Ivent101 Operator'S Manual

iVent101
Operator’s Manual
iVent101 Operator’s Manual

VersaMed Part Number OM-101-02
GE Part Number M1162065
Rev: 1
Revised June 2009 /
Copyright© 2007 by VersaMed™ Medical Systems
Owner’s Record
The model number and serial number of your iVent101 are on the back 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:
Manufacturer’s Address
VersaMed Medical Systems, Hasharon Industrial Park, Ornat Building, Kadima Israel.
P.O.B 5011, Kadima 60920, Israel
Tel: (972) 9 891 54000
Fax: (972) 9 899 7776
EC REP
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
Table of Contents
Chapter 1: Introduction 1
1.1. Overview 1
1.2. How to use this manual 2
1.3. Cautions and Warnings 4
1.4. Intended Use 7
1.5. Contraindications 7
1.6. The iVent101 Ventilator 8
1.7. iVent101 Indicator Lights 11
1.8. Symbols and Labels 11
1.8.1. Front Panel Labeling 12
1.8.2. Back Panel Labeling – Connectors 13
1.8.3. Filter Side 14
1.8.4. Nameplate 15
1.9. Ventilator Specifications 16
1.9.1. Size and Weight 16
1.9.2. Environmental Specifications 16
1.9.3. Power Supply 17
1.9.4. Ventilation Modes 17
1.9.5. O2 Supply 18
1.9.6. Inspiratory and Expiratory Resistance 18
1.9.7. Ventilation Setting and Measured Value Parameters 18
1.9.8. Default Settings 20
1.9.9. Additional Displayed Parameters 20
1.9.10. Displayed Waveforms 21
1.9.11. iVent101 Ventilator Alarms 21
1.9.12. User Adjustable Alarms 21
1.9.13. Non-Adjustable Alarms 21
1.9.14. Accessories 22
1.9.15. Software Open Source Information 23
1.10. Standards and Safety Requirements 23
Chapter 2: Setting Up 25
2.1. Understanding The Ventilator Power Sources 25
2.1.1. Integrated Battery 27
2.2. Patient Circuit 27
2.2.1. Circuit Accessories 30
2.3. Attaching Air Inlet Filter 31
2.4. Choosing a Location for the Ventilator 32
2.5. Connecting the Ventilator to an Oxygen Source 33
2.6. Connecting the Ventilator to an AC Power Source 35
2.7. Powering up the Ventilator 36
2.8. Shutting Down the Ventilator 38
Chapter 3: Main Screens 39

3.1. View Options 39
3.2. Basic View and Basic Night View Main Screens 41
3.3. Clinical View Main Screen 43
Chapter 4: Operating the Ventilator 47

4.1. Menu Options 48
4.2. Setting the Ventilation Parameters 49
4.2.1. Setting Default Settings for a New Patient 50
4.2.2. Setting Ventilation Modes 51
4.2.3. Modifying the Parameters 54
4.3. Starting and Stopping Ventilation 61
4.3.1. Manual Breath 62
4.4. Initiating and Releasing the Screen Lock 63
4.5. The Information Screen 64
4.6. General Configuration 65
4.6.1. Setting the Time and Date 66
4.6.2. Setting the Sound Levels 67
4.6.3. Setting the Screen lock and Screen Save 68
4.6.4. Enabling the O2 sensor 69
4.6.5. Setting the Screen Brightness 70
4.7. Changing to Graph Tab 72
Chapter 5: Alarms 73
5.1. Alarm Priorities 73
5.2. Setting the Alarm Parameters 74
5.2.1. Setting the Alarm Volume 78
5.3. The Alarm Display Screen 78
5.4. Alarm Definition and Troubleshooting 81
5.5. Alarm Tests 91
5.6. The Log Book 92
Chapter 6: Maintenance 95
6.1. Cleaning and Maintenance Procedures 95
6.1.1. Cleaning Procedures 95
6.1.2. Preventive Maintenance 96
6.1.3. Preventive Maintenance Service Parts 97
6.1.4. Cleaning the ventilator 98
6.1.5. Exhalation Valve Maintenance 98
6.1.6. Integrated Battery Maintenance 102
6.2. Ventilation Circuit Test 104
6.3. Service Screens 106
Chapter 7: Troubleshooting 107

C.1. Default Apnea Settings 126
E.1. Patient Triggering 132
E.2. Breath Styles 133
E.2.1. Mandatory Breaths Types 133
E.2.2. Spontaneous Breath Types 138
E.2.3. Breath types – Summary 139
TM TM
E.2.4. Adaptive Peak Flow and Adaptive I -Time 141
F.1. Assist/Control Mode 143
F.2. SIMV Mode 145
F.3. Continuous Positive Airway Pressure Mode (CPAP) 148
F.4. Adaptive Bi-Level 149
F.5. Easy ExhaleTM 150
F.6. Apnea Backup Mode 151
F.7. Emergency Backup Mode 151
F.8. Resolving Dysynchrony 151
F.8.1. Excessive Ventilation 152
F.8.2. Excessive Leak 152
F.8.3. Non Triggered Breaths (Inspiratory Trigger Failure) 152
F.8.4. Excessive Triggering (Auto Cycling) 153
F.8.5. Cycling Dysynchrony 153
G.1. Introduction 155
G.1.1. Scope 155
G.1.2. Purpose 155
G.1.3. Overview 155
G.1.4. Applicable documents: 155
G.2. Licenses of Open Sources Software which Combined with the
iVent101 156
G.2.1. DSP Gateway 156
G.3. Licenses of Open Sources Software which Aggregated with the
iVent101 as External Components 157
G.3.1. Kernel 157
G.3.2. Busybox 164
Index 173
iVent101Operator's Manual
Chapter 1: Introduction
This manual is intended for the operator and qualified personnel.
This manual contains information about the proper setup, function and
maintenance of your iVent101 ventilator.
It is important that you read and understand all of the information presented in
this manual.
1.1. Overview
The iVent101 is a microprocessor-controlled ventilator, intended for use in home,
institutional and portable environment. It is compact, portable and feature-rich,
supporting both invasive and non- invasive ventilation.
The iVent101 ventilator is easy to use and enables rapid control and continuous
real-time monitoring of the patient's ventilation. The ventilation parameters and
alarm settings are fully adjustable and may be saved for future use. With its
bright, well-organized and easy-to-read touch-screen, the iVent101 ventilator
displays pressure and flow waveform data in a full array of graphical and
numerical modes.
The iVent101 ventilator supports the following ventilation modes:
A/C volume control
A/C pressure control
A/C PRVC (Pressure regulated volume control)
SIMV volume control
SIMV pressure control
SIMV PRVC (Pressure regulated volume control)
Adaptive Bi-Level:
CPAP/PSV
1
Introduction
In addition, the iVent101 ventilator has the following advanced features:

Selecting preset parameters according to the patient type, to enable quick
setup.
Determining and delivering Inspiratory Peak Flow Rate according to a
target mandatory tidal volume, typically maintaining a 1:2 ratio.
Determining and delivering a respiratory cycle time to sustain 1:2 I:E
ratio.
Enabling a leak-tolerance for facemask ventilation or other specialized
high-leak tube ventilation.
Enabling Easy Exhale, an advanced PEEP mode, which reduces the
expiratory work of breathing for patients with respiratory insufficiency.
Operating according to specifications in any physical orientation.
Upgrading Software by means of USB flash drive.
1.2. How to use this manual

This manual comprises the following chapters:
Chapter 1: Introduction - Introduces the iVent101 ventilator and lists its
specifications.
Chapter 2: Setting Up - Includes how to set up the iVent101 ventilator
before starting ventilation. It includes explanations for connecting to a
power source, patient circuit, filters, and other connections as well as how
to power up the iVent101 ventilator. Refer to page 25.
Chapter 3: Main Screens - Explains the elements in the Main screens of
the different views. Refer to page 35.
Chapter 4: Operating the Ventilator- Explains how to operate the
ventilator including setting ventilation modes and parameters as well as
changing the display to view graph display. Refer to page 47.
2
Chapter 5: Alarms- Explains the iVent101 ventilator alarms and the
appropriate response and how to set the alarm parameters.
Refer to page 73.
Chapter 6: Maintenance: Explains how to care for and maintain the
iVent101 ventilator as well as the necessary test procedures. Refer to page
95.
Chapter 7: Troubleshooting - Troubleshooting guide for common issues
you may encounter while operating the iVent101 ventilator. Refer to page
107.
Appendices: Glossary, operation, and breath delivery theory, explanation
of the ventilations modes and the Hold function.
Screens names and tapping areas appear in Bold.
3
Introduction
1.3. Cautions and Warnings

Warnings and cautions appear in bold, with a sign.
The iVent101 ventilator is a life-sustaining device. Do not rely solely on

the ventilator’s performance. Always make sure an alternative means
of ventilation is available. It is mandatory that the patient receives
frequent and adequate clinical supervision.
To ensure patient safety, an appropriately trained caregiver should

monitor ventilation. Qualified personnel should also determine
whether the patient requires an alternative means of ventilation in the
event of ventilator malfunction.
VersaMed cannot be held responsible for incidents caused by this

device unless the installation, maintenance or modification are made
by an authorized and trained person (in particular, training for
handling of products sensitive to electro-static discharge must include
a section on the use of ESD protected devices), using original spare
parts and respecting quality assurance and traceability rules approved
by VersaMed .
To prevent explosion hazard, do not use the ventilator in the presence

of flammable anesthetics.
The iVent101 should be used with a bacteria filter to protect the

patient.
Using the iVent101 ventilator 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 excessively
increase resistance to the airflow provided by the iVent101 ventilator.
4
Do not connect the iVent101 ventilator to a high pressure oxygen
supply.
Close the oxygen valve on the flow meter prior to disconnecting the
oxygen from the iVent101 ventilator.
Do not cover the iVent101 ventilator while it is in use. Make sure that
the unit is positioned so that its inlet ports are open to freely
circulating air.
During infant ventilation with a high sensitivity, false triggers may

occur in certain clinical conditions. In this case, it is recommended to
decrease the sensitivity (to set its number higher).
During infant ventilation, in certain clinical conditions, Vt accuracy

might exceed + 10cc.
The iVent101 ventilator must not be operated immediately following

storage or transport outside the recommended operating conditions.
Do not use the iVent101 ventilator in an explosive atmosphere.
Your ventilator is an electronic instrument. Any electronic instrument

is subject to electrical interference. Electrical interference in excess of
20 V/m may prevent your ventilator from working properly.
The iVent101 ventilator shall not be used with flammable agents.
If another device interferes with your ventilator:

Television sets, cordless or cellular telephones, microwave ovens, air
conditioners, food processors, and other appliances can be sources of
electrical interference. In the event that you experience interference, the
following steps may be taken to eliminate it:
Do not place your ventilator near other appliances.
Do not plug the ventilator into the same AC electrical outlet or into the
electrical outlets on the same circuit as other appliances.
Do not place the ventilator cables near other appliances.
5
Introduction
If your ventilator causes interference with another device:
If the ventilation equipment causes harmful interference to other devices,
you are encouraged to correct the interference by one or more of the
following measures:
Reorient the antenna on the affected device, such as, radio, television,
or cordless phone.
Move the device away from the ventilator.
Connect the equipment to an outlet which is on a different circuit than
the affected device.
Consult the dealer or an experienced radio/TV technician for help.
It is important to check the inspiratory/ expiratory resistance

specification of the Patient circuit used with the iVent101, to ensure it
does not exceed the following limits when other components are
attached to the Patient circuit:
For an adult patient: 5 cmH2O at 60 L/min
For a pediatric patient: 4 cmH2O at 30 L/min
6
1.4. Intended Use

The iVent101 ventilator (with single or dual limb configuration) is intended to
provide continuous or intermittent ventilatory support for the care of individuals
who require mechanical ventilation. The ventilator is a restricted medical device
intended for use by qualified, trained personnel under the direction of a physician.
Specifically, the ventilator is applicable for infants from 5 kg through adult
patients who require invasive or non-invasive support via the following
ventilatory modalities:
Assist/Control and SIMV with either Volume, Pressure, or Pressure
Regulated Volume Control (PRVC)
CPAP with Pressure Support
Adaptive Bi-Level for either NIV or invasive ventilation.
The iVent101 ventilator is suitable for use in institution, home and portable
settings.
1.5. Contraindications
Not for use with anesthetic gases.
Do not use or store in the presence of strong electromagnetic fields such as an
MRI environment.
7
Introduction
1.6. The iVent101 Ventilator
Figure 1.1 Front View of the iVent101 Ventilator
8
ITEM NUMBER DESCRIPTION
1 Exhalation Exhaust
2 Exhalation Valve Connector
(one limb configuration only)
3 Proximal Pressure Connector
(one limb configuration only)
4 Inspiratory Port
5 LCD Touch Screen
6 Activity LED
7 Battery LED
8 Alarm LED
9 Expiratory Port (Two limb configuration only)
10 Air Inlet Filter
9
Introduction
Figure 1.2 Rear View of the iVent101 Ventilator
ITEM NUMBER DESCRIPTION
1 O2 Inlet Connector
2 External DC Connector
3 On/ Off Button
4 Remote Alarm Connector
5 MMC Connector
6 SpO2 Connector
7 LAN Connector
10
8 USB Connector
9 Fuse
10 RS232 Connector
11 AC Connector
12 Power Pack
13 Power pack mounting knobs
Note: The MMC, the serial and Ethernet ports, and the SpO2 connectors are not
applicable in the current version.
1.7. iVent101 Indicator Lights

The indicator lights, located on the front panel of the iVent101 ventilator (Figure
1.1), indicate the status of the iVent101 ventilator.
NAME COLOR WHEN ACTIVE
Activity Green
Battery Yellow: Charging
Yellow blinking: slow charge or the battery in

cool-down mode
Blue: Fully charged
Alarm Red
1.8. Symbols and Labels

The following symbols and labels for warnings and connectors are found on the
iVent101 ventilator:
11
Introduction
1.8.1. Front Panel Labeling
The labeling on the front panel of the iVent101 ventilator includes the following:
Upper Panel Symbols
Lower Panel Symbols
Upper Panel Symbols

The symbols on the upper panel of the iVent101 ventilator are listed below:
FUNCTION ICON/ SYMBOL LOCATION
VersaMed Logo Above the touch
screen,
General Electric Logo Below the touch

screen, in the middle
Ventilator name Above the touch

screen, in the middle.
On/Off indicator On the right side of

the LEDs.
Battery Charge indicator
Alarm indicator
To Patient Below the inspiratory

port.
12
Lower Panel Symbols
The symbols below appear on the lower panel of the iVent101 ventilator.
FUNCTION ICON/ SYMBOL LOCATION

Expiratory port On the plastic panel
(Only for the two limb model) below the pipe.
Exhalation Valve On the plastic panel

below the pipes.
One limb model only
Proximal Pressure
1.8.2. Back Panel Labeling – Connectors

The symbols below appear on the back panel of the iVent101 ventilator.
FUNCTION ICON/SYMBOL LOCATION
On/Off button On the power switch
RS232 icon Left side of the RS232

connector
USB Above the USB
connector
LAN Above the LAN

connector
AC Left side of the AC
connector
Voltage, current, frequency Below the AC

connector
Ext DC Battery Above the Ext DC

connector
13
Introduction
O2 inlet Left side of the O2 inlet
connector
Remote Alarm Above the Remote
Alarm connector
SpO2 Above the SpO2
connector
Fuse Below the Fuse
connector
MMC Card Below the MMC

connector
1.8.3. Filter Side

The following label appears below the filter.
Filter Below the filter.
14
1.8.4. Nameplate
The nameplate is attached underneath the ventilator and contains the following
symbols and information:
FUNCTION ICON/WORDING
Ventilator Name
Manufacturer
”
Date of manufacturing
Barcode
Class 2 – double isolation (electrical)
Type BF – Body Floating
S/N
Read this manual prior to use.
CE Mark
Caution: Text: “Caution: US federal law restricts this device

to sale by or on order of a physician.”
IP 31
Do not discard – per WEEE directive
15
Introduction
1.9. Ventilator Specifications
1.9.1. Size and Weight

The size and weight of the iVent101 ventilator are as follows:
Length: 25.3 cm
Width: 25.5 cm
Height: 19 cm
Screen: 9 x 15.1 cm
Weight without battery: 5.1 kg
Battery Weight (standard): 1.0 kg
Extended Battery: 1.4 kg
Overall Weight: 6.1 kg (with standard battery)
1.9.2. Environmental Specifications

Operating Temperature: 5 to 40°C
Storage Temperature (without the battery and O2 sensor): -20 to +60°C
Battery Storage: -20 to +35°C
In long term storage it is advised to store the batteries between -20°C to 35°C
to reduce self discharge and to avoid frequent maintenance.
Relative Humidity: 10% to 95%
Operating Altitude: -440m to 3500m (600 hpa to 1100 hpa)
Water resistance: IP 31
16
1.9.3. Power Supply

AC Input 100–240V, 50–60Hz, 2A max
DC Input 24-28V, 5A max
Integral Standard: 24V, 2700mAh, up to 4 hours
(Integrated) (depending on ventilation settings).
Battery Extended: 24V, 4500mAh, up to 6.5 hours
(depending on the ventilation settings).
External Battery Up to 10 hours (depending on ventilation
settings).
Backup Battery 3.6V, 500mAh, Up to 5 minutes (For hot swap
capability, please refer to section 6.1.6, on page
102).
Shelf Life 1 year (you may need to re-charge the battery
during storage.)
1.9.4. Ventilation Modes

For more information regarding ventilation modes, refer to section 4.2.2: Setting
Ventilation Modes on page 51.
Adaptive Bi-Level
SIMV: Volume Control, Pressure Control, or PRVC.
A/C: Volume Control, Pressure Control, or PRVC.
CPAP/PSV
17
Introduction
1.9.5. O2 Supply
Pressure: 100 cmH20 maximum
Flow: 20 L/min maximum
1.9.6. Inspiratory and Expiratory Resistance

In the event that the ventilator is unable to provide pneumatic support,
spontaneous respiration may be achieved through the pneumatic unit and a 1.8m
patient circuit with the following resistance:
PATIENT CIRCUIT TYPE PRESSURE [CMH2O] FLOW [LPM]
Adult two limb Patient Inspiratory -8 60

Breathing Circuit (22 mm)
Expiratory 3.8 60
Pediatric two limb Patient Inspiratory -3 30
Breathing Circuit (15 mm)
Expiratory 2 30
1.9.7. Ventilation Setting and Measured Value

Parameters
The following table displays the ventilation settings including the range and the
accuracy of the ventilation parameters.
VENTILATION PARAMETER UNIT OF ACCURACY
SETTING RANGE MEASURE
Inspiratory Pressure 5 – 60 cmH2O + 2 cmH2O or 10%
whichever is greater
Pressure limit 5 – 60 cmH2O + 2 cmH2O or 10%
PEEP 0 – 45 cmH2O + 2 cmH2O or 10%
18
VENTILATION PARAMETER UNIT OF ACCURACY
SETTING RANGE MEASURE
Tidal Volume 40 – 2500 ml + 10% or 10 ml
Delivered whichever is greater
Tidal Volume Limit 40 – 2500 ml + 10% or 10 ml
Peak Flow 5 – 120 or L/min + 2 lpm or 10% of
(mandatory) Adaptive Peak setting whichever is
Flow greater
Respiratory Rate 1 – 80 bpm + 1 bpm or 10% of
setting, whichever is
greater
Inspiratory Time 0.3 – 3.00 seconds 0.1sec or 10% of
setting, whichever is
greater
FiO2 (monitoring 21-100 % + 3% percentage
only) points up to 30% FiO2,
+ 7% percentage
points between 30 -
60% FiO2 (See note
below)
Rise Time 0-9 N/A N/A
ESens 5 –80 % + 1% for 5% -10%
+10 of the settings for
10% or greater.
Sensitivity 1-9 N/A N/A
Note: Above 60% FiO2 it is recommended to use an external oxygen analyzer for
the O2 monitoring.
Note: All flow, volume and pressure measurements in iVent-101 are expressed at
STPD conditions (Standard Temperature and Pressure Dry -0 °C. and 101,3 kPa
(760 mm mercury column)
The following table lists the displayed measured values including the range of the
ventilation parameters.
19
Introduction
MEASURED VALUE MEAUSRED RANGE UNIT OF
MEASURE
Exhaled Tidal Volume 0 – 9999 ml
Minute Volume Exhaled 0 – 99 L/min L/min
Respiratory Rate 1 – 99 bpm
Inspiratory Time 0.3 – 48 seconds
Peak Inspiratory Pressure 0 – 99 cmH2O
Peak Flow 0 – 240 L/min
Measurement Oxygen Mix (FiO2) 21 – 100 %
1.9.8. Default Settings

For the default ventilation settings refer to Appendix C: Default ventilation
Settings on page 121.
1.9.9. Additional Displayed Parameters

Ventilation Mode
Patient type
Breath indicator
Date/Time
Power Source
Battery Charge Indicator
Battery State Indicator
Alarm Message Indicator
Alarm Suspend Indicator and Timer
20
1.9.10. Displayed Waveforms
Real Time Pressure and Flow Waveforms can be displayed on screen.
1.9.11. iVent101 Ventilator Alarms

For a complete explanation of the various alarms, refer to Chapter 5: Alarms on
page 73.
1.9.12. User Adjustable Alarms

ALARM RANGE
RESPIRATORY RATE Infant: 1-99 bmp, child and adult: 1 – 80 bpm
MINUTE VOLUME Infant: 0-20L/Min, Child: 0-30 L/Min,
Adult: 0-50 L/min
PRESSURE: High: 5 – 60 cmH2O

Low: 1 – 55 cmH2O
APNEA 5 – 120 seconds
FiO2 High: 21–100%
Low: 21–100%
PATIENT DISCONNECT On or Off
1.9.13. Non-Adjustable Alarms

