This copy of the User Manual shall be used only in accordance with the conditions of sale of Natus Medical Incorporated or its distributors, including without limitation the Natus Software License Agreement. Natus Medical Incorporated makes no representations or warranties of any kind whatsoever with respect to this document.
Glossary of Symbols The following labels and symbols may be affixed to the UltraPro S100 system: Symbol Title Standard Title as per Symbol Standard Reference Explanation of Symbol Referenced Standard ISO 15223-1 Medical devices An indication This product is a Symbol 5.7.7...
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Symbol Title Standard Title as per Symbol Standard Reference Explanation of Symbol Referenced Standard 21 CFR 801.109(b)(1) Labeling- Device is Indicates that the Prescription cleared for the product is authorized devices US market as for sale by or on the requiring a order of a licensed prescription...
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Symbol Title Standard Title as per Symbol Standard Reference Explanation of Symbol Referenced Standard Medical devices Country of Indicates the country ISO 15223-1 — Symbols to be Origin of origin. Symbol 5.1.11 used with information to be supplied by the manufacturer —...
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Symbol Title Standard Title as per Symbol Standard Reference Explanation of Symbol Referenced Standard ISO 15223-1 Medical devices Distributor Indicates the entity Symbol 5.1.9 — Symbols to be distributing the used with medical device into medical device the locale. This labels, labelling symbol shall be and information...
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Symbol Title Standard Title as per Symbol Standard Reference Explanation of Symbol Referenced Standard ISO 15223-1 Medical devices Do not re-use Indicates that the Symbol 5.4.2 — Symbols to be medical device is used with intended for one use, information to be or for use on a single supplied by the patient during a...
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Symbol Title Standard Title as per Symbol Standard Reference Explanation of Symbol Referenced Standard IEC 60601-1 Medical electrical Follow Refer to instruction Table D.2 #10 equipment – Part Instructions for manual/Booklet. 1: General NOTE on ME requirements for EQUIPMENT basic safety and “Follow Instructions essential for use”.
Intended Users ................................. 15 Patient Population and Target Group ........................15 Residual Risks and Side Effects ..........................15 UltraPro S100 System Essential Performance ......................15 General and Network Security Measures ........................ 15 Networked Environments ............................16 Protective and Equipment Classifications ........................ 16 Ancillary Accessories ..............................
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PERFORMING AN EXAM ......................60 Setting up the System .............................. 60 Getting started ................................. 60 Using UltraPro S100, Study Menu vs Test Menu ....................... 60 Testing using Study menu ............................60 Testing using Test menu ............................61 Patient to report in seven steps ..........................61 Example Motor Nerve Conduction Study .........................
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Natus Technical Support Contact Information ......................74 ELECTROMAGNETIC COMPATIBILITY (EMC) ................75 List of UltraPro S100 items; additional and optional parts ..................75 Table 1 - Electromagnetic emissions ........................77 Table 4 - Immunity Test Levels - Enclosure Port ...................... 77 Table 5 –...
A PDF copy of this user guide is available on the USB flash drive, Information for Use, provided with your system. Copies of the user guide may also be accessed at natus.com in the Support section. Scroll to the EMG Product IFUs, select UltraPro S100 and choose the version for your local language.
Intended Users The UltraPro S100 is intended to be used by a qualified healthcare provider. Qualified healthcare providers include those with specialized training in the use of Electrodiagnostic (EDX) instrumentation for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular system.
UltraPro S100 system. It is recommended that the surface electrodes selected are those that have been cleared or approved for nerve conduction and or evoked potential studies.
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recommended that the needle electrodes selected are those that have been cleared or approved for electromyography applications. Use a length and gauge appropriate for the test being conducted. The connector is a circular 5 pin DIN connector. This nonproprietary pin connector is an industry standard for EMG systems. The pin configuration for this connector is as follows: pin 1 is active, pin 2 is reference, pin 3 is driven shield and pins 4 and 5 are patient ground.
