ALPHA OMEGA Neuro Omega User manual

March 2016
ALPHA OMEGA
U.S. Office:
Toll Free 1-877-919-6288
Fax [phone]
Europe Office:
Toll Free: 00-800-2-574-2111
Tel [phone]
Home Office:
Nazareth Industrial Park Building, M ount
Precipice
P.O. Box 2268 Nazareth 1612102, Israel.
Tel. [phone] Fax: [phone]
Email: [e-mail]
Website: www.alphaomega-eng.com
Neuro Omega™
Physiological Navigation System for
Neurosurgery and Neurophysiological
Medical Applications
User Manual
Revision 1.4.2

March 2016
PROPRIETARYNOTICE
This publication, or parts thereof, contains information proprietary to Alpha Omega Engineering
and may not be reproduced, recorded or transmitted in any form, by any method, for any purpose
without written permission from Alpha Omega Engineering.
Alpha Omega Engineering Ltd. makes no warranty, expressed or implied, including but not
limited to any implied warranties of merchantability or fitness for a particular purpose or use,
regarding these materials and makes such materials available solely on an “as-is” basis.
In no event shall Alpha Omega Engineering Ltd. be liable to anyone for specific, collateral,
incidental, or consequential damages in connections with or arising from purchase or use of these
materials. The sole and exclusive liability to Alpha Omega Engineering Ltd., regardless of the
form of actions, shall not exceed the purchase price of the materials described herein.
The Neuro Omega and Alpha Omega are trademarks of Alpha Omega Engineering Ltd.
For additional information on the device, including questions on infection control procedures,
please contact:
Contact Information:
Name and Address of the European
Authorized Representative:
ALPHA OM EGA ENGINEERING
Nazareth Industrial Park Building
M ount Precipice
P.O. Box 2268
Nazareth 1612102
Israel
Tel: [phone]
Fax: [phone]
Email:
[e-mail]
[e-mail]
http://www.alphaomega-eng.com
M r. Yousef Bsul
Europe Sales M anager
Alpha Omega GmbH
Ubstadter Str. 28
Ubstadt-Weiher,76698
Germany
Tel: [phone]
Fax: [phone]
Toll free: 00-800-2574-2111
Email:
[e-mail]
http://www.alphaomega-eng.com
U.S. Office: Toll Free: 1-877-919-6288, Fax: [phone]
Europe Office: Toll Free: 00-800-2-574-2111, Tel [phone]
© Alpha Omega 2015

March 2016
Contents
CHAPTER 1. Overview .............................................................................................. 9
1.1. Scope........................................................................................................................... 9
1.2. Regula tory .................................................................................................................... 9
1.2.1. Adverse Effects ....................................................................................................... 9
1.2.2. FDA System Classification .......................................................................................10
1.3. Intended Uses .............................................................................................................10
1.4. Conditions of Use .........................................................................................................11
1.5. Warnings .....................................................................................................................11
1.6. Electromagnetic Conformance.......................................................................................13
CHAPTER 2. System Description ...............................................................................17
2.1. Main Unit and Trolley ...................................................................................................17
2.2. Drive Headstage Module...............................................................................................24
2.2.1. Drive Headstage .....................................................................................................25
2.2.2. Electrode Holder and Bengun ..................................................................................26
2.2.3. Frame Adaptor .......................................................................................................27
2.2.4. Electrodes ..............................................................................................................27
2.2.5. Electrode Input Cable .............................................................................................28
2.2.6. Cannulas ................................................................................................................28
2.2.6.1. Using CRW and MicroMar Frames .............................................................29
2.2.6.2. Using Leksell and Libenger Frames ...........................................................30
2.2.6.3. Using Nexframe Frames............................................................................31
2.2.6.4. Using Starfix Frames.................................................................................32
2.3. MER Only Headstage Module ........................................................................................33
2.3.1. MER Only Headstage ..............................................................................................33
2.3.2. MER Only Electrode Input Cable ..............................................................................33
2.4. Headbox Modules .........................................................................................................34
2.5. Remote Control............................................................................................................36
CHAPTER 3. Preparing the Neuro Omega System ......................................................37
3.1. Cleaning and Sterilizing the Neuro Omega Components ..................................................37

