ALPHA OMEGA Neuro Omega User manual

December, 2014
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, Mount
Precipice
P.O. Box 2268 Nazareth 1612102, Israel.
Tel. [phone] Fax: [phone]
Email: [email protected]
Website: www.alphaomega-eng.com
Neuro Omega™
Physiological Navigation System for
Neurosurgery
and Neurophysiological Clinical Applications
Neuro Omega SDK User Manual
Version 1.3
Refer to Neuro Omega User Manual

Neuro Omega SDK User Manual V1.3
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PROPRIETARY NOTICE
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 OMEGA ENGINEERING
Nazareth Industrial Park Building
Mount Precipice
P.O. Box 2268
Nazareth 1612102
Israel
Tel: [phone]
Fax: [phone]
Email:
[email protected]
[email protected]
http://www.alphaomega-eng.com
Mr. Yousef Bsoul
Europe Sales Manager
Alpha Omega GmbH
Ubstadter Str. 28
Ubstadt-Weiher,76698
Germany
Tel: [phone]
Fax: [phone]
Toll free: 00-800-2574-2111
Email:
[email protected]om
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]

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Contents
1Overview...............................................................................................................4
1.1 Regulatory ..............................................................................................................4
1.1.1 Adverse Effects .....................................................................................4
1.1.2 FDA System Classification ..................................................................4
1.2 Intended Uses ........................................................................................................5
1.3 Conditions of Use ..................................................................................................5
1.4 Warnings ................................................................................................................6
1.5 Electromagnetic Conformance ............................................................................7
2Software Development Kit Research Capabilities .....................................11
2.1 Software Development Kit Research Overview..............................................11
2.2 Connecting External Systems ............................................................................11
2.3 Controlling Stimulation Paradigms through Coding.....................................13
2.3.1 Preparing the External Computer ....................................................13
2.3.2 MATLAB Functions and Usage........................................................15
2.3.3 C++ Functions and Usage .................................................................34
3Technical Specifications ..................................................................................53
4Use Case Code ...................................................................................................54
4.1 MATLAB Use Case #1 ........................................................................................54
4.2 MATLAB Use Case #2 ........................................................................................55
4.3 MATLAB Use Case #3 ........................................................................................56
5 Troubleshooting Guidline ..............................................................................57
5.1 MEX Compiler Error...........................................................................................57
5.2 Missing Runtime Libraries.................................................................................58
5.3 Supported and Compatible Compilers –Release 2010B................................59

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1Overview
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 Regulatory
1.1.1 Adverse Effects
The possible adverse effects relating to Sterotactic Neurosurgery are:
The possibility of intracranial hemorrhage associated with the introduction
of probes into the brain.
Visual field impairment with optic tract injuries.
Contra lateral motor deficit with corticospinal injury.
1.1.2 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

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Electromyograph
Diagnostic
Trade Name: Neuro Omega System
Common Name: lntraoperative neurophysiological recording and
stimulating device
Classification: Class II
1.2 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).
1.3 Conditions of Use
The device may be used by medical personnel within a hospital, laboratory, clinic, or
nursing home setting, or outside of a medical facility under direct supervision of a
medical professional. The device may also be placed in the intensive care unit or
operating room for continuous recording.
The following are the Neuro Omega system use conditions:
Environment:
Conditions of visibility:
Ambient luminance range: Normal
Viewing distance: N/A
Viewing angle: N/A
Physical:
Temperature range: 0°C to +40°C
Relative humidity range: 10% - 80%, non-condensing
Ambient pressure range: 500 hPa to 1060 hPa

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Background sound pressure level: Normal
Frequency of Use: As per specific case
Mobility: Mobile
1.4 Warnings
Warnings:
This is a Class A product. In a medical environment this product may cause
radio interference in which case the user will be required to take
adequate measures.
Only qualified personnel, who have been trained by Alpha Omega Ltd.,
should be allowed to operate this equipment.
Any modifications made to the equipment without explicit approval from
Alpha Omega Ltd., voids warranty and service contract obligations, and
poses a potential safety threat to both operators and patients.
Do not install any software packages (Matlab, C++, SDK software or other)
on the system unless provided by Alpha Omega Ltd. for the explicit use on
the Neuro Omega.
Neuro Omega system and Neuro Omega drive should be connected to Alpha
Omega NeuroProbes for recording and stimulation
External systems connected to the Neuro Omega must be independently
isolated, or powered through the trolley, as this has its own isolation
transformer.
The Neuro Omega system should be placed outside of the patient
environment or any area that can, intentionally or unintentionally, come
in contact with the patient.
A thorough understanding of the technical principles, clinical applications,
and risks associated with this treatment is necessary before using this
system. Please read this entire manual before attempting to activate the
system. Completion of the training program is required prior to use of the
Neuro Omega system.
The analog and digital input output panel (ADIO) is not an applied part,
and therefore should not be connected to the patient without proper
electrical isolation.
Cautions:
US federal law restricts the sale of this device to or on the order of a
physician.
Discard according to the local regulations and law.
Notes:
The Neuro Omega system is provided non-sterile or sterile. Please refer to
the Neuro Omega Manual for detailed sterilization instructions of system
and accessories.
It is the user’s responsibility to qualify any deviations from the
recommended method of processing.