The following alarms sound automatically and may not be adjusted in order to
ensure patient safety.
Set pressure not delivered Occlusion
Vt not delivered Volume limit reached
Integrated battery failure Emergency Backup
O2 calibration required AC Power Disconnect
21
Introduction
O2 sensor worn out Battery Empty

O2 sensor disconnect Low Battery (about 20 minutes left)
VVT recommended OVT recommended
Lost last clinical settings Over Temperature
Lost last apnea settings Service Notices
Lost last user configuration Lost last technical configuration
Sensors calibration required Factory calibration required
1.9.14. Accessories
The following accessories are provided with the ventilator:
DESCRIPTION VERSAMED GE
PART NUMBER PART NUMBERS
Europe Ac cable (1.8m length) 404J1802-01 M1161938
US AC Cable (1.8m length) 404J21111-01 M1184228
O2 Sensor 130B0002-03 M1161179
Red Cap (Sealing Cap) 32500004-A0 M1161821
Operator Manual 385OM001-01 M1184166
One Limb Kit 504HC051-01 M1184155
Two Limb disposable Patient 620B0101-A0 M1184227
Circuit (1)
2L Test Lung (Reservoir Bag) 910V0005-01 M1162061
Rp20 Resistor 910V0004-A0 M1161188
Exhalation Membranes (3 each) 323MHC01-01 M1161820
(1) The GE part number of this item refers to kit containing 10 units.
22
1.9.15. Software Open Source Information
The Product is based on Software which is developed and owned by the Supplier
(the "Software"). The Software may include or use certain open source code
software and materials which are subject to certain license terms which are
located at websites listed in Appendix G: Software Open Sources hereto (on page
155). The Open Source Licenses are displayed in Appendix G: hereto. By
accepting the terms and conditions of this Agreement, you also accept the terms
and condition of the Open Source Licenses. In the event of any inconsistencies or
conflicting provisions between the provisions of the Open Source Licenses and
the provisions of this Agreement, the provisions of the Open Source Licenses
shall prevail. Without derogating the generality of the foregoing, it is clarified that
the Open Source Licenses contains no warranties and/or liabilities from any kind
and under any circumstances, and the rights granted under this Agreement are
subject to Copyright Notice, to the extent that such notice appear in the Open
Source Licenses. Appendix G: hereto listed and contains certain open source code
software and materials which are not part of the Product, but supports the
Software operation as an external components to the Product.
The Kernel source can be viewed at
http://code.google.com/p/vm101hc/downloads/list.
1.10. Standards and Safety Requirements

The iVent101 meets the applicable safety requirements per the standards below:
ASTMF1100-90 Standard Specifications for ventilators intended

for use in critical care
ASTMF1246-91 Standard Specifications for electrically powered
Homecare ventilators
IEC60601-1: 1988 +A1: 1991 Medical Electrical Equipment - General
EN60601-1: 1990+A1: 1993+ requirements for safety
A21995+A13: 1996
23
Introduction
EN 60601-1-2:2001 Electromagnetic Compatibility (EMC)

IEC 60601-1-2:2005
* ISO 10651-2: 2004 Lung Ventilators for medical use - Particular
requirements for Home Care Ventilators
dependent patients
** ISO 10651-6: 2004 Lung Ventilators for medical use - Home-care
ventilatory support devices
IEC60601-2-12: 2001 Medical Electrical equipment- particular
requirements for the safety of lung ventilators –
critical care ventilator.
IEC 60601-1-8: 2003 General Requirements for safety: test and
Guidance for alarm system in medical electrical
equipment/system
ISO 14971 Medical Devices – Application of risk
management to medical devices
**The iVent101 with the single limb configuration complies with the
requirements of ISO 10651-6: 2004.
*The iVent101 with the dual limb configuration complies with the requirements
of ISO 10651-2: 2004.
24
Chapter 2: Setting Up
This chapter explains how to set up the iVent101 ventilator before starting
ventilation and comprises the following sections:
Understanding The Ventilator Power Sources, section 2.1 below.
Patient Circuit, refer to section 2.2 on page 27.
Choosing a Location for the Ventilator, section 2.4 on page 32.
Connecting the Ventilator to an Oxygen Source, section 2.5 on page 33.
Connecting the Ventilator to an AC Power Source, section 2.6 on page
35.
Powering up the Ventilator, section 2.7 on page 36.
Shutting Down the Ventilator, section 2.8 on page 38.
If used in accordance with the product labeling contained in this manual, and your
doctor’s prescription, the ventilator is intended to provide reliable ventilation for
patients with respiratory insufficiencies or failures.
2.1. Understanding The Ventilator Power

Sources
The iVent101 ventilator has three power sources:
External alternating current (AC)
External direct current (DC)
Integrated battery
Both the AC and DC input are located on the back panel of the ventilator (see
Figure 1.2 on page 10).
25
Setting Up
Before connecting the ventilator to an AC or DC outlet, verify that the

external power supply is the correct voltage and frequency.
If the power cord is damaged, worn, or frayed, replace it immediately.

The following icons indicate the power status of the iVent101 ventilator:
ICON DESCRIPTION REMARKS
AC power is connected. The AC power icon appears in
green.
AC power is disconnected.
External DC is connected without AC The External DC icon appears in

power connected. green.
.
External DC is disconnected or connected
while AC power is connected.
Integrated battery is fully charged. The Battery icon appears in green.
Integrated battery is partly discharged. The indicator moves downward in

10% increments.
Only part of the battery icon appears
in green.
Low battery. When the remaining power level is
10%, a hazard sign appears on the
battery indicator.
Empty Battery Replace A/C power immediately.
Ventilation continues until there is no
power left
26
2.1.1. Integrated Battery
When the iVent101 ventilator detects an external power loss, it switches to the
integrated battery. When fully charged, the integrated battery provides up to 4
hours of power, depending on the ventilation conditions and settings.
Only use integrated batteries supplied by VersaMed.

To recharge and replace the integrated battery, refer to section:6.1.6: Integrated
Battery Maintenance on page 102.
2.2. Patient Circuit

The patient circuit is the tubing that carries the air from the ventilator to the
patient. The iVent101 ventilator supports both a one limb and two limb patient
circuit. The functionality of both is similar except that the two limb patient circuit
includes the ability to measure expiratory volume.
Note: When ventilating against high-resistance or with high leak, it is
recommended to use a two limb patient circuit configuration.
Note: The ventilator has to be configured by a qualified technician in order to

change from One limb to Two limb configuration and vice versa. You may use
most standard one or two limb patient circuits.
Disposable one limb and two limb patient circuits are intended for a
single patient use only.
Reusable one limb and two limb patient circuits should be handled
according to their manufacturer’s specifications.
Note: The ventilator was tested with Hudson (Universal Single-Limb Ventilator
Circuit, Cat. No. 1696) and MPV TRUMA single limb patient circuit
27
Setting Up
(Dahlhausen Ref. No. 8065G). Using other patient circuit may affect ventilation
performance.
Inspect the patient circuit every day to:
Make sure there are no cracks or holes in the hose.
Be certain all the connections are secure and free from leaks.
Use a pediatric circuit when ventilating a pediatric or infant patient.
When the patient circuit type is changed (from an adult circuit to a

pediatric and vice versa), a patient circuit compensation must
be performed by qualified personnel prior to using the new patient
circuit.
Before connecting the patient to the ventilator with a new patient

circuit, you must perform a complete Ventilation Circuit Test. To
perform the test, refer to section 6.2: Ventilation Circuit Test on page
104.
To prevent water and/or secretions from entering the pressure sensor

tubing while using single limb circuits, always keep the patient
pressure line tilted upward.
When ventilating against high resistance (for example, when

ventilating an infant) or with high leak it is recommended to use a
dual limb setup, as the readings during exhalation allow for improved
ventilation performance.
If the patient circuit is obstructed there may be auto triggers

generated against the obstruction.
To connect a Dual limb Patient Circuit:
1. Connect the patient circuit tubing to the Inspiratory Outlet Port (refer to
Figure 1.1 on page 8) by twisting and pushing it until it is firmly in place.
28
2. Connect the second tubing to the Exhalation Inlet Port (refer to Figure 1.1
on page 8) by twisting and pushing it until it is firmly in place.
Figure 2.1: Two Limb Patient Circuit connected
To connect a One limb Patient Circuit:

1. At one end of the patient circuit, connect the exhalation valve and the
Proximal Pressure tube according to the manufacturer’s instructions.
2. Connect the Exhalation valve tube to the exhalation valve, according to
the patient circuit’s manufacturer instructions.
3. Connect the other end of the patient circuit tube to the Inspiratory Outlet
port (refer to Figure 1.1 on page 8) by twisting and pushing it until it is
firmly in place.
4. Connect the Proximal Pressure tube to the Proximal Pressure connector
on the ventilator (identified by the icon).
29
Setting Up
5. Connect the Exhalation valve tube to the exhalation valve connector on
the ventilator (identified by the icon).
2.2.1. Circuit Accessories

If you wish to humidify the inspired gas attach one of the following components
to the patient circuit as an accessory:
Heat and Moisture Exchanger (HME)
Heated Humidifier and Water Trap.
Note: Heated humidifiers can be associated with excess water accumulation in the
expiratory side of the patient circuit. Elevating the expiratory side of the circuit
above the expiratory valve should be avoided in this circumstance. A large bolus
of water pushed into the expiratory valve can cause occlusion of the pressure
sensing tubes interfering with ventilator performance. Using a water trap in the
circuit when using heated humidifiers is recommended and can reduce the
likelihood of this occurrence.
To connect a heated humidifier:

1. Connect the corrugated tubing from the Inspiratory Outlet Port on the
front panel of the iVent101 ventilator to the humidifier inlet port (refer to
Figure 1.1 on page 8).
2. Refer to the humidifier operator's manual to complete the humidifier
setup.
Note: Follow the manufacturer's instructions for operating the humidifier.
30
2.3. Attaching Air Inlet Filter
Do not operate the iVent101 ventilator without an air inlet filter.
The iVent101 utilizes an air inlet filter that prevents the entry of any substance
greater than 5 microns.
Figure 2.3: Air Inlet Filter
Note: The air inlet filter must be replaced every 1 month of operating.
To replace the air inlet filter:
1. Turn the air inlet filter (shown in Figure 2.3 above) counterclockwise and
release it from the ventilator.
2. Insert a new air inlet filter to the air inlet and turn it clockwise until it is
securely in place.
31
Setting Up
2.4. Choosing a Location for the Ventilator
It is recommended that the iVent101 should be placed on a solid
surface so that the cooling air can flow through the vents in the
lower chassis without obstruction.
Verify that the air inlet is not obstructed.

When selecting a place for the ventilator, it is important that the alarms can be
heard. Before using the ventilator, you need to test how well the alarms can be
heard in every location of the home:
1. Put the ventilator where it will be used most.
2. Plug the ventilator into a wall outlet.
3. Verify that the patient circuit is not connected to the ventilator.
4. Turn on the unconnected ventilator and start ventilation. For more
information, refer to section 4.3: Starting and Stopping Ventilation on
page 61. An alarm condition will occur, and an audible alarm will
sound.
While the patient is not connected to the ventilator, use a backup

source of ventilation as required.
5. Go to each part of the home and verify that the alarm is audible.
Identify any activities or devices that make loud sounds (e.g., radio,
television, tools and appliances), operate those devices, and verify that
you are still able to hear the ventilator’s alarm.
Note: The alarm volume can be adjusted. Refer to section 4.6.2, on page 67.
If the placement test reveals areas of the home or noisy activities over
which the alarm cannot be heard, do not leave the patient unattended
while you are in those areas or engaging in those activities.
32
2.5. Connecting the Ventilator to an Oxygen
Source
The iVent101 ventilator uses oxygen from a low pressure oxygen source such as
an oxygen concentrator or a flow meter. The low pressure oxygen supply is
connected to the iVent101 ventilator through an O2 connector.
The low pressure O2 should not exceed the following parameters:
Pressure: 100 cmH20 maximum
Flow: 20 L/min maximum
For the monitoring accuracy refer to section 1.9.7: Ventilation Setting and
Measured Value Parameters, on page 18.
Validation of the oxygen measurements was performed up to 100% FiO2. Above
60% FiO2 it is recommend to use an external oxygen analyzer for the FiO2
monitoring. It is advised not to exceed oxygen flows above 20 L/min.
Do not directly connect the iVent101 ventilator to a high pressure

oxygen supply. Use an oxygen regulator, and do not exceed the flow
parameter which specified above.
There are 2 different O2 connector types offered as accessories: Christmas tree
type and compression nut type.
Figure 2.4: Christmas tree connector Figure 2.5: Compression nut connector
33
Setting Up
Verify that Oxygen source is closed and that there is no pressure in the
tube prior to connecting the oxygen tubing to ventilator.
To connect a low pressure oxygen supply with a Christmas tree connector:

1. Connect the Oxygen source tubing to the connector. Verify that you are
using a standard grade oxygen tube, compatible with low pressure O2
application.
2. Connect the O2 connector to the O2 connector inlet in the back panel.
Figure 2.6: The O2 connector inlet on the ventilator

To connect a low pressure oxygen supply with a Compression nut connector:
1. Unfasten the locking nut from the O2 connector.
2. Connect the oxygen source tubing to the connector. Verify that you are
using a standard grade oxygen tube, compatible with low pressure O2
application.
3. Lock the tube to the O2 connector by fastening the locking nut to the
connector (as shown in Figure 2.5).
4. Connect the O2 connector to the O2 connector inlet in the back panel.
To release the O2 connector:
1. Close the O2 source.
34
2. Press the Thumb Latch on the side of connector and pull the connector
(shown in Figure 2.6 above).
2.6. Connecting the Ventilator to an AC Power

Source
To connect the ventilator to an AC power source:

1. Make sure that the socket end of the power cord is plugged into the power
cord connector on the back of the ventilator.
2. Make sure that the strain relief is connected firmly to the AC power cord.
3. Plug the other end of the cord into a wall outlet. The Battery Charging
LED will light.
The battery is charged only if the integrated battery is connected, the ventilator
is plugged in to external power source, and the yellow LED is light.
For the list of possible battery charging LED descriptions, refer to section 1.7:
iVent101 Indicator Lights on page 11.
Note: While operating, keep the ventilator connected to an AC power whenever
possible.
Note: When not connected wrap the power cord around the battery knobs on the
back panel, as shown in Figure 2.7
35
Setting Up
Battery knobs
Figure 2.7: The battery knobs can be used to wrap the power cord.
2.7. Powering up the Ventilator

Note: Whenever the ventilator is restarted (intentional or unintentional) the
prevailing settings prior to shutdown are automatically reloaded.
To power up the iVent101 ventilator:
Push in the power button for two seconds to power up the iVent101. The
power button is located on the back panel of the ventilator. (Refer to
Figure 1.2 on page 10.) The iVent101 ventilator starts up in the following
stages.
After several seconds, the Splash screen is displayed on the touch screen.
36
Figure 2.8: The Splash Screen

As the system continues to start up, a small cursor appears in the middle
of the iVent101 logo.
The Main screen will then be displayed.
37
Setting Up
Figure 2.9: iVent101 ventilator main screen
2.8. Shutting Down the Ventilator

To shut down the iVent101 ventilator, push in the power button for
several seconds while the ventilator is in the Standby mode. You can
force a complete shutdown of the ventilator while ventilating by pressing
the power button for 25 seconds.
When you force a shutdown during ventilation, a red alert screen appears
accompanied by a high pitch sound to warn that continued pressing the power
button will shut down the iVent101.
38
Chapter 3: Main Screens

You operate the iVent101 ventilator through its touch screen, which is located on
the front panel (see Figure 1.1 on page 8). The Main screen is the first screen
displayed after start-up, and you return to the Main screen after completing any
operation.
In this chapter, we cover:
View Options, section 3.1, below, which describes the different views of
the Main screens and their respective purposes.
Basic View and Basic Night View Main Screens, section 3.2 on page 41,
which describes the main areas and buttons of Basic View and Basic Night
View.
Clinical View Main Screen, section 3.3 on page 43, which describes the
main areas and buttons of Clinical View.
3.1. View Options

Depending on the selected view of the iVent101 ventilator, the Main screen
displays different information.
Note: In this manual, the Main screen usually refers to Clinical View, which is
the view that enables access to more functionality.
The View options of the iVent101 ventilator are explained below:
NAME PURPOSE VIEW ICON EXAMPLE
Basic View Used for monitoring the patient. In this Figure 3.2
view you can only start, pause, stop the
ventilation, or initiate a manual breath.
A limited number of menu options are
also accessible.
Basic Night View Identical information as the Basic View --
except that color scheme has lower
tones in Basic Night View.
39
Main Screens
NAME PURPOSE VIEW ICON EXAMPLE
Clinical View Used for advanced monitoring and Figure 3.3
operation of the ventilator, designed for
clinicians and technicians to operate
the ventilator. Changing of ventilation
settings and alarms and performing
service operations can be done only
through this view
For additional viewing options, refer to
section 4.7: Changing to Graph Tab on
page 72.
To change the iVent101 View:

1. On the Side Bar, tap the View button. (Refer to the View Icon column in
the table above.) The Select View screen is displayed.
Figure 3.1: The Select View Screen

2. Tap one of the following:
Basic View
Basic Night View
Clinical View
The Main screen displays the selected view, and the icon on the View
button changes to reflect the selection.
40
3.2. Basic View and Basic Night View Main

Screens
The Basic View and Basic Night View Main screens are used for monitoring the
patient and do not enable access to settings and more advanced features. They
include many of the same screen elements and appear essentially identical, except
that color scheme has lower tones in Basic Night View.
The Basic View screen is displayed below:
Figure 3.2: The iVent101 Ventilator in Basic View and in Standby mode
The Main screen in Basic View and Basic Night View contains the following
areas and buttons:
41
Main Screens
1. Current Measurements area: Displays six of the current ventilation
monitored parameters in table format. Displayed area only. Located at
the center of the screen.
2. Ventilation Mode Summary: Displays the current ventilation mode,
default patient type, and respiratory indicator. Displayed area only.
Located at the top of the screen.
3. Alarms area: Displays the most recent alarms and their severity. See
Chapter 5: Alarms on page 73. Tapped area. Located at the right side of
the screen.
4. Power Status area: Displays the power supply status. Refer to section
2.1: Understanding The Ventilator Power Sources on page 25. Displayed
area only. Located at the lower right side of the screen.
5. Screen Lock: Initiates and releases the screen lock. Refer to section 4.4:
Initiating and Releasing the Screen Lock on page 63. Tapped area.
Located at the bottom of the screen.
6. Start/ Pause button: Starts the ventilation process when the ventilator is
in Standby mode. Once the ventilation is started the button changes to a
Pause button. Refer to section 4.3: Starting and Stopping Ventilation, on
page 61. Located at the bottom of the screen.
7. Patient Tube Testing button: Opens the Patient Tube Test screen.
Refer to section: 6.2: Ventilation Circuit Test on page 104. Located at the
bottom of the screen.
8. Information Button: Provides general information about the ventilator.
Refer to section 4.3: on page 61.
9. Side Bar: Tapped area. Located at the left side of the screen, and
includes the following buttons:
View: Changes the current view. Refer to section 3.1: View
Options on page 39.
Manual Breath: Delivers one manual breath to the patient.
Refer to section 4.3.1: Manual Breath on page 62. Note that
this button is displayed only when the device is ventilating.
42
Menu: Opens a menu bar to enable changing option
settings. Refer to section 4.1: Menu Options on page 48.
3.3. Clinical View Main Screen

The Main screen in Clinical View is used for operating the iVent101 ventilator
with easy access to more functions.
Only doctors or qualified clinicians should set the ventilation

parameters through Clinical View.
The Clinical View Main screen (Figure 3.3) is displayed below:
Figure 3.3: The iVent101 Ventilator in Clinical View during ventilation

The Main screen in Clinical View contains the following areas and buttons:
1. Current Measurements area: Displays eight current ventilation
monitored parameters in table format. You may also view the
43
Main Screens
measurements in graph format. To change the view, refer to section 4.7:
Changing to Graph Tab on page 72. Displayed area only. Located at the
upper central area of the screen.
2. Current Settings area: Displays the ventilation settings in table format
(as shown above). Displayed area only. Located at the lower central area
of the screen.
3. Ventilation Mode Summary: Displays the current ventilation mode,
default patient type and respiratory indicator. Displayed area only.
Located at the top of the screen.
4. Alarms area: Displays the most recent alarms and their severity. See
Chapter 5: Alarms on page.73. Tapped area. Located at the right side of
the screen.
5. Power Status area: Displays the power supply status. Refer to section
2.1: Understanding The Ventilator Power Sources on page 25. Located at
the lower right side of the screen.
6. Screen Lock: initiates and releases the screen lock. Refer to section 4.4:
Initiating and Releasing the Screen Lock on page 63. Tapped area.
Located at the bottom of the screen.
7. Start/ Pause button: Starts the ventilation process when the ventilator is
in Standby mode. Once the ventilation is started the button changes in a
Pause button. Refer to section 4.3: Starting and Stopping Ventilation, on
page 61. Located at the bottom of the screen.
8. Patient Tube Testing button: Opens the Patient Tube Test screen.
Refer to section 6.2: Ventilation Circuit Test on page 104. Located at the
bottom of the screen.
9. Information Button: Provides general information about the ventilator.
Refer to section 4.3, on page 61.
10. Monitor tabs: Change the monitor display. By default, the current
parameters are displayed in a table format, but graphical waveform can
also be displayed. Refer to section 4.7: Changing to Graph Tab on page
72. Located below the Current Settings area.
44
11. Side Bar: Tapped area. Located at the left side of the screen, and
includes the following buttons.
View: Changes the current view. Refer to section3.1: View
Options on page 39.
Manual Breath: Delivers one manual breath to the patient.
Refer to section 4.3.1: Manual Breath on page 62. Note that
this button is displayed only when the device is ventilating
Settings: Opens the Settings screen in order to change the
ventilation settings. Refer to section 4.2.2:Setting the
Ventilation Parameters on page 51.
Menu: Opens a menu bar to enable changing option
settings. Refer to section 4.1: Menu Options on page 48.
45
Main Screens
Notes:
46
Chapter 4: Operating the Ventilator

This chapter describes how to operate the iVent101 ventilator, mainly from the
Clinical View screen and includes the following sections:
Initiating and Releasing the Screen Lock, section 4.4 below, describes
the screen lock and how to release it in order to change the iVent101
ventilator settings.
Menu Options, section 4.1 on page 48, describes the iVent101 ventilator
menus and their availability in Basic View and Clinical View.
Setting the Ventilation Parameters, section 4.2, on page 49, describes
how to select the default type for a new patient and to set the correct
settings according to the ventilation mode.
Setting Ventilation Modes on page 51, briefly describes the ventilation
modes and how to select one for ventilator operation.
Starting and Stopping Ventilation, section 4.3, on page 61, describes
how to start ventilating the patient after setting the ventilation parameters.
Initiating and Releasing the Screen Lock section 4.4, on page 63,
describes how initiate and release the screen lock that locks the touch
screen when not in use.
The Information Screen, section 4.5, on page 64, describes the
information screen and how to reach it.
General Configuration, section 4.6, on page 65,describes how to
configure some of the device settings via the General Configuration
screen.
Changing to Graph Tab, section 4.7 on page 61, describes how to view
real-time ventilation parameters to waveforms format.
47
erating the VentilatorOp
4.1. Menu Options
The Menu bar provides advanced options for operating the iVent101. The Menu
bar in Clinical View is displayed below:
Figure 4.1: Menu Bar in Clinical View

The available options change depending on the selected view, as described below:
BASIC VIEW MENU CLINICIAN VIEW DESCRIPTION

MENU
New Patient Opens the New Patient screen. Refer to
--- section 4.2.1 Setting Default Settings for a
New Patient on page 50.
Services Opens the Services screen. Refer to the
---
Service Manual.
Open the General Configuration screen.

