iVent101 Operator’s Manual Rev 1

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 ClevAir Ventilator

8

1.7.

ClevAir® Configurations and the modular ventilation system 11

1.7.1.

Configurations

11

1.7.2.

The modular system

11

1.8.

Indicator Lights

11

1.9.

Symbols and Labels

12

1.9.1.

Front Panel Labeling

12

1.9.2.

Back Panel Labeling – Connectors

13

1.9.3.

Filter Side

14

1.9.4.

Nameplate

15

1.10.

Ventilator Specifications

16

1.10.1.

Size and Weight

16

1.10.2.

Environmental Specifications

16

1.10.3.

Power Supply

17

1.10.4.

Ventilation Modes

17

1.10.5.

O2 Supply

18

1.10.6.

Inspiratory and Expiratory Resistance

18

1.10.7.

Ventilation Setting and Measured Value Parameters

18

1.10.8.

Default Settings

20

1.10.9.

Additional Displayed Parameters

20

1.10.10.

Displayed Waveforms

21

1.10.11.

ClevAir Ventilator Alarms

21

1.10.12.

User Adjustable Alarms

21

1.10.13.

Non-Adjustable Alarms

21

1.10.14.

Accessories

22

1.10.15.

Software Open Source Information

23

Standards and Safety Requirements

23

1.11.

Chapter 2: Setting Up 2.1.

Understanding The Ventilator Power Sources

2.1.1.

2.2.

Integrated Battery

Patient Circuit

2.2.1.

25 25 27

27

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

Chapter 4: Operating the Ventilator

43

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

Starting and Stopping Ventilation

61

4.3.

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

Chapter 5: Alarms

72

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 6.1.

Cleaning and Maintenance Procedures

95 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

Appendix A: Glossary

113

Appendix B: Warranty

117

Appendix C: Default ventilation Settings

121

C.1.

Default Apnea Settings

126

Appendix D: Pneumatic Unit Scheme

127

Appendix E: Theory of Breath Delivery

131

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. E.2.4.

Breath types – Summary Adaptive Peak Flow

TM

139 TM

and Adaptive I -Time

Appendix F: Ventilation Modes

141

143

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

Appendix G: Software Open Sources G.1.

Introduction

155 155

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 ClevAir 156 G.2.1.

DSP Gateway

156

G.3. Licenses of Open Sources Software which Aggregated with the ClevAir as External Components 157 G.3.1.

Kernel

157

G.3.2.

Busybox

164

Appendix H: Compliance with Section 6 of IEC 60601-1-2 167 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

iVent101Operator's Manual 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

iVent101Operator's Manual 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

iVent101Operator's Manual

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

iVent101Operator's Manual

ITEM NUMBER

9

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

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

iVent101Operator's Manual 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.

1.8. 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

11

Red

Introduction

1.9. Symbols and Labels The following symbols and labels for warnings and connectors are found on the iVent101 ventilator:

1.9.1. 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.

12

iVent101Operator's Manual FUNCTION

ICON/ SYMBOL

LOCATION

Battery Charge indicator Alarm indicator

Below the inspiratory port.

To Patient

Lower Panel Symbols The symbols below appear on the lower panel of the iVent101 ventilator. FUNCTION

ICON/ SYMBOL

LOCATION

Expiratory port (Only for the two limb model)

On the plastic panel below the pipe.

Exhalation Valve

On the plastic panel below the pipes. One limb model only

Proximal Pressure

1.9.2. 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

13