Ventec VOCSN User manual

Clinical and Technical Manual

Software Version 4.06

VOCSN offers mechanical Ventilation, Oxygen, Cough, Suction, and Nebulizer therapies in one compact, portable,

NEBULIZER

lightweight device.

Critical Care Ventilator

VOCSN is one of the few portable ventilators to achieve the rigorous critical care standard1 for safety and accuracy. The ventilator provides invasive, noninvasive, and mouthpiece ventilation and delivers a comprehensive set of modes and settings to meet patient needs.

VENTILATION

6 L/min Equivalent Internal Oxygen Concentrator

The VOCSN internal oxygen concentrator and Oxygen DirectTM system deliver the equivalent of

OXYGEN

6 L/min of oxygen or up to 40% FiO2. External high pressure and low pressure oxygen sources can be connected when needed.

Touch Button Cough

Touch Button CoughTM therapy is activated in seconds rather than minutes, without changing the circuit. Breath Sync monitors patient breathing and triggers a cough at a natural point in the breathing cycle.

COUGH

Hospital Grade Suction

Hospital grade suction system provides consistent high ows throughout the entire suction experience.

VOCSN Suction therapy is up to three times quieter than traditional portable suction machines.

SUCTION

High Performance Nebulizer

VOCSN automatically compensates for the airow from the nebulizer drive to ensure accurate

ventilation and comfortable breathing. VOCSN records each medication use and turns off the nebulizer when the therapy is complete.

Part Number: LBL-00001-001, Rev M

CAUTION: Federal law restricts this device to sale and use by or on the order of a physician.

ISO 80601-2-12

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Table of Contents

Introduction 12

Therapy Overview 12 VOCSN Congurations 13

Leak+ Performance 13 Ventilation 14 Oxygen Direct 14 Touch Button Cough 15 Suction 15 Nebulization 15

Portability 16 Indications for Use 16 VOCSN Training 16 Suggested Environments of Use 17

Home Environments 17

Hospital Environments 17

Institutional Environments 17

Transport Environments 17 Getting Started 18

Package Contents 18

Contraindications 18

System Overview 19

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Table of Contents

Setup 20

VOCSN Placement 21 Power Setup 22

The Power Supply 23

The Optional 24 Volt Wheelchair Power Cable 24

The Removable, Rechargeable Batteries 24 Ventec One-Circuit Setup 25

Using a Trach, ET Tube, or Non-Vented Mask 26

Using a Vented Mask 26

Using a High Flow Nasal Cannula 26

Connecting an Active, Passive, or Valveless Ventec One-Circuit 27

Ventec One-Circuit Component Connection Order 28 Connecting an External Bacterial Filter 29

Connecting a Ventec One-Circuit Without a Humidier 29 Connecting a Humidier and Heated Wire Ventec One-Circuit 30 Connecting a Ventec One-Circuit to a Humidier (Without the Ventec Humidier Bypass) 31 Connecting a Ventec One-Circuit, Humidier, and Ventec Humidier Bypass 32

Connecting a Ventec One-Circuit O2 Tube 33 Connecting an Active Ventec One-Circuit 34

Connecting Ventec One-Circuit Components 35

Connecting an HME (Heat-Moisture Exchanger) 35

Connecting a Nebulizer Cup to the Patient Circuit 36

Connecting a Ventec Secretion Trap to the Patient Circuit 38

Connecting a Closed-Suction Catheter to the Patient Circuit 39 Setting up Ventilation therapy with a Speaking Valve 39 Mouthpiece Patient Circuit Setup 40 Oxygen Therapy Setup 41

Setting Up the Internal O2 Concentrator 42

Setting Up External Oxygen Sources 42

Connecting External High-Pressure Oxygen 43 Connecting External Low-Pressure Oxygen 44

Suction Setup 45

Removing and Reattaching the VOCSN Suction Cap 45

Connecting the Ventec Travel Suction Canister 46

Connecting Suction Tubing to the Travel Canister 47

Connecting the External Suction Canister Adapter 48

Connecting Suction Tubing to Suction Interfaces 48 Connecting a Nurse Call System or Remote Alarm 49 Running the Pre-Use Test 50

