User Guide
390 Pages
Preview
Page 1
This page is intentionally left blank.
Part Number: 0208-0001-03 M0029
© Compumedics Limited, 2002 Issue 1 Issue 2 Issue 3 Issue 4 Issue 5 Issue 6 Issue 7 Issue 8 Issue 8.1 Issue 8.2 Issue 8.3 Issue 9 Issue 10 Issue 11 Issue 12
March 1996 June 1996 October 1996 April 1997 May 1998 (Draft) September 1999 October 1999 April 2000 May 2000 (Addendum 1 Configuring Network for the EEG Control Box) July 2000 (Update to Chapter 1) September 2000 (Addendum 2 – Digital Video) February 2001 February 2002 June 2002 December 2002
This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without written permission from Compumedics Limited. Requests and inquiries concerning reproduction and rights should be addressed to: The Documentation Manager Compumedics Limited 30-40 Flockhart Street Abbotsford VIC 3067 AUSTRALIA
Revision History (Issue 10 to Issue 11) CHAPTER
DESCRIPTION
Before You Begin 1 2
• Update contact details • Add Safiro to supported systems where applicable • Add Safiro information where applicable • Add Safiro information where applicable • Add support for Windows XP • Add Safiro information where applicable • Add TCP/IP setup information for Windows XP • Add Safiro information where applicable • Add Safiro information where applicable • Add Safiro information where applicable • Add Safiro information where applicable • Various changes to improve print set out
3 4 5 6 12
Revision History (Issue 11 to Issue 12) CHAPTER
DESCRIPTION
Entire User Guide
• Various changes to correct graphical errors and improve print set out and format
Table of Contents BEFORE YOU BEGIN
I
Brief Description
i
Indications for Use
i
Contraindications
ii
Symbols and Notational Conventions
ii
Limited Warranty - Hardware
iii
Limited Warranty (electrodes, sensors and leads)
iii
Safety and Effectiveness Considerations
iv
Warnings
v
Precautions
vi
Interference
vii
Conformance to Standards
vii
Symbols on Labelling
vii
Repair of Equipment
vii
Product Support
viii
1
SYSTEM OVERVIEW
1-1
1.1
Introduction
1-1
1.2
EEG System Hardware Items
1-2
1.3
Workstations
1-3
1.4
E-Series Patient Interface Box (PIB)
1-5
1.5
E-Series Control Module
1-6
1.6
E-Series Control Module Power Supply
1-7
1.7
Siesta Recording Unit
1-7
1.8
Safiro Recording Unit
1-10
1.9
Storage Devices
1-11
1.10
Printer
1-11
1.11
Video Recording
1-11
1.12
Video Camera
1-11
ProFusion EEG User Guide © Compumedics Limited 2002
Table of Contents ID 30
2
2
3
4
TABLE OF CONTENTS 1.13
Seizure Button
1-12
1.14
Siesta / Safiro Event Button
1-12
1.15
Patient Simulator
1-12
1.16
Powering the EEG System
1-13
1.17
Voltage Settings
1-14
HARDWARE INSTALLATION
2-1
2.1
PC Requirements
2-1
2.2
Operating Systems
2-1
2.3
Specialised EEG PC Modules
2-2
2.4
Printers
2-2
2.5
Hardware Setup Procedure
2-2
2.6
Input Connections for the E-Series EEG Control Module
2-3
2.7
Input Connections for Siesta Recording Unit
2-5
2.8
Input Connections for Safiro Recording Unit
2-5
2.9
Software Protection Key (Dongle)
2-6
SOFTWARE INSTALLATION
3-1
3.1
System Requirements
3-1
3.2
Operating System
3-1
3.3
Software Installation Procedure
3-2
3.4
Configuring the Network for the EEG Control Module
3-3
3.5
