VersaMed iVent201 User manual

iVent201
Operator’s Manual
iVent201 Operator’s Manual Part Number OM-01-04
Rev: 11 Revised: December 2006
Copyright © 2006 by VersaMed™ Medical Systems, Inc.
0473

iVent201 Operator's Manual
Manufacturer’s Address
P.O. Box 1512, Blue Hill Plaza, Pearl River, New York 10965 USA.
Authorized Representative in the European Community for regulatory affairs
Obelis S.A.
Av. de Tervuren 34, bte 44
B-1040 Brussels
Belgium
Tel: [phone]
Fax: [phone]
European Community Sales office:
Bismarckstr.77
46047 Oberhausen
Phone :[phone]
Fax: [phone]

iVent201 Operator's Manual
Calling for Help
Owner’s Record
The model number and serial number of your iVent201 are on
the rear panel of your ventilator. Record the serial number in
the space provided below to have this information should you
need to call for service or support.
Model Number:
Serial Number:
If you have a ventilator problem you cannot solve and you purchased your
ventilator directly from VersaMed, call:
800-475-9239 - Customer Care and Service Assistance Line
NOTE: If this ventilator has not been purchased directly from
VersaMed, please ensure that it has been purchased from an authorized
distributor of VersaMed. To obtain a list of authorized distributors
contact VersaMed at [e-mail].
If you have a ventilator problem that you cannot solve and you purchased
your ventilator from an authorized VersaMed distributor, please contact
your distributor directly to report the problem.
Manufacturer’s Address
P.O. Box 1512, Blue Hill Plaza, Pearl River, New York 10965 USA.
Authorized Representative in the European Community
Obelis S.A.
Av .de Tervuren 34, bte 44
B-1040 Brussels
Belgium
Tel: [phone]
Fax: [phone]
Visit our web site at versamed.com
Customer Support
and Service

iVent201 Operator's Manual
Table of Contents
1Introduction ............................................... 1
1.1 How To Use This Manual ...................................................................... 3
1.2 Looking at the iVent201............................................................................ 4
1.3 Cautions and Warnings .......................................................................... 6
1.4 Symbols and Labels ................................................................................ 8
1.5 Performance and Parameters ................................................................. 9
1.6 Specifications........................................................................................... 11
1.6.1 Monitored Data Range, Resolution and Accuracy ........................ 11
1.6.2 Size and Weight................................................................................ 13
1.6.3 Ventilation Modes ............................................................................ 14
1.6.4 Environmental Specifications.......................................................... 14
1.6.5 Power Supply.................................................................................... 15
1.6.6 O2 Supply Specifications ................................................................. 15
1.6.7 Ventilation Performance and Controlled Parameters ................... 16
1.7 Standards and Safety Requirements..................................................... 17
1.8 Displayed Parameters ............................................................................. 17
1.9 User Adjustable Alarms ......................................................................... 19
1.10 Additional Alarms................................................................................. 19
1.11 Waveforms and Diagnostics Packages ............................................... 20
1.12 Intended Use .......................................................................................... 21
1.13 Use of the iVent201 with MRi.............................................................. 22
2Setting Up................................................... 27
2.1 Power Connection ................................................................................... 28

iVent201 Operator's Manual
2.1.1 External power.................................................................................. 28
2.1.2 Internal Battery ................................................................................. 31
2.2 Oxygen Supply ........................................................................................ 36
2.2.1 High Pressure Oxygen Supply ........................................................ 36
2.2.2 Low Pressure Oxygen Supply ......................................................... 38
2.3 Breathing Circuit ..................................................................................... 39
2.3.1 Circuit Resistance.............................................................................. 42
2.4 Other Connections................................................................................... 43
2.4.1 HME................................................................................................... 43
2.4.2 MDI .................................................................................................... 43
2.4.3 Using the iVent201 with Heated Humidification (1.4 models
only) ................................................................................................... 43
2.4.4 Synchronized Nebulizer Device...................................................... 46
2.4.5 Pulse Oximeter.................................................................................. 47
2.4.6 Sensor Line Maintenance ................................................................. 50
2.5 Patient Connection .................................................................................. 50
2.6 Filters......................................................................................................... 51
2.6.1 Air Inlet Filter.................................................................................... 51
2.6.2 Bacterial Filter ................................................................................... 51
2.6.3 Chemical, Biological, Radiological, and Nuclear Filter ................. 52
2.7 Operational Case ..................................................................................... 53
2.8 The iVent201 User Interface..................................................................... 54
2.9 Controls and Powering Up..................................................................... 55
2.9.1 The Front Panel................................................................................. 55
2.9.2 LED Indicators .................................................................................. 58
2.9.3 The Screen ......................................................................................... 59
3Operating the iVent201 – Setting Modes
and Parameters...........................................63