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Table of Contents

Breath Types and Therapy Modes 51

Breath Types 51

Pressure Breaths 52

Volume Breaths 53

Spontaneous Breaths 53 VOCSN Ventilation Modes 54

Bi-Level Mode 54

Assist/Control-Pressure with an Active, Passive, or Valveless Ventec One-Circuit 55 Assist/Control-Pressure with a Mouthpiece Patient Circuit 55

SIMV-Pressure Mode 56

CPAP Function 56 High Flow Therapy 56

Assist/Control-Volume Mode 57

Assist/Control-Volume with an Active, Passive, or Valveless Ventec One-Circuit 57 Assist/Control-Volume with a Mouthpiece Patient Circuit 57

SIMV-Volume Mode 58

CPAP Function 58

High Flow Therapy 58 Volume Targeted Ventilation Overview 59 Vol. Targeted-PS Mode 60

Vol. Targeted-PS with an Active, Passive, or Valveless Ventec One-Circuit 60

Vol. Targeted-PS with a Mouthpiece Patient Circuit 60 Vol. Targeted-PC Mode 61

Vol. Targeted-PC with an Active, Passive, or Valveless Ventec One-Circuit 61

Assist/Control-Pressure with a Mouthpiece Patient Circuit 61 Vol. Targeted-SIMV Mode 62 Comparable Volume Ventilation Modes 63 Comparable Pressure Ventilation Modes (Including Volume-Targeted Ventilation) 64 Comparable Non-Invasive Ventilation Modes 65

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Table of Contents

The Touchscreen 66

Locking the Touchscreen 66 The Status Bar 67 The Home Screen 68

Night Mode and Day Mode 68

The Therapy Screen 69 The Monitors Screen 70

The Customization Button 70 The Waveforms Button 70

The Menu Screen 71

The Pre-Use Test Button 71 The Settings & Alarms Button 72 The Device Settings Button 72 The Logs Button 72 The Clinician Access Button 72 The Enable Prescribed Therapies Button 73 The Permissions Button 73 The My VOCSN Button 73

Controls and Settings 74

Ventilation Therapy Controls 75

Changing Ventilation Therapy Settings 75 Available Ventilation Therapy Settings 76 Control Limiting 83 Controls Available in Each Ventilation Mode 84 Setting VOCSN Controls for Mouthpiece Ventilation 87 Setting VOCSN Controls for High Flow Therapy 87

Enabling and Disabling Prescribed Therapies 88 Oxygen Controls 90

Changing Oxygen Settings 90 Available Oxygen Settings 91

Cough Therapy Controls 93

Changing Cough Therapy Settings 93 Available Cough Therapy Settings 94

Changing Suction Settings 96 Changing Nebulizer Settings 97 Clinician Access Mode 98

Entering the Clinician Access Passcode 98

Conguring Permissions 99 Device Settings 100

Changing Device Settings 100 Available Device Settings 101

VOCSN Therapy Interactions 102

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Table of Contents

Alarms 103

Alarm Silence Button 104 Changing Alarm Settings 104 Alarm Conditions and Settings 105 The Alarm Log 113 The Event Log 114

Clearing an Alarm 115

Remote Alarms and Nurse Call Systems (Optional) 115

Monitors 116

Ventilation Monitors 117

Waveform Monitors 119 Monitor Screen Customization 120

Oxygen Therapy Monitors 121

FiO2 Monitor 121 Calculated FiO2 Monitor 122

Cough Therapy Monitors 123 Suction Therapy Monitor 124 Nebulizer Therapy Monitor 125 System Monitors 126

Multi-View 127

Exporting Multi-View Data to a USB Drive 128 Generating Multi-View Reports 129 Reading Multi-View Reports 130

Report Information 130 Trend Summary 131 Compliance Calendar 131 Therapy Use 132 Settings Overview 132 Monitor Details 133 Logs 134

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Table of Contents

Checkout Procedure 135

Visual Inspections 135 Inop Alarm Test 135 Power Testing Procedures 136 Ventilation and Oxygen Testing Procedures 137

Ventilation And Oxygen Tests 138

Ventilation Alarm Verication 139 Remote Alarm Test (Optional) 139 Decannulation Alarm Verication 140 Patient Circuit Disconnect Alarm Verication 140