General Config General Config
Refer to section 4.3: on page 61.
Log Book Log Book Open the Logbook. Refer to section: 5.6 The
Log Book, on page 92.
48
BASIC VIEW MENU CLINICIAN VIEW DESCRIPTION
MENU
Pause Ventilator! Pause Ventilator! Stops the ventilation. Refer to section 4.3
Starting and Stopping Ventilation on page 61.
Close Close Closes the Menu bar.
To operate the menu bar:

1. Tap the Menu button on the Main screen. The menu bar is displayed.
2. Tap the menu you want to access. The menu's respective screen is
displayed.
3. To close the menu bar, tap Close.
4.2. Setting the Ventilation Parameters

This section describes how to set the ventilation parameters, which includes
setting the patient default settings according to patient type, the ventilation mode,
and modifying the ventilation settings.
Note: Whenever the ventilator is restarted the prevailing settings prior to
shutdown are automatically reloaded.
To ensure that each patient is ventilated with the correct parameters, you should
set the parameters each time you connect the ventilator to a new patient. The
iVent101 default ventilation parameters are set according to the patient type. You
can later change these parameters if needed.
Do not ventilate a patient before verifying that the settings are

correct.
Making radical changes to settings during ventilation may cause nuisance alarms
that will disappear shortly after.
Setting the parameters includes three main steps:
1. Select the patient type. The patient's type determines the default
parameters. Refer to Setting Default Settings for a New Patient, below.
49
Operating the Ventilator
2. Set the ventilation mode according to the patient's needs. Refer to Setting
3. Set the ventilation parameters and alarms according to the patient’s needs.
Refer to Modifying the Parameters on page 54.
4.2.1. Setting Default Settings for a New Patient

Before ventilating a new patient, select the patient type in order to determine the
default ventilation settings. There are three possible patient types and weight
ranges, each is represented by an icon.
PATIENT TYPE WEIGHT RANGE ICON
Infant Up to 25 kg
Child 25 to 45 kg
Adult Over 45 kg
For a complete list of the default settings associated with each patient type, refer
to Appendix C: Default ventilation Settings on page 121.
To select a patient type for a new patient:
1. On the Main screen (Figure 3.2), tap Menu - New Patient. The New
Patient screen appears.
50
Figure 4.2: The New Patient Screen

2. Select Infant, Child, or Adult according to the patient weight.
Selecting a new a patient type will restore the ventilation settings to

defaults settings and override any previous settings.
Once a new patient has been tapped the operation cannot be aborted, and
restoring previous settings can be done only manually.
The Ventilation Settings screen is displayed with the default settings.
3. Tap Accept to start ventilation with the default settings, or modify the
ventilation settings (refer to section 4.2.3: Modifying the Parameters on
page 54).
4.2.2. Setting Ventilation Modes

The first step in configuring the ventilation settings is setting the ventilation
mode. You set the ventilation mode on the Ventilation Mode screen opened from
the Setting screen (see section 4.2.3, on page 54).
iVent101 provides the following ventilation modes:
51
A/C pressure control: Delivers patient triggered or set breath rate. Every
breath is a pressure preset breath.
A/C volume control: Delivers patient triggered or set breath rate. Every
breath is a volume preset breath.
A/C PRVC: Delivers patient triggered or set breath rate. Every breath is a
PRVC volume targeted breath.
Adaptive Bi-Level: Utilizes two levels of pressure to deliver ventilator
support with a set backup rate. Support can be either for invasive or non
invasive patients.
SIMV pressure control: Synchronizes mandatory pressure breaths with
the patient’s spontaneous breathing with pressure support.
SIMV volume control: (Synchronized Intermittent Mandatory
Ventilation). Synchronizes mandatory tidal volume breaths with the
patient’s spontaneous breathing with pressure support.
SIMV PRVC: Synchronizes a mandatory volume targeted breaths with
the patient’s spontaneous breathing with pressure support.
CPAP/PSV: Applies continuous positive pressure throughout the breath
cycle with pressure support ventilation.
For more information regarding the ventilation modes, refer to Appendix F:
To set a ventilation mode:

1. In the Main screen tap Settings and then tap the name of the current
ventilation mode at the top of the Settings screen. The Ventilation Mode
screen is displayed.
52
Figure 4.3: Ventilation Mode Screen

2. Tap the ventilation mode you want. The Ventilation Mode screen is
closed, and the Settings screen is displayed with the settings that can be
adjusted in selected ventilation mode, and with the name of the mode at
the top of the screen.
3. Tap Accept to start ventilation with the displayed settings, or modify the
ventilation settings. Refer to section 4.2.3: Modifying the Parameters,
below.
53
4.2.3. Modifying the Parameters

Parameters can be modified according to the current ventilation mode and
selected alarms. For example, if the current ventilation mode is SIMV Pressure
Control, the parameters are different than those available in Adaptive Bi-Level
ventilation mode.
For more information regarding which parameters may be modified in each
ventilation mode, refer to Appendix F: Ventilation Modes on page 143.
Note: Only qualified clinicians should modify the clinical settings of the
iVent101.
Note: When changing settings on a patient ventilated using adaptive peak flow,
the peak flow calculation is restarted, and ventilation waveform shape may
change, and will gradually return to the previous state.
The following table lists the available ventilation parameters from all ventilation
modes and their respective range of values:
PARAMETER NAME MEANING RANGE OF VALUES

Ventilation Mode Refer to Setting Ventilation Modes
above
Rate Respiratory Rate setting 1 – 80 bmp
Insp. Press Inspiratory Pressure setting 5 – 60 cmH2O
above PEEP
Sensitivity Flow and Pressure Trigger 1-9
Sensitivity setting
Vt. Limit Tidal Volume Limit setting Adult: 200-2500 ml.
Child: 40-700ml.
Infant: 40-400ml.
Insp. Time Inspiratory Time setting 0.3 – 3 sec
54
PARAMETER NAME MEANING RANGE OF VALUES
PEEP PEEP setting 0 – 45 cmH2O
Press. Limit (Limit) Pressure Limit ventilation 5 – 60 cmH2O
setting
Vt. Set Set Tidal Volume setting Adult: 200-2500ml.
Child: 40-700ml.
Infant: 40-400ml
Peak Flow Peak Flow setting 5-120 L/min
IPAP High Pressure setting in 5-60 cmH20 (actual desired
Adaptive Bi-Level pressure)
EPAP Low Pressure setting in 0-45 cmH20
Adaptive Bi-Level
Insp. Time Inspiratory Time setting 0.3 – 3 seconds
ESens Termination of pressure 5-80 %
support breath after flow drop
detection
Rise Time Speed of the engine 1-9
acceleration during the
inspiratory phase.
PSV Pressure Support setting above 3 – 60 cmH2O
PEEP
Apnea Apnea alarm settings
Alarms Alarms settings Refer to section 5.2: Setting the
Alarm Parameters on page 74.
To modify ventilator parameters:

1. On the Main screen, tap Settings.
The Settings screen appears, and the settings and the parameters of the current
ventilation mode are displayed. On the right side of the screen, the Slider is
displayed, and the Settings Calculator icon appears next to it.
55
Slider
Calculator
Icon
Figure 4.4: The Settings Screen for A/C Pressure Control

Note that the green area, on the left side of the slider, depicts the recommended
range. The red section denotes less common ranges and suggests caution.
2. Tap the parameter you want to change. The parameter is highlighted and
the name above the slider changes to reflect that of the selected parameter.
3. Do one of the following:
Tap the Up or Down arrows on the slider to set the desired
value for the parameter.
Tap the Calculator icon. The calculator appears (see Figure
4.5). Tap the setting you want and tap Enter. The slider will
display the new settings.
56
Figure 4.5: The Settings Calculator

4. Tap Accept All to close the Settings screen and apply your modifications.
You will return to the Main screen.
I:E Ratio Warning

When possible, the iVent101 checks the ventilation settings and verifies the I:E
ratio that will be provided will be 1:1 or higher. This is affected by rate,
Insp.Time (in pressure control modes) and non-adaptive peak flow (in volume
control modes). In case the settings will cause the I:E ratio to be lower than 1:1 a
warning will be issued, requesting an approval of the settings, and allowing for
the settings to be corrected before being applied.
If the warning is issued:

1. Tap Return to return to the settings dialog and correct the settings.
2. Tap Accept to apply the settings regardless of the warning.
57
Figure 4.6: I:E Ratio Warning
Apnea Settings
Apnea is a backup mode that is automatically activated when no breath
(mandatory or spontaneous) has been delivered during the set apnea time interval.
The ventilation will continue with an apnea rate set by the clinician with the same
mandatory breath settings of the ventilation mode that is currently chosen.
If the ventilation mode is CPAP/PSV at the time when apnea occurs, the
ventilation is delivered according to the mode chosen by the clinician or with
default apnea settings. The default mode in CPAP/PSV for all patients is A/C
pressure control ventilation to allow appropriate ventilation regardless of the
patient size. Refer to section C.1: Default Apnea Settings on page 126.
You can change the default apnea settings for CPAP/PSV mode from the Settings
screen.
For all other ventilation modes you can set the ventilation rate delivered during
apnea.
58
To change the apnea default settings:

1. On the Main screen tap Settings. The Settings screen is displayed.
(Figure 4.4).
2. Tap the Apnea button located at the lower left side of the screen. The
Apnea Settings screen is displayed.
Figure 4.7: Apnea Settings Screen

3. Tap the Ventilation Mode button if you wish to change the Apnea
ventilation mode. The Select Apnea Mode box is displayed.
59
Figure 4.8: Select Apnea Mode Box

4. Tap the ventilation mode you want. The Select Apnea Mode screen is
closed. The Apnea Settings screen then displays the ventilation
settings for the selected mode.
5. Tap the parameter you want to change. The parameter is highlighted
and the name above the slider changes to reflect that of the selected
parameter.
6. Do one of the following:
Tap the Up or Down arrows on the slider to set the desired
value for the parameter.
Tap the Calculator icon. The calculator appears (Figure 4.5).
Tap the setting you want and then tap Enter. The slider
displays the new settings.
7. Tap Accept to close the Apnea Settings screen and apply your
modifications. You will return to the Settings screen.
8. Tap Accept All to close the Settings screen. You will return to the
Main screen.
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Tapping Discard all in the Settings screen will discard the changes in the
Apnea settings even if you tap Accept in the Apnea Settings screen. You
have to tap Accept all in the Settings screen to apply the alarm settings
you changed
4.3. Starting and Stopping Ventilation

You can start and stop ventilation from the Clinical View, the Basic View or the
Basic Night View.
After setting the ventilation parameters, you can start ventilating the patient.
Do not ventilate a patient before verifying that the current settings are
correct.
To start ventilation while in Standby:
On the Main screen, tap the Start button.
To stop ventilation:
1. Perform one of the following option:
 On the Main screen tap Pause.
 On the side bar, tap Menu - Pause Ventilator.
A confirmation box is displayed.
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Figure 4.9: The Pause Ventilation Confirmation Box

2. Tap Pause to stop ventilation.
The ventilation stops.
4.3.1. Manual Breath

Note: The Manual Breath is displayed and can be initiated only when the device
is ventilating. It may be initiated from the Basic and Basic Night views also.
Manual Breath is an initiated ventilator breath. When you initiate a manual breath,
the iVent101 ventilator delivers the set mandatory breath. In CPAP/PSV the
settings of mandatory breath parameters in apnea ventilation are delivered. If the
apnea parameters have not been set in CPAP/PSV, the breath is delivered
according to the default settings.
For more details, refer to section E.2.1:Mandatory Breaths Types on page 133.
To activate a manual breath:
On the Side bar, tap Manual Breath. The manual breath is
delivered on the next inspiratory phase.
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4.4. Initiating and Releasing the Screen Lock
The iVent101 screen locks after it has not been used for a set period of time.
When locked, the iVent101 does not respond to tapping to prevent unintentional
change to the ventilation settings.
Note: When tapping several keys in rapid succession even with the screen lock
activated it might be possible to perform an action on the ventilator.
The initiation time can be set from the General Settings screen. The default time
is 3 minutes. To change the default time refer to section 4.6.3: Setting the on
page 68.
You can manually initiate the screen lock by tapping the Screen Lock icon
located at the bottom of the screen.
To release the screen:
1. Tap anywhere on the screen. The Screen Lock box is displayed.
Figure 4.10: The Screen Lock Box

2. Tap Unlock to release the screen lock.
Note: If you do not tap Unlock, the Screen Lock box disappears after 10 seconds.
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4.5. The Information Screen
To open the Information Screen:
Tap the Information ( ) button, located on the lower left side of the
screen.
Figure 4.11 The Information Screen

The Information screen contains the following information:
Software Version – The current software version installed on the device.
(The caption “Not Performed” will be shown always, regardless of the
software being updated).
Total PU Working Hours – The total working hours of the ventilator’s
pneumatic unit.
Last Calibration – Lists the date and time when the calibration procedure
was last performed.
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Last VVT – Lists the date and time when the VVT procedure was
performed. On the right side the status of the last VVT is displayed:
succeeded or failed.
Last OVT – The last time that OVT procedure was performed. On the
right side the status of the last OVT is displayed: succeeded or failed.
4.6. General Configuration

The General Configuration screen allows you to modify some of the iVent101
configuration. The settings which can be modified in this screen include:
Date and time – setting the time and date of the device. Refer to section
4.6.1 on page 66.
Sound levels – setting the alarms and buttons sound levels. Refer to
section 4.6.2 on page 67.
Screen lock – setting the time for the screen lock and the screen saver.
Refer to section 4.6.3 on page 68.
Enable O2 – enabling the O2 sensors and monitoring. Refer to section
4.6.4,on page 69.
Brightness – set the touch screen brightness. Refer to section 4.6.5 on
page 70.
To configure the iVent101 general settings:
1. From the Main screen tap Menu – General Config.
This option is also available in the Basic and Basic Night view
The General Configuration screen is displayed. The screen opens with the
last settings that have been modified.
2. On the left side of the screen tap the settings you want to configure. The
display on the right side is changed accordingly.
3. Change the settings and click Accept to close the screen
65
4.6.1. Setting the Time and Date
You can set the date and the time of the iVent101. Setting the time and date will
change the date display in the Main screen and in the logbook.
To set the Date & Time:
1. In the General Configuration screen tap Date & Time. The Set Date
and Time panel is displayed on the right side of the screen.
Figure 4.12: The Set Date and Time Panel

2. Tap the down or up arrows of the settings you want to change: Year,
Month, Day, Hour, or Minute.
Note: When changing the date, it may be possible to select a non-valid date
(such as 31-Feb). The ventilator, however, will not accept it, and the date will
remain the same.
3. Verify that the date and time you have inserted are the correct ones.
66
4. Tap Accept to save the settings and to close the screen.
5. Examine the time and date display at lower right side of the Main screen
to verify that the date and time have been changed and that they are
correct.
4.6.2. Setting the Sound Levels

In this panel the button volume (the sound heard when tapping a button) or the
alarm sound can be adjust.
Make sure that the alarm can still be heard easily where caregivers are
located when you lower the alarm sound level. If the Alarm is not
heard increase the sound level.
To set the Sound levels:
1. In the General Configuration screen tap Sound Levels. On the right
panel two sliders are displayed: Button Volume and Alarm volume.
Figure 4.13: The Sound Levels Panel
67
2. Tap the down or up arrows on each slider to change the sound level. The
slider displays the sound level accordingly, and a click is heard at a
volume corresponding to the current displayed sound level.
3. Tap Accept to save the settings and to close the screen.
4.6.3. Setting the Screen lock and Screen Save

The default setting of the automatic screen lock is 3 minutes. This time can be
adjusted to a value between 1 to 60 minutes, or it can be disabled. In addition, you
can enable or disable a screen saver when the screen is locked. If the screen saver
is enable you can choose to dim the screen display or to turn off the screen
display while the screen is locked.
To change the auto lock screen settings:
1. In the General Configuration screen tap Screen Lock. The Auto Lock
Screen slider is displayed on the right panel.
Figure 4.14: The Auto Lock Screen Panel
68
2. Tap the down or up arrows to change the screen lock time. The slider
displays the time accordingly.
Select the Disable Auto Lock to enable or disable the screen lock (works as a
toggle). When the box is selected the automatic activation of the lock screen is
disabled.
If you enabled the screen lock the screen saver options are displayed.
Note: the screen-saver options are not available when the Auto Lock is disabled.
3. Select the Enable Screen Saver box to enable or disable the screen-saver (works as a
4. Tap the relevant screen saver option you want: Dim or Screen Off.
5. Tap Accept to save the settings and close the screen.
4.6.4. Enabling the O2 sensor

By default the O2 sensor, as well O2 monitoring, are disabled, preventing false O2
alarms. You can enable O2 measurement which allows monitoring and alarming
for the delivered FiO2.
To enable the O2 monitoring functionality:
1. In the General Configuration screen tap Enable O2. The Enable O2 box
is displayed on the right panel.
69
Figure 4.15: The Enable O2 Panel

2. Select the box to select or clear it (works as a toggle). When the box is
selected the O2 measurement functionality is enabled.
4.6.5. Setting the Screen Brightness

You can change the screen brightness and set it to the level that is suitable for
your sight. Lower brightness settings will also increase battery life.
Note: Changing the brightness will affect all the views and screen display on the
touch screen.
To set the screen brightness:
1. In the General Configuration screen tap Set Brightness. The Brightness
slider is displayed on the right panel.
70
Figure 4.16: The Brightness Panel

2. Tap the down or up arrows to change the brightness level. The slider
displays the brightness level accordingly.
71
4.7. Changing to Graph Tab

The Graph tab displays the waveforms of two ventilation parameters if you are in
the Clinical View screen:
Pressure: Circuit pressure delivered to the patient.
Flow: Airflow delivered to the patient. Exhaled flow is also
shown when dual limb circuits are used.
Figure 4.17: The Graph Tab

To switch to graph tab or to numerical tab:
Tap the Tab icons located below current measurement or the
graphs area on the main screen of the Clinical View screen.
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Chapter 5: Alarms
When the iVent101 ventilator detects a condition that requires your intervention,
an alarm sounds and a large message box appears that describes the alarm, often
including recommendation for possible solutions as well.
This chapter includes:
Alarm Priorities: Explanation of alarm severities along with the
alarm sound and pop-up screen associated with each severity.
Refer to section 5.1, below.
Setting the Alarm Parameters: Lists the alarms parameters that
can be set. Refer to section 5.2 on page 74.
The Alarm Display Screen: describes the Alarm screen and how
to suspend the audio alarm. Refer to section 5.3 on page 78.
Alarm Definition and Troubleshooting: List of alarm definitions
and the corrective actions that should be performed for each alarm.
Refer to section 5.3 on page 78.
The Log Book: Describes the iVent101 ventilator logbook. Refer
to section 5.6 on page 92.
5.1. Alarm Priorities

The iVent101 ventilator supports three alarm priorities, according to severity:
PRIORITY AUDIBLE VISUAL WHEN THE ALARM IS WHEN THE
SIGNAL SIGNAL ACCEPTED: ALARM IS
CLEARED:
High 5 tone high Red pop- The alarm screen is closed and The alarm is
priority alarm up screen. the alarm is displayed in red at cleared from the
signal the top of the alarm list on the Main screen.
right side of the Main screen.
Mid 3 tone mid Yellow The alarm screen is closed and The alarm is
(medium) priority Alarm pop-up the alarm is displayed in yellow cleared from the
signal screen. on the Alarm list on the right side Main screen.
of the Main screen.
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Alarms
PRIORITY AUDIBLE VISUAL WHEN THE ALARM IS WHEN THE
SIGNAL SIGNAL ACCEPTED: ALARM IS
CLEARED:
Low -- Yellow The Alarm screen is closed and The alarm is
pop-up the alarm is displayed at the cleared from the
Screen. bottom of Alarm list on the right Main screen.
side of the Main screen.
5.2. Setting the Alarm Parameters

Only doctors and qualified clinicians should change alarm settings.
You can set the parameters of the clinical alarms, which detect and notify
significant changes in ventilation. Alarm settings allow both upper and the lower
limits of the normal ventilation range. Ventilation exceeding the set range results
in an alarm condition.
For a list of the alarms parameters that can be modified, refer to section 1.9.12:
User Adjustable Alarms on page 21.
Note: The iVent101 ventilator sets the parameters automatically according to
patient type.
To set the alarms parameters:
1. On the Main screen tap Settings – Alarms.
The Alarm Settings screen appears, and the settings and current parameters of
the following alarms settings are displayed.
Rate (Respiratory Rate)
PIP (Peak Inspiratory Pressure)
MV (Minute Volume)
Apnea
FiO2
Patient Disconnect
74
Figure 5.1: The Alarm Settings Screen

The underlined numbers on the slider display the current alarm settings.
2. Tap the parameter you want to change. The name of the parameter appears
above the enlarged slider on the right, and the Alarm Calculator icon
appears to the right of the enlarged slider.
3. Modify the alarm setting according to the table below:
ALARM MODIFYING PROCEDURES
Rate Tap the High button to set the upper alarm

limit. Do one of the following:
PIP
Tap the Up or Down arrows on the slider until the
MV setting is correct.
FiO2 Tap the Calculator icon. The calculator appears (Figure
4.5). Tap the setting you want and tap Enter. The
enlarged slider on the right side and the smaller one on
75
Alarms
ALARM MODIFYING PROCEDURES
the left side will both display the new settings.
Tap the Low button to set the lower alarm limit. Do
one of the following:
Tap the Up or Down arrows on the slider until the
setting is correct.
Tap the Calculator icon. The calculator appears (Figure
4.5). Tap the setting you want and tap Enter. The
enlarged slider on the right side and the smaller one on
the left side will both display the new settings.
Apnea Tap the Calculator icon. The calculator appears

(Figure 4.5). Tap the setting you want and tap Enter.
The enlarged slider on the right side and the smaller
one on the left side will both display the new settings.
Patient Tap the On/Off button.

