Ventec Life Systems V-Home User manual

Clinical and Technical Manual
V Home, Software Version 5.02

VentecLife.com 2
Copyright: © 2023, Ventec Life Systems
22002 26th Ave SE
Bothell, WA 98021 USA
Part Number: LBL-00354-000, Rev B
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 10
Therapy Overview 10
Leak+ Performance 11
Ventilation 11
Portability 11
Indications for Use 12
V*Home Training 12
Suggested Environments of Use 13
Home Environments 13
Hospital Environments 13
Institutional Environments 13
Transport Environments 13
Getting Started 14
Package Contents 14
Contraindications 14
System Overview 15
Setup 16
V*Home Placement 17
Power Setup 18
The Power Supply 19
The Optional 24 Volt Wheelchair Power Cable 20
The Removable, Rechargeable Batteries 20
Ventec One-Circuit Setup 21
Using a Trach, ET Tube, or Non-Vented Mask 22
Using a Vented Mask 22
Using a High Flow Nasal Cannula 22
Connecting a Passive or Valveless Ventec One-Circuit 23
Ventec One-Circuit Component Connection Order 24
Connecting an External Bacterial Filter 25

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Connecting a Passive Ventec One-Circuit with HME 25
Connecting a Humidier and Heated Wire Ventec One-Circuit 26
Connecting Ventec One-Circuit Components 27
Connecting an HME (Heat-Moisture Exchanger) 27
Connecting an External Nebulizer Cup to the Patient Circuit 28
Setting up Ventilation Therapy with a Speaking Valve 29
Mouthpiece Patient Circuit Setup 30
Oxygen Therapy Setup 31
Setting Up External Oxygen Sources 31
Connecting External Low-Pressure Oxygen 32
Connecting a Nurse Call System or Remote Alarm 33
Running the Pre-Use Test 34
Connecting a React DataLink™ 35
Breath Types and Therapy Modes 36
Breath Types 36
Pressure Breaths 37
Volume Breaths 38
Spontaneous Breaths 38
V*Home Ventilation Modes 39
Bi-Level Mode 39
Assist/Control-Pressure with a Passive, or Valveless Ventec One-Circuit 40
Assist/Control-Pressure with a Mouthpiece Patient Circuit 40
SIMV-Pressure Mode 41
CPAP Function 41
High Flow Therapy 41
Assist/Control-Volume Mode 42
Assist/Control-Volume with a Passive, or Valveless Ventec One-Circuit 42
Assist/Control-Volume with a Mouthpiece Patient Circuit 42
SIMV-Volume Mode 43
Volume Targeted Ventilation Overview 44
Vol. Targeted-PS Mode 45
Vol. Targeted-PS with a Passive, or Valveless Ventec One-Circuit 45
Vol. Targeted-PS with a Mouthpiece Patient Circuit 45
Vol. Targeted-PC Mode 46
Vol. Targeted-PC with a Passive or Valveless Ventec One-Circuit 46
Assist/Control-Pressure with a Mouthpiece Patient Circuit 46
Vol. Targeted-SIMV Mode 47
Comparable Volume Ventilation Modes 48
Comparable Pressure Ventilation Modes (Including Volume-Targeted Ventilation) 49
Comparable Non-Invasive Ventilation Modes 50
The Touchscreen 51

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Locking the Touchscreen 51
Quick View 51
The Status Bar 52
The Home Screen 53
Night Mode and Day Mode 53
The Therapy Screen 54
The Monitors Screen 54
The Customization Button 55
The Waveforms Button 55
The Menu Screen 56
The Pre-Use Test Button 56
The Settings & Alarms Button 57
The Device Settings Button 57
The Logs Button 57
The Clinician Access Button 57
The Enable Prescribed Therapies Button 58
The Permissions Button 58
The My VOCSN Button 58
Controls and Settings 59
Ventilation Therapy Controls 60
Changing Ventilation Therapy Settings 60
Available Ventilation Therapy Settings 61
Control Limiting 67
Controls Available in Each Ventilation Mode 68
Setting V*Home Controls for Mouthpiece Ventilation 71
Setting V*Home Controls for High Flow Therapy 71
Enabling and Disabling Prescribed Therapies 72
Oxygen Controls 73
Changing Oxygen Settings 73
Available Oxygen Settings 73
Changing Nebulizer Compensation Settings 75
Clinician Access Mode 76
Entering the Clinician Access Passcode 76
Conguring Permissions 77
Device Settings 78
Changing Device Settings 78
Available Device Settings 79
Alarms 80
Alarm Silence Button 81
Changing Alarm Settings 81
Alarm Conditions and Settings 82

