iVent201 Operators Manual Ver 12 Sept 2009

iVent201 Operator's Manual

Manufacturer’s Address VersaMed Medical Systems Hasharon Industrial Park; Ornat Building Kadima, Israel Authorized Representative in the European Community for regulatory affairs

Obelis S.A. Av. de Tervuren 34, bte 44 B-1040 Brussels Belgium Tel: +32-2-732-59.54 Fax: +32-2-732-60.03 European Community Sales office:

Bismarckstr.77 46047 Oberhausen Phone :+491732808345 Fax: +492088823267

iVent201 Operator's Manual

Calling for Help Owner’s Record The model number and serial number of your iVent201 are located on the rear panel of your ventilator. Record the serial number in the space below in case service or support is necessary. Model Number: Serial Number: Customer 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. 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

VersaMed Medical Systems Hasharon Industrial Park; Ornat Building Kadima, Israel Authorized Representative in the European Community Obelis S.A. Av .de Tervuren 34, bte 44 B-1040 Brussels Belgium Tel: +32-2-732-59.54 Fax: +32-2-732-60.03

Visit our web site at versamed.com

iVent201 Operator's Manual

Table of Contents 1

Introduction... 1 1.1 How To Use This Manual...3 1.2 Looking at the iVent201 ...4 1.3 Cautions and Warnings...8 1.4 Symbols and Labels...10 1.5 Performance and Parameters ...11 1.6 Specifications ...13 1.6.1 Monitored Data Range, Resolution and Accuracy...13 1.6.2 Size and Weight...16 1.6.3 Ventilation Modes...16 1.6.4 Environmental Specifications...17 1.6.5 Power Supply ...17 1.6.6 O2 Supply Specifications ...18 1.6.7 Ventilation Performance and Controlled Parameters ...18 1.6.8 Pulse Oximetry Specifications...19 1.7 Standards and Safety Requirements ...20 1.8 Displayed Parameters...21 1.9 User Adjustable Alarms...22 1.10Additional Alarms ...23

iVent201 Operator's Manual

1.11Waveforms and Diagnostics Packages...24 1.12Intended Use ...25 1.13Use of the iVent201 with MRi ...26

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Setting Up... 33 2.1 Power Connection ...34 2.1.1 External power ...34 2.1.2 Internal Battery...37 2.2 Oxygen Supply ...41 2.2.1 High Pressure Oxygen Supply...42 2.2.2 Low Pressure Oxygen Supply...43 2.3 Patient Circuit ...44 2.3.1 Disposable Patient Circuit ...44 2.3.2 Reusable Patient Circuit...46 2.3.3 Dual Limb Patient Circuit...46 2.3.4 Circuit Resistance...49 2.4 Other Connections ...49 2.4.1 HME ...49 2.4.2 MDI ...50 2.4.3 Using the iVent201 with Heated Humidification (1.4 models only) ...50 2.4.4 Synchronized Nebulizer Device ...52 2.4.5 Pulse Oximeter ...53 2.4.6 Sensor Line Maintenance ...56 2.5 Patient Connection...56 2.6 Filters ...56 2.6.1 Air Inlet Filter ...56 2.6.2 Bacterial Filter...57 2.6.3 Chemical, Biological, Radiological, and Nuclear Filter ...57

iVent201 Operator's Manual

2.7 Operational Case ...58 2.8 The iVent201 User Interface...59 2.9 Controls and Powering Up...59 2.9.1 The Front Panel ...59 2.9.2 LED Indicators...62 2.9.3 The Screen ...63

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Operating the iVent201 – Setting Modes and Parameters... 67 3.1 Operation Advanced Mode ...68 3.1.1 Power Up and Weight Selection ...68 3.1.2 O.V.T. ...69 3.1.3 Standby and Patient Ventilation ...71 3.1.4 Changing Ventilation Mode ...72 3.2 Common Parameters...75 3.2.1 Changing Ventilation Parameters - Overview...76 3.2.2 The Selection Interface ...78 3.2.3 Adjusting Breath Rate ...79 3.2.4 Adjusting Tidal Volume...81 3.2.5 Adjusting Pressure...86 3.2.6 Adjusting FiO2 ...88 3.2.7 Adjusting Peak Flow ...90 3.2.8 Adjusting Pressure Support Ventilation...93 3.2.9 Adjusting PEEP ...95 3.2.10

