iVent201 User’s Reference Manual Rev13

VersaMed, a General Electric Company, doing business as GE Healthcare.

Calling for Help Owner’s Record The model number and serial number of your iVentTM201 are located on the rear panel of your ventilator. Record the serial number in the space below in case service or support is necessary. Model Number: Serial Number: Customer Service

If you have a ventilator problem you cannot solve and you purchased your ventilator directly from GE, call: US number 800-345-2700 - Customer Service If you have a ventilator problem that you cannot solve and you purchased your ventilator from an authorized GE distributor, please contact your distributor directly to report the problem.

TABLE OF CONTENTS 1

INTRODUCTION ... 1 Introduction ... 3 How to Use This Manual ... 4 Looking at the iVent™201 ... 5 Cautions and Warnings ... 7 Symbols and Labels ... 8 Performance Parameters ... 12 Specifications... 13 Monitored Data Range, Resolution and Accuracy ... 13 Size and Weight ... 15 Ventilation Modes ... 15 Environmental Specifications... 16 Power Supply ... 16 O2 Supply Specifications ... 17 Ventilation Performance and Controlled Parameters ... 17 Pulse Oximetry Specifications... 18 Standards and Safety Requirements ... 19 User Adjustable Alarms ... 22 Additional Alarms and Indicators ... 23 Waveforms and Diagnostics Packages ... 23 Intended Use ... 25 Use of the iVentTM201 With MRI ... 25 MRI Conditional Tests Specifications ... 29

2

SETTING UP ... 31 Introduction ... 32 Power Connection ... 32 External Power ... 32 Internal Battery ... 35 Oxygen Supply ... 38 High Pressure Oxygen supply ... 38 Low Pressure Oxygen Supply ... 39 Patient Circuit ... 40 Disposable Patient Circuit ... 41 Reusable Patient Circuit ... 41 Dual Limb Patient Circuit ... 42 Circuit Resistance ... 44

I

Other Connections ... 44 HME ... 44 MDI ... 44 Using the iventTM201 with heated humidification (1.4 Stepper Based models only) ... 44 PneUmaTIC Nebulizer ... 46 Pulse Oximeter ... 46 Remote Alarm ... 49 Sensor Line Maintenance... 49 Patient Connection... 49 Filters ... 49 Air Inlet Filter ... 50 Bacterial Filter... 50 Chemical, Biological, Radiological and Nuclear Filter... 50 Operational Case ... 51 The iVentTM201 User Interface ... 51 Controls and Power Up ... 52 The Front Panel ... 52 Silence... 52 Manual Breath ... 53 Hold ... 53 Clear... 53 LED Indicators ... 53 The Screen ... 54

3

OPERATING THE IVENTTM201 – SETTING MODES AND PARAMETERS... 57 Introduction ... 59 Operation of the iVentTM201 ... 59 Power Up and Weight Selection ... 59 O.V.T ... 60 Standby and Patient Ventilation ... 61 Changing Ventilation Mode... 62 Common Parameters... 64 Changing Ventilation Paramters – Overview ... 65 The Selection Interface... 66 Adjusting the Breath Rate ... 67 Adjusting the Tidal Volume ... 69 Breath Types ... 70

Adjusting Pressure... 71 Adjusting FiO2 ... 73 Adjusting Peak Flow... 74 Adjusting Pressure Support Ventelation ... 76

II

Adjusting PEEP... 78 Adjusting Trigger Sensitivity... 79 Adjusting Inspiratory Time ... 80 Adjusting Rise Time ... 82 Adjusting Flow Termination (Esens) ... 84 4

THE MAIN MENU... 87 Introduction ... 89 Navigating the Main Menu ... 89 Alarm Settings ... 90 Advanced Settings ... 91 Sigh Breath ... 91 Easy Exhale™ ... 93 Oxygen Supply ... 94 High Option ... 95 Alarm Messages ... 96 Low + Monitoring Option ... 97 Low Option... 97 None Option ... 98

Adaptive Peak Flow... 98 Humidifier Setting ... 99 Pulse Oximetry ...100 Pneumatic Nebulizer ...102 Set Time and Date ...103 Restore Default Settings ...105 Default parameters Settings ...106 Show Graphs ...108 Browse Waveforms...108 Select Range ...110 Show Trends ...112 Selecting Trends To Display ...114 Browsing Trends ...115 Show Loops ...117 Show Mechanics ...119 Pulse Oximetry Screen...120 Pulse Oximetery Alarms ...122 Show Log Book ...123 Display...124 O.V.T. ...127 Maintenance ...127

