VersaMed i Vent201 User Manual
iVent
201
Operator’s Manual
iVent
Copyright © 2006 by VersaMed™ Medical Systems, Inc.
Operator’s Manual Part Number OM-01-04
201
Rev: 11 Revised: December 2006
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: +32-2-732-59.54
Fax: +32-2-732-60.03
European Community Sales office:
Bismarckstr.77
46047 Oberhausen
Phone :+491732808345
Fax: +492088823267
iVent201 Operator's Manual
Customer Support
Calling for Help
Owner’s Record
The model number and serial number of your iVent
are on
201
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:
and Service
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 sales@versamed.com.
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: +32-2-732-59.54
Fax: +32-2-732-60.03
Visit our web site at versamed.com
iVent201 Operator's Manual
Table of Contents
1 Introduction ............................................... 1
1.1 How To Use This Manual ...................................................................... 3
1.2 Looking at the iVent
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
............................................................................ 4
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1.11 Waveforms and Diagnostics Packages ............................................... 20
1.12 Intended Use .......................................................................................... 21
1.13 Use of the iVent201 with MRi.............................................................. 22
2 Setting 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 iVent
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 iVent
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
User Interface..................................................................... 54
201
with Heated Humidification (1.4 models
201
3 Operating the iVent
and Parameters........................................... 63
– Setting Modes
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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
4 The 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
5 Adaptive 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
6 Alarms ......................................................... 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
7 Care, 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 FiO2 Setting.......................................................................... 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 O
Adapter and Filter (optional) .................... 251
2
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 Flow
TM
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 Introduction
The iVent
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, wellorganized, 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.
is a compact, portable, fully-featured,
201
The iVent
supports many modes:
201
• 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)
1
Introduction
(Note: Certain modes are optional features and may not be operational in
some iVent
models.)
201
In addition, the iVent
has these advanced features:
201
• 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 iVent
's Adaptive Bi-Level feature
201
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 iVent
is designed to operate according
201
to specifications in any physical orientation –
such as during transport use
2
iVent201 Operator's Manual
1.1 How To Use This Manual
You must read this manual before you use the iVent
201
. 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).
3
Introduction
Exhalation valve luer inlet
Keypad
Ventilator outlet
Display
Nebulizer outlet
1.2 Looking at the iVent
201
Sensor line luer inlets
Figure 1.1 Front View of the iVent
201
Control knob
4
iVent201 Operator's Manual
Cooling
Grounding
probe
connector
connector
On/off
Carrying handle
fan
AC cord
connector
Keyboard
connector
SPO
2
connector
Remote
alarm
pin
DC cord
connector
AC fuses
DC fuse
Internal
battery
handle
Figure 1.2 Rear View of the iVent
201
External
screen
LAN
connector
RS 232
connector
High
pressure
oxygen
inlet
connector
switch
Battery
AC cable clip
pack
screws
(4)
5
1.3 Cautions and Warnings
WARNING: The iVent
not rely solely on the ventilator performance: always
make sure an alternative source of ventilation is
available. Clinical supervision of the patient is
mandatory.
is a life-sustaining device. Do
201
Introduction
CAUTION: The iVent
is a restricted medical device to
201
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 iVent
ventilator to treat
201
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.
6
iVent201 Operator's Manual
CAUTION: Using the iVent
in combination with
201
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 iVent
WARNING: Do not cover the iVent
Make sure that the iVent
is positioned so that its inlet
201
201
.
while it is in use.
201
ports and cooling vents are open to freely circulating air.
CAUTION: The iVent
must not be operated
201
immediately following storage or transport outside the
recommended operation condition
CAUTION: The iVent
internal battery contains lead
201
.
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.
7
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
Introduction
8
iVent201 Operator's Manual
1.5 Performance and Parameters
Ventilation
Component
Respiratory
rate
Inspired Tidal
Volume
Measurement
Exhaled Tidal
Volume
Measurement
Inspiratory
Pressure Limit
Inspiratory
Time
Peak Flow
Unit of
Range
1-12
12-80
50-2000 mL
50-300
300-2000
5 to 80 cmH2O
0.2 to 3 or
Adaptive ITime
up to 120 or
Adaptive
Flow
Measure
bpm
mL
sec.