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3.1.1. Sterilization Checklist ..............................................................................................44
3.1.2. Sterile Items ..........................................................................................................44
3.2. Setting the Electrode Starting Point ...............................................................................45
3.2.1. Setting Electrode Starting Depth Method 1 ...............................................................46
3.2.2. Setting Electrode Starting Depth Method 2 ...............................................................46
3.3. Assembling the Headstage............................................................................................51
3.4. Headbox Modules Assembly..........................................................................................59
3.4.1. Assembling the EMG Module ...................................................................................59
3.4.2. Assembling the EEG Module ....................................................................................60
3.5. Connecting External Systems ........................................................................................61
CHAPTER 4. Operation of the Neuro Omega System ..................................................63
4.1. Using the Neuro Omega System for Implanting the DBS .................................................63
4.2. Powering On the Neuro Omega .....................................................................................64
4.3. Workspace Maker.........................................................................................................64
4.3.1. Create New Workspace ...........................................................................................65
4.3.1.1. EEG Module:............................................................................................66
4.3.1.2. EMG Module ............................................................................................67
4.3.1.3. ADIO Panel ..............................................................................................68
4.3.2. Edit Workspace ......................................................................................................70
4.3.3. Delete Workspace...................................................................................................70
4.3.4. Windows Default ....................................................................................................70
4.4. Supplying Patient Info ..................................................................................................71
4.5. Selecting an Existing Patient .........................................................................................72
4.6. Neuro Omega Interface Navigation ...............................................................................73
4.6.1. Toolbar ..................................................................................................................73
4.6.2. Workspace .............................................................................................................75
4.6.2.1. Closing and Opening a Workspace Window................................................76
4.6.2.2. Popping a Workspace Window In and Out ..................................................77
4.6.2.3. Restoring the Workspace Layout ...............................................................77
4.6.2.4. Clearing All Workspace Windows...............................................................77
4.6.2.5. Pausing Workspace Windows....................................................................77
4.6.3. Trajectory Graph ....................................................................................................78

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4.6.4. Viewing System Diagnostics ....................................................................................79
4.7. Event Definition ...........................................................................................................80
4.7.1. Defining Events ......................................................................................................80
4.7.2. Editing Events ........................................................................................................82
4.7.2.1. Deleting an Event......................................................................................83
4.7.3. Events Definition Table ...........................................................................................83
4.8. Verifying Diagnostic Indicators ......................................................................................84
4.9. Configuring Drive and Save Settings ..............................................................................84
4.10. Verifying Starting Depth ...............................................................................................86
4.10.1. Drive Headstage Module .........................................................................................86
4.10.2. MER Only Headstage Module...................................................................................86
4.11. Creating a New Trajectory ............................................................................................87
4.12. Setting Drive Position ...................................................................................................89
4.13. Checking Impedance ....................................................................................................90
4.14. Manipulating the Drive Headstage .................................................................................91
4.15. Monitoring Activity .......................................................................................................92
4.15.1. Monitoring Channels ...............................................................................................92
4.15.1.1. Adjusting Channel Scales ..........................................................................94
4.15.1.2. Toggling a Channel’s Sound ......................................................................95
4.15.1.3. Grounding a Channel ................................................................................95
4.15.1.4. Changing a Channel Name........................................................................96
4.15.1.5. Using the Information Line.........................................................................96
4.15.1.6. Applying a Recording Reference to a Contact .............................................96
4.15.2. Monitoring Digital Input Channels ............................................................................97
4.15.3. Monitoring Micro Segmentation Spike Sorting ...........................................................98
4.15.3.1. Main Segmentation Window Navigation......................................................98
4.15.3.2. Defining Spike Sorting Templates ............................................................ 100
4.15.3.3. Defining the Template Variation ............................................................... 102
4.15.3.4. Adding Include Windows ......................................................................... 104
4.15.3.5. Monitoring the Spike Templates ............................................................... 105
4.15.4. Monitoring Spikes in the Spikes Raster Graph .........................................................106
4.15.5. Monitoring Spikes in the Interspike Interval (ISI) Graph..........................................108

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4.15.6. Monitoring EEG signals in Color Density Spectral Array Graph. .................................109
4.16. OPRA ........................................................................................................................112
4.16.1. Assessing OPRA Feedback.....................................................................................112
4.16.2. OPRA Best Practices .............................................................................................113
4.17. User Events ...............................................................................................................114
4.17.1. Marking Events from the Events Control Panel ........................................................114
4.17.2. Marking Events from the Events Definition Table ....................................................115
4.17.3. Adding Remarks ...................................................................................................115
4.18. Trajectory Printing .....................................................................................................116
4.18.1. Printing the Selected Track....................................................................................116
4.18.2. Printing an Active Track ........................................................................................117
4.19. Saving Data to the Log File .........................................................................................119
4.20. Stimulation ................................................................................................................119
4.20.1. Setting Up Stimulation ..........................................................................................120
4.20.2. Applying Stimulation to the Patient from the Toolbar ..............................................122
4.20.3. Monitoring Stimulation in the Current Monitor Window ............................................123
4.21. Defining and Monitoring the Evoked Potential ..............................................................124
4.22. Defining and Monitoring the Peristimulus Histogram (PSTH) .........................................128
4.23. Operation of the Neuro Omega Player Mode ................................................................131
4.23.1. Player Offline Mode ..............................................................................................131
4.24. Dry Run: DBS Electrode Handling ................................................................................136
CHAPTER 5. Advanced Capabilities .........................................................................141
5.1. Advanced Over view ....................................................................................................141
5.2. Filtering and Sampling Properties ................................................................................141
5.2.1. Controlling Micro Filtering and Sampling Properties .................................................142
5.2.2. Controlling Macro Filtering and Sampling Properties ................................................144
5.2.3. Controlling EEG Filtering and Sampling Properties ...................................................146
5.2.4. Controlling EMG Filtering and Sampling Properties ..................................................148
5.2.5. Changing Channel Names .....................................................................................150
5.3. Logging Options.........................................................................................................151
5.3.1. Defining Logging Options ......................................................................................151

