iVent201E User’s Reference Manual Rev 2 June 2011

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iVe n t 2 0 1 E User’s Reference Manual

iVent201E User’s Reference Manual GE Part Number M1225570 Rev: 2 Revised June, 2011

GE Healthcare

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Calling for Help Owner’s Record TM

The model number and serial number of your iVent 201E 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

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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.

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TABLE OF CONTENTS 1

INTRODUCTION ...1 Introduction ...3 How to Use This Manual ...4 Looking at the iVent™201E...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 ...24 Intended Use ...25 Use of the iVentTM201E With MRI...25 MRI Conditional Tests Specifications...29

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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 Dual Limb Patient Circuit...41 Circuit Resistance...43

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Other Connections...43

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HME...43 MDI...43 Using the iVentTM201E with heated humidification (1.4 Stepper Based models only) ...44 PneUmaTIC Nebulizer ...45 Pulse Oximeter...46 Sensor Line Maintenance ...48 Patient Connection ...48 Filters...49 Air Inlet Filter ...49 Bacterial Filter ...49 The iVentTM201E User Interface...50 Controls and Power Up...50 The Front Panel...50 Silence...50 Manual Breath ...51 Hold...51 Clear ...51 LED Indicators ...51 The Screen...52

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OPERATING THE IVENTTM201E – SETTING MODES AND PARAMETERS ...55 Introduction ...57 Operation of the iVentTM201E ...57 Power Up and Weight Selection ...57 O.V.T...58 Standby and Patient Ventilation...59 Changing Ventilation Mode...60 Common Parameters ...62 Changing Ventilation Paramters – Overview...63 The Selection Interface...64 Adjusting the Breath Rate...65 Adjusting the Tidal Volume...67 Breath Types ...68

Adjusting Pressure ...69 Adjusting FiO2...71 Adjusting Peak Flow ...72 Adjusting Pressure Support Ventelation...74 Adjusting PEEP ...76 Adjusting Trigger Sensitivity...77 Adjusting Inspiratory Time...78

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Adjusting Rise Time...80

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Adjusting Flow Termination (Esens)...82 4

THE MAIN MENU ...85 Introduction ...87 Navigating the Main Menu ...87 Alarm Settings ...88 Advanced Settings...89 Sigh Breath ...89 Easy Exhale™...91 Oxygen Supply...92 High Option...93 Alarm Messages ...94 Low + Monitoring Option ...95 Low Option ...95 None Option ...96

Adaptive Peak Flow ...96 Humidifier Setting...97 Pulse Oximetry...98 Pneumatic Nebulizer ... 100 Set Time and Date... 101 Restore Default Settings ... 103 Default parameters Settings ... 104 Show Graphs... 106 Browse Waveforms ... 107 Select Range ... 108 Show Trends ... 110 Selecting Trends To Display... 112 Browsing Trends ... 113 Show Loops ... 115 Show Mechanics ... 118 Pulse Oximetry Screen ... 119 Pulse Oximetery Alarms... 121 Show Log Book ... 121 Display ... 122 O.V.T... 125 Maintenance... 125 5

ADAPTIVE BI-LEVEL ... 127 Introduction ... 129 About Adaptive Bi-Level ... 129

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Guide to Adaptive Bi-Level ... 129

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Indications and Warnings ... 130 Indications ... 130 Warnings ... 130 Setup... 130 Adaptive Bi-Level Alarm Settings ... 132 Other Alarm Options ... 132 Adjusting Adaptive Bi-Level Parameters ... 132 Adaptive Bi-Level Window ... 133 Easy Exhale ... 135 Optimizing the Patient Ventilator Interface ... 135 Resolving Patient Ventilator Dysynchrony... 135 Excessive Ventilation ... 135 Excessive Leak... 135 Non-Triggered Breaths (Inspiratory Trigger Failure)... 136 Excessive Triggering (auto cycling):... 136 I:E Cycling Dysynchrony ... 136 Premature I:E Cycling ... 136 6

ALARMS... 139 Introduction ... 141 How Alarms Work ... 141 Responding to an Alarm ... 141 Alarm settings ... 142 Changing Individual Alarm Settings ... 143 Setting the Respiratory Rate Alarm... 144 Setting the Minute Volume Alarm ... 145 Setting the Pressure Alarm ... 146 Setting the Apnea Time Alarm ... 146 Setting the FiO2 Alarm ... 147 Setting the Leak Alarm ... 148

Auto Settings ... 149 Alarm Options... 150 Setting the Alarm Volume... 151 Setting the Inverse I:E Ratio Alarm ... 151 Setting the Tidal Volume Not Delivered Alarm... 152 Disabling or Enabling the Patient Circuit Disconnect Alarm... 153

Guide to Alarm Definitions and Priorities ... 155 Alarms Test... 164 The Sensor Failure Alarm... 165 Patient Disconnect Alarm ... 166

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Patient Circuit Failed Alarm ... 167

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CARE, MAINTENANCE AND TESTS... 169 Introduction ... 171 Cleaning and Maintenance... 171 Cleaning the Ventilator... 172 Planned Maintenance ... 172 Storage Planned Maintenance ... 174 The O.V.T... 174 The Maintenance Screen... 174 Calibration ... 174 O2 Calibration ... 175

Ventilator Verification tests... 177 Required Equipment and Supplies: ... 178 Starting the VVT... 179 The Alarm Sound Test ... 179 Pressure Tests... 180 Flow Tests... 180 O2 Tests ... 180 Battery Test ... 181 Watchdog Timer Tests ... 181 VVT Completion ... 181

