SynAmps 2TM User's Guide Rev B

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.neuroscan.com). Or, if you live in the USA or Canada, please call 1-800 474-7875. International callers should use 877-717-3975. For Sales related questions, please contact your local distributor, or contact us at [email protected].

Copyright  2007 - 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 Compumedics/Neuroscan. Compumedics Neuroscan USA Ltd. 6605 West W.T. Harris Blvd., Suite F Charlotte, NC 28269 Phone: 877-717-3975 (8am – 5pm EST) E-mail: [email protected] Web: www.neuroscan.com

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Table of Contents Device Classification... 5 Introduction... 15 Hardware Installation... 16 Unpacking the SynAmps2... 16 Connecting the Components...16 Installing the SynAmps2 Driver... 20 The Amplifier/Headbox...23 Connecting Multiple Headboxes... 24 Installing the SynAmps2 as the Amplifier for SCAN... 25 Configuring the SynAmps2 in the ACQUIRE Program... 29 Amplifier Settings... 29 DC Electrode Considerations... 31 Deblocking... 33 Filter Values... 36 Low-pass Filters... 36 High-pass Filters... 37 Notch Filters and Noise... 37 Triggering... 39 High-Level Inputs... 39 Reassignment of Channels... 46 Calibration Check... 47 Impedance... 49 -3-

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Diagnostic and Related Information... 52 Subject Ground... 58 Electrode Safety... 59 MRI Environment Recording Configurations... 59 Appendix A - Trigger Port Interfacing... 60 Appendix B - Configuring Multiple SynAmps2... 67 Appendix C - Electrode Cap Connector Pinout... 69 Appendix D - Guidance and Declaration...71 Appendix E - Shorting Plug Details... 74

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Device Classification

ATTENTION: CONSULT ACCOMPANYING DOCUMENTS BEFORE USING The SynAmps2TM Model 8050 EEG amplifier and data acquisition system is a line-powered 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 USA Ltd. 6605 West W.T. Harris Blvd., Suite F Charlotte, NC 28269 Phone: 877-717-3975 (8am – 5pm EST) E-mail: [email protected] Web: www.neuroscan.com

This equipment has been tested and found to comply with the limits and requirements for a Class A 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 to correct the interference by one or more of the following measures: (1) Change the orientation of the two devices relative to one another; -5-

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(2) Increase the separation between the two devices; (3) Check the power source and grounding for the two devices; and 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 00080586 Deblock Interface Cable P/N 00081300

Classification per IEC601-1:1988 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, 50/60Hz, 10/5A Fuses: T5A 250V (2 each, 5 X 20mm) Headbox Weight: 1.5 kg Dimensions: Height: 4.5 cm Width: 18.7 cm Depth: 21.8 cm -6-

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System Unit Weight: Dimensions Power Unit Weight: Dimensions

4.3kg Height: Width: Depth:

23.0 cm 11.6 cm 32.5 cm

12.5kg Height: Width: Depth:

23.0 cm 11.6 cm 32.5 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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CAUTION! Read instructions before using! ATTENTION! Lire le mode d'emploi avant usage!. VORSICHT! Vor Verwendung Gebrauchsanleitung lesen! PRECAUCION! Lea las instrucciones antes de su uso! ATTENZIONE! Leggere le instruzioni prima dell'uso!

CLASSIFICATION: Class 1, Type BF CLASSFICATION: classe 1, type BF KLASSIFIZIERUNG: Klasse 1, Typ BF CLASIFICACION: Clase 1, Tipo BF CLASSIFICAZIONE: Classe 1, Tipo BF

Subject connection is isolated from power mains (Type CF).

Volts AC

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Volts DC

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System Unit

Headbox Unit

Patient Connected

Patient Not Connected

Signal Input

USB Connection

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. ATTENTION: pour reduire tout risque de choc electrique, ne pas oter le couvercie. S'adresser a un technician qualifie en cas de mauvais fonctionnement. VORSICHT: Zur Vermeidung der Stromschlaggefahr die Abdeckung nicht entiemen. Wartungsarbeiten sind nur von geschultem Personel vorzunehmen! PRECAUCION: Para reducir el riesgo de que se produzca un electrochoque, no retire la tapa. Consulte a personal cualilicado para efectuar el servicio! ATTENZIONE: Per ridurre il rischlo di scossa elettrica non rimouvere il coperchio. Rivolgersi a personale qualificato. WARNING: For continued protection against fire hazard, replace fuse with same type and rating. AVERTISSEMENT: pour une protection permanente contre les risques d'incendie, utiliser des fusibles de rechange du meme amperage. -9-