Cough Therapy Testing Procedures 141 Suction Therapy Testing Procedures 142 Nebulizer Therapy Testing Procedures 142 Congure and Verify Control and Alarm Settings 142 Checkout Worksheet 143

Operating Instructions 144

Powering On VOCSN 145 Starting VOCSN Therapies 146

Starting Ventilation Therapy 147

Changing Between Congured Ventilation Presets 148 Starting Oxygen Therapy 149

Using O2 Flush 150

Using the Internal O2 Concentrator to Provide Pulse Dose Oxygen Direct Therapy 151

Using External High-Pressure Oxygen 152

Using External Low-Pressure Oxygen 152 Starting Cough Therapy 153 Starting Suction Therapy 154 Starting Nebulizer therapy 156

Responding to Alarms 158 Powering Off VOCSN 158

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Table of Contents

Cleaning and Maintenance 159

Cleaning VOCSN 159

Cleaning VOCSN Exterior 160 Cleaning the Air and Fan Filters 161

Replacing Components 162

Emptying the Ventec Travel Suction Canister and Replacing Suction Components 162 Replacing the Power Supply 163 Replacing the Ventec One-Circuit or Ventec Humidier Bypass 163 Replacing Ventec One-Circuit Components 164 Replacing the Nebulizer Filter 164 Replacing the External Bacterial Filter 164 Replacing the Internal Bacterial Filter 165

Recommended Maintenance Schedule 166 Battery Care, Maintenance, and Replacement 167 Software Updates 168

Locating the VOCSN Software Version 168

Environmental Considerations 169 Shipping Considerations 169

Glossary 170

Glossary of Symbols 170 Glossary of Indicators 174 Glossary of Terms 176

Troubleshooting 177

Troubleshooting Alarms 177 Device Troubleshooting 183 Ventilation and Cough Troubleshooting 184 Oxygen Troubleshooting 185 Suction Troubleshooting 186 Nebulizer Troubleshooting 186 Multi-View Troubleshooting 187 Patient Circuit Troubleshooting 187 Recalibrating Batteries 188

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Table of Contents

Technical Specications 189

Physical 189 Environmental 190 Inputs and Outputs 190 External Power Requirements 191 Removable, Rechargeable Batteries 191 Internal Rechargeable Battery 191 Expected Service Life and Intervals 192 Audible Volume 192 O2 Concentrator 192 Nebulizer Drive 193 FiO2 Monitor 193 Control Accuracy 194 Monitor Resolution and Accuracy 196 Classications 198 Standards Applied 198 Ventec One-Circuit Compliance 199 Pressure During Inop 199 Biocompatibility 199

Accessories 200

Available from Ventec Life Systems 200 Available from Other Manufacturers 205

EMC Information 206

Electromagnetic Emissions 207 Electromagnetic Immunity 208 Recommended Separation Distance Between Portable and Mobile RF Communications Equipment and VOCSN 210

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Table of Contents

Technical Description 211

Theory of Operation 211

Ventilation Therapy and FiO2 Oxygen Therapy 211 Leak Compensation 212

Leak Compensation with an Active Ventec One-Circuit 212

Leak Compensation with a Passive or Valveless Ventec One-Circuit 213

Leak Compensation with a Mouthpiece Circuit 213 The Oxygen Direct System 214 Touch Button Cough therapy and the Ventec Humidier Bypass 215 Suction 215 Nebulization 216

Internal Nebulizer Therapy 216

External Nebulizer Compensation 216

VOCSN Measurements 217

Airway Pressure Measurements 217 Flow Measurements 217 Volume Measurements 217 FiO2 Measurements 217

Alarm Detection Criteria 218 System Fault Detection Criteria and Recommended Action 219 Low-Pressure Oxygen Blending 221

Input Flow 100% Oxygen, Flow Trigger Set to 1-3 222 Input Flow 100% Oxygen, Flow Trigger Set to 9 222 Input Flow 93% Oxygen, Flow Trigger Set to 1-3 223 Input Flow 93% Oxygen, Flow Trigger Set to 9 223 Input Flow 100% Oxygen, High Flow Therapy 224 Input Flow 93% Oxygen, High Flow Therapy 224

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Introduction

NEBULIZERSUCTIONCOUGHOXYGEN

Introduction

Therapy Overview

Using the Ventec One-CircuitTM, clinicians, home caregivers, and patients can use VOCSN to ventilate, provide air enriched with oxygen to the patient, simulate natural coughs to clear secretions, remove those secretions from the patient airway or circuit, and administer nebulized medication, minimizing the need to connect additional medical

equipment or recongure the patient circuit.