Caution A CAUTION indicates that there is a risk of injury to the user or patient or risk of damage to the device. Any serious incident that has occurred in relation to the Natus UltraPro S100 system be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.
Use of non-Natus supplied, or recommended components or accessories may prevent the application of the risk control measures unique to Natus parts from being applied, which may cause electrical shock. Damaged power cord contacting ungrounded metal component(s) may cause electrical shock.
To help ensure patient safety and prevent cross contamination, reusable electrodes and stimulators must be properly cleaned and maintained. This maintenance includes cleaning before use on each patient. Always follow the specific instructions that accompany these patient contacting devices (e.g., electrodes, probe tips) and your institution's guidelines for cleaning patient contacting devices.
Do not connect items (accessories and peripherals) which are not specified as part of the system. Use only the accessories and peripherals specified by Natus as part of the system, which have been tested with the equipment. The use of accessories and consumer goods supplied by other manufacturers or not specifically indicated by Natus may affect the proper functionality of the equipment.
Auditory Stimulation Use of improper auditory transducer or setting high stimulation levels could cause excess stimulation and hearing damage. Use of high level or prolonged sound pressure levels may cause permanent hearing loss. Pacemakers and Defibrillation Using electrical stimulation on a patient with a cardiac pacemaker or implanted defibrillator may disrupt the proper functioning of these devices leading to patient injury.
Incorrect fusing could lead to a possibility of fire. The power outlets on the ISO box are intended for use only with Natus approved system components. Use of any other equipment could result in damage to the power system or compromise patient isolation.
The output waveform of the Natus Electrical stimulator is AC coupled through a transformer. Therefore, there is no DC component. The pulse durations can range from 10uS to 1000uS, the repetition frequencies range from 0.1Hz to 200Hz.
Maximum constant voltage (not supported by all Natus equipment), as listed in the product specifications, will not be achievable with load impedances less than the 4k ohm rated load. Accuracy of Controls Stimulator values are determined by the operator based on the electrophysiological responses and the subjective reaction of the patient to the stimulus, therefore an accuracy of ±30% pro vides acceptable levels for safe use of this equipment in the...
Following directions for the UltraPro version (Generation 1, 2, or 3), connect interface cables # 1, 2, 3 as shown in the following illustrations. Do not connect the power cord until you are ready to power the system. When ready to power the system, follow the Powering the UltraPro and Launching Natus Elite Software instructions in Chapter 4.
Cable Connections - Generation #3 Component styles may vary from those shown above. Item Description Item Description Laptop USB 2.0 Cable (2M) Base Unit High-Speed Link Cable (Proprietary) Power Adapter Power Adapter IEC Cable (1ft) Electrical Stimulator Probe Hospital Grade Power Cable, Shielded •...
Right side panel - Generation #3 Stimulator Output (isolated) The stimulator output connectors are electronically isolated. Stimulator Output Socket (isolated) For connection of stimulus electrodes with DIN plugs. Support for the active stimulus probe. Auditory Transducer Connection LED Goggles Transducer Connection Left side panel - Generation #3 Speaker Power switch...
Rear panel - Generation #3 Protective Earth Functional Earth To be used for suppression of noise. Dual USB Connectors – Type A Limited power available. Only used for footswitch and memory stick. USB Connector – Type B For computer interface. Trigger Input / Output Connector - Option 1 Trigger Input / Output Connector - Option 2 HS Link Output Connector...
Power On/Standby indicators Run Indicator * Lights continuously during system initialization * Lights continuously once Application has initialized the Main Unit Standby Indicator * Flashes slowly when UltraPro base is powered on and USB is connected but EMG application is not running * Flashes rapidly during system initialization * Continuously lit if powered on but the USB cable is not connected Software functions...
Stimulus The Stimulator Indicator * Flashes rapidly during system initialization * Flashes at Rep rate when stimulator is active * Flashes rapidly when impedance test is active Repetitive Stimulus key Press to present a repetitive stimulus. The indicator blinks intermittently. To stop repetitive stimulus, press either the Repetitive Stimulus key or the Single Stimulus key.
