First Use . .. .. .. .. ... ... ... ... .. .. .. .. .. .. .. ... ... ... .31
4.2 Placing the Vivo 65..................................................................32
4.3 Connecting the Vivo 65 to AC power (Mains). .. .. .. .. .. . .. .. .. .. .. ..... .. .. .. .. .. .33
4.4 Connecting the Patient Circuit . .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. ..... .34
4.4.1 Connect Patient Circuit Insert . .. .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. ..34
4.4.2 Connect Dual Limb Circuit for Integrated Exhalation
Valve ......................................................................38
4.4.3 Connect a Single Limb Circuit with Leakage Port .. .. .. . .. .. .. .. .. .. .. .38
4.4.4 Connect a Single Limb Circuit with Active Exhalation
Valve ......................................................................39
4.5 Inspecting the Vivo 65 before Use. .. .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. ..39
4.6 Perform the Pre-Use Test .. .. .. .. ... .. .. ... .. .. ... .. .. ... .. .. ... .. ... .. .. ... .. .. ... .40
4.6.1 Actions At Pre-Use Test Failure . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. ..40
5 How to Use the Vivo 65.......................................................................42
5.1 Turning the Vivo 65 On and Off. .. .. .. .. ....... .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .42
5.1.1 Turn On and Enter Operating Mode. . .. . .. . .. . .. . . .. . .. .. . .. . .. . .. . . .. . .42

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5.1.2 Stopping Treatment and Turning Off . . . .. .. . .. .. . .. . .. .. . .. .. . .. .. . .. .. .43
5.2 Using the Menu......................................................................44
5.2.1 Navigating with the Buttons. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .44
5.2.2 Symbols Used in the Menu .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .45
5.2.3 Menu Overview...........................................................47
5.2.4 The Vivo 65 Display .. ... .. ... ... .. .. ... ... .. ... ... .. .. ... ... .. ... ... .. .. .48
5.2.5 The Setup Section . .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .50
5.2.6 Home Adjust..............................................................50
5.2.7 The Alarm Section. .. .. .. ..... .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .. . .50
5.2.8 The Monitor Section.. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. ..... .. .. .. .. .. .51
5.2.9 The Others Section. . . . . . . . .. . . . .. . . . .. . . .. . . . .. . . . .. . . . .. . . .. . . . .. . . . .. . .51
5.3 Monitored Values in the Vivo 65 . .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. ..53
5.3.1 Ppeak .....................................................................53
5.3.2 PEEP......................................................................53
5.3.3 Pmean ....................................................................53
5.3.4 Leakage...................................................................54
5.3.5 MVe .......................................................................54
5.3.6 MVi........................................................................54
5.3.7 % in TgV ..................................................................54
5.3.8 Vte.........................................................................54
5.3.9 Vti .........................................................................54
5.3.10 FiO2.......................................................................54
5.3.11 Total Rate.................................................................55
5.3.12 Spont Rate................................................................55
5.3.13 % Spont...................................................................55
5.3.14 SpO2(Oxygen Saturation) . . . .. .. . .. . .. . .. . .. .. . .. . .. . .. . .. .. . .. . .. . .. .. .55
5.3.15 Pulse Rate................................................................55
5.3.16 I:E .........................................................................55
5.3.17 PScalc ....................................................................55
5.3.18 Insp. Time.................................................................55
5.3.19 Rise Time .................................................................55
5.3.20 EtCO2.....................................................................56
5.3.21 InspCO2...................................................................56
5.4 Functions and Parameters in the Vivo 65 .. .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. ..56
5.4.1 Parameters’ Availability in Different Modes. .. .. .. .. .. .. . .. .. .. .. .. .. .. .56
5.4.2 Insp. Pressure ...........................................................57
5.4.3 PEEP......................................................................57