III

5

ADAPTIVE BI-LEVEL ... 129 Introduction ...131 About Adaptive Bi-Level...131 Guide to Adaptive Bi-Level ...131 Indications and Warnings ...132 Indications ...132 Warnings...132 Setup ...132 Adaptive Bi-Level Alarm Settings ...134 Other Alarm Options...134 Adjusting Adaptive Bi-Level Parameters ...134 Adaptive Bi-Level Window ...135 Easy Exhale ...137 Optimizing the Patient Ventilator Interface ...137 Resolving Patient Ventilator Dysynchrony ...137 Excessive Ventilation ...137 Excessive Leak ...137 Non-Triggered Breaths (Inspiratory Trigger Failure)...138 Excessive Triggering (auto cycling): ...138 I:E Cycling Dysynchrony ...138 Premature I:E Cycling ...138

6

ALARMS... 141 Introduction ...143 How Alarms Work ...143 Responding to an Alarm ...143 Alarm settings ...144 Changing Individual Alarm Settings ...145 Setting the Respiratory Rate Alarm ...146 Setting the Minute Volume Alarm ... 147 Setting the Pressure Alarm... 148 Setting the Apnea Time Alarm ... 149 Setting the FiO2 Alarm ... 150 Setting the Leak Alarm ... 151

Auto Settings ...152 Alarm Options ...153 Setting the Alarm Volume ... 154 Setting the Inverse I:E Ratio Alarm ... 154 Setting the Tidal Volume Not Delivered Alarm ... 155 Disabling or Enabling the Patient Circuit Disconnect Alarm ... 156

Guide to Alarm Definitions and Priorities ...158

IV

Alarms Test ...167 The Sensor Failure Alarm ...169 Patient Disconnect Alarm ...170 Patient Circuit Failed Alarm...170 7

CARE, MAINTENANCE AND TESTS ... 171 Introduction ...173 Cleaning and Maintenance ...173 Cleaning the Ventilator...174 Planned Maintenance ...174 Storage Planned Maintenance ...176 The O.V.T...176 The Maintenance Screen...176 Calibration ...176 O2 Calibration ... 177

Ventilator Verification tests ...179 Required Equipment and Supplies: ... 180 Starting the VVT ... 181 The Alarm Sound Test ... 181 Pressure Tests ... 182 Flow Tests... 182 O2 Tests... 182 Battery Test ... 183 Watchdog Timer Tests ... 183 VVT Completion ... 183

Configuration Screen ...184 Choosing a Different Startup Screen ...184 Setting the Startup Weight ...185 Default FiO2 Setting ...185 VersaMed Service Functions ...186 Communication Port ...186 Communication Rate ...186 Localization...186 Total Operating Hours ...188 APPENDIX A: GLOSSARY ... 191 APPENDIX B: WARRANTY ... 199 Warranty ...201 APPENDIX C: OPERATING THEORY ... 203 Operating Theory ...205

V

Theory ...205 Ambient Air Filter...205 CBRN Filter (optional) ...205 Low Pressure O2 Adapter and Filter (optional) ...205 Air/Oxygen Blending System ...205 Inlet Manifold ...205 Turbine Unit ...206 Turbine Pressure Sensor ...206 Turbine Valves ...206 Over Pressure Relief Valve ...206 Airway Flow and Pressure Sensors ...206 Pressure Switch ...206 Inlet and Outlet Mufflers ...206 APPENDIX D: THEORY OF BREATH DELIVERY ... 211 Breath Delivery...213 Patient Triggering ...213 Breath Types ...214 Adaptive Flow and Adaptive I-Time ...215 Mandatory Volume Control Breath ...216 Pressure Control Breath...217 Manual Mandatory Breath ...218 Patient Pressure Support Breath ...218 Patient Spontaneous Breath ...219 Summary ...220 APPENDIX E: VENTILATION MODES... 223 Assist/Control Mode...225 Definition ...225 Available Breath Types ...225 Description ...225 Parameters Setting ...226 Synchronized Intermittent Mandatory Ventilation Mode...226 Definition ...226 Available Breath Types ...226 Description ...226 Parameters Setting ...227 Continuous Positive Airway Pressure Mode ...228 Definition ... 228 Available Breath Types ... 228 Description... 228