Run selectors Previous run Press to move to the previous run. Next run Press to advance to the next run. Audio Volume Audio keys Press the top of the button to increase the volume and the bottom of the button to decrease the volume. Audio Mute key Press to switch between the On and Off function.
Delete and Move Delete key Press the Delete key to delete the selected trace, the last typed character or the selected entry. Selection knob Rotate the knob to move the traces, markers, or trigger cursor. Test Selection Select Test key Press to access the Home page Test menu.
Cable Connections - Generation #1 Component styles may vary from those shown above. Item Description Item Description Laptop USB 2.0 Cable (2M) Base Unit High-Speed Link Cable (Proprietary) Power Adapter Power Adapter IEC Cable (1ft) Electrical Stimulator Probe Hospital Grade Power Cable, Shielded •...
Right side panel Generation #1 Stimulator Output (isolated) The stimulator output connectors are electronically isolated. Stimulator Output Socket (isolated) For connection of stimulus electrodes with DIN plugs. Support for the active stimulus probe. HS Link Output Connector Amplifier Connection Cat5 with built-in EMI Suppression Proprietary Cable Auditory Transducer Connection LED Goggles Transducer Connection...
Rear panel - Generation #1 Protective Earth Functional Earth To be used for suppression of noise. Dual USB Connectors – Type A Limited power available. Only used for footswitch and memory stick. USB Connector – Type B For computer interface. Patient Response, Tendon Hammer Connector Trigger Input / Output Connector Visual Transducer Connector...
Cable Connections - Generation #2 Component styles may vary from those shown above. Item Description Item Description Laptop USB 2.0 Cable (2M) Base Unit High-Speed Link Cable (Proprietary) Power Adapter Power Adapter IEC Cable (1ft) Electrical Stimulator Probe Hospital Grade Power Cable, Shielded •...
Right side panel - Generation #2 Stimulator Output (isolated) The stimulator output connectors are electronically isolated. Stimulator Output Socket (isolated) For connection of stimulus electrodes with DIN plugs. Support for the active stimulus probe. Auditory Transducer Connection LED Goggles Transducer Connection EMG Speaker...
Rear panel - Generation #2 Protective Earth Functional Earth To be used for suppression of noise. Dual USB Connectors – Type A Limited power available. Only used for footswitch and memory stick. USB Connector – Type B For computer interface. Patient Response, Tendon Hammer Connector Trigger Input / Output Connector HS Link Output Connector...
Power On/Standby indicators Stand By Screen navigation / software functions Screen Navigation Keys – Color Coded The Software Screen Navigation keys allow you to navigate through the application tabs. The 6 Software Navigation keys’ colors and functions correspond to the Software Screen Navigation buttons on the application.
Stimulus Stimulus Indicator The stimulus indicator yellow light (LED) blinks once for Single Stimulus, and intermittently for Repetitive Stimulus. Single Stimulus Key When the Single Stimulus key is pressed, a single stimulus is presented and the indicator blinks once. The Single Stimulus key can also be used to stop Repetitive Stimulus. Repetitive Stimulus Key When the Repetitive Stimulus key is pressed, repetitive stimulus is presented and the indicator blinks intermittently.
Audio / Volume / Cursor Mode / Trace / Marker / Trigger Audio Keys The Left and Right arrow keys are used to decrease/ increase the audio volume. Audio Mute Key / Indicator Press the Loudspeaker Mute key to switch between the On and Off function. The yellow light (LED) indicates the loudspeaker is muted.
UltraPro S100 Amplifier Module - 3 and 4 Channels Natus UltraPro S100 Natus UltraPro S100 3 Channel Amplifier 4 Channel Amplifier Front Panel Amplifier Input Connectors (1-3) / (1-4) The amplifier input connectors feature both a DIN-type socket and a pair of 1.5 mm touch-proof connectors.
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Natus UltraPro S100 Natus UltraPro S100 3 Channel Amplifier 4 Channel Amplifier 3 Channel Side Panel 4 Channel Rear Panel HS Link Input Connector - Main Unit - Side Panel / Rear Panel 3 and 4 Channel Amplifier...