Disconnect Tap the slider Up (on) or Down (off).
When you disable the Patient Disconnect alarm a
warning message appears (see Figure 5.2). Tap OK to
disable the Patient Disconnect alarm.
76
Figure 5.2: Patient Disconnect Warning Box
Occasional significant leak conditions might result in nuisance

disconnect alarms. Alternate alarms should be set in this case to alert
caregivers of diminished ventilation if the disconnect alarm is turned
off.
Note: You cannot set the upper alarm limit below the lower limit, or set the
lower limit above the upper limit.
4. Tap Accept to close the Alarm Settings and apply your modifications.
The Alarm settings screen is closed and the Settings screen is then
displayed.
5. In the Settings screen tap Accept. The Settings screen is closed and the
Main screen is then displayed.
Tapping Discard all in the Settings screen will discard the changes in the
Alarms settings even if you tap Accept in the Alarm Settings screen. You
have to tap Accept all in the Settings screen to apply the alarm settings
you changed.
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Alarms
5.2.1. Setting the Alarm Volume

You can set the alarm volume, turning it up or down according to the ventilator’s
surroundings.
You change the alarm volume in the General Configuration screen. Refer to
section 4.6.2: Setting the Sound Levels on page 67, for instructions.
Exposure to the alarm sound at maximum volume for prolong time

may affect your hearing.
5.3. The Alarm Display Screen

A large Alarm screen is displayed when a new alarm is activated. The screen
contains a short explanation of the alarm and offers remedies recommendation.
You can silence the alarm sound from this screen for 30 seconds or close the large
alarm screen.
VersaMed recommends silencing an alarm only after trying to rectify the
condition that prompted it.
78
Figure 5.3: The Alarm Screen

To suspend an audible alarm sound:
1. Tap the Suspend (Bell icon) button on the screen.
Note: After tapping the Suspend button, it may take a few seconds for the
alarm sound to stop.
While the alarm sound stops for 30 seconds, the visual alert for the alarm
continues to be displayed. .
2. Tap the Close button on the Alarm Alert screen to close the screen and
return to the Main screen.
The alarm is then displayed in the Alarm area on the upper right corner of the
Main screen. See Figure 5.4 below.
79
Alarms
Figure 5.4: The Main Screen with two Active Alarms

If there is a high priority alarm the audible and visual large alarm screen will
reappear in 30 seconds if not corrected. Alternately there is an Alarm suspend
(bell) icon displayed on the top of the alarm display area on the Main screen,
which can suspend the alarm sound for 2 minutes. This Alarm suspend can be
used to pre-silence the alarm sound for 2 minutes if the caregiver is about to
institute care that is known to cause inappropriate alarms.
3. Tap the Suspend button on the Main screen to suspend the alarm sound
for two minutes.
Figure 5.5: The Alarm Icon with the 2 minutes countdown

After two minutes, if the alarm has not been cleared, the alarm screen
reappears, and the alarm sound is heard again.
80
4. The Alarm suspend can be turned off when the alarm condition is
corrected. Tapping the Alarm suspend icon again will turn off the Alarm
suspend icon on the Main screen and restore the audible alarm
functionality.
5.4. Alarm Definition and Troubleshooting

Note: when an alarm is activated, first and foremost check the patient’s status and
well-being. Verify that patient is well and being ventilated properly. If not, take
action to resolve the situation.
Notes:
1. Only qualified clinicians should modify the clinical settings of the
iVent101.
2. When changing a limit of an alarm that is currently active to meet the
current ventilation conditions the alarm will not clear immediately, but
will take several breaths to clear.
3. While the appearance of breath based alarms such as low/high rate and
low/high minute volume is limited by time, it can also include a slight
delay related to the set rate.
4. If the pressure tube of a single limb circuit is disconnected, a false patient
disconnect alarm may appear.
A medium priority alarms can indicate a more serious problem. Check

the cause of the alarm according to table, and take the recommended
corrective actions.
Note: The iVent101 ventilator sends a signal to a remote monitoring station if

utilized immediately when an alarm is activated. A remote monitoring station
receives the alarm signal without any other delays than those specified in the table
below.
81
Alarms
The following table displays the iVent101 ventilator alarms. The value in
parenthesis, either in the Activated or Cleared column, represents the delay
between the alarm condition and the ventilator response.
82
ALARM PRIORITY ACTIVATED WHEN PROBABLE CAUSE CORRECTIVE ACTION CLEARED WHEN
AC POWER Medium AC power failure If not intentionally Connect the ventilator to an The AC power is
DISCONNECT occurs, and the disconnected the alternative AC outlet. restored.
ventilator switches alarm might indicate a Verify the connection. (Immediately)
automatically to the failure in the AC
internal battery or power source, a Replace the electrical cord.
external DC. failure in the electrical Change to DC external power
(Immediately) cord, or internal source.
failure
APNEA High No breath is detected The patient clinical Verify that the patient is Spontaneous
during the apnea situation – when the adequately ventilated. triggers are
interval (as set by the ventilator is not Check the changes in the detected.
operator). detecting the patient patient symptoms and vital (After one minute,
(Immediately) efforts or when the signs. when three patient
mandatory breath spontaneous
rate is set too low. Verify appropriate sensitivity
trigger settings breaths are
detected).
Set a higher rate.
BATTERY High The integrated battery The ventilator Connect the ventilator to When an external
EMPTY nearly depleted – only operates with the external power source (AC or power source (AC
a few minutes of integrated battery DC), and recharge the or DC) is
ventilation left. only and the battery is battery. connected.
(Immediately) nearly depleted. (Immediately)
EMERGENCY High System switches to Hardware malfunction Assess the patient, Remove The ventilator
BACKUP Open Loop mode. or invalid sensors from the ventilator and returns to normal
(Immediately) calibration. provide alternative means of ventilation
ventilation if not sufficient. (immediately)
Follow the service notice
instruction (which follow the
Open Loop message)
83
Alarms
FACTORY Low Factory calibration is Calibration has not Have a qualified technician Factory calibration
CALIBRATION missing or invalid been performed, or perform factory calibration passed
REQUIRED internal malfunction. successfully.
HIGH FIO2 Medium Oxygen concentration Improper alarm Verify acceptable patient FiO2 is below the
exceeds the upper setting, a change in condition. alarm setting.
limit. the patient breathing Adjust the alarm setting. (4 breaths)
(One minute - see pattern, O2 sensor is
Verify the O2 concentration
note 2 below) out of calibration.
with an external analyzer.
Refer the ventilator to
qualified service technician
for calibration.
HIGH Medium The ventilator internal Block in the cooling Replace Air Inlet Filter. Internal
TEMPERATURE temperature has vents of the iVent101 Verify that the cooling vents temperature
exceeded 65ºC ventilator, high are clear and clean. decreases below
external heat, or 65ºC.
internal malfunction. Protect the iVent101
ventilator from external heat (Immediately)
source.
Refer the iVent101 ventilator
to qualified service personnel.
HIGH MINUTE Medium Minute Volume The patient clinical Check the patient condition. Volume is below
VOLUME exceeds the upper condition, alarm Increase the upper limit of the the alarm setting.
limit. setting too low, or the alarm setting. (2 breaths or 30
(One minute - see breath rate too high. seconds, whichever
Decrease the trigger
note 1 below) sensitivity. occurs first).
84
HIGH High 2 continuous events Patient agitation or Adjust the alarm setting. The pressure is
PRESSURE of High Pressure coughing, poor Assure no tubing occlusions below the alarm
synchronization setting.
between the ventilator More actions are subject to
clinical judgment. (One breath).
settings and patient
breathing, incorrect
alarm setting, circuit
or trachea tubes
occluded.
HIGH Medium Respiration exceeds Escalation of the Check the patient condition. Rate is lower the
RESPIRATORY the upper rate limit. patient breath rate, or Increase the alarm setting. alarm setting.
RATE (One minute – see if the iVent101 (Two breaths)
ventilator is auto- Decrease the trigger
note 1 below) sensitivity or the set breath
triggering.
rate.
INTEGRATED Medium Integrated battery Integrated battery Replace the integrated Integrated battery
BATTERY readings are invalid malfunction or battery. readings are valid
FAILURE (Immediately) disconnection, burned If the problem continues with (Immediately)
fuse. a new battery refer the
ventilator to qualified service
technician.
LOST LAST Low The last APNEA Internal malfunction Turn the ventilator off and Apnea settings are
APNEA settings cannot be then turn it on again. valid.
SETTINGS read If the problem persists modify (Immediately)
(Immediately) the settings again to match
the previously prescribed
settings.
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Alarms
LOST LAST Medium The last Clinical Internal malfunction Turn the ventilator off and Clinical settings are
CLINICAL (ventilation) settings then turn it on again. valid.
SETTINGS cannot be read If the problem persists modify (Immediately)
(Immediately) the settings again to match
the previously prescribed
settings.
LOST LAST Low The last Technical Internal malfunction Turn the ventilator off and Technical
TECHNICAL configuration cannot then turn it on again. configuration
CONFIGURATION be read settings are valid.
If the problem persists refer
(Immediately) the ventilator to qualified (Immediately)
service personnel.
LOST LAST USER Low The last user Internal malfunction Turn the ventilator off and Technical
CONFIGURATION configuration cannot then turn it on again. configuration
be read If the problem persists match settings are valid.
(Immediately) the previously prevailing (Immediately)
settings.
LOW BATTERY Medium Integrated battery Ventilator operates Connect the ventilator to an When an external
running low, about 20 without external external power source (AC or power source (AC
minutes left. power source (AC or DC). or DC) is
(Immediately) DC). connected
(Immediately)
LOW FIO2 High Oxygen concentration Alarm setting too Check the oxygen supply. FiO2 is above the
is below the lower high, low or no Decrease the lower limit of alarm setting.
alarm limit. oxygen flow, out of the alarm setting.
calibration, high (Four breaths)
(One minute - see Refer the ventilator to
note 2 below) variability in the
patient breathing. qualified service technician
for calibration.
86
LOW MINUTE High Minute volume is A big leak, decrease Check the patient condition. Volume exceeds
VOLUME below the lower in the patient minute Increase ventilation. the alarm setting.
minute volume limit. volume or the lower (Four breaths)
limit of the alarm is Decrease the lower limit of
(One minute - see the alarm setting.
note 1 below) set too high, or might
indicates internal
malfunction of the
ventilator.
LOW Medium Airway pressure Patient clinical Verify that the patient circuit Pressure exceeds
PRESSURE never reaches the condition, incorrect is connected. the alarm setting.
lower pressure limit alarm setting, patient Correct the alarm setting. (One breath)
during inspiration. disconnect, high leak.
More actions are subject to .
(Three breaths or 30 clinical judgment.
seconds, whichever
occurs first)
LOW High Respiration is below Patient clinical Check the patient condition. Rate is higher than
RESPIRATORY the lower rate limit. condition, trigger Decrease the alarm setting. the lower alarm
RATE (One minute - see sensitivity set too low, setting.
set rate too low, Increase the trigger sensitivity
note 1 below)) or the breath rate. (Two breaths or
alarm setting too one minute,
high. whichever is last).
O2 Low O2 calibration is Calibration has not Disable the O2 monitoring O2 monitoring is

CALIBRATION missing or invalid been performed, or and have a qualified service disabled, or O2
REQUIRED internal malfunction personnel perform O2 calibration passed
calibration. successfully/
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Alarms
O2 SENSOR Low O2 sensor is O2 sensor is Disable the O2 monitoring O2 sensor is
DISCONNECT disconnected. disconnected. and have the O2 sensor connected, or O2
replaced by a qualified monitoring is
service personnel. disabled
O2 SENSOR Low O2 sensor Aged O2 sensor or Disable the O2 monitoring O2 calibration
WORN OUT parameters are out of malfunctioning. and have the O2 sensor passed
scale. replaced by qualified service successfully, or O2
personnel. sensor is
disconnected, or
O2 monitoring is
disabled
OCCLUSION High 5 breaths in which Occlusion in the Check patient circuit and After 1 breath
occlusion is detected patient circuit or remove occlusions.
- see note 2 below) exhalation valve Check and clean the
Exhalation valve.
OVT Low Patient Tube Testing Patient circuit Check Patient circuit OVT passes
RECOMMENDED failed, or no data of connections, connections, perform Patient successfully
valid test. Exhalation valve not Tube Testing, check the
properly assembled, exhalation valve assembly
or Patient tubing test
has failed.
PATIENT High Loss of patient Patient or tubing Reconnect the tubing Reconnection of
DISCONNECT resistance or loss of disconnected or a Reconnect the patient. the patient is
exhaled volume. very large leak in the detected.
patient circuit, Correct the leak or revise
settings. (Immediately).
improper settings.
SENSORS Low Sensors calibration is Calibration has not Have a qualified technician Sensors calibration
CALIBRATION missing or invalid been performed, or perform factory calibration passed
REQUIRED internal malfunction successfully
88
SERVICE High A technical Power surge, multiple Provide alternative The system failure
NOTICE irregularity occurs sensor disconnection, ventilation. Turn the that caused the
that requires a needed calibration, or ventilator off and then turn it Service notice is
qualified technical other malfunctions. on again. fixed.
service. If the problem persists refer (Immediately)
(Immediately) the ventilator to qualified
service personnel.
SET PRESSURE Medium In Pressure control, Decreased patient Check the patient. The set pressure is
NOT Adaptive Bi-level, or effort or lung Checks for leaks. achieved for 2
DELIVERED CPAP/PSV mode – compliance, pressure consecutive
the monitored mode settings too high, or Reduce the pressure setting if breaths.
is 5 cmH2O or 25% may indicate internal applicable.
below the set malfunction in the
pressure (whichever ventilator.
is greater)
(8 consecutive
breaths - see note 2
below)
VOLUME LIMIT Medium In pressure control Increased patient Check the patient. The limit volume
REACHED mode - the set effort or lung Reduce the inspiratory has not been
volume limit has been compliance, or too pressure or pressure limit reached.
reached. low of a limit setting. setting. (one breath)
(8 breaths, or 20 Increase the volume limit.
seconds, whichever
occurs first - see note
2 below)
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Alarms
VOLUME NOT Medium In Volume control Decreased patient Check the patient. The volume has
DELIVERED mode – the set effort or lung Check for occlusions. been reached for 2
volume has not compliance, or conclusive breaths.
delivered. volume setting to Reduce the volume setting if
high. applicable.
(8 breaths or 20
seconds, whichever
come first - see note
2 below)
VVT Low VVT failed, or no data Internal malfunction Provide alternative VVT passes
RECOMMENDED of valid VVT. ventilation. Turn the successfully
ventilator off and then turn it
on again.
Refer the ventilator to
qualified service personnel.
Notes:
1. Alarms conditions are checked after 30 seconds have elapsed from ventilation initiation or patient
reconnection after disconnect or ventilation settings change.
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iVent101Operator Manual
5.5. Alarm Tests

You need to test the following alarms every three months to verify the alarms
system functioning:
Patient Disconnect
AC Disconnect
A full alarm tests will be performed by a qualified technician as part of the
annually Preventive Maintenance procedures.
To test iVent101 alarms:
1. Connect the iVent101 ventilator to AC power. Refer to section 2.6:
Connecting the Ventilator to an AC Power Source on page 35.
2. Assure the iVent101 ventilator is on and ventilating (not is Standby
mode). Refer to section 4.3: Starting and Stopping Ventilation on page 61.
The alarm tests are as follows:
3. AC Disconnect: Disconnect the AC cable from the iVent101 ventilator.
Verify that the AC Disconnect alarm is activated.
Reconnect the AC cable to the iVent101 ventilator, and verify that AC
Disconnect alarm stops automatically.
Do not test the Patient Disconnect alarm while the patient is connected
to the iVent101 ventilator.
4. Patient Disconnect: Disconnect the patient circuit tubing from the
Inspiratory Outlet Port (refer to Figure 1.1 on page 8). Verify that the
Patient Disconnect alarm is activated.
Reconnect the patient circuit tubing to the Inspiratory Outlet, and verify
that the Patient Disconnect alarm stops automatically when ventilating a
test lung or simulated patient resumes.
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Alarms
5.6. The Log Book

Events are registered in the iVent101 log book when:
A setting is enabled or an alarm sounds.
The operator adjusts the ventilator.
The logbook stores events for at least 72 hours, on the hardware board.
To view the Log book:
1. Tap Menu – Log Book.
Note: this option is also available from the Basic View and Basic Night
View.
The Log Book screen appears.
Figure 5.6: The Log Book Screen
92
The events on the Logbook are ordered chronologically. The date and time of
the event are written on the left side of the screen, and the event description on
the right.
2. Tap the fast-upward and fast-downward buttons to browse
the Logbook by a page. Tap the Upward or Downward

buttons to move between adjacent single entries.
3. Tap the Close button the exit from the Log Book screen.
93
Alarms
Notes:
94
Chapter 6: Maintenance
This chapter covers the maintenance and test procedures you perform on the
iVent101 ventilator.
These procedures include:
Cleaning and maintenance procedures, refer to section 6.1 below.
Performing the Ventilation Circuit Test, refer to section 6.2: Ventilation
Circuit Test , page 104.
Note: When moving the iVent101 ventilator, make sure that you hold it with both
hands and not just by the handle.
6.1. Cleaning and Maintenance Procedures
6.1.1. Cleaning Procedures

The iVent101 ventilator is designed to resist damage, staining, and wear. The
following routine cleaning procedure is recommended.
PART PROCEDURE COMMENTS
Ventilator Wipe the exterior with a damp Refer to section 6.1.4:
cloth and mild detergent Cleaning the ventilator on page
98
Air Inlet Filter Replace every month. Refer to section 2.3: Attaching
Air Inlet Filter on page 31.
Do not attempt to clean or
reuse the air inlet filter.
Battery Pack Recharge every 180 days or Refer to section 6.1.6:
after prolonged storage. Integrated Battery
Charging will take place during Maintenance on page 102.
normal usage.
Exhalation Valve Remove and clean once per Refer to section 6.1.5
month or more frequently as 6.1.4:Exhalation Valve
necessary when high humidity Maintenance, page 98
or nebulized medications are
used.
95
Maintenance
PART PROCEDURE COMMENTS
O2 Sensors Replace every 1year or as Refer to the Service Manual
needed.
6.1.2. Preventive Maintenance

The following preventive maintenance procedures are recommended within the
time frame listed in the table below.
FREQUENCY PART / PROCEDURE MAINTENANCE
Patient circuit test (OVT) Perform the patient circuit test
using the newly connected
With every replacement of a patient circuit.
patient circuit Refer to section 6.2:
Ventilation Circuit Test on
page 104
Air inlet filter Replace the air inlet filter with
a new one.
Refer to section 2.3: Attaching
Air Inlet Filter on page 31:
Monthly
Exhalation valve Clean the exhalation valve.
Refer to section 6.1.5:
Exhalation Valve Maintenance,
on page 98
Exhalation valve membrane Replace the exhalation valve
membrane with a new one.
Refer to section
6.1.4:Exhalation Valve
3 months of operation Maintenance, page 98.
Alarms test Perform the alarms test.
Refer to section 5.5: Alarm
Tests, page 91.
Integrated battery Fully discharge and recharge
the battery. Refer to section
6 months of operation
6.1.6: Integrated Battery
Maintenance, page 102.
O2 Sensor (1) Calibrate if used, performed by
authorized service technician.
96
FREQUENCY PART / PROCEDURE MAINTENANCE
Ventilation Verification Test VVT procedures, performed by
(VVT) an authorized service
technician.
Calibration and alarm tests Perform all calibration
procedures, and all alarm
tests, performed by authorized
service technician.
Exhalation valve Replace the exhalation valve
with a new one. Refer to
Annually section 6.1.4:Exhalation Valve
Integrated battery (2) Replace the integrated battery.
Refer to section 6.1.6:
Integrated Battery
Every 10,000 operating hours Pneumatic unit Replace the unit by an
authorized service technician.
(1) Performing O2 sensor calibration at a higher frequency interval than

recommended above will assure improved measurement accuracy.
(2) Replacement frequency interval of the integrated battery is dependent on its
usage profile, and may be delayed when rarely used.
6.1.3. Preventive Maintenance Service Parts