L/min
±1
±2
±10%
±10 mL or +15%
whichever is greater
+10%
±5
±10%
±10%
Set
Displayed
Y Y 80
Y Y 83
Y Y
N Y 87
Y Y 98
Y Y 91
Page
Peak Flow
(Spontaneous)
Oxygen Mix
(FiO2)
PEEP 0 to 40 cmH2O
Trigger
sensitivity
up to 180 L/min
21 to 100%
1 to 20, off
-0.5 to –20, off
9
L/min
cmH2O
±10%
±5%
±1 or ±10%,
whichever is greater
Y Y 91
Y Y 89
Y Y 95
Y Y 96
Introduction
Ventilation
Component
PSV 0 to 60 cmH2O
Positive
Pressure relief
valve
Controlled
Pressure
FiO2 at power
up
Purging cycle 1, 2, 5, 10, off
Range
80 cmH2O N N
5 to 80 cmH2O
21%, 40%,
60%, 100%
(selectable)
Unit of
Measure
Y Y 234
minute
s
Set
Displayed
±10%
±5
Y Y 141
Y Y 93
Y Y
Page
10
iVent201 Operator's Manual
1.6 Specifications
1.6.1 Monitored Data Range, Resolution and
Accuracy
Parameter Range, resolution, accuracy
Breath type Range: Type: - Control, assist, spontaneous, sigh
Resolution: N/A
Accuracy: N/A
Respiratory
Rate
Exhale tidal
volume
Exhaled Minute
Volume
Peak flow Range: 0 to 140 L/min
Range: 0 to 150/min
Resolution: 1/min
Accuracy: ±1 for 1 to 12/min
±2 for 12 to 150/min
Range: 0 to 5000 mL
Resolution: 1 mL
Accuracy: ±10 mL or ±15% (whichever is greater)
for 0 to 300 mL
±10% for 300 to 5000 mL
Range: 0 to 99.9L
Resolution: 0.1 L
Accuracy: ±10%
Resolution: 1 L/min
Accuracy: ±10%
11
Parameter Range, resolution, accuracy
Introduction
PIP (Peak
Inspiratory
Pressure)
Inspiratory time Range: 0 to 3.0 sec
I:E ratio Range: 1:11 to 3:1
Delivered O2% Range: 21 to 100%
Flow Leak Range: 0 to 100%
Range: 0 to 99 cmH2O
Resolution: 1 cmH2O
Accuracy: ± 2 (+ 5 % of reading) cm H2O
Resolution: 0.1 sec
Accuracy: ±10%
Resolution: 0.1 for 1:1 to 1:5
1 for 1:5 to 1:11 and 3:1 to 1:1
Accuracy: ±0.1
Resolution: 1%
Accuracy: ±5%
Resolution: 1%
Accuracy: ±15%
Mean Airway
Pressure
Resistance
(dynamic)
Compliance
(dynamic)
Range: 0 to 99 cmH2O
Resolution: 1 cmH2O
Accuracy: ± 2 (+ 5 % of reading) cmH2O
Range: 0 to 99.9 cmH2O/L/s
Resolution: 0.1 cmH2O/L/s
Accuracy: ± (2 + 20% of actual value) cmH2O/L/s
Range: 0 to 99.9 ml/cmH2O
Resolution: 0.1 ml/cmH2O
Accuracy: ± (2 +20% of actual value) ml/cmH2O
12
iVent201 Operator's Manual
Parameter Range, resolution, accuracy
RR/Vt-Rapid
Shallow
Breathing Index
(RSBI)
Static
compliance
Auto PEEP Range: 0 to 99 cmH2O
Time Constant Range: 0.0 to 9.9 sec
Range: 0 –200 /min*L
Resolution: 1 /min*L
Accuracy: ± (5 + 20% of actual value). /min*L
Range: 0 to 99 ml/cmH2O
Resolution: 1 ml/cmH2O
Accuracy: ± (2 + 20 % of actual value). ml/cmH2O
Resolution: 1 cmH2O
Accuracy: ± 2 (+ 5 % of reading) cmH2O
Resolution: 0.1 sec
Accuracy: ±20%
1.6.2 Size and Weight
Height: 13” / 33 cm
Width: 9.5” / 24 cm
Depth:
Screen:
Weight 15.4 lb / 7 kg (without battery)
Battery Weight 6.5 lb / 3 kg
Overall Weight 22 lb / 10 kg
10.3” / 26 cm
8.4” / 21.3 cm diagonal
13
1.6.3 Ventilation Modes
• Assist/Control (A/C
• Volume Controlled (A/C)
• Pressure Controlled (A/C)
• Synchronized Intermittent Mandatory
Ventilation (SIMV)
• Volume Controlled SIMV (Vctrl)
• Pressure Controlled SIMV (Pctrl)
• Continuous Positive Airway Pressure (CPAP)
with Pressure Support Ventilation (PSV)
Note: Certain modes are not operational in all
iVent
models.
