iVent201 User’s Reference Manual Rev 11 Aug 2007

iVent201 Operator's Manual

Manufacturer’s Address P.O. Box 1512, Blue Hill Plaza, Pearl River, New York 10965 USA. Authorized Representative in the European Community for regulatory affairs

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

European Community Sales office:

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

iVent201 Operator's Manual

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 [email protected]. If you have a ventilator problem that you cannot solve and you purchased your ventilator from an authorized VersaMed distributor, please contact your distributor directly to report the problem. Manufacturer’s Address P.O. Box 1512, Blue Hill Plaza, Pearl River, New York 10965 USA. Authorized Representative in the European Community Obelis S.A. Av .de Tervuren 34, bte 44 B-1040 Brussels Belgium Tel: +32-2-732-59.54 Fax: +32-2-732-60.03

Visit our web site at versamed.com

iVent201 Operator's Manual

Table of Contents 1

Introduction ... 1 1.1 How To Use This Manual ... 3 1.2 Looking at the 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 1.6.8 Pulse Oximetry Specifications... 17 1.7 Standards and Safety Requirements ... 18 1.8 Displayed Parameters ... 18 1.9 User Adjustable Alarms ... 20 1.10Additional Alarms... 21 1.11Waveforms and Diagnostics Packages ... 22 1.12Intended Use... 22 1.13Use of the iVent201 with MRi ... 23

iVent201 Operator's Manual

2

Setting Up ... 27 2.1 Power Connection ... 28 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 ... 37 2.3 Breathing Circuit ... 38 2.3.1 Circuit Resistance... 40 2.4 Other Connections... 41 2.4.1 HME... 41 2.4.2 MDI ... 41 2.4.3 Using the iVent201 with Heated Humidification (1.4 models only) ... 41 2.4.4 Synchronized Nebulizer Device ... 44 2.4.5 Pulse Oximeter... 45 2.4.6 Sensor Line Maintenance ... 47 2.5 Patient Connection ... 48 2.6 Filters... 49 2.6.1 Air Inlet Filter... 49 2.6.2 Bacterial Filter ... 49 2.6.3 Chemical, Biological, Radiological, and Nuclear Filter ... 50 2.7 Operational Case ... 51 2.8 The iVent201 User Interface... 52 2.9 Controls and Powering Up... 53 2.9.1 The Front Panel... 53 2.9.2 LED Indicators ... 55 2.9.3 The Screen ... 56

iVent201 Operator's Manual

3

Operating the iVent201 – Setting Modes and Parameters ... 59 3.1 Operation... 59 3.1.1 Power Up and Weight Selection ... 59 3.1.2 O.V.T... 61 3.1.3 Standby and Patient Ventilation ... 64 3.1.4 Changing Ventilation Mode ... 64 3.1.5 Changing Ventilation Parameters - Overview... 68 3.2 Common Parameters ... 71 3.3 The Selection Interface ... 72 3.3.1 Adjusting Breath Rate ... 73 3.3.2 Adjusting Tidal Volume ... 76 3.3.3 Adjusting Pressure Limits in Volume Control Ventilation Modes ... 80 3.3.4 Adjusting FiO2 ... 81 3.3.5 Adjusting Peak Flow ... 83 3.3.6 Adjusting Pressure Support Ventilation... 86 3.3.7 Adjusting PEEP... 87 3.3.8 Adjusting Trigger Sensitivity ... 89 3.3.9 Adjusting Inspiratory Time ... 90

4

The Main Menu... 93 4.1 Navigating the Main Menu... 94 4.2 Alarm Settings ... 95 4.2.1 Changing Individual Alarm Settings... 95 4.2.2 Auto Settings... 105 4.2.3 Alarm Options ... 106 4.3 Advanced Settings... 113

iVent201 Operator's Manual

4.3.1 Sigh Breath ... 115 4.3.2 Rise Time ... 116 4.3.3 Easy Exhale™... 117 4.3.4 Oxygen Supply ... 119 4.3.5 Adaptive Peak Flow ... 125 4.3.6 Humidifier Setting... 126 4.3.7 Pulse Oximetery... 128 4.3.8 Synchronized Nebulizer... 133 4.3.9 Set Time and Date... 135 4.4 Restore Default Settings... 136 4.4.1 To Restore Defaults:... 136 4.5 Show Graphs... 140 4.5.1 Browse Waveforms... 141 4.5.2 Select Range... 143 4.6 Show Trends ... 145 4.6.1 Selecting Trends To Display ... 148 4.6.2 Browsing Trends... 150 4.7 Show Loops ... 151 4.8 Show Mechanics ... 154 4.9 Show Log Book ... 155 4.10Display ... 156 4.11O.V.T. ... 160 4.12Maintenance... 160

5

Adaptive Bi-Level... 161 5.1 About Adaptive Bi-Level... 161 5.2 Guide to Adaptive Bi-Level ... 162 5.3 Indications and Warning ... 163 5.3.1 Indications ... 163

iVent201 Operator's Manual

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... 168 5.6 Adaptive Bi-Level Window... 169 5.7 Easy Exhale™... 170 5.8 Optimizing the Patient Ventilator Interface... 171 5.9 Resolving Patient Ventilator Dysynchrony... 171

6

Alarms ... 175 6.1 How Alarms Work... 175 6.1.1 Responding to an Alarm... 176 6.1.2 Alarm settings... 178 6.2 Guide to Alarm Definitions and Priorities ... 180 6.3 Alarms Tests... 190 6.4 The Sensor Failure Alarm ... 194 6.5 Patient Disconnect Alarm... 196 6.6 Patient Circuit Failed Alarm ... 197

