SynAmps 2TM User's Guide Rev A

For Technical Support... If you have any questions or problems, please contact Technical Support through any of the following routes. If you live outside the USA or Canada, and purchased your system through one of our international distributors, please contact the distributor first, especially if your system is under warranty. In all other cases, please use [email protected], or see the other Support options on our web site (http://www.neuro.com/neuroscan/support.htm). Or, if you live in the USA or Canada, please call 1-800 474-7875. International callers should use 915-845-5600, ext 223.

For Sales related questions, please contact your local distributor, or contact us at [email protected].

Copyright  2003 - Compumedics Neuroscan. All rights reserved. Printed in the United States of America. No part of this manual may be used or reproduced in any form or by any means, or stored in a database or retrieval system, without prior written permission of the company. Making copies of any part of this document for any purpose other than your own personal use is a violation of United States copyright laws. For information, contact Neuroscan. Compumedics Neuroscan 7850 Paseo Del Norte El Paso, TX 79912 Telephone: 915-845-5600 Fax: 915-845-2965 E-mail: [email protected] Web: www.neuro.com

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Table of Contents Device Classification... 4 Introduction... 9 Hardware Installation... 9 Unpacking the SynAmps2... 9 Connecting the Components... 10 Installing the SynAmps2 Driver... 13 The Amplifier/Headbox... 13 Connecting Multiple Headboxes... 14 Installing the SynAmps2 as the Amplifier for SCAN... 15 Configuring the SynAmps2 in the ACQUIRE Program... 22 Amplifier Settings... 23 DC Correction... 24 Manual correction of DC offset... 24 Automatic correction of DC offset... 25 DC Electrode Considerations... 27 Filter Values... 29 Low-pass Filters... 29 High-pass Filters... 30 Notch Filters and Noise... 30 Reference Mode... 31 Triggering... 32 High-Level Inputs... 34 Reassignment of Channels... 36 Calibration... 37 Internal Calibration... 37 External Calibration... 40 Impedance... 41 Subject Ground... 43 Electrode Safety... 43 MRI Environment Recording Configurations... 43 Appendix A - Trigger Port Interfacing... 44 Appendix B - Configuring Multiple SynAmps2... 48 Appendix C -Electrode Cap Connector Pinout... 50 Appendix D -Comparison of SynAmps and SynAmps2... 51 Appendix E - Guidance and Declaration... 52

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Device Classification

ATTENTION: CONSULT ACCOMPANYING DOCUMENTS BEFORE USING The SynAmps2TM Model 8050 EEG amplifier and data acquisition system is a linepowered instrument designed to meet the applicable requirements of IEC601-1:1988. The SynAmps2 should be used only according to the manufacturer's instructions. Replacement parts and accessories may be obtained from the manufacturer. Manufacturer:

Compumedics Neuroscan 7850 Paseo Del Norte El Paso, TX 79912 Phone: 915-845-5600 Fax: 915-845-2965 Internet: [email protected] [email protected] Web: http://www.neuro.com

This equipment has been tested and found to comply with the limits and requirements for a Class B device per EN60601-1-2. These limits and requirements are designed to provide reasonable protection under conditions of normal use from interference with and by other devices. There is, however, no guarantee that interference will not result from operation of this device in proximity or connected to some other device. If interference occurs, the user or operator is encouraged to try and correct the interference by one or more of the following measures: (1) Change the orientation of the two devices relative to one another. (2) Increase the separation between the two devices. (3) Check the power source and grounding for the two devices. (4) Consult the dealer, Neuroscan Technical Support, or an experienced technician for help. The safety and electromagnetic compatibility of this system was tested with the following accessories, parts, and associated devices. The user or operator is cautioned to ensure that when using accessories, parts, or associated devices other than those listed, that the safety and electromagnetic compatibility of the system is maintained. 1) 2) 3)

Neuroscan SCAN Computer P/N 0010915 or 0010914 Headbox Cable – P/N 00080580 Deblock Interface Cable P/N 00081300

