Ventec Life Systems Vocsn V+Pro User manual

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

VentecLife.com 2
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

Table of Contents
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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

Introduction
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Introduction
Therapy Overview
Using the Ventec One-CircuitTM, clinicians, home caregivers, and patients can use the VOCSN V+Pro to ventilate, and
provide air enriched with oxygen to the patient, minimizing the need to connect additional medical equipment or
recongure the patient circuit.
NOTE: This manual describes the features included with version 4.08 to 4.13 for the V+Pro Conguration only.
For instructions for use for other VOCSN congurations and software versions, see the links to Clinical and Technical
manuals available at VentecLife.com/resources.

Introduction
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VOCSN Conguration
This manual provides intructions for use for the VOCSN V+Pro Emergency conguration, enabling it to provide
Ventilation and Oxygen therapy from a high- or low-pressure oxygen source.
Conguration
(Located on Device
Rear Label)
Ventilation
(V)
O2
Concentration
(+O)
Cough
(+C)
Suction
(+S)
Nebulizer
+(N)
High-Pressure
External Oxygen
and FiO2 Monitor
(+Pro)
Low-Pressure
External
Oxygen
V+Pro Emergency Yes No No No No Yes Yes
Leak+ Performance
The Leak+ feature allows VOCSN to deliver High Flow ventilation, as well as provide compensation for leaks up to
175 L/min at 20 cmH2O. The improved Leak Compensation may be particularly useful during non-invasive ventilation.
Leak+ is available on devices with compatible hardware running software version 4.06R and newer.
To see if your VOCSN is capable of Leak+ performance, install the latest software and check for the “V”
icon with a white background in the status bar. The availability of this feature can also be found on the
My VOCSN screen next to “Leak+.”
For more information about VOCSN leak compensation, see “Leak Compensation” on page 184.
WARNING: Delivered and monitored ventilation therapy may be affected by large leaks around the patient interface.
V

Introduction
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Ventilation
VOCSN provides invasive or non-invasive ventilation. Using one of six ventilation modes, and an active, passive,
valveless, or mouthpiece Ventec One-Circuit, VOCSN delivers congurable pressure, volume, and/or spontaneous
breaths.
The congurable Flow Trigger control, in combination with the powerful integrated Leak Compensation feature, allows
VOCSN to perform well for both invasive and non-invasive applications, even with signicant leaks in the patient circuit.
VOCSN devices with the Leak+ feature can compensate for leaks up to 175 L/min at 20 cmH2O. Ventilation controls such
as Rise Time and Pressure Control Flow Termination can be adjusted to improve patient comfort.
The Ventilation therapy Presets feature allows clinicians to set up, label, and store up to three unique Ventilation therapy
congurations. Using the touchscreen, clinicians, home caregivers, and patients can switch between these three pre-
congured therapies as needed. For example, some patients may benet from one ventilation Preset while awake,
another Preset while active, and a third Preset during sleep.
The Permissions feature allows clinicians to lock VOCSN control settings. VOCSN controls can be set to User and
Clinician, or Clinician Only. Controls set to Clinician Only cannot be modied until the Clinician Access Passcode is
entered. Controls set to User and Clinician will remain adjustable at all times.
Optional integrated oxygen blending provides a congurable FiO2 to the patient, utilizing an external high-pressure
oxygen source. The internal FiO2 monitor continuously monitors the FiO2 of the delivered gas as it ows to the Ventec
One-Circuit, to ensure the accuracy of delivered Oxygen therapy. The VOCSN also includes an internal O2 Concentrator,
which may be used to provide Oxygen DirectTM therapy to the patient. Alternatively, oxygen can be owed into the
Ventec One-Circuit through the low-pressure oxygen port.
Portability
VOCSN is designed to support the transport of mechanically ventilated patients. VOCSN includes two removable,
rechargeable batteries and an internal rechargeable battery, used to power the device when no external source of
continuous power is available.
Using the power supply, VOCSN can be connected to a wall outlet or other AC power source. Ventec Life Systems also
offers an optional 24 Volt Wheelchair Power Cable, which can be used to power VOCSN from wheelchair outlets. VOCSN
batteries charge whenever an external power source is applied.