Configuring the IP Address for the Radio LAN Device
3-19
3.6
Software Protection Key (Dongle)
3-19
3.7
Starting the Software
3-23
PROFUSION EEG SOFTWARE OVERVIEW
4-1
4.1
Introduction
4-1
4.2
Study Applications
4-2
4.3
Study Window Hierarchy
4-3
4.4
Dialogue Box Conventions
4-5
4.5
Study Window Structures
4-6
4.6
System Options – Presets and Defaults
4-12
ProFusion EEG User Guide © Compumedics Limited 2002
Table of Contents ID 30
TABLE OF CONTENTS
5
6
3
4.7
Study Setup Programs
4-13
4.8
Recorded Events Databases
4-16
4.9
Digital Video Recording
4-16
4.10
Navigation in the Study Windows
4-16
4.11
Measurements in the Study Window
4-17
4.12
Study Manager
4-17
4.13
Security System
4-17
4.14
Identification of Hardware Connections
4-17
SYSTEM OPTIONS
5-1
5.1
Introduction
5-1
5.2
Options
5-1
5.3
General Tab
5-2
5.4
Preferences Tab
5-8
5.5
New Study Tab
5-12
5.6
Replay Tab
5-15
5.7
Monitor Tab
5-18
5.8
Summary Tab
5-20
5.9
Appearance Tab
5-24
5.10
Video Tab
5-27
5.11
Photic Tab
5-29
5.12
Brain Mapping Tab
5-31
5.13
Signal Processing Tab
5-33
RECORDING A STUDY
6-1
6.1
Introduction
6-1
6.2
Preparing the Equipment
6-1
6.3
Preparing the Patient
6-2
6.4
Setting up the Software Tools
6-2
6.5
Recording a New E-Series EEG Study
6-3
6.6
Recording a New Siesta Attended EEG Study
6-8
6.7
The Recording Study Window
6-11
ProFusion EEG User Guide © Compumedics Limited 2002
Table of Contents ID 30
4
7
TABLE OF CONTENTS 6.8
Patient Information
6-11
6.9
Study Information
6-12
6.10
Check Electrode Impedances
6-13
6.11
Check System Calibration
6-16
6.12
Start Recording
6-17
6.13
Digital Video
6-17
6.14
Stop Recording
6-19
6.15
Recording Pauses
6-19
6.16
Controlling Montages During Recording
6-20
6.17
Study Status Indicator
6-22
6.18
Trace Management During Recording
6-23
6.19
Adding User Annotations
6-29
6.20
Controlling the Photic Strobe
6-29
6.21
Using the Toolbar
6-31
6.22
Long - Term Monitoring (E-Series EEG only)
6-32
6.23
Freezing the Traces
6-33
6.24
Hyperventilation
6-33
6.25
Indicators in the Recording Study Window
6-35
6.26
Measurements in the Recording Window
6-37
6.27
Initiating PageBack
6-39
6.28
On-Line Monitoring
6-39
6.29
Terminating Recording
6-39
6.30
Completing the study
6-39
6.31
Notes on Study Limitations
6-39
6.32
Removing a study
6-40
6.33
Siesta EEG Ambulatory Studies
6-40
6.34
Recording a New Safiro Ambulatory EEG Study
6-49
PAGEBACK
7-1
7.1
Introduction
7-1
7.2
Opening the PageBack Window
7-1
ProFusion EEG User Guide © Compumedics Limited 2002
Table of Contents ID 30
TABLE OF CONTENTS
8
9
5
7.3
The PageBack Study Window
7-2
7.4
Digital Video
7-2
7.5
Patient and Study Information
7-3
7.6
Controlling Montages
7-3
7.7
Trace Management During Replay
7-4
7.8
Study Status Indicator
7-5
7.9
Adding User Annotations
7-6
7.10
Using the Toolbar
7-7
7.11
Indicators in the PageBack Study Window
7-8
7.12
Measurements in the PageBack Window
7-9
7.13
Go to and View Tools
7-9
7.14
Closing the PageBack Window
7-10
7.15
Printing
7-10
NETVIEW
8-1
8.1
Introduction
8-1
8.2
To Open a NetView Study
8-2
8.3
The NetView study window
8-3
8.4
Digital Video
8-4
8.5
Patient and Study Information
8-5
8.6
Controlling Montages
8-5
8.7
Trace Management During NetView