Classification per IEC601-1:1988

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The device is ordinary equipment not protected against ingress of water and should not be used in the presence of any spilled liquids. It is not designed to be suitable for use in the presence of a flammable anesthetic mixture of air and oxygen or nitrous oxide. The device is capable of continuous operation. Class and degree of protection against electrical shock is Class 1, Type CF. Technical Description Input: 120-230VAC, 47-63Hz, 5A Fuses: 2 each 5A 250V 5 X 20mm Type 'T' Headbox Weight: 1.5 kg Dimensions: Height: 4.3 cm Width: 17.8 cm Depth: 21.4 cm System Unit Weight: 4.2kg Dimensions Height: 22.6 cm Width: 11.6 cm Depth: 27.9 cm Power Unit Weight: 12.5kg Dimensions Height: 22.6 cm Width: 11.6 cm Depth: 27.9 cm Shipping and Storage Maximum Limits -20° C to +70° C, 10% to 100% humidity, non-condensing RH, 500 hPa to 1060 hPa. After unpacking, allow devices to adjust to room temperature for at least two hours prior to interconnection and application of power. Operational Limits +15°C to +30°C, 25% to 95% humidity, non-condensing RH, 700hPa to 1060hPa pressure. Warnings and Precautions Instructions Read instructions before operating the device. Symbols The following symbols are found on the SynAmps2:

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Attention! Read instructions before using!

Subject connection is isolated from power mains.

Volts AC

Volts DC The SynAmps² operates using line voltages which are present inside the enclosure and so is marked "CAUTION: To reduce risk of electric shock, do not remove cover. Refer servicing to qualified personnel." This device is not equipped with appropriate alarms required for use in monitoring clinical parameters of a patient where it is necessary to alert the user of situations which could lead to death or severe deterioration of the patient's state of health. WARNING: The SynAmps² system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the SynAmps² system should be observed to verify normal operation in the configuration in which it will be used. WARNING: Connection to the High-Level Input Connector (J3 on the headbox REF 00080460) may result in increased EMISSIONS or decreased IMMUNITY of the SynAmps² system. Care should be taken by the user or operator to verify normal operation with a cable attached to the High Level Input Connector. CAUTION: MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC (ElectroMagnetic Compatibility) and needs to be installed and put into service according to the EMC information provided in the ACCOMPANYING DOCUMENTS. CAUTION: Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT. Use of this type of equipment in -6-

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close proximity to the SynAmps² should be prohibited. If portable or mobile RF communications devices are used in the vicinity of the SynAmps² the user or operator should verify normal operation of the device. Neuroscan does not specify a minimum amplitude or value of the patient physiological signal. DANGER: Risques d'explosion si cet apparail est utilisé à proximité d'anesthesiques inflammables ou en présence de gaz ou de liquides inflammables. REMARQUE: USA et Canada, la fiabilité de la mise à la masse de cet équipment ne peut ètre réalisé que si celui-ci est connecté à une price marquée "Hôpital Suelement" ou "Classe Hôpital". ATTENTION: Ce product doit ètre refroidit par convection. Une ventilation appropriée est indespensable. Un espace de 2" (5cm) doit ètre laissé libre de chaque côté. ATTENTION: Pour réduire les risques de choc électrique, ne pas ouvrir le bôitiér de protection. Aucune functionalite necessaire à l'utilisateur ne se trouve a l'intérieur. Environment The SynAmps² is designed to be used in a clinical laboratory or office environment. Extremes of humidity, temperature, or pressure should be avoided. The device should not be used in a location where contact with liquids is possible, and if liquids are spilled on or in the area of the device, it should not be used until it can be ensured that the fluid or its residue will not affect device operation. Questions should be directed to the manufacturer or its representatives. Cleaning Instructions The SynAmps² enclosure may be cleaned with a damp sponge or cloth and mild nonabrasive cleanser. Take care to ensure that liquid does not spill in or on the device. Do not use abrasives or detergents. Sterilization and Cleaning of Patient-Contact Parts Parts for contact with the patient such as electrodes are not supplied as part of the SynAmps² system. The manufacturer’s instructions should be followed for sterilization and cleaning of the parts used. Some devices are designed for -7-