Natus Stimulus Probe Output Electrode Pins For direct stimulus on the skin, see the description of the stimulus electrodes in this section. Polarity and Stimulus Indicators The stimulus cathode is indicated by a constant green light (LED). During stimulus, the other LED indicator will flash yellow –...
RS10 Comfort Probe Polarity The Cathode prong on the RS10 probe is designated by the negative sign with raised oval symbol Footswitch with 3 Pedals (Option) A footswitch is available as a triple pedal model, with a USB interface. Pedals may be programmed by selecting Test Options/Hardware Controls and inserting the desired function into each pedal designation.
Function Description Mains Input Plug the shielded mains power cord supplied with the system into this socket. NOTE Only use a shielded power cord from Natus. Rating Frequency: 50/60Hz. - Continuous Operation: max. 1000VA - Momentary Operation: max 1500VA 9031D040x: 100/120V~...
Function Description Spring Retaining Clamp for Power Cord Place the spring retaining clamp around the power cord to ensure a safe connection. Auxiliary Outlet-6 Outlets: 50/60Hz 9031D040x: 100-120V~ total max. - Continuous Operation 7.4A - Momentary Operation 12.4A 7.4A equals 850VA, and 12.4A equals 1425VA at 115V~ 9031D041x: 200-240V~ total max.
Operation at high load over prolonged time may cause thermal cut out. After cooling down (hours) internal thermal fuse will reset and normal operation can be resumed. Additional UltraPro S100 Accessories The following accessories are available for use with the UltraPro S100. Contact your sales representative or technical support representative for information. Part Number...
The Windows login screen appears. Click the correct user icon and type in your password (if you have a password). Installing Natus Elite Software Follow these procedures to install and license your Natus Elite software if it has not been installed and licensed or if you are conducting a software upgrade.
Basic System Operations Software system operations are described below. Refer to Chapter 3 for Control Panel operations. Controls Operation System Menus Using the mouse, click the drop-down menus to display, select and enable functions Using the mouse or the control panel keys, click the desired function key to enable the Function Keys operation.
Shutting Down the UltraPro System Follow these procedures for a proper shutdown of your system to prevent damages to the unit. From the Natus Elite Viking or Synergy Home page, click File > Exit. The application is closed, and the windows desktop is displayed.
Software Error Codes In the Natus Elite Viking or Synergy Application, errors and other informational messages are designed to be self-explanatory. Additional descriptions are provided below: Code ID Cause(s) Suggested Action Hardware device connection failure. 1. Disconnect/Reconnect hardware. Usually proceeded/accompanied by more 2.
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Code ID Cause(s) Suggested Action 1012 Problem with registry, user rights or file Check user rights, registry and/or file system 1014 system. Reinstall if persists. Could not access the crash recovery folder. 1200 Cannot open a connection to the 1. If networked, may be caused by databases.
10. Visit information can be added by pressing the Visit Details button. Selecting or Editing Patient Information Click the Patient List function key in the main UltraPro S100 screen to list all the patients in the Patient Database or use the Search utility to find a patient.
Starting a new visit Click the Patient List function key in the main UltraPro S100 screen to list all the patients in the Patient Database or use the Search utility to find a patient. Use the vertical scroll bar or up/down arrow keys to scroll down the fields to the patent. To load the patient, double- click the patient or highlight the patient and click Load Patient.
Deleting exams from a patient file Click the Patient List button to display all patients in the pane to the right. Highlight to select a patient. Click the Catalog button to display the visits and data files for this patient. Find and highlight either the waveform file or visit to delete.
When you switch on the main power, the system may display the Windows Logon screen. After you log on to the system: Double-click the Natus Elite - Viking or Natus Elite - Synergy icon on the desktop and then log in. Enter the patient’s demographic information.
Testing using Test menu From Test Menu, select the test type from the folder. From the waveform screen, the Select protocol dialog box appears. Choose the protocol and side to use for this exam and click OK. Proceed with testing. When this test is completed, while still in the waveform screen, press or click the New Nerve navigation key (if performing a nerve of the same type) or Exit Test (if the nerve is from another folder).