8-7
8.8
Using the Toolbar
8-9
8.9
Indicators in the NetView Window
8-9
8.10
Measurements in the NetView Window
8-10
8.11
Closure of the Study on the Master Recording Workstation
8-10
8.12
Closing the NetView Window
8-10
MONTAGE MANAGER AND MONTAGE SEQUENCE MANAGER
9-1
9.1
Introduction
9-1
9.2
Montage Manager
9-2
9.3
Creating a Montage
9-3
ProFusion EEG User Guide © Compumedics Limited 2002
Table of Contents ID 30
6
TABLE OF CONTENTS 9.4
Editing a Montage
9-5
9.5
Deleting a Montage
9-16
9.6
Adding a Montage to a Study
9-17
9.7
Montage Sequence Manager
9-18
9.8
Using the Sequences
9-23
PHOTIC PROGRAMMING
10-1
10 10.1
Introduction
10-1
10.2
Photic Programmer
10-2
10.3
Creating a photic program
10-3
10.4
Editing a photic program
10-5
10.5
To Reload a photic program
10-7
10.6
To Delete a photic program
10-8
10.7
Selecting the Default program
10-9
10.8
Closing the Photic Programmer
10-10
10.9
Photic Events Log
10-11
11
12
PROFUSION EEG STUDY MANAGER
11-1
11.1
Introduction
11-1
11.2
Starting the ProFusion EEG Study Manager
11-2
11.3
EEG Study Manager Dialogue Box
11-3
11.4
Backing up a study
11-7
11.5
Highlighting studies
11-7
11.6
Copying studies
11-7
11.7
Moving studies
11-7
11.8
Labelling
11-8
11.9
Creating a ProFusion EEG Lite CD
11-9
11.10
Deleting studies
11-10
11.11
Renaming studies
11-10
11.12
Recordable CD-ROM Archiving
11-11
11.13
Recovering Studies from a CD
11-12
REPLAYING A STUDY
ProFusion EEG User Guide © Compumedics Limited 2002
12-1 Table of Contents ID 30
TABLE OF CONTENTS
7
12.1
Introduction
12-1
12.2
Preparing the Equipment
12-1
12.3
Setting up the Software Tools
12-1
12.4
Preliminary Steps
12-1
12.5
Opening a Study
12-2
12.6
Replay Study Window
12-5
12.7
Patient information
12-8
12.8
Viewing Study information
12-8
12.9
Impedance Testing
12-9
12.10
Controlling Montages
12-10
12.11
Trace Management During Replay
12-12
12.12
User Annotations
12-14
12.13
Study Marker
12-14
12.14
Using the Toolbar
12-15
12.15
Indicators in the Replay Study Window
12-17
12.16
Initiating Study Analyses
12-19
12.17
Go to and View Tools
12-21
12.18
Printing
12-22
12.19
Measurements in the Replay Window
12-23
12.20
Exporting Study Data
12-24
12.21
Closing a study
12-24
12.22
Removing a study
12-24
USER ANNOTATION
13-1
13 13.1
Introduction
13-1
13.2
To view programmed user annotations
13-1
13.3
To Edit User Annotation Text
13-2
13.4
To Clear User Annotation Text
13-2
13.5
Adding User Annotations in the Recording window
13-3
13.6
Adding User Annotations in the PageBack Window
13-5
13.7
Adding User Annotations in the Replay window
13-5
ProFusion EEG User Guide © Compumedics Limited 2002
Table of Contents ID 30
8
TABLE OF CONTENTS 13.8
Editing a User Annotation in the PageBack or Replay window
13-6
13.9
Printing User Annotations
13-8
13.10
Deleting a User Annotation in the PageBack or Replay window
13-8
13.11
To View User Annotations
13-8
GOTO AND VIEW TOOLS
14-1
14 14.1
General
14-1
14.2
Goto time
14-2
14.3
User annotations
14-4
14.4
Bookmarks
14-6
14.5
Montage Changes
14-8
14.6
Photic Events
14-9
14.7
Find
14-10
15
SPECTRAL ANALYSIS
15-1
15.1
Introduction
15-1
15.2
Spectral Analysis Window
15-2
15.3
Study Settings
15-7
15.4