5.4.4 Breath Rate...............................................................57
5.4.5 Backup Rate..............................................................57
5.4.6 SIMV Rate ................................................................58
5.4.7 Insp. Time (Inspiratory Time) .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .58

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5.4.8 Backup Insp. Time (Backup Inspiratory Time). .. . .. .. .. .. .. .. .. .. . .. .. .59
5.4.9 Sigh Parameters . .. .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .59
5.4.10 Rise Time .................................................................60
5.4.11 Insp. Trigger (Inspiratory Trigger) . .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. ..60
5.4.12 Sup. Pressure (SIMV mode).. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. ..61
5.4.13 Exp. Trigger (Expiratory Trigger) ... . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. ..61
5.4.14 Minimum Inspiratory Time (Min Insp. Time) .. .. .. .. .. .. .. .. . .. .. .. .. .. .61
5.4.15 Maximum Inspiratory Time (Max Insp. Time) .. .. . .. .. .. .. .. .. .. .. . .. .. .61
5.4.16 Target Volume ............................................................62
5.4.17 Max Pressure.............................................................62
5.4.18 Min Pressure .............................................................62
5.4.19 Tidal Volume..............................................................63
5.4.20 Flow Pattern ..............................................................63
5.4.21 CPAP......................................................................63
5.5 Modes................................................................................63
5.5.1 Standby and Operating Mode . .. .. . .. .. .. .. .. ..... .. .. .. .. .. ... .. .. .. .. .63
5.5.2 Patient Mode .............................................................64
5.5.3 Ventilation and Breath Modes .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. ..64
5.6 Transferring Data between the Vivo 65 and a PC . .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. ..69
5.7 Using Batteries ......................................................................71
5.7.1 Power Source Priority . . .. . . . . .. . . .. . . . .. . . . . .. . . .. . . . .. . . . .. . . .. . . . . .. . . .71
5.7.2 Charging the Batteries . .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .71
5.7.3 Battery Icons..............................................................72
5.7.4 Internal Battery . .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .72
5.7.5 Click-on Battery . .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. ..73
5.7.6 Battery Operating Time (Internal and Click-on) . . .. .. .. .. .. .. .. .. . .. .. .75
5.7.7 Storing the Internal Battery and the Click-on Battery . .. .. .. .. ..... .. ..76
5.7.8 External DC...............................................................76
5.8 Using Accessories...................................................................78
5.8.1 Connecting and Disconnecting the Cables .. .. .. . .. .. .. .. .. .. .. .. . .. .. .78
5.8.2 Using the Vivo 65 with a Nurse Call System.. .. . .. .. .. .. .. .. .. . .. .. .. ..78
5.8.3 Using the Vivo 65 with the FiO2Sensor.. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .79
5.8.4 Using the Vivo 65 with the Remote Alarm . .. . .. .. .. .. .. .. .. . .. .. .. .. .. .81
5.8.5 Using the Vivo 65 with the CO2Sensor.................................81
5.8.6 Using the Vivo 65 with the SpO2Module . .. .. .. .. .. .. .. . .. .. .. .. .. .. ...85
5.8.7 Using the Vivo 65 with the Trolley . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. ..85
5.8.8 Using the Vivo 65 with the Protective Cover. . .. .. .. .. .. .. .. . .. .. .. .. .. .86
6 Alarms .........................................................................................88
6.1 Alarm Function.......................................................................88
6.1.1 Alarm Indication . .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. ..88
6.1.2 Audible Signal Pause . .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. ..89

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6.1.3 Audible Signal Presilence. .. .. .. .. .. . .. .. .. .. .. .. ..... .. .. .. .. .. . .. .. .. ..89
6.1.4 Alarm Reset ..............................................................90
6.2 Operator’s Position..................................................................90
6.3 Physiological Alarms . .. .. ..... .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .91
6.3.1 High Pressure Alarm .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .91
6.3.2 Low Pressure Alarm . .. .. .. .. . .. .. .. .. .. .. ..... .. .. .. .. .. . .. .. .. .. .. .. .. .92