Example Motor Nerve Conduction Study Position and secure the electrodes to the patient according to your conventions for the type of test you are performing. About the waveform screen The filter and/or stimulator settings are indicated on the tool bar. The trace labels and settings are indicated to the right of the waveform.
Motor NCS electrode placement • The active recording electrode is placed over the endplate zone of a muscle innervated by the tested nerve. The reference electrode is placed nearby in an electrically “quiet” area. • • The ground electrode is usually placed between the stimulating and recording electrodes. Using electrolytic gel between the skin and recording electrode improves the “electrical contact”...
To manually position latency or amplitude markers, select the marker from the Cursor Panel below the waveform screen. From that panel, you can Clear, Clear All, Hide, Show, Fast Mark or place individual marker. To remove a marker, click the undesired marker on the waveform, it turns red. Then select Clear from the Cursor Panel To repeat on additional traces, use the Up/down Cursor keys to activate the correct trace and repeat the previous steps.
Graphs Up to two graphs can be displayed on the test screen. Up to six graphs can be displayed in the full screen RESULTS view. Select Results > Graph Options to select the results to view. Test Menu and History To display the patient Test History and Test Menu while in a test, from the View drop down menu, select Test Menu and History.
EMG screen displays There are two basic EMG displays available from the function keys: Complex 1 or Complex 2. Complex 2 displays a full screen of Monitor EMG and Cascades. Complex 1 displays a quadrant of Monitor EMG, a quadrant of Long Trace EMG and a half screen of Cascades. In both cases, to acquire either Cascades or Long Trace EMG, press or select Acquire from the function keys.
Example Evoked Potential Study Position and secure the electrodes to your patient according to your conventions for the type of test you are performing. About the waveform screen The filter and/or stimulator settings are indicated on the tool bar. The trace labels and settings are indicated to the right of the waveform. The results table.
Test Menu and History To display the patient Test History and Test Menu while in a test, from the View drop down menu select Test Menu and History. Acquire the data Data is acquired by the system, displayed on-screen, and marked and saved automatically. The waveforms along with the measured values are then transferred to a report.
Resetting the markers If you have repositioned markers that have been placed automatically by the system, you can return those markers to their original positions by pressing Results > Reanalyze in the menu bar. Erasing data Click the waveform to highlight it. Right-click the waveform.
7 Backup and Restore Data This chapter provides instructions on backing up and restoring patient information and settings. Backing Up Files It is recommended that data be backed upped monthly. Backing up data is easily done via the menu bar above the Patient Information screen.
When using a cart, inspect the cart to ensure casters and caster locks are functioning and system components are properly placed, referring to the UltraPro Cart IFU as needed. The UltraPro S100 system is designed to be portable. Take care to not allow the system to hit objects during transport •...
• Use large surface ground electrodes Check the protocol test settings to insure they are appropriate for the test. If unsure, use the Natus default settings: LFF – Filters out low-frequency interference. • • HFF – Filters out high-frequency interference.
Equipment) Regulations 2014. These regulations state that electrical and electronic waste must be separately collected for the proper treatment and recovery to ensure that WEEE is reused or recycled safely. In line with that commitment Natus may pass along the obligation for take back and recycling to the end user unless other arrangements have been made.
Refer to Chapter 5 for error message descriptions Screen captures, Producer files, and/or reports exhibiting the problem • The Natus representative may ask for system Log Files or debugging information to gain more details. The Natus representative will guide you through this process.
List of UltraPro S100 items; additional and optional parts List of all modules, cables and accessories with which the manufacturer of the UltraPro S100 claims compliance. The customer or the user of the UltraPro S100 should assure that it is used with these parts.
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Radio transmitting equipment, cellular phones, etc., shall not be used in the close proximity of the device since this could influence the performance of the device. Portable and mobile RF communications equipment can affect the UltraPro S100. Install and operate the UltraPro S100 according to the EMC information presented in this section.