VENTILATION

NOTE: This manual describes the features included with version 4.06. Not all functionality is available in previous versions of the VOCSN software. See “Software Updates” on page 168 for a description of features included in each release, and instructions to check the software version of your device. To view revisions of the Clinical and Technical manual associated with previous software versions, see VentecLife.com/resources.

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Introduction

VOCSN Congurations

VOCSN offers mechanical Ventilation, Oxygen, Cough, Suction, and Nebulizer therapies in one compact, portable,

lightweight device. VOCSN is customizable and may be purchased in various congurations of the available integrated therapies. There are many possible VOCSN congurations. This allows patients and caregivers to select a device that

provides therapies that meet the patient’s individual needs.

Your device may include all ve therapies and all the features described in this manual, or just the set of therapies and features purchased or prescribed by the treating physician. Depending on its conguration, VOCSN will be able to

provide Ventilation, +Oxygen Concentration, +Cough, +Suction, and/or +Nebulizer therapy. It may also be able to

provide oxygen from an external high-pressure source and FiO2 monitoring (+Pro congurations) or low-pressure oxygen (all congurations). The conguration name is based on the therapies VOCSN can provide. For example, the V+C conguration provides Ventilation+Cough therapies. The conguration name is printed on the back of the device, and is

also visible on the My VOCSN screen.

Conguration (Located on Device Rear Label)

V+O+C+S+N+Pro

(or “VOCSN”)

V+O+C+S+N

V+C+Pro

(or “VOCSN-VC”)

V+C

High-Pressure

Ventilation

(V)

Yes Yes Yes Yes Yes Yes Yes

Yes Yes Yes Yes Yes No Yes

Yes No Yes No No Yes Yes

Yes No Yes No No No Yes

Concentration

(+O)

Cough

(+C)

Suction

(+S)

Nebulizer

+(N)

External Oxygen

and FiO2 Monitor

(+Pro)

Low-Pressure

External

Oxygen

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 212.

WARNING: Delivered and monitored ventilation therapy may be affected by large leaks around the patient interface.

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Introduction

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 precon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.

Oxygen Direct

The VOCSN internal O2 Concentrator delivers Oxygen Direct therapy to the patient without requiring an external oxygen source. It is intended for the administration of non-life-sustaining, supplemental oxygen to stable individuals. Using the O2 Flow Equivalent control, the internal O2 Concentrator delivers the equivalent of up to 6 L/min as pulse doses through a small integrated oxygen tube in the Ventec One-Circuit.

Traditional, portable oxygen concentrators include a pulse dose oxygen mode, used to deliver oxygen through a high

ow nasal cannula, but do not have a way to trigger pulsed doses of oxygen through a patient circuit for ventilation. VOCSN unies ventilation and oxygen concentration to deliver oxygen as pulse doses through a small oxygen tube in

the Ventec One-Circuit, in synchronization with patient breathing.

VOCSN can also be connected to an external source of high-pressure oxygen to deliver oxygen through the Ventec One-

Circuit as a congured FiO2, or in pulse dose mode using an integrated Ventec One-Circuit O2 tube.

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Introduction

Touch Button Cough

Integrated VOCSN Touch Button CoughTM therapy can be delivered with the touch of a button without modifying the Ventec One-Circuit. Once initiated using the touchscreen, VOCSN transitions to Cough therapy and then back to

Ventilation therapy automatically. Touch Button Cough therapy delivers an insufation (positive) pressure, and then an exsufation (negative) pressure through the Ventec One-Circuit to simulate a natural cough, moving secretions out of the

patient airway.

The Cough+Suction feature allows VOCSN to activate Suction therapy automatically when Cough therapy is initiated, to simultaneously move secretions out of the patient airway, and from the Ventec One-Circuit.

