FCC ID: XFYCADWELL-1 Wireless EEG Recorder

CADWELL EASY III OPERATORS MANUAL PART NUMBER 100840-620 REV 3.5.1 - AUGUST - 2009 909 North Kellogg Avenue Kennewick, Washington 99336 800.245.3001 509.735.6481 509.783.6503 Fax www.cadwell.com info@cadwell.com international@cadwell.com 1 Cadwell Easy III Version 3.5 COPYRIGHT 2009 Cadwell. All rights reserved. No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, translated into any language or computer language, in any form, by any means, electronic, mechanical, optical, chemical, manual, or otherwise without prior written consent of Cadwell. Disclaimer Clinical conclusions and decisions based on the use of this product are the responsibility of the user. Cadwell does not accept any liability or responsibility for damages arising out of the use of or inability to use this product. This document may contain technical inaccuracies or typographical errors. Changes are periodically made to the information herein; these changes will be incorporated in future revisions of this document. Features and specifications are subject to change without notice. Cadwell does not accept any liability for the use or misuse, direct or indirect, of this product. Users must accept all responsibility for any results obtained by or concluded from data obtained by the products. The user must accept all responsibility for results obtained by software from Cadwell Laboratories, Inc. Trademark Notices Cadwell, Easy, EasyNet, and Q-Video are registered trademarks of Cadwell, Inc. This document also contains trademarks of other companies. 2 EASY III DATA ACQUISITION SYSTEM The Cadwell Easy III is an advanced data acquisition system for recording brain wave and other physiological signals. Easy III provides control, display, event notation, storage and reporting on acquired data. The Easy III's software supports multiple amplifier platforms available from Cadwell. Data management includes viewing or reading EEG data on a reader computer, saving and recalling some or all of the record for future reference, and being able to easily find records among the hundreds generated by each system each year. Easy III is designed to facilitate report generation for both the individual patient and for the clinic. Intended Use The Easy III system is intended for the acquisition of EEG and other polygraphic channels. The Easy III system is intended for use by a physician or a trained technician under the supervision of a physician. The Easy III intended recording environment is in a hospital, clinic, physicians office, or other appropriate testing environments. Operator's Manual Intended Use This manual provides an operational summary of the Easy III Data Acquisition System. This manual does not provide clinical training. It is assumed that the user has adequate clinical training to perform procedures involving the Easy III. Please refer to the following sources for more information on the Easy III. Cadwell Easy III Help File. Available with installed Easy III application and at www.cadwell.com Cadwell Easy III Technical Manual. www.cadwell.com Cadwell Customer Support. 3 Cadwell Easy III Version 3.5 New Features and Enhancements in Easy III, Version 3.5 General Features 1. Record Optimizations have been added to reduce overall file size. Compression is dynamically applied as data is saved. A new option has also been added that allows the user to eliminate unused inputs before data is collected. Note page 153. 2. Paging Speed Enhancements (with and without video) have been added to increase paging speed during review. Users will see improvement when paging through studies that are on the local or remote/network drives. 3. End users have requested that new windows added through the Show Window option be displayed at all times (this now applies to all windows added such as Q-Video, additional trace windows, etc.). 4. The Easy III Office Server can now be configured as a Service, eliminating the requirement to leave the Office Server system logged in at all times. Note page 65. 5. The Report Generator will now import Word templates. 6. Implemented new software for the KWorld video to USB adapter to optimize performance with Q-Video. 7. Record Opening time has been improved for remote records. Some marginal improvements are also seen with local records. 8. Trace Band Clipping Feature. This new option will allow the user to configure how much overlap is allowed between recorded channels. Settings can be accessed through the montage editor or by left clicking on the trace labels during review or data collection. Trace band overlap settings can also be adjusted on-the-fly by left clicking on the trace label during data collection or review. Note Page 101. 9. Implemented additional changes to improve Easy III time synchronization (when comparing Easy III real time calculation to operating system time setting). 10. Changes have been made to the measurement tool to make sure the tool works consistently. 11. When paging, the page with focus will page at the displayed page duration. For example, if you are looking at data in a 1 second page, the paging tool will advance by 1 second pages. 12. Linked channel EEG settings, montage name, and notch filter status have been added to the top of waveform printouts. 13. Implemented new performance monitoring output tool. This tool is available in the Tools menu. Selecting this option will place several performance metrics in the Windows clip board. Select paste to copy the contents into MS Word. 4 14. Default Bookmark durations have been added based on user feedback. 15. Event text placement has been improved. Text will entries will be displayed adjacent to each other. The event line helps the user quickly associate the event text/event location. 16. Comment text placement in the trace window has been modified based on user feedback. 17. Real time values have been added to the bookmark list. The comment column has also been expanded to display more characters. 18. Added bookmark-specific grid line colors to the trace window. 19. New Impedance Default Setting. Impedance LEDs on amp now default to 5K when launching impedance from software. 20. Trace Window Record Editing has been changed to allow the user to specify the type of data

(waveform, video or audio) to be edited when right clicking in the trace window. The selected data types for editing are saved with the users Easy login name. 5 Cadwell Easy III Version 3.5 21. EDF file export has been added. Right click in the trace window to access the EDF export tool. Montage changes will no longer break the EDF file extraction. 22. New Hot Keys The following hot keys have been added. F2 - Event List F3 - Q-Video Player in review window only F4 - Default Report 1 (R1) F5 - Default Report 2 (R2) F6 - Default Report 3 (R3) The following keyboard hot keys require the mouse to be placed over the trace window. CTRL B - Go forward to next bookmark CTRL G - Go to page number tool will appear CTRL - Decrease displayed paper speed of trace window with mouse focus CTRL - Increase displayed paper speed of trace window with mouse focus CTRL M - Display montage list CTRL + Auto page forward (press CTRL + again to increase paging speed, CTRL to decrease paging speed) CTRL - Auto page backward (press CTRL + again to increase paging speed, CTRL to decrease paging speed) CTRL A - Change displayed montage with mouse focus back to as recorded CTRL 1- 9 - Change the displayed montage to the default montage specified for M1-M9 CTRL P - Reposition to start of photic stimulation (EEG) CTRL H- Reposition to start of hyperventilation (EEG) CTRL L - Reposition to Lights Out (PSG) CTRL S - Reposition to Sleep Onset (PSG) 6 CTRL R - Reposition to REM Onset (PSG) CTRL C - Advance to next CPAP/Bilevel pressure (PSG) Home Key Reposition to Start of Recording End Key Reposition to End of Recording Space Bar Advance forward one page Pg Up Advance backward one page Pg Dn Advance forward one page

- Increase linked sensitivity

- Decrease linked sensitivity Page forward Page backward EEG, LTM, and ICU Specific Features 1. Recording Timer. The Timer can be used to keep track of elapsed time and pages. Events will be added to the trace window every 10 seconds. The user can select an option to not write the events to the trace window if required. 2. Added the option to allow users to delete Persyst spike events from Easy Event list. 7 Cadwell Easy III Version 3.5 3. The recording date is now displayed in the trace window. Right click in the trace window, select setup to add the date to the trace window. 4. The impedance button has been put in the EEG review menu based on user feedback. 5. More EEG montage buttons have been added to the review menu based on user feedback. 6. Easy III Photic Stimulator improvements for EEG customers. Fixed some issues whereby the Photic stimulator tick marks and accompanying frequency text were not always displayed correctly. 7. Implemented Patient Event Marker detection. Events are displayed in the event list and position bar now. The new patient event button plugs into an Easy III or Easy II DC input. 8. Remote Viewing of Magic Marker. Remote viewing of Magic Marker data through Easy III has been added. PSG Features 1. New Chronological CPAP table for PSG customers (lists pressures chronologically, duplicate pressures on separate rows.) 2. A new Quick Delete feature has been added to quickly delete PSG events. Place the mouse cursor over an event, when the pop-up details are displayed, press the delete key. The event will be quickly deleted. 3. Sleep stage tick marks have been added to the position bar for PSG customers. 4. A new PSG Split Night report has been added. 5. Added a new WASO calculation (wake after sleep onset including out of bed time) for PSG customers. 6. Added the ability to add multiple Optimal PAP pressures. The Optimal Pressure report and the new Split Night Report will use the combined optimal pressures for report generation. 7. The PSG Event Detection menu option has been added to the Tools button. 8. New PSG CPAP table has been added based on market feedback. 9. ETCO2 (End Tidal CO2) signal trending has been added for PSG and ICU customers. 8 10. Computer Assisted Periodic Breathing Event detection for PSG customers (includes new graphs, tokens and tables.) NOTE: Central apneas detected during period breathing will not be included in AHI and RDI calculations. If enabled, the periodic breathing event detection will occur on all records where the patient age is 13 years or less. This age setting is user definable. 11. The PSG Comprehensive CPAP table has been updated (removed Hypopnea 1 and 2, added total sleep time at each pressure, added more heart rate information) 12. Added New pH-related features (trace info tool, tokens, tables, Digital Value panel) for PSG customers. 13. Simplified Event Marking for associating arousals with LM and snore events for PSG customers. A manually marked arousal is now associated with a LM or snore event if the arousal starts during or within two seconds after the LM or snore event. 14. Improved Body Position Detection. Added additional filtering to body position channel to insure position change has really occurred (not movement). 15. Improved system performance when multiple sleep event detectors are used. 16. Added notch filter on to default event scanning on EKG channel to improve low and high heart rate event detection. 17. Digital Value Panel improvements allow the user to now display ETCO2 and pH values. The panel has been improved to increase visibility of the displayed text in various horizontal and vertical views. 18. Updated PSG Comprehensive Report. The calculations for limb movement events on the PSG Comprehensive Report have been updated. 19. PSG customers can now advance forward and backward by 1 second increments from a 30 second epoch. After moving the epoch by 1 second increments, Easy III will realign the view on the adjacent epoch when the user pages forward or backwards by one page. 20. Monitor Mode. The monitor mode will allow the user to modify channel settings