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The Alarm Log 91
The Mark Event Button 91
The Event Log 92
Clearing an Alarm 93
Remote Alarms and Nurse Call Systems (Optional) 93
Monitors 94
Ventilation Monitors 95
Waveform Monitors 97
Monitor Screen Customization 98
Oxygen Therapy Monitors 99
FiO2 Monitor 99
Nebulizer Compensation Monitor 100
System Monitors 101
Multi-View 102
Exporting Multi-View Data to a USB Drive 103
Generating Multi-View Reports 104
Reading Multi-View Reports 105
Report Information 105
Trend Summary 106
Compliance Calendar 106
Therapy Use 107
Settings Overview 107
Monitor Details 108
Logs 109
Checkout Procedure 110
Visual Inspections 110
Inop Alarm Test 110
Power Testing Procedures 111
Ventilation Testing Procedures 112
Ventilation Tests 113
Ventilation Alarm Verication 114
Remote Alarm Test (Optional) 114
Decannulation Alarm Verication 115
Patient Circuit Disconnect Alarm Verication 115
Congure and Verify Control and Alarm Settings 115
Checkout Worksheet 116
Operating Instructions 117

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Powering On V*Home 118
Starting V*Home Therapies 119
Starting Ventilation Therapy 120
Changing Between Congured Ventilation Presets 121
Starting Oxygen Therapy 122
Starting Nebulizer Compensation 123
Responding to Alarms 124
Powering Off V*Home 124
Cleaning and Maintenance 125
Cleaning V*Home 125
Cleaning V*Home Exterior 126
Cleaning the Air and Fan Filters 127
Replacing Components 128
Replacing the Power Supply 128
Replacing the Ventec One-Circuit 128
Replacing Ventec One-Circuit Components 129
Replacing the External Bacterial Filter 129
Replacing the Internal Bacterial Filter 130
Recommended Maintenance Schedule 131
Battery Care, Maintenance, and Replacement 132
Battery Storage Mode 133
Software Updates 134
Locating the V*Home Software Version 135
Environmental Considerations 135
Shipping Considerations 135
Glossary 136
Glossary of Symbols 136
Glossary of Indicators 139
Glossary of Terms 141
Troubleshooting 143
Troubleshooting Alarms 143
Device Troubleshooting 148
Ventilation and Troubleshooting 149
Oxygen Troubleshooting 150
Multi-View Troubleshooting 150
Patient Circuit Troubleshooting 150
Recalibrating Batteries 151

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Technical Specications 152
Physical 152
Environmental 153
Inputs and Outputs 153
External Power Requirements 153
Removable, Rechargeable Batteries 154
Internal Rechargeable Battery 154
Expected Service Life and Intervals 155
Audible Volume 155
FiO2 Monitor 155
Control Accuracy 156
Monitor Resolution and Accuracy 158
Classications 160
Standards Applied 160
Ventec One-Circuit Compliance 161
Pressure During Inop 161
Biocompatibility 161
Accessories 162
Available from Ventec Life Systems 162
Available from Other Manufacturers 166
EMC Information 167
Electromagnetic Emissions 168
Electromagnetic Immunity 169
Recommended Separation Distance Between Portable and Mobile RF Communications Equipment and V*Home
171
Technical Description 172
Theory of Operation 172
Ventilation Therapy 172
Leak Compensation 173
Leak Compensation with a Passive or Valveless Ventec One-Circuit 173
Leak Compensation with a Mouthpiece Circuit 173
Nebulization 174
External Nebulizer Compensation 174
V*Home Measurements 175
Airway Pressure Measurements 175
Flow Measurements 175
Volume Measurements 175
FiO2 Measurements 175
Alarm Detection Criteria 176

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System Fault Detection Criteria and Recommended Action 177
Low-Pressure Oxygen Blending 178
Input Flow 100% Oxygen, Flow Trigger Set to 1-3 179
Input Flow 100% Oxygen, Flow Trigger Set to 9 179
Input Flow 93% Oxygen, Flow Trigger Set to 1-3 180
Input Flow 93% Oxygen, Flow Trigger Set to 9 180
Input Flow 100% Oxygen, High Flow Therapy 181
Input Flow 93% Oxygen, High Flow Therapy 181

Introduction
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Introduction
Therapy Overview
Using the Ventec One-Circuit®, clinicians, home caregivers, and patients can use V*Home to ventilate the patient.
NOTE: This manual describes the features included with software version 5.02 for the V*Home Conguration
only. For instructions for use of other model VOCSN congurations and software versions, see the links to Clinical and
Technical Manuals available at Venteclife.com/resources.