The Breath Sync feature synchronizes cough maneuvers with patient effort to improve patient comfort. VOCSN also monitors Peak Cough Flow and Cough Volume to help ensure Cough therapy is delivered effectively.

Suction

VOCSN includes a high-ow suction system designed to safely aid in effective airway clearance for both pediatric and

adult patients. If enabled, Suction therapy can be initiated at any time during Ventilation or Cough therapy, to help remove secretions from the patient airway or Ventec One-Circuit.

Suction therapy can be used with a Ventec Secretion Trap, or closed- or open-suction catheter. The Ventec Secretion Trap collects secretions as they enter the Ventec One-Circuit during Cough therapy. Suction tubing connected to the Ventec Secretion Trap vacuums those secretions out of the Ventec One-Circuit and into the detachable Ventec Travel Suction Canister.

Nebulization

Optional Nebulizer therapy provides an integrated 6 L/min nebulizer drive, to power a nebulizer connected to the Ventec One-Circuit. Nebulization can be initiated using the VOCSN touchscreen, and turns off automatically when the

congured Nebulizer therapy duration has elapsed. While Nebulizer therapy is active, VOCSN automatically adjusts the delivered Ventilation therapy to compensate for nebulization ows.

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Introduction

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.

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.

The integral oxygen concentrator is intended for the administration of supplemental oxygen. The integral suction

pump is intended for airway uid removal and oral/pharyngeal hygiene. The integral cough assist option is intended for

patients who are additionally unable to cough or clear secretions effectively.

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.

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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

Introduction

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.

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Getting Started

Package Contents

VOCSN includes the following items:

• One VOCSN (therapy conguration may vary)

• Two removable, rechargeable batteries

• One power supply

• One Ventec One-Circuit

• Bacterial lters

• One Quick Start Guide

• One Ventec Travel Suction Canister (included with VOCSN congurations with Suction therapy)

• One Nebulizer Filter (included with VOCSN congurations with Nebulizer therapy)

Introduction

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 200 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

Consult the patient’s healthcare professional before using Cough therapy if the patient experiences any of the following medical conditions:

• A medical history of bullous emphysema

• Recent barotrauma

• Susceptible to pneumothorax or pneumo-mediastinum

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System Overview

Introduction

5 6

Description Description

1 Touchscreen 13 Handle (back view)

2 Speaker 14 T-Slot mount

3 Alarm Silence button 15 Cooling air outlet and Cough therapy exhaust

4 External Power / Charge Status indicator light 16 High-pressure O2 Inlet

5 On/Off button and indicator light 17 Low-pressure O2 Inlet

(+Pro congurations only)

6 Removable, rechargeable battery (right side) 18 Remote alarm port

7 Active exhalation valve connection port 19 USB port for use by trained personnel only. See “Exporting

Multi-View Data to a USB Drive” on page 127 for

instructions.

8 Ventec One-Circuit O2 tube connection port (+O

congurations only)

9 Nebulizer drive port

(+N congurations only)

10 External bacterial lter and Ventec One-Circuit

connection port

11 Handle (side view) 23 Removable, rechargeable battery (left side)

12 Cooling air outlet 24 Suction canister cap to protect suction canister interface

20 Cooling air intake and lter

21 Power connection port

22 Patient air inlet and lter

port (+S congurations only)

25 Cooling air outlets

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Setup

This chapter includes instructions for placing and setting up VOCSN, including instructions for connecting Ventec OneCircuits, 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.

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Setup

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 190 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.

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Setup

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 C-3 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 136 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.

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The Power Supply

The power supply included with VOCSN 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 VOCSN so that it can be easily disconnected from the AC supply mains. To disconnect VOCSN from the AC supply mains, unplug the power supply from the outlet.

Setup

NOTE: Do not use portable (e.g., external 115-volt AC) power supplies to power VOCSN, unless the power supply voltage variations are known to be within VOCSN operating limits. See

“External Power Requirements” on page 191.

To connect VOCSN 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 VOCSN, 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.

VentecLife.com 23

Setup

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 VOCSN to external sources of DC power, such as wheelchair power outlets.