Configuration Screen... 182 Choosing a Different Startup Screen ... 182 Setting the Startup Weight... 183 Default FiO2 Setting ... 183 Service Functions ... 183 Communication Port... 184 Communication Rate... 184 Localization ... 184 Total Operating Hours ... 186 APPENDIX A: GLOSSARY ... 189 APPENDIX B: WARRANTY ... 197 Warranty... 199 APPENDIX C: OPERATING THEORY... 201 Operating Theory ... 203 Theory ... 203 Ambient Air Filter... 203 CBRN Filter (optional)... 203 Low Pressure O2 Adapter and Filter (optional) ... 203

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Air/Oxygen Blending System ... 203

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Inlet Manifold ... 203 Turbine Unit... 204 Turbine Pressure Sensor ... 204 Turbine Valves... 204 Over Pressure Relief Valve... 204 Airway Flow and Pressure Sensors ... 204 Pressure Switch ... 204 Inlet and Outlet Mufflers ... 204 APPENDIX D: THEORY OF BREATH DELIVERY ... 209 Breath Delivery... 211 Patient Triggering... 211 Breath Types... 212 Adaptive Flow and Adaptive I-Time... 213 Mandatory Volume Control Breath... 214 Pressure Control Breath... 215 Manual Mandatory Breath ... 216 Patient Pressure Support Breath... 216 Patient Spontaneous Breath ... 217 Summary ... 218 APPENDIX E: VENTILATION MODES ... 221 Assist/Control Mode... 223 Definition... 223 Available Breath Types ... 223 Description... 223 Parameters Setting... 224 Synchronized Intermittent Mandatory Ventilation Mode ... 224 Definition... 224 Available Breath Types ... 224 Description... 225 Parameters Setting... 225 Continuous Positive Airway Pressure Mode... 226 Definition ... 226 Available Breath Types... 226 Description... 226

Parameters Setting... 226 Apnea Back-Up Ventilation... 227 Open Loop Mode ... 227

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Adaptive Bi-Level Mode ... 228 APPENDIX F: HOLD FUNCTION AND STATIC MECHANICS MEASUREMENTS... 231

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Front Panel Controls... 233 Static Compliance Measurements ... 233 Static Compliance ... 233 Respiratory Time Constant ... 234 Performing a Static Respiratory Mechanics Measurement ... 234 Clinical Considerations... 235 End Expiratory Hold ... 235 Performing and End Expiratory Hold Maneuver... 236 Reviewing Static Mechanics and Intrinsic PEEP Measurements... 236 RR/Vt Ratio ... 236 APPENDIX G: ACCESSORIES... 239 Disposable Breathing Circuit... 241 Instructions for Use... 241 Instructions for Use With a Pneumatic Nebulizer ... 242

Dual Limb Patient Circuit Adapter... 243 Kit Contents... 243 Phthalates... 243 Transport Mounting Panel ... 244 Kit Contents... 244 Installation ... 244 Installation ... 245 Installing the Exhalation Valve... 245 Installing the Patient Circuit ... 246

Extended Battery... 248 To replace the battery: ... 248 Specifications... 250 Instructions for Use ... 250 Instructions for Use With the Humidifier ... 251 Support Arm for Breathing Circuit... 252 connecting the Patient circuit to the Support Arm... 252 Roll Stand ... 253 Mounting the iVentTM201E On The Roll Stand ... 253 Dismounting the iVentTM201E From The Roll Stand... 253 Connecting the optional Battery Holder Accessory P/N: M1162050... 254 APPENDIX I: PART NUMBERS AND ACCESSORIES ... 257

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INDEX ... 261

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1 INTRODUCTION

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This chapter contains the following sections: Introduction

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Specifications

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Intended Use

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Use of the iVentTM201E With MRI

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1 Introduction

INTRODUCTION TM

The iVent 201E 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, quickchoice 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. TM

The iVent 201E 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 TM iVent 201E models

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In addition, the iVent™201E 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™201E 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™201E 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™201E 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™201E 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™201E 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.

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For more information about the Adaptive Bi-Level feature see About Adaptive BiLevel, page 129.

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1 Introduction

LOOKING AT THE IVENT™201E

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2

5

3

6

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Figure 1: Front View of the iVent™201E

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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

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1 2

3

17 4 16 5 15

6

14

7 8

13 9 12

10

11

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

Description

1

Carrying handle

2

Keyboard connector

3

Remote alarm connector

4

External screen connector

5

LAN connector*

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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)

6

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High pressure oxygen inlet connector

10

4 x Battery pack screws

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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

TM

The iVent 201E 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. TM

Using the iVent 201E 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 TM resistance to the airflow provided by the iVent 201E. TM

The iVent 201E must not be operated immediately following storage or transport outside the recommended operation condition TM

The iVent 201E 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 606011. The factory default setting for Leak Alarm is set to Off. Users must manually set the leak alarm to enable it.

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WARNING

TM

The iVent 201E is a life-sustaining device. Do not rely solely on the

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ventilator performance: always make sure an alternative source of ventilation is available. Clinical supervision of the patient is mandatory. Qualified medical personnel should visually monitor patients on lifesupport 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 iVent TM201E while it is in use. Make sure that the iVent TM201E 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

Manufacturer

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EC Representative

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1 Introduction

Location AC Connector

Label

AC IN 100-240V 50-60Hz 1.6A

2xT3.15AL (250V)

AC Fuses

Air Inlet

INLET AIR FILTER DO NOT OBSTRUCT

Cooling Fan

COOLING FAN DO NOT OBSTRUCT

Connector

DC IN 12-15V 8.5A

DC Fuse

T15A (250V)

Device ID

Device Product

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Ethernet Connector (not on all units)

External Display Connector

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