GE iVent 201 Series Assembly instructions

GE Healthcare
iVentTM201
User’s Reference Manual
Revision: 13

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.

I
TABLE OF CONTENTS
1INTRODUCTION.................................................................................................................................................. 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
2SETTING 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

II
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
3OPERATING 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

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

IV
5ADAPTIVE 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
6ALARMS............................................................................................................................................................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

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

VI
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

VII
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

VIII
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

1
1INTRODUCTION
This chapter contains the following sections:
Introduction Page 3
Specifications Page 13
Intended Use Page 25
Use of the iVentTM201 With MRI Page 25

1 Introduction
3
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)
oVolume Controlled A/C
oPressure Controlled A/C
Synchronized Intermittent Mandatory Ventilation (SIMV)
oVolume Controlled SIMV (Vctrl SIMV)
oPressure 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

4
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 Bi-
Level, page 131.

1 Introduction
5
LOOKING AT THE IVENT™201
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
1
2
3
4
5
6
7

6
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
1
2 3
4
5
6
7
8
9
10
11
12
13
14
15
16
17

1 Introduction
7
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

8
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