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onetime use only, and no attempt should be made to reuse them, whether sterilization has been attempted or not. Contact Neuroscan technical support if you have questions about sterilization or cleaning of the SynAmps² device or electrodes to be used with the device. Repair There are no user serviceable parts in the SynAmps² amplifier system. Fuses in the System Unit power input module and in the Power Unit power input module should be replaced with the type and rating indicated on the back panel label. Contact your dealer or Neuroscan Technical Support if you believe the SynAmps² system is in need of repair. Maintenance Neuroscan suggests that the earth and patient leakage currents be tested at least once per year to ensure continued safe use of the device. Also at least once per year, visually inspect the device, including the power cord. Replace any worn or frayed cables, and contact your dealer or Neuroscan technical support if you have concerns about what you see. This inspection interval may be shortened for devices that are moved often or experience unusually heavy use. Periodic calibration of the device, using internal or external sources, is recommended. The calibration procedure is described in the Calibration section below. No other maintenance or service is required. Installation Precaution Proper grounding is important for continued safe use of your SynAmps² system. Ensure that the outlet supplying power to your SynAmps² is grounded, and that the power cords supplied with your system are used. Other devices in the same patient area should be at the same ground potential, and should preferably use the same branch circuit. See the Hardware and Software Installation directions below for more details. Power Source Characteristics The SynAmps² amplifier is designed, produced, and tested to ensure reliable operation when connected to power systems having normal variability. If you believe that your power system may experience excessive noise or variability, Neuroscan recommends use of a power conditioner. Interconnection with Other Devices Care should be taken when multiple devices are connected to a patient, or when devices are connected together. Leakage currents for individual devices may sum to values higher than expected for single devices. In particular care should be taken when connecting Information Technology (computer) equipment to Medical equipment. Allowable leakage current levels for IT equipment are higher than for Medical equipment. Use With HF Surgical Equipment -8-

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This device does not contain protection against burning of the patient when used with high frequency (HF) surgical equipment. Neuroscan can recommends that the SynAmps² device not be connected to the patient during use of HF surgical equipment. Electrode Safety The SynAmps² amplifier inputs and attached electrodes are Type CF, which means in part that they are not connected to Earth Ground or Chassis Ground. Maintain this separation from Earth Ground by ensuring that the electrodes and any conductive parts of their connectors do not touch conductive parts, including the system enclosure or other grounded devices. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, mechanical, electronic, photocopying, recording, or otherwise, without written permission of Neuroscan. No license, express or implied, is granted with respect to any of the technology described in this manual. Neuroscan retains all intellectual property rights associated with the technology described in this manual. This manual is intended to assist application developers in the use of applications for Neuroscan SynAmps² data acquisition system. Even though Neuroscan has reviewed this manual, NEUROSCAN MAKES NO WARRANTY OR REPRESENTATION , EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THIS MANUAL, ITS QUALITY, ACCURACY, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT WILL NEUROSCAN BE LIABLE FOR DIRECT, INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES RESULTING FROM ANY DEFECT OR INACCURACY IN THIS MANUAL, even if advised of the possibility of such damage.

Introduction The Neuroscan SynAmps² are AC/DC amplifiers designed to record a wide variety of multichannel neurophysiological signals. The SynAmps² are intended for the researcher who needs both a broadband amplifier and a high speed digital acquisition system. A SynAmps² contains the analog components needed to amplify low level neurophysiological signals and the digital components needed to digitize, digitally filter, log external events, and transfer data to a host computer. This design allows for high speed acquisition of signals from multiple electrode sites. This distributed processing approach allows data to be acquired at much higher rates with greater precision from more channels than could be obtained from a single computer performing the same task. Listed below are some of the features of the SynAmps²: • A USB 2.0 interface is used to link the SynAmps² and computer. One USB 2.0 chain can be used to connect up to four headboxes for a total of 256 EEG channels (plus -9-

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additional bipolar and HLI channels). An additional USB 2.0 chain can be used to achieve a higher number of channels (depending on your computer's speed and the AD rate). • Real-time digital filtering provides a wide range of filter settings from DC to 3.0kHz. • Sampling rates up to 20kHz from 1 to 64 EEG channels on a single headbox. Sampling rate is independent of the number of headboxes attached to a system. • 64 monopolar, 4 bipolar, and 2 high-level input channels. An high density connector on the headbox is provided for quick connection to electrode cap arrays. • Amplification and acquisition in the headbox near the subject to reduce noise pickup. • Amplification stages are matched to the A/D input range to give resolutions to 0.019uV/bit in DC mode, and 0.993uV/bit in AC mode • Built in impedance and calibration checking. • 24-bit AD conversion provides greater resolution (and flows seamlessly into the 32bit SCAN 4.3 acquisition software)

Hardware Installation Installation of a SynAmps² amplifier is very easy. Here is a summary of the steps that you will need to perform: Unpacking the SynAmps2 The SynAmps² has been shipped in containers designed to reduce damage due to shipping. Please retain these boxes and their contents in case you need to return the system for any reason. The three main components - Amplifier/headbox, System Unit, and Power Unit are packaged in smaller boxes within the larger box. Open the boxes and check for the following contents: 1. Amplifier/headbox unit(s) 2. System Unit(s) 3. Power Unit 4. Amplifier/headbox cable(s) 5. USB cable(s) 6. Shorting plug(s) for calibration 7. Deblocking Interface Cable - 10 -