6.3.3 High PEEP Alarm. . . . .. .. . . .. . .. .. . .. . .. . .. . .. . .. .. . .. . . .. .. . .. . .. . .. . .. . .93
6.3.4 Low PEEPAlarm .........................................................93
6.3.5 High Vti(High Inspired Tidal Volume Alarm) . .. .. .. .. .. .. .. . .. .. .. .. .. .94
6.3.6 High VteAlarm (High Expired Tidal Volume) . .. .. .. .. .. .. .. . .. .. .. .. .. .95
6.3.7 Low VtiAlarm (Low Inspired Tidal Volume) .. . .. .. .. .. .. .. .. . .. .. .. .. .. .96
6.3.8 Low VteAlarm (Low Expired Tidal Volume).. .. .. .. .. . .. .. .. .. .. .. .. .. . .97
6.3.9 High MViAlarm (High Inspired Minute Volume Alarm). . .. .. .. .. .. .. .. .98
6.3.10 High MVe(High Expired Minute Volume Alarm) .. ... ... .. .. ... ... ... ...99
6.3.11 Low MVi(Low Inspired Minute Volume Alarm) . . .. .. .. .. .. .. .. . .. .. .. 100
6.3.12 Low MVeAlarm (Low Expired Minute Volume) . . .. .. .. .. .. .. .. . .. .. .. 101
6.3.13 High Breath Rate Alarm.. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. . 102
6.3.14 Low Breath Rate Alarm . .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. 103
6.3.15 Apnea Alarm............................................................ 104
6.3.16 Disconnection Alarm . .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. . 104
6.3.17 Rebreathing Alarm .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. ..... .. .. .. .. .. .. . .. . 106
6.3.18 Obstruction Alarm . .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .. 107
6.3.19 High FiO2Alarm ........................................................ 107
6.3.20 Low FiO2Alarm......................................................... 108
6.3.21 High SpO2Alarm....................................................... 108
6.3.22 Low SpO2Alarm........................................................ 109
6.3.23 High EtCO2Alarm...................................................... 109
6.3.24 Low EtCO2Alarm....................................................... 110
6.3.25 High InspCO2Alarm (High Inspired CO2)............................. 110
6.3.26 High Pulse Rate Alarm.. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .....111
6.3.27 Low Pulse Rate Alarm .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. 112
6.4 Technical Alarms . .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. . 112
6.4.1 Power Failure Alarm .. .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. 112
6.4.2 High Patient Air Temp. (High Patient Air Temperature) .. .. .. .. .. . .. . 113
6.4.3 High Internal Temperature (High Internal Temp) . .. .. .. .. .. . .. .. .. .. . 113
6.4.4 Low Last Power Source Alarm .. .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. 113
6.4.5 Lost Mains Alarm .. .. .. .. ..... .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .. 114
6.4.6 Crit. Low Last Power Source Alarm . .. ... .. ... .. ... .. ... .. .. ... .. ... .. 114
6.4.7 Circuit Type/Insert Mismatch Alarm .. ... .. ... .. ... .. .. .. .. .. ... .. ... .. 115
6.4.8 Patient Mode/Insert Mismatch Alarm . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. 115
6.4.9 Exhalation Valve Control Error Alarm .. .. .. .. . .. .. .. .. .. ..... .. .. .. .. . 116

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6.4.10 Vte/MVe Accuracy Unspecified Alarm . .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. . 116
6.4.11 Vte/MVe Sensor Error Alarm . .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. . 116
6.4.12 SpO2/CO2/Remote Start/Stop Failure Alarm (SpO2/CO2Remote
Fail) ..................................................................... 117
6.4.13 SpO2Disconnected (SpO2Sensor Failure/Disconnection
Alarm)................................................................... 117
6.4.14 SpO2Signal Inadequacy Alarm (SpO2Signal) .. . .. .. .. .. .. .. .. .. . .. . 118
6.4.15 CO2Disconnected (CO2Sensor Failure/Disconnection
Alarm)................................................................... 118
6.4.16 CO2Sensor Accuracy Unspecified Alarm
(CO2Accuracy Unspec) . .. .. .. .. .. . .. .. .. .. .. ..... .. .. .. .. .. . .. .. .. .. . 118
6.4.17 CO2Sensor Error Alarm . .. .. ....... .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. . 119
6.4.18 FiO2Disconnected (FiO2Sensor Failure/Disconnection
Alarm)................................................................... 119
6.4.19 Ambient Pressure Compensation Lost Alarm . .. . .. .. .. .. .. ....... .. . 120
6.4.20 Temperature Comp. Lost (Ambient Temperature Compensation
Lost Alarm) ............................................................. 120
6.4.21 Humidity Comp. Lost (Humidity Compensation Lost
Alarm)................................................................... 121
6.4.22 LED Failure Alarm. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .. 121
6.4.23 Low Alarm Battery Alarm .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. . 121
