Operator’s Manual
184 Pages
Preview
Page 1
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
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
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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
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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.
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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
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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
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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.
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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