201
1.6.4 Environmental Specifications
Introduction
Operating Temperature -15 to +50 °C / +5 to +122 °F
Storage Temperature
Relative Humidity 15 to 95% @ 30 °C / 86 °F
Water and Dust
Resistance
Atmospheric Pressure 430 - 825 mmHg (up to 15,000 feet)
Vibration IEC 68-2-6, IEC 68-2-34
without battery: -15 to +70 °C / +5 to +158
°F
with battery: -15 to +30 °C / +5 to +86 °F
IP-54 (Splash proof)
MIL-STD-810E
14
iVent201 Operator's Manual
Shock IEC 68-2-27 (100 g)
MIL-STD-810E
Total External Sound
Level
40 – 45 dBa at one meter
1.6.5 Power Supply
External AC 100 to 240 V, 50-60 Hz, max 1.6 A.
External DC
Battery
Internal Battery Sealed Lead-Acid, 12 V 8 Ah (rechargeable)
Recharge Time Over 8 hours, <1 Ampere
Operating Time
(internal battery)
12 to 15 V max 8.5 A.
Up to 2 hours (varies with ventilation
parameters)
1.6.6 O2 Supply Specifications
Pressure Range 40-60 psi (2.8-4.2 bar)
Minimum flow 120L/min at 40 psi (2.8 bar)
15
Introduction
1.6.7 Ventilation Performance and Controlled
Parameters
Respiratory Rate 1 – 12 ±1, 12 – 80 ± 2 bpm
Tidal Volume 50-2000 mL
Accuracy of Tidal
Volume Delivery
Accuracy of Respiratory
Volume Measurement
Inspiratory Pressure
Limit
Inspiratory Time Adaptive Time
Peak Flow (PIF)
Oxygen Mix (FiO2 ) 21% to 100% ±5% O2
PEEP
Trigger Sensitivity
PSV 0 to 60 ±10% cmH2O
Positive Pressure Relief
Valve
Controlled Pressure 5 to 80 cm ±5 cm
±10% or ±10 mL whichever is greater
±15% above 100 mL from actual reading
or ±10 cc below 100 mL
5 to 80 ±5 cmH2O
TM
or 0.2 to 3 ±10% sec
Adaptive Flow
Spontaneous to 140 ±10% L/min
0 to 40 ±1 cmH2O or ±10%, whichever is
greater
1 to 20 L/min Flow, Off
- 0.5 to – 20 cmH2O Pressure, Off
80 cmH2O
TM
or to 120 ±10% L/min
FiO2 at Power up 21%, 40%, 60%, 100% (configurable)
Purging Cycle 1, 2, 5, 10 minutes, Off (configurable)
16
iVent201 Operator's Manual
1.7 Standards and Safety Requirements
The iVent
ISO 10651-1
ISO 10651-2
ISO 10651-3
ASTM F1100-90
IEC 60601-1
IEC 60601-1-2
IEC 60601-2-12
UL 60601-1
ASTM F1246-96
meets or exceeds the following international standards:
201
Lung Ventilators for medical use
Particular requirements for Home Care Ventilators
Requirements for Emergency and Transport
Ventilators
Standard Specifications for Ventilators intended
for use in Critical Care
Electrical Safety
Electromagnetic Compatibility (EMC)
Medical Electrical Equipment – Particular
Requirements for the Safety of Lung Ventilators Critical Care Ventilators
Medical Electrical Equipment, part1: General
Requirements for Safety
Standard Specification for Electrically Powered
Home Care Ventilation.
1.8 Displayed Parameters
The following table presents the displayed parameters and indicates
whether the displayed values are set, measured or both.
Parameter
Exhaled Tidal Volume (VT) mL + +
Rate bpm + +
Ventilation Mode + +
17
Unit of
Measure
Set
Displayed
Introduction
Parameter
Oxygen Concentration
Inspiration to Expiration time ratio I:E ratio +
Inspiratory Time (I
Sensitivity Values (Triggers): Pressure and
Flow
Pressure Support Ventilation (PSV) cmH2O +
Alarm Pressure / Limit Pressure cmH2O + +
Positive End Expiratory Pressure (PEEP) cmH2O + +
Exhaled Minute Volume L +
Peak Inspiratory Pressure cmH2O +
Pressure/Flow Wave Forms +
Electrical Power Source (Ext./Int.) +
In Adaptive Bi-Level Mode:
P High (Ins Pressure) cmH2O + +
) sec + +
time
Unit of
Measure
FiO
2
cmH2O/LPM + +
Set
+ +
Displayed
P Low (Exp. Pressure) cmH2O + +
Tidal Volume (estimated) mL +
Leak (estimated) LPM +
Rise Time Setting +
Non-Displayed Additional Parameters
Sigh Breath Setting +
Purge Cycle Setting +
18
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