(sensitivity, filter setting) before recording data. After entering all patient information, click on the yellow button to start the monitor mode. The system will prompt the user that data is not being recorded. Clicking on the monitoring mode before starting a recording will not start the recording timer. Clicking on the monitoring mode during data collection will pause data collection; however blank pages will be displayed in the recorded data. 9 Cadwell Easy III Version 3.5 General Warnings and Precautions Federal law restricts sale of this system to, or on the order of, a physician. The operator must be trained to recognize the difference between signal artifacts and valid bio-signals caused by movements, interference, or misplacement of sensors or electrodes. This manual provides an operational summary for the Easy III system. It does not provide clinical training. It is assumed that the user has adequate clinical training. The system is not defibrillator proof. The system is not designed to operate in an explosive environment. Do not immerse the amplifier, remote input box, power-communications module, flash stimulator, and system cables in liquid. The system is designed to be used with one patient at a time. Do not connect multiple patients to one amplifier. Never place an isolation transformer on the ground. When attaching the Easy III system to a patient, verify that the subject will not become entangled in the wires. Do not allow the electrode wires to wrap around the patient's neck. Do not update Persyst software components without Cadwell approval. Do not try to service internal parts of the Easy III system. Only service by Cadwell, Inc. or authorized bodies. Inspect all cables before and after each use. Discard cable if insulation is damaged or if the cable or connectors are damaged in any manner. The proper use of this device, for its intended use, can only be assured once all instructions have been read and understood. Contact Cadwell with Easy III operational questions. Do not use the system in an MRI environment. A possible loss of data can occur if acquiring data on a machine that has a network data folder. Do not use power strips with the system unless they are connected downstream of an isolation transformer. Do not connect items which are not specified as part of or for use with the Easy III system. Do not exceed the medical isolation transformer maximum load. Do not use the isolation transformer to power non-system components; it may overload the transformer or defeat the separation by providing additional leakage sources. Do not exceed the medical isolation transformer maximum load. Do not plug non-medical electrical equipment in the patient environment directly into a wall outlet. This may cause excessive leakage current in the patient environment. 10 EASY III TABLE OF CONTENTS CADWELL EASY III ............................................................................................................................................... 1 EASY III DATA ACQUISITION SYSTEM ............................................................................................................. 3 INTENDED USE .......................................................................................................................................................... 3 OPERATOR'S MANUAL INTENDED USE .................................................................................................................... 3 NEW FEATURES AND ENHANCEMENTS IN EASY III, VERSION 3.5 .......................................................................... 4 GENERAL WARNINGS AND PRECAUTIONS ............................................................................................................. 10 EASY HARDWARE ................................................................................................................................................. 13 SETUP INSTRUCTIONS ............................................................................................................................................. 13 COMPUTER-AMPLIFIER CONNECTION DIAGRAM ................................................................................................. 14 BASIC HARDWARE CONFIGURATION ..................................................................................................................... 15 EASY III HARDWARE COMPONENTS ...................................................................................................................... 17 EASY III AMPLIFIER OVERVIEW ........................................................................................................................... 19 EASY III POWER/COMMUNICATIONS MODULE ..................................................................................................... 25 EASY III DC AMPLIFIER ........................................................................................................................................ 29 EASY III PHOTIC STIMULATOR .............................................................................................................................. 29 EASY II AMPLIFIER HARDWARE ............................................................................................................................ 33 EASY II DC AMPLIFIER .......................................................................................................................................... 35 EASY II POWER COMMUNICATIONS UNIT ............................................................................................................. 35 EASY II DC AMPLIFIER SPECIFICATIONS .............................................................................................................. 36 EASY II REMOTE INPUT BOXES ............................................................................................................................. 36 EASY II PHOTIC STIMULATOR ............................................................................................................................... 37 EASY AMBULATORY ............................................................................................................................................... 40 EASY AMBULATORY HARDWARE .......................................................................................................................... 40 AMBULATORY RECORDER FEATURES, LEDS, CONNECTORS ............................................................................... 42 AMBULATORY BATTERY HOLDER ......................................................................................................................... 45 EASY AMBULATORY WIRELESS ............................................................................................................................. 49 EASY AMBULATORY WIRELESS HARDWARE ........................................................................................................ 49 AMBULATORY RECORDER FEATURES, LEDS, CONNECTORS ............................................................................... 51 WIRELESS AMBULATORY RECORDER RECHARGEABLE BATTERIES ................................................................... 54 EASY REMOTE INPUT BOXES ................................................................................................................................. 59 EASY III EASYNET MODULES* .............................................................................................................................. 62 EASYNET CABLE TESTER....................................................................................................................................... 65 MINIMUM COMPUTER HARDWARE REQUIREMENTS ............................................................................................ 67 Q-VIDEO CAMERA HARDWARE ............................................................................................................................. 69 IP CAMERA SETUP .................................................................................................................................................. 70 EASY III SOFTWARE ............................................................................................................................................. 72 PREPARING FOR SOFTWARE INSTALLATION ......................................................................................................... 72 PARTY SOFTWARE REQUIREMENTS ............................................................................. 72 OPERATING SYSTEM, 3RD INSTALLING EASY III SOFTWARE .......................................................................................................................... 73 SOFTWARE OVERVIEW ........................................................................................................................................... 95 CADWELL SCHEDULER OPTIONS ........................................................................................................................... 99 CLINICAL DATABASE OPTIONS ............................................................................................................................ 106 EASY III SYSTEM SETTING ................................................................................................................................... 107 AVERAGE REFERENCES ........................................................................................................................................ 114 FLASH PROGRAMS ................................................................................................................................................ 114 DATA MAPS .......................................................................................................... ERROR! BOOKMARK NOT DEFINED. ACCESS SCRIPTS .................................................................................................. ERROR! BOOKMARK NOT DEFINED. MANAGE USERS ................................................................................................... ERROR! BOOKMARK NOT DEFINED. USER-DEFINED PSG EVENTS .............................................................................. ERROR! BOOKMARK NOT DEFINED. PSG SETTINGS ..................................................................................................... ERROR! BOOKMARK NOT DEFINED. PSG EVENT DETECTION SETTINGS .................................................................... ERROR! BOOKMARK NOT DEFINED. 11 Cadwell Easy III Version 3.5 SELECTING A PROTOCOL .................................................................................... ERROR! BOOKMARK NOT DEFINED. EDITING PROTOCOLS .......................................................................................... ERROR! BOOKMARK NOT DEFINED. SETTING UP WORKSPACE WINDOWS .................................................................. ERROR! BOOKMARK NOT DEFINED. ADDING, MODIFYING, AND CALIBRATING DC DEVICES .................................... ERROR! BOOKMARK NOT DEFINED. RECORD MANAGER ............................................................................................. ERROR! BOOKMARK NOT DEFINED. PREPARE A PATIENT FOR DATA COLLECTION ................................................... ERROR! BOOKMARK NOT DEFINED. START EASY III PROCEDURE .............................................................................. ERROR! BOOKMARK NOT DEFINED. EASY III TOOLBAR OPTIONS .............................................................................. ERROR! BOOKMARK NOT DEFINED. MARKING EVENTS ............................................................................................... ERROR! BOOKMARK NOT DEFINED. EASY STAMP ........................................................................................................ ERROR! BOOKMARK NOT DEFINED. SLEEP EVENTS ..................................................................................................... ERROR! BOOKMARK NOT DEFINED. SLEEP SUMMARY EVENTS ................................................................................... ERROR! BOOKMARK NOT DEFINED. COMPUTER ASSISTED PSG EVENT DETECTORS ................................................ ERROR! BOOKMARK NOT DEFINED. BOOKMARKS ........................................................................................................ ERROR! BOOKMARK NOT DEFINED. Q-VIDEO .............................................................................................................. ERROR! BOOKMARK NOT DEFINED. GENERATE A REPORT .......................................................................................... ERROR! BOOKMARK NOT DEFINED. SELECT REPORT .................................................................................................. ERROR! BOOKMARK NOT DEFINED. QUICKREPORT DOCUMENT ................................................................................ ERROR! BOOKMARK NOT DEFINED. SAVE THE REPORT ............................................................................................... ERROR! BOOKMARK NOT DEFINED. REPORT HEADER ................................................................................................. ERROR! BOOKMARK NOT DEFINED. PERSYST TOOLS ................................................................................................... ERROR! BOOKMARK NOT DEFINED. MAGIC MARKER .................................................................................................. ERROR! BOOKMARK NOT DEFINED. MAGIC MARKER MENU OPTIONS ....................................................................... ERROR! BOOKMARK NOT DEFINED. REVEAL SPIKE DETECTOR .................................................................................. ERROR! BOOKMARK NOT DEFINED. SPIKE REVIEW ..................................................................................................... ERROR! BOOKMARK NOT DEFINED. REVIEW RECORDS ............................................................................................... ERROR! BOOKMARK NOT DEFINED. SCROLL THROUGH RECORDS .............................................................................. ERROR! BOOKMARK NOT DEFINED. SAFETY INFORMATION ........................................................................................ ERROR! BOOKMARK NOT DEFINED. ELECTROMAGNETIC COMPATIBILITY ................................................................ ERROR! BOOKMARK NOT DEFINED. MAINTENANCE ..................................................................................................... ERROR! BOOKMARK NOT DEFINED. CLEAN THE EASY III SYSTEM ............................................................................. ERROR! BOOKMARK NOT DEFINED. TECHNICAL .......................................................................................................... ERROR! BOOKMARK NOT DEFINED. CUSTOMER SUPPORT ........................................................................................... ERROR! BOOKMARK NOT DEFINED. USING HELP FILES ............................................................................................... ERROR! BOOKMARK NOT DEFINED. 12 EASY HARDWARE Setup Instructions The Easy III system is comprised of several system components. Your particular configuration of equipment may include amplifier hardware, cables, sensors, video equipment, and computer hardware. Unpack Easy Hardware Inspect your shipping documentation. Verify that you have accounted for all boxes and components shipped to you from Cadwell. If the total number of boxes delivered to your facility does not match the total number of boxes listed on your shipping documents, please contact Customer Service at Cadwell Labs. Carefully unpack all hardware. Verify that you have completely removed all hardware, cables, and documentation from each box. Place all documentation and shipping lists in a safe location for future reference. Your Cadwell authorized installer will connect all of the Easy equipment and verify that the system is properly configured. Unpack Computer Hardware Inspect your shipping documentation. Verify you have accounted for all boxes and components shipped to you from Cadwell Labs. Please complete all product registration forms and return them to each hardware manufacturer as specified. Your Cadwell authorized installer will set up your new computer hardware during the system installation and training session. If you have purchased your computer hardware from Cadwell Labs all Easy III software has been previously installed by our configuration team. The illustration on the following page provides a simplified illustration showing how Easy III amplifier hardware is connected to a computer. 13 Cadwell Easy III Version 3.5 Computer-Amplifier Connection Diagram 1. Connect the Easy III Amplifier (1) to the Power/Com Module (3) with the Easy III Amplifier Cable (7). 2. Connect the Photic Stimulator (2) to the Power/Com Module (3) with the CPN Cable (8). 3. Connect the Power/Com Module (3) to the Computer (5) with the 4. Ground the Power/Com Module (3) to the Computer (5) with the grounding wire (10). 5. Plug in the video to USB adapter (4) to a USB port on the computer (5). 6. Connect the monitor (6) to the computer (5) with the video splitter cable (12) and the monitor cable

(13). 7. Connect the monitor (6) to a power supply with the AC Power Cord (14). 8. Connect the keyboard (11) to a USB port on the computer (5). 9. Connect the mouse (15) to a USB port on the computer (5). 10. Connect the Power/Com Module (3) to a power supply with the AC Power Cord (9). Press the On button on the front of the Power/Com Module and verify the power LED is on. 11. Verify EasyNet Modules are connected. See EasyNet Module Connections. 14 Basic Hardware Configuration Easy hardware can be configured in multiple amplifier and system cart configurations to meet your needs. Patient Room/Recording Area You can configure your Easy III hardware on a variety of carts and trolleys from Cadwell. The following options are available:

Wide Trolley The wide trolley is 38H x 29D x 30W. The cart is shipped pre-assembled (U.S. shipments only). The wide trolley has multiple adjustable height shelves, mounting brackets for amplifier or flash stimulator articulating arms. An optional LCD mounting bracket is available. This cart is designed to handle large monitors, computers, and printers. The wide trolley has several options, including an accessory bag, isolation transformer, and an extending keyboard tray. Contact Cadwell to discuss all of the options available for this trolley. Narrow Trolley The narrow trolley is 38H x 29D x 24W. The cart is shipped pre-assembled (U.S. shipments only). The narrow trolley has multiple height-adjustable shelves, and mounting brackets for amplifier or flash stimulator articulating arms. An LCD mounting bracket is also available. The narrow cart is designed to help you maneuver your Easy system in environments with limited space. The cart's options include an accessory bag, storage bin, isolation transformer, and an extending keyboard tray. Contact Cadwell to discuss all the options available for the narrow trolley.

* Cart configurations and options are subject to change. Contact Cadwell if you have specific questions about your cart configuration. 15 Cadwell Easy III Version 3.5 Articulating Trolley Arms There are two different articulating arms that can be used with the wide and narrow trolleys. One arm is designed to hold the Easy III 32 channel amplifier (or Easy II EEG amplifier); the other articulating arm is designed to hold the Easy III flash stimulator (or the Easy II flash stimulator). The photograph displayed to the right shows the Easy III amplifier photic stimulator mounted on articulating arms on a trolley cart. Printer Setup All necessary printer drivers and software are already installed on your computer from the Cadwell factory. There is no need for you to install any additional drivers or software. Please put the CDs and documentation that came with your printer in a secure place for future reference. If you purchased your printer from a source other than Cadwell, you must install the printer driver on your PC. Please refer to the instruction manual accompanying your printer for instructions on printer setup and software installation. Additional Setup Supplies You may purchase additional items from Cadwell that can assist you in setting up and configuring your equipment to allow optimal performance and patient comfort. Call Cadwell at 1.800.245.3001 for product information. 16 Hardware Overview Easy III Hardware Components The Easy III system is comprised of several system components. Your particular configuration of equipment may include amplifier hardware, cables, sensors, video equipment, and computer hardware. Easy III Amplifiers Remote Input Boxes Power/Com Module Photic Stimulator Electrodes 17 Cadwell Easy III Version 3.5 Easy III Device Symbols Symbol Description Symbol Description See manual or help file Power Off Recording Type BF Type CF Input Signal Output Signal Amplifier Patient Input Connector Headphones Input WEEE Conformity Easy III Cable Connections 18 Easy III Amplifier Overview The basic Easy III amplifier includes 32 AC channels. Seven of these are bipolar and two additional channels are ambient light detection channels. Eight DC channels may be added internally. For studies requiring more recording channels, the amplifier may be expanded to include 64 or 128 EEG channels. The EasyNet expansion port allows additional channels to be added to the system, including oximetry, heart rate, body position, accelerometers for limb movement, and multiple patient event channels. In all, the Easy III has the capacity for more than 150 patient event channels. 19 Cadwell Easy III Version 3.5 Easy III Amplifier Specifications EEG Amplifier Inputs:

46 Channel Configuration: 32 EEG channels, capable of 12 EasyNet channels, ambient light, and infrared light. 54 Channel Configuration: 32 EEG channels, 8 DC inputs, capable of 12 EasyNet channels, ambient light, and infrared light. 86 Channel Configuration: 64 EEG channels, 8 DC inputs, capable of 12 EasyNet channels, ambient light and infrared light. 150 Channel Configuration: 128 EEG channels, 8 DC inputs, capable of 12 EasyNet channels, ambient light and infrared light. Active/Reference Pairs:

7 (46 or 54 ch), 14 (86 ch), or 28 (150 ch) sets of inputs Noise:

DC Inputs:

< 2uV , Mains noise rejection > 110 dB at 50 and 60 Hz 8 inputs (+/-) 10V, 200Hz storage rate Photic Stimulator:

White LEDs. (1 60 Hz flash rate range) ISO Ground Connectors:

2 inputs Low Cut Filter:

Act/Ref pairs: 9 steps (0.032 10 Hz) EEG channels: 8 steps (0.16-10 Hz) High Cut Filter:

5 steps (15 100 Hz) EEG Channel Sampling Rate:

4000 Hz per channel EEG Channel Storage Rate:

250 Hz per channel EEG Differential Input Impedance:

20 Mohm EEG A/D Conversion System:

18 bit A/D Conversion System EEG Sensitivity:

19 steps between 0.5 1000 uV/mm Amplifier/Computer Interface:

Ethernet LEDs:

-Power -Ethernet Link -Status

-Ethernet Data Transfer -EasyNet Connection -Recording Transport and Storage Limits:

Temperature: -4F to 149F (-20C to 65C) Relative Humidity: 10-90% non-condensing Atmospheric Pressure: 500-1060 hPa Operational Limits:

Temperature: +10 C (+50 F) to +40 C (104 F) Relative Humidity: 30% to 75% non-condensing UL60601-1 CSA 601.1 EN 60601-1 EN 60601-1-1 (medical systems) EN 60601-2-26 (EEG equipment) EN 60601-1-2 (EMC) EN 60601-1-4 (programmable electrical medical systems) Regulatory Approvals:

20 Easy III Amplifier Placement The Easy III Amplifier can connect to:

A 4-inch deep wall-mount bracket that can be attached to a wall adjacent to the patient monitoring area. The Easy III amplifier articulating arm. This arm can be attached to a trolley cart. Screw the Amplifier Bracket into the back of the Amplifier, and then connect it to the articulating arm. The amplifier can also be placed on a nightstand or table adjacent to the patient. 21 Cadwell Easy III Version 3.5 Easy III Amplifier LEDs Easy III LEDs Description The Power LED indicates that the amplifier is receiving power from the Power/Com Module. This LED flashes green at 1 Hz when there is idle power. It is solid green during data collection. The Recording LED indicates that the amplifier is collecting data. The Impedance LEDs indicate the impedance level for each EEG input, ground input, and active reference pair input. Pressing the adjacent 5K, 10K, or 20K button is illuminate a LED for any corresponding input that has a higher impedance level than selected. Pressing the OFF button will turn off the impedance measurement feature. Note: The amplifier must be in the record mode to use the impedance LEDs. The Ambient Light Detector can detect when the ambient light adjacent to the amplifier changes. LED 1, 3, and 4 indicate amplifier status. LED 2 is inactive. Power Recording Impedance Ambient Light Detector Amplifier Connection Status 22 Easy III Amplifier Impedance Buttons The 20K, 10K, 5K and OFF buttons on the Easy III amplifier perform manual impedance checks. NOTE: The amplifier must be recording data for the impedance buttons to be operational. The OFF button halts the impedance check. It does not turn off the amplifier. Easy III Amplifier Connectors and Cables Easy III Amplifier Connectors Description Remote Inputs EasyNet Expansion Ports DC Inputs Connects to Remote Input Boxes through the Remote Input Box Cable. Add 12 or more optional channels, including oximetry, oral/nasal airflow, body position, and multiple accelerometers for limb movement. Add up to 8 internal DC channels. Amplifier Power/Com Cable Input Connects to the Power/Com Module with a 2- or 4- meter cable. CPN/Photic Input Electrode Ports Supplies power and information to the Photic Stimulator through the Photic Stimulator cable. EEG electrodes and seven Act/Ref pair electrodes can be plugged into the inputs on the top of the amplifier or into a remote input box. The input connectors are designed for 0.059 inch (1.5mm) diameter molded safety connectors. 23 Cadwell Easy III Version 3.5 Easy III Amplifier Cables Description Length Amplifier Cable Cat 5 Cable Electrodes Connects the Easy III Amplifier to the Power/Com Module. 6.5 or 13 feet (2 or 4 meters) Connects the Power/Com Module to network card in computer. Straight-through RJ-

