Breas Vivo 45 LS User manual

Vivo 45 LS User manual
Breas Medical AB, Företagsvägen 1, SE-4 5 Mölnlycke, Sweden
Phone [phone] Order [phone] Technical Support [phone]
Fax [phone] www.breas.com, Date: 2021-01-28
Vivo 45 LS,User’s
ENGLISH (US)
UUSSEERR MMAANNUUAALL
007 01 EN-US K-1
7 321820 073016

Table of Contents 3
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Table of Contents
1 Introduction....................................................................................11
1.1 What is the Vivo 45 LS?. .. .. . .. .. .. . .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. .. . . 11
1.2 Intended Use.........................................................................13
1.3 Indications for Use...................................................................13
1.4 Contraindications....................................................................14
1.5 Intended Environment. .. .. . . . .. . . . . . .. . . . .. . . . . . .. . . . . . .. . . . .. .. . . . .. .. . .. .. .. . .. .. .14
1.6 Intended Users ......................................................................14
1.6.1 Respiratory Health Care Specialists . . .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. . . . .14
1.6.2 Lay Operators ............................................................15
1.6.3 Service Personnel. . .. . . . .. .. . . . .. .. . .. .. .. . .. .. .. . .. .. . .. .. .. . .. .. .. . .. ..15
1.7 About this Manual ...................................................................16
1.7.1 Audience..................................................................16
1.7.2 Icons in this Manual . .. .. . .. .. . . . .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. . . . .. .. . . . .16
1.8 Manufacturer Information . .. . .. .. .. . .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. . . . .. .. . . . .. . . . . . .18
2 Safety Information ............................................................................19
2.1 General User Precautions .. .. . . . .. . . . . . .. . . . . . . . . . . .. . . . . . .. . . . .. .. . . . .. .. . .. .. .. . .19
2.1.1 Requirements for Life Supporting Treatment.. . . . .. . . . . . .. . . . . . .. . . . .. .22
2.2 Electrical Safety .....................................................................23
2.3 Environmental Conditions. . . . .. .. .. . .. .. . .. .. . .. .. . .. . . . .. .. . .. .. . .. . . . .. .. . .. . . .. . .24
2.4 Usage of Patient Circuit . .. .. . .. .. .. . .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. . . . .. .. . . . .. . . . . . .26
2.5 Usage of Filters......................................................................29
2.6 Humidification........................................................................29
2.7 Cleaning and Maintenance .. . . . .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. . . . .. .. . . . .. . . . . . .. . . .30
2.8 Usage of Oxygen ....................................................................31
3 Product Description...........................................................................34
3.1 Main Components...................................................................34
3.2 Front View............................................................................36
3.3 Side Views ...........................................................................37
3.3.1 Detaching and Reattaching the Side Panels . .. .. .. . .. .. . . . .. .. . . . .. . . .39
3.4 Equipment Designation . .. .. . .. .. . . . .. .. . .. .. . . . .. .. . . . .. . . . . . .. . . . .. .. . . . .. .. . .. .. .41
3.4.1 Additional Symbols.. .. .. . .. .. . . . .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. . . . .. .. . . . .42
4 Preparing the Vivo 45 LS for Use . .. . . . .. .. . .. .. . . . .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. . . . .. .. . . . .45
4.1 Checking the Vivo 45 LS before First Use . .. . .. .. . . . .. .. . . . .. . . . .. .. . . . .. . . . . . .. . .45

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4.2 Placing the Vivo 45 LS . .. ... ... ... .. ... ... ... ... .. ... ... ... ... .. ... ...45