6.4.24 Alarm for Beeper Failure. .. .. ....... .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. . 122
6.4.25 Int. Function Failure (Internal Function Failure Alarm). .. .. .. .. .. .. .. 122
6.5 Alarm Test.......................................................................... 122
6.5.1 Instructions ............................................................. 122
7 Cleaning and Maintenance .. .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. ..... .. .. .. .. .. . .. .. .. .. . 124
7.1 Cleaning the Vivo 65 .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. . 124
7.1.1 Main Unit................................................................ 124
7.1.2 Insert.................................................................... 125
7.1.3 Patient Circuit. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. 125
7.2 Cleaning and Replacing the Patient Air Filters . .. .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. . 126
7.3 Change of Patients . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .. 127
7.4 Regular Maintenance . .. .. .. ... .. .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. 127
7.5 Service and Repair ..... .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .. 127
7.6 Storage............................................................................. 128
7.7 Disposal............................................................................ 128
8 Technical Specifications . . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. ... .. 129
8.1 System Description. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. . 129
8.1.1 Dual Limb Circuit with Integrated Exhalation Valve . .. .. .. .. .. . .. .. .. 129
8.1.2 Single Limb Circuit with Active Exhalation Valve .. .. .. .. .. .. .. .. . .. . 130
8.1.3 Single Limb Circuit with Leakage Port . .. . .. .. .. .. .. .. ... .. .. .. .. .. ... 130
8.1.4 MPV Breath Model .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. 131
8.1.5 Pneumatic Diagram for the Vivo 65 with Dual Limb
Circuit ................................................................... 132

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8.1.6 Pneumatic Diagram for the Vivo 65 with Single Limb
Circuit ................................................................... 133
8.1.7 Worst Case Accuracy . .. ..... .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .. 133
8.2 Data Parameters .................................................................. 134
8.2.1 Settings ................................................................. 134
8.2.2 Monitored Values .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .. 134
8.2.3 Alarms .................................................................. 135
8.2.4 Technical Specifications and Conditions. . .. .. .. .. .. .. .. . .. .. .. .. .. .. . 135
8.3 Emission and Immunity Declaration. .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. . 139
8.3.1 Vivo 65 Essential Performance. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. .. .. 139
8.3.2 Guidance and Manufacturer's Declaration – Electromagnetic
Immunity................................................................ 139
8.3.3 Guidance and Manufacturer's Declaration – Electromagnetic
Emission................................................................ 142
8.3.4 Recommended separation distances between portable and
mobile RF communications equipment and the
ventilator................................................................ 142
8.3.5 Recommended separation distances between external power
conductors and the ventilator. .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. 143
8.4 Default Settings.................................................................... 143
9 Accessories and Parts...................................................................... 146
9.1 Patient Circuits and Air Delivery Accessories . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. 146
9.2 Power Accessories . .. .. ... .. .. ... .. .. .. . .. .. .. .. .. .. .. . .. .. .. .. .. .. .. ... .. .. .. . .. . 149
9.3 Monitoring Accessories . .. .. .. .. . .. .. .. .. .. ..... .. .. .. .. .. .. ... .. .. .. .. .. .. . .. .. .. 150
9.4 Ventilator Filters and Detachable Parts . .. .. .. . .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. 153
9.5 Other Accessories................................................................. 154
10 Patient Settings ............................................................................. 159
11 FAA Compliance ............................................................................ 160
11.1 FAA Compliance................................................................... 160
Index ............................................................................................... 161

1 Introduction
WARNING!