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WARNUNG: Zur Wahrung des Schutzes gegen Feuergefahr Sicherung nur durch eine Sicherung desselben Typs und derselven Leistung emeuem! ADVERTENCIA: Para obtener una proteccion continuada contra el riesgo de incendio, reemplace el fusible con uno del mismo tipo y potencia. ATTENZIONE: per una protezione continuativa contro rischi di incendio, sostituire il fisible con uno dello stesso tipo e voltagio. DANGER: Possible explosion hazard when used in the presence of a flammable anaethetic mixture with air or with oxygen or nitrous oxide. DANGER: Risque possible d'explosion en cas d'utilisation en presence d'un melange d'anesthesique inflammable et d'air, d'oxygene ou de protoxyde d'azote. GEFAHR: Mogliche Explosionsgefahr bel Verwendung in Gegenwart von entzundbarer Anasthetikummischung mit Luft oder mit Sauerstoff oder Stickstoffoxid! PELIGRO: Riesgo posible de explosion cuando se usa cerca de un anestesico inflamable mezclado con aire, con oxigeno o con oxido nitroso. PERICOLO: Possibile rischio di esplosione se utilizzato in presenza di una miscela di gas inflammabile ed aria oppure ossigeno o protossido d'azoto. 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 - 10 -

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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 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. CAUTION: Grounding continuity should be checked periodically. CAUTION: This product requires convection cooling. Adequate ventilation is required. Clearance of 2" minimum on any side. 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. NOTE: USA and Canada: Grounding reliability can only be achieved when this equipment is connected to a receptacle marked "Hospital Only" or "Hospital Grade". 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". - 11 -

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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 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.

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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. - 13 -

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Use With HF Surgical Equipment This device does not contain protection against burning of the patient when used with high frequency (HF) surgical equipment. Neuroscan 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 manual 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.

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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 main features: • A USB 2.0 interface is used to link the SynAmps² and computer. This single connection serves up to four headboxes for a total of 256 EEG channels (plus additional bipolar and HLI channels) via a single System Unit. A second System Unit can be used for more 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 3.5kHz. • 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. A 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. • Built in impedance and system checking. • 24-bit AD conversion provides greater resolution (using the 32-bit SCAN 4.3 acquisition software). - 15 SynAmps2 Copyright  2007 CM/NS Document Number 8065, Revision B

Hardware Installation Installation of a SynAmps² amplifier is very easy. Here is a summary of the installation steps:

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. 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. Open the boxes and check for the following contents: 1. 2. 3. 4. 5. 6.

Amplifier/headbox unit(s) Amplifier/headbox cable(s) (15ft.) Cap Connector Shorting plug(s) System Unit(s) (one for every four headboxes) USB cable(s) (15 ft.) Deblocking Interface Cable

7. Isolation Power Unit 8. SynAmps2 User Manual 9. Power Unit Manual 10. Warranty Card 11. Declaration of Conformity

Connecting the Components The Amplifier/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 and system checks. - 16 -

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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. Follow these steps to connect the components: 1. The amplifier/headbox is connected to the System Unit via a 15 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.

Make sure the System Unit and SCAN computer are off whenever you connect the USB or headbox cables. Do not "hot swap" the USB cable or headboxes. Use the thumbscrew connections to attach the cables securely. - 17 -

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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 Inter-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 a USB connection on 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. - 18 SynAmps2 Copyright  2007 CM/NS Document Number 8065, Revision B

6. All components connected to the SCAN and SynAmps2 units MUST be powered by the Power Unit. Connect the power cables to the computers, monitors, printer, 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 230V. 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. Note: Install the SCAN software prior to turning on the SynAmps2 amplifiers.

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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 drivers for them. If you have installed the software first, the drivers will be found more automatically.

Installing the SynAmps2 Drivers When you connect the System Unit to the SCAN computer, or when the SCAN computer first boots after you have connected the SynAmps², Windows will find the new hardware. Each headbox unit and each System Unit has its own drivers, so the process below will be repeated several times. If you subsequently change the order of the headboxes, Windows will detect the change and the drivers will need to be installed again. The entire installation of all of the drivers will take several minutes; once done, you will not need to do it again (unless you change the headbox order).

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