Ventec Life Systems Vocsn V+Pro User manual

Clinical and Technical Manual
V+Pro Emergency Conguration, Software Versions 4.08 to 4.13

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Copyright: © 2020, Ventec Life Systems
22002 26th Ave SE
Bothell, WA 98021 USA
Part Number: LBL-00176-000, Rev C
CAUTION: Federal law restricts this device to sale and use by or on the order of a physician.

Table of Contents
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Table of Contents
Introduction 11
Therapy Overview 11
VOCSN Conguration 12
Leak+ Performance 12
Ventilation 13
Portability 13
Indications for Use 14
VOCSN Training 14
Suggested Environments of Use 15
Home Environments 15
Hospital Environments 15
Institutional Environments 15
Transport Environments 15
Getting Started 16
Package Contents 16
Contraindications 16
System Overview 17

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Setup 18
VOCSN Placement 19
Power Setup 20
The Power Supply 21
The Optional 24 Volt Wheelchair Power Cable 22
The Removable, Rechargeable Batteries 22
Ventec One-Circuit Setup 23
Using a Trach, ET Tube, or Non-Vented Mask 24
Using a Vented Mask 24
Using a High Flow Nasal Cannula 24
Connecting an Active, Passive, or Valveless Ventec One-Circuit 25
Ventec One-Circuit Component Connection Order 26
Connecting an External Bacterial Filter 27
Connecting a Ventec One-Circuit Without a Humidier 28
Connecting a Ventec One-Circuit to a Humidier (Without the Ventec Humidier Bypass) 28
Connecting a Ventec One-Circuit, Humidier, and Ventec Humidier Bypass 29
Connecting an Active Ventec One-Circuit 30
Connecting a Valve Bacterial Filter 31
Connecting Ventec One-Circuit Components 32
Connecting an HME (Heat-Moisture Exchanger) 32
Setting up Ventilation therapy with a Speaking Valve 33
Mouthpiece Patient Circuit Setup 34
Oxygen Therapy Setup 35
Setting Up External Oxygen Sources 35
Connecting External High-Pressure Oxygen 36
Connecting External Low-Pressure Oxygen 37
Connecting a Nurse Call System or Remote Alarm 38
Running the Pre-Use Test 39

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Breath Types and Therapy Modes 40
Breath Types 40
Pressure Breaths 41
Volume Breaths 42
Spontaneous Breaths 42
VOCSN Ventilation Modes 43
Bi-Level Mode 43
Assist/Control-Pressure with an Active, Passive, or Valveless Ventec One-Circuit 44
Assist/Control-Pressure with a Mouthpiece Patient Circuit 44
SIMV-Pressure Mode 45
CPAP Function 45
High Flow Therapy 45
Assist/Control-Volume Mode 46
Assist/Control-Volume with an Active, Passive, or Valveless Ventec One-Circuit 46
Assist/Control-Volume with a Mouthpiece Patient Circuit 46
SIMV-Volume Mode 47
CPAP Function 47
High Flow Therapy 47
Volume Targeted Ventilation Overview 48
Vol. Targeted-PS Mode 49
Vol. Targeted-PS with an Active, Passive, or Valveless Ventec One-Circuit 49
Vol. Targeted-PS with a Mouthpiece Patient Circuit 49
Vol. Targeted-PC Mode 50
Vol. Targeted-PC with an Active, Passive, or Valveless Ventec One-Circuit 50
Assist/Control-Pressure with a Mouthpiece Patient Circuit 50
Vol. Targeted-SIMV Mode 51
Comparable Volume Ventilation Modes 52
Comparable Pressure Ventilation Modes (Including Volume-Targeted Ventilation) 53
Comparable Non-Invasive Ventilation Modes 54

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The Touchscreen 55
Locking the Touchscreen 55
The Status Bar 56
The Home Screen 57
Night Mode and Day Mode 57
The Therapy Screen 58
The Monitors Screen 58
The Customization Button 59
The Waveforms Button 59
The Menu Screen 60
The Pre-Use Test Button 60
The Settings & Alarms Button 61
The Device Settings Button 61
The Logs Button 61
The Clinician Access Button 61
The Enable Prescribed Therapies Button 62
The Permissions Button 62
The My VOCSN Button 62
Controls and Settings 63
Ventilation Therapy Controls 64
Changing Ventilation Therapy Settings 64
Available Ventilation Therapy Settings 65
Control Limiting 72
Controls Available in Each Ventilation Mode 73
Setting VOCSN Controls for Mouthpiece Ventilation 76
Setting VOCSN Controls for High Flow Therapy 76
Enabling and Disabling Prescribed Therapies 77
Oxygen Controls 79
Changing Oxygen Settings 79
Available Oxygen Settings 80
Changing Nebulizer Compensation Settings 81
Clinician Access Mode 82
Entering the Clinician Access Passcode 82
Conguring Permissions 83
Device Settings 84
Changing Device Settings 84
Available Device Settings 85