4.3 Connecting the Vivo 45 LS to Mains . . . .. . . . . . .. . . . .. .. . . . .. .. . .. .. ..47
4.4 Connecting the Patient Circuit. . . . . . .. . . . .. .. . . . .. .. . .. .. .. . .. .. .. . .. .48
4.4.1 Connect an Active Exhalation Valve Patient
Circuit.......................................................48
4.4.2 Connect a Leakage Patient Circuit .. . .. .. .. . .. .. .. . .. .. . .49
4.4.3 Connect an MPV Circuit . .. . .. .. .. . .. .. .. . .. .. . . . .. .. . . . .. .49
4.5 Inspecting the Vivo 45 LS before Use ... . . . .. .. . .. .. .. . .. .. .. . .. .. ..50
4.6 Adjusting the Vivo 45 LS Patient Settings .. . . . . .. . . . .. . . . . . .. . . . .. ..51
4.7 Performing the Pre-use Test. .. . .. .. .. . .. .. . . . .. .. . . . .. . . . . . .. . . . . . . . .52
5 How to Use the Vivo 45 LS. .. .. . . . .. .. . . . .. . . . . . .. . . . . . .. . . . .. .. . . . .. .. . .. .. . . .54
5.1 Switch the Vivo 45 LS On and Off.. .. . . . . . .. . . . .. .. . . . .. .. . .. .. .. . .. .54
5.2 Using the Menu.. . . .. . . . .. .. . . . .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. . . . .. .. . ..56
5.2.1 Navigating with the Buttons .. .. .. . .. .. .. . .. .. .. . .. .. .. . .. .56
5.2.2 Symbols Used in the Menu .. . . . .. . . . . . .. . . . .. .. . . . .. .. . .. .57
5.2.3 Menu Overview . . .. . . . .. .. . . . .. . . . .. .. . . . .. .. . .. .. .. . .. .. ..59
5.2.4 Display Overview .. .. . . . .. . . . . . .. . . . . . . . . . . .. . . . . . .. . . . .. ..61
5.2.5 The Main Display, Home Mode . .. .. . .. .. . . . .. .. . . . .. . . . ..62
5.2.6 The Setup Section, Home Mode .. .. . .. .. .. . .. .. .. . .. .. . ..63
5.2.7 The Alarm Section . .. . . . .. .. . . . .. . . . . . .. . . . . . . . . . . .. . . . . . ..64
5.2.8 The Monitor Section . .. . .. .. .. . .. .. .. . .. .. .. . .. .. . . . .. .. . ..65
5.2.9 The Others Section . .. . . . . . . . . . . .. . . . . . .. . . . .. .. . . . .. .. . .. .65
5.3 Monitored Values in the Vivo 45 LS . ... .. . .. .. .. . .. .. .. . .. .. .. . .. .. . .66
5.3.1 Ppeak.......................................................67
5.3.2 PEEP .......................................................67
5.3.3 Pmean......................................................67
5.3.4 Leakage .. .. . . . .. . . . . . .. . . . .. .. . . . .. .. . . . .. .. . .. .. .. . .. .. . ..68
5.3.5 MVe.........................................................68
5.3.6 MVi..........................................................68
5.3.7 Vte ..........................................................68
5.3.8 Vti ...........................................................68
5.3.9 FiO2.........................................................68
5.3.10 % in TgV....................................................68
5.3.11 Total Rate. .. .. . . . .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. . . . .. .. . . . .. .68

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5.3.12 Spont Rate................................................................69
5.3.13 % Spont...................................................................69
5.3.14 SpO2(Oxygen Saturation) . . .. . .. .. . .. .. .. . .. .. . .. .. . .. .. . .. . . . .. .. . .. .. .69
5.3.15 Pulse Rate................................................................69
5.3.16 I:E .........................................................................69
5.3.17 Insp. Time.................................................................69
5.3.18 Rise Time .................................................................70
5.3.19 EtCO2.....................................................................70
5.3.20 InspCO2...................................................................70
5.3.21 PtcCO2....................................................................70
5.4 Modes in the Vivo 45 LS .. .. . . . . . .. . . . .. . . . . . .. . . . .. .. . . . .. .. . .. .. .. . .. .. .. . .. .. .. . .70