iVent201 Operator's Manual
3.1 Operation.................................................................................................. 63
3.1.1 Power Up and Weight Selection ..................................................... 63
3.1.2 O.V.T.................................................................................................. 65
3.1.3 Standby and Patient Ventilation ..................................................... 69
3.1.4 Changing Ventilation Mode ............................................................ 69
3.1.5 Changing Ventilation Parameters - Overview............................... 74
3.2 Common Parameters ............................................................................... 78
3.3 The Selection Interface ........................................................................... 79
3.3.1 Adjusting Breath Rate ...................................................................... 80
3.3.2 Adjusting Tidal Volume .................................................................. 83
3.3.3 Adjusting Pressure Limits in Volume Control Ventilation
Modes ................................................................................................ 87
3.3.4 Adjusting FiO2.................................................................................. 89
3.3.5 Adjusting Peak Flow ........................................................................ 91
3.3.6 Adjusting Pressure Support Ventilation......................................... 93
3.3.7 Adjusting PEEP................................................................................. 95
3.3.8 Adjusting Trigger Sensitivity .......................................................... 96
3.3.9 Adjusting Inspiratory Time ............................................................. 98
4The Main Menu......................................... 101
4.1 Navigating the Main Menu.................................................................... 102
4.2 Alarm Settings ......................................................................................... 103
4.2.1 Changing Individual Alarm Settings.............................................. 103
4.2.2 Auto Settings..................................................................................... 117
4.2.3 Alarm Options .................................................................................. 118
4.3 Advanced Settings................................................................................... 125
4.3.1 Sigh Breath ........................................................................................ 127
4.3.2 Rise Time........................................................................................... 128
4.3.3 Easy Exhale™.................................................................................... 130

iVent201 Operator's Manual
4.3.4 Oxygen Supply ................................................................................. 132
4.3.5 Adaptive Peak Flow ......................................................................... 140
4.3.6 Set Purge Interval ............................................................................. 141
4.3.7 Pulse Oximetery................................................................................ 143
4.3.8 Synchronized Nebulizer................................................................... 148
4.3.9 Set Time and Date............................................................................. 150
4.4 Restore Default Settings......................................................................... 153
4.4.1 To Restore Defaults:.......................................................................... 153
4.5 Show Graphs............................................................................................ 157
4.5.1 Browse Waveforms........................................................................... 158
4.5.2 Select Range....................................................................................... 160
4.6 Show Trends............................................................................................. 163
4.6.1 Selecting Trends To Display ............................................................ 166
4.6.2 Browsing Trends............................................................................... 168
4.7 Show Loops .............................................................................................. 170
4.8 Show Mechanics ...................................................................................... 173
4.9 Show Log Book ........................................................................................ 174
4.10 Display .................................................................................................... 175
4.11 O.V.T. ...................................................................................................... 178
4.12 Maintenance ........................................................................................... 178
5Adaptive Bi-Level......................................179
5.1 About Adaptive Bi-Level........................................................................ 179
5.2 Guide to Adaptive Bi-Level.................................................................... 180
5.3 Indications and Warning ........................................................................ 181
5.3.1 Indications......................................................................................... 181
5.4 Setup.......................................................................................................... 181
5.4.1 Adaptive Bi-Level Alarm Settings................................................... 183
5.4.2 Other Alarm Options........................................................................ 184

iVent201 Operator's Manual
5.5 Adjusting Adaptive Bi-Level Parameters............................................. 186
5.6 Adaptive Bi-Level Window.................................................................... 187
5.7 Easy Exhale™........................................................................................... 188
5.8 Optimizing the Patient Ventilator Interface........................................ 189
5.9 Resolving Patient Ventilator Dysynchrony ......................................... 189
6Alarms......................................................... 193
6.1 How Alarms Work................................................................................... 193
6.1.1 Responding to an Alarm.................................................................. 194
6.1.2 Alarm settings................................................................................... 196
6.2 Guide to Alarm Definitions and Priorities .......................................... 199
6.3 Alarms Tests............................................................................................. 209
6.4 The Sensor Failure Alarm....................................................................... 215
6.5 Patient Disconnect Alarm....................................................................... 218
6.6 Patient Circuit Failed Alarm .................................................................. 219
7Care, Maintenance, and Tests................. 221
7.1 Cleaning and Maintenance .................................................................... 221
7.2 Preventive Maintenance......................................................................... 222
7.3 The O.V.T. ................................................................................................ 223
7.4 The Maintenance Screen ........................................................................ 224
7.4.1 Calibration......................................................................................... 224
7.4.2 Ventilator Verification Tests............................................................ 224
7.5 Configuration Screen.............................................................................. 232
7.5.1 Choosing a different Startup Screen ............................................... 232
7.5.2 Setting the startup weight................................................................ 233
7.5.3 Default FiO2Setting.......................................................................... 234
7.6 VersaMed Service Functions ................................................................. 234
7.7 Communication Rate .............................................................................. 235