Risk of Personal Injury
The Vivo 65 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 65 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 65.
Breas Medical reserves the right to make changes to this product without any prior
notification.
1.1 What is the Vivo 65?
The Vivo 65 is a pressure and volume ventilator capable of delivering continuous or inter-
mittent ventilatory support for patients who require invasive or non-invasive mechanical
ventilation.
The Vivo 65 can be operated in 13 different combinations of ventilation and breath modes:
• PSV – Pressure Support Ventilation
• PSV(TgV) – Pressure Support Ventilation with Target Volume
• PCV – Pressure Controlled Ventilation
• PCV(TgV) – Pressure Controlled Ventilation with Target Volume
• PCV(A) – Assisted Pressure Controlled Ventilation
• PCV(A+TgV) – Assisted Pressure Controlled Ventilation with Target Volume
• PCV-SIMV – Pressure Controlled Ventilation with Synchronized Intermittent Manda-
tory Ventilation
• PCV-MPV – Pressure Controlled Ventilation with MouthPiece Ventilation
• VCV – Volume Controlled Ventilation
• VCV(A) – Assisted Volume Controlled Ventilation
• VCV-SIMV – Volume Controlled Ventilation with Synchronized Intermittent Manda-
tory Ventilation
• VCV-MPV – Volume Controlled Ventilation with MouthPiece Ventilation
• CPAP – Continuous Positive Airway Pressure
Introduction 7
Doc. 006150 M-1 User manual

The Vivo 65 can be used with the following patient circuit configurations:
• Dual limb circuit (adult or paediatric), connected to an integrated active exhalation valve,
for internal measurement of expired volume, pressure and flow.
• Single limb circuit with external leakage port or external active exhalation valve.
• Circuit with mouthpiece interface.
1.1.1 Multiple Use
This is a multiple patient multiple use device. If it should be used by multiple patients, see
the cleaning instructions in 7.3 Change of Patients, page 127 before assigning it to a new
patient.
1.2 Intended Use
The Vivo 65 (with or without the SpO2 and CO2 sensor) is intended to provide continuous
or intermittent ventilatory support for the care of individuals who require mechanical venti-
lation. Specifically, the ventilator is applicable for paediatric through adult patients weighing
more than 5 kg.
The Vivo 65 with the SpO2 sensor is intended to measure functional oxygen saturation of
arterial hemoglobin (%SpO2) and pulse rate. The Vivo 65 with the CO2 sensor is intended
to measure CO2 in the inspiratory and expiratory gas.
The device is intended to be used in home, institution, hospitals and portable applications
such as wheelchairs and gurneys. It may be used for both invasive and non-invasive
ventilation.
1.3 Contraindications
• The use of the Vivo 65 is contraindicated for patients who need to be ventilated with
oxygen concentrations (FiO2) higher than achievable when combining inlet from a low
pressure oxygen source at 15 l/min with actual ventilator settings.
• Generally, after surgery, the surgeon should be consulted to avoid organ damage and
help determine ventilator parameters that do not adversely affect hemodynamics or have
a negative impact on the patient’s health status.
• In case of facial surgery, make sure to choose a suitable patient interface, in order to
avoid discomfort and injury.
1.3.1 Undesirable Side Effects
WARNING!
The Vivo 65 is not intended to be used as an emergency transport ventilator or critical
care ventilator.
If the patient experiences chest discomfort, pain, severe headache or shortness of breath
while using the Vivo 65, a physician or responsible clinician shall be contacted immediately.
1.4 About this Manual
CAUTION!
Always read this manual before setting up and using the Vivo 65 or performing mainte-
nance on the machine, to ensure correct usage, maximum performance and serviceability.
8Introduction
User manual Doc. 006150 M-1

Breas Medical reserves the right to make changes to this product without any prior
notification.
1.4.1 Audience
This manual is intended for patients and other lay users operating the Vivo 65.
• Care providers, clinical personnel, physicians and others who require a working
knowledge of the Vivo 65 will find additional information on settings and func-
tions in the Clinician’s Manual. The Clinician’s manual should be of the same revi-
sion 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.