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The UltraPro S100 has been tested for EMC emissions and immunity as a standalone instrument. Do not use the UltraPro S100 adjacent to or stacked with other electronic equipment. If adjacent or stacked use is necessary, the user should verify normal operation in the configuration.
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Table 5 – Immunity Test Levels – Input A.C. Power Port Immunity Test Levels - Professional Healthcare Phenomenon Basic EMC Standard Facility Environment ± 2 kV Electrical Fast Transients / Bursts IEC 61000-4-4 100 kHz repetition frequency Surges IEC 61000-4-5 ±...
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Table 8 – Immunity Test Levels - Signal Input / Output Parts Port Immunity Test Levels - Professional Healthcare Phenomenon Basic EMC Standard Facility Environment ± 8 kV contact Electrostatic Discharge IEC 61000-4-2 ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air ±...
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Table 9 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test Maximum Immunity Band Distance Service Modulation Frequency Power Test Level (MHz) (MHz) (V/m) 380 – 390 TETRA 400 Pulse modulation 18 Hz 430 – 470 GMRS 460, ±...
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Notes The Natus UltraPro S100 system is designed to function under a wide range of environmental conditions without compromise to Safety or Essential Performance. In the event that an environmental artifact (e.g., ESD, line voltage fluctuations, etc.) is of sufficient intensity and/ or duration to possibly affect the system performance, the system is designed to enter a fail-safe mode and temporarily discontinue operation.
10 System Symbols This chapter contains additional symbol descriptions which may appear on the UltraPro S100 system. IEC 60417 Symbols Symbol Description Warnings associated with this device. A warning indicates that there is a risk of death or serious injury to the user or patient.
UltraPro System Symbols Symbol Description Patient Response, Tendon Hammer Connector Trigger Input / Output Connector LED Goggles Transducer Connection Constant Current Stimulus Visual Transducer Connector Auditory Transducer Connection Dual USB Connectors – Type A LINK HS Link Output Connector Trace up (for Synergy, icon is for Next Trace only) Trace down (for Synergy, icon is for Next Trace only) Set Markers Decrease Duration...
Power switch 3 and 4 Channel Amplifier: Active Electrode - Black The Active electrode corresponds to the black input connector. 3 and 4 Channel Amplifier: Reference Electrode - Red The Reference electrode corresponds to the red input connector. 4 Channel Amplifier: Run/Standby indicator UltraPro Software Symbols NOTE: Hover the mouse over the software symbol to display the symbol’s function.
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Symbol Description Hide Patient Names Save Settings Test History Add EMG Summary Add Report Order By Delete Reverse Side Study Menu Test Menu Level: Panel Single Sweep Repetitive Sweep Test Options Setup Right Trace Area On/Off Marker Bar On/Off Average Repeat Test Refilter Sum and Difference...
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Symbol Description Match Sensitivity Smooth Reference Setup EMG Volume Capture Screen Capture Video Review: Previous and Next Print Screen Complex: 1 and 2 Cursors: Vertical and Horizontal Trigger: Edge and Type EMG Display Options: Monitor, Cascade, Long Trace Motor Unit Stage EMG Filter...
11 Technical Specifications This chapter contains the technical specifications of the UltraPro system. For further information please refer to the UltraPro S100 Specification Sheet, part number 019823, provided with your system and available at natus.com. Amplifiers 3- and 4-Channel Amplifiers: Each channel includes its own 1.5 mm touch-proof DIN connector...
Visual Stimuli: Visual Stimulator Pattern Types: Checkerboard, Horizontal Gratings (Bars), or Vertical Gratings (Bars) Pattern Sizes: 8 x 8, 16 x 16, 32 x 32, 64 x 64, 128 x 128 Pattern Field Screen Format: Full, Left Half, Right Half, Right Upper Quadrant, Right Lower Quadrant, Left Upper Quadrant, Left Lower Quadrant Stimulus Types: Onset/Offset, Reversal Fixation Target Options: Off (None), + (Option 1), X (Option 2), ><...