Adjusting Trigger Sensitivity ...96

3.2.11

Adjusting Inspiratory Time ...98

3.2.12

Adjusting Rise Time ...100

3.2.13

Adjusting Flow Termination (Esens) ...103

iVent201 Operator's Manual

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The Main Menu... 107 4.1 Navigating the Main Menu...108 4.2 Alarm Settings ...109 4.3 Advanced Settings ...110 4.3.1 Sigh Breath ...111 4.3.2 Easy Exhale™ ...113 4.3.3 Oxygen Supply ...114 4.3.4 Adaptive Peak Flow ...121 4.3.5 Humidifier Setting ...122 4.3.6 Pulse Oximetery ...124 4.3.7 Synchronized Nebulizer ...126 4.3.8 Set Time and Date ...128 4.4 Restore Default Settings ...130 4.4.1 Default Parameters Settings ...132 4.5 Show Graphs...135 4.5.1 Browse Waveforms...136 4.5.2 Select Range ...137 4.6 Show Trends ...139 4.6.1 Selecting Trends To Display...142 4.6.2 Browsing Trends ...143 4.7 Show Loops ...146 4.8 Show Mechanics...149 4.9 Pulse Oximetry Screen ...150 4.9.1 Pulse Oximetery Alarms ...153 4.10Show Log Book...154 4.11Display ...155 4.12O.V.T...159 4.13Maintenance...159

iVent201 Operator's Manual

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Adaptive Bi-Level... 161 5.1 About Adaptive Bi-Level ...161 5.2 Guide to Adaptive Bi-Level ...161 5.3 Indications and Warning ...162 5.3.1 Indications...162 5.4 Setup ...163 5.4.1 Adaptive Bi-Level Alarm Settings ...165 5.4.2 Other Alarm Options...166 5.5 Adjusting Adaptive Bi-Level Parameters...166 5.6 Adaptive Bi-Level Window...168 5.7 Easy Exhale™ ...169 5.8 Optimizing the Patient Ventilator Interface...169 5.9 Resolving Patient Ventilator Dysynchrony ...170

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Alarms... 173 6.1 How Alarms Work ...173 6.1.1 Responding to an Alarm ...174 6.2 Alarm settings ...176 6.2.1 Changing Individual Alarm Settings ...177 6.2.2 Auto Settings...186 6.2.3 Alarm Options ...187 6.3 Guide to Alarm Definitions and Priorities ...195 6.4 Alarms Tests...205 6.5 The Sensor Failure Alarm...209 6.6 Patient Disconnect Alarm...211 6.7 Patient Circuit Failed Alarm ...212

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Care, Maintenance, and Tests ... 213 7.1 Cleaning and Maintenance ...213

iVent201 Operator's Manual

7.1.1 Cleaning the Ventilator ...214 7.2 Preventive Maintenance ...215 7.3 Storage Preventive Maintenance...216 7.4 The O.V.T. ...217 7.5 The Maintenance Screen...217 7.5.1 Calibration...217 7.5.2 Ventilator Verification Tests...222 7.6 Configuration Screen ...228 7.6.1 Choosing a different Startup Screen...228 7.6.2 Setting the startup weight...229 7.6.3 Default FiO2 Setting ...229 7.7 VersaMed Service Functions ...230 7.7.1 Communication Port ...230 7.7.2 Communication Rate ...230 7.8 Localization ...231 7.9 Total Operating Hours ...233

Appendix A : Glossary ... 235 Appendix B : Warranty ... 241 Appendix C : Operating Theory... 245 C.1 Ambient Air Filter ...245 C.2 CBRN Filter (optional) ...245 C.3 Low Pressure O2 Adapter and Filter (optional) ...245 C.4 Air/Oxygen Blending System ...245 C.5 Inlet Manifold ...245 C.6 Turbine Unit...246 C.7 Turbine Pressure Sensor ...246

iVent201 Operator's Manual

C.8 Turbine Valves ...246 C.9 Over Pressure Relief Valve ...246 C.10 Airway Flow and Pressure Sensors...246 C.11 Pressure Switch ...246 C.12 Inlet and Outlet Mufflers ...246