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Parameters Setting ...228 Apnea Back-Up Ventilation ...229 Open Loop Mode ...229 Adaptive Bi-Level Mode ...230 APPENDIX F: HOLD FUNCTION AND STATIC MECHANICS MEASUREMENTS ... 233 Front Panel Controls ...235 Static Compliance Measurements ...235 Static Compliance...235 Respiratory Time Constant ...236 Performing a Static Respiratory Mechanics Measurement ...236 Clinical Considerations ...237 End Expiratory Hold ...237 Performing and End Expiratory Hold Maneuver ...238 Reviewing Static Mechanics and Intrinsic PEEP Measurements ...238 RR/Vt Ratio ...239 APPENDIX G: ACCESSORIES ... 241 Disposable Breathing Circuit ...243 Instructions for Use... 244 Instructions for Use With a Pneumatic Nebulizer ... 245

Reuseable Patient Breathing Circuit ...245 Contents... 245 Warnings and Cautions ... 245 Sterilization and Duration of Use ... 246 Phthalates ... 246 Instructions for use ... 247 Instructions for use with the humidifier... 247 Cleaning and Sterilization ... 248 Reassembly ... 249

Dual Limb Patient Circuit Adapter...250 Kit Contents ...250 Phthalates ...251 Installation...251 Installing the Exhalation Valve... 252 Installing the Patient Circuit ... 252

Extended Battery ...254 To replace the battery: ...254 Specifications...256 MRI Extension Tubing Set for Patient Breathing Circuit ...256 Warnings...256

VII

Instructions for Use ...258 Instructions for Use With the Humidifier ...258 Transport Mounting Panel ...259 Kit Contents ...259 Installation...259 Support Arm for Breathing Circuit ...261 connecting the Patient circuit to the Support Arm ...261 Roll Stand ...262 Mounting the iVentTM201 On The Roll Stand ...262 Dismounting the iVentTM201 From The Roll Stand ...262 Connecting the optional Battery Holder Accessory P/N: M1162050...263 APPENDIX H: REMOTE ALARM PINOUT ... 265 APPENDIX I: PART NUMBERS AND ACCESSORIES ... 269 INDEX ... 275

VIII

1 INTRODUCTION

This chapter contains the following sections: Introduction

Page 3

Specifications

Page 13

Intended Use

Page 25

Use of the iVentTM201 With MRI

Page 25

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1 Introduction

INTRODUCTION The iVentTM201 is a compact, portable, multi-featured, microprocessor-controlled ventilator, which has the versatility and capability of larger and more costly ventilators. A turbine-powered air source and a rechargeable internal battery provide freedom from wall air and power outlets. An intuitive turn-and-click Control Knob, quick-choice pushbuttons, and a bright, well-organized easy-to-read screen, allow for rapid control and continuous real-time monitoring of patient ventilation. Alarm settings are fully adjustable. Optional Waveform and Diagnostic Software package displays pressure and flow waveform data, loops, trends, and logged totals in a variety of graphical and numerical modes. The iVentTM201 supports the following modes: 



Assist/Control (A/C) o

Volume Controlled A/C

o

Pressure Controlled A/C

Synchronized Intermittent Mandatory Ventilation (SIMV) o

Volume Controlled SIMV (Vctrl SIMV)

o

Pressure Controlled SIMV (Pctrl SIMV)



Continuous Positive Airway Pressure (CPAP)



Pressure Support Ventilation (PSV)

NOTE

Certain modes are optional features and may not be operational in some iVentTM201 models

In addition, the iVent™201 has the following advanced features: 

Quick setup enabled by Preset Parameters according to Patient Weight



Adaptive Peak Flow™ and Adaptive I-Time to adapt to patient flow demand during volume control breath delivery or to maintain a 1:2 I:E ratio in the event of no patient flow demand.



Rise time is adjustable



The iVent™201 s Adaptive Bi-Level feature enables leak-tolerance for facemask ventilation or other specialized high-leak tube ventilation



Easy Exhale™ is an advanced feature when PEEP>0 is selected, designed to shorten expiratory time and reduce risk of auto-PEEP.