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5.3.2. Saving Files by Digital Triggers ..............................................................................156
5.4. Channel Routing of Analog Outputs .............................................................................156
5.4.1. Routing a Pre-Selected Channel.............................................................................157
5.4.2. Routing the Channel in Focus ................................................................................158
5.5. Editing a Channel Contact...........................................................................................158
5.6. Defining Impedance Settings ......................................................................................158
CHAPTER 6. Technical Specifications ......................................................................160
6.1. General .....................................................................................................................160
6.2. Sorting ......................................................................................................................161
6.3. Drive Headstage/MER Only Headstage ........................................................................161
6.4. Headbox Modules for EEG/EMG...................................................................................165
6.5. Headbox Modules Stimulation for EMG ........................................................................166
6.6. General Purpose Analog Inputs ...................................................................................167
6.7. General Purpose Analog Outputs .................................................................................168
6.8. Audio Outputs............................................................................................................168
6.9. General Purpose Single Bit Digital Inputs .....................................................................169
6.10. General Purpose Digital Input 16-bit Ports ...................................................................169
6.11. General Purpose Digital Outputs .................................................................................169
6.12. Analog Digital Inputs and Outputs Pinout ....................................................................170
6.12.1. ADD DIG-OUT Pinout ............................................................................................171
6.12.2. ADD ANALOG-IN Pinout ........................................................................................171
6.12.3. ADD DIG-IN Pinout ...............................................................................................172
6.12.4. PORT-1 16 BIT, PORT-2 16 BIT Pinout...................................................................172

Overview
Neuro Omega User Manual
for Medical Applications V1.4.2
Page 9
CHAPTER 1. OVERVIEW
The Neuro Omega is a physiological navigation system intended for different
neurosurgery and neurophysiological clinical applications, including recording from and
stimulating brain motor and sensory neurons to accurately navigate for neurosurgery
target localization in treatment of movement disorders and to aid in the placement of
depth electrodes.
The system records and stimulates brain peripheral-nerve electrical activity from various
areas of the brain (deep structures and surface areas).
The device is also designed to measure bioelectric signals produced by muscles (EMG)
and stimulate peripheral nerves to aid in the diagnosis and prognosis of neuromuscular
disease for target localization surgeries for motor movement disorders or for intra-
operative skeletal muscles activity. This can be done with recording or stimulation.
The device may also be used to measure and record the electrical activity of the patient's
brain, obtained by placing two or more electrodes on the head (EEG). This is for cortical
and surface electrical activity levels of the brain.
The device is also designed for temporary monitoring of brain electrical activity from
deep or cortical brain during neurosurgery in the operating room or outside the clinical
environment.
1.1. SCOPE
The purpose of the Neuro Omega Medical Manual is to provide information for the use of
the Neuro Omega system in medical treatment.
Warning:
Do not use this manual for conducting research procedures.
1.2. REGULATORY
1.2.1. Adverse Effects
The possible adverse effects relating to Stereotactic Neurosurgery are:
The possibility of intracranial hemorrhage associated with the introduction of
probes into the brain.
Visual field impairment with optic tract injuries.

Overview
Neuro Omega User Manual
for Medical Applications V1.4.2
Page 10
Contra lateral motor deficit with corticospinal injury.
1.2.2. FDA System Classification
Product Code: GZL
Subsequent Product Code: GWF, IKN, GWQ
CFR Section: 21 CFR 882.1330
Regulation Name: Depth electrode
Subsequent Regulation Names:
Electroencephalograph
Stimulator
Electrical
Evoked response
Electromyography
Diagnostic
Trade Name: Neuro Omega System
Common Name: Intraoperative neurophysiological recording and
stimulating device
Classification: Class II
1.3. INTENDED USES
The Neuro Omega System is intended for the following:
Assisting neurosurgeons in the operating room during functional
neurosurgery.
Recording from and stimulating brain motor and sensory neurons to aid in
the placement of depth electrodes.
Monitoring, recording, and displaying the bioelectric signals produced by
muscles.
Stimulating peripheral nerves.
Monitoring, recording, and displaying the electrical activity produced by
nerves (EMG) for aiding the clinician in the diagnosis and prognosis of
neuromuscular disease.
Measuring and recording the electrical activity of the patient's brain obtained
by placing two or more electrodes on the head (EEG).