Appendix D : Theory of Breath Delivery... 249 D.1 Breath Delivery ...249 D.2 Patient Triggering ...250 D.3 Breath Types ...251 D.3.1 Adaptive FlowTM and Adaptive I-Time™ ...252 D.3.2 Mandatory Volume Control Breath ...255 D.3.3 Pressure Control Breath...256 D.3.4 Manual Mandatory Breath ...257 D.3.5 Patient Pressure Support Breath ...258 D.3.6 Patient Spontaneous Breath ...259 D.4 Summary...260

Appendix E : Ventilation Modes ... 263 E.1 Assist/Control Mode ...263 E.1.1 Definition...263 E.1.2 Available Breath Types ...263 E.1.3 Description ...263 E.1.4 Parameters Setting ...264 E.2 Synchronized Intermittent Mandatory Ventilation Mode ...265 E.2.1 Definition...265 E.2.2 Available Breath Types ...265 E.2.3 Description ...266 E.2.4 Parameters Setting ...267

iVent201 Operator's Manual

E.3 Continuous Positive Airway Pressure Mode ...267 E.3.1 Definition...267 E.3.2 Available Breath Types ...267 E.3.3 Description ...267 E.3.4 Parameters Setting ...268 E.4 Apnea Back-Up Ventilation...269 E.5 Open Loop Mode ...270 E.6 Adaptive Bi-Level Mode ...271

Appendix F : Hold Function and Static Mechanics Measurements... 273 F.1 Front Panel Controls...273 F.2 Static Compliance Measurements ...274 F.2.1 Static Compliance ...275 F.2.2 Respiratory Time Constant ...275 F.2.3 Performing a Static Respiratory Mechanics Measurement ...275 F.2.4 Clinical Considerations...278 F.3 End Expiratory Hold...278 F.3.1 Performing and End Expiratory Hold Maneuver ...279 F.3.2 Reviewing Static Mechanics and Intrinsic PEEP Measurements ..280 F.4 RR/Vt Ratio ...281

Appendix G : Part Numbers and Accessories ... 283 Appendix H : Index... 285

iVent201 Operator's Manual

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

Assist/Control  Volume Controlled A/C  Pressure Controlled A/C



Synchronized Intermittent Mandatory Ventilation (SIMV)  Volume Controlled SIMV (Vctrl SIMV)  Pressure Controlled SIMV (Pctrl SIMV)



Continuous Positive Airway Pressure (CPAP)



Pressure Support Ventilation (PSV

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

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Introduction

In addition, the iVent201 has these advanced features:

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

Rise time is adjustable



Preset Parameters by Patient Weight enables quick setup



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



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



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



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



Firmware is upgradeable via a PC connection



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

iVent201 Operator's Manual

1.1 How To Use This Manual The iVent201 must only be operated by authorized medical personnel well trained in the use of this product. It must by operated according to instruction in this Operator’s Manual. 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 the manual 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

Almost out every function or operation of the iVent is accessible through one of the Main screen menus. Be aware of the notes, warnings, and cautions, 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 the Adaptive Bi-Level feature, read Section 5 (page 161).

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Introduction

1.2 Looking at the iVent201

1

2

3 7

6

5

Figure 1.1 Front View of the iVent201

4

4

iVent201 Operator's Manual

Table 1-1 Front View of the iVent201 Item Number

Description

1

Display

2

Keypad

3

Control knob

4

Exhalation valve luer inlet

5

Ventilator outlet

6

Sensor line luer inlets

7

Nebulizer outlet

5

Introduction

1 1

4

2

17

16 3

15

4

14

5

6

13

7

12

8

11

9

10 10

Figure 1.2 Rear View of the

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iVent201 Operator's Manual

Table 1-2 Rear View of the iVent201 Item Number

Description

1

Carrying handle

2

Keyboard connector

3

Remote alarm connector

4

External screen connector

5

LAN connector

6

AC cable clip

7

RS 232 connectors (COM1 and COM2)

8

High pressure oxygen inlet connector

9

On/off switch (with cover)

10

4 x Battery pack screws

11

Internal battery handle

12

DC fuse

13

AC fuses

14

DC cord connector

15

Grounding pin

16

AC cord connector

17

Cooling fan

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

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iVent201 Operator's Manual

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. CAUTION: The remote alarm connector should be connected to a nurse station device on a low voltage less than 24Vdc and compliant with IEC 60601-1. CAUTION: The factory default setting for “Leak Alarm” is set to ”off.” Users must manually set the leak alarm to enable it.

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