5.4.1 Standby and Operating Mode . .. . . . .. .. . . . .. . . . . . .. . . . .. . . . . . .. . . . . . .. . .70
5.4.2 Device Mode..............................................................70
5.4.3 Patient Mode .............................................................71
5.4.4 Ventilation and Breath Modes . . . .. .. . . . .. . . . . . .. . . . .. . . . . . .. . . . .. .. . . . ..71
5.5 Functions and Parameters in the Vivo 45 LS . .. .. . . . .. . . . . . .. . . . .. . . . . . .. . . . .. .. . .76
5.5.1 Parameters’ Availability in Different Modes. .. . . . .. . . . .. .. . . . .. . . . . . .. . .76
5.5.2 Insp. Pressure ...........................................................79
5.5.3 PEEP......................................................................79
5.5.4 Breath Rate...............................................................80
5.5.5 Backup Rate..............................................................80
5.5.6 SIMV Rate ................................................................81
5.5.7 Insp. Time (Inspiratory Time) ... .. .. . .. .. .. . .. .. . . . .. .. . . . .. . . . . . .. . . . . . .81
5.5.8 Backup Insp. Time (Backup Inspiratory Time)... . .. .. . . . .. .. . . . .. . . . . . .82
5.5.9 Sigh Rate .................................................................82
5.5.10 Sigh % ....................................................................83
5.5.11 Rise Time .................................................................83
5.5.12 Insp. Trigger (Inspiratory Trigger) .. .. .. . . . .. .. . . . .. . . . .. .. . . . .. . . . . . .. . .84
5.5.13 Sup. Pressure( SIMV mode). .. .. .. . .. .. . . . .. .. . . . .. . . . .. .. . . . .. . . . . . .. . .84
5.5.14 Exp. Trigger (Expiratory Trigger) .. .. .. . .. .. .. . .. .. .. . .. .. . . . .. .. . . . .. . . .85
5.5.15 Max Insp. Time (Maximum Inspiratory Time). .. .. .. . .. .. .. . .. .. . . . .. .. .85
5.5.16 Min Insp. Time (Minimum Inspiratory Time) .. .. .. .. . .. .. .. . .. .. .. . .. .. .86
5.5.17 Target Volume ............................................................86
5.5.18 Tidal Volume..............................................................87

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5.5.19 Flow Pattern . .. .. . .. . . .. . . .. .. .. .. .. .. . .. .. .. .. .. .. .. . .. . . ..88
5.5.20 Max Pressure . .. . . . .. .. . . . .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. . ..88
5.5.21 Min Pressure . . .. .. .. . .. .. . . . .. .. . . . .. . . . . . .. . . . .. .. . . . .. . . .89
5.5.22 CPAP .......................................................89
5.6 Using Batteries . . . . . . . . .. . . . . . .. . . . .. .. . . . .. .. . .. .. .. . .. .. .. . .. .. .. . .. .89
5.6.1 Power Source Priority.. . .. .. .. . .. .. . . . .. .. . . . .. . . . . . .. . . . ..90
5.6.2 Power Switchover Tests .. . .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. . .90
5.6.3 Charging the Batteries . . .. .. . . . .. . . . . . .. . . . . . . . . . . .. . . . . . ..91
5.6.4 Battery Icons . . .. . . . . . .. . . . .. .. . . . .. .. . .. .. .. . .. .. .. . .. .. . ..92
5.6.5 Internal Battery . . ... .. .. .. .. .. .. .. .. .. .. .. .. .. . .. .. .. .. .. .. .93
5.6.6 Click-in Battery . .. .. . .. .. .. . .. .. . .. .. .. . .. .. .. . .. .. . . . .. .. . .93
5.6.7 Battery Operating Time (Internal and Click-
in) ...........................................................94
5.6.8 Storing the Internal Battery and the Click-in
Battery......................................................95
5.6.9 External DC . . .. .. . . . .. .. . . . .. . . . .. .. . . . .. . . . . . .. . . . .. .. . . . .95
5.7 Using Accessories . .. .. . .. .. .. . .. .. . . . .. .. . .. .. . . . .. .. . . . .. . . . . . .. . . . .96
5.7.1 Connecting and Disconnecting the Cables. . .. . . . . . .. . . . .96
5.7.2 Using the ventilator with a Nurse Call
System......................................................97
5.7.3 Using the ventilator with the FiO2Sensor . . .. .. . . . .. . . . ..97
5.7.4 Using the ventilator with the Remote Alarm .. . . . . . .. . . . ..99