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As you remove the components from the boxes, examine them for any obvious damage due to shipment. Save the boxes in case you need to return the SynAmps² for repairs. Connecting the Components Turn off and unplug all computers, monitors, printers, etc. before connecting the SynAmps² to the rest of the system. This is for the initial connection of components only, allowing you to specify the drivers when the SynAmps² is first detected (if needed). After that step has been completed, the order in which you turn components on does not matter. The Headbox provides the interface into which patient electrodes may be connected, and contains amplification and data acquisition circuits. The amplifier converts the analog biological signals to digital ones and sends the data to the host computer. It performs electrode impedance measurements internal calibration. The System Unit serves as an interface between the Headbox and the host computer, as well as providing distribution of power, controls, and data to multiple Headboxes. Additionally the System Unit provides user access to functions such as input triggers, synchronization signals, and other user interface functions. The System Unit is line powered through the Power Unit. The Power Unit provides isolation through a transformer from line power. Input and output voltages are selected via switches. All IT (Information Technology) devices attached to the system must be powered through the Power Unit.

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1. The amplifier/headbox is connected to the System Unit via a long (15 or 30 foot) cable. If you received more than one amplifier/headbox unit, there will be a cable for each one. One end should be plugged into the headbox connector (J1), and the other end should be plugged into the System Unit. Please refer to Appendix B for additional connection information.

2. On the back of the System Unit, there is a connector (top right) for synchronizing acquisition between two System Units (please refer to Appendix B for connection information, if needed). This connector is also involved if you are using the Deblocking option. Included with the System Unit is a Deblocking Interface Cable (P/N 00081300). One end of the cable connects to the System Unit / System Unit connector on the back of the System Unit, and the other connects to the peripheral device sending the TTL pulse. Please see the Triggering section below for more details. 3. If you have a STIM system, connect the STIM-to-SCAN trigger cable to the D-25 trigger input connector on the back of the System Unit (top left connector; see Appendix A for pinout information). 4. Connect the USB 2.0 cable to the back of the System Unit and to the back of the SCAN computer. 5. Connect the power cable to the back of the System Unit, and connect the other end to one of the plugs in the back of the Power Unit. Note that there is a power switch above the connector on both the System and Power Units; turn them off for the time being.

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6. All components connected to the SCAN, STIM and SynAmps2 units MUST be powered by the Power Unit. Connect the power cables to the computers, monitors, printer, STIM box, and System Unit(s) to the upper power connectors on the back of the Power Unit. Make sure you have the input and output voltages set correctly for 115 or 230 Volts. Connect the AC power cable from the back of the Power Unit to a grounded AC wall plug. Verify that there is a true earth ground in the building (otherwise, you may experience 50Hz or 60Hz line noise interference in the recordings). The completely connected system is shown below. The Power Unit contains an isolation transformer that is rated up to 1000 watts. While that should be sufficient to safely power the components mentioned, you should verify that you are not surpassing that limit. A fully loaded System Unit with four amplifier/headboxes attached consumes a maximum of 150W. The demand will come primarily from your computer(s), monitor(s) and any peripherals. The wattage demands are usually displayed on the back of the components (or in their documentation). Neuroscan is not responsible for damage to the Power Unit resulting from an overload.

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7. After all of the components are connected, turn on the Power Unit, the System Unit(s), and the SCAN computer. The SynAmps² amplifiers should be found as the computer boots, and the next step is to install the driver for them. Installing the SynAmps2 Driver When the SCAN computer first boots after you have connected the SynAmps², Windows should find the new hardware. If instead you connect the SynAmps² USB 2.0 cable while the SCAN PC is on, you should see the same message. The drivers will either be installed automatically, or you will be directed to install them (the relevant ones used by SynAmps² are Syn2Ldr.sys and SynAmps².sys). The Amplifier/Headbox Each amplifier/headbox connected to a SynAmps² provides 64 monopolar, 4 bipolar, and 2 high level inputs channels. The amplifier/headbox unit also provides amplification, AD conversion, filtering and other signal processing. The 64 monopolar channels are laid out in an 8x8 grid on the face of the headbox, and are labeled numerically. The four bipolar channels contain the plus and minus poles. The differential, or bipolar inputs are used for EOG, EMG, and EKG channel recordings. - 14 -

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The High Level Inputs (HLI's) are noncephalic leads that are galvanically isolated from both the patient and the SISO (computer) connections. They are typically used to input analog voltage outputs from peripheral psychophysiological devices, where the signal levels are far in excess of standard biologic signals (the input range of the HLI's is + 5Vs). The HLI's are located on the bottom edge of the headbox (14 pin Redel connector; J3). Please refer to HLI section below for pinout and connection information.