iVent201 Operator's Manual
7.8 Localization .............................................................................................. 235
7.9 Total Operating Hours............................................................................ 238
Appendix A : Glossary.....................................239
Appendix B : Warranty ....................................247
Appendix C : Operating Theory .................... 251
C.1 Ambient Air Filter............................................................................ 251
C.2 CBRN Filter (optional) ................................................................... 251
C.3 Low Pressure O2Adapter and Filter (optional) .................... 251
C.4 Air/Oxygen Blending System...................................................... 251
C.5 Inlet Manifold.................................................................................... 251
C.6 Turbine Unit....................................................................................... 252
C.7 Turbine Pressure Sensor................................................................ 252
C.8 Turbine Valves .................................................................................. 252
C.9 Over Pressure Relief Valve........................................................... 252
C.10 Airway Flow and Pressure Sensors......................................... 252
C.11 Pressure Switch............................................................................... 252
C.12 Inlet and Outlet Mufflers............................................................ 252
Appendix D : Theory of Breath Delivery.....255
D.1 Breath Delivery....................................................................................... 255
D.2 Patient Triggering .................................................................................. 256
D.3 Breath Types ........................................................................................... 258
D.3.1 Adaptive FlowTM and Adaptive I-Time™...................................... 259
D.3.2 Mandatory Volume Control Breath................................................ 262
D.3.3 Pressure Control Breath................................................................... 263

iVent201 Operator's Manual
D.3.4 Manual Mandatory Breath.............................................................. 264
D.3.5 Patient Pressure Support Breath..................................................... 265
D.3.6 Patient Spontaneous Breath ............................................................ 266
D.4 Summary ................................................................................................. 267
Appendix E : Ventilation Modes................... 269
E.1 Assist/Control Mode............................................................................... 269
E.1.1 Definition........................................................................................... 269
E.1.2 Available Breath Types .................................................................... 269
E.1.3 Description ........................................................................................ 269
E.1.4 Parameters Setting............................................................................ 270
E.2 Synchronized Intermittent Mandatory Ventilation Mode................ 271
E.2.1 Definition........................................................................................... 271
E.2.2 Available Breath Types .................................................................... 271
E.2.3 Description ........................................................................................ 272
E.2.4 Parameters Setting............................................................................ 273
E.3 Continuous Positive Airway Pressure Mode ...................................... 273
E.3.1 Definition........................................................................................... 273
E.3.2 Available Breath Types .................................................................... 273
E.3.3 Description ........................................................................................ 273
E.3.4 Parameters Setting............................................................................ 274
E.4 Apnea Back-Up Ventilation................................................................... 275
E.5 Open Loop Mode .................................................................................... 276
E.6 Adaptive Bi-Level Mode........................................................................ 276
Appendix F : Hold Function and Static
Mechanics Measurements ....................... 277
F.1 Front Panel Controls ............................................................................... 277
F.2 Static Compliance Measurements......................................................... 278

iVent201 Operator's Manual
F.2.1 Static Compliance.............................................................................. 278
F.2.2 Respiratory Time Constant ............................................................. 279
F.2.3 Performing a Static Respiratory Mechanics Measurement ........... 279
F.2.3.1 Table - Maximum Inspiratory Hold Time for Different Tidal
Volumes:............................................................................................ 281
F.2.3.2 Table - Maximum Expiratory Hold Time for Different Tidal
Volumes............................................................................................. 281
F.2.4 Clinical Considerations..................................................................... 282
F.3 End Expiratory Hold ............................................................................... 282
F.3.1 Performing and End Expiratory Hold Maneuver .......................... 283
F.3.2 Reviewing Static Mechanics and Intrinsic PEEP Measurements.. 284
F.4 RR/Vt Ratio ............................................................................................. 285
Appendix G : Part Numbers and
Accessories.................................................. 287
Appendix H : Index .......................................... 291