5.7.5 Using the ventilator with the EtCO2Sensor .. . . . .. . . . . . 100
5.7.6 Using the ventilator with the PtcCO2Cable . .. .. .. . .. .. 105
5.7.7 Using the Ventilator with the SpO2module . . . .. .. .. . .. . 106
5.7.8 Using the ventilator with the Remote Start/
Stop....................................................... 106
5.7.9 Using the ventilator with the Protective
Cover ..................................................... 106
5.7.10 Using the Vivo 45 LS with the Trolley. .. . .. .. .. . .. .. .. . . 107
6 Alarms ........................................................................ 109
6.1 Alarm Function . . .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. . . . .. .. . . . .. . . . . . .. . . . 109
6.1.1 Alarm Indication . . .. .. .. . .. . . .. . . .. . . .. .. .. .. .. .. .. .. .. .. . 109
6.1.2 Audible Signal Pause .. . . ... .. ... .. .. ... .. .. .. . ... .. ... .. 110
6.1.3 Alarm Reset . .. .. . . . .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. . .111
6.2 Operator’s Position.. . .. .. .. . .. .. . . . .. .. . . . .. . . . . . .. . . . . . . . . . . .. . . . . . .111

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6.3 Physiological Alarms . .. . . . .. . . . . . .. . . . .. . . . . . .. . . . .. .. . . . .. .. . .. .. .. . .. .. .. . .. .. .. .111
6.3.1 High Pressure Alarm .. .. . .. .. . . . .. .. . . . .. . . . . . .. . . . . . . . . . . .. . . . . . .. . . . 112
6.3.2 Low Pressure Alarm . . .. .. . . . .. .. . . . .. . . . . . .. . . . .. . . . . . .. . . . .. .. . . . .. .. 113
6.3.3 High PEEP Alarm. .. .. . .. . . . .. . .. . . . .. .. . .. .. . .. .. . .. .. . .. . .. . . . .. .. . .. . 114
6.3.4 Low PEEP Alarm . . .. .. .. . .. .. . .. .. .. . .. .. . . . .. .. . . . .. . . . . ... .. .. . .. .. .. 115
6.3.5 High Vti(High Inspired Tidal Volume Alarm) . .. .. .. . .. .. .. . .. .. .. . .. . 116
6.3.6 Low Vti Alarm (Low Inspired Tidal Volume). .. .. . .. .. . . . .. .. . .. .. .. . .. 117
6.3.7 High MViAlarm (High Inspired Minute Volume Alarm). . . . . .. . . . .. . . . 118
6.3.8 Low MVi(Low Inspired Minute Volume Alarm) . . .. . . . .. .. . . . .. . . . . . .. 119
6.3.9 High VteAlarm (High Expired Tidal Volume) . .. . .. .. . .. .. .. . .. .. .. . .. 120
6.3.10 Low VteAlarm (Low Expired Tidal Volume). . . .. . . . .. . . . . . .. . . . .. .. . . . 121
6.3.11 High MVe(High Expired Minute Volume Alarm) .. .. ... .. .. ... .. .. ... . 122
6.3.12 Low MVeAlarm (Low Expired Minute Volume) . .. .. . .. .. . . . .. .. . . . .. . 123
6.3.13 High Breath Rate Alarm. .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. . .. .. .. . .. .. . . . .. 124
6.3.14 Low Breath Rate Alarm . .. .. . .. .. .. . .. .. .. . .. .. . . . .. .. . .. .. . . . .. .. . . . .. 125
6.3.15 Apnea Alarm............................................................ 126
6.3.16 Disconnection Alarm .. .. . .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. . . . .. .. . . . .. . . . . 126
6.3.17 Rebreathing Alarm . .. . .. .. .. . .. .. . . . .. .. . . . .. . . . . . .. . . . .. . . . . . .. . . . .. .. 128
6.3.18 Obstruction Alarm .. .. . .. .. .. . .. .. .. . .. .. . . . .. .. . . . .. . . . .. .. . . . .. . . . . . .. 129
6.3.19 High FiO2Alarm ........................................................ 129
6.3.20 Low FiO2Alarm......................................................... 130
6.3.21 High SpO2Alarm ....................................................... 130
6.3.22 Low SpO2Alarm........................................................ 131
6.3.23 High EtCO2Alarm...................................................... 132
6.3.24 Low EtCO2Alarm....................................................... 133
6.3.25 High InspCO2Alarm (High Inspired CO2)............................. 134
6.3.26 High Pulse Rate Alarm. .. . .. .. . . . .. .. . . . .. . . . . . .. . . . .. . . . . . .. . . . .. .. . . . 135
6.3.27 Low Pulse Rate Alarm . .. . .. .. .. . .. .. .. . .. .. .. . .. .. . . . .. .. . . . .. . . . . . .. . 136