PRECAUTION: When connected to an external battery (such as a wheelchair battery), VOCSN 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 VOCSN 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 VOCSN, 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 VOCSN operating limits, and that the power source has the correct connection type. See “External Power Requirements” on page 191.

The Removable, Rechargeable Batteries

VOCSN includes two removable, rechargeable batteries. These batteries may be removed and reinstalled during VOCSN 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 VOCSN and into the well.

3 Press the battery tab down so that it is at against

the battery.

VentecLife.com 24

Setup

Ventec One-Circuit Setup

VOCSN was designed for use with Active, Passive, Valveless, or Mouthpiece Ventec One-Circuits. Do not use third-party patient circuits with VOCSN. Assemble Ventec One-Circuits and Ventec One-Circuit accessories using the procedures and sequences depicted in this manual.

NOTE: See “Mouthpiece Patient Circuit Setup” on page 40 for detailed setup instructions for that circuit type.

Ventec Life Systems offers single-patient use adult and pediatric Ventec One-Circuits for use with VOCSN, which

incorporate an optional active or passive exhalation valve, an optional Ventec One-Circuit O2 tube (to deliver pulse dose Oxygen Direct therapy), and an optional heated wire (for connection to a humidier). See “Accessories” on page 200

for a list of Ventec One-Circuits available from Ventec Life Systems.

Each time the Ventec One-Circuit or its conguration is changed, or the Circuit Type control is modied, run a Pre-Use

Test before initiating therapy. The Pre-Use Test will calculate the resistance, and leak of the Ventec One-Circuit to ensure Ventilation therapy is delivered accurately.

WARNING: Adding unauthorized attachments, components, or sub-assemblies to the Ventec One-Circuit can change the pressure gradient of the Ventec One-Circuit and adversely affect the performance of VOCSN.

WARNING: Ventec One-Circuit accessories (including but not limited to lters, nebulizers, and humidiers) may

increase the resistance of the Ventec One-Circuit and affect the accuracy of delivered Ventilation therapy. Inspect all

patient circuit lters frequently for signs of increased resistance or blockages, and ensure alarms are set appropriately

to verify the accuracy of delivered Ventilation therapy.

WARNING: To reduce the risk of electric shock, do not use anti-static or electrically conductive patient circuits or hoses with the VOCSN system. Only Ventec One-Circuits are approved for use with VOCSN.

WARNING: To ensure patient safety, check the Ventec One-Circuit and verify that all system settings and Presets are appropriate before providing therapy, and on a routine basis during therapy.

WARNING: Any components added to the breathing circuit between the Ventec One-Circuit exhalation valve and the patient will increase the amount of gas that the patient rebreathes with each breath. The addition of components into the breathing circuit should be considered carefully, especially for small pediatrics.

NOTE: When providing non-invasive ventilation, use CO2 monitoring equipment compliant with ISO 80601-2-55 to ensure patient safety.

Ventec One-Circuits may be connected to a humidier and/or other patient circuit components as needed. See

“Connecting Ventec One-Circuit Components” on page 35 for detailed instructions.

VentecLife.com 25

Setup

Using a Trach, ET Tube, or Non-Vented Mask

VOCSN may be connected to a non-vented mask, trach or ET tube to provide Ventilation therapy using an Active or Passive Ventec One-Circuit. These circuit types include an exhalation valve designed to expel exhaled gases. See the following pages for detailed setup instructions.

NOTE: Masks with an anti-asphyxia valve should not be used with an Active Ventec One-Circuit, because bias ow may not be sufcient to close the valve when needed. Active circuit valves open automatically when there is no pressure in

the circuit, serving the same purpose as anti-asphyxia valves.

Using a Vented Mask

VOCSN may be connected to a vented mask to provide Ventilation therapy using a Valveless or Passive Ventec OneCircuit. This circuit type does not include an exhalation valve, and is designed for use with a mask patient interface

incorporating a xed leak. See the following pages for detailed setup instructions.

NOTE: Vented masks used with VOCSN must be connected with a Valveless or Passive Ventec One-Circuit and have an integrated leak of 20 to 50 L/min at 10 cmH2O to ensure proper device performance.

WARNING: Masks are not recommended for use with patients <7 kg, due to the unavailability of masks sized to provide a seal tight enough to deliver effective Ventilation therapy.