45, Cat 5 cable. Connects the patient to the Remote Input boxes. max 325 feet (99 meters) lengths and types vary Easy III Amplifier Warnings & Precautions Do not immerse the amplifier in liquid. No user-serviceable parts inside. Service by Cadwell Laboratories, Inc. and other authorized bodies only. Inspect cables before and after each use. Discard cable if insulation is damaged or if the cable or connectors are damaged in any manner. Test the system regularly. The system is not defibrillator-proof. The system is designed to be used with one patient at a time. Do not connect multiple patients to one amplifier. External devices connected to DC inputs must comply with IEC 60601-1 and all relevant collateral standards. Do not use the system in an MRI environment. Strictly adhere to the cleaning instructions in this manual. The system is not designed to operate in an explosive environment. Use only Cadwell-approved mounting hardware to attach the Easy III amplifier to an articulating arm. Use only Cadwell-approved cables for connecting your Cadwell Easy III hardware components. Sensors attached to EEG inputs to monitor other functions must provide at least basic insulation to ground and be passive in nature or provide at least double insulation if mains powered. 24 Easy III Power/Communications Module Power/Com Module Overview The Power-Communications (Power/Com) Module is the central connection point for the Easy III and computer hardware for power supply and information exchange. The amplifier and photic stimulator hardware plug into the power/com module, and the PC connects to the Power/Com Module with an Ethernet cable to communicate with the amplifier and photic stimulator. Easy III Power/Com Placement The Power/Communications module connects the Easy III amplifier to its host computer. In a cart configuration, the Power/Communications Module can be mounted to the cart with a Power/Communications Module Holder Kit, placing it in proximity to the devices it connects to: the PC, the Easy III Amplifier, and the Isolation Transformer. The Power/Communications Module also utilizes a grounding wire, which attaches to the cart. The Power/Communications module can also be placed adjacent to the patient on a night stand or on the floor. Note: Verify the power communication module is placed in a location where the patient will not trip or become entangled in the wires. 25 Cadwell Easy III Version 3.5 Easy III Power/Com LEDs Green LED- ON indicates that the Power/Com module is receiving power. Easy III Power/Com Buttons The Power button turns the Power/Com Module and the Amplifier on or off. Easy III Power/Com Connectors and Cables 26 Easy III Connectors and Cables Easy III Power/Com Connectors Description AC Power Port Inputs power from the AC power cord. 100-240VAC, 1 AMP Max, 50-60Hz. Voltage Equalization Screw To reduce noise, use a grounding wire from the thumb-screw grounding post to the cart. Ethernet Port Amplifier Cable Port CPN Port Connects Easy III hardware to Easy III software in PC. Isolated 10/100 Base T, Straight-through RJ-45. Connects to the male end of the Amplifier Cable. Connects to the Photic Stimulator cable (either connector may be used with the photic stimulator) Easy III Power/Com Cables Description Length Amplifier Cable Photic Cable AC Power Cord Ethernet Cable Connects the Easy III Amplifier to the Power/Com Module. 6.5 or 13 feet/

2 or 4 meters Connects the Easy III Photic Stimulator to the Power /Com Module. Supplies power to the Power /Com Module. Connect to an isolation transformer. 6.5 or 13 feet/

2 or 4 meters 8 feet/ 2.4 meters Connects the Power /Com Module to the network card in computer. 325 feet/ 99 meters 27 Cadwell Easy III Version 3.5 Easy III Power/Com Warnings & Precautions Do not immerse the Power/Com module or its cables in liquid. No user-serviceable parts inside. Service by Cadwell Laboratories, Inc. and other authorized bodies only. Inspect cables before and after each use. Discard cable if insulation is damaged or if the cable or connectors are damaged in any manner. Verify the patient will not trip or become entangled in the Power/Communications cables. The system is not defibrillator proof. Potential Equalization terminal may only be used for noise reduction. Potential equalization does not qualify as a redundant protective earth connection for non-medical electrical equipment. Do not use the system in an MRI environment. Cleaning instructions in this manual need to be strictly adhered to. The system is not designed to operate in an explosive environment. Use only Cadwell-approved cables for connecting your Cadwell Easy III hardware components. Only use with one patient at a time. A possible shock hazard can be created by the summation of leakage currents when several equipments are interconnected. 28 Easy III DC Amplifier Cadwell Easy III The 54, 86 and 150 channel Easy III Amplifier are equipped with eight (8) internal DC inputs configured to collect multiple channels such as oximetry, patient event swithch, pulse rate, air flow, pressure, CPAP leak and pH. The input voltage range is - 10V to + 10V. The DC Amplifier connects to a DC device with the DC Amplifier Cable, which is available in a variety of lengths. Easy III Photic Stimulator Photic Stimulator Overview The Easy III Photic Stimulator is an ancillary piece of equipment used during EEG recording to provide visual stimulation to a patient. It can be run manually or through default or custom Flash Programs. The photic stimulator has a Run/Stop button on the back of the flash stimulator. For manual use, point the photic stimulator at the patient at the appropriate distance from the patient, and push the Run button. The Easy system will use the first default flash program. Push the button again to stop the flash program. Photic Stimulator Placement The photic stimulator connects to the CPN/Photic port on the Cadwell Power/Com Module or the Easy III Amplifier. The Easy III Photic Stimulator is designed to attach to a photic stimulator arm mounted on a trolley cart. The photic stimulator has a 2- or 4-meter cable that connects to the Power/Com Module. 29 Cadwell Easy III Version 3.5 Attach Photic Stimulator to Articulating Arm 1. Mount the articulating arm onto the trolley cart. 2. Line up the screws of the articulating arm with the sockets on the side of the photic stimulator, with the arrow pointing towards the flash. 3. Connect the screws and sockets, and finger-tighten until secure. Photic Stimulator LEDs Green Yellow The green LED flashes at 1 Hz during flash stimulation. The yellow LED flashes at 1 Hz when power is connected, but flash stimulation is idling. Photic Stimulator Buttons Run/Stop To run manually, or to turn off quickly, push the Run/Stop button. 30 Photic Stimulator Connectors and Cables Photic Stimulator Connector Description CPN Input Attaches the Photic Stimulator to the Amplifier or the Power/Com Module with the Photic Cable. Description Length Used to connect the Easy III Photic Stimulator to the Power/ Com Module. 6.5 or 13 feet (2 or 4 meters) Easy III Cables Easy III Photic Cable 31 Cadwell Easy III Version 3.5 Photic Stimulator Warnings & Precautions Use of the Cadwell Easy III Photic Stimulator may induce seizures in epileptic or epilepsy-prone patients. Persons who are photosensitive to light may have convulsions, seizures, or a myoclonic reaction to the photic stimulator. The system is not defibrillator proof. The system is not designed to operate in an explosive environment. The Photic Stimulator must be at least 12 inches (30 cm) from the patients eyes. If used on an anesthetized patient, a means should be provided to ensure that the patient's eye lids remain closed. Cleaning instructions in this manual need to be strictly adhered to. Use only Cadwell-approved mounting hardware to attach the Easy III flash stimulator to an articulating arm. Inspect cables before and after each use. Discard cable if insulation is damaged or if the cable or connectors are damaged in any manner. When using the photic stimulator on a Cadwell photic stimulator arm, do not allow the arm or the stimulator to come in contact with the patient. The operator must be trained to recognize EEG waveforms and patient symptoms consistent with reactions to photic stimulation. The operator must follow laboratory medical policies and procedures when using the flash stimulator to care for the patient undergoing photic stimulation. Do not use in an MRI environment. Do not immerse the photic stimulator in liquid. The photic stimulator is not intended for patient connection, but meets IEC 60601-1 leakage requirements in normal and single-fault conditions. The photic stimulator is appropriate for use in the patient environment. Use only Cadwell-approved cables for connecting your Cadwell Easy III hardware components. The system is designed to be used with one patient at a time. No user-serviceable parts inside. Service by Cadwell Laboratories, Inc. and other authorized bodies only. Use caution when extending, moving or adjusting the photic stimulator arm. Do not pinch your hands and fingers in the connectors, articulating joints, or extending joints on the photic stimulator arm. 32 Easy II Amplifier Hardware Easy II Intended Use The Easy II system is intended for use by a physician or trained technician under the supervision of a physician for the acquisition of EEG and other polygraphic channels. The intended recording environment for the Easy II is the hospital, clinic, physicians office, and other testing environments. Easy II Amplifier Hardware The Easy II amplifier can be used to collect up to 32 channels of EEG and/or polysomnographic data. EEG electrodes can be plugged into the connectors on the top of the amplifier, or plugged into a remote input box. The input connectors are designed for 0.059-inch (1.5mm) diameter molded safety connectors. The Easy II Amplifier connects to a Power Communications module with a 3 meter cable. Easy II Amplifier Connection Overview 33 Cadwell Easy III Version 3.5 Easy II Amplifier Specifications EEG Amplifier Inputs:

32 Channel Configuration: 25 EEG only channels and 7 channels which are switchable between individual active/reference pairs and EEG channels Active/Reference Pairs:

7 inputs on the 32 channel amplifier Noise:

DC Inputs:

< 2uV 4 (+10/- 5V) Photic Stimulator:

1 25 Hz flash rate range ISO Ground Connectors:

2 inputs EEG Common Mode Rejection:

100 Db at 50 or 60 Hz Low Cut Filter:

Act/Ref pairs: 9 steps (0.032 10 Hz) EEG channels: 8 steps (0.16-10 Hz) High Cut Filter:

5 steps (15 100 Hz) EEG Channel Sampling Rate:

2300 Hz per channel EEG Channel Storage Rate:

200 Hz per channel EEG Differential Input Impedance:

20K M ohm EEG A/D Conversion System:

16 bit A/D Conversion System EEG Sensitivity:

19 steps between 0.5 1000 uV/mm Amplifier/Computer Interface:

Ethernet Temperature:

+10 C (+50 F) to +40 C (+104 F) Relative Humidity:

30% - 75%

Atmospheric Pressure:

700 hPa to 1060 hPa Temperature:

Do not expose to temperatures below -20 C (-4 F) or above 65 C (149 F) Relative Humidity:

Do not expose to relative humidity below 10% or above 90% non-condensing Atmospheric Pressure:

500 hPa to 1060 hPa UL60601-1 CSA 601.1 EN 60601-1 EN 60601-1-1 (medical systems) EN 60601-2-26 (EEG equipment) EN 60601-1-2 (EMC) EN 60601-1-4 (programmable electrical medical systems) Operational Limits:

Transport and Storage Limits:

Regulatory Approvals:

34 Easy II DC Amplifier The Easy II DC amplifier has 4 DC inputs. The amplifier also has an internal Nonin oximeter and body position senor input. The Easy II DC Amplifier is connected to the Easy II Power Communications Module with a cable that plugs into the Auxiliary connector on the DC Amplifier. Easy II Power Communications Unit The Power-Communications (power com) Module is the central connection point for the Easy II hardware. The amplifier and photic stimulator hardware plug into the power/com module. The module has a thumb screw on the back panel to allow a ground cable to reduce noise. Connectors AC Input 100-240 VAC, 1 AMP Max, 50-60 Hz Ethernet Isolated 10/100 Base T, Straight-through RJ-45 Amplifier 24 pin, submini-D connector. Auxiliary 15 pin, submini-D connector for photic stimulator. Power On/Off LED 4 meter cable with 15 pin sub mini-D connectors LED 's Cable 35 Cadwell Easy III Version 3.5 Easy II DC Amplifier Specifications Connectors LEDs DC Inputs One Sub D 9 pin connector for oximetry input. One Sub D 15 pin connector for auxiliary input. One RJ45 connector for body position sensor input. DC Inputs - Four 1/8 inch female stereo connectors. Power - The power on LED indicates that the unit is receiving power from the power-