Go to and View Tools
15-13
15.5
Spectral Analysis Configuration Files
15-14
15.6
Spectral Analysis Configuration File Manager
15-15
15.7
Printing
15-20
16
BRAIN MAPPING
16-1
16.1
Introduction
16-1
16.2
Brain Mapping Window
16-2
16.3
Study Settings
16-6
16.4
Go to and View Tools
16-9
16.5
Brain Mapping Configuration Files…
16-10
16.6
Brain Mapping Configuration File Manager
16-11
16.7
Palette Manager
16-15
16.8
Brain Map Palette Manager
16-16
16.9
Printing
16-21
ProFusion EEG User Guide © Compumedics Limited 2002
Table of Contents ID 30
TABLE OF CONTENTS
17
STUDY SUMMARY
17-1
17.1
Introduction
17-1
17.2
Opening the Summary Window
17-1
17.3
The Summary Window
17-2
17.4
Summary Graph
17-3
17.5
Summary Table
17-5
17.6
Control Panel
17-6
17.7
Summary Window Tool bar
17-7
17.8
Editing
17-8
17.9
Go to and View Tools
17-12
18
EXPORTING DATA
18-1
18.1
General
18-1
18.2
To Initiate Export
18-1
18.3
Exporting in ASCII
18-2
18.4
Exporting in EDF
18-4
18.5
Exporting in Binary
18-5
19
A
9
PROFUSION EEG LITE MODE OPERATION
19-1
19.1
General
19-1
19.2
Facilities Available with EEG Lite
19-2
19.3
Facilities Not Available with EEG Lite
19-2
19.4
To Open a Study
19-3
19.5
To Open Multiple Studies
19-4
19.6
Opened Study
19-5
TROUBLESHOOTING
A-1
A.1
Introduction
A-1
A.2
Signals shown on incorrect traces, missing signals
A-1
A.3
Waveforms look chunky
A-1
A.4
Waveform(s) look flat
A-1
A.5
Printer does not print
A-1
ProFusion EEG User Guide © Compumedics Limited 2002
Table of Contents ID 30
10
B
TABLE OF CONTENTS
A.6
Cannot write data to backup drive
A-1
A.7
Photic device does not operate
A-2
A.8
NetView, recorded data or digital video not available via the network
A-2
A.9
Cannot access various options or facilities
A-2
A.10
Cannot open the Study Manager
A-2
A.11
Cannot add/delete/manage data in replay
A-2
A.12
User events cannot be seen on the screen
A-2
A.13
Calibration failure
A-2
A.14
Device communication failure
A-3
VIDEO RECORDING
B-1
B.1
Introduction
B-1
B.2
Digital Video Recording
B-1
B.3
Computer Requirements – Digital Video Server
B-2
B.4
Computer Requirements – Digital Video Client
B-3
B.5
Digital Video Requirements
B-4
B.6
Videotape Recording
B-6
C
SECURITY SYSTEM
C-1
D
EDITING PATIENT INFO DIALOGUE BOX
D-1
D.1
Introduction
D-1
D.2
Editing the drop-down lists
D-1
E
KEYBOARD COMMANDS
E-1
F
SOURCE DERIVATION ALGORITHMS
F-1
G
CLEANING AND DISINFECTING
G-1
G.1
Contamination with AIDS, viral hepatitis or CJD
G-1
G.2
Damage or Deterioration
G-1
G.3
Patient Interface Box, Control Box and Leads
G-1
G.4
Gold Cup Electrodes
G-1
G.5
Other Electrodes
G-1
G.6
General
G-2
ProFusion EEG User Guide © Compumedics Limited 2002
Table of Contents ID 30
TABLE OF CONTENTS G.7
H
I
J
References
TECHNICAL SPECIFICATIONS
11 G-2
H-1
H.1
Patient Interface Box Inputs
H-1
H.2
Control Box
H-2
H.3
Control Box Power Supply
H-2
H.4
Environmental Conditions for Storage and Transport
H-2
REF AND GND FUNCTIONS
I-1
I.1
Introduction
I-1
I.2
Reference Electrode (REF)
I-1
I.3
Ground Electrode (GND)
I-2
I.4
Electrode Impedance
I-2
GLOSSARY
INDEX
ProFusion EEG User Guide © Compumedics Limited 2002
J-1 1
Table of Contents ID 30
12
TABLE OF CONTENTS
This page is left intentionally blank.