Using a High Flow Nasal Cannula

VOCSN may be connected to a high ow nasal cannula to provide High Flow therapy using a Valveless Ventec One-

Circuit.

NOTE: When using a Valveless Ventec One-Circuit, leave the circuit connected to VOCSN, and disconnect the mask or

high ow nasal cannula while running the Pre-Use Test.

VentecLife.com 26

Setup

Connecting an Active, Passive, or Valveless Ventec One-Circuit

The Ventec One-Circuit comes with an optional active or passive exhalation valve, an optional Ventec One-Circuit O2

tube (to deliver pulse dose Oxygen Direct therapy), and an optional heated wire (for connection to a humidier). The

setup procedure will depend on the type of Ventec One-Circuit and the accessories used. To connect a Ventec OneCircuit to VOCSN:

1 Connect a bacterial lter. See “Connecting a Bacterial Filter” on page 29.

2 Connecting the Ventec One-Circuit depends on whether you are using an HME or a humidier, and whether or

not you are connecting the Ventec Humidier Bypass (for Touch Button Cough therapy). Follow the instruction below the corresponds to the Ventec One-Circuit conguration:

• To congure the Ventec One-Circuit with an HME instead of a humidier, see “Connecting a Ventec

One-Circuit Without a Humidier” on page 29.

• To congure the Ventec One-Circuit with a humidier, without connecting a Ventec Humidier Bypass,

see “Connecting a Ventec One-Circuit to a Humidier (Without the Ventec Humidier Bypass)” on page

31.

• To congure the Ventec One-Circuit with a humidier and the Ventec Humidier Bypass (for Touch Button Cough therapy), see “Connecting a Ventec One-Circuit, Humidier, and Ventec Humidier

Bypass” on page 32.

3 If the Ventec One-Circuit includes an integrated O2 tube, connect it to VOCSN. See “Connecting a Ventec One-

Circuit O2 Tube” on page 33 for instructions.

4 If you are using an active Ventec One-Circuit, connect the ow sensor (multilumen) tubing to VOCSN. See

“Connecting an Active Ventec One-Circuit” on page 34.

5 To attach other components to the Ventec One-Circuit, such as a nebulizer or closed suction catheter, see

“Connecting Ventec One-Circuit Components” on page 35.

6 The diagram on the next page illustrates the Ventec One-Circuit and optional components in the correct

conguration. Consult “Ventec One-Circuit Component Connection Order” on page 28 to verify that

everything is connected in the correct order.

VentecLife.com 27

Ventec One-Circuit Component Connection Order

PATIENT

INTERFACE

Setup

BACTERIAL

FILTER

(optional

tube)

PATIENT

CIRCUIT

(optional

heated wire)

HUMIDIFIER

BYPASS

(required

for Cough)

HUMIDIFIER

VOCSN

Item Name Required? Additional Information

VOCSN Bacterial Filter

Ventec Humidier

Bypass

Required See “Connecting a Bacterial Filter” on page 29 for instructions.

Required for using Touch Button Cough therapy with a

connected humidier

The Ventec Humidier Bypass prevents water damage to VOCSN during Cough

therapy.

HME

(choose one)

NEBULIZER

(optional)

NEBULIZER

FILTER

SECRETION

TRAP

(optional)

Humidier Optional Include a form of humidication (either an HME or humidier).

Ventec One-Circuit Required Use either an Active, Passive, or Valveless Ventec One-Circuit. Ventec One-

Circuits may include an integrated O2 tube and/or a heated wire. Active

Ventec One-Circuits include ow sensor tubing. (For Mouthpiece Patient Circuit

instructions, see “Mouthpiece Patient Circuit Setup” on page 40.)

Heat-Moisture

Exchanger (HME)

Optional Include a form of humidication (either an HME or humidier). See “Connecting

an HME (Heat-Moisture Exchanger)” on page 35 for instructions.

Nebulizer Optional Connect a nebulizer to the nebulizer drive port. See “Connecting a Nebulizer

Cup to the Patient Circuit” on page 36 for instructions.

Ventec Secretion Trap Optional Connect a Ventec Secretion Trap, using suction tubing, to a suction canister.