1.4.2 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)
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.
Introduction 9
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1.5 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]
UK Sales and Support Information
UK Responsible Person: Breas Medical Ltd
Phone UK Head Office
[phone]
Fax UK Head Office
[phone]
General Enquiries and Ordering
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10 Introduction
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2 Safety Information
2.1 General User Precautions
WARNING!
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.
Always have immediate access to an alternative means of ventilation, which is ready for
use, to avoid patient death or serious injury. Failure to have an alternate means of ventila-
tion can result in serious injury or patient death if ventilator fails.
Failure to have an alternative means of ventilation can result in serious injury or patient
death if ventilator fails.
The Vivo 65 must be turned off and on at least every 90 days. This is necessary in order
for the Vivo 65 to perform a complete self-test. The self-test automatically tests the
alarm sound and certain components.
If you are admitted to a hospital or are prescribed any other form of medical treatment,
always inform the medical staff that you are on mechanical ventilation treatment.
The Vivo 65 must only be used:
• for the intended treatment in accordance with this operating manual and with the
instructions given by the responsible clinical personnel;
• in accordance with the operating conditions specified in this operating manual;
• in original and unmodified form and only with accessories specified or approved
by Breas Medical.
Do not use the Vivo 65 in the event of suspected damage to the device, unexplainable or
sudden pressure, performance or sound changes during operation, or if the delivered air
from the Vivo 65 is abnormally hot or emits an odour. In these cases, contact the
patient’s responsible care provider for an inspection.
The Vivo 65 may not work properly if any part has been dropped, damaged or sub-
merged in water.
Inadequate use of device or accessories may cause loss of treatment or decreased
performance.
The Vivo 65 therapy settings must always be based on medical advice and must be car-
ried out by authorised clinical personnel only. Blood gas measurement shall be per-
formed when changing treatment settings or changing to another device.
Always perform the procedure in4.5 Inspecting the Vivo 65 before Use, page 39 before use.
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The Vivo 65 can be used for life-supporting treatment provided an emergency equip-
ment (e.g. resuscitation bag) is available, and that one of the following configurations is
used for surveillance of ventilator-dependent patient breathing:
• Dual limb patient circuit and insert with integrated exhalation valve: The Vivo 65’s
internal measurement and monitoring of exhaled volume must be supervised.
• Single limb with leakage patient circuit: The Vivo 65’s monitoring of exhaled vol-
ume must be supervised
• Single limb with exhalation valve patient circuit: The CO2sensor or an external
EtCO2monitor (capnometer) must be used. The CO2sensor must be connected
between the patient and the exhalation valve to be able to measure exhaled gases.
The CO2monitor shall fulfil the ISO 80601-2-55 standard (Medical electrical
equipment - Particular requirements for the basic safety and essential performance
of respiratory gas monitors).
Make sure that accessories are compatible with the Vivo 65 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.
CAUTION!
• 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.
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 4.5 Inspecting
the Vivo 65 before Use, page 39. 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 manufacturer and the competent authority.
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2.2 Electrical Safety
WARNING!
Risk of Electric Shock
High voltage contact may cause cardiac arrhythmia.
• Do not operate the Vivo 65 if it has a damaged power cord, power supply or
casing.
• To avoid electrical shock, only clean the Vivo 65 according to instructions in this
manual. Do not soak or immerse the Vivo 65 into any fluids.
• 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.
WARNING!
Risk of Faulty Treatment
Electromagnetic Interference may cause electrical equipment to malfunction.
• The aspects of electromagnetic compatibility must be considered.
• The Vivo 65 should not be used adjacent to or stacked with other equipment; if
adjacent or stacked use is necessary, the Vivo 65 should be observed to verify
normal operation in that configuration.
• Mobile or transportable radio transmitters may interfere with the Vivo 65.
• 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 65.
• 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 65, including cables specified. Otherwise, degradation of the
performance of this equipment could result.
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.
2.3 Environmental Conditions
WARNING!
Risk of Intoxication
Do not use the Vivo 65 in a toxic environment.
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WARNING!