iVent201 Operator's Manual
1
1Introduction
The iVent201 is a compact, portable, fully-featured,
microprocessor-controlled ventilator offering the versatility and
capability of larger and costlier 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 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 full array
of graphical and numerical modes.
The iVent201 supports many modes:
• Assist/Control
• Volume Controlled A/C
• Pressure Controlled A/C
• Synchronized Intermittent Mandatory
Ventilation (SIMV)
• Volume Controlled SIMV (Vctrl SIMV)
• Pressure Controlled SIMV (Pctrl
SIMV)
• Continuous Positive Airway Pressure (CPAP)
• Pressure Support Ventilation (PSV)

Introduction
2
(Note: Certain modes are optional features and may not be operational in
some iVent201 models.)
In addition, the iVent201 has these advanced features:
• Rise time is adjustable
• Preset Parameters by Patient Weight enables
quick setup
• Adaptive Peak Flowcan determine and
deliver Inspiratory Peak Flow Rate according
to a target mandatory tidal volume,
maintaining a 1:2 I:E ratio
• Adaptive I-Timeallows the ventilator to
determine and deliver a respiratory cycle time
to sustain a 1:2 I:E ratio
• The iVent201's Adaptive Bi-Level feature
enables leak-tolerance for facemask
ventilation or other specialized high-leak tube
ventilation
• Easy Exhaleis an advanced PEEP mode
designed to reduce expiratory work of
breathing
• Firmware is upgradeable via a PC connection
• The iVent201 is designed to operate according
to specifications in any physical orientation –
such as during transport use

iVent201 Operator's Manual
3
1.1 How To Use This Manual
You must read this manual before you use the iVent201. In
particular, the first several sections are critical for an
understanding of the iVent. This manual is primarily
organized according to the available screens, menus, options
and settings and begins with a look at the hardware, including
power considerations and patient circuit setup.
Study them with the iVent close at hand, 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
Just about every function or operation of the iVent is accessible
through one of these screens. Be aware of the notes, warnings,
and cautions, generally marked in bold print.
⇒ Useful user tips are in bold and set off with an arrow.
Refer to the index if you need information. Table 1.1 may also
be used as a general guide.
If you are not familiar with Adaptive Bi-Level feature, read
Section 0 5 (page 179).

Introduction
4
Control knob
Exhalation valve luer inlet
1.2 Looking at the iVent201
Figure 1.1 Front View of the iVent201
Keypad
Ventilator outlet
Sensor line luer inlets
Display
Nebulizer outlet

iVent201 Operator's Manual
5
Cooling
fan
AC cord
connector
Grounding
pin
DC cord
connector
DC fuse
AC fuses
Internal
battery
handle
SPO2
probe
connector
(optional)
Keyboard
connector
Remote
alarm
connector
External
screen
connector
RS 232
connector
High
pressure
oxygen
inlet
connector
On/off
switch
AC cable clip
Battery
pack
screws
(4)
Figure 1.2 Rear View of the iVent201
LAN
connector
Carrying handle

Introduction
6
1.3 Cautions and Warnings
WARNING: The iVent201 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
mandatory.
CAUTION: The iVent201 is a restricted medical device to
be operated by qualified medical personnel under the
direction of a qualified medical practitioner.
WARNING: Qualified medical personnel should
visually monitor patients on life-support ventilation.
Life-threatening conditions may arise that might not
activate alarms.
CAUTION: 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.
WARNING: Do not use the iVent201 ventilator to treat
infants weighing less than 10 kg/ 22 lb.
CAUTION: The factory default setting for “Leak Alarm”
is set to ”off.” Users must manually set the leak alarm to
enable it.
WARNING: To prevent explosion hazard, do not use the
ventilator in the presence of flammable anaesthetics.

iVent201 Operator's Manual
7
CAUTION: Using the iVent201 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 iVent201.
WARNING: Do not cover the iVent201 while it is in use.
Make sure that the iVent201 is positioned so that its inlet
ports and cooling vents are open to freely circulating air.
CAUTION: The iVent201 must not be operated
immediately following storage or transport outside the
recommended operation condition.
CAUTION: The iVent201 internal battery contains lead
and must be disposed of in accordance with local
ordinances and environmental regulations.
CAUTION: Do not connect the O2 supply when
equipment is not in use.

Introduction
8
1.4 Symbols and Labels
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