VersaMed i Vent201 User Manual

iVent201

Operator’s Manual

iVent201 Operator’s Manual Part Number OM-01-04

Rev: 11 Revised: December 2006 Copyright © 2006 by VersaMed™ Medical Systems, Inc.

0473

iVent201 Operator's Manual

Manufacturer’s Address

P.O. Box 1512, Blue Hill Plaza, Pearl River, New York 10965 USA.

Authorized Representative in the European Community for regulatory affairs

Obelis S.A.

Av. de Tervuren 34, bte 44

B-1040 Brussels

Belgium

Tel: [phone]

Fax: [phone]

European Community Sales office:

Bismarckstr.77

46047 Oberhausen

Phone :[phone]

Fax: [phone]

iVent201 Operator's Manual

Calling for Help

Owner’s Record

The model number and serial number of your iVent201 are on the rear panel of your ventilator. Record the serial number in the space provided below to have this information should you need to call for service or support.

Model Number:

Serial Number:

Customer Support

and Service

If you have a ventilator problem you cannot solve and you purchased your ventilator directly from VersaMed, call:

800-475-9239 - Customer Care and Service Assistance Line

NOTE: If this ventilator has not been purchased directly from VersaMed, please ensure that it has been purchased from an authorized distributor of VersaMed. To obtain a list of authorized distributors contact VersaMed at [e-mail].

If you have a ventilator problem that you cannot solve and you purchased your ventilator from an authorized VersaMed distributor, please contact your distributor directly to report the problem.

Manufacturer’s Address

P.O. Box 1512, Blue Hill Plaza, Pearl River, New York 10965 USA.

Authorized Representative in the European Community

Obelis S.A.

Av .de Tervuren 34, bte 44

B-1040 Brussels

Belgium

Tel: [phone]

Fax: [phone]

Visit our web site at versamed.com

iVent201 Operator's Manual

Table of Contents

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

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

3Operating the iVent201 – Setting Modes

and Parameters...........................................

63

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

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

iVent201 Operator's Manual
5.5	Adjusting Adaptive Bi-Level Parameters.............................................	186
5.6 Adaptive Bi-Level Window....................................................................		187
5.7 Easy Exhale™ ...........................................................................................		188
5.8	Optimizing the Patient Ventilator Interface........................................	189
5.9	Resolving Patient Ventilator Dysynchrony .........................................	189
6	Alarms .........................................................	193
6.1 How Alarms Work...................................................................................		193
6.1.1 Responding to an Alarm..................................................................		194
6.1.2 Alarm settings...................................................................................		196
6.2	Guide to Alarm Definitions and Priorities ..........................................	199
6.3	Alarms Tests.............................................................................................	209
6.4	The Sensor Failure Alarm.......................................................................	215
6.5	Patient Disconnect Alarm.......................................................................	218
6.6	Patient Circuit Failed Alarm ..................................................................	219
7	Care, Maintenance, and Tests .................	221
7.1 Cleaning and Maintenance ....................................................................		221
7.2	Preventive Maintenance .........................................................................	222
7.3 The O.V.T. ................................................................................................		223
7.4 The Maintenance Screen ........................................................................		224
7.4.1 Calibration.........................................................................................		224
7.4.2 Ventilator Verification Tests ............................................................		224
7.5	Configuration Screen ..............................................................................	232
7.5.1 Choosing a different Startup Screen ...............................................		232
7.5.2 Setting the startup weight................................................................		233
7.5.3 Default FiO2 Setting..........................................................................		234
7.6	VersaMed Service Functions .................................................................	234
7.7 Communication Rate ..............................................................................		235