ProFusion EEG User Guide © Compumedics Limited 2002
Table of Contents ID 30
Before You Begin Brief Description User Guide This User Guide is designed to enhance your knowledge of Compumedics Limited E-Series EEG, E-Series EEG/PSG, Siesta and Safiro data acquisition systems and the ProFusion EEG data acquisition and analysis software. It contains information and procedures required to record EEG studies, then review, analyse and archive the study data. Software The ProFusion EEG software is a Microsoft Windows-based package used to configure, record and replay digitised patient neurological signals acquired during the recording of EEG studies. The signals may be acquired by the E-Series EEG, E-Series EEG/PSG, Siesta or Safiro System hardware, displayed on a Recording workstation and stored on the workstation or other medium. This data may be used to assist trained physicians, clinicians or technologists in the investigation of neurological disorders. Note that the specifications for the ProFusion EEG software can change at any time without prior warning. Hardware This User Guide contains information on the E-Series EEG System hardware. For information on the E-Series EEG/PSG, Siesta or Safiro Systems, refer to their respective user guides. The EEG System hardware comprises the input connections from the patient, the recording hardware and the peripherals used to acquire and store patient neurological data for later replay and analysis. Recording is performed on a Recording workstation. Replay and analysis can be performed on the Recording workstation or on other workstations using the data collected during the patient study. Access to archived data and printer facilities can be provided to other workstations via a network. Note that the specifications and hardware arrangements can change at any time without prior warning. Indications for Use The EEG System is intended to be used as an aid in the diagnosis of neurological disorders and should only be used under the supervision of a physician, technologist or clinician. It is a data recording system, and will not prevent or restore the interruption or loss of any physiological system. EEG studies should only be carried out under the recommendation of a physician. The ProFusion EEG software is intended for use by persons trained in professional health care.
ProFusion EEG User Guide © Compumedics Limited 2002
Before You Begin ID 17
ii
BEFORE YOU BEGIN
Contraindications Discontinue use if patient displays distress, discomfort or adverse reaction to electrode and/or sensor attachment. Discontinue use if patient perspires excessively. This may cause signal distortion. Symbols and Notational Conventions Visual Clues The following special typefaces and symbols are used throughout this manual. Typeface bold type
Type of Information The names of keys on the keyboard. For example, Esc, F1, Alt, menu selections and button selections in the study window.
italic type
Place holders for information that you must type in. For example, if you are asked to enter the Patient's Surname, you would type the actual surname, instead of the word shown in italic print.
Symbol
Meaning Hint:
A Hint provides helpful hints, suggestions and shortcuts.
Note:
A Note provides additional or vital information to the topic being discussed.
I
Caution:
A Caution provides information on prevention of potential equipment damage, malfunction, inaccurate operation or damage to other property.
N
Warning:
A Warning provides information on prevention of potential harmful situations to the patient or operator.
Keyboard Formats All key names are shown in bold type. Keys Hot keys
Comments Keys are often used in combinations as hot keys. For example, Press Alt+F1 means that you should press the Alt key and hold it down, then press the F1 key and release both keys.
Cursor keys (↑,↓,←,→)
The four arrow keys are usually used to move the cursor around the screen.
Home, End, Page Up, Page Down
These four keys are usually used for cursor and data movement.
Tab and Shift+Tab
These keys are normally used for moving between fields, or text blocks, within a window.
ProFusion EEG User Guide © Compumedics Limited 2002
Before You Begin ID 17
BEFORE YOU BEGIN
iii
Limited Warranty - Hardware Compumedics warrants each new device to be free from defects in workmanship and materials under normal use and service for a period of twelve (12) months from the date of shipment. Compumedics’ sole obligation under this warranty will be to repair or replace, at its option, products that prove to be defective during the warranty period. The foregoing shall be the sole warranty remedy. Except as set forth herein, seller makes no warranties, either expressed or implied, including the implied warranties of merchantability and fitness for a particular purpose. This warranty is not assignable. Limited Warranty (electrodes, sensors and leads) Compumedics warrants each of the Products as free from material defect for a period of three (3) months from the date of delivery to the Distributor. During such period of three (3) months as aforesaid, Compumedics will replace without charge any component found to be materially defective and shall be responsible for all labour or other charges involved in repairing the Product(s) provided that Compumedics shall not be liable to replace components which are defective due to accident or misuse.