Risk of Fire
Do not use the Vivo 65 in environments where explosive gases or flammable anesthetic
agents present.
WARNING!
The delivered patient air can be as much as 4°C (7°F) higher than ambient temperature.
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 65.
The performance of the Vivo 65 may deteriorate at ambient temperatures below -20°C
(-4°F) and above 40°C (104°F). However, the treatment shall always be started in an
ambient temperature warmer than 5°C (41°F).
Risk of Faulty Treatment
Do not use or store the Vivo 65 in a magnetic resonance (MR) environment.
Use of the Vivo 65 in an MR environment may result in malfunction of the Vivo 65 and
pose unacceptable risk to the patient, medical staff or other persons.
Do not expose the Vivo 65 to rain or snowfall.
Do not use the Vivo 65 while positioned in a warm place, such as direct sunlight or close
to a radiator .
CAUTION!
The device complies with the EMC requirements of standards. Measures should include
but not be limited to:
• normal precautions with regard to relative humidity and conductive characteristics
of clothing in order to minimize the build-up of electrostatic charges.
• avoiding the use of radio emitting devices closer than 1 meter to the Vivo 65.
Radio emitting devices include cellular or cordless telephones, microwave ovens
and high-frequency surgery apparatus.
Avoid using RFID devices closer than 1 meter to the Vivo 65.
Avoid using the Vivo 65 within 1 meter of electronic article surveillance (EAS) system
antennae.
WARNING!
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. Follow the instructions above and the guidance pro-
vided in 8.3 Emission and Immunity Declaration, page 139 to mitigate the effects of electro-
magnetic disturbances.
14 Safety Information
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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.
The performance of the Vivo 65 and treatment of the patient may deteriorate if the oper-
ation conditions in 8.2.4.2 Environmental Conditions, page 136 are not fulfilled. Do not use
the Vivo 65 immediately after storage or transport outside the recommended operating
conditions.
2.4 Usage of Patient Circuit
WARNING!
For the ventilator to deliver treatment according to settings, it is important that the selec-
tion of the patient circuit type (see 5.2.2 Symbols Used in the Menu, page 45)is correctly set.
Only use the Vivo 65 with accessories recommended by Breas Medical.
The pressurized air from the ventilator causes a continuous flow of air to exhaust from
the leakage ports or exhalation valve, flushing exhaled gas from the circuit. If having a
patient circuit with leakage port, the ventilator should be turned on and the function of
the leakage port should be checked before use. The ventilator should be turned on and
the function of the leakage port or exhalation valve should be checked before use.
Do not breathe in the connected patient circuit unless the Vivo 65 is turned on and oper-
ating properly.
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!
Always make sure that the patient circuit and joined parts are undamaged and correctly
connected, in order to avoid unwanted leakage.
Always perform a pre-use test when the patient circuit or insert is replaced or modified.
Patient connected parts and all filters must be replaced regularly to ensure correct func-
tion of the ventilator. All replaced parts must be disposed of according to local environ-
mental regulations regarding the disposal of used equipment and parts.
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Patient circuits used with the Vivo 65 shall have the following characteristics:
• Length: Max 6 feet (2 meters).
• Connector: 22 mm.
• Resistance: Max 2 mbar at 40 l/min.
If an active exhalation valve is used:
• Minimum inner diameter of the exhalation valve control pressure tube: 3 mm.
• The exhalation valve must be of the type that is open (letting the exhaled patient
air out) when unpressurized by the control pressure.
By conducting a pre-use test (see 4.6 Perform the Pre-Use Test, page 40), the compatibility
of the complete patient circuit configuration with the Vivo 65 can be verified. If a pre-
use test is successfully performed the circuit configuration meets the required
characteristics.
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 65 to ensure no water flows back into the Vivo 65.
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.
When using the Vivo 65 invasively, the low volume alarm and the low breath rate alarm
must be carefully set, to ensure safe use.