6.3.28 PtcCO2Alarm........................................................... 137
6.4 Technical Alarms .. . .. .. .. . .. .. .. . .. .. .. . .. .. . . . .. .. . . . .. . . . . . .. . . . .. . . . . . .. . . . .. .. 138
6.4.1 Power Fail Alarm . .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. . . . .. .. . .. .. . . . .. .. . . . .. 138
6.4.2 High Patient Air Temp. (High Patient Air Temperature) . .. . .. .. . . . .. . 138
6.4.3 Low Patient Air Temp. (Low Patient Air Temperature
Alarm)................................................................... 139

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6.4.4 Low Last Power Source Alarm .. .. . . ... .. .. . . .. . .. .. . . .. 139
6.4.5 Crit. Low Last Power Source Alarm. .. . . . .. .. . . . .. . . . . . . 139
6.4.6 Lost Mains Power Alarm.. .. .. . .. .. .. . .. .. .. . .. .. . . . .. .. . 140
6.4.7 Exhalation Valve Control Error Alarm. .. .. .. . .. .. .. . .. .. 140
6.4.8 SpO2Disconnected (SpO2Sensor Failure/Discon-
nection Alarm). . .. .. . . . .. .. . .. .. . . . .. .. . .. .. .. . .. .. .. . .. .. 141
6.4.9 SpO2Signal Lost Alarm .. .. . . . .. . . . . . .. . . . .. . . . . . .. . . . .. 141
6.4.10 Poor SpO2Signal ........................................ 142
6.4.11 CO2Disconnected (CO2Sensor Failure/Discon-
nection Alarm). . .. .. . . . .. .. . .. .. . . . .. .. . .. .. .. . .. .. .. . .. .. 142
6.4.12 CO2Accuracy Error Alarm . .. .. .. . .. .. .. . .. .. .. . .. .. . . . . 143
6.4.13 Check CO2Adapter Alarm ... . .. .. .. . .. .. . . . .. .. . . . .. . . . 143
6.4.14 CO2Sensor Error Alarm .. ... ... ... ... ... .. . .. ... ... ... .. 143
6.4.15 FiO2Disconnected (FiO2Sensor Failure/Discon-
nection Alarm). . .. .. . . . .. .. . .. .. . . . .. .. . .. .. .. . .. .. .. . .. .. 144
6.4.16 Ambient Pressure Compensation Lost
Alarm ..................................................... 144
6.4.17 Temperature Comp. Lost (Ambient Temperature
Compensation Lost Alarm) .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. 145
6.4.18 Humidity Comp. Lost (Humidity Compensation
Lost Alarm) ............................................... 145
6.4.19 LED Failure Alarm . . .. . . . . . .. . . . .. . . . . . .. . . . .. .. . . . .. .. . . 146
6.4.20 Low Alarm Battery Alarm .. . .. .. .. . .. .. .. . .. .. .. . .. .. . . . . 146
6.4.21 Alarm Battery Error Alarm .. . . . .. . . . . . .. . . . . . . . . . . .. . . . . . 146
6.4.22 Internal/Click-In Battery Hot Alarm.. . . . . . .. . . . .. .. . . . .. . 147
6.4.23 Internal Function Failure.. .. . . . .. . . . . . .. . . . . . . . . . . .. . . . . . 147
6.4.24 Air Temp. Sensor Fail Alarm . .. .. . . . .. .. . .. .. .. . .. .. .. . . 148
6.4.25 Internal Error Alarm . . . .. ... . . ... .. . . ... .. . . ... .. . . ... .. . . 148
6.4.26 Database Integrity Fail Alarm . .. .. .. . .. .. .. . .. .. .. . .. .. . 148
6.4.27 Cooling Fan Error Alarm.. . .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. 149
6.4.28 Clock Failure Alarm . . . ... .. . . ... .. . . ... .. . . ... .. . . ... .. . . 149
6.4.29 Internal Temp High Alarm . .. . . . .. . . . . . .. . . . . . .. . . . .. .. . . 149
6.4.30 Bypass Loose Alarm . .. .. .. . .. .. .. . .. .. . . . .. .. . . . .. . . . . . . 150
6.4.31 Alarm Speaker Fail . . . .. .. . . . .. . . . .. .. . . . .. .. . . . .. .. . .. .. 150
6.5 Alarm Test ........................................................... 150
6.5.1 Alarm Signal Test .. .. .. . .. .. . . . .. .. . . . .. . . . . . .. . . . . . . . . . . 150

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6.5.2 Mandatory Alarm Tests .. . .. .. .. . .. .. .. . .. .. .. . .. .. . . . .. .. . . . .. . . . . . .. . 151
6.5.3 Optional Alarm Tests . ... ... ... .. ... ... ... .. ... .. ... .. .. . ... ... .. ... ... . 154
7 Cleaning and Maintenance .. .. . . . .. .. . .. .. .. . .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. . . . .. .. . . . .. . . . . 156
7.1 Cleaning the Vivo 45 LS .. . . .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. . . . .. .. . .. .. . . . .. .. . . . .. 156