See “Connecting a Ventec Secretion Trap to the Patient Circuit” on page 38 for instructions.

Patient interface Required Examples of a patient interface include a mask, trach, or ET tube. Active and

Passive Ventec One-Circuits include an exhalation valve and are intended for use with non-vented masks, trach, or ET tubes. Valveless Ventec One-Circuits are intended for use with vented masks, or nasal cannulas for High Flow therapy.

VentecLife.com 28

Setup

Connecting an External Bacterial Filter

Connect an external bacterial lter to reduce the risk of cross-contamination. Attach a bacterial lter to the Ventec One-

Circuit connection port before connecting a Ventec One-Circuit.

Fit the bacterial lter against VOCSN, aligning the icons on the lter and VOCSN, then twist the lter to lock it into place.

VOCSN contains a secondary, internal bacterial lter to help protect against cross-contamination in case of external bacterial lter failure. The internal bacterial lter should be replaced whenever it may have become cross-contaminated, such as when the external bacterial lter becomes compromised, or if an infectious disease specialist recommends its

replacement. See “Replacing the Internal Bacterial Filter” on page 165 for instructions.

Connecting a Ventec One-Circuit Without a Humidier

When not using a humidier as part of the Ventec One-Circuit conguration, connect the circuit to the bacterial lter. Connect an HME to the Ventec One-Circuit to provide the patient with humidication, following the instructions in

“Connecting an HME (Heat-Moisture Exchanger)” on page 35.

VentecLife.com 29

Setup

Connecting a Humidier and Heated Wire Ventec One-Circuit

When using a humidier, use a heated-wire Ventec One-Circuit to manage water condensation inside the Ventec OneCircuit. Place the humidier below VOCSN and the patient to prevent water from leaking into the patient.

WARNING: Do not use heated wire Ventec One-Circuits on, within, or under localized heat sources or insulating materials such as blankets or thermal chambers. External sources of heat or insulation may impair the performance of heated wire Ventec One-Circuits.

CAUTION: Before delivering Cough therapy when using a heated humidier, verify a Ventec Humidier Bypass is installed, or disconnect the humidier from the Ventec One-Circuit. Cough therapy may cause water damage to VOCSN when a humidier is attached to the Ventec One-Circuit without an installed Ventec Humidier Bypass. See

“Connecting a Ventec One-Circuit, Humidier, and Ventec Humidier Bypass” on page 32 for installation instructions

and more information. The Ventec Humidier Bypass was designed to remain connected to the Ventec One-Circuit during Ventilation therapy, allowing the delivery of Touch Button Cough therapy while using a humidier, without reconguring the Ventec One-Circuit.

NOTE: Using humidiers or other accessories not specied for use with this system may impair VOCSN performance.

Ventec Life Systems recommends use of the Fisher & Paykel HC550, the Fisher & Paykel MR850, or equivalent.

Humidiers connected to the VOCSN Ventec One-Circuit should comply with ISO 8185.

Depending on whether you will use Touch Button Cough therapy with a connected humidier, follow the setup

instructions as described in “Connecting a Ventec One-Circuit to a Humidier (Without the Ventec Humidier Bypass)” on

page 31 or “Connecting a Ventec One-Circuit, Humidier, and Ventec Humidier Bypass” on page 32 to connect a

humidier, humidier bypass (if necessary), and heated wire Ventec One-Circuit to VOCSN.

VentecLife.com 30

+ 195 hidden pages

Ventec VOCSN User manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Introduction

Therapy Overview

Leak+ Performance

Ventilation

Oxygen Direct

Touch Button Cough

Suction

Nebulization

Portability

Indications for Use

VOCSN Training

Suggested Environments of Use

Home Environments

Hospital Environments

Institutional Environments

Transport Environments

Getting Started

Package Contents

Contraindications

System Overview

Setup

VOCSN Placement

Power Setup

The Power Supply

The Optional 24 Volt Wheelchair Power Cable

The Removable, Rechargeable Batteries

Ventec One-Circuit Setup

Using a Trach, ET Tube, or Non-Vented Mask

Using a Vented Mask

Using a High Flow Nasal Cannula

Ventec One-Circuit Component Connection Order

Connecting an External Bacterial Filter