ProFusion EEG User Guide © Compumedics Limited 2002
Before You Begin ID 17
iv
BEFORE YOU BEGIN
Safety and Effectiveness Considerations General Be sure to read, understand and follow the instructions in this User Guide and others that come with the E-Series EEG, E-Series EEG/PSG, Siesta and Safiro Systems, and their accompanying accessories. For all third party equipment used with these systems, follow all of the manufacturer's recommendations and instructions. Place EEG System components on a sturdy and level surface. Do not place any component on the floor or in the bed with the patient. If a system component is dropped, discontinue using it until it is determined that the component can be safely operated. Contact Compumedics Product Support or your authorised representative for assistance. EEG Systems should be used only in hygienic locations. Cleaning Always unplug the components from all electrical power sources when cleaning the EEG System hardware or any of its accessories. Unless specified within these instructions, follow the manufacturer's recommendations and instructions for reusing, cleaning, disinfecting, or sterilising electrodes, sensors and monitoring equipment used with the EEG System. Do not autoclave, gas, or pressure sterilise any of the EEG System components. If any liquid is spilled on an EEG System component, discontinue using it until it is determined that the component can be safely operated. Contact Compumedics Product Support or your authorised representative for assistance. Refer to Appendix G “Cleaning and Disinfecting” for more detailed information. Environmental Conditions for Operation, Storage and Transport The EEG System should be used at ambient temperatures between +10°C (+50°F) and +40°C (+104°F), with a non-condensing relative humidity of between 25% and 95%. The EEG System should be stored and transported at temperatures between -20°C (- 4°F) and 50°C (122°F), with a non-condensing relative humidity of between 30% and 95%.
ProFusion EEG User Guide © Compumedics Limited 2002
Before You Begin ID 17
v
BEFORE YOU BEGIN Warnings
The following warnings provide information on prevention of potential harmful situations to the patient or operator. General
N N
Warning:
Warning:
The electrical safety of the EEG system should be regularly tested, at intervals not exceeding 12 months. Contact your Biomedical Engineering department. Such testing should include patient leakage current, enclosure leakage current, earth leakage current and earth resistance. The EEG System should not be used in the presence of flammable liquids or gases, for example: a flammable anaesthetic mixture with air or a flammable anaesthetic mixture with oxygen or nitrous oxide. This may present an explosion hazard.
N
Warning:
Do not allow electrode wires, sensor leads or connecting leads to become tangled, coiled, or crossed, or wrapped around the patient's neck, arms or legs. This condition may cause strangulation.
Electrical shock hazards
N
Warning:
Conductive parts of electrodes and their connectors, including the reference electrodes, should not contact other conductive parts, including earth. This condition will be met if all electrodes have one end connected to the Patient Interface Box and the other end attached to the patient.
N
Warning:
If applied parts from other equipment are attached to the patient, in addition to the electrodes of the EEG System, it is possible for the total patient leakage current to exceed the requirements for type CF applied parts.
N
Warning:
The EEG System is not protected against the effects of a cardiac defibrillator discharge. If a cardiac defibrillator is to be used on a patient, then all EEG electrodes must be disconnected from the patient.
N
Warning:
The cover on the 37-way ‘D’ connector on top of the Patient Interface Box must be securely screwed in position at all times, except when the connector is being used.
N N N
Warning:
Do not use the EEG System if the cover of any component of the EEG System is removed.
Warning:
Do not use in conditions where the EEG System may be exposed to liquids
Warning:
Ensure that medical equipment connected to the DC Inputs socket of the Control Box is IEC 60601-1 compliant.
Use of EEG System During Electrosurgery
N
Warning:
If the EEG System is used to monitor a patient undergoing electrosurgery, take the following precautions to reduce the hazard of burns: • Use only an isolated electrosurgical generator • Use bipolar electrosurgery instead of monopolar electrosurgery • Position the EEG electrodes as far away as possible from the site of electrosurgery
ProFusion EEG User Guide © Compumedics Limited 2002
Before You Begin ID 17