Introduction
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Leak+ Performance
The Leak+ feature allows V Home 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 V*Home 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 leak compensation, see “Leak Compensation” on page 173.
WARNING: Delivered and monitored ventilation therapy may be affected by large leaks around the patient interface.
Ventilation
V*Home provides invasive or non-invasive ventilation. Using one of six ventilation modes, and a passive, valveless, or
mouthpiece Ventec One-Circuit, V*Home 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
V*Home to perform well for both invasive and non-invasive applications, even with signicant leaks in the patient circuit.
V*Home 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 V*Home control settings. V*Home 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.
Oxygen can be owed into the Ventec One-Circuit through the low-pressure oxygen port.
Portability
V*Home is designed to support the transport of mechanically ventilated patients. V*Home 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, V*Home 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 V*Home from wheelchair outlets.
V*Home batteries charge whenever an external power source is applied.
V

Introduction
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Indications for Use
V*Home 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. V*Home 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.
V*Home Training
The V*Home clinician or caregiver must be capable of responding to alarm conditions, and trained to use V*Home. A list
of available V*Home training options is available at VentecLife.com.
CAUTION: Clinicians responsible for conguring and operating V*Home must be trained to use it and should review
this manual in its entirety before using V*Home 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
V*Home.

Introduction
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Suggested Environments of Use
V*Home 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 V*Home within magnetic resonance (MR) environments. Using V*Home within MR environments
may affect V*Home 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

Introduction
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Getting Started
Package Contents
V*Home includes the following items:
• One V*Home
• 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 162 for a list of V*Home components and accessories available from Ventec Life Systems.
Contraindications
Consult the patient’s healthcare professional before using a non-invasive interface with V*Home 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 10 Handle (back view)
2 Speaker 11 T-Slot mount
3 Alarm Silence button 12 Cooling air outlet
4 External Power / Charge Status indicator light 13 Low-pressure O2 Inlet
5 On/Off button and indicator light 14 Remote alarm port
6 Removable, rechargeable battery (right side) 15 USB port for use by trained personnel only. See “Exporting
Multi-View Data to a USB Drive” on page 103 for
instructions.
7 External bacterial lter and Ventec One-Circuit
connection port
16 Cooling air intake and lter
8 Handle (side view) 17 Power connection port
9 Cooling air outlet 18 Patient air inlet and lter
19 Removable, rechargeable battery (left side)
20 Cooling air outlets
1
2
345 6
7
8
9
10
11
13 14
15
16
17 18 19
20
12

Setup
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Setup
This chapter includes instructions for placing and setting up V*Home, including instructions for connecting Ventec One-
Circuits, and additional Ventec One-Circuit components. V*Home was designed for use with Ventec One-Circuits from
Ventec Life Systems. Do not use third-party patient circuits with V*Home.
WARNING: Put V*Home into service in accordance with the information provided in this Clinical and Technical Manual.
V*Home 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 V*Home. All modications made, and
accessories used with V*Home, must meet the requirements of IEC 60601-1. The organization responsible for device
setup must ensure the compatibility of V*Home and all parts and accessories used to provide therapy to the patient
prior to use.
WARNING: V*Home 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 V*Home setup or conguration without
direction and/or supervision from a clinician.
WARNING: Do not use lubricants on V*Home 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
V*Home 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 V*Home, impaired device performance, and risk to the patient.
NOTE: The V*Home 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 V*Home 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 V*Home, follow all instructions from
the equipment manufacturer.

Setup
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V*Home Placement
Place V*Home in a well-ventilated area, ensuring air ows freely around its inlets and vents.
WARNING: Incorrect placement of V*Home may affect device performance. Do not cover V*Home, 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: V*Home emits heat and gas, including nitrogen, during normal operation. Use V*Home in a well‑ventilated area.
When used in a home environment, V*Home should be kept away from concentrations of lint, dust, pet dander, and pests.
Small particles and/or pests can clog V*Home lters over time and become lodged inside V*Home. Clean the air and fan
lters regularly to prevent clogging, and move V*Home to a new location if large volumes of particulate are pulled into
the lters. Place V*Home somewhere it will not be easily accessible by children or pets, such as on a roll stand.
WARNING: Keep V*Home 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. V*Home includes a hook-and-loop strap to wrap power adapter cabling
when not in use.
Over time, direct sunlight may compromise the integrity of V*Home plastic housing or the Ventec One-Circuit. Place
V*Home in a location that is not exposed to extended periods of direct sunlight.
WARNING: Use of V*Home outside its recommended range of temperature, altitude, and/or relative humidity may
adversely affect the ventilation ow rate and oxygen concentration from V*Home, and may result in patient harm. See
“Environmental” on page 153 for details.
WARNING: Do not use V*Home in contaminated, hazardous, or explosive environments. Use of V*Home can be
hazardous in these conditions.
WARNING: To protect against EMI (electromagnetic interference) affecting device performance:
• Do not use V*Home within electromagnetic elds exceeding the limits specied in “EMC Information” on page
167. Common sources of electromagnetic elds include security systems, wireless communications equipment,
appliances, and medical imaging systems.
• Do not stack V*Home with other electrical devices during use.
• Do not connect V*Home to unauthorized cables or accessories. Use of cables or other accessories not approved for
use with V*Home 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 V*Home 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 V*Home touchscreen or its buttons. Use the touchscreen lock feature during cleaning or transport.