The following service parts are available to the operator in order to perform
preventive maintenance:
DESCRIPTION VERSAMED GE
PART NUMBER PART NUMBERS
Two Limb disposable Patient 900P0101-01 M1184227
Circuit kit (X 10)
Air filter 660BL001-01 M1184151
Two Limb Kit 900BL007-01 M1184153
One Limb Kit 504BL051-01 M1184155
Integrated Battery 900BL006-01 M1184149
97
Maintenance
In order to obtain the full service parts list, please refer to the service manual.
6.1.4. Cleaning the ventilator

Clean the exterior of the ventilator when necessary with a soft damp cloth
moistened with one of the following cleaning solutions:
Water
Mild detergent or soapy water
Medical grade 70% alcohol.
Do not allow liquid to penetrate into the ventilator.
6.1.5. Exhalation Valve Maintenance

The exhalation valve should be cleaned and sterilized prior to being
used on different patient.
The exhalation valve should be cleaned and sterilized once a month.
The exhalation valve should be cleaned prior to sterilization.
To clean the exhalation valve:
1. Disassemble the exhalation valve as instructed on page 99.
2. Put the exhalation valve components in a bath of hot tap water with a
commercial soap liquid (between 50° - 60° C) for 10-15 minutes.
3. Remove debris from all exhalation valve surfaces.
4. Rinse the exhalation valve components with tap water for 1-2 minutes.
5. Dry the exhalation valve components before reassembling the exhalation
valve, as instructed on page 101.
98
To sterilize the exhalation valve:

Sterilization of the exhalation valve components should follow the
individual institution and guidelines for Steam sterilization (recommended
parameters - 134°C for 6 Minutes).
Note: These parameters have been validated for 100 steam autoclaves cycles.
To disassemble and reassemble the exhalation valve:

1. Carefully place the ventilator on its rear panel.
2. Remove the exhalation compartment cover. (Figure 6.1)
Figure 6.1: The Exhalation Cover on the lower panel

3. On the exhalation compartment, turn the locking lever
through 90 degrees to release the exhalation valve (see
Figure 6.2 and Figure 6.4).
99
Maintenance
Lever
handle
Figure 6.2: Unlocking the exhalation valve lever

4. Carefully pull the release lever to disengage the
exhalation valve from the exhalation compartment (see
Figure 6.4 and Figure 6.4).
Lever
handle
Figure 6.3: Releasing the exhalation valve
100
Figure 6.4: The Exhalation Valve
5. Release the latch from the cover and detach the cover and
the membrane (see Figure 6.4).
6. Clean the exhalation valve or put it in the sterilization
device, as instructed above.
7. Replace the membrane if needed.
The Exhalation membrane has to be replaced every 3 months.
8. Re-assemble the exhalation membrane and cover. Note
the exhalation membrane asterisk should be facing the
cover asterisk. You do not have to push the membrane
into its place, just to place it inside the cover and the
membrane will seat when the cover is pressed on.
9. Open the cover. Verify that the membrane sits in its
place.
Note: you have to verify that the membrane is in its place before continuing
the assembly.
10. Close the cover.
11. Close the latch and verify that the cover is closed.
101
Maintenance
12. Insert the exhalation valve back into the exhalation
compartment ensuring the pneumatic connectors are
properly engaged.
13. Rotate the locking lever and turn the lever back through
90 degrees in order to lock the exhalation valve in
position.
14. Place the exhalation valve compartment cover back in
position.
6.1.6. Integrated Battery Maintenance

The integrated battery is automatically charged when attached to an external
power source, regardless of whether the ventilator is operating, in Standby mode,
or switched off.
You must fully recharge the battery to maximize the battery life in the following
cases:
Prior to initial use.
After prolonged storage.
Every 180 days during normal usage.
Note: When the Empty Battery alarm message is displayed, you must
immediately recharge the battery. If not, it will lead to battery failure and affect
the battery charging capability.
This procedure requires as much as 24 hours to complete.
To recharge the battery:
1. Assure that the AC power cord has been plugged into the ventilator and
the battery is fully charged. On the front panel of the iVent101 ventilator
(Figure 1.1), the Charging light will be either yellow, indicating that the
battery is charging or blue if already fully charged.
2. Assure that the battery has been charged for at least 10 hours.
102
3. If the ventilator was shut down then turn it on.
4. Connect the iVent101 ventilator to a patient circuit attached to an Rp20
resistor and reservoir bag. Refer to section 2.2: Patient Circuit, page 27.
Note: You may connect the iVent101 ventilator to the patient at this time, if
needed.
Adequate supervision is necessary to assure reattaching the A/C Power

when the battery alarm sounds.
5. Tap Start.
6. Disconnect the AC power cord from the power source and continue to
ventilate.
The Battery icons at the bottom of the Main screen change to reflect the
diminishing charge left in the battery. Refer to section 2.1: Understanding
The Ventilator Power Sources, page 25, for an explanation of these icons.
7. When the Low Battery alarm message is displayed, (after approximately 4
or 8 hours, depending on battery type and the ventilation settings) tap
Silence.
Note: Allowing the ventilator to discharge until you see the Empty Battery
alarm can increase the discharge recharge efficiency and improve battery life.
Be sure to provide close supervision to quickly reattach A/C power at the
Empty Battery alarm if you choose to use this method. Ventilation after the
Empty Battery alarm can be compromised although the ventilator will attempt
to deliver ventilation until power is no longer available.
8. Connect the AC power cord at the back panel (Figure 1.2), and recharge
the battery for at least 10 hours. The charge indicator should be yellow
during charging and blue when charged.
The Fully Charged icon is displayed on the Main screen. If the Fully
Charged icon is not displayed, you need to replace the battery.
103
Maintenance
To replace the integrated battery:

1. At the back of the iVent101 ventilator (Figure 1.2), unscrew the two
battery knobs until the knobs roll freely.
2. Pull both knobs to remove the battery from the iVent101 ventilator.
3. Insert a new integrated battery so that the wider part of the battery is on
the right side. Note: It is not possible to insert the battery incorrectly.
4. Screw the battery knobs into the iVent101 ventilator to tighten them.
5. Recharge the battery according to the procedure described above.
Note: The ventilator allows you to replace the battery during battery operated
ventilation (Hot Swap), using an additional small internal battery. This battery
cannot maintain ventilation, but will keep the current ventilation settings.
Ventilation will stop until a new battery is placed. When a new battery is
connected the ventilation will resume immediately
Assure that alternative means of ventilation is available or that the

patient can be sustained during the Hot Swap process since ventilation
will not continue until power is re-restored.
6.2. Ventilation Circuit Test

You must check the integrity of the patient circuit each time it is connected to the
iVent101. The following Test checks the patient circuit integrity is a simple and
quick test. Note that this test is also referred as OVT.
To Perform the Patient Tube Test:
1. From the Main screen tap the (Ventilation Circuit Test) button.
Note: This button is also displayed on both the Basic View and Basic Night
View screens.
The Patient Tube Testing screen is displayed.
104
Figure 6.5: The Patient Tube Testing screen

2. Seal the patient wye using the red sealing cap (supplied by VersaMed).
3. Tap Start. The iVent101 performs the automated tests. After
approximately 30 seconds the following screen is displayed:
Figure 6.6; Patient Tube Testing pass

4. Tap Close to close the Patient Tube Testing screen.
105
Maintenance
5. Remove the plastic cap from the patient wye.
If the Test fails:

Verify that you sealed the circuit wye properly and repeat the test.
Replace the patient circuit and repeat the test.
Remove and inspect the exhalation valve membrane. Replace if necessary
and repeat the test.
Refer the ventilator to qualified service personnel.
Do not ventilate the patient with a ventilator that failed the Ventilation
Circuit Test.
6.3. Service Screens

Only trained personnel should change the settings in the Service
screens and perform calibration.
Note: For a description of the Service screens refer to the Service Manual.
106
Chapter 7: Troubleshooting
The iVent101 has a built-in safety and internal monitoring mechanism whose
purpose is to ensure the patient is safely ventilated, detect internal faults, and
initiate recovery when possible.
In the table below is a list of fault scenarios, their possible causes, and suggested
solutions.
Note: when an alarm is activated, first and foremost check the patient’s status and
well-being. Verify that patient is well and being ventilated properly. If not, take
action to resolve the situation.
Note: Whenever the ventilator is restarted (intentional or unintentional) the

prevailing settings prior to shutdown are automatically reloaded.
CONDITION POSSIBLE CAUSE SUGGESTED SOLUTION
Refer to section 5.4: Alarm

An alarm message Depends on the alarm Definition and
popped up. message. Troubleshooting, on page
81.
The alarm sound Refer to section 4.6.2:

The alarm audio alert is
levels are not set Setting the Sound Levels, on
too weak or too loud.
correctly. page 67.
The touch-screen Refer to section 4.6.5:

The touch-screen display Setting the Screen
brightness is not set
is too bright or too dim. Brightness, on page 70.
correctly.
107
Troubleshooting
1. Verify that the patient
is being ventilated.
2. The SW should auto
recover the problem in
The ventilator is up to 20 seconds.
ventilating and the 3. If the problem persists
display is visible, but the provide alternative
Internal malfunction
touch-screen does not means of ventilation.
respond to the operator’s 4. Turn the ventilator off
tapping and then on again.
5. If the problem persists
contact qualified
service personnel.
The ventilator is Power up the ventilator.
turned off.
The ventilator is not
ventilating, the touch- Connect the ventilator to an
screen is black without AC power supply and power
any display, and the There is no power it up.
green LED is off. supply to the device
Let the integrated battery
charge.
108
1. Check the ventilator
connection to power
ventilating, the touch-
and provide power if
screen is black without
found missing.
any display, but the
2. If the splash screen is
ventilator is turned on,
visible within 10
and a constant beep can
seconds, it is very
be heard.
likely that the
ventilation will resume
automatically within 20
No AC power to 30 seconds.
connected, and the 3. If the problem persists
integrated battery has Provide alternative
just been depleted, or means of ventilation.
internal malfunction 4. The device should
recover completely
within 50 to 60 seconds
from the onset of the
condition. If not turn
the ventilator off and
on again.
refer the ventilator to
qualified service
personnel.
109
Troubleshooting
1. Tap the touch-screen
The ventilator is
ventilating, but the touch- several times.
2. The device should
screen is black without
recover completely
any display, an
within 50 seconds from
alternating beep sound
the onset of the
may be heard. Screen saver is on, or condition. If not turn
internal malfunction the ventilator off and
on again.
qualified service
personnel.
1. If there is no visible
alarm it is very likely
ventilating, but the
display is visible, and a that the ventilation will
resume automatically
constant beep sound can
within 2 to 5 seconds.
be heard. Accompanying
alarms may be displayed. 2. If the problem persists
provide alternative
means of ventilation.
3. The device should
Internal malfunction recover completely
within 50 to 60 seconds
from the onset of the
condition. If not turn
the ventilator off and
on again.
qualified service
personnel.
110
1. Disconnect the
The exhalation valve
exhalation valve, and
was re-assembled
re-assemble it
incorrectly after
High leak from the following the
cleaning it.
exhalation valve. instructions on section
6.1.5: Exhalation Valve
The exhalation valve Maintenance, on page
was bumped when the 98.
ventilator was moved. 2. If the problem persists
contact qualified
service personnel.
An alarm is visible but Speaker malfunction Refer the ventilator to

only two beeps are heard. qualified service personnel.
1. Check for object
A red alert screen appears The power is
pressing against the
with a warning “pause accidentally pressed or
power switch.
ventilation and then press internal malfunction.
the power switch,” 2. If the problem persists,
accompanying by provide alternative
means of ventilation
alternating beep sound,
and contact qualified
while no one is pressing
service personnel.
the power switch.
111
Troubleshooting
1. Provide an alternative
Repeated instances of Patient conditions
clinical alarms, with no changed, obstructed means of ventilation,
and check if the
apparent cause. inlet, internal
condition is solved, if
malfunction
not refer to a qualified
clinician.
2. Check that the inlet is
not obstructed.
3. Replace the inlet filter
if needed. Refer to
section 2.3, on page 31.
contact qualified
service personnel.
112
Appendix A: Glossary
TERM DEFINITION
Adaptive Bi-Level Combination of a facemask and invasive mode of ventilation,
which utilizes two levels of pressure for each breath cycle, IPAP
during inspiration and EPAP or PEEP during exhalation.
TM
Adaptive Peak Flow Inspiratory Peak Flow Rate determined and delivered to meet the
target mandatory tidal volume, while maintaining an I:E ratio of
1:2 or reasonable inspiratory time.
Adaptive I-TimeTM Inspiratory time determined by the iVent101 ventilator to maintain
a more physiologic I:E ratio.
Airway Pressure Measured pressure, estimating pressure, at the proximal airway
of the breathing circuit. Measurement unit- cmH2O.
Alarm Combination of an audible buzzer and message pop-up
generated when the iVent101 ventilator detects an operating
condition that requires intervention.
Apnea Cessation of breathing.
Apnea Mode Ventilation mode that automatically starts when apnea is
detected. The apnea period, which is the number of seconds
from the last breath until apnea is detected, is configurable.
Assist Mode Ventilator operation in which a machine breath is delivered only
when an inspiratory effort by the patient is sensed by the
ventilator.
Assist/Control Mode Ventilator operation in which a machine breath is delivered when
an inspiratory effort by the patient is sensed by the ventilator
(Assist), or at set time intervals if the rate of occurrence of
inspiratory efforts falls below a set rate (Control).
Auto PEEP Positive End-Expiratory Pressure in the lung that is higher than
the pressure seen at the airway opening.
Breath Period The length of time from the start of a ventilator-initiated breath to
the start of the next breath.
Breath Termination End of the inhalation phase of the breath.
CMV Mode Controlled Machine Ventilation. A ventilation mode in which the
patient receives only a fixed number of ventilator breaths per
minute.
Compliance A measure of the stiffness of the lung and chest wall.
113
Glossary
TERM DEFINITION
CPAP Continuous Positive Airway Pressure. A mode of ventilator
operation in which the airway pressure remains constant above
ambient during spontaneous breaths.
TM
Easy Exhale Pressure relief at the very beginning of the exhalation phase to
enhance exhalation.
EPAP The absolute low pressure setting for Adaptive Bi-Level.
Analogous to PEEP.
ESens A percentage of the peak flow used as a termination criteria for
pressure support breaths – a breath is terminated once the flow
has dropped to the ESens level. Also known as Exhalation
sensitivity.
Exhalation Phase The part of the breath cycle which starts with the end of
inspiration and ends with the start of the next breath.
Exhaled Tidal Volume The exhaled volume of a single breath measured by the flow
sensor for all breath types.
Flow Trigger Method of initiating breath in response to the patient effort, by
measuring an increase in the inspiratory flow.
High Pressure Alarm Pressure at the entrance of the patient airway exceeds the
defined pressure alarm limit. The usual response is the
immediate termination of the breath, and an alarm sounds.
I:E Ratio Ratio of the inspiratory phase time to the expiration phase time.
Inspiratory Phase The phase of the breath in which the patient inhales, or
inspiratory flow is delivered into the lungs.
Inspiratory Pressure Pressure above the PEEP level during the inspiratory phase of
the breath.
Inspiratory Time Duration of the inspiratory inhalation phase.
IPAP The absolute inspiratory pressure setting for Adaptive Bi-Level.
Low Pressure Alarm Pressure at the entrance of the patient's airway is lower than the
defined pressure alarm limit. An alarm sounds.
Mandatory Breath Any breath that is controlled and terminated by the ventilator, in
order to achieve either a preset tidal volume or target pressure
for a preset time.
Manual Breath An operator initiated ventilator breath.
Maximum Inspiratory Time A predetermined time limit for inspiratory time for all breath types.
Maximum Pressure In PRVC, maximum allowed pressure.
TERM DEFINITION
Mean Airway Pressure The average airway pressure throughout the breath cycle.
Minimum Exhalation Time A period of time from the beginning of the exhalation phase,
during which no breath type may be initiated.
Minimum Pressure In PRVC, minimum allowed pressure.
Patient Breathing Circuit The tubing, valve, and flow sensor, which provides the ventilatory
interface between the patient and ventilator.
Patient Breath Any ventilator delivered breath that is initiated and terminated by
the patient. Could be either Spontaneous or Pressure Support.
The breath is initiated by flow or pressure trigger, and terminated
by decrease in flow or increase in pressure. Available in SIMV,
Adaptive Bi-Level, and CPAP modes.
Patient Effort Any inspiratory effort initiated by the patient.
PCV Pressure Controlled Ventilation. A type of ventilation in which the
ventilator breaths are controlled by pressure, terminated by time,
and can be limited by volume.
Pressure Limit In volume control ventilation, the patient pressure is limited to
this pressure level. The tidal volume delivery may decrease
when the pressure limit is reached which can cause an alarm.
PRVC Pressure Regulated Volume Control Breath. A type of ventilation
in which the ventilator adjusts the pressure for each successive
breath in order to target a set tidal volume.
PEEP Positive End Expiratory Pressure. Positive pressure in the lung
during expiration.
PIP Peak Inspiratory Pressure. The maximum airway pressure that
occurs during inspiration.
Pressure Control Mode A mode of ventilator operation in which the ventilator attempts to
deliver a preset pressure waveform during inspiration. Sufficient
flow is provided to achieve and maintain a set pressure in the
patient circuit during the inspiratory phase of the breath.
Pressure Support Breath A support mode in which the patient effort is accompanied with
an elevated pressure augmenting tidal volume. The patient
determines the inspiratory time. Available in SIMV and
CPAP/PSV modes.
Pressure Trigger A method of initiating a breath in response to patient efforts by
measuring a decrease in airway pressure below the baseline.
Rise Time The rate of acceleration of pressure to reach the set pressure
level.
115
Glossary
TERM DEFINITION
RR/Vt The ratio of spontaneous breathing rate to the exhaled tidal
volume. Typically used as a measurement of breathing stress.
SIMV Synchronized Intermittent Mandatory Ventilation. A mode of
ventilation in which both mandatory and spontaneous breath
types are allowed. The mandatory breaths are synchronized with
the patient efforts.
Spontaneous Breath A patient initiated breath in which inspiratory time is determined
by the patient
Static Compliance A measurement of stiffness of the lung and chest wall. Typically
measured as the volume exhaled after the hold maneuver
divided by the change in the pressure from plateau pressure to
PEEP.
Tidal Volume (VT) The amount of volume inhaled or exhaled in one breath.
Measured in milliliters.
Tidal Volume Limit In pressure control ventilation, the maximum volume allowed to
be delivered to the patient.
Tidal Volume Set In volume control ventilation, the volume preset by the clinician
and delivered to the patient.
Time Constant A measurement of the time it takes to produce a percentage of
breath exchange either into or out from the lung. The product of
the resistance and the static compliance.
Total Breath Rate Total number of breaths per minute, including both patient and
mandatory breaths.
Total Minute Volume The volume delivered to the patient for all breath types over one
minute. Measured in liters per minute.
Trigger Defines the patient effort that starts a breath.
Ventilator Breath A ventilator delivered breath that is initiated, controlled, and
terminated by the ventilator. Available in Assist Control and SIMV
modes.
Volume Controlled Ventilation A type of ventilation in which the ventilator breaths are controlled
by flow and terminated by volume, as long as the airway
pressure is lower than the limit pressure.
Appendix B: Warranty
VersaMed (“the Supplier”) guarantees to the Purchaser the material and
workmanship used in the manufacture of the iVent101 ventilator (“the Product”)
sold to the Purchaser, and will repair any defects which may develop within 12
months from the delivery date to the Purchaser, which are not due to fire,
dampness, willful or accidental damage, or improper use or care, or other causes
beyond the control of the Supplier. This 12 months warranty does not extend to
expendable items such as membranes, hoses, and filters which are warranted to be
free from defects only at the time of the original delivery.
The express warranties set forth above specifically exclude defects in the Products
that are (1) caused through no fault of Supplier during shipment to or from the
Purchaser, (2) caused by the use of or operation of the Products in any application
or environment other than that instructed, intended or recommended by the
Supplier, (3) caused by modifications or alterations made to the Products by the
Purchaser or any third party, (4) caused by unauthorized maintenance performed
on the Products by the Purchaser or any third party, (5) caused by failure of the
Purchaser to comply with any the return procedures, (6) are the result of the
Products being subjected to unusual physical and/or electrical stress.
Except for the above express limited warranties or conditions, Supplier makes and
Purchaser receives no warranties in connection with the Products, express and/or
implied and/or statutory, and the Purchaser specifically disclaims any implied
warranty or condition or merchantability or fitness for a particular purpose. In no
event shall the Supplier be liable for any damages, including loss of profits,
incidental or consequential damages, arising out of or in connection with the use,
or inability to use the Products.
117
Warranty
Subject to the following, the Purchaser shall send the Products with defects that
are covered by this warranty to the Supplier repair center.
The Purchaser shall request a written return authorization from the Supplier prior
to the return of each defective Product for repair or replacement by the Supplier.
Upon request, Supplier will provide the Purchaser with a Return Goods
Authorization (RGA) number to be prominently displayed on the shipping
container for the defective Products.
Once the Supplier authorizes the return of defective Products, the Purchaser shall
ship such Products to the repair facility, freight and insurance expenses prepaid in
its original container and without relieving the Purchaser from its responsibility
for the shipment. If such defective Products are received by the Supplier during
the applicable warranty period, the Supplier shall, at its sole option and expense,
repair or replace such Products, to make such repair or replacement, and shall
ship the repaired or replaced Products to the Purchaser.
In any case and subject to the terms hereof the Supplier will be responsible for the
repair of or replacement of such defective Products only.
Items returned without such approval shall be returned to the Purchaser at its
expense. The Purchaser undertakes that the Products be shipped by a certified
carrier experienced in handling sensitive freight. The Products returned by the
Purchaser for repair or replacement must include a report indicating the type of
failure.
Supplier reserves the right at any time to change the specifications or design of
the Products. In the event of any such change in specifications or design, Supplier
shall be under no obligation to make the same or similar change in the Products
previously produced or sold by the Supplier, unless the change is made to correct
a safety or operational deficiency, or is required by the US Food and
Administration.
Neither this Warranty nor any of the rights of the Purchaser under this Warranty
may be assigned, transferred, or conveyed by the operation of law or otherwise,
without the prior written consent of the Supplier nor shall this warranty or any
rights of the Purchaser inure to the benefit of any trustee in bankruptcy, receiver,
creditor, trustee or successor of the Purchaser’s business or its property, whether
by operation of the law or otherwise, or to a purchaser or successor of the
business or any of the assets of the Purchaser, without the written consent of the
Supplier.
This Warranty shall apply only to Products purchased by end users directly from
VersaMed and provided they are paid for in full. This warranty shall not apply to
distributors or resellers (“Distributor”). VersaMed may provide individual
warranty protection to its authorized Distributors, according to the terms and
conditions agreed upon between VersaMed and each Distributor.
119
Warranty
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Appendix C: Default ventilation Settings