The use of equipment such as endotracheal tubes, oral/nasal tubes, adaptors, etc. with
small inner diameters or high resistance filters (such as humidifiers) increases the resist-
ance in the patient circuit which may interfere with the operation of the patient discon-
nect function. It may also interfere with the device trigger function. The impact can be
reduced by conducting a pre-use test properly. (See 4.6 Perform the Pre-Use Test, page 40.)
In case of invasive application, the use of an appropriate external heated humidifier or
HME (Heat and Moisture Exchanger, artificial nose)/HCH (Hygroscopic Condenser
Humidifier ) is recommended.
Make sure that the exhalation valve or the leakage port never is blocked or obstructed.
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.
Always follow the instructions of the mask manufacturer.
The Vivo 65 is equipped with a rebreathing alarm. The alarm is not a substitute for oper-
ator vigilance in ensuring that the leakage port or exhalation valve remains clear at all
times. Periodically check the patient circuit during therapy.
In general, as pressure decreases, the potential of rebreathing increases. Lower pressures
produce less flow through the leakage port which may not clear all CO2from the circuit
to prevent rebreathing.
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To reduce the risk of rebreathing CO2:
• Single limb circuit use: make sure that the leakage port or active exhalation valve is
present as close as possible to the patient connection.
• Dual limb circuit use: make sure that the Y-piece is present as close as possible to
the patient connection.
CAUTION!
Contact Injuries: Skin irritation may occur due to prolonged exposure to either a mask (if
used) or the SpO2module.
WARNING!
Always use a new patient circuit when the Vivo 65 is to be used by a new patient.
NOTE
The Vivo 65 and its packaging do not contain any natural rubber latex.
2.5 Usage of Filters
WARNING!
Always use the ventilator with patient air inlet filters installed. Only use the ventilator
with accessories recommended by Breas Medical.
Replace or clean the filters regularly to ensure correct function of the Vivo 65.
Failure to replace or clean a dirty filter may cause the Vivo 65 to operate at higher tem-
peratures than intended. A dirty filter may be caused by dust or animal hair in the home
environment.
Risk of Insufficient Ventilation
Insufficient ventilation may cause transient hypoxia.
Replace or clean the inlet filters as specified in the Maintenance chapter.
Using old or clogged filters may cause the Vivo 65 to operate at higher temperatures
than intended.
When operating the Vivo 65, make sure that the air inlet and filters are not obstructed or
occluded.
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.
This impact can be reduced by conducting a pre-use test.
When adding or removing any kind of filter, always perform a pre-use test.
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2.6 Humidification
WARNING!
Humidification must only be used if this has been prescribed by your physician. The
Vivo 65 therapy settings must always be prescribed by a physician or other licensed
health care professional, and be carried out by authorized clinical personnel.
When using an external heated humidifier, it should be located below the Vivo 55 and
the patient to prevent injury from accidental spillage.
When using a humidifier or a nebuliser any patient air filter will need more frequent
replacement to prevent increased resistance or blockage.
During transportation of the Vivo 65, the humidifier must be disconnected.
If the condensation in the patient circuit is excessive, the use of a heated humidifier may
require the installation of a water trap in the circuit. The water trap prevents any con-
densed water in the patient circuit from running into the patient airways and causing per-
sonal injury.
When adding or removing an HME (Heat and Moisture Exchanger, artificial nose) or
HCH (Hygroscopic Condenser Humidifier), always reassess the settings, including alarm
settings, and perform a pre-use test.
Any humidifier connected to the Vivo 55 must comply with ISO 8185 or 80601-2-74.
Any HME connected to the ventilator must comply with ISO 9360.
The use of an HME or an external humidifier may require readjustment of the ventilator
low-pressure alarm.
CAUTION!
Certain HMEs and HCHs are sufficient to provide humidification when the ventilator is
used invasively. Check specific suppliers’ recommended use.
NOTE
The ventilator has been tested and validated with the Fisher & Paykel MR850 heated
humidifier
2.7 Cleaning and Maintenance
WARNING!
The Vivo 65 should be cleaned and maintained in accordance with this operating manual.
(See 7 Cleaning and Maintenance, page 124.)
CAUTION!
Do not attempt to autoclave or sterilize the Vivo 65.
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