Firmware is upgradeable via a PC connection



The iVent™201 is designed to operate according to specifications in any physical orientation, such as during transport use

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HOW TO USE THIS MANUAL The iVent™201 must only be operated by authorized medical personnel certified trained in the use of this product. It must be operated according to the instructions provided in the Operator’s Manual. The manual is primarily organized according to available screens, menus, options and settings and begins with a look at the hardware, including power considerations and patient circuit setup. Study the manual with the iVent™201 in close proximity, along with a patient circuit (preferably with a test lung and Rp20 resistor). Become comfortable with the Control Knob and the front panel buttons. The user interface consists of three primary screens/menus: 

The Main Screen



The Main Menu



The Mode Menu

Almost every function or operation of the iVent™201 is accessible through one of the Main screen menus. Be aware of the notes, warnings, and cautions marked in bold print. Refer to the index and the Table of Contents to assist you in finding information. For more information about the Adaptive Bi-Level feature see About Adaptive BiLevel, page 131.

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1 Introduction

LOOKING AT THE IVENT™201

1

7 2 5 3

6

4 Figure 1: Front View of the iVent™201

Item Number

Description

1

Display

2

Keypad

3

Control Knob

4

Exhalation valve luer inlet

5

Ventilator outlet

6

Sensor line luer inlets

7

Nebulizer outlet

5

1 2

3

17 16 4 15

5 6

14

7 8

13 9 12

10

11

Figure 2: Back View of the iVent™201 Item Number

Description

1

Carrying handle

2

Keyboard connector

3

Remote alarm connector

4

External screen connector

5

LAN connector* Do not remove connector cap. This connection port is not in use

6

AC cable clip

7

RS 232 connectors (COM1 and COM2)

8

On/off switch (with cover)

9

High pressure oxygen inlet connector

6

1 Introduction

10

4 x Battery pack screws

11

Internal battery handle

12

DC fuse

13

AC fuses

14

DC cord connector

15

Grounding pin

16

AC cord connector

17

Cooling fan

CAUTIONS AND WARNINGS CAUTION

The iVentTM201 is a restricted medical device to be operated by qualified medical personnel under the direction of a qualified medical practitioner Always perform a complete Operation Verification Test (O.V.T.) when connecting a new patient circuit to the ventilator, and before using it on a patient. Standard facility policy should be followed. Using the iVentTM201 in combination with devices such as humidifiers or filters can increase the pressure gradient across the breathing system. Make sure that such devices do not produce excessive resistance to the airflow provided by the iVentTM201. The iVentTM201 must not be operated immediately following storage or transport outside the recommended operation condition The iVentTM201 internal battery contains lead and must be disposed of in accordance with local ordinances and environmental regulations. Do not connect the O2 supply when equipment is not in use. The remote alarm should be considered secondary to the ventilator’s primary alarm system. Verify the remote alarm device functionality before use The remote alarm connector should be connected to a nurse station device on a low voltage less than 24Vdc and compliant with IEC 60601-1. The factory default setting for Leak Alarm is set to Off. Users must manually set the leak alarm to enable it.

WARNING

The iVentTM201 is a life-sustaining device. Do not rely solely on the ventilator performance: always make sure an alternative source of ventilation is available. Clinical supervision of the patient is

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mandatory. Qualified medical personnel should visually monitor patients on life-support ventilation. Life-threatening conditions may arise that might not activate alarms, To prevent explosion hazard, do not use the ventilator in the presence of flammable anesthetics. Do not cover the iVentTM201 while it is in use. Make sure that the iVentTM201 is positioned so that its inlet ports and cooling vents are open to freely circulating air.

SYMBOLS AND LABELS Symbol

Meaning Indicates that you should “Refer to documentation for further information.” Refer to manual per IEC 601-1 Potential equalization (Ground) point Direct Current ( DC) and Alternating Current (AC) Type BF equipment, per IEC 601-1 MR conditional per ASTM 2503-05 Nebulizer

Sensor line luer inlets

Ventilator outlet Exhalation valve luer inlet

8

1 Introduction

Location

Label

AC Connector

AC IN 100-240V 50-60Hz 1.6A 2xT3.15AL (250V)

AC Fuses

INLET AIR FILTER

Air Inlet

DO NOT OBSTRUCT

COOLING FAN

Cooling Fan

DO NOT OBSTRUCT

DC IN

Connector

12-15V 8.5A

T15A (250V)

DC Fuse

Device ID

Device Product

Ethernet Connector (not on all units)

External Display Connector

9

High Pressure Oxygen Inlet

Keyboard Connector Power Pack Fuse

T15A (250V)

Power Switch

ON OFF

Remote Alarm Connector

REMOTE ALARM

Serial Communication Connector

RS-232

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