iVent201 Operator's Manual
7.8 Localization ..............................................................................................		235
7.9 Total Operating Hours ............................................................................		238
Appendix A : Glossary.....................................		239
Appendix B : Warranty ....................................		247
Appendix C : Operating Theory ....................		251
C.1	Ambient Air Filter ............................................................................	251
C.2	CBRN Filter (optional) ...................................................................	251
C.3	Low Pressure O2 Adapter and Filter (optional) ....................	251
C.4 Air/Oxygen Blending System......................................................		251
C.5	Inlet Manifold....................................................................................	251
C.6 Turbine Unit .......................................................................................		252
C.7	Turbine Pressure Sensor................................................................	252
C.8 Turbine Valves ..................................................................................		252
C.9	Over Pressure Relief Valve...........................................................	252
C.10 Airway Flow and Pressure Sensors.........................................		252
C.11 Pressure Switch ...............................................................................		252
C.12 Inlet and Outlet Mufflers............................................................		252
Appendix D : Theory of Breath Delivery .....		255
D.1 Breath Delivery.......................................................................................		255
D.2 Patient Triggering ..................................................................................		256
D.3 Breath Types ...........................................................................................		258
D.3.1 Adaptive FlowTM and Adaptive I-Time™......................................		259
D.3.2 Mandatory Volume Control Breath................................................		262
D.3.3 Pressure Control Breath...................................................................		263

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

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

iVent201 Operator's Manual

1 Introduction

The iVent201 is a compact, portable, fully-featured, microprocessor-controlled ventilator offering the versatility and capability of larger and costlier ventilators. A turbine-powered air source and a rechargeable internal battery provide freedom from wall air and power outlets. An intuitive turn-and-click control knob, quick-choice pushbuttons, and a bright, wellorganized, easy-to-read screen allow rapid control and continuous real-time monitoring of patient ventilation. Alarm settings are fully adjustable. Optional Waveform and Diagnostic Software package displays pressure and flow waveform data, loops, trends, and logged totals in a full array of graphical and numerical modes.

The iVent201 supports many modes:

•Assist/Control

•Volume Controlled A/C

•Pressure Controlled A/C

•Synchronized Intermittent Mandatory Ventilation (SIMV)

•Volume Controlled SIMV (Vctrl SIMV)

•Pressure Controlled SIMV (Pctrl SIMV)

•Continuous Positive Airway Pressure (CPAP)

•Pressure Support Ventilation (PSV)

1

Introduction

(Note: Certain modes are optional features and may not be operational in some iVent201 models.)

In addition, the iVent201 has these advanced features:

•Rise time is adjustable

•Preset Parameters by Patient Weight enables quick setup

•Adaptive Peak Flow can determine and deliver Inspiratory Peak Flow Rate according to a target mandatory tidal volume, maintaining a 1:2 I:E ratio

•Adaptive I-Time allows the ventilator to determine and deliver a respiratory cycle time to sustain a 1:2 I:E ratio

•The iVent201's Adaptive Bi-Level feature enables leak-tolerance for facemask ventilation or other specialized high-leak tube ventilation

•Easy Exhale is an advanced PEEP mode designed to reduce expiratory work of breathing

•Firmware is upgradeable via a PC connection

•The iVent201 is designed to operate according to specifications in any physical orientation – such as during transport use

2

iVent201 Operator's Manual

1.1 How To Use This Manual

You must read this manual before you use the iVent201. In particular, the first several sections are critical for an understanding of the iVent. This manual is primarily organized according to the available screens, menus, options and settings and begins with a look at the hardware, including power considerations and patient circuit setup.

Study them with the iVent close at hand, along with a patient circuit (preferably with a test lung and Rp20 resistor). Become comfortable with the control knob and the front panel buttons.

The user interface consists of three primary screens/menus:

•The Main Screen

•The Main Menu

•The Mode Menu

Just about every function or operation of the iVent is accessible through one of these screens. Be aware of the notes, warnings, and cautions, generally marked in bold print.

Useful user tips are in bold and set off with an arrow.

Refer to the index if you need information. Table 1.1 may also be used as a general guide.

If you are not familiar with Adaptive Bi-Level feature, read Section 05 (page 179).

3

Introduction

1.2 Looking at the iVent201

Display

Keypad

Nebulizer outlet

Ventilator outlet

Sensor line luer inlets

Exhalation valve luer inlet

Control knob

Figure 1.1 Front View of the iVent201

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iVent201 Operator's Manual

Carrying handle

Cooling fan

AC cord connector

Grounding pin

DC cord connector

AC fuses

DC fuse

Internal battery handle

Keyboard connector

SPO2 probe connector

Remote alarm connector

External screen connector

LAN connector

RS 232 connector

High pressure oxygen inlet connector

On/off switch

Battery

pack AC cable clip screws

(4)

Figure 1.2 Rear View of the iVent201

5

Introduction

1.3 Cautions and Warnings

WARNING: The iVent201 is a life-sustaining device. Do not rely solely on the ventilator performance: always make sure an alternative source of ventilation is available. Clinical supervision of the patient is mandatory.