The following table displays the default ventilation and alarms settings which set automatically when you select
new patient from the Clinical View – Menu – New Patient (refer to section 4.2.1: Setting Default Settings for a
New Patient on page 50).
You can change these default settings in the Settings Screen. Refer to section 4.2.3: Modifying the Parameters
on page 54.
Parameter MEANING INFANT CHILD ADULT FULL RECCOM- LOW HIGH

RANGE ENDED CAUTION CAUTION
8-25 KG 25-45 KG >45KG RANGE ZONE ZONE
Mode Ventilation A/C A/C A/C
Mode pressure pressure pressure Yes N/A N/A N/A
control control control
Rate (bpm) Respiration 30 N/A N/A 1-80 20 - 35 10 50
Rate
N/A 20 N/A 1-80 15 - 30 5 40
N/A N/A 12 1-80 10 - 20 3 30
Vt (ml) Tidal 100 N/A N/A 40 - 400 50 - 200 N/A 300
Volume
(Volume N/A 250 N/A 40–700 200 - 400 100 500
Control)
N/A N/A 400 200- 2500 300 - 1000 200 1200
121
Default ventilation Settings
VtLimit (ml) Volume 300 N/A N/A 40 - 400 50 - 200 None 300
Limit
(Pressure N/A 500 N/A 40–700 200 - 400 100 600
Control)
N/A N/A 1000 200- 2500 400 - 1000 None 1200
Pinsp Inspiratory
(cmH20) Pressure
(Pressure
15 15 15 5 - 60 15 - 30 10 40
Control)
Plim Pressure
(cmH20) Limit
(Volume
35 35 35 5 - 60 20 - 35 10 40
Control)
Tinsp (sec) Inspiratory
Time
0.6 0.8 1.2 0.3 - 3 0.5-1.5 0.4 2.0
Thold Inspiratory
Hold Time
(Volume
0 0 0 Yes No setting recommendations
Control)
Peep Set Peep
5 5 5 0 - 45 3 - 20 3 20
(cmH20)
PSV Pressure
(cmH20) Support
Ventilation
5 5 5 3 - 60 5 - 20 N/A 25
(SIMV)
122
Trigger The 3 3 3 1–9 1-9 N/A N/A
sensitivity Triggers’
sensitivity
level
Peak Flow The Peak Adaptive N/A N/A 5 – 120 8 - 20 N/A 30
(L/min) flow
N/A Adaptive N/A 5 – 120 20 - 40 10 60
N/A N/A Adaptive 5 - 120 30 - 50 20 80
Peak Flow Adaptive
Adaptive State of
(true/ false) Peak Flow
Adaptive Adaptive Adaptive Yes N/A N/A N/A
Adaptive or
Not
Adaptive
Peak Flow The peak 12 N/A N/A 5 – 120 8-20 N/A 30
not flow when
adaptive is N/A 20 N/A 5 – 120 20 – 40 10 60
Adaptive
(L/min) cleared
N/A N/A 30 5 – 120 30 – 50 20 80
Low Peak Low
Pressure Pressure
Alarm 5 5 5 1 - 55 N/A N/A N/A
Alarm
(cmH2o)
123
High Peak High
Pressure Pressure
Alarm 35 35 35 5 - 60 20 - 35 10 40
Alarm
(cmH2o)
Apnea Alert Apnea
Time Alarm 15 15 20 Yes N/A N/A N/A
(seconds)
High O2 High O2
Alarm 100 100 100 Yes 21-100 N/A N/A
Alarm (%)
Low O2 Low O2 21 21 21 Yes 21-100 N/A N/A
Alarm (%) Alarm
High Mvol High 8 N/A N/A 0 – 20 N/A N/A N/A

Alarm (ml) Minute
Volume N/A 16 N/A 0 – 30 N/A N/A N/A
Alarm
N/A N/A 24 0 - 50 N/A N/A N/A
Low Mvol Low Minute Up to high
Alarm (ml) Volume 1 2 3 MV alarm N/A N/A N/A
Alarm max - 1
High Rate High Rate
Alarm Alarm 60 50 40 Yes N/A N/A N/A
(bpm)
124
Low Rate Low Rate
Alarm Alarm 10 5 3 Yes N/A N/A N/A
(bpm)
Patient Whether
Disconnect Patient
Alarm (true/ Disconnect
Alarm Is
True True True N/A N/A N/A N/A
false)
Enabled Or
Disabled.
Rise time The rate of
acceleratio
n of
pressure to
reach the
1 1 1 0-9 1-9 NA NA
set
pressure
level
ESens Termination
of pressure
support
breath after
25% 25% 25% 5-80 5-80 NA NA
flow drop
detection
125
C.1. Default Apnea Settings

Following are the default apnea settings for the iVent101 ventilator.
RATE
(ALSO INITIAL INSP. INSP.
MODE
DEFAULT IN PRESSURE TIME
OTHER MODES)
INFANT A/C Pressure 30 15 0.6
CHILD A/C Pressure 20 15 0.8
ADULT A/C Pressure 12 15 1.2
126
Appendix D: Pneumatic Unit Scheme
The Pneumatic unit Schematic Diagram for 2-limb configuration

The air is drawn to the iVent101 ventilator from external environment through
ambient air filter. The filter is able to capture particles greater than 5 microns with
99% efficiency.
Filtered Oxygen is added through low-pressure O2 adapter, which enables the
usage of low O2 pressure sources, such as concentrators, to provide O2
enrichment. The O2 level is checked by the O2 sensor.
The air circulation in the ventilator is generated by a variable 3 Phase DC motor,
which spins the turbine that generates the airflow. The Proportional Outlet Valve
(POV) assists the turbine in controlling the flow and pressure, in order to ventilate
the patient at a set volume or pressure.
127
Pneumatic Unit Scheme
The POV – Proportional Outlet Valve is a flap unit, which controls the air volume
by adjusting between an open and closed position. The different positions allow
variable air volumes to be delivered to the patient, in order that the patient will be
ventilated at the set volume or pressure. The surplus air is returned to the turbine
inlet through a bypass.
The core of the pneumatic unit – the motor, impeller, and the POV - is surrounded
by the acoustic box. The acoustic box, built from metal or high density plastic and
covered, on the inside, by air foam, reducing the noise level generated by the
airflow and blower in the system. The airflow sensor measures the flow near the
acoustic box outlet, and the software uses this measurement in controlling the
POV.
From the ventilator, the air is delivered to the patient via the patient circuit. The
pressure-tap assists or measures the air pressure at the patient wye in the single
limb circuit or at the exhalation valve in a dual limb circuit. Pressure inside the
pneumatic unit also measures pressure on the inspiratory side and estimates wye
pressure. This estimated wye pressure is utilized in comparing pressure readings
for various functions and assuring maximum safety.
The exhalation valve is controlled by adjusting pneumatic unit pressures with the
POV valve. Rapid servo control with this valve allows regulation of both PEEP
and inspiratory pressure. The valve is constantly adjusting to prevent higher than
set target pressure during the inspiratory phase of the breath when there is patient
breathing or coughing efforts. This servo-regulation results in venting of pressure
during patient effort and free breathing during all phases of the breath.
128
The Pneumatic unit Schematic for One limb Configuration
129
Pneumatic Unit Scheme
Notes:
130
Appendix E: Theory of Breath Delivery

The iVent101 ventilator is a positive pressure mechanical ventilator that delivers
air to the patient lungs under positive pressure. The ventilator operates in two
phases that compound the Breath Cycle.
The following diagram depicts a Pressure breath cycle:
Figure E- 1: Pressure Breath Cycle

The two breath phases are:
First Phase: Inspiratory: Air is delivered to the lungs and the airway
pressure may or may not increase. At the end of the inspiratory phase, the
ventilator stops the air delivery and allows the patient to exhale.
Second Phase: Exhalation: the air flows out of the patient lungs and the
pressure returns to the baseline pressure. The baseline pressure may be
either the ambient pressure (curve 1 in Figure E- 1) or a higher positive
end-expiratory pressure PEEP (curve 2 in Figure E- 1).
At the end of the exhalation phase, the ventilator restarts air delivery to the
patient.
131
Theory of Breath Delivery
The ventilator control system manages the ventilation cycle by a mechanism

which:
Initiates inspiration
Controls the flow or the pressure during inspiration phase.
End inspiration or begin exhalation
Maintains exhalation pressure
E.1. Patient Triggering
A patient may trigger a breath by making an inspiratory effort detected by the
ventilator. The iVent101 ventilator has three methods for triggering breaths, as
displayed in the following figure.
Figure E- 2: Pressure and Flow triggering by Patient

The three methods are:
Pressure trigger: Breath is initiated when the airways pressure drops
below the baseline in amount greater than a set sensitivity value.
(a in Figure E- 2).
Flow trigger: Breath is initiated when the initial inspiratory flow
generated by the patient effort is greater than the set sensitivity value.
(b in Figure E- 2).
Dual trigger: Breath is initiated when either flow or pressure exceeds the
set sensitivity values, whichever occurs first. The iVent101 utilizes a
132
combined flow and pressure triggering system that utilizes relative
sensitivity units from 1 – 9, 1 being the most sensitive. Clever algorithms
looks for the shape as well as level of pressure and flow changes to
maximize triggering sensitivity while simultaneously resisting auto
triggering from leaks.
The trigger sensitivity is set in the Settings screen (Refer to section 4.2.3:
Modifying the Parameters on page 54.)
E.2. Breath Styles

The ventilator delivers two primary breath styles:
Mandatory Breath: A breath in which the ventilator controls and
terminates the inspiratory phase.
Spontaneous Breath: A breath in which the patient initiates and
terminates the inspiratory phase.
E.2.1. Mandatory Breaths Types
The mandatory breath, controlled by the ventilator, includes the following breath
initiations:
Ventilator breath: Initiated by the ventilator (time triggered).
Assist breath: Initiated by the patient.
Manual breath: Initiated by the operator. Refer to page 137.
Each mandatory breath can be either Volume Controlled, Pressure Controlled,
or Volume Targeted as explained below.
Volume Control Breath

Mandatory volume control breath in which the ventilator delivers a set tidal
volume at an Adaptive Peak FlowTM or manually set value and can be pressure
limited. The flow is controlled by the ventilator in a way that the flow at the end
of the inspiratory phase will be half of the peak inspiratory flow. The breath can
be initiated by the ventilator (time triggering), by the operator (manual breath), or
133
by the patient (pressure or flow triggering) in Assist Control or SIMV. When
initiated it is controlled and terminated by the ventilator according to the settings.
Figure E- 3: Volume control Breath Waveform

Inspiratory phase is terminated when a set tidal volume (VT) is delivered.
Volume Control Parameter Settings

The following parameters may be set:
Sensitivity
PEEP
Rate
Tidal volume
Peak Flow or Adaptive Peak Flow
Pressure Limit
For setting the parameters, refer to section 4.2.3: Modifying the Parameters on
page 54.
134
Pressure Control Breath
A pressure control breath is a mandatory breath in which the ventilator provides a
constant pressure during the inspiratory phase according to the settings. The
breath can be initiated by the ventilator or by the patient in Assist Control or
SIMV. The inspiratory phase is terminated by the ventilator when inspiration time
is elapsed or when the set tidal volume has been delivered (whichever occurs
first).
Figure E- 4 below demonstrates the pressure and flow behavior when the
ventilator delivers a pressure control breath. When the breath initiated, the
ventilator delivers the maximum possible flow until the patient airway pressure
exceeds the set level. Once the pressure level is exceeded, the ventilator adjusts
the flow to whatever rate is required to maintain the airway pressure between the
target pressure and the actual value, which about 2 cmH2O lower. At the end of
the inspiratory phase the ventilator terminates flow and opens the exhalation
valve allowing the patient to exhale.
Figure E- 4: Pressure Control Breath Waveform
Pressure Control Parameter Settings

Sensitivity
PEEP
Rate
135
Inspiratory Pressure
Inspiratory Time
Tidal Volume Limit
Rise Time
page 54.
PRVC Breath
A PRVC breath is a mandatory breath in which the ventilator provides a constant
pressure during the inspiratory phase according to the settings. The breath can be
initiated by the ventilator or by the patient in Assist Control or SIMV. The
inspiratory phase is terminated by the ventilator when inspiration time is elapsed
or if the tidal volume limit is reached at1.5 X set target volume (whichever occurs
first).
Pressure and flow behavior are similar to the pressure control breath above for
each individual breath. The difference is that the ventilator continually adjusts the
pressure target on subsequent breaths attempting to deliver the set target tidal
volume. If the volume delivered is lower than set, the pressure is raised on the
next breath to correct the discrepancy. If the volume is higher than set, the
subsequent breath is delivered with a lower pressure. The amount of change from
breath to breath is greater if the error is greater but never more than 4 cm H20
between breaths.
When PRVC is initiated, the patient receives three test breaths of a set tidal
volume with a short plateau. The ventilator determines the compliance and correct
target pressure and initiates the pressure breaths at the calculated pressure. The
pressure is then adjusted as described to maintain target volumes although the
delivered tidal volumes will change temporarily as demand or compliance
changes.
136
PRVC Parameter Settings
Sensitivity
PEEP
Rate
Inspiratory Time
Target Tidal Volume
Rise Time
Max Inspiratory Pressure
page 54.
Manual Breath
Manual breath is a ventilator breath that is initiated by the operator (Refer to
Manual Breath on page 62.) This breath may be delivered in all ventilation
modes.
If the Manual Breath is initiated during inspiration or during minimum
exhalation time, the iVent101 ventilator waits and delivers the manual breath at
the end of the minimum exhalation time (see Figure E- 5 below).
137
Figure E- 5: Delivery of Manual Breath

The manual breath always delivers the mandatory breath type set.
In CPAP/PSV ventilation mode, where there is no definition for machine breath,
the manual breath will be set according to the default volume control for the set
patient weight.
E.2.2. Spontaneous Breath Types
The patient breath, initiated and terminated by the patient, includes one basic type
- Pressure Support Breath - see explanation below.
Pressure Support Breath

Pressure Support breaths are initiated and terminated by the patient, and
controlled by the ventilator. This is a positive pressure breath in which the
ventilator maintains an elevated target pressure during inspiration.
When the patient initiates a pressure support breath, the ventilator raises the
inspiratory flow to meet the demand at the set level of airway pressure. The
Pressure Support level is above the PEEP pressure, when PEEP is in use.
The Pressure support breath is terminated when one of the following occurs
(whichever occurs first):
The flow decreases to ESens level (% of the peak flow).
138
The airway pressure exceeds a value of 5 cmH2O above the target
pressure.
Three seconds have elapsed.
At that point the ventilator terminates flow, allowing the patient to exhale.
Figure E- 6: Patient Support Breath Waveform (ESens set to 25%)
Pressure Support Parameter Settings

Sensitivity
PEEP
Inspiratory Pressure (PSV)
ESens
Rise Time
page 54.
E.2.3. Breath types – Summary

The table on the following page summarizes the different breath types:
139
BREATH TYPE INITIATION CONTROLLED LIMITING TERMINATION

PARAMETERS PARAMETER
MANDATORY BREATH
VENTILATOR By Ventilator Flow Pressure or By the Ventilator,
VOLUME (time- Time when set VT is
CONTROL triggered) delivered.
ASSIST By Patient Flow Pressure or By the Ventilator,
VOLUME Time when set VT is
CONTROL delivered
VENTILATOR By Ventilator Pressure Level Volume By the Ventilator,
PRESSURE when Inspiratory
CONTROL time is elapsed.
ASSIST By Patient Pressure Level Volume By the Ventilator,
PRESSURE when Inspiratory
CONTROL time is elapsed.
VENTILATOR By Ventilator Pressure Level Pressure or By the Ventilator,
PRVC to achieve Volume when Inspiratory
target Vt set time is elapsed.
ASSIST PRVC By Patient Pressure Level Pressure or By the Ventilator,
to achieve Volume when Inspiratory
target Vt set time is elapsed.
MANUAL By Operator Volume or Pressure or By the Ventilator,
Pressure Level Time. when set VT is
delivered, or when
Inspiratory time is
elapsed.
PATIENT BREATH
PRESSURE By Patient Target Inspiratory By Patient (flow drop
SUPPORT Pressure Time or pressure
BREATH (above PEEP) increase).
140
E.2.4. Adaptive Peak FlowTM and Adaptive I -

TimeTM
Unique to VersaMed ventilators Adaptive Peak FlowTM and Adaptive I-TimeTM
are automated ventilator controls that determine peak inspiratory flow and
inspiratory time during breath delivery.
Adaptive Peak FlowTM and Adaptive I-TimeTM work together only in volume
control modes (SIMV and A/C). When used together these two features seek to
achieve a physiologic I:E ratio of 1:2 at higher rates and a reasonable inspiratory
time at lower rates. When the clinician turns on Adaptive Peak Flow™ Adaptive
I-Time™ is automatically turned on as well.
Changes in the overall breath rate are tracked and the Adaptive I-TimeTM
algorithm will seek to adjust the inspiratory time over 10 breaths in order to
maintain the physiologic I:E ratio. The Adaptive Peak FlowTM algorithm will
accommodate changes in the inspiratory time and automatically adjust the peak
flow so that the delivery of the set tidal volume for the inspiratory time
determined by the Adaptive I-TimeTM algorithm is assured.
If the respiratory rate increases, the inspiratory time will decrease and the
mandatory peak inspiratory flow will increase to deliver the set tidal volume. If
the respiratory rate decreases, the inspiratory time will increase and the
mandatory peak inspiratory flow will decrease to deliver the set tidal volume.
Should the Adaptive Peak FlowTM algorithm determine that the peak flows
achieved by the patient spontaneous breathing exceed the peak flows, which are
necessary to achieve the set tidal volume, the algorithm will match the patient
peak flow to avoid feeling of “air hunger” in the patient. In this situation, the
ventilator will not retain an I:E ratio of 1:2.
If the flow is insufficient to deliver the tidal volume, inspiratory time will be
gradually increased in attempt to deliver the set tidal volume. In this situation, the
ventilator will not achieve I:E ratios of 1:2. If inverse I:E ratios are achieved, it is
recommended that the ventilator controls be set manually.
141
The speed of change for peak flows and inspiratory time is based upon the
difference between the target flow/time and the desired flow/time. The greater the
difference, the greater the steps changes in peak flow or inspiratory time during
the next breath. Most changes are gradual and may take eight to ten breaths to
make a full change to the desired patient condition. The iVent101 ventilator can
deliver up to 200 liters per minute, but there are other factors limiting the delivery
of air flow. Theses factors include the patient lung compliance, airway resistance,
and the patient circuit compliance and resistance. Inspiratory time is limited to
two seconds or 1:1 I:E ratio based upon the set rate.
Another feature of Adaptive Peak FlowTM is its ability to track and match the
mandatory breath inspiratory flow rate to the patient spontaneous inspiratory flow
demand during SIMV. The ventilator constantly monitors the patient spontaneous
inspiratory flow demand during SIMV. The ventilator constantly monitors the
patient spontaneous breath flow rate. If the mandatory inspiratory flow is less
than the patient average spontaneous inspiratory flow demand, the mandatory
inspiratory flow is increased to the same value to minimize the feeling of “air
hunger” in the patient.
The Adaptive Peak Flow™ value is displayed on Settings screen when the
Ventilation Mode is SIMV Volume Control or A/C Volume Control. Refer to
Setting Ventilation Modes on page 51.
Notes
1. When setting a manual inspiratory flow during low flow conditions, this
flow target may briefly be exceeded as the ventilator controls the flow to
the patient. However, the average flow will be maintained at the set value.
2. If the target flow is set higher than the capability of the ventilator, due to
high resistance and/or low compliance of the patient circuit, the ventilator
attempts to deliver the highest possible flow during the inspiratory phase.
Under these conditions, the inspiratory time is increased in order to deliver
the set tidal volume.
142
Appendix F: Ventilation Modes
F.1. Assist/Control Mode
Definition
Assist/Control mode combines two traditional modes of ventilation: Assist
Ventilation and Control Mechanical Ventilation (CMV). Unlike the standard
Control Ventilation mode, a patient may breathe more frequently than the set
respiratory rate by triggering a mandatory assist breath before the end of CMV
breath cycle.
iVent101 ventilator offers A/C Pressure Control, A/C Volume Control, and A/C
PRVC as three Assist/Control modes.
Available Breath Types

Mandatory ventilator breath
Mandatory assist breath
Manual breath
All breath types may be either pressure control or volume control.
Description
Figure F- 1 illustrates breath delivery in Assist/Control mode.
143
Ventilation Modes
Figure F- 1: Breath Pattern in Assist/Control Mode