Introduction
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Indications for Use
VOCSN Unied Respiratory System is intended to provide continuous or intermittent ventilatory support for the care
of individuals who require mechanical ventilation. It may be used in invasive and non-invasive applications. VOCSN is
intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional,
and transport settings, including portable applications.
VOCSN Training
The VOCSN clinician or caregiver must be capable of responding to alarm conditions, and trained to use VOCSN. A list
of available VOCSN training options is available at VentecLife.com.
CAUTION: Clinicians responsible for conguring and operating VOCSN must be trained to use it and should review
this manual in its entirety before using VOCSN to administer therapy. Home caregivers must also receive training,
and must review the Home Caregiver and Patient Guide (available at VentecLife.com) prior to setting up or operating
VOCSN.

Introduction
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Suggested Environments of Use
VOCSN is suitable for use in the following environments:
Home Environments
• Home care
• Home-based transport
Hospital Environments
• Emergency departments
• Step-down units
• Military hospitals
WARNING: Do not use VOCSN within magnetic resonance (MR) environments. Using VOCSN within MR environments
may affect VOCSN or MR device performance, damage the devices, or harm individuals.
Institutional Environments
• Long-term acute care
• Skilled nursing facilities
• Long-term care/nursing homes
Transport Environments
• Intra-hospital transport
• Inter-hospital transport
• Emergency medical services
• Military transport
NOTE: VOCSN that include an airplane symbol on the back label are compliant with the regulations
for device use on board aircraft.

Introduction
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Getting Started
Package Contents
VOCSN includes the following items:
• One VOCSN, V+Pro Emergency Conguration
• Two removable, rechargeable batteries
• One power supply
• One Ventec One-Circuit
• Bacterial lters
• One Quick Start Guide
NOTE: Contact Ventec Life Systems at 1-844-MY-VOCSN for assistance with setup, maintenance, or to report
unexpected device operation.
See “Accessories” on page 172 for a list of VOCSN components and accessories available from Ventec Life Systems.
Contraindications
Consult the patient’s healthcare professional before using a non-invasive interface with VOCSN if the patient experiences
any of the following medical conditions:
• Inability to maintain a patent airway
• Risk of aspirating gastric contents
• Epistaxis that causes pulmonary aspiration of blood
• Acute sinusitis or otitis media
• Hypotension

Introduction
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System Overview
Description Description
1 Touchscreen 11 Handle (back view)
2 Speaker 12 T-Slot mount
3 Alarm Silence button 13 Cooling air outlet
4 External Power / Charge Status indicator light 14 High-pressure O2 Inlet (+Pro congurations only)
5 On/Off button and indicator light 15 Low-pressure O2 Inlet
6 Removable, rechargeable battery (right side) 16 Remote alarm port
7 Active exhalation valve connection port 17 USB port for use by trained personnel only. See “Exporting
Multi-View Data to a USB Drive” on page 109 for
instructions.
8 External bacterial lter and Ventec One-Circuit
connection port
18 Cooling air intake and lter
9 Handle (side view) 19 Power connection port
10 Cooling air outlet 20 Patient air inlet and lter
21 Removable, rechargeable battery (left side)
22 Cooling air outlets
1
2
345 6
7
8
9
10
11
12
14
15 16
17
18
19 20 21
22
13

Setup
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Setup
This chapter includes instructions for placing and setting up VOCSN, including instructions for connecting Ventec One-
Circuits, and additional Ventec One-Circuit components. VOCSN was designed for use with Ventec One-Circuits from
Ventec Life Systems. Do not use third-party patient circuits with VOCSN.
WARNING: Put VOCSN into service in accordance with the information provided in this Clinical and Technical Manual.
VOCSN operation may be impaired or become unsafe by failure to follow setup and operating instructions, the
connection of unauthorized accessories, or the unauthorized modication of VOCSN. All modications made, and
accessories used with VOCSN, must meet the requirements of IEC 60601-1. The organization responsible for device
setup must ensure the compatibility of VOCSN and all parts and accessories used to provide therapy to the patient
prior to use.
WARNING: VOCSN should be set up, congured, and used by trained clinicians and caregivers under the direction
of a physician. Patients and caregivers should be instructed not to modify the VOCSN setup or conguration without
direction and/or supervision from a clinician.
WARNING: Do not use lubricants on VOCSN or on any part of the Ventec One-Circuit. Lubricating ttings, connections,
tubing, or other accessories may result in re and burns to the patient or caregiver.
WARNING: Use only spare parts recommended by Ventec Life Systems. Using spare parts not recommended by the
VOCSN manufacturer may result in re and burns to the patient or caregiver.
WARNING: Only use carrying cases approved by Ventec Life Systems. Use of unauthorized carrying cases may result in
damage to VOCSN, impaired device performance, and risk to the patient.
NOTE: The VOCSN Ethernet and USB ports are intended for use by trained personnel only. The remote alarm port
and power connection port can be used with third-party equipment. However, it is the responsibility of the person
connecting the third-party equipment to ensure the system complies with clause 16 of IEC 60601-1, 3rd ed., as well as
any local laws.
NOTE: When using VOCSN to provide non-invasive ventilation, Ventec Life Systems recommends use of CO2
monitoring equipment compliant with ISO 80601-2-55. To connect and use CO2 monitoring with VOCSN, follow all
instructions from the equipment manufacturer.