7

Care, Maintenance, and Tests ... 199 7.1 Cleaning and Maintenance ... 199 7.2 Preventive Maintenance... 201 7.3 The O.V.T. ... 202 7.4 The Maintenance Screen ... 202 7.4.1 Calibration... 202 7.4.2 Ventilator Verification Tests ... 202 7.5 Configuration Screen... 209 7.5.1 Choosing a different Startup Screen ... 209 7.5.2 Setting the startup weight... 210

iVent201 Operator's Manual

7.5.3 Default FiO2 Setting... 211 7.6 VersaMed Service Functions... 211 7.7 Communication Rate... 211 7.8 Localization ... 212 7.9 Total Operating Hours... 214

Appendix A : Glossary... 215 Appendix B : Warranty ... 221 Appendix C : Operating Theory ... 225 C.1 Ambient Air Filter ... 225 C.2 CBRN Filter (optional) ... 225 C.3 Low Pressure O2 Adapter and Filter (optional) ... 225 C.4 Air/Oxygen Blending System ... 225 C.5 Inlet Manifold ... 225 C.6 Turbine Unit ... 226 C.7 Turbine Pressure Sensor ... 226 C.8 Turbine Valves ... 226 C.9 Over Pressure Relief Valve... 226 C.10 Airway Flow and Pressure Sensors ... 226 C.11 Pressure Switch ... 226 C.12 Inlet and Outlet Mufflers... 226

Appendix D : Theory of Breath Delivery ... 229 D.1 Breath Delivery... 229 D.2 Patient Triggering ... 230 D.3 Breath Types ... 232

iVent201 Operator's Manual

D.3.1 Adaptive FlowTM and Adaptive I-Time™ ... 233 D.3.2 Mandatory Volume Control Breath... 236 D.3.3 Pressure Control Breath... 237 D.3.4 Manual Mandatory Breath... 238 D.3.5 Patient Pressure Support Breath... 239 D.3.6 Patient Spontaneous Breath ... 240 D.4 Summary ... 241

Appendix E : Ventilation Modes... 243 E.1 Assist/Control Mode... 243 E.1.1 Definition... 243 E.1.2 Available Breath Types ... 243 E.1.3 Description ... 243 E.1.4 Parameters Setting... 244 E.2 Synchronized Intermittent Mandatory Ventilation Mode... 245 E.2.1 Definition... 245 E.2.2 Available Breath Types ... 245 E.2.3 Description ... 246 E.2.4 Parameters Setting... 247 E.3 Continuous Positive Airway Pressure Mode ... 247 E.3.1 Definition... 247 E.3.2 Available Breath Types ... 247 E.3.3 Description ... 247 E.3.4 Parameters Setting... 248 E.4 Apnea Back-Up Ventilation... 249 E.5 Open Loop Mode ... 250 E.6 Adaptive Bi-Level Mode ... 251

iVent201 Operator's Manual

Appendix F : Hold Function and Static Mechanics Measurements... 253 F.1 Front Panel Controls ... 253 F.2 Static Compliance Measurements... 254 F.2.1 Static Compliance... 254 F.2.2 Respiratory Time Constant ... 255 F.2.3 Performing a Static Respiratory Mechanics Measurement ... 255 F.2.3.1 Table - Maximum Inspiratory Hold Time for Different Tidal Volumes:... 256 F.2.3.2 Table - Maximum Expiratory Hold Time for Different Tidal Volumes... 257 F.2.4 Clinical Considerations... 258 F.3 End Expiratory Hold ... 258 F.3.1 Performing and End Expiratory Hold Maneuver ... 259 F.3.2 Reviewing Static Mechanics and Intrinsic PEEP Measurements.. 260 F.4 RR/Vt Ratio ... 261

Appendix G : Part Numbers and Accessories... 263 Appendix H : Index ... 267

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)

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

1

Introduction

In addition, the iVent201 has these advanced features:

2

•

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 leaktolerance for facemask ventilation or other specialized highleak 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 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 5 (page 161).

3

Introduction

1.2

Looking at the iVent201

Display

Keypad

Nebulizer outlet Ventilator outlet

Sensor line luer inlets

Exhalation valve luer inlet

Figure 1.1 Front View of the iVent201

4

Control knob

iVent201 Operator's Manual

Carrying handle

Keyboard connector

Cooling fan

SPO2 probe connector (optional) Remote alarm connector

AC cord connector

Grounding pin

External screen connector LAN connector

DC cord connector

RS 232 connector

AC fuses

High pressure oxygen inlet connector

DC fuse

On/off switch

Internal battery handle

Battery pack screws (4)

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

6

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.

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

Nebulizer

8

iVent201 Operator's Manual

1.5

Performance and Parameters

bpm

±1

Page

Ac Accuracy

Displayed

Unit of Measure

Set

Ventilation Pa Parameters/ Component Range

Y

Y

73

±10%

Y

Y

76

±10 mL or +15% whichever is greater

Y

Y

±5

N

Y

80

sec.

±10%

Y

Y

90

up to 120 or Adaptive Flow

L/min

±10%

Y

Y

83

Peak Flow (Spontaneous)

up to 180

L/min

±10%

Y

Y

83

Oxygen Mix (FiO2)

21 to 100%

±5%

Y

Y

81

PEEP

0 to 40

cmH2O

±1 or ±10%, whichever is greater

Y

Y

87

Trigger sensitivity

1 to 20, off

L/min cmH2O

Y

Y

89

Respiratory rate

1-12

Inspired Tidal Volume Measurement

50-2000

mL

Exhaled Tidal Volume Measurement

50-300

mL

Inspiratory Pressure Limit

5 to 80

cmH2O

Inspiratory Time

0.2 to 3 or Adaptive ITime

Peak Flow

12-80

±2

300-2000

-0.5 to –20, off

+10%

9