At the beginning of the breath cycle (event a), the ventilator delivers a ventilator
breath. After the ventilator breath is delivered, the patient does not attempt to
trigger an assist breath. The ventilator waits for an exhalation period to elapse
(determined by the rate setting) and delivers another ventilator breath (event b).
An insufficient inspiratory effort (event c) has no effect on the normal delivery of
the next mandatory breath. After the third ventilator breath (event d) the patient
efforts reduces the airway pressure below PEEP (pressure triggering) or generates
initial inspiratory flow (flow triggering) by an amount equal to or greater than the
set sensitivity (event e). Therefore, an assist breath is initiated (event f). This
delivers a breath before the set breath cycle, thus breath rate is increased. If the
patient does not initiate an assist breath during the next breath cycle, the ventilator
delivers a ventilator breath at the end of the breath cycle.
Parameter Settings
Breath Rate
Sensitivity
Inspiratory Pressure (A/C Pressure Control)
144
Inspiratory time
Pressure Limit
Peak Flow, Adaptive or set value
PEEP
Tidal Volume (A/C Volume Control)
Tidal Volume Limit (A/C Pressure Control)
Volume Target (A/C PRVC)
Rise Time (A/C Pressure Control and A/C PRCV)
page 54.
F.2. SIMV Mode
Definition
Synchronized Intermittent Mandatory Ventilation Mode (SIMV)) ensures that in
spontaneously or partly spontaneously breathing the patient will receive a set
number of mandatory breaths. All breath types are available in this mode.
This mode is identical to Assist/Control mode except that in this mode patient
spontaneous breaths are allowed between mandatory breaths. Another difference
is that although mandatory breaths are synchronized with the patient inspiration,
the breath period is not reset when patient initiates an assist breath. Therefore the
average mandatory rate does not change.
Available Breath Types:

Mandatory ventilator breath
Mandatory assist breath
Manual mandatory breath
Patient spontaneous breath
Patient pressure support breath
145
Ventilation Modes
All types of mandatory breaths may be either pressure or volume control.
Description
During an SIMV breath cycle, mandatory breath may be initiated and/or occur
during any breath period or at the end of a breath period when no patient efforts
are detected. Spontaneous or Pressure Support breaths may be initiated and/or
occur during breath periods between mandatory breaths.
Figure F-2 illustrates breath delivery in SIMV mode.
Figure F- 2: Breath Patterns in SIMV Pressure and Volume Control Mode

If the patient initiated breath overlaps with the next mandatory period, a breath
period begins, and the ventilator either waits for the next patient effort or delivers
the next mandatory breath at the end of the breath period.
146
Mandatory breaths are terminated when:

The set tidal volume is delivered.
The pressure limit is reached.
The I:E ratio reaches 1:1 when an inverse ratio is not manually set.
SIMV Parameters Settings

Inspiratory Pressure (SIMV Pressure Control)
Inspiratory Time
Pressure Limit
Mandatory Breath Rate
Sensitivity
PEEP
PSV
Tidal Volume (SIMV Volume Control)
Tidal Volume Limit (SIMV Pressure Control)
Volume Target (SIMV PRVC)
Support pressure for pressure support breaths
Tidal Volume Limit
Rise Time
ESens
page 54.
147
Ventilation Modes
F.3. Continuous Positive Airway Pressure Mode

(CPAP)
Definition
Continuous Positive Airways Pressure (CPAP) is a ventilation mode intended for
patients who are breathing spontaneously at a rate and depth sufficient to meet
their ventilation requirements. During CPAP, the airway pressure remains above
ambient all the times, reducing the work of breathing. A small amount of Pressure
Support is always present (minimum 3 cm H20) to maximize response time and
guarantee minimal imposed work of breathing at all CPAP levels. Many
ventilators deliver this small level of pressure support during spontaneous
breathing whether it is set or not.
Available Breath
Patient pressure support breaths
Manual breath
Description
Figure F-3 illustrates breath delivery in CPAP mode.
Figure F- 3: Pressure during CPAP mode with Pressure Support
148
Patient triggering results in the delivery of a patient breath. The iVent101
ventilator maintains airway (Figure F- 3) during the inspiratory phase at a PEEP
level. Breaths can be initiated only after inspiration has ended, and the minimum
exhalation time has elapsed.
CPAP Parameter Settings

PEEP
PSV
Sensitivity
Rise Time
ESens
F.4. Adaptive Bi-Level
Definition
Adaptive Bi-Level is a support mode of ventilation, intended for use in high leak
situations, such as when using a facemask or a nasal CPAP mask but can be used
in intubated patients as well. In this mode, the spontaneous breathing efforts are
supported at high (inspiratory) and lower (expiratory) pressure.
Adaptive Bi-Level is intended for patients who exhibit clinically appropriate
conditions for facemask ventilation. Such patients include those with acute or
chronic respiratory insufficiency secondary to acute exacerbation COPD,
hypercapnic acute respiratory failure, or decompensated heart failure.
Patients who exhibit an altered level of consciousness, inability to

tolerate facemask ventilation (injury, burns, etc.), inability to
maintain their airway, or severe decompensated respiration, should
not be treated with a facemask.
Description
149
Ventilation Modes
Adaptive Bi-Level combines Pressure Control and pressure support modes.
Pressure Support Ventilation is delivered and ventilation rate and breath
termination is determined by the patient. If breathing slows or stops the iVent101
ventilator provides mandatory breaths at a rate indicated by the respiratory rate
settings. The default setting should be lower than the spontaneous breathing rate
to reduce dysynchrony with the patient breathing efforts.
Breaths are terminated by a reduction in peak flow to the ESens % setting of the
delivered peak flow.
Adaptive Bi-Level Parameter Settings

Sensitivity
IPAP
EPAP
Rate
Rise Time
ESens
For setting the parameters, refer to 4.2.3: Modifying the Parameters, on page 54.
F.5. Easy ExhaleTM

Easy ExhaleTM is an advanced PEEP strategy used in cases of intrinsic PEEP due
to severe airflow limitation in which clinically critical airways are obstructed or
do decrease expiratory work of breathing. Its purpose is to improve the
downstream airway emptying while potentially matching the intrinsic PEEP to
optimize alveolar ventilation.
In this mode, the ventilator circuit is depressurized during the very early phase of
expiration to facilitate downstream dead space ventilation. The ventilator
reestablishes the PEEP value as the flow begins to slow to prevent the alveolar
pressure from falling below the alveolar pressure.
150
F.6. Apnea Backup Mode

Apnea backup ventilation can be activated from all breathing modes. Alarm alert
will notify an apnea event if breathing has ceased for a set period of time (refer to
Apnea, page 78). When apnea is detected the patient will be ventilated in the
current ventilation mode except for CPAP. For volume control the rate is
determined according to set tidal volume. For all other modes the rate is based on
the default Apnea settings.
The ventilator will remain in apnea mode for at least one minute, and will exit
from this mode when the patient initiates 2 +1 consecutive breaths within period
of one minute. The ventilator will return to the previous ventilation mode.
F.7. Emergency Backup Mode

Emergency Backup mode is a backup mode designed for short-term ventilation.
Emergency Backup is used as a safety mode in the events when the iVent101
ventilator does not receive a reliable reading from the pressure or flow sensor.
During the Emergency Backup mode the ventilation is an approximation of the
ventilation settings that were used before the ventilator switch to Emergency
Backup mode.
When the iVent101 ventilator receives a reliable reading from the flow sensor, the
ventilation switches back to the ventilation mode that preceded the Open Loop
mode.
F.8. Resolving Dysynchrony

This section explains how to resolve Patient-Ventilator Dysynchrony while using
a facemask.
When the patient is using a facemask the Adaptive Bi-Level Mode is
recommended on the iVent101
151
Ventilation Modes
F.8.1. Excessive Ventilation
In case of excessive ventilation, decrease the respiratory rate or the P-high level.
F.8.2. Excessive Leak
Detection
An excessive leak is indicated by detecting flow during the EPAP phase or by
visually examining mask fit on the patient's face.
Intervention
Ensure that an approved and suitable sized nasal or facemask is being used (check
the manufacturer instructions). Adjust the headgear and ensure that there is equal
tension among all the straps. If necessary, apply padding across the nasal bridge
and chin.
F.8.3. Non Triggered Breaths (Inspiratory

Trigger Failure)
Detection
Failure to trigger the ventilator is detected by patient dysynchrony with
mechanical breaths. These are apparent as spontaneous efforts, on the flow
waveform, that do not result in a rise in pressure on the pressure waveform.
Intervention
Make sure that the enclosed volume of the facemask is not too large, or that the
facemask is too loose (Refer to Excessive Leak, page 152). Decrease the
Sensitivity level if appropriate.
152
F.8.4. Excessive Triggering (Auto Cycling)
Detection
Auto cycling is detected by observation of a rapid auto cycling pattern,
independent of the patient breathing pattern.
Intervention
Increase the sensitivity setting. Observe the patient and confirm that auto cycling
persists.
Confirm that the facemask interface has a tight seal.
If the condition persists, recalibrate the ventilator, or refer it to a qualified service
technician.
F.8.5. Cycling Dysynchrony
Detection
Delayed I:E cycling is indicated by ventilator patient dysynchrony and breath
stacking.
Intervention
Observe the patient condition and change the settings to synchronized between
the patient breath and the iVent101 ventilator.
Optimizing expiratory synchrony is important for patients with obstructive
ventilatory disorder. These patients generally require prolonged expiratory
periods to optimize airway emptying, and to minimize breath stacking. In these
patients it may be necessary to switch to Pressure Control if managing inspiratory
time is deemed necessary.
153
Ventilation Modes
Notes:
154
Appendix G: Software Open Sources

This Appendix lists the Open source software that are used in the iVent101
product or necessary to its operation, and their licenses.
G.1. Introduction
G.1.1. Scope
To list the open sources software which are used in the iVent101 or support its
operation as external components, and provide their licenses.
G.1.2. Purpose
To provide the operator of the iVent101 a list of all the open source software that
have been used in programming the Software or are necessary to its operation,
and to provide the information required in order to comply with the licenses of
such open source software.
G.1.3. Overview
During the development of the iVent101 certain open source software were been
used. In addition, different open source software are support its operation as
external components, without being a part of the iVent101. The following
document provides the licenses which have to be distributed with any product that
combined or aggregated with such open source software. .
G.1.4. Applicable documents:
Kernel (Linux): GNU General Public License - GNU Project - Free
Software Foundation (FSF)
BusyBox: http://www.busybox.net/license.html
DSP Gateway:
http://dspgateway.sourceforge.net/pub/index.php?Page=License
155
Software Open Sources
G.2. Licenses of Open Sources Software which
Combined with the iVent101
The followings is the open sources software that has been used for developing the
iVent101 and is combined in it as integral part:
DSP Gateway, see section 2.1
G.2.1. DSP Gateway
The SW uses BSD for DSP, version 3. The ARM uses the Kernel, see section
G.3.1.
The license was taken on November 9, 2006.
Current License applied

Version 3 of the DSP Gateway contains ARM part and DSP part. The license applied for each part
of the program is different: The ARM pack is provided under GPL, and the DSP pack provided
under BSD. The ARM pack is part of the Kernel (see section 3.1 below), and it is can not be
considered as part of iVent101 or a software which combined with the iVent101.
BSD License Terms

Copyright (c) 2003 - 2004, Nokia
All rights reserved.
Redistribution and use in source and binary forms, with or without modification, are permitted
provided that the following conditions are met:
Redistributions of source code must retain the above copyright notice, this list of conditions and
the following disclaimer.
Redistributions in binary form must reproduce the above copyright notice, this list of conditions
and the following disclaimer in the documentation and/or other materials provided with the
distribution.
Neither the name of Nokia nor the names of its contributors may be used to endorse or promote
products derived from this software without specific prior written permission.
156
THIS SOFTWARE IS PROVIDED BY THE COPYRIGHT HOLDERS AND CONTRIBUTORS
"AS IS" AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT
LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR
A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE COPYRIGHT
OWNER OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL,
SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT
LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE,
DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON
ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT
(INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE
OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.
G.3. Licenses of Open Sources Software which

Aggregated with the iVent101 as External
Components
The followings are the open sources software that aggregate with the iVent101,
supports its operations as external components, and are not part of it:
Kernel, see section G.3.1 below
BusyBox, protected by a GPL license, see section G.3.2, on page 164.
lob, protected by a GPL license, see section G.3.1 below.
G.3.1. Kernel
The SW uses Kernel version 2.6.15
This license was taken on December 20, 2006
The Kernel source can be viewed at

http://code.google.com/p/vm101hc/downloads/list.
157
Preamble
The licenses for most software are designed to take away your freedom to share and change it. By
contrast, the GNU General Public License is intended to guarantee your freedom to share and
change free software--to make sure the software is free for all its users. This General Public
License applies to most of the Free Software Foundation's software and to any other program
whose authors commit to using it. (Some other Free Software Foundation software is covered by
the GNU Library General Public License instead.) You can apply it to your programs, too.
When we speak of free software, we are referring to freedom, not price. Our General Public
Licenses are designed to make sure that you have the freedom to distribute copies of free software
(and charge for this service if you wish), that you receive source code or can get it if you want it,
that you can change the software or use pieces of it in new free programs; and that you know you
can do these things.
To protect your rights, we need to make restrictions that forbid anyone to deny you these rights or
to ask you to surrender the rights. These restrictions translate to certain responsibilities for you if
you distribute copies of the software, or if you modify it.
For example, if you distribute copies of such a program, whether gratis or for a fee, you must give
the recipients all the rights that you have. You must make sure that they, too, receive or can get
the source code. And you must show them these terms so they know their rights.
We protect your rights with two steps: (1) copyright the software, and (2) offer you this license
which gives you legal permission to copy, distribute and/or modify the software.
Also, for each author's protection and ours, we want to make certain that everyone understands
that there is no warranty for this free software. If the software is modified by someone else and
passed on, we want its recipients to know that what they have is not the original, so that any
problems introduced by others will not reflect on the original authors' reputations.
Finally, any free program is threatened constantly by software patents. We wish to avoid the
danger that redistributors of a free program will individually obtain patent licenses, in effect
making the program proprietary. To prevent this, we have made it clear that any patent must be
licensed for everyone's free use or not licensed at all.
The precise terms and conditions for copying, distribution and modification follow.
GNU GENERAL PUBLIC LICENSE
TERMS AND CONDITIONS FOR COPYING, DISTRIBUTION AND MODIFICATION
0. This License applies to any program or other work which contains a notice
placed by the copyright holder saying it may be distributed under the terms of
this General Public License. The "Program", below, refers to any such program
158
or work, and a "work based on the Program" means either the Program or any
derivative work under copyright law: that is to say, a work containing the
Program or a portion of it, either verbatim or with modifications and/or
translated into another language. (Hereinafter, translation is included without
limitation in the term "modification".) Each licensee is addressed as "you".
Activities other than copying, distribution and modification are not covered by this
License; they are outside its scope. The act of running the Program is not restricted,
and the output from the Program is covered only if its contents constitute a work
based on the Program (independent of having been made by running the Program).
Whether that is true depends on what the Program does.
1. You may copy and distribute verbatim copies of the Program's source code as
you receive it, in any medium, provided that you conspicuously and
appropriately publish on each copy an appropriate copyright notice and
disclaimer of warranty; keep intact all the notices that refer to this License and
to the absence of any warranty; and give any other recipients of the Program a
copy of this License along with the Program.
You may charge a fee for the physical act of transferring a copy, and you may at
your option offer warranty protection in exchange for a fee.
2. You may modify your copy or copies of the Program or any portion of it, thus
forming a work based on the Program, and copy and distribute such
modifications or work under the terms of Section 1 above, provided that you
also meet all of these conditions:
a. You must cause the modified files to carry prominent notices stating that
you changed the files and the date of any change.
b. You must cause any work that you distribute or publish, that in whole or
in part contains or is derived from the Program or any part thereof, to be
licensed as a whole at no charge to all third parties under the terms of this
License.
c. If the modified program normally reads commands interactively when
run, you must cause it, when started running for such interactive use in
the most ordinary way, to print or display an announcement including an
appropriate copyright notice and a notice that there is no warranty (or
else, saying that you provide a warranty) and that users may redistribute
the program under these conditions, and telling the user how to view a
copy of this License. (Exception: if the Program itself is interactive but
does not normally print such an announcement, your work based on the
Program is not required to print an announcement.)
159
These requirements apply to the modified work as a whole. If identifiable sections of
that work are not derived from the Program, and can be reasonably considered
independent and separate works in themselves, then this License, and its terms, do
not apply to those sections when you distribute them as separate works. But when
you distribute the same sections as part of a whole which is a work based on the
Program, the distribution of the whole must be on the terms of this License, whose
permissions for other licensees extend to the entire whole, and thus to each and every
part regardless of who wrote it.
Thus, it is not the intent of this section to claim rights or contest your rights to work
written entirely by you; rather, the intent is to exercise the right to control the
distribution of derivative or collective works based on the Program.
In addition, mere aggregation of another work not based on the Program with the
Program (or with a work based on the Program) on a volume of a storage or
distribution medium does not bring the other work under the scope of this License.
3. You may copy and distribute the Program (or a work based on it, under Section
2) in object code or executable form under the terms of Sections 1 and 2 above
provided that you also do one of the following:
a. Accompany it with the complete corresponding machine-readable source
code, which must be distributed under the terms of Sections 1 and 2
above on a medium customarily used for software interchange; or,
b. Accompany it with a written offer, valid for at least three years, to give
any third party, for a charge no more than your cost of physically
performing source distribution, a complete machine-readable copy of the
corresponding source code, to be distributed under the terms of Sections
1 and 2 above on a medium customarily used for software interchange;
or,
c. Accompany it with the information you received as to the offer to
distribute corresponding source code. (This alternative is allowed only
for noncommercial distribution and only if you received the program in
object code or executable form with such an offer, in accord with
Subsection b above.)
The source code for a work means the preferred form of the work for making
modifications to it. For an executable work, complete source code means all the source
code for all modules it contains, plus any associated interface definition files, plus the
scripts used to control compilation and installation of the executable. However, as a
special exception, the source code distributed need not include anything that is
normally distributed (in either source or binary form) with the major components
(compiler, kernel, and so on) of the operating system on which the executable runs,
unless that component itself accompanies the executable.
160
If distribution of executable or object code is made by offering access to copy from a
designated place, then offering equivalent access to copy the source code from the same
place counts as distribution of the source code, even though third parties are not
compelled to copy the source along with the object code.
4. You may not copy, modify, sublicense, or distribute the Program except as
expressly provided under this License. Any attempt otherwise to copy, modify,
sublicense or distribute the Program is void, and will automatically terminate
your rights under this License. However, parties who have received copies, or
rights, from you under this License will not have their licenses terminated so
long as such parties remain in full compliance.
5. You are not required to accept this License, since you have not signed it.
However, nothing else grants you permission to modify or distribute the
Program or its derivative works. These actions are prohibited by law if you do
not accept this License. Therefore, by modifying or distributing the Program (or
any work based on the Program), you indicate your acceptance of this License
to do so, and all its terms and conditions for copying, distributing or modifying
the Program or works based on it.
6. Each time you redistribute the Program (or any work based on the Program), the
recipient automatically receives a license from the original licensor to copy,
distribute or modify the Program subject to these terms and conditions. You
may not impose any further restrictions on the recipients' exercise of the rights
granted herein. You are not responsible for enforcing compliance by third
parties to this License.
7. If, as a consequence of a court judgment or allegation of patent infringement or
for any other reason (not limited to patent issues), conditions are imposed on
you (whether by court order, agreement or otherwise) that contradict the
conditions of this License, they do not excuse you from the conditions of this
License. If you cannot distribute so as to satisfy simultaneously your obligations
under this License and any other pertinent obligations, then as a consequence
you may not distribute the Program at all. For example, if a patent license would
not permit royalty-free redistribution of the Program by all those who receive
copies directly or indirectly through you, then the only way you could satisfy
both it and this License would be to refrain entirely from distribution of the
Program.
If any portion of this section is held invalid or unenforceable under any particular
circumstance, the balance of the section is intended to apply and the section as a
whole is intended to apply in other circumstances.
It is not the purpose of this section to induce you to infringe any patents or other
property right claims or to contest validity of any such claims; this section has the
161
sole purpose of protecting the integrity of the free software distribution system,
which is implemented by public license practices. Many people have made
generous contributions to the wide range of software distributed through that system
in reliance on consistent application of that system; it is up to the author/donor to
decide if he or she is willing to distribute software through any other system and a
licensee cannot impose that choice.
This section is intended to make thoroughly clear what is believed to be a
consequence of the rest of this License.
8. If the distribution and/or use of the Program is restricted in certain countries
either by patents or by copyrighted interfaces, the original copyright holder who
places the Program under this License may add an explicit geographical
distribution limitation excluding those countries, so that distribution is permitted
only in or among countries not thus excluded. In such case, this License
incorporates the limitation as if written in the body of this License.
9. The Free Software Foundation may publish revised and/or new versions of the
General Public License from time to time. Such new versions will be similar in
spirit to the present version, but may differ in detail to address new problems or
concerns.
Each version is given a distinguishing version number. If the Program specifies a
version number of this License which applies to it and "any later version", you have
the option of following the terms and conditions either of that version or of any later
version published by the Free Software Foundation. If the Program does not specify
a version number of this License, you may choose any version ever published by the
Free Software Foundation.
10. If you wish to incorporate parts of the Program into other free programs whose
distribution conditions are different, write to the author to ask for permission.
For software which is copyrighted by the Free Software Foundation, write to the
Free Software Foundation; we sometimes make exceptions for this. Our
decision will be guided by the two goals of preserving the free status of all
derivatives of our free software and of promoting the sharing and reuse of
software generally.
NO WARRANTY
11. BECAUSE THE PROGRAM IS LICENSED FREE OF CHARGE, THERE IS
NO WARRANTY FOR THE PROGRAM, TO THE EXTENT PERMITTED
BY APPLICABLE LAW. EXCEPT WHEN OTHERWISE STATED IN
WRITING THE COPYRIGHT HOLDERS AND/OR OTHER PARTIES
PROVIDE THE PROGRAM "AS IS" WITHOUT WARRANTY OF ANY
162
KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING, BUT NOT
LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY
AND FITNESS FOR A PARTICULAR PURPOSE. THE ENTIRE RISK AS
TO THE QUALITY AND PERFORMANCE OF THE PROGRAM IS WITH
YOU. SHOULD THE PROGRAM PROVE DEFECTIVE, YOU ASSUME
THE COST OF ALL NECESSARY SERVICING, REPAIR OR
CORRECTION.
12. IN NO EVENT UNLESS REQUIRED BY APPLICABLE LAW OR AGREED
TO IN WRITING WILL ANY COPYRIGHT HOLDER, OR ANY OTHER
PARTY WHO MAY MODIFY AND/OR REDISTRIBUTE THE PROGRAM
AS PERMITTED ABOVE, BE LIABLE TO YOU FOR DAMAGES,
INCLUDING ANY GENERAL, SPECIAL, INCIDENTAL OR
CONSEQUENTIAL DAMAGES ARISING OUT OF THE USE OR
INABILITY TO USE THE PROGRAM (INCLUDING BUT NOT LIMITED
TO LOSS OF DATA OR DATA BEING RENDERED INACCURATE OR
LOSSES SUSTAINED BY YOU OR THIRD PARTIES OR A FAILURE OF
THE PROGRAM TO OPERATE WITH ANY OTHER PROGRAMS), EVEN
IF SUCH HOLDER OR OTHER PARTY HAS BEEN ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES.
END OF TERMS AND CONDITIONS
How to Apply These Terms to Your New Programs