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Alarms 86
Alarm Silence Button 87
Changing Alarm Settings 87
Alarm Conditions and Settings 88
The Alarm Log 97
The Event Log 98
Clearing an Alarm 99
Remote Alarms and Nurse Call Systems (Optional) 99
Monitors 100
Ventilation Monitors 101
Waveform Monitors 103
Monitor Screen Customization 104
Oxygen Therapy Monitor 105
Nebulizer Compensation Monitor 106
System Monitors 107
Multi-View 108
Exporting Multi-View Data to a USB Drive 109
Generating Multi-View Reports 110
Reading Multi-View Reports 111
Report Information 111
Trend Summary 112
Compliance Calendar 112
Therapy Use 113
Settings Overview 113
Monitor Details 114
Logs 115

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Checkout Procedure 116
Visual Inspections 116
Inop Alarm Test 116
Power Testing Procedures 117
Ventilation and Oxygen Testing Procedures 118
Ventilation And Oxygen Tests 119
Ventilation Alarm Verication 120
Remote Alarm Test (Optional) 120
Decannulation Alarm Verication 121
Patient Circuit Disconnect Alarm Verication 121
Congure and Verify Control and Alarm Settings 122
Checkout Worksheet 122
Operating Instructions 123
Powering On VOCSN 124
Starting VOCSN Therapies 125
Starting Ventilation Therapy 126
Changing Between Congured Ventilation Presets 127
Starting Oxygen Therapy 128
Using O2 Flush 129
Using External High-Pressure Oxygen 130
Using External Low-Pressure Oxygen 130
Starting Nebulizer Compensation 131
Responding to Alarms 132
Powering Off VOCSN 132
Cleaning and Maintenance 133
Cleaning VOCSN 133
Cleaning VOCSN Exterior 134
Cleaning the Air and Fan Filters 135
Replacing Components 136
Replacing the Power Supply 136
Replacing the Ventec One-Circuit 136
Replacing Ventec One-Circuit Components 137
Replacing the External Bacterial Filter 137
Replacing the Internal Bacterial Filter 138
Recommended Maintenance Schedule 139
Battery Care, Maintenance, and Replacement 140
Battery Storage Mode 141
Software Updates 142
Locating the VOCSN Software Version 142
Environmental Considerations 143
Shipping Considerations 143

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Glossary 144
Glossary of Symbols 144
Glossary of Indicators 148
Glossary of Terms 150
Troubleshooting 151
Troubleshooting Alarms 151
Device Troubleshooting 157
Ventilation Troubleshooting 158
Oxygen Troubleshooting 159
Multi-View Troubleshooting 160
Patient Circuit Troubleshooting 160
Recalibrating Batteries 161
Technical Specications 162
Physical 162
Environmental 163
Inputs and Outputs 163
External Power Requirements 164
Removable, Rechargeable Batteries 164
Internal Rechargeable Battery 164
Expected Service Life and Intervals 165
Audible Volume 165
FiO2 Monitor 165
Control Accuracy 166
Monitor Resolution and Accuracy 168
Classications 170
Standards Applied 170
Ventec One-Circuit Compliance 171
Pressure During Inop 171
Biocompatibility 171
Accessories 172
Available from Ventec Life Systems 172
Available from Other Manufacturers 177

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EMC Information 178
Electromagnetic Emissions 179
Electromagnetic Immunity 180
Recommended Separation Distance Between Portable and Mobile RF Communications
Equipment and VOCSN 182
Technical Description 183
Theory of Operation 183
Ventilation Therapy and FiO2 Oxygen Therapy 183
Leak Compensation 184
Leak Compensation with an Active Ventec One-Circuit 184
Leak Compensation with a Passive or Valveless Ventec One-Circuit 185
Leak Compensation with a Mouthpiece Circuit 185
Nebulization 186
External Nebulizer Compensation 186
VOCSN Measurements 187
Airway Pressure Measurements 187
Flow Measurements 187
Volume Measurements 187
FiO2 Measurements 187
Alarm Detection Criteria 188
System Fault Detection Criteria and Recommended Action 189
Low-Pressure Oxygen Blending 190
Input Flow 100% Oxygen, Flow Trigger Set to 1-3 191
Input Flow 100% Oxygen, Flow Trigger Set to 9 191
Input Flow 93% Oxygen, Flow Trigger Set to 1-3 192
Input Flow 93% Oxygen, Flow Trigger Set to 9 192
Input Flow 100% Oxygen, High Flow Therapy 193
Input Flow 93% Oxygen, High Flow Therapy 193