communications module. 4 Inputs (5V to -10V) Easy II Remote Input Boxes The Remote Input Boxes allow electrode extension 10 to 15 feet from the amplifier. Top panel Remote Input Boxes are labeled for 10-20 EEG inputs. Side-input Remote Input Boxes are also available. Input Box Details 25 EEG only channels and 7 active/reference pair inputs with 0.059-inch (1.5mm) diameter molded safety connectors. A recessed 50 pin mini-D connector is used for the remote input box cable. Remote Input Box Cable (3 m.) Each cable has a 50 pin, locking mini-D connector at each end of the cable. 36 Easy II Photic Stimulator The Easy II Photic Stimulator is designed to attach to a photic stimulator arm mounted on a trolley/cart. The photic stimulator has a 4 meter cable that connects to the Cadwell Power Com Module. Photic Stimulator Details Flash Rate/Intensity - 1 25 Hz/0.72 J/flash LEDs - Power Connectors - 15 pin mini-D Cable - 4 meter cable with 9 pin sub mini-D connector 37 Cadwell Easy III Version 3.5 Easy II Warnings and Cautions Do not immerse the amplifier, remote input box, power-communications module, flash stimulator, and system cables in liquid. No user serviceable parts inside the Easy II Amplifier or remote input boxes. Service by Cadwell Laboratories, Inc. and other authorized bodies only. The system is not defibrillator proof. The system is not designed to operate in an explosive environment. Use only Cadwell approved cables. The system is designed to be used with one patient at a time. Do not connect multiple patients to one amplifier. Use caution when extending, moving, or adjusting the Easy II Amplifier Arm. Verify that your hand and fingers will not be pinched in the connectors, articulating and extending joints on the Amplifier Arm. The Easy II remote Input Box inputs are Type CF rated. CF rating ensures that no current higher than 50uA flows to or from the applied part if mains voltage is inadvertently connected to the patient. When using the Easy II photic stimulator on a Cadwell Photic Stimulator Arm, do not allow the arm or photic to come in contact with the patient. The Photic stimulator is not intended for patient connection, but meets IEC 60601-1 leakage requirements in normal and single fault conditions. The photic stimulator is appropriate for use in the patient environment. The Cadwell Easy II photic stimulator must be at least 30 cm away from the patients eyes. If used on an anesthetized patient a means should be provided to ensure that the eye lids remain closed. Use only Nonin SpO2 sensors with the Easy II DC Amplifier. Though Cadwell has tested the Nonin 8000J sensor with the EasyNet SpO2 module, other sensors have not been tested or validated. Discontinue using any module or sensor if the patient exhibits any allergic reactions to adhesive or materials. Cleaning instructions in this manual need to be strictly adhered to. Always disconnect equipment from power source and patient before cleaning. Inspect cables before and after each use. Discard cable if insulation is damaged or if the cable or connectors are damaged in any manner. Do not use the system in an MRI environment. Use only Cadwell approved mounting hardware to attach the Easy II amplifier to an articulating arm. When attaching the Easy II system to a recording subject, verify that the subject will not become entangled in the wires. Do not allow the electrode wires to wrap around the subjects neck. The Easy II amplifier inputs are Type CF rated. CF rating ensures that no current higher than 50uA flows to or from the applied part if mains voltage is inadvertently connected to the patient. Conductive parts of electrodes and their connectors, including the neutral electrode, should not contact other conductive parts including earth. Cleaning instructions in this manual need to be strictly adhered to. Always disconnect equipment from power source and patient before cleaning. Inspect cables before and after each use. Discard cable if insulation is damaged or if the cable or connectors are damaged in any manner. 38 Easy II Warnings and Cautions continued. The use of the Cadwell Easy II flash stimulator may induce seizures in epileptics or people prone to epilepsy. Persons who are photosensitive to light may have convulsions, seizures, or a myoclonic reaction to the photic stimulator. The operator must be trained to recognize EEG waveforms and patient symptoms that are consistent with a patients reaction to photic stimulation. The operator must follow laboratory medical policies and procedures when using the flash stimulator to care for the patient undergoing photic stimulation. Potential Equalization terminal may only be used for noise reduction. Potential equalization terminal DOES NOT qualify as a redundant protective earth connection for non medical electrical equipment. This manual provides an operational summary for the Easy II system. It does not provide clinical training. It is assumed that the user has adequate clinical training. Do not immerse the photic stimulator or its cable in liquid. Use caution when extending, moving, or adjusting the Cadwell Photic Stimulator Arm. Verify that your hand and fingers will not be pinched in the connectors, articulating and extending joints on the Photic Stimulator Arm. The Power Com Module is not intended for patient connection, but meets IEC 60601-1 leakage requirements in normal and single fault conditions. The Power Com Module is appropriate for use in the patient environment. 39 Cadwell Easy III Version 3.5 Easy Ambulatory Ambulatory Intended Use The Easy Ambulatory system is intended for use by a physician or trained technician under the supervision of a physician for the acquisition of EEG and other polygraphic channels. The intended recording environment for the Easy Ambulatory is the home, hospital, and other testing environments. Easy Ambulatory Hardware The Easy Ambulatory system is comprised of three different modules, the recorder, battery holder, and amplifier. The Ambulatory Recorder and Battery Holder The recorder is a small, lightweight module that uses compact flash memory to record patient data. The recorder utilizes EasyNet technology to connect to multiple amplifier modules used to amplify EEG and other physiological channels. The recorder is worn by the patient in a small waist mounted pouch. The illustration below shows the recorder in the pouch. The EasyNet cable from the amplifier is plugged into the side of the recorder. The battery holder is a lightweight module used to hold the batteries that power the recorder and amplifier. Batteries can be quickly replaced by removing the battery cover from the battery holder. The recorder is mounted on the battery holder, and then placed in the Ambulatory recorder pouch for data collection. 40 The Ambulatory Amplifier The Ambulatory amplifier is a compact module that serves as a connector box and amplifier for EEG and other physiological channels. The amplifier uses EasyNet technology to send data to the recorder. The amplifier has multiple EEG inputs and active reference pair inputs. The amplifier can be worn by the patient on a small chest/shoulder strap or on the waist belt provided with the Easy system. The illustration below shows the amplifier with an EasyNet cable plugged into the amplifier. Ambulatory Amplifier LEDs, Connectors Ambulatory EasyNet Connectors An EasyNet cable can be used to connect the Amplifier to the Ambulatory Recorder. Other EasyNet modules can be plugged in to the other EasyNet connector on the Amplifier. Ambulatory LEDs S Yellow Status LED. Lights or flashes to indicate error condition. I Green LED. Flashes to indicate power is being received from the recorder. 41 Cadwell Easy III Version 3.5 Ambulatory Electrode input connectors FP1, FP2, F3, F4, F7,F8, T3,T4, T5, T6, A1, A2, C3, C4, P3, P4, O1, O2, FZ, CZ, PZ International 10-20 lead placement descriptors used on the Easy Amplifier IG x2, 1A, 1R, 2A, 2R, Voice Event Additional input descriptors placed on the Easy Amplifier. IG - Isolated Ground (x 2) 1A 1R Active Reference Pair 2A 2R Active Reference Pair Voice event connector. The Voice Event input for the microphone is not supported in Easy III, Version 3.2.54. Ambulatory Recorder Features, LEDs, Connectors Recorder 3 Dimensional View Recorder P1 Ethernet Connector An ethernet adapter is attached to this connector for data downloading and data review. 42 Recorder D LED The Data (D) LED indicates data is being transferred between the recorder and the computer. Recorder L LED The Link (L) LED indicates that the recorder has established an ethernet connection to the computer. Recorder Event Button The event button allows the patient to time synchronize an event during data collection. For each button press, the recorder will record a time-synchronized event during data collection. If the button is pressed for 4 seconds while the recorder is attached to a computer, a signal will be sent to the network card identifying the recorder. Recorder I LED The I LED indicates that the recorder is receiving power from the batteries. Recorder S LED The Status (S) LED flashes when an error condition is detected. Recorder R LED The EasyNet (R) LED flashes one time per second during data collection. Recorder N LED The EasyNet (N) LED flashes when an EasyNet error condition is detected. 43 Cadwell Easy III Version 3.5 Recorder EasyNet Connector The EasyNet connector allows a cable connection from the recorder to other modules such as the Amplifier/Connector module. Recorder C Door The Compact (C) Door can be removed to access the compact flash card. Cadwell recommends that the compact flash door remain attached to the recorder during data collection. Recorder P2 Connector The P2 Connector is for the battery connection. Connect the battery cable from the battery holder to the P2 connector on the recorder. Recorder P3 Connector The P3 connector is reserved for future use. 44 Ambulatory Battery Holder The Ambulatory Battery Holder is placed in the Ambulatory Recorder/Battery Holder pouch. A white battery cable connects the battery power to the Ambulatory Recorder. 45 Cadwell Easy III Version 3.5 Easy Ambulatory Specifications EEG Amplifier Inputs:

21 inputs Active/Reference Pairs:

2 sets of inputs ISO Ground Connectors:

2 inputs EEG Channel Sampling Rate:

3200 Hz per channel EEG Channel Storage Rate:

200 Hz per channel EEG Differential Input Impedance:

20K M ohm EEG A/D Conversion System:

16 bit A/D Conversion System Battery Power 2 C or D alkaline batterries Recording Time/Battery Life 29 hours per set of C cells 70 hours per set of D cells Data Storage/Memory Capacity

+ 165 hours with 4GB CF Amplifier/Computer Interface:

Ethernet Operational Limits:

Regulatory Approvals:

Temperature:

+10 C (+50 F) to +40 C (+104 F) Relative Humidity:

30% - 95% non-condensing UL601-1 2003 CSA 601.1 1990 EN 60601-1:1990 + A1:1993 + A2:1995 + A13:1996 EN 60601-1-1:2001 (medical systems) EN 60601-2-26:1994 (EEG equipment) EN 60601-1-2:2001 (EMC) EN 60601-1-4:1996 (programmable electrical medical systems) EN ISO 114971:2000 (risk) 46 Ambulatory Warnings and Cautions Federal law restricts sale of this system to, or on the order of, a physician. No user serviceable parts inside. Service by Cadwell Laboratories, Inc. and other authorized bodies only. Inspect battery cable before and after each use. Discard cable if insulation is damaged or if the cable or connectors are damaged in any manner. Caution must be taken to ensure that cables do not encircle the patient's neck or entangle the patient in any way. The system is not defibrillator proof. Cleaning instructions in this manual need to be strictly adhered to. When attaching the Easy Ambulatory 2 system to a recording subject, verify that the subject will not become entangled in the wires. Do not allow the electrode wires to wrap around the subjects neck. Instruct the patient in the proper way to wear the Easy Ambulatory system and not become entangled. Do not remove compact flash card if the recorder has power or is actively collecting data. Do not place recorder on a television, radio, or CPAP device. Always place the recorder and battery holder in the Easy Ambulatory Pouch when collecting patient data. The EEG electrode connectors are only designed for 1.5 mm touch proof connectors. High levels of static discharge can cause a momentary pause in data collection. Inspect EasyNet cables before and after each use. Discard cable if insulation is damaged or if the cable or connectors are damaged in any manner. Do not immerse the recorder, amplifier, battery holder, or EasyNet Modules in liquid. Do not attempt to use any Ambulatory system components if they have been immersed in liquid. The system is not water resistant or splash proof. The contact of liquids with the internal parts and connectors of the Cadwell Easy Ambulatory 2 system should be avoided at all times. The operator must be trained to be able to recognize the difference between signal artifact and valid bio-signals caused by movements, interference, or misplacement of sensors or electrodes. Do not use the system in an MRI environment. When applying the stockinet to the patient, verify that the stockinet is not covering the patients eyes, nose, mouth, or ears. Verify that the stockinet does not entangle the patients neck, restrict airflow, or restrict circulation. The system is not designed to operate in an explosive environment. Inspect EasyNet cables before and after each use. Discard cable if cable insulation is damaged or if the cable or connectors are damaged in any manner. Use only Cadwell authorized cables and accessories. Type BF, IC601 Isolation Do not autoclave. 47 Cadwell Easy III Version 3.5 Ambulatory Warnings and Cautions continued. Do not connect more than one amplifier/Connector box to the Recorder. Use only alkaline batteries, or those recommended by Cadwell Labs. Only use batteries authorized by Cadwell Laboratories, Inc. Do not store batteries in battery holder. Remove batteries after use. Do not re-use battery holder if battery leakage has occurred. Do not use the battery holder without the battery cover. When using the amplifier to collect data, verify that the amplifier has been placed in a Cadwell authorized pouch. Verify the amplifier has been securely attached to the amplifier belt or chest/shoulder strap. Do not mix battery types. Do not re-use old batteries. Inspect battery cable before and after each use. Discard cable if insulation is damaged or if the cable or connectors are damaged in any manner. Use only replacement fuses authorized by Cadwell. An extra fuse is located on the battery holder. Do not immerse battery holder in liquid. 48 Easy Ambulatory Wireless Ambulatory Wireless Intended Use The Easy Ambulatory wireless system is intended for use by a physician or trained technician under the supervision of a physician for the acquisition of EEG and other polygraphic channels. The intended recording environment for the Easy Ambulatory Wireless is the home, hospital, and other testing environments. Easy Ambulatory Wireless Hardware The Easy Ambulatory Wireless system is comprised of two different modules, the wireless recorder and the amplifier. The Ambulatory Wireless Recorder The wireless recorder is a small, lightweight module that uses compact flash memory to store patient data. The recorder has an internal antenna that can be used to transfer recorded data wirelessly to a host system. The recorder also has a wired Ethernet connector to allow the recorder to be directly connected to a host computer. The recorder utilizes EasyNet technology to connect to multiple wired amplifier modules used to amplify EEG and other physiological channels. The recorder is worn by the patient in a small waist mounted pouch. The illustration below shows the top side of the wireless recorder. 49 Cadwell Easy III Version 3.5 The Ambulatory Amplifier The Ambulatory amplifier is a compact module that serves as a connector box and amplifier for EEG and other physiological channels. The amplifier uses EasyNet technology to send data to the recorder. The amplifier has multiple EEG inputs and active reference pair inputs. The amplifier can be worn by the patient on a small chest/shoulder strap or on the waist belt provided with the Easy system. The illustration below shows the amplifier with an EasyNet cable plugged into the amplifier. Ambulatory Amplifier LEDs, Connectors Ambulatory EasyNet Connectors An EasyNet cable can be used to connect the Amplifier to the Ambulatory Recorder. Other EasyNet modules can be plugged in to the other EasyNet connector on the Amplifier. Ambulatory LEDs S Yellow Status LED. Lights or flashes to indicate error condition. I Green LED. Flashes to indicate power is being received from the recorder. 50 Ambulatory Electrode input connectors FP1, FP2, F3, F4, F7,F8, T3,T4, T5, T6, A1, A2, C3, C4, P3, P4, O1, O2, FZ, CZ, PZ International 10-20 lead placement descriptors used on the Easy Amplifier IG x2, 1A, 1R, 2A, 2R, Voice Event Additional input descriptors placed on the Easy Amplifier. IG - Isolated Ground (x 2) 1A 1R Active Reference Pair 2A 2R Active Reference Pair Voice event connector. The Voice Event input for the microphone is not supported in Easy III, Version 3.3. Ambulatory Recorder Features, LEDs, Connectors Wireless Recorder Top Panel View 51 Cadwell Easy III Version 3.5 Wireless Recorder Side View, P1 Ethernet Connector The Power/Com cable from the Power/Com module is attached to this connector for a wired connection to initialize the recorder, monitor data, download data and recharge the batteries. Recorder D LED The Data (D) LED indicates data is being transferred between the recorder and the computer. Recorder L LED The Link (L) LED indicates that the recorder has established an ethernet connection to the computer. Wireless Recorder Side View, EasyNet Connection, Event Button, Status LEDs Wireless Recorder Event Push Button on Side of Recorder The event button allows the patient to time synchronize an event during data collection. For each button press, the recorder will record a time-synchronized event during data collection. If the button is pressed for 4 seconds while the recorder is attached to a computer, a signal will be sent to the network card identifying the recorder. 52 Recorder Wireless Signal LED The EasyNet wireless signal LED will be on when the recorder is wirelessly attached to the host computer. Recorder I LED The I LED indicates that the recorder is receiving power from the batteries or Power/Com. This LED will flash rapidly when the battery levels are critically low. Recorder S LED The Status (S) LED flashes when an error condition is detected. Recorder R LED The EasyNet (R) LED flashes one time per second during data collection. Recorder N LED The EasyNet (N) LED flashes when an EasyNet error condition is detected. Recorder Battery Strength LEDs All LEDs will be on when the batteries are completely charged. As the available battery power is reduced, fewer LEDs will be on. When the battery levels are at critically low levels, the I LED will flash rapidly to indicate low battery power. Recorder EasyNet Connectors The EasyNet connector allows a cable connection from the recorder to other modules such as the Amplifier/Connector module. 53 Cadwell Easy III Version 3.5 Wireless Ambulatory Recorder Rechargeable Batteries The Wireless Ambulatory rechargeable (Lithium Iron Phosphate) batteries are located in Wireless Recorder. The batteries do not need to be removed for recharging. The batteries are recharged when the Power/Com cable from the Power/Com module is plugged into the P1 connector and the Power/Com is turned on. To replace the batteries, remove the battery access screw located on the bottom of the wireless recorder. The battery compartment will slide out of the recorder for replacement. Ambulatory Wireless Recorder Bottom View 54 55 Cadwell Easy III Version 3.5 Easy Ambulatory Wireless Specifications EEG Amplifier Inputs:

21 inputs Active/Reference Pairs:

2 sets of inputs ISO Ground Connectors:

2 inputs EEG Channel Sampling Rate:

3200 Hz per channel EEG Channel Storage Rate:

200 Hz per channel EEG Differential Input Impedance:

20K M ohm EEG A/D Conversion System:

16 bit A/D Conversion System Battery Type:

Lithium Iron Phosphate with nearly 2000 discharge life cycles Recording Time:

Nominally 4-8 hours. Battery recording time will vary based on the number of EasyNet modules attached to the system. The system uses an adaptive power management approach to provide power to the wireless antenna. If the wireless signal is weak, additional power will be provided to the wireless to improve signal transmission. Data Storage/Memory Capacity:

+ 165 hours with 4GB CF Wireless Signal/Range 802.11 b\g, 200 ft. range in non obstructed environment Amplifier/Computer Interface:

View, Battery Charging, or;

2. Wireless Ethernet (802.11b\g) for Live Viewing 1. Wired Ethernet connection for Recorder Initialization, Impedance Measurement, Live Operational Limits:

Temperature:

+10 C (+50 F) to +40 C (+104 F) Relative Humidity:

30% - 95% non-condensing UL601-1 2003 CSA 601.1 1990 EN 60601-1:1990 + A1:1993 + A2:1995 + A13:1996 EN 60601-1-1:2001 (medical systems) Regulatory Approvals:

EN 60601-2-26:1994 (EEG equipment) EN 60601-1-2:2001 (EMC) EN 60601-1-4:1996 (programmable electrical medical systems) EN ISO 114971:2000 (risk) FCC ID: XFY CADWELL-1 56 Ambulatory Wireless Warnings and Cautions Caution: Exposure to Radio Frequency Radiation This device emits radio frequency radiation. The output of this device is below acceptable FCC skin absorption rate levels if used according to manufacturers instructions. Do not place the recorder in any other pack or pouch than that supplied with or recommended by Cadwell. Use of packs or pouches other than those specified or approved by Cadwell could alter the Radio Frequency emission pattern and intensity. The maximum performance for wireless is derived from IEEE Standard 802.11 specifications. Actual performance can vary, including lower wireless network capacity, data throughput rate, range and coverage. Performance depends on many factors, conditions and variables, including distance from the access point, volume of network traffic, building materials and construction, operating system used, interference and other adverse conditions. Federal law restricts sale of this system to, or on the order of, a physician. When attaching the Easy Ambulatory system to a recording subject, verify that the subject will not become entangled in the wires. Do not allow the electrode wires to wrap around the subjects neck. Instruct the patient in the proper way to wear the Easy Ambulatory system and not become entangled. No user serviceable parts inside. Service by Cadwell Laboratories, Inc. and other authorized bodies only. Caution must be taken to ensure that cables do not encircle the patient's neck or entangle the patient in any way. The system is not defibrillator proof. Do not open or disassemble the batteries. Do not place recorder on a television, radio, or CPAP device. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

(1) This device may not cause harmful interference, and

(2) this device must accept any interference received, including interference that may cause undesired operation. Warning: Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. Do not immerse the recorder, amplifier, battery holder, or EasyNet Modules in liquid. Do not attempt to use any Ambulatory system components if they have been immersed in liquid. The system is not water resistant or splash proof. The contact of liquids with the internal parts and connectors of the Cadwell Easy Ambulatory 2 system should be avoided at all times. High levels of static discharge can cause a momentary pause in data collection. Dispose the batteries in accordance with applicable local laws. Li-ion batteries may be subject to federal, state or local regulations. Batteries should be discharged fully prior to disposal. The battery terminals should be capped to prevent a short circuit. Inspect EasyNet cables before and after each use. Discard cable if insulation is damaged or if the cable or connectors are damaged in any manner. The operator must be trained to be able to recognize the difference between signal artifact and valid bio-signals caused by movements, interference, or misplacement of sensors or electrodes. Do not use the system in an MRI environment. Type BF, IC601 Isolation Use only Cadwell authorized cables and accessories. 57 Cadwell Easy III Version 3.5 Always place the recorder in the Easy Ambulatory Pouch when collecting patient data. The EEG electrode connectors are only designed for 1.5 mm touch proof connectors. Do not connect more than one amplifier/Connector box to the Recorder. Batteries should remain in the wireless recorder for storage. Only use rechargeable batteries authorized by Cadwell Laboratories, Inc. Inspect the recorder before each use. Do not use the recorder if any visible damage is present to the recorder. When applying the stockinet to the patient, verify that the stockinet is not covering the patients eyes, nose, mouth, or ears. Verify that the stockinet does not entangle the patients neck, restrict airflow, or restrict circulation. The system is not designed to operate in an explosive environment. Do not autoclave or immerse the recorder in liquid. Cleaning instructions in this manual need to be strictly adhered to. Do not use the recorder if battery leakage has occurred. Do not attempt to re-charge batteries outside of the wireless recorder. Do not use the wireless recorder if the battery cover is not secured with the set screw on the bottom panel of the recorder. When using the amplifier to collect data, verify that the amplifier has been placed in a Cadwell authorized pouch. Verify the amplifier has been securely attached to the amplifier belt or chest/shoulder strap. 58 Easy Remote Input Boxes Remote Input Boxes Overview The Remote Input Boxes allow electrode extension 10 to 20 feet from the amplifier. Top panel Remote Input Boxes are labeled for 10-20 EEG inputs. The top panel input box is compatible with Easy II and Easy III amplifier hardware. Side-input Remote Input Boxes are color-coded and labeled for:

10-20 EEG inputs Inputs 1-32 Inputs 33-64 Inputs 65-96 Inputs 97-128 Remote Input Boxes Placement Remote Input Boxes connect to the Easy Amplifiers with a detachable 10-foot (3-meter) cable. 59 Cadwell Easy III Version 3.5 Remote Input Boxes Connectors and Cables Remote Input Box Connectors Description Cable Connection Connects to the Remote Input Box Cable for data feed. The Cable then plugs into the input labeled 1-32 on the side of the Amplifier. EEG electrodes can be plugged into the inputs on the top of the amplifier or into a remote input box. The input connectors are designed for 0.059 inch

(1.5mm) diameter molded safety connectors. One grounding electrode connector is available on the side-input box, and two ISO ground electrode ports are available on the top-panel box. Description Length Connects the remote input box to the Easy III Amplifier. Plugged into the remote input box, electrode input connectors are designed for 0.059 inch

(1.5mm) diameter molded safety connectors. 9.8 feet (3 meters) Lengths vary Electrode Ports Remote Input Cables Remote Input Box Cable EEG Electrodes 60 Remote Input Boxes Warnings & Precautions Do not immerse remote input boxes in liquid. No user-serviceable parts inside. Service by Cadwell Laboratories, Inc. and other authorized bodies only. Inspect cables before and after each use. Discard cable if insulation is damaged or if the cable or connectors are damaged in any manner. The system is not defibrillator proof. Do not use the system in an MRI environment. Cleaning instructions in this manual need to be strictly adhered to. The system is not designed to operate in an explosive environment. Use only Cadwell-approved cables for connecting your Cadwell Easy III hardware components. The system is designed to be used with one patient at a time. 61 Cadwell Easy III Version 3.5 Easy III EasyNet Modules*

*For use with Easy III and Easy Ambulatory amplifiers only. EasyNet Modules are plug-and-play devices that can be configured to collect up to 12 channels such as body position, limb movements, and SpO2 data concurrently with other PSG or EEG channels. The following EasyNet modules can be centrally connected to the EasyNet hub:

SpO2 Module Body Position Module Limb Movement Module Nasal Pressure Airflow Module EasyNet Modules are plug-and-play devices that can be configured to collect up to 12 channels such as body position, limb movements, and SpO2 data concurrently with EEG data. EasyNet Hub The six-port EasyNet Hub (# 190214-200) may be secured within a chest belt with its Velcro backing, providing a central connection port for EasyNet Modules on the patient. EasyNet Cables and Connections EasyNet cables can connect either to the hub itself, or daisy-chain to each other. Each module has two cable ports; one for connection, and one for daisy-chaining module to module. EasyNet cables are available in five, 10, 20, 35, 40, 70, 96 and 180-inch lengths. Limb movement modules are placed on the wrists and legs of the patient. The SpO2 module is placed on the wrist or chest belt. All modules plug into the EasyNet Hub. The EasyNet Hub can be connected to the EasyNet input connector on the side of the Easy III amplifier. EasyNet cables are available in multiple lengths from 3 inches to 15 feet in length. Connecting EasyNet Cables to EasyNet Hub or Module Insert the cable end into the cable port on the hub or any module. Push gently until the connection clicks. Remove EasyNet Cable from EasyNet Hub or Module Push down on the cable lever to release the cable lock. Push the cable connection down from the lever, and then pull gently to release. 62 EasyNet Hub to EasyNet Module Connections EasyNet Modules Body Position Module The Body Position Module is designed to detect Left Position, Right Position, Prone Position, Supine Position and the Upright Position. The Body Position Module has Velcro on the back side of the module. The sensor is placed inside a chest belt worn by the patient. This module can be used to detect body position during an EEG, PSG, or LTM recording. 63 Cadwell Easy III Version 3.5 Limb Movement Module The Limb Movement module is designed to detect limb movements. The Limb Movement modules are placed in Velcro straps worn on the wrists and ankles. These modules can be used for EEG, PSG, and LTM recordings. SpO2 Module The EasyNet SpO2 Module is an oximeter that is designed to be worn on the wrist or chest belt. This module may be configured to collect two channels: SpO2 signal (pulse) and pulse rate. Nasal Pressure Module The EasyNet Nasal Pressure Module is designed to record up to four channels: nasal flow, oral flow, nasal snoring and oral snoring. The module uses a 2-channel cannula that captures pressure changes recorded at the nose and mouth. 64 EasyNet Chest Belt The chest belt is designed to hold the Body Position and EasyNet Hub in a small pocket located on the front of the chest belt. Place the Chest Belt on the Patient Place the chest strap on the patient. Center the small envelope/pocket on the front of the chest. Insert the Body Position Module and the EasyNet Hub inside the pocket on the chest strap. The arrow on the front of the Body Position Module should be pointing up. Connect a short EasyNet cable from the Body Position Module to the EasyNet Hub. You can use any connector on the Body Position Module and Hub. Place the Limb Straps on the patient. Connect each module to the hub in the Chest Belt. When setting up your patients, route the cables through the chest strap to each limb movement module. EasyNet Cable Tester The EasyNet Cable Tester allows you to check the integrity of EasyNet module and Ambulatory battery cables. Testing EasyNet Cables Test one cable at a time. Connect both ends of an EasyNet or Ambulatory battery cables into its corresponding ports on the EasyNet Cable Tester. Both green and yellow LEDs will illuminate. The cable is good if the green LED stays lit, and the yellow LED turns off. The cable is not good if the green and yellow LEDs remain lit. Please dispose of the EasyNet Cable and replace it with a good one. Battery Cable Replace EasyNet Cable Tester AA Batteries If the green LED on the EasyNet Cable Tester does not illuminate when a cable is connected for testing, replace the Tester batteries. Use the thumb grip on the battery panel on the back of the Cable Tester to open the battery compartment. Remove the batteries, and replace them with two (2) AA batteries. Replace the cover, and check to make sure the Tester works by testing a cable. If the green LED illuminates, the Tester batteries are good. EasyNet Cable 65 Cadwell Easy III Version 3.5 EasyNet Modules Warnings & and Precautions Federal law restricts sale of this system to, or on the order of, a physician. High levels of static discharge can cause a momentary pause in data collection. No user-serviceable parts inside. Service by Cadwell Laboratories, Inc. and other authorized bodies only. Do not immerse the amplifier, recorder, or modules in liquid. Do not attempt to use the system and its modules if it has been immersed in liquid. The system is not water resistant or splash proof. Avoid contact of liquids with the internal parts and connectors of the Cadwell Easy system. The system is not designed to operate in an explosive environment. Do not use a broken body position module, SpO2, nasal pressure, or limb movement module if the case or connectors are cracked or broken. Inspect EasyNet cables before and after each use. Discard cable if insulation is damaged or if the cable is damaged in any manner. When using the body position and limb movement modules, verify that they have been placed in a Cadwell authorized pouch, belt, or holder. The system is not defibrillator proof. The operator must be trained to be able to recognize the difference between signal artifact and valid bio-signals caused by movements, interference, or misplacement of sensors or electrodes. Cleaning instructions in this manual need to be strictly adhered to. Check the oximeter sensor application site frequently to determine the circulation, positioning, and skin sensitivity of the patient. Each patients sensitivity to sensors may vary depending on their medical status or condition of their skin. Do not attempt to use the Easy system in an MRI environment. Do not autoclave EasyNet modules. Discontinue using any module or sensor if the patient exhibits any allergic reactions to adhesive or materials. When applying tape for the oximeter sensor, do not stretch the adhesive tape. This may cause inaccurate readings or skin blisters. When attaching the Easy system to a recording subject, verify that the subject will not become entangled in the wires. Do not allow the electrode wires to wrap around the subjects neck. 66 Minimum Computer Hardware Requirements Application Listed below are the minimum requirements for a computer to operate Cadwell Easy III. Regulatory Requirements Domestic (U.S. and Canada) computers: third-party certified to UL 1950 or IEC 950. European Union computers: third-party certified to EN 60950. Minimum Computer Hardware Requirements Operating System Windows XP Professional (SP2) Processor Dual Core, 2.13 GHz Recommend Dual Core, 3.1 GHz Hard Disk Drive 160 GB, NTFS file system, (Recommend 750 GB if the system is used for long term epilepsy monitoring or if several weeks of data storage is required.) Memory (RAM) 2 GB. (Recommend 3 GB.) Archive Device Recordable DVD+R/+RW and CD-RW Drive. USB Graphics Network Card USB 2.0 (2 port minimum) 1600 x 1200, 256 MB, optional dual monitor output 10 Base-T Ethernet card required for connection to amplifier. A second network card is required for connection to a LAN, or IP based camera.