CAUTION: The iVent201 is a restricted medical device to be operated by qualified medical personnel under the direction of a qualified medical practitioner.

WARNING: Qualified medical personnel should visually monitor patients on life-support ventilation. Life-threatening conditions may arise that might not activate alarms.

CAUTION: Always perform a complete Operation Verification Test (O.V.T.) when connecting a new patient circuit to the ventilator, and before using it on a patient. Standard facility policy should be followed.

WARNING: Do not use the iVent201 ventilator to treat infants weighing less than 10 kg/ 22 lb.

CAUTION: The factory default setting for “Leak Alarm” is set to ”off.” Users must manually set the leak alarm to enable it.

WARNING: To prevent explosion hazard, do not use the ventilator in the presence of flammable anaesthetics.

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iVent201 Operator's Manual

CAUTION: Using the iVent201 in combination with devices such as humidifiers or filters can increase the pressure gradient across the breathing system. Make sure that such devices do not produce excessive resistance to the airflow provided by the iVent201.

WARNING: Do not cover the iVent201 while it is in use. Make sure that the iVent201 is positioned so that its inlet ports and cooling vents are open to freely circulating air.

CAUTION: The iVent201 must not be operated immediately following storage or transport outside the recommended operation condition.

CAUTION: The iVent201 internal battery contains lead and must be disposed of in accordance with local ordinances and environmental regulations.

CAUTION: Do not connect the O2 supply when equipment is not in use.

7

Introduction

1.4 Symbols and Labels

Indicates that you should “Refer to documentation for further information.” Refer to manual per IEC 601-1

Potential equalization (Ground) point

Direct Current ( DC) and Alternating Current (AC)

Type BF equipment, per IEC 601-1

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iVent201 Operator's Manual

1.5 Performance and Parameters

Ventilation	Parameters/	Unit of	Accuracy	Set	Displayed	Page
Component	Range	Measure
Respiratory	1-12	bpm	±1	Y	Y	80
rate	12-80		±2
Inspired Tidal	50-2000	mL	±10%	Y	Y	83
Volume
Measurement
Exhaled Tidal	50-300	mL	±10 mL or +15%	Y	Y
Volume			whichever is greater
Measurement	300-2000		+10%
Inspiratory	5 to 80	cmH2O	±5	N	Y	87
Pressure Limit
Inspiratory	0.2 to 3 or	sec.	±10%	Y	Y	98
Time	Adaptive I-
	Time
Peak Flow	up to 120 or	L/min	±10%	Y	Y	91
	Adaptive
	Flow
Peak Flow	up to 180	L/min	±10%	Y	Y	91
(Spontaneous)
Oxygen Mix	21 to 100%		±5%	Y	Y	89
(FiO2)
PEEP	0 to 40	cmH2O	±1 or ±10%,	Y	Y	95
			whichever is greater
Trigger	1 to 20, off	L/min		Y	Y	96
sensitivity	-0.5 to –20, off	cmH2O

9

							Introduction
	Ventilation	Parameters/	Unit of	Accuracy	Set	Displayed		Page
	Component	Range	Measure
	PSV	0 to 60	cmH2O	±10%	Y	Y		93
	Positive	80	cmH2O		N	N
	Pressure relief
	valve
	Controlled	5 to 80	cmH2O	±5	Y	Y
	Pressure
	FiO2 at power	21%, 40%,			Y	Y		234
	up	60%, 100%
		(selectable)
	Purging cycle	1, 2, 5, 10, off	minute		Y	Y		141
			s