The Impedance Threshold lets you select one of six impedance thresholds. Impedances in excess of the level you set will be indicated by a lit LED for that channel label. The 80 pin connector (J2) on the bottom edge of the headbox is for the electrode cap. During calibration, you must connect the shorting plug in place of the electrode cap. The pinout information for your cap is included with the documentation you received with the cap. The pinout information for the 80 pin connector is contained in Appendix C. - 15 -

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Connecting Multiple Headboxes The current Quik-Caps are wired to send the ground and reference information to all headboxes. It is therefore not necessary to connect the ground and reference jacks across headboxes. If you are using older caps, or individual electrodes instead of caps, you will need to connect the headboxes together. Jumper the ground of one headbox to the ground of next headbox and repeat this procedure for all headboxes. Do the same for the reference connections. Note: Do not apply multiple ground or multiple reference electrodes just because there are multiple headboxes. Note: You should ALWAYS connect the reference electrode to the subject even if you use a different channel for the reference, or if you select the common average reference.

Installing the SynAmps2 as the Amplifier for SCAN After you have installed the driver for the SynAmps², you need to install SynAmps² as the amplifiers used in the SCAN software. This is done by running the ampinstall.exe program. If you do not have the AmpInst icon on your desktop, go to the Scan4.3 folder and double click on the program, or run the program from Start/Run/etc. The SCAN 4.3 "Select an Amplifier" window will appear. Select SynAmps² and click OK.

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You will then see the SCAN 4.3 AmpInst screen. Click <<Back... to select a different amplifier, or click Finished.

The program takes a fraction of a second to run; it is creating or modifying the scan43.ini file in the WINDOWS or WINNT directory. When the SCAN 4.3 Amp/Inst window reappears, click the Done button. If you wish to change the amplifiers or the A/D card, run the Uninstall option, then run Install with the new selection, and click Done when finished. To verify that the computer and amplifiers are communicating correctly, please do the following. Make sure that the software lock provided with the SCAN CD is connected to the parallel port (or USB, depending on the type of lock you received) of your computer. Double-click the SCAN 4.3 icon , and then click on the ACQUIRE icon from the Program Launcher to start the ACQUIRE program.

The Main screen will appear.

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Click Edit, and at the bottom of the pull-down menu you should see the SynAmps² Hardware option.

Select that option, and a dialog box will appear. THIS WILL CHANGE

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In multiple systems it is possible to query each amplifier by clicking on the dropdown arrow and selecting the desired SynAmps². If your SynAmps² and PC are communicating correctly you will see the dates and version information in the fields. If not, there is a communication problem with the SynAmps². In most cases, this is resolved by installing the correct drivers (see Installing the SynAmps² Driver above). If you still have communication problems, contact [email protected].

Configuring the SynAmps2 in the ACQUIRE Program The configuration of the SynAmps² is accomplished within the ACQUIRE program, and the parameters are saved in a "setup file" (.ast extension). Go into the ACQUIRE part of the program, select a setup file from the ones provided, or create your own from scratch. The complete operation of the ACQUIRE program is contained in the ACQUIRE manual. Settings specific to SynAmps² are described below. Go to Edit, then Overall Parameters, and select the Amplifiers tab to begin. Amplifier Settings AD Rate. The maximum AD rate with SynAmps² is 20 kHz for any number of channels. The SynAmps² AD converters over-sample by 64x, making the effective sampling rate greater than 20 kHz. However, for the digitized data, the maximum rate is 20 kHz. Click the pull-down arrow to see the available AD rates.

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Number of Channels. Enter the total number of desired channels, including any bipolar and HLI channels. If you are adding channels to whatever is displayed in the setup file you retrieved, you will likely need to click the Reset Positions button.

Example. Let's say you want to have 32 EEG channels, plus two bipolar channels for EOG artifact, and one HLI. Enter 35 for the number of channels, and click Reset Positions. Select any other amplifier settings you want (AC/DC, filters, etc.). Then go to the Channel Assignment page. Chances are that the EEG channels shown are not the ones you want, and no bipolar or HLI channels are selected.

The SynAmps² is hardwired, that is, Physical channel 1 is always O2 (assuming you are using an electrode cap). AC/DC option. With SynAmps², you have the option to record in true DC mode, or to record in AC mode. With the AC mode enabled, a decoupling single pole RC high-pass filter (.05 Hz , -6dB/octave/pole) is switched into the signal path.

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