7.1.1 Main Unit ............................................................... 157
7.1.2 Air Pathway Disinfection .. .. ... .. .. ... .. .. ... . . .. ... . . ... .. . . ... .. . . ... 157
7.1.3 Patient Circuit. . . . . . . . . . . .. . . . . . .. . . . .. .. . . . .. .. . .. .. .. . .. .. .. . .. .. .. . .. . 157
7.2 Cleaning and Replacing the Filters . . .. . . . . . .. . . . .. .. . . . .. .. . .. .. . . . .. .. . .. .. .. . .. 158
7.2.1 Washing a coarse filter. .. . .. .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. . . . .. . . . . . .. . 159
7.3 Change of Patients .. .. . .. .. .. . .. .. . . . .. .. . . . .. . . . . . .. . . . . . .. . . . .. . . . . . .. . . . .. .. . . . 159
7.4 Regular Maintenance . . . . . . .. . . . . . .. . . . .. .. . . . .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. . . . .. . 160
7.5 Service and Repair .. .. . .. .. .. . .. .. .. . .. .. . . . .. .. . . . .. . . . . . .. . . . .. . . . . . .. . . . .. .. . . . 160
7.6 Storage............................................................................. 160
7.7 Disposal............................................................................ 161
8 Technical Specifications . .. .. .. . .. .. .. . .. .. .. . .. .. . .. .. .. . .. .. . . . .. .. . . . .. . . . . . .. . . . .. .. . . . . 162
8.1 System Description. .. . .. .. .. . .. .. .. . .. .. . .. .. .. . .. .. .. . .. .. . . . .. .. . . . .. . . . . . .. . . . . 162
8.1.1 Pneumatic Diagram for the ventilator .. . . . .. .. . . . .. . . . . . .. . . . . . .. . . . . 163
8.2 Data ................................................................................ 163
8.2.1 Worst Case Accuracy . . . . .. . . . .. . . . . . .. . . . .. .. . . . .. .. . .. .. .. . .. .. .. . .. . 163
8.2.2 Settings Specifications.. . . . . . .. . . . . . . . . . . .. . . . . . .. . . . .. .. . . . .. .. . .. .. .. 163
8.2.3 Monitored Values Specifications .. .. .. . .. .. .. . .. .. . . . .. .. . . . .. . . . . . .. . 168
8.2.4 Power Supply.. .. .. . .. .. .. . .. .. .. . .. .. . . . .. .. . . . .. . . . . . .. . . . . . . . . . . .. . . . 170
8.2.5 Environmental Conditions .. .. .. . . . .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. . . . .. . 170
8.2.6 Other.................................................................... 171
8.3 Emission and Immunity Declaration.. .. . .. .. .. . .. .. . . . .. .. . . . .. . . . . . .. . . . . . .. . . . . 172
8.3.1 Vivo 45 LS Essential Performance . .. .. .. . .. .. .. . .. .. .. .. .. . .. .. .. . .. . 173
8.3.2 Guidance and Manufacturer's Declaration – Electromagnetic
Immunity................................................................ 173
8.3.3 Guidance and Manufacturer's Declaration – Electromagnetic
Emission................................................................ 176
8.3.4 Frequencies of portable and mobile transmitters for which the
recommended separation distance is 30 cm (12 inches) . ... ... .. ... 177
8.3.5 Recommended separation distances between external power
conductors and the ventilator. .. .. . . . .. .. . . . .. . . . . . .. . . . .. .. . . . .. .. . .. . 177
8.4 Delivery Settings. . . . . .. . .. . .. . . .. . . . . . .. . . . . . .. . . . . . .. . . . . . .. . . . . . .. . .. . .. . .. . .. . .. 178

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9 Accessories and Parts. . . . . .. . . . .. . . . . . .. . . . .. .. . . . .. .. . .. .. .. . .. .. .. . .. .. .. . . 181
9.1 Air Delivery Accessories .. ... ... ... .. . .. ... ... ... ... ... .. .. .. ... ... . 181
9.2 Power Accessories. . . .. . . . .. .. . . . .. .. . .. .. . . . .. .. . .. .. .. . .. .. .. . .. .. 181
9.3 Other Accessories. . . . . . . . .. . . . . . . . .. . . . .. . . . . . . . .. . . . .. . . . . . . . .. . . . . 183
9.4 Monitoring Accessories . .. . . .. . .. .. . . . .. .. . .. .. . . . .. .. . . ... .. .. . .. .. 187
9.5 Ventilator Filters and Detachable Parts . .. .. .. ... .. ... ... .. .. .. ... . 191
10 Patient Settings............................................................... 194

1 Introduction
WARNING!