Setup
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VOCSN Placement
Place VOCSN in a well-ventilated area, ensuring air ows freely around its inlets and vents.
WARNING: Incorrect placement of VOCSN may affect device performance. Do not cover VOCSN, place it in an area
in which the vents may become obstructed (such as on its back or on top of compliant bedding), or use it in hazardous
environments (such as atmospheres containing pollutants).
NOTE: VOCSN emits heat and gas, including nitrogen, during normal operation. Use VOCSN in a well-ventilated area.
When used in a home environment, VOCSN should be kept away from concentrations of lint, dust, pet dander, and
pests. Small particles and/or pests can clog VOCSN lters over time and become lodged inside VOCSN. Clean the
air and fan lters regularly to prevent clogging, and move VOCSN to a new location if large volumes of particulate are
pulled into the lters. Place VOCSN somewhere it will not be easily accessible by children or pets, such as on a roll stand.
WARNING: Keep VOCSN out of reach of children to avoid the risk of strangulation by cords and tubes, as well as the
risk of inhalation or swallowing of small parts. VOCSN includes a hook-and-loop strap to wrap power adapter cabling
when not in use.
Over time, direct sunlight may compromise the integrity of VOCSN plastic housing or the Ventec One-Circuit. Place
VOCSN in a location that is not exposed to extended periods of direct sunlight.
WARNING: Use of VOCSN outside its recommended range of temperature, altitude, and/or relative humidity may
adversely affect the ventilation ow rate and oxygen concentration from VOCSN, and may result in patient harm. See
“Environmental” on page 163 for details.
WARNING: Do not use VOCSN in contaminated, hazardous, or explosive environments. Use of VOCSN can be
hazardous in these conditions.
WARNING: To protect against EMI (electromagnetic interference) affecting device performance:
• Do not use VOCSN within electromagnetic elds exceeding the limits specied in Appendix E, “EMC Information”.
Common sources of electromagnetic elds include security systems, wireless communications equipment,
appliances, and medical imaging systems.
• Do not stack VOCSN with other electrical devices during use.
• Do not connect VOCSN to unauthorized cables or accessories. Use of cables or other accessories not approved for
use with VOCSN may result in increased electromagnetic emissions or decrease its immunity from other sources of
EMI.
WARNING: Accidental button presses could result in inadvertent alteration of the VOCSN conguration or its
operation. To reduce the possibility of accidental button presses, do not place in areas that might result in inadvertent
touching of the VOCSN touchscreen or its buttons. Use the touchscreen lock feature during cleaning or transport.

Setup
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Power Setup
VOCSN operates using external power (such as a wall outlet), or VOCSN batteries. Ventec Life Systems recommends
connecting VOCSN to a continuous external power source whenever possible. During transport, Ventec Life Systems
recommends the use of external power or the removable batteries. Use the internal (non-removable) battery in case of
power failure or power transition only.
NOTE: Use only the power supply approved by Ventec Life Systems to connect VOCSN to external sources of power.
Ensure the external source of power is rated for use with VOCSN. See “External Power Requirements” on page 164 for
more information.
The VOCSN batteries will begin charging whenever an external power source is applied. All VOCSN features and
functions operate normally during battery charging. The charge status indicator light on the front of VOCSN will
illuminate orange when the batteries are charging, and illuminate green when the batteries are fully charged. In the
status bar, a lightning bolt will appear on the battery indicator of the charging battery.
NOTE: When VOCSN is disconnected from external power and transitions to running on battery power, or switches from
running on removable battery to internal battery power, the medium-priority Battery Use alarm will activate.
WARNING: Check the batteries and external power supply regularly to ensure functionality. VOCSN power failure may
interrupt ventilation therapy and result in patient harm or death. See “Power Testing Procedures” on page 117 for
instructions.
If the internal battery depletes fully, VOCSN Date and Time settings will reset to their default values. To ensure the Alarm
and Event logs record information accurately, verify the VOCSN Date and Time settings before use, and set them to the
correct values if necessary.