*Computer requirements are subject to change. Always contact Cadwell prior to purchasing computer hardware for your facility. Qualified Computer Platforms Dell OptiPlex 755 (small form factor configuration) *

Core 2 Duo, 2.33 GHz, 2 GB RAM, 160 GB Hard Drive, Windows XP Pro (SP2), NTFS file system, Dual monitor-256 MB graphics card, additional low profile network card. Dell Precision T3400*

Core 2 Duo, 2.33 GHz, 4 GB RAM, 750 GB Hard Drive, Windows XP Pro (SP2), NTFS file system, Dual monitor-256 MB graphics card, additional network card. Dell Latitude D830 Laptop *

Core 2 Duo, T7500 2.20 GHz, 2 GB RAM, 120 GB Hard Drive, Windows XP Pro (SP2), NTFS file system, 15.4" display at 1680 x 1050. Toshiba Tecra A9 *

Core 2 Duo, T7300 2 GHz, 2 GB RAM, 120 GB Hard Drive, Windows XP Pro (SP2), 15.4" display at 1680 x 1050.

*Computer specifications and requirements are subject to change. Always contact Cadwell prior to purchasing computer hardware for your facility. 67 Cadwell Easy III Version 3.5 Additional Software Requirements Report Generator MS Word 2003 Belkin Video to USB Software Belkin Video to USB adapter software is required if Easy III Q-

Video software is used. Sony IPELA Software Sony IPELA Network Driver is required when the IPELA camera is used. Server Installation Validated on Server 2003, SP2 Standard Edition X Number Users Client Misc. Support Requirements Remote Diagnostics Citrix GoToAssist (internet access required) Regulatory Requirements Domestic (U.S. and Canada) computers must be third-party certified to UL 1950 or IEC 950. European Union computers must be third-party certified to EN 60950. 68 Cadwell Easy III Q-Video Camera Hardware Q-Video allows digital video to be collected concurrently with PSG or EEG recordings. The Q-

Video program captures incoming video signal and compresses the video data real time. Q-Video Requirements To use Q-Video, you must have:

A valid software license enabling Q-Video on your Easy III system, A video input to your computer via a 'video to USB adapter', and A standard video camera (NTSC/PAL) or a low-light camera for use during data collection

(The camera may be black-and-white or color, or a VCR with video output). You may also have the optional components: sound mixer, speakers, or tilt, pan and zoom unit. If you did not purchase Q-Video and a camera from Cadwell, you must Purchase a licensed copy of the Q-Video software, Install the Q-Video software, Install camera software (follow camera software installation instructions), Verify the camera connects to Q-Video, Set camera for low-light input. 69 Cadwell Easy III Version 3.5 IP Camera Setup Sony IPELA - Model # RZ25 Before using our Sony IPELA camera, you must connect the camera to the local network. In most configurations, the camera will be connected to a network switch shared by all Easy III systems. The camera will be connected to the switch with an ethernet/network cable. Assigning a IP Address to the Sony IPELA Camera Note: The Sony factory setting of the camera is as follows: IP address: 192.168.0.100. The subnet mask is 255.0.0.0. 1. Insert the supplied CD-ROM disc into your CD drive. 2. Click on the Setup icon of the IP Setup Program. The 'File Download" dialog will open. 3. Click Open NOTE: If you click "Save this program to disk" on the File Download dialog, you can not install the software correctly. Delete the downloaded file, and click the Setup icon again. 4. Install the IP Setup Program to your computer following the software wizard displayed. If the software license agreement is displayed, read and accept the agreement to precede. 5. Start the IP Setup Program. The program will detect the Sony camera and list all Sony IP cameras in the Network tab window. 6. Click on the camera you would like to assign an IP address. 7. To obtain the IP address automatically from a DHCP server, select 'Obtain an IP address automatically'. The IP address, Subnet mask and Default gateway are assigned automatically. 8. To specify the IP address manually, select 'Use the following IP address'. Type in the IP address, Subnet mask and Default gateway. 9. To set the DNS server address automatically, select 'Obtain DNS server address automatically. 70 Cadwell Easy III 10. To specify the DNS server address, select 'Use the following DNS server address'. Enter the Primary DNS server address and the Secondary server address. NOTE: The third and fourth DNS address fields do not work with the Sony IPELA camera. 11. Set the HTTP port No. Normally select 80 for the HTTP port No. To use another port number, select the text box and type a number between 1024 and 65535. 12. Type in the Administrator name and Administrator password. The default settings for both items are "admin" NOTE: You cannot change the Administrator name and password in this step. 13. Confirm that all items are set correctly and click OK. If 'Setting OK' is displayed, the IP address is set correctly. 14. To access the camera directly, double click on the camera name in the camera list. 15. The following setup screen should appear after step 14. Accessing the Sony Camera via Internet Explorer 1. Launch Internet Explorer 2. Enter the IP address of the camera in the URL box. 3. Click Enter. The main viewer will be displayed. When the camera picture is displayed correctly, the IP assignment is complete. 4. When the main viewer is displayed for the first time, a security warning will be displayed. Click on OK to install Active X controls. 5. NOTE: If Automatic Configuration is enabled in the LAN settings in Internet Explorer, the camera image may not be displayed. In this case disable Automatic Configuration and set the Proxy server manually. Consult your network administrator to set the Proxy server. 71 Cadwell Easy III Version 3.5 EASY III SOFTWARE Preparing for Software Installation Notify Bio-Med/IT dept. of Easy III install. Staff must be on call or available during installation. Provide a network receptacle if a network connection is required. Provide internet connection to PC if possible

(Cadwell can remotely connect to PC if necessary) Installation will require administrative privileges from operating system. Workstations and server must be physically accessible. Install and mount camera hardware if video equipment is required. Pull network, video, audio cable prior to installation of software. Verify if hospital/lab safety team must inspect configuration and setup of Easy III and computer hardware. Operating System, 3rd Party Software Requirements Installing the Easy III software requires Windows XP Service Pack 2 (or later) and Microsoft Word. Easy III software is not compatible with Windows 98. Easy III requires Windows XP Pro, Service Pack 2. Easy III requires Flash 9.1. QuickMed and Easy III must be installed by a user with administrator rights (however, administrator rights are now required after the installation of software). The Easy III installer will verify that Windows SP2 and Flash 9.1 are installed. Connect the PC to the Microsoft website or install Windows SP2 if necessary. If an earlier version of Flash is installed on the local PC, the Easy III installer will upgrade the Flash software to Version 9.1. 72 Cadwell Easy III Installing Easy III Software From an install CD: Step 1 - Installing QuickMed Office The office server should be set up before any of the other Easy III systems. Only one office server is needed per site. If you have already installed the Office Server on another system, skip this section and proceed to Step 2, Installing QuickMed Workstation. Step 1 - Installing QuickMed Office 1. Click on the setup.exe from the Easy III folder on the installation disc. 2. If the version of Microsoft .NET Framework is out of date, the installer will prompt you to install a new version of .NET. If you are presented with the menu displayed below, click on Accept. The Easy III installer will install the .NET Framework software. Note: The installation of the .NET Framework software may take several minutes. After installation is complete, reboot if prompted to do so. After rebooting, the Easy III installation will automatically continue. 73 Cadwell Easy III Version 3.5 3. You will be prompted with the message below. Click Yes. 4. The Install Utility will be displayed. Note the picture displayed below. Enter the default Clinic ID is IHS35NYV25ZY4833D. 5. Enter the default Product Key is 1Z0OSEHY. Note: Do not enter the Product Key if the system you are installing is not the Office Server system used in your facility. Only one system can be configured as an Office Server system. 6. After entering the Product Key, select the QuickMed Office option, then click Install. 74 Cadwell Easy III 7. The QuickMed Office installation panel will be displayed. Click the Install Program button to start up the QuickMed Office installation wizard. 8. Step through the wizard clicking Next on each page. Do Not Change the Destination Folder when installing QuickMed Office. Install the software in the default destination

(C:\Cadwell\Easy III). 9. On the last page of the wizard, click Install and wait for the install to complete, then click Finish. You should now see the following options displayed in the QuickMed installation panel:

75 Cadwell Easy III Version 3.5 10. Click the Install Databases button. Once the databases are finished installing, click the Close button. Note: If youve previously installed QuickMed Office, you may see an error message about databases already existing. This is expected. Simply dismiss that error dialog. AT THIS POINT, DO NOT REBOOT THE COMPUTER, EVEN IF PROMPTED TO DO SO 11. You should now be back at the Install Utility dialog. Leave the Install Utility menu open;

proceed to the next section for information on installing the QuickMed Workstation. 76 Cadwell Easy III Optional: Setting up the Office Server as a Service:

This configuration allows the Office Server to run in the background without having a specific user logged into the system. To configure the Office Server to run as a service, follow the instructions below. 1. Select and copy all 4 batch files located in the Office Server Service folder on the installation DVD. InstallService UninstallService, XYNTService, and XYNTService. 2. Paste all 4 files into C:\Cadwell\Easy III 3. Double click on Install Service. A dialogue box will flash quickly on the screen and go away. 4. Reboot the server. 5. When server starts up make sure that QMAssistant and RPOfficeserver do not start up, the icons should not show up in the bottom right task tray. 6. Check in Task Manager that the applications are running. 7. Verify that the computers networked to the server and running Easy III are synching appropriately by opening the QMAssistant. The dialogue should say Connected to Office Server. 77 Cadwell Easy III Version 3.5 Step 2 - Installing QuickMed Workstation 1. Select the QuickMed Workstation option and click the Install button. 2. Select or type the name of your office server machine in the Office Server Name combo box. If the machine youre installing on is also the office server or you dont have an office server on your network, dont change the default value. If you dont have an office server on your network and the box is empty, type your computer name. If you are unsure what Office Server name to enter, Call Cadwell for assistance. 3. Click the Install Program button to start up the QuickMed Workstation installation wizard. 78 Cadwell Easy III 4. Step through the wizard clicking Next on each page. Do Not Change the Destination Folder when installing QuickMed Workstation. Install the software in the default destination (C:\Cadwell\Easy III). 5. On the last page of the wizard, click Install and wait for the installation to complete, and then click Finish. 79 Cadwell Easy III Version 3.5 6. You should now see the following options:

7. Next, click the Install Databases button to install the QuickMed Workstation database. Note: If youve previously installed QuickMed Workstation, you may see an error message about databases already existing. This is expected. Simply dismiss that error dialog. Once the database are finished copying, click the Close button on the above dialog. AT THIS POINT, DO NOT REBOOT THE MACHINE EVEN IF PROMPTED TO DO SO. 8. You should now be at the Install Utility dialog. Click the Exit button. 80 Cadwell Easy III Step 3 Installing Easy III Software 1. Launch the setup.exe (again) from the Easy III folder on the installation disc. You should now see the following dialog:

2. Step through the Easy III installation wizard by clicking Next on each of the pages. When the installation is complete you will see the following dialog:

3. You will be prompted to select the Easy Products you would like to install. Select the products you have purchased. Click on the OK button. 81 Cadwell Easy III Version 3.5 4. Click Close to complete the installation. At this point, you will be asked to restart you machine. Please do so. 82 Cadwell Easy III Step 4 - Installing the Cadwell Scheduler The Easy Scheduler should be installed after the Office Server system or the Workstation system has been configured with Easy III software. The Easy Scheduler can be installed on a separate computer system without installing the Easy III client. 1. Click on the Setup program in the Scheduler installation folder. 2. The installer will install Crystal Reports for Visual Studio 2008 (x86, x64) if it is not present on your system. Click on the Accept button to install the Crystal Reports. Note: The Cadwell Scheduler Setup program will install Crystal Reports. This may take several minutes. 3. Click on Next to install the Scheduler program on your computer. 83 Cadwell Easy III Version 3.5 4. Select the default folder. The folder must be C:\Cadwell\Scheduler\

84 Cadwell Easy III 5. Click on Next to install the Scheduler. 6. You will be prompted with the Installation Complete dialog. Click on Close to exit. 7. To access the scheduler you can click on the desktop shortcut. 8. The scheduler can also be opened by clicking on the shortcut displayed in Easy III. 85 Cadwell Easy III Version 3.5 Step 5 - Installing the Cadwell Clinical Database The Cadwell Clinical Database should be installed after the Easy III software has been installed. 1. Click on the setup.exe file in the Clinical Database installation folder. 2. Click on Next to continue. 86 Cadwell Easy III 3. Click on Next to confirm the installation of the Clinical Database Report Generator. Do not change the default folder location. 4. Proceed through the installation. When the installation is complete, click on the Close button. 5. Click on the Clinical Database shortcut on your desktop to access the database. 87 Cadwell Easy III Version 3.5 Step 6 Setting up File Sharing (required for all systems) In Windows Explorer, move to the C:\ directory. 1. 2. Click the Tools menu in Windows Explorer and select the Folder Options menu item. Select the View tab and scroll to the bottom of the list. Uncheck the Use simple file sharing checkbox as shown here:

88 Cadwell Easy III 3. Click OK to dismiss this dialog. Right-click on the C:\QMWorkstation directory and select the Properties menu item, then select the Security tab to get the following dialog:

4. If the desired group (for example, Everyone, Power Users, Easy III Users) is not in the list, select the Add button, select (or type) the desired group and click OK. Now, for the desired group, click the Allow Full Control check box and click OK. 5. Allow Easy III Access: Repeat step 4.3, but replace the directory that we are giving rights to from C:\QMWorkstation to C:\Cadwell\Easy III. 89 Cadwell Easy III Version 3.5 Making video and data available to other client computers All data files and video files are written to C:\Cadwell\Easy III\Data In order for a remote machine to view a record remotely, the recording system must have the C:\Cadwell\Easy III\Data folder shared as E3VideoData. In Windows Explorer, go to C:\Cadwell\Easy III. a. b. Right-click on the Data folder and select Properties c. Select the Sharing tab and select the Share this folder radio button. d. Type E3VideoData for the share name as seen below. e. Click the Permissions button. f. If the desired group or user (for example, Power Users, Easy III Users) is not in the list, select the Add button, select (or type) the desired group or user and click OK. Now, for the desired group, click the Allow Full Control check box and click OK. 90 Cadwell Easy III g. Now, select the Security tab. h. If the desired group or user (for example, Power Users, Easy III Users) is not in the list, select the Add button, select (or type) the desired group or user and click OK. Now, for the desired group, click the Allow Full Control check box and click OK. 91 Cadwell Easy III Version 3.5 NOTE: This all assumes that the hosting and remote viewing machines are on a network where they are visible to one another. 92 Cadwell Easy III Configure the Network Card Easy III communicates with the PC over an Ethernet link. A dedicated Ethernet network card must be installed in the PC, and the card must be configured to a specific IP address to communicate correctly. Connecting to a local area network will require a second network card. To configure the IP address in a Windows XP operating system:

1. If necessary, install a network card in the computer. Follow the network card's manufacturer's instructions. 2. Login as a user with administrative rights. 3. From the Windows desktop, open the Start menu. a. Open the Control Panel and open Network and Internet Connections. b. Click on Network Connections. A separate icon for each network card installed will be displayed. By default, each is named "Local Area Connection."

c. Rename the network card used to connect to the Easy III hardware. Do so by right-

clicking on the icon and select Rename, then typing a new name, such as "Easy III". 4. Right-click over the renamed network connection icon. a. Remove checkmarks next to everything except Internet Protocol (TCP/IP). b. If desired, checkmark the "Show icon in notification area when connected" to enable a pop-up message in the system tray showing when the connection to the Easy III system has been made. 5. Click the Configure button. a. Under the Advanced tab, select your link speed or media type, and change the value to 10mbs Full Duplex. b. Under the Power Management tab, remove checkmark next to "Allow computer to turn off this device to save power."

c. Click the OK button. 6. Return to the Properties window. 7. Click on Internet Protocol (TCP/IP) so it is highlighted. 8. Click the Properties button. a. Select "Use the following IP address". b. Enter IP address: 192.168.113.166 and Subnet mask: 255.255.255.0. c. Click the Advanced button and open the WINS tab. d. Remove the checkmark next to "Enable LMHosts lookup". e. Checkmark "Disable NetBIOS over TCP/IP". f. Click the OK button. 9. Click the OK button and then click the Close button. 93 Cadwell Easy III Version 3.5 Activate Software Licenses Easy III software features require a software key for:

EEG data collection PSG data reader Archiving capabilities EEG data reader Video data collection PSG data collection and review Video review only Video review and editing 94 Cadwell Easy III Software Overview Open Easy III Software 1. Launch the Easy III software:

Click on the Easy III desktop icon. or or Open the Start menu, select All Programs, select Cadwell, select Easy III and select Easy III. Select Easy III from the Quick Launch taskbar. To add Easy III to the Quick Launch menu, right-click on the toolbar, select Toolbars, and make sure there is a checkmark next to Quick Launch. Right-click the toolbar again, and make sure there is no checkmark next to Lock the Taskbar. Then click and drag the Easy III desktop icon and drop it into the taskbar. Right-click the taskbar, and select Lock the Taskbar. 2. Log in. Select your log in from the drop-down menu, enter your password and click the OK button. The Start Page will open. By default, your initial password is the same as the Login ID. See Manage Users to change your password. 3. Maximize Start Screen display. Click on the Window button to maximize the display. The system will default open to a maximized screen unless it is closed while in a minimized screen. 95 Cadwell Easy III Version 3.5 Close Easy III Software 1. When finished with a procedure, press the Run button to stop recording. 2. Click the Close to exit the patient procedure, or click the top right-hand X to exit Easy III. Start Page Overview Start Page Options The start page in Easy III will vary based on the specific modality you have purchased from Cadwell. Below are some of the typical options you will find when entering the Easy III software. Menu Options New Patient - Select this option to enter new patient information and start a new recording. Select Patient - Select this option to select the name of a patient that is already in the Easy patient database. Use this option to import patient information and start a new recording. Append - This option can be used to add data to a previously saved data file. This option is helpful when data collection is interrupted due to power loss. Click on this option to find the original file, append the file, and resume data collection. Select Record - Use this option to select a record to review and analyze. 96 Cadwell Easy III System Setup - Select this option to:

Select Default Amplifier Select Default Data Map Select Default Notch Filter Select Default Data Folder Location Edit or Create Montages Edit or Create Average References Edit or Create Flash Programs Edit or Create Data Maps Edit Hyperventilation Scripts Edit or Create Easy Users/Passwords Edit or Create User Defined PSG Events Enable/Disable AASM PSG Settings Edit PSG Event Detection Settings Protocols - Use this option to configure the default recording layout that will be used during data collection. The protocol editor will allow the user to do the following:

Select the default protocol used for data collection Modify or create the protocol used for data collection Create data collection workspace layouts Create default user events Assign default reports to R1, R2, and R3 buttons Assign default montages to M1- M6 montage buttons Assign default paper speed, amplifier type, and calibration montage to workspace Record Manager - User this option to Archive, Export, Copy, Move and Delete data files. The Record Manager also has an archive database to allow the user to quickly review a list of all studies archived. 97 Cadwell Easy III Version 3.5 Scheduler- The Scheduler allows Easy III users to create and review appointments associated with Easy III equipment, patient rooms, physicians, and technicians. The scheduler can be synchronized across all systems. Ambulatory Tools - Use this option to view ambulatory recorder status information (battery level, memory capacity, recorder status). The user can also start a new recording, download a recording, and clear a recorders memory from this menu option. 98 Cadwell Easy III Cadwell Scheduler Options The Cadwell Scheduler is a powerful tool that will allow Easy III users to schedule and manage appointments. The scheduler allows the user to set up and manage schedules for multiple locations based on the following categories:

Room Number Physician Technician Equipment Type (EEG, PSG, Ambulatory recorder) Scheduler Features Multiple calendar views (monthly, weekly, daily) All appointments are synchronized between all Easy III based systems. A separate installation is supported for systems that require access to the Scheduler only. Quick Recording Launch is supported by right-clicking on an appointment in the calendar. 99 Cadwell Easy III Version 3.5 Accessing the Scheduler From the Easy III desktop, click on the Scheduler option. The Scheduler can also be accessed by clicking on the Cadwell Scheduler shortcut from the Windows desktop. Note: A user name and password is required to log into the Cadwell Scheduler. Calendar Options Searching for an Appointment Click on the Appointment Search bar. The following options will appear. 100 Cadwell Easy III Search by Options:

Last Name First Name Location Physician Technician Room Equipment Note the illustration above. When the correct patient is found, highlight the patient name, Right Click on the highlighted name and select New Appointment or Open Appointment to proceed. Configuring the Scheduler for Use 1. Add Facility Information. Click on File, Manage, Locations. Enter facility information. 2. Add Resource Information. Click on File, Manage, Resources. Enter room number, and equipment information. Select physician and technician names that will be used in the Cadwell Scheduler. Note: You must create Easy user names and passwords for all physicians and technicians that will be included as resources in the Cadwell Scheduler. 101 Cadwell Easy III Version 3.5 Picking a Specific Date to View on the Calendar Click on the Date Navigator to find a specific date. Viewing the Scheduler by Resources In the window below, note the following steps. 1. Select the Location 2. Select View by Room. The calendar will display the current calendar by room. 102 Cadwell Easy III 3. Multiple views are available for use. Note the illustration below, the views are filtered by Room Number. Month View Day View Week View Scheduler View 4. Within each view, the user can select to view the calendar by:

Physician Name Technician Name Room Number/Name Equipment Type 103 Cadwell Easy III Version 3.5 Adding a Patient to the Scheduler 1. Click on 'New' or double click on a selected date in any calendar view (monthly, weekly, daily, scheduler). 2. Click on 'Add New Patient' or 'Select an Existing Patient'. Select or enter patient details. 3. If the Scheduler is used for more than one facility, select the Facility you would like to use. 4. Select the appointment Start and End dates and times. 5. Select the Study Type. 6. Select the Appointment Status. 7. Assign the patient to the correct Resources (Physician, Technician, Room, Equipment). 8. Click on OK. The appointment will be copied to all accessible Easy III systems configured with the Cadwell Scheduler. Adding an Appointment from the Scheduler View The user can add and edit an appointment by dragging across the calendar with a mouse, Right Click on the selected time period and Left Click to Add Appointment. 104 Cadwell Easy III Starting a Recording from the Scheduler To start a recording, the user right-clicks on an appointment in the calendar in any view monthly, daily, etc. - and selects Start Recording from the pop up menu. If the Easy program is not already open, the Easy software will start up and a new live recording session will be started. If the study type does not have a default protocol (PSG, EEG, etc.), the user will be prompted to select one. Printing a Schedule Summary Report 1. Click on File 2. Click on Report 3. Click on Scheduled Appointments 4. The Report Generator will be displayed. Select the time range for the report. 5. Click on Print Report 105 Cadwell Easy III Version 3.5 Clinical Database Options The Easy III system can be configured with a Clinical Database. The database will allow the user to create multiple reports that summarize clinical and administrative information. Users define the date range used with a selected report. The following default reports are generated by Crystal Reports:

Clinical Database Options Note the illustration. 1. Select this option to export the displayed report. You can export the report in the following formats:

Crystal Reports (.rpt) Adobe Acrobat (.pdf) Microsoft Excel (.xls) Microsoft Work (.doc) Rich Text Format (.rtf) 2. Click on this option to print the displayed report. 3. Click on this option to determine the date range you would like to use for the report. 4. Click on this option to select the specific report you would like to generate. 5. Click on this option after you have selected a report type. The report will be generated and displayed in the Report Generator window. 106 Cadwell Easy III Easy III System Setting Default Instrument -The Default Instrument may be set for use with the Easy 3, Easy II, and Easy Ambulatory amplifiers. Default Data Map - A specific Data Map can be selected for use with an Easy Amplifier. Default data maps exist for EEG, PSG, and ambulatory based recordings. Notch Frequency - The default notch frequency is 60 Hz, but may be changed to 50 Hz. Data Folder - The data folder is the location where all data files and video files are written during data collection. Note the illustration below. IMPORTANT NOTES:

Cadwell recommends that this path always be set to a local drive on all Easy Systems configured to collect/record data. If a network data folder is selected, data may be lost if the network path is not accessible during data collection. The Easy system can be configured to copy or move data to a network location after data collection with the Centralized Data Manager Utility. If you change the default data path, all files in the Easy III data folder will automatically be moved to the new location. If you set your data folder location to a network path, deleted files will not be saved in the Windows Recycle Bin. 107 Cadwell Easy III Version 3.5 Montages Montages support an unlimited number of channels. Montage channels can be defined from head pattern, grid electrodes, DC inputs and EasyNet devices. Edit Montages Montage creation or editing is controlled by user permissions. If the user has the right to create montages, the montages will be distributed to other Easy III systems via the synchronized database. Add a user-defined PSG Event to a Montage/Channel. 1. Select a montage from the List. 2. Create a new montage in the Edit Montage Window (see below). 3. Edit Select a montage from the list and click the Edit button to open the Edit Montage Window (see below). 4. Copy Select a montage from the list and click the Copy button to create a copy of the Montage at the bottom of the list (shown above). 5. Delete Select a montage from the list and click the Delete button to remove the montage and all of its properties. Edit Montage Window Name Edit or create a name for a new montage. Head Tab Manually build a montage channel by channel. This tab represents the view a technician will see from a 10-20 map; most commonly used for EEGs. 108 Cadwell Easy III Grid Tab Create a montage for up to four remote input boxes. This tab shows all grid inputs. 109 Cadwell Easy III Version 3.5 Data Type Tab Data type mapping reduces click strokes to one click per channel by assigning default properties to each channel. Each channel in the Data Type tab has been previously defined. All relevant settings are automatically imported when a channel is added to a montage from the Data Type tab. 1. First Click in the Input(s) cell in the row you would like to add a new channel. 2. Verify that you are using the correct Data Map. Select a different Data Map from the drop-down list on the Data Type tab if a different map is required. The selected map will be the default map used with the current montage. 3. Click the name of the channel from the Data Map table to add a channel to the displayed montage. The channel that you have selected will automatically populate the columns with the correct settings. Note in the example below, the EKG channel has been added to channel 20. The data type, group, sensitivity, and filter settings do not have to be selected. These settings are previously defined in the EEG/EKG data map. Repeat for additional channels. DC Inputs Add a DC Input to a channel by clicking one of the DC1- DC8 buttons. 110 Trace Band Clipping Feature. Cadwell Easy III This option will allow the user to configure how much overlap is allowed between recorded channels. Settings can be accessed through the montage editor or by left clicking on the trace labels during review or data collection. Trace band overlap settings can also be adjusted on-the-fly by left clicking on the trace label during data collection or review. Trace Clipping Range No Clipping = Full amplitude range of recorded data will be displayed 0% = No clipping or overlap allowed over adjacent channels 25% = Recorded data will overlap up to 25% of adjacent channels 50% = Recorded data will overlap up to 25% of adjacent channels 100% = Recorded data will overlap up to 25% of adjacent channels 200% = Recorded data will overlap up to 25% of adjacent channels 500% = Recorded data will overlap up to 25% of adjacent channels 111 Cadwell Easy III Version 3.5 Reference and Average Reference Inputs 1. Click on the Input cell for the channel you would like to edit. 2. Click on the active input you would like to use (Fp2 in the example below):

3. Select the Reference (Ref) or Average (Avg) you would like to add to the selected channel; or, 4. to toggle the available reference configurations, click on the Select button. Note the Avg button will change to the next available reference. 112 Edit Channel Group Settings Cadwell Easy III For any or each channel, modify the channel group settings. Add or delete channel groups, set the scale to V/mm, set sensitivity, filters, notch filter and color. Selecting 'Not Specified' as a Channel Group color will allow the user to apply different channel color settings within a single montage. Montage Rules A notch filter setting may be turned on and off during data acquisition and during review. When active/reference pairs 1A-Ref, etc. are used, their references cannot be changed during review. Usually these channels are unlinked and are used to monitor non-EEG signals such as ECG or respiration. If an active/reference pair is used, the active electrode cannot be used in any other channel. For example, 4A-Ref and 4a-C3 cannot exist in the same montage. Montages used during a recording are permanently saved with the record, although you may select another montage for viewing at any time during review. Even if you change the montage while reviewing, you can still re-display the EEG as originally recorded. 113 Cadwell Easy III Version 3.5 Average References Average References can be used as a channels reference input, and can be defined from head pattern or grid electrodes. Average references are built by combining several individual reference inputs, such as all of the scalp electrodes, or A1 and A2 (linked ears). Add a new Avg Ref by clicking the Add button, and then use the checkboxes to select Avg Ref electrodes. Click OK to save. Flash Programs Follow your laboratory procedures and protocols while running the Cadwell Easy III Photic Stimulator. An unlimited number of flash programs can be defined, each with an unlimited number of steps. Photic stimulation is limited to a rate of 1-60 Hz. Creating a Flash (Photic) Program Click on Setup Flash Program. Click on Add. 114