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iVent201 Operator's Manual

1.6 Specifications

1.6.1Monitored Data Range, Resolution and Accuracy

Parameter	Range, resolution, accuracy
Breath type	Range: Type: - Control, assist, spontaneous, sigh
	Resolution: N/A
	Accuracy: N/A
Respiratory	Range: 0 to 150/min
Rate	Resolution: 1/min
	Accuracy: ±1 for 1 to 12/min
	±2 for 12 to 150/min
Exhale tidal	Range: 0 to 5000 mL
volume	Resolution: 1 mL
	Accuracy: ±10 mL or ±15% (whichever is greater)
	for 0 to 300 mL
	±10% for 300 to 5000 mL
Exhaled Minute	Range: 0 to 99.9L
Volume	Resolution: 0.1 L
	Accuracy: ±10%
Peak flow	Range: 0 to 140 L/min
	Resolution: 1 L/min
	Accuracy: ±10%

11

Introduction

Parameter		Range, resolution, accuracy
	PIP (Peak	Range: 0 to 99 cmH2O
	Inspiratory	Resolution: 1 cmH2O
	Pressure)
		Accuracy: ± 2 (+ 5 % of reading) cm H2O
	Inspiratory time	Range: 0 to 3.0 sec
		Resolution: 0.1 sec
		Accuracy: ±10%
	I:E ratio	Range: 1:11 to 3:1
		Resolution: 0.1 for 1:1 to 1:5
		1 for 1:5 to 1:11 and 3:1 to 1:1
		Accuracy: ±0.1
	Delivered O2%	Range: 21 to 100%
		Resolution: 1%
		Accuracy: ±5%
	Flow Leak	Range: 0 to 100%
		Resolution: 1%
		Accuracy: ±15%
	Mean Airway	Range: 0 to 99 cmH2O
	Pressure	Resolution: 1 cmH2O
		Accuracy: ± 2 (+ 5 % of reading) cmH2O
	Resistance	Range: 0 to 99.9 cmH2O/L/s
	(dynamic)	Resolution: 0.1 cmH2O/L/s
		Accuracy: ± (2 + 20% of actual value) cmH2O/L/s
	Compliance	Range: 0 to 99.9 ml/cmH2O
	(dynamic)	Resolution: 0.1 ml/cmH2O
		Accuracy: ± (2 +20% of actual value) ml/cmH2O

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iVent201 Operator's Manual

	Parameter	Range, resolution, accuracy
	RR/Vt-Rapid	Range: 0 –200 /min*L
	Shallow	Resolution: 1 /min*L
	Breathing Index
	(RSBI)	Accuracy: ± (5 + 20% of actual value). /min*L
	Static	Range: 0 to 99 ml/cmH2O
	compliance	Resolution: 1 ml/cmH2O
		Accuracy: ± (2 + 20 % of actual value). ml/cmH2O
	Auto PEEP	Range: 0 to 99 cmH2O
		Resolution: 1 cmH2O
		Accuracy: ± 2 (+ 5 % of reading) cmH2O
	Time Constant	Range: 0.0 to 9.9 sec
		Resolution: 0.1 sec
		Accuracy: ±20%

1.6.2Size and Weight

Height:	13” / 33 cm
Width:	9.5” / 24 cm
Depth:	10.3” / 26 cm
Screen:	8.4” / 21.3 cm diagonal
Weight	15.4 lb / 7 kg (without battery)
Battery Weight	6.5 lb / 3 kg
Overall Weight	22 lb / 10 kg

13

Introduction

1.6.3Ventilation Modes

•Assist/Control (A/C

•Volume Controlled (A/C)

•Pressure Controlled (A/C)

•Synchronized Intermittent Mandatory Ventilation (SIMV)

•Volume Controlled SIMV (Vctrl)

•Pressure Controlled SIMV (Pctrl)

•Continuous Positive Airway Pressure (CPAP) with Pressure Support Ventilation (PSV)

Note: Certain modes are not operational in all iVent201 models.

1.6.4Environmental Specifications

Operating Temperature	-15 to +50 °C / +5 to +122 °F
Storage Temperature	without battery: -15 to +70 °C / +5 to +158
	°F
	with battery: -15 to +30 °C / +5 to +86 °F
Relative Humidity	15 to 95% @ 30 °C / 86 °F
Water and Dust	IP-54 (Splash proof)
Resistance
Atmospheric Pressure	430 - 825 mmHg (up to 15,000 feet)
Vibration	IEC 68-2-6, IEC 68-2-34
	MIL-STD-810E

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iVent201 Operator's Manual

Shock	IEC 68-2-27 (100 g)
	MIL-STD-810E
Total External Sound	40 – 45 dBa at one meter
Level