The Vivo 45 LS 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 LS
is operated and maintained before taking it into use, to ensure correct usage, maxi-
mum performance and serviceability. Non-professional caregivers (e.g. family mem-
bers) 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 LS.
U.S. Federal law restricts this device to sale by or on order of a physician.
1.1 What is the Vivo 45 LS?
The Vivo 45 LS is a pressure and volume ventilator capable of delivering continuous or
intermittent ventilatory support for patients who require invasive or non-invasive
mechanical ventilation. The Vivo 45 LS is capable of running 24 hours/day.
The Vivo 45 LS can be operated in the following 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 Man-
datory Ventilation
• PCV-MPV – Pressure Controlled Ventilation with MouthPiece Ventilation
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• VCV – Volume Controlled Ventilation
• VCV(A) – Assisted Volume Controlled Ventilation
• VCV-SIMV – Volume Controlled Ventilation with Synchronized Intermittent Man-
datory Ventilation
• VCV-MPV – Volume Controlled Ventilation with MouthPiece Ventilation
• CPAP – Continuous Positive Airway Pressure
Compatible Patient Circuits
The Vivo 45 LS can be used with a leakage circuit, an MPV circuit or a circuit with
active exhalation valve.
For leakage 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 recommen-
ded 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.
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Data Log
The Vivo 45 LS 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 LS is 8 years.
1.2 Intended Use
To provide continuous or intermittent ventilatory support for the care of individuals
who require mechanical ventilation.
1.3 Indications for Use
The Vivo 45 LS ventilator (with or without the SpO2and CO2sensors) is intended to
provide continuous or intermittent ventilatory support for the care of individuals who
require mechanical ventilation. Specifically, the ventilator is applicable for pediatric
through adult patients weighing more than 5 kg (11 lbs.), however, the mouthpiece ven-
tilation modes are for adult patients only.
The Vivo 45 LS with the SpO2sensor is intended to measure functional oxygen satura-
tion of arterial hemoglobin (%SpO2) and pulse rate.
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The Vivo 45 LS with the CO2sensor is intended to measure CO2in the inspiratory and
expiratory gas.
The device is intended to be used in home, institution, hospitals and portable applica-
tions such as wheelchairs and gurneys. It may be used for both invasive and non-invasive
ventilation. The Vivo 45 LS is not intended to be used as an emergency transport or crit-
ical care ventilator.
1.4 Contraindications
• The use of the Vivo 45 LS 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 hemodynam-
ics 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.
Undesirable Side Effects
If the patient experiences chest discomfort, pain, severe headache or shortness of breath
while using the Vivo 45 LS, a physician or responsible clinician shall be contacted
immediately.
1.5 Intended Environment
The Vivo 45 LS is intended to be used in clinical settings (e.g. hospitals, sub-acute care
institutions), public spaces and home environments as well as during portable applica-
tions such as wheelchairs and personal family vehicles.
It is not intended for use during emergency transport or as a critical care ventilator.
1.6 Intended Users
This section describes the intended users of the Vivo 45 LS, their qualifications and their
related documents.
1.6.1 Respiratory Health Care Specialists
Health care professionals such as physicians and respiratory therapists are specialists
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.