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Please contact the manufacturer or local distributor to request a copy of
the insulation diagram if needed.
This product has been tested and found to comply with the limits for Class
a Medical Device according to IEC 60601-1 and IEC 60601-1-2 Standards.
The limits for Class A equipment were derived for medical environments to
provide reasonable protection against interference with licensed
communication and medical equipment.
1.5 Electromagnetic Conformance
The following tables contain information on electromagnetic emissions for guidance and
manufacturer’s declaration:
Guidance and Manufacturer’s Declaration –Electromagnetic Emissions
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
Recommended Separation Distances between Portable and Mobile RF
Communications Equipment and the Neuro Omega
Notes:
This product has been tested and found to comply with the limits for Class
a Medical Device according to IEC 60601-1 and IEC 60601-1-2 Standards.
The limits for Class A equipment were derived for medical environments to
provide reasonable protection against interference with licensed
communication and medical equipment.
This product must be installed and put into service according to the EMC
information provided in the tables below.
Portable and mobile RF communications equipment can affect this
product.
Warnings:
This is a Class A product. This product is intended for use by healthcare
professionals only. This equipment/system may cause radio interference or
may disrupt the operation of nearby equipment. It may be necessary to
take mitigation measures, such as re-orienting or relocating the Neuro
Omega or shielding the location.
The use of accessories, transducers, and cables other than those specified
by the manufacturer may result in increased emissions or the decreased
immunity of the Neuro Omega.
The Neuro Omega should not be used adjacent to or stacked with other
equipment. If adjacent of stacked use is necessary, the Neuro Omega
should be observed to verify normal operation in the configuration in
which it will be used.
The Neuro Omega is intended for use in the electromagnetic environment specified in
Table 1. The user of the Neuro Omega should assure that it is used in such an
environment.
Table 1: Guidance and Manufacturer’s Declaration –Electromagnetic Emissions

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Emissions Test
Compliance
Electromagnetic Environment Guidance
RF emissions CISPR 11
Group 1
The Neuro Omega uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are
not likely to cause any interferences in nearby electronic
equipment.
RF emissions CISPR 11
Class A
The Neuro Omega is suitable for use in all establishments
other than domestic, and may be used in domestic
establishments and those directly connected to the public
low-voltage power supply network that supplies buildings
used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
Complies
The Neuro Omega is intended for use in the electromagnetic environment specified in
Table 2. The customer or the user of the Neuro Omega should assure that it is used in
such an environment.
Table 2: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
Immunity Test
IEC 60601 test
level
Compliance
Electromagnetic Environment
Guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
±6kV contact
±8kV air
±6kV contact
±8kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be less than 30%.
Electrostatic fast
transient/burst
IEC 61000-4-4
±2kV for power
supply lines
±1kV for
input/output
lines
±2kV for power
supply lines
±1kV for
input/output
lines
Mains power quality should be that of
a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1kV line(s) to
line(s)
±2kV line(s) to
earth
±1kV line(s) to
line(s)
±2kV line(s) to
earth
Mains power quality should be that of
a typical commercial or hospital
environment.
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11
<5% UTfor 0.5
cycles
40% UTfor 5
cycles
70% UTfor 25
cycles
<5% UTfor 5 s
<5% UTfor 0.5
cycles
40% UTfor 5
cycles
70% UTfor 25
cycles
<5% UTfor 5 s
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the Neuro
Omega requires continued operation
during power mains interruptions, it is
recommended that the NeuroOmega
be powered from an uninterruptible
power supply battery.
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Mains power quality should be that of
a typical commercial or hospital
environment.

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Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms 150 kHz
to 80 MHz
3 V/m 80 MHz
to 2.5 GHz
3 Vrms 150 kHz
to 80 MHz
3 V/m 80 MHz
to 2.5 GHz
Portable and mobile RF
communications equipment should be
used no closer to any part of the
NeuroOmega, including cables, than
the recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance:
d=1.2√P
d=1.2√P 80 MHz to 800 MHz
d=2.4√P 800 MHz to 2.5GHz
Where P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and dis the
recommended separation distance in
meters (m).
Field strength from fixed RF
transmitters, as determined by an
electromagnetic site survey,1should
be less than the compliance level in
each frequency range.2
Interference may occur in the vicinity
of equipment marked with the
following symbol:
Notes:
At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic
propagation is affected be absorption and reflection from structures,
objects and people.
1. Field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters,
an electromagnetic site survey should be considered. If the measured field strength in the location in
which the Neuro Omega is used exceeds the applicable RF compliance level above, the Neuro Omega
should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the Neuro Omega.
2. Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m.

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The Neuro Omega is intended for use in the electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the Neuro Omega
can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the
Neuro Omega as recommended in Table 3, according to the maximum output power of
the communications equipment.
Table 3: Recommended Separation Distances between Portable and Mobile RF
Communications Equipment and the Neuro Omega
Rated maximum output
power of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d=1.2√P
80 MHz to 800 MHz
d=1.2√P
800 MHZ to 2.5 GHz
d=2.4√P
0.01
0.12
0.12
0.24
0.1
0.37
0.37
0.74
1
1.2
1.2
2.4
10
3.7
3.7
7.4
100
12
12
24
For transmitters rated at maximum output power not listed above, the recommended separation distance d
in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where pis
the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
Notes:
At 80 MHz and 800 MHz, the separation distance for the higher frequency
range applies.
These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures,
objects and people.