1.6.5Power Supply

External AC	100 to 240 V, 50-60 Hz, max 1.6 A.
External DC	12 to 15 V max 8.5 A.
Battery
Internal Battery	Sealed Lead-Acid, 12 V 8 Ah (rechargeable)
Recharge Time	Over 8 hours, <1 Ampere
Operating Time	Up to 2 hours (varies with ventilation
(internal battery)	parameters)

1.6.6O2 Supply Specifications

Pressure Range	40-60 psi (2.8-4.2 bar)
Minimum flow	120L/min at 40 psi (2.8 bar)

15

Introduction

1.6.7Ventilation Performance and Controlled Parameters

Respiratory Rate	1 – 12 ±1, 12 – 80 ± 2 bpm
Tidal Volume	50-2000 mL
Accuracy of Tidal	±10% or ±10 mL whichever is greater
Volume Delivery

Accuracy of Respiratory

Volume Measurement

Inspiratory Pressure

Limit

±15% above 100 mL from actual reading or ±10 cc below 100 mL

5 to 80 ±5 cmH2O

Inspiratory Time	Adaptive TimeTM or 0.2 to 3 ±10% sec
Peak Flow (PIF)	Adaptive FlowTM or to 120 ±10% L/min
	Spontaneous to 140 ±10% L/min
Oxygen Mix (FiO2 )	21% to 100% ±5% O2
PEEP	0 to 40 ±1 cmH2O or ±10%, whichever is
	greater
Trigger Sensitivity	1 to 20 L/min Flow, Off
	- 0.5 to – 20 cmH2O Pressure, Off
PSV	0 to 60 ±10% cmH2O
Positive Pressure Relief	80 cmH2O
Valve
Controlled Pressure	5 to 80 cm ±5 cm
FiO2 at Power up	21%, 40%, 60%, 100% (configurable)
Purging Cycle	1, 2, 5, 10 minutes, Off (configurable)

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iVent201 Operator's Manual

1.7 Standards and Safety Requirements

The iVent201 meets or exceeds the following international standards:

ISO 10651-1	Lung Ventilators for medical use
ISO 10651-2	Particular requirements for Home Care Ventilators
ISO 10651-3	Requirements for Emergency and Transport
	Ventilators
ASTM F1100-90	Standard Specifications for Ventilators intended
	for use in Critical Care
IEC 60601-1	Electrical Safety
IEC 60601-1-2	Electromagnetic Compatibility (EMC)
IEC 60601-2-12	Medical Electrical Equipment – Particular
	Requirements for the Safety of Lung Ventilators -
	Critical Care Ventilators
UL 60601-1	Medical Electrical Equipment, part1: General
	Requirements for Safety
ASTM F1246-96	Standard Specification for Electrically Powered
	Home Care Ventilation.

1.8 Displayed Parameters

The following table presents the displayed parameters and indicates whether the displayed values are set, measured or both.

	Unit of	Set	Displayed
Parameter	Measure
Exhaled Tidal Volume (VT)	mL	+	+
Rate	bpm	+	+
Ventilation Mode		+	+
			17

Introduction

	Unit of	Set	Displayed
Parameter	Measure
Oxygen Concentration	FiO2	+	+
Inspiration to Expiration time ratio I:E ratio			+
Inspiratory Time (Itime)	sec	+	+
Sensitivity Values (Triggers): Pressure and	cmH2O/LPM	+	+
Flow
Pressure Support Ventilation (PSV)	cmH2O	+
Alarm Pressure / Limit Pressure	cmH2O	+	+
Positive End Expiratory Pressure (PEEP)	cmH2O	+	+
Exhaled Minute Volume	L		+
Peak Inspiratory Pressure	cmH2O		+
Pressure/Flow Wave Forms			+
Electrical Power Source (Ext./Int.)			+
In Adaptive Bi-Level Mode:
P High (Ins Pressure)	cmH2O	+	+
P Low (Exp. Pressure)	cmH2O	+	+
Tidal Volume (estimated)	mL		+
Leak (estimated)	LPM		+
Rise Time Setting		+
Non-Displayed Additional Parameters
Sigh Breath Setting		+
Purge Cycle Setting		+

18