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They are allowed to change the clinical settings of a ventilator and prescribe new settings.
They may also operate software applications for follow-up on patient’s ventilator
treatment.
Training
The respiratory health care specialists shall be trained to a good knowledge of the
Vivo 45 LS, its capabilities and the settings that can be made. This training consists of
reading the Clinician’s manual in full and it shall be conducted before operating the
Vivo 45 LS.
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 LS.
1.6.2 Lay Operators
Day-to-day caregivers, patients, relatives and other non-professional users that operate
the Vivo 45 LS within the prescribed settings.
They are allowed to operate the Vivo 45 LS with the Home mode activated. The lay
operator may also perform basic maintenance that doesn’t require special equipment or
a service environment.
In Home mode, the device is locked in order to limit settings accessibility and hide fea-
tures/controls.
The User Manual contains the information intended for patients and lay operators.
Training
The lay operator shall be trained to basic knowledge of the Vivo 45 LS and in the spe-
cific 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 LS.
1.6.3 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.
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Certified service personnel may perform any repairs, upgrades or service operations that
they have been certified to perform, as long as they have the required equipment and
the operation is performed in an appropriate environment. They may also operate soft-
ware applications for follow-up on ventilators usage and for troubleshooting.
Training and Certification
Service personnel shall be trained on the Vivo 45 LS and certified by Breas for being
allowed to perform any service, repairs or other operations on the Vivo 45 LS. The
training consists of reading the services manual in full.
Related Documents
• The Service Manual.
• The Clinician’s Manual.
• Service bulletins, available for certified service personnel on the Breas extranet.
1.7 About this Manual
CAUTION!
Always read this manual before setting up and using the Vivo 45 LS or performing
maintenance on the machine, to ensure correct usage, maximum performance and
serviceability.
1.7.1 Audience
This manual is intended for patients and other lay users operating the Vivo 45 LS.
• Care providers, clinical personnel, physicians and others who require a working
knowledge of the Vivo 45 LS will find additional information on settings and
functions in the Clinician’s Manual.
• Service personnel may order the Service Manual that contains detailed technical
information for maintenance, service, repair and disposal procedure.
1.7.2 Icons in this Manual
In this manual, icons are used to highlight specific information. The meaning of each
icon is explained in the table below.
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Icon Explanation
Warning!
Risk of death or personal injury.
Warning!
Risk of Cross-contamination.
Warning!
Risk of electric shock.
Warning!
Hot surface, risk of burns.
Warning!
Flammable material, risk of fire.
Caution!
Risk of equipment damage, loss of data, extra work, or unexpected
results.
MR Unsafe. The device should not enter a magnetic resonance (MR)
environment, such as an MRI scanner room.
Note
Information that may be valuable but is not of critical importance,
tips.
Reference
Reference to other manuals with additional information on a specific
topic.
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1.8 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]
US Manufacturing Site
Postal address
Breas Medical Inc.
16 Esquire Road
N. Billerica, MA 01862
USA
US Sales and Support Information
Phone
1-855-436-8724 ext 110
Fax
1-540-301-0881
Sales and Orders Email
[e-mail]
Tech Support Email
[email protected]
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2 Safety Information
2.1 General User Precautions
WARNING!
The Vivo 45 LS 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 LS 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 LS might affect safety fea-
tures and performance negatively. Only use the Vivo 45 LS 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 LS.
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
treatment in order to take care of alarms and conditions that the patient cannot solve
on their own.
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When a ventilator-dependent patient is treated outside a health care facility (e.g. in
the home setting) there should always be a trained caregiver present to respond to
alarms or conditions the patient is unable to solve on their own (e.g., troubleshooting
alarm conditions and taking appropriate corrective action). The home medical equip-
ment provider will ensure that the family caregivers are appropriately trained in
responding to alarms and taking appropriate corrective action prior to the patient’s
discharge from the health care facility to the home, and will provide on-going train-
ing to new caregivers as required or indicated.
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
ventilation can result in serious injury or patient death if ventilator fails.
To prevent death or serious injury, monitor the patient and the ventilator regularly in
order to determine the need to provide emergency ventilation when an alarm sounds
or the ventilator malfunctions.
Measured values for volume and expired CO2may differ from the actual patient val-
ues due to unintentional leaks.
Do not obstruct the gas intake port.
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.
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