Setup
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Power Setup
V*Home operates using external power (such as a wall outlet), or V*Home batteries. Ventec Life Systems recommends
connecting V*Home 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 V*Home to external sources of power.
Ensure the external source of power is rated for use with V*Home. See “External Power Requirements” on page 153 for
more information.
The V*Home batteries will begin charging whenever an external power source is applied. All V*Home features and
functions operate normally during battery charging. The charge status indicator light on the front of V*Home 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 V*Home 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. V*Home power failure may
interrupt ventilation therapy and result in patient harm or death. See “Power Testing Procedures” on page 111 for
instructions.
If the internal battery depletes fully, V*Home Date and Time settings will reset to their default values. To ensure the
Alarm and Event logs record information accurately, verify the V*Home Date and Time settings before use, and set them
to the correct values if necessary.

Setup
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The Power Supply
The power supply included with V*Home is part of the ventilation system,
and powers the device from AC wall outlets.
Before and during use, periodically inspect the power supply for damage
or frays, and to ensure the power supply cords are rmly connected. Do
not use damaged power supplies. Replace the power supply if necessary.
The power supply includes a wire retention clip. To ensure the cabling
remains seated in the adapter, rotate the retention clip so that it
secures the cable to the adapter.
The power supply also comes with a hook-and-loop strap to manage
excess cabling. Coil extra cabling between the outlet and VOCSN, and
then wrap the strap around the cabling to secure it.
NOTE: Position V*Home so that it can be easily disconnected from the
AC supply mains. To disconnect V*Home from the AC supply mains,
unplug the power supply from the outlet.
NOTE: Do not use portable (e.g., external 115‑volt AC) power supplies
to power V*Home, unless the power supply voltage variations are known to be within V*Home operating limits. See
“External Power Requirements” on page 153.
To connect V*Home to a continuous source of external power using the AC Adapter:
1 Plug the power supply into the power connection port on the back of V*Home, and screw the connector
clockwise to secure it in place.
2 Plug the power supply into a power socket, such as a wall outlet, and verify the external power indicator ( )
appears on the touchscreen.
ROTATE SCREW COLLAR ONLY
DO NOT ROTATE CABLE

Setup
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The Optional 24 Volt Wheelchair Power Cable
An optional 24 Volt Wheelchair Power Cable is available from Ventec
Life Systems. The 24 Volt Wheelchair Power Cable can be used to
connect V*Home to external sources of DC power, such as wheelchair
power outlets.
PRECAUTION: When connected to an external battery (such as a
wheelchair battery), V*Home pulls power from it to run and charge
its own batteries. This may affect battery life and/or wheelchair
performance (for instance, driving uphill).
When connected to wheelchair power for long periods of time, it may
be benecial to implement a supplemental energy use strategy. For
example, traveling with an AC power supply and/or additional, charged
V*Home removable batteries.
The 24 Volt Wheelchair Power Cable comes with a hook-and-loop
strap to manage excess cabling. Coil extra cabling between the outlet and V*Home, and then wrap the strap around the
cabling to secure it.
NOTE: Before connecting the 24 Volt Wheelchair Power Cable to a power source, you must verify the voltage and
current emitted from the DC power source are within the range of V*Home operating limits, and that the power source
has the correct connection type. See “External Power Requirements” on page 153.
The Removable, Rechargeable Batteries
V*Home includes two removable, rechargeable batteries.
These batteries may be removed and reinstalled during
V*Home use.
To remove a battery:
1 Lift the blue battery tab.
2 Use the tab to pull the battery out of the well gently.
To install a battery:
1 Lift the blue battery tab.
2 Gently press the battery into the well. Place the base
of the battery into the well rst, and then press the
top of the battery toward V*Home and into the well.
3 Press the battery tab down so that it is at against
the battery.
1
2
ROTATE SCREW COLLAR ONLY
DO NOT ROTATE CABLE