If you develop a new program, and you want it to be of the greatest possible use to the public, the
best way to achieve this is to make it free software which everyone can redistribute and change
under these terms.
To do so, attach the following notices to the program. It is safest to attach them to the start of each
source file to most effectively convey the exclusion of warranty; and each file should have at least
the "copyright" line and a pointer to where the full notice is found.
<one line to give the program's name and a brief idea of what it does.>
Copyright (C) <year> <name of author>
This program is free software; you can redistribute it and/or modify it under the
terms of the GNU General Public License as published by the Free Software
Foundation; either version 2 of the License, or (at your option) any later version.
This program is distributed in the hope that it will be useful, but WITHOUT ANY
WARRANTY; without even the implied warranty of MERCHANTABILITY or
FITNESS FOR A PARTICULAR PURPOSE. See the GNU General Public License
for more details.
163
You should have received a copy of the GNU General Public License along with this
program; if not, write to the Free Software Foundation, Inc., 51 Franklin St, Fifth
Floor, Boston, MA 02110-1301 USA
Also add information on how to contact you by electronic and paper mail.
If the program is interactive, make it output a short notice like this when it starts in an interactive
mode:
Gnomovision version 69, Copyright (C) year name of author
Gnomovision comes with ABSOLUTELY NO WARRANTY; for details type `show
w'.
This is free software, and you are welcome to redistribute it under certain conditions;
type `show c' for details.
The hypothetical commands `show w' and `show c' should show the appropriate parts of the
General Public License. Of course, the commands you use may be called something other than
`show w' and `show c'; they could even be mouse-clicks or menu items--whatever suits your
program.
You should also get your employer (if you work as a programmer) or your school, if any, to sign a
"copyright disclaimer" for the program, if necessary. Here is a sample; alter the names:
Yoyodyne, Inc., hereby disclaims all copyright interest in the program `Gnomovision' (which
makes passes at compilers) written by James Hacker.
<signature of Ty Coon>, 1 April 1989
Ty Coon, President of Vice
This General Public License does not permit incorporating your program into proprietary
programs. If your program is a subroutine library, you may consider it more useful to permit
linking proprietary applications with the library. If this is what you want to do, use the GNU
Library General Public License instead of this License.
G.3.2. Busybox
The uses BusyBox version 1221
This license was taken on the 28 December 2006.
164
BusyBox is licensed under the GNU General Public License, version 2
BusyBox is licensed under the GNU General Public License version 2, which is often abbreviated
as GPLv2. (This is the same license the Linux kernel is under, so you may be somewhat familiar
with it by now.)
A complete copy of the license text is included in the file LICENSE in the BusyBox source code.
Anyone thinking of shipping BusyBox as part of a product should be familiar with the licensing
terms under which they are allowed to use and distribute BusyBox. Read the full test of the GPL
(either through the above link, or in the file LICENSE in the busybox tarball), and also read the
Frequently Asked Questions about the GPL.
Basically, if you distribute GPL software the license requires that you also distribute the source
code to that GPL-licensed software. So if you distribute BusyBox without making the source code
to the version you distribute available, you violate the license terms, and thus infringe on the
copyrights of BusyBox. (This requirement applies whether or not you modified BusyBox; either
way the license terms still apply to you.) Read the license text for the details.
A note on GPL versions

Version 2 of the GPL is the only version of the GPL which current versions of BusyBox may be
distributed under. New code added to the tree is licensed GPL version 2, and the project's license
is GPL version 2.
Older versions of BusyBox (versions 1.2.2 and earlier, up through about svn 16112) included
variants of the recommended "GPL version 2 or (at your option) later versions" boilerplate
permission grant. Ancient versions of BusyBox (before svn 49) did not specify any version at all,
and section 9 of GPLv2 (the most recent version at the time) says those old versions may be
redistributed under any version of GPL (including the obsolete V1). This was conceptually similar
to a dual license, except that the different licenses were different versions of the GPL.
However, BusyBox has apparently always contained chunks of code that were licensed under GPL
version 2 only. Examples include applets written by Linus Torvalds (util-linux/mkfs_minix.c and
util_linux/mkswap.c) which stated they "may be redistributed as per the Linux copyright" (which
Linus clarified in the 2.4.0-pre8 release announcement in 2000 was GPLv2 only), and Linux
kernel code copied into libbb/loop.c (after Linus's announcement). There are probably more,
because all we used to check was that the code was GPL, not which version. (Before the GPLv3
draft proceedings in 2006, it was a purely theoretical issue that didn't come up much.)
To summarize: every version of BusyBox may be distributed under the terms of GPL version 2.
New versions (after 1.2.2) may only be distributed under GPLv2, not under other versions of the
GPL. Older versions of BusyBox might (or might not) be distributable under other versions of the
GPL. If you want to use a GPL version other than 2, you should start with one of the old versions
such as release 1.2.2 or SVN 16112, and do your own homework to identify and remove any code
that can't be licensed under the GPL version you want to use. New development is all GPLv2.
165
License enforcement
BusyBox's copyrights are enforced by the Software Freedom Law Center (you can contact them at
gpl@busybox.net), which "accepts primary responsibility for enforcement of US copyrights on the
software... and coordinates international copyright enforcement efforts for such works as
necessary." If you distribute BusyBox in a way that doesn't comply with the terms of the license
BusyBox is distributed under, expect to hear from these guys. Their entire reason for existing is to
do pro-bono legal work for free/open source software projects. (We used to list people who violate
the BusyBox license in The Hall of Shame, but these days we find it much more effective to hand
them over to the lawyers.)
Our enforcement efforts are aimed at bringing people into compliance with the BusyBox license.
Open source software is under a different license from proprietary software, but if you violate that
license you're still a software pirate and the law gives the vendor (us) some big sticks to play with.
We don't want monetary awards, injunctions, or to generate bad PR for a company, unless that's
the only way to get somebody that repeatedly ignores us to comply with the license on our code.
166
Appendix H: Compliance with Section 6 of

IEC 60601-1-2
a) The iVent101 needs special precautions regarding EMC and needs to be installed and put
into service according to the EMC information provided in the accompanying documents
b) Portable and mobile RF communications equipment can affect iVent101.
c) The iVent101 was tested with the following accessories/cables to meet with the standard
emission and immunity requirements.
Port Port Connected Connector Cable Indoor /

Qty. Cable type
type description From To type Length outdoor
Power AC power EUT AC mains 2-pole 1 Unshielded 2m Indoor

Power DC power EUT Battery pack XLB2-42 1 Unshielded 2m Indoor
Signal SpO2 EUT Sensor 10214-6212VC 1 Unshielded 2.9 m Indoor
Signal Ext. alarm EUT Not connected Microphone 1 NA NA Indoor
Signal Ethernet (LAN)* EUT Not connected RJ 45 1 NA NA Indoor
Signal RS 232* EUT Not connected RJ 45 1 NA NA Indoor
Signal USB* EUT Not connected USB 1 NA NA Indoor
* Used for maintenance only.
d) The use of accessories, transducers and cables other than those specified, with the
exception of transducers and cables sold by the manufacturer of the iVent101 as
replacement parts for internal components, may result in increased emissions or decreased
immunity of the iVent101
e) The iVent101 should not be used adjacent to or stacked with other equipment and that if
adjacent or stacked use is necessary, the iVent101 should be observed to verify normal
operation in the configuration in which it will be used.
d) The use of the accessory, transducer or cable with equipment and systems other than those
specified may result in increased emissions or decreased immunity of the iVent101.
e) Electro Magnetic Declaration – IVent101:
167
Index
Electro-magnetic emissions
The iVent101 is designed to be used in the electro-magnetic environment specified below. The
equipment’s customer or user must ensure that it is used in such an environment.
Emission test Compliance Recommended electro-magnetic environment
RF emissions The iVent101 uses RF energy only for its internal function.
Group 1 Therefore its RF emissions are very low and are not likely to cause
CISPR 11
any interference in nearby electronic equipment.
RF emissions
Class B
CISPR 11
Harmonic
emissions Class A The iVent101 is suitable for use in all establishments, including
IEC 61000-3-2 domestic establishments and those directly connected to the public
Voltage low-voltage power supply network that supplies buildings used for
fluctuations/flick domestic purposes.
Complies
er emissions
IEC 61000-3-3
168
Electro-magnetic immunity
Immunity IEC 60601 Compliance Recommended electro-magnetic
test test level level environment
Electrostatic
The floors should be wood, concrete or ceramic tile.
discharge ± 6 kV contact ± 6 kV contact
If the floors are covered with synthetic material, the
(ESD) IEC ± 8 kV air ± 8 kV air
relative humidity should be at least 30%.
61000-4-2
± 2 kV on
± 2 kV on
power supply
Electrical fast power supply
lines Mains power quality should be that of a typical
transient/ burst lines
± 1 kV on commercial or hospital environment.
IEC 61000-4-4 ± 1 kV on input
input / output
/ output lines
lines
± 1 kV ± 1 kV
differential differential
Surge Mains power quality should be that of a typical
mode mode ± 2 kV
IEC 61000-4-5 commercial or hospital environment.
± 2 kV common common
mode mode
< 5% UT < 5% UT
(>95% dip in (>95% dip in
Mains power quality should be that of a typical
UT) for 0.5 UT) for 0.5
commercial or hospital environment. If the user of
Voltage dips, cycles 40% UT cycles 40% UT
short (60% dip in UT) (60% dip in the iVent101 requires continued operation during
interruptions for 5 cycles UT) for 5 power mains interruptions, it is recommended that
and voltage 70% UT cycles the iVent101 be powered from an uninterruptible
variations on (30% dip in UT) 70% UT power supply or a battery.
power supply for 25 cycles (30% dip in
input lines < 5% UT UT) for 25 Note: Voltage reduction didn't influence the
IEC 61000-4-11 (>95% dip in cycles iVent101 which is always supplied with the back
UT) for 5 s < 5% UT
up battery
(>95% dip in
UT) for 5 s
Power
frequency Power frequency magnetic fields should be at levels
(50/60 Hz) 3 A/m 3 A/m characteristic of a typical location in a typical
magnetic field commercial or hospital environment.
IEC 61000-4-8
NOTE: UT is the AC mains voltage prior to application of the test level.
169
Index
Electro-magnetic immunity (follows)

Immunity IEC 60601 Compliance Recommended electro-magnetic
test test level level environment
Portable and mobile RF communications equipment
should be used no closer to any part of iVent101
including cables, than the recommended separation
distance calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance:
d = 0.35√P from 150 kHz to 80 MHz outside ISM
bands
d = 1.2√P from 150 kHz to 80 MHz within ISM bands
where P is the maximum output power rating of the
3 V rms
transmitter in watts (W) according to the transmitter
150 kHz to 80
manufacturer and d is the recommended separation
Conducted MHz outside b
10 V distance in metres (m) .
Radio ISM bandsa
150 kHz to 80
frequency 10 V rms Field strengths from fixed RF transmitters, as
MHz
IEC 61000-4-6 150 kHz to 80 determined by an electromagnetic site surveyc,
MHz within should be less than the compliance level in each
ISM bandsa frequency ranged.
Interference may occur in the vicinity of equipment
marked with the following symbol:
Recommended separation distance:

d = 1.2√P from 80 MHz to 800 MHz
d = 2.3√P from 800 MHz to 2.5 GHz
where P is the maximum output power rating of the
Radiated Radio transmitter in watts (W) according to the transmitter
10 V/m 10V/m
frequency manufacturer and d is the recommended separation
80 MHz to 2.5 80 MHz to 2.5
IEC 61000-4-3 distance in metres (m) b.
GHz GHz
Field strengths from fixed RF transmitters, as
c
determined by an electromagnetic site survey ,
should be less than the compliance level in each
frequency ranged.
Interference may occur in the vicinity of equipment
170
marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the highest frequency interval is applied NOTE 2: This guide is not
applicable in every situation. The issue of electro-magnetic waves is affected by the absorption and the
reflection of structures, objects and people.
(a) The ISM bands (Industrial, Scientific and Medical) between 150 kHz and 80 MHz are 6.765 MHz to 6.795
MHz, 13.553 MHz to 13.567 MHz, 26.957 MHz to 27.283 MHz and 40.66 to 40.70 MHz.
(b) Compliance levels in ISM frequency bands between 150 kHz and 80 MHz and between 80 MHz and 2.5
GHz are intended to decrease the likelihood that mobile/portable communication equipment could cause
interference if it is inadvertently brought into patient areas. This is why an additional 10/3 factor is used in
calculating the distance of separation for emitters in these frequency ranges.
(c) Fields from fixed emitters, such as cordless telephone bases, mobile radios, CB radios, AM and FM radio
emissions, TV emissions may not be accurately predicted in theory. In order to evaluate the electro-
magnetic environment from fixed emitters, an electro-magnetic surveillance site must be considered. If the
force field measured in the environment where the iVent101 has to be used, exceeds the above
applicable RF levels, theiVent101 must be watched to check if it is working normally. If abnormal
performance is observed, extra measures have to be taken such as redirecting or moving the iVent101.
(d) Above the 150 kHz to 80 MHz frequency range, force fields should be less than 10 V/m.
171
Index
Recommended distance between portable and mobile RF communications

equipment and iVent101
The iVent101 is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the iVent101 can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and iVent101 as recommended below, according to the maximum output power of the
communications equipment.
Distance apart in terms of the emitter’s frequency (m)
Maximum 150 kHz to 80
150 kHz to 80
power of the MHz within 80 MHz to
MHz outside
emitter (W) the ISM 800 MHz d 800 MHz to 2.5 GHz d = 2.3√P
the ISM bands
bands d = = 1.2√P
d = 0.35√P
1.2√P
0.01 0.035 0.12 0.12 0.23
0.1 0.11 0.38 0.38 0.73
1 0.35 1.2 1.2 2.3
10 1.1 3.8 3.8 7.3
100 3.5 12 12 23
For checked emitters with a maximum power not listed above, the recommended separation distance « d »
in meters (m) may be determined using the equation applicable to the emitter’s frequency, where « P » is
the maximum power of the emitter in Watts (W) according to the emitter’s manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance of the highest frequency range is applied.
NOTE 2: ISM bands (Industrial, Scientific and Medical) between 150 kHz and 80 MHz are 6.765 MHz to
6.795 MHz,
13.553 MHz to 13.567 MHz, 26.957 MHz to 27.283 MHz and 40.66 to 40.70 MHz.
NOTE 3: An additional factor of 10/3 is used in calculating the separation distance for emitters in the 150
kHz and 80 MHz ISM range as well as the frequency range between 80 MHz and 2.5 GHz in order to
reduce the probability that mobile/portable communication equipment causes interference if they are
unknowingly taken near the patient.
NOTE 4: This guide is not applicable in every situation. The issue of electro-magnetic waves is affected by
the absorption and the reflection of structures, objects and people.
172
Index
PRVC breath 136
A
Button volume 67
A/C pressure control 52
A/C PRVC 52 C
A/C volume control 52 Cleaning Procedure 95
Adaptive Bi-Level 52, 149 Clinical view 40
Alarm Continuous Positive Airways
Parameters 74 Pressure 148
Priority 73 CPAP 148
Settings 74 CPAP/PSV 52
Severity 73
D
Silencing 78
Volume 78 Date 66
Alarm volume 67 Default settings 121
Apnea 58, 151 Dysynchrony 150, 151
Apnea Mode 60 E
Apnea Settings 58
Assist breath 133 Easy ExhaleTM 150
Assist/Control mode 143 Emergency Backup 151
Exhalation phase 131
B
F
Basic Night View 39
Basic View 39 Filter
Battery Air Inlet 31
Integrated 27, 102 Flow 72
Maintenance 102 G
Breath Styles 133
Mandatory 133 General configuration 65
Mandatory volume control 133 Graph tab 72
Manual Breath 137 H
Patient breath 138
Heated humidification 30
Pressure control 135
HME 30
Pressure support 138
173
Index
I Patient breath 138
I. Time 54 Patient triggering 132
Patient type 50
I:E 141, 153
Inspiratory phase 131 Pause ventilator 61
Peak flow 55, 141
Inspiratory time 54
PEEP 55, 131, 138, 144, 149, 150
Integrated Battery 27, 102
Pressure 72
Recharge 102
Pressure control breath 135
Intended Use 7
Pressure limit 55
L Pressure support breath 138
Leak 149, 152 Preventive maintenance procedures
Lock screen 68 96
Log book 92 PRVC breath 136
PSV 55
M
R
Maintenance 96
Battery 102 Rate 54
Mandatory breath 133 S
Manual breath 62, 137
Screen 43
MDI 30
Screen brightness 70
Menu 48
Screen lock 63
N Sensitivity 54, 132
New patient 50 Settings
Type 50
O Ventilation parameters 49
O2 69 Silencing the alarm 78
O2% SIMV 145
Low Oxygen Supply 33 SIMV pressure control 52
OVT 104 SIMV PRVC 52
SIMV volume control 52
P Sounds levels 67
P (Limit) 55 Starting ventilation 61
P. High 55 Stopping ventilation 61
P. Low 55 Synchronized Intermittent
Mandatory Ventilation Mode 145
174
T Adaptive Bi-Level 149
Apnea 151
Tab
Assist/Control mode 143
Graph 72
CPAP 148
Settings 44
Easy ExhaleTM 150
Test
OVT 104 Emergency Backup 151
Tidal volume 133, 135, 136, 141 SIMV 145
Time 66 Ventilation parameters 49
Trigger 132 Volume 78
Volume control breath 133
V Vt. Limit 54
Ventilation Vt. Set 55
Pausing 61 W
Starting 61
Stopping 61 Weight selection 50
Ventilation Mode 17, 51
175
Index
Notes:
176

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iVent101

iVent101 Operator’s Manual

Chapter 3: Main Screens 39

Chapter 4: Operating the Ventilator 47

Chapter 7: Troubleshooting 107

In addition, the iVent101 ventilator has the following advanced features:

1.2. How to use this manual

1.3. Cautions and Warnings

The iVent101 ventilator is a life-sustaining device. Do not rely solely on

To ensure patient safety, an appropriately trained caregiver should

VersaMed cannot be held responsible for incidents caused by this

To prevent explosion hazard, do not use the ventilator in the presence

The iVent101 should be used with a bacteria filter to protect the

Using the iVent101 ventilator in combination with devices such as

During infant ventilation with a high sensitivity, false triggers may

During infant ventilation, in certain clinical conditions, Vt accuracy

The iVent101 ventilator must not be operated immediately following

Do not use the iVent101 ventilator in an explosive atmosphere.

Your ventilator is an electronic instrument. Any electronic instrument

The iVent101 ventilator shall not be used with flammable agents.

If another device interferes with your ventilator:

It is important to check the inspiratory/ expiratory resistance

1.4. Intended Use

Figure 1.1 Front View of the iVent101 Ventilator

ITEM NUMBER DESCRIPTION

Figure 1.2 Rear View of the iVent101 Ventilator

ITEM NUMBER DESCRIPTION

1.7. iVent101 Indicator Lights

Yellow blinking: slow charge or the battery in

1.8. Symbols and Labels

Upper Panel Symbols

General Electric Logo Below the touch

Ventilator name Above the touch

On/Off indicator On the right side of

Battery Charge indicator

To Patient Below the inspiratory

FUNCTION ICON/ SYMBOL LOCATION

Exhalation Valve On the plastic panel

1.8.2. Back Panel Labeling – Connectors

RS232 icon Left side of the RS232

LAN Above the LAN

Voltage, current, frequency Below the AC

Ext DC Battery Above the Ext DC

MMC Card Below the MMC

1.8.3. Filter Side

Class 2 – double isolation (electrical)

Type BF – Body Floating

Caution: Text: “Caution: US federal law restricts this device

1.9.1. Size and Weight

1.9.2. Environmental Specifications

1.9.3. Power Supply

1.9.4. Ventilation Modes

1.9.6. Inspiratory and Expiratory Resistance

PATIENT CIRCUIT TYPE PRESSURE [CMH2O] FLOW [LPM]

Adult two limb Patient Inspiratory -8 60

1.9.7. Ventilation Setting and Measured Value

1.9.8. Default Settings

1.9.9. Additional Displayed Parameters

1.9.11. iVent101 Ventilator Alarms

1.9.12. User Adjustable Alarms

PRESSURE: High: 5 – 60 cmH2O

1.9.13. Non-Adjustable Alarms

O2 sensor worn out Battery Empty