Note the Edit Flash Program dialog below. 1. Enter the name you would like to use for the photic program 2. Enter the Rate you would like to use for step number 1, press the tab button to advance to the Duration box after you have entered the Rate. 3. Enter the Duration; press the tab button to advance to the Delay box after you have entered the Duration. 4. Enter the Delay; press the tab button to advance to the next step. Enter the Rate for the next step. Continue until all steps have been defined. Click on OK when you have completed all steps. To associate a flash program with the Program 1 or Program 2 button in the Photic Stimulator control box during data collection, you must edit the recording protocol. Refer to the Protocols section for information on how to configure the photic program for use during data collection. Data Maps Data maps allow laboratories to standardize how channels will be displayed and defined. Easy III system will refer to a data map to allow the system to collect data from multiple amplifier types available from Cadwell. Opening the Data Map Option To open or create a Data Map, click on the Data Map option. Editing or Selecting a Data Map (note the menu displayed below) 1. Select the Data Map you would like to review. 2. To add a new Data Map, click on the Add button. 3. To edit the selected Data Map, click on the Edit button. 4. To make a copy of the selected Data Map, click on the Copy button. 5. To delete the selected Data Map, click on the Delete button. Note: All changes made to data maps will be automatically copied to all systems. Any Data Maps deleted from this list will also be deleted from all systems. 116 Adding a Channel to a Data Map Selecting a Data Map from the Data Map list and clicking on Edit will allow the user to edit the selected map. Click on the Data Type drop down, select a channel type. In the example below, an airflow channel will be added to the EEG/EKG Data Map. Note the Airflow channel is now automatically placed in the second row of the EEG/EKG Data Map displayed below. To select the inputs you would like to use:

1. Click in the Input(s) cell 2. Click in the Active input you would like to use (in this example 2A is used) 3. Click on the Reference input you would like to us (in this example 2R is used). The Inputs box will now display 2A-2R. 4. Click on the Channel Group and select Airflow. 5. Click on OK to save the changes added to the data map. The 2A - 2R inputs will now be configured for use for the Airflow channel. 118 Adding a Data Map Channel to a Montage Open the montage you would like to edit. Click on the Data Type tab. Verify you are using the correct Data Map. 1. Click in the Input(s) box in the row you would like to add the channel. 2. Click on the channel you would like to add to the montage (in the example below, the airflow channel will be added to the displayed montage). 3. Click on OK to save. Access Scripts From the Easy III Start Page, click the System Setup button, and then click the Scripts button. The Select Script window will open. Choose a script and click the OK button. Hyperventilation A Hyperventilation window will open. Hyperventilation (seconds) Enter the total number of seconds you would like the hyperventilation session to last. Easy III will automatically place a text event (indicating that the patient is hyperventilating) every 10 seconds (or as specified in the Documentation Interval). Normal Breathing (seconds) Enter the total number of seconds you would like the post-hyperventilation session to last. Easy III will automatically place a text event (indicating that the patient is in post hyperventilation) every 10 seconds (or as specified in the Documentation Interval). Documentation Interval (seconds) Enter the interval (seconds) you would like Easy III to automatically place a text in the trace window during activation. 120 Patient Status The following options will be displayed during data collection if the recording technician clicks on the script option. These events can only be entered during data collection in a live window. Cadwell can create a patient status report summarizing these events as they were entered during data collection. Manage Users The Easy user can access the Manage Users option to do the following tasks:

1. Add a New User 2. Edit a Current User a. Modify User Details b. Change Access Rights 3. Delete a User 4. Change a Password 5. Reset a Password Adding a New User Click on Manage Users from the Easy III System Settings dialog. Note the the illustration below. Click on Add to create a new user. 122 From the Edit User rights dialog, verify the following fields are correctly entered:

Last Name - Enter the last name of the user. If you would like to include the credentials of the user, include them with the last name. For example, type in 'RPSGT' if you would like to include the RPSGT credential with the users name (see example below) First Name Middle Initial (MI) Position (physician, referring physician, technician) Assigning Access Rights Easy III provides powerful user rights options that allow laboratories to provide custom access settings per user. The following User Rights Options are available within Easy III. Easy III User Permissions - Description of Permissions General Administrative- Adding a check mark to the administrative check box will allow the user to reset and access other users login data. Edit Permissions Change Default Instrument - Adding a check mark to the check box will allow the user to change the default amplifier displayed in the System Settings dialog (note the illustration below). If your laboratory uses multiple Easy amplifier types, you should add a check mark to this box to allow users to swap hardware as necessary. Data Maps - Removing a check mark from the check box will prohibit users from changing your default channel configurations for your laboratory. If you place a check mark in this check box, the user can add and remove default channel configurations. Data maps determine what inputs, channel settings, colors, filters, etc will be used for each channel type used in recording montages. Note: If a user deletes all data maps on a specific system, all data maps on all other networked systems will be deleted also. Montages - Removing a check mark from this check box will prohibit the user from adding, modifying, or deleting saved montages. Removing this check mark does not prohibit the user from modifying montages during data collection. The user will have the ability to modify existing montages as necessary during data collection and review. Photic Stim Programs - Removing a check mark from this check box will prohibit the user from modifying, deleting, or creating new Photic Stimulation Programs. Protocol Events and Buttons Only- Remove this check mark from the check box if you want to prohibit the user from accessing protocols and buttons. If you want to provide the user limited rights to default protocols, place a check mark in the check box. The user will not be able to modify workspace layout (the layout of trace windows and menus); however they will be able to create a new protocol using the existing workspace. The user can create their own custom events and report buttons used while viewing data. Protocols- Remove the check mark from this check box to prohibit the user from changing the default configurations and views used for data collection. Cadwell recommends that only key users, trained to alter the system configuration be granted access to this option. Default views and configurations are tied directly to the data file. If a data file is collected with a specific view/protocol, that view will always be used when the file is opened. 124 Restore Defaults - This feature is currently not supported. System Paths and Drives - Remove the check mark from this check box to prohibit the user from changing the default Data Folder location. Cadwell highly recommends that you remove the check mark from this check box for most users. A possible loss of data can occur if acquiring data on a machine that has a network data folder. If you allow users to change the default data path, the Easy III will automatically move all data files to any new folder immediately after it is selected by the user. Record Permissions Access Record Manager - Removing the check mark from the check box for this option will prohibit the user from copying, deleting, archiving, moving, exporting, and importing patient data. Delete EEG and Video Segments - Removing the check mark from the check box will prohibit the user from accessing the record editor. The record editor allows the user to select sections of a recording for deletion. Note the record editor below. The blue bar represents the entire data file. The green bar above and below the blue bar represents that data marked for saving. If you place a check mark in the user rights for the Delete EEG and Video Segments option, the user will be able to remove portions (or all) of the green line displayed in the record editor. Once segments are marked for deletion, the user can proceed with deleting data. Data can not be recovered after deletion. Edit Other Users' PSG Scoring- If you are training a new user, you may want to prohibit the user from importing another users scoring. If you place a check mark in the check box for this option, the user will be able to login under their own name, access a record scored by another user, and import their scoring and staging events. View All Records- This option will filter the Read Data/Select Record view for the physician. This is a powerful option for filtering records. Removing this check mark from the check box will only allow the physician to see his/her own patients. It is critical that the physician have a user name in Easy III. The referring physician must also be selected from the patient information dialog (see below). View Other Users' PSG Scoring - If you are training a new user, you may want to allow the user to view another users scoring. If you place a check mark in the check box for this option, the user will be able to login under their own name, access a record scored by another user, and view their scoring and staging events. Recording Permissions Removing the Recording Permissions check mark from the Check box will prohibit the user from recording data from the selected recording modality. 126 Tool Permissions Scorer-to-Scorer Analysis - Add a check mark to this option to allow the user to compare their scoring to another users scoring. Using the Record Permissions, Edit Others Scoring and View Others Scoring, you can further restrict the users access rights. For example, if you wanted to allow a technologist to view another scoring results, but not import them into his/her own scoring results, you could set the permissions as follows:

Sample User Rights Managing Users - Password Controls Changing Passwords - Any user can log in under his/her login and modify the default password associated with their user name. Click on Change Password to change your default password. Click on OK to close. Exit the Easy III software and log back in with your new password. Resetting Passwords - Any user with Administrative rights can reset another users password. User-Defined PSG Events Select the User-Defined PSG Events option to edit custom events. Note the RERA event listed below. The user can define the following for each user defined event. Description - This is the label that will be used when the event is marked. This label will show up in the event list. Color - This is the color of the event bar that will be placed on the channel where the event is marked. Event Bar Type - This is the type of event bar that will be placed on the selected channel. The bar can be filled (solid) or hollow (a rectangle box). 128 Include in RDI - This option will allow the user defined event to be included in the RDI calculation used by Easy III. PSG Settings Edit PSG Settings - Using the AASM Standard AASM Standard Add a check mark to the AASM Standard Sleep Scoring check box to use the nomenclature from the AASM Manual for the Scoring of Sleep and Associated Events, published by the American Academy of Sleep Medicine (AASM) in 2007. The AASM Standard Sleep Scoring defines sleep stages as Wake (W), N1, N2, N3, and REM based on the AASM guidelines. An epoch can also be marked as Unscored (Uns) if it has no staging. To score a sleep record the montage page speed must be set to 10mm/sec, so that each page is 30 seconds long. You can also an epoch of sleep from a live window. To score a sleep record, go into review mode by selecting a point in time along the position bar, or by dragging the blue scroll across the position bar. Score a sleep record by clicking one of the scoring buttons: Uns, Wake, N1, N2, N3, or REM. The Staging History bar will show the color-coded and labelled scores for each epoch within nine (9) epochs. The displayed epoch will always be in the middle, and will always be highlighted by a light green dash underneath. The Staging Marker is also color-coded, and shows the sleep stage for the current epoch across the top of the trace window. In the Staging History Bar, the light green colored line displayed under an epoch indicates the stage of the page you are presently viewing. 130 Using the Older R&K Sleep Scoring Standard The older sleep stage categories are Awake (Awk), Movement (Mvt), Stages 1-4 (S1, S2, S3, S4), and REM based on R&K Guidelines (1967). An epoch can also be marked as Unscored (Uns) if it has no staging. Count SpO2 Occurrences Below % Setting This setting is used in the oximetry report. The total amount of time below this setting will be used in the oximetry report. Use Pediatric Scoring Rules This setting is used to specify the age limit for pediatric respiratory event scoring. The patient must be less than or equal to the age in this setting. PSG Event Detection Settings The Easy III system provides time saving tools to help the trained clinician detect events that meet user defined criteria. NOTE: It is important to realize that the computerized process of event detection is only an aid for the physician in the establishment of a diagnosis. It does not replace the physician or diminish the requirement to use sound professional judgment when reviewing and marking events. Easy III System Settings - PSG Event Detection Click on the PSG Event Detection button to access PSG Event Detection settings. To review settings (note the illustration below) use the scroll bar in the PSG Event Detector column to review detector settings. 1. Left click on a detector category you would like to review 132 2. To modify a specific user setting, left on the specific setting and type in a new value. In the sample below, clicking in the blue area (where the number 2 is displayed) will allow the user to type in a different Long R-R Minimum Percent. The user could type in 100 and then move on to the next category, or simply click on OK to save the new default setting. The new default setting will be synchronized across all Easy III systems. All PSG records will now use the new setting during data collection and review. NOTE: Systems previously collected with the old RR settings will not be automatically updated to the new settings. Auto-detection for RR to intervals must be re-run to use the new settings. PSG Event Detector To enable PSG Event Detection, click on the PSG Event Detector Group. Place a check mark in the PSG Event Detector check box. All event detectors that have been enabled (with a check box setting of True) will be auto detected. Note: If the check mark is removed, no auto-detection of events based on your settings will occur. Body Position Event Detector To enable Body Position Event Detection, click on the Body Position Event Detector. Place a check mark in the Body Position Detector check box. Note that the Body Position Detector setting will display True in the column on the left side of the menu. This will indicate that the event detector has been set to detect body position changes from a body position module. Heart Rate Event Detector To enable the Heart Rate Detector, click on the enable heart rate detector check box. Note the heart rate detector will display True on the column on the left side. Minimum Event Duration is the minimum number of seconds required for a Tachycardia or Bradycardia event. Maximum Event Duration is the maximum number of seconds allowed for a Tachycardia or Bradycardia event. Minimum Tachycardia bpm is the minimum heart rate required to trigger a tachycardia event. The default setting is set to 90 bpm as recommended by the AASM (July, 2007) Maximum Bradycardia bpm must be at this level or lower for at least the minimum event duration for a Bradycardia event to be detected. The default setting is set to 40 bpm as recommended by the AASM (July, 2007). Ignore Values Below. Values recorded below this level will be ignored by the event detector. Ignore Values Above. Values recorded above this level will be ignored the event detector. Long R-R Minimum Percent. This setting looks at the percent increase in time between R-

R waves required to mark an R-wave-to-R-wave interval as "Long R-R." The long R-R algorithm compares the current R-R interval to the previous R-R interval. If the second interval has increased by the percent specified, the second R-wave-to-R-wave (R-R) interval is marked as a long R-R event. A long R-R interval is then ignored in determining the next interval. To reduce the number of Long R-R events detected, increase the Long R-R % setting. In the sample below, the duration of interval 2 is 150%

longer than the previous interval. As the detector examines interval 1 and interval 2, the second interval is marked because 150% of the previous interval has been exceeded. 134 Short R-R Maximum Percent. This setting looks at the percent decrease in time between R-waves required to mark an R-wave-to-R-wave interval as "Short R-R." The short R-R algorithm compares the current R-R interval to the previous R-R interval. If the second interval has decreased by the percent specified, the second R-wave-to-R-wave (R-R) interval is marked as a short R-R event. A short R-R interval is then ignored in determining the next interval. To reduce the number of Short R-R events detected, decrease the Short R-R setting. In the sample below, the duration of interval 1 is less than 75% of the previous interval. EKG Low and High Cut Filter Settings. When artifact is encountered, use these settings as necessary to change heart rate detector results. NOTE: It is important to realize that the computerized process of event detection is only an aid for the physician in the establishment of a diagnosis. It does not replace the physician or diminish the requirement to use sound professional judgment when reviewing and marking events. Limb Movement Event Detector To enable the LM (Limb Movement) Event Detector, click on the LM Event Detector. Place a check mark in the LM Event Detector check box. Note that the LM Detector setting will display True in the column on the left side of the menu. This will indicate that the event detector has been set to detect LM events and PLM Series (as defined by the AASM, July 2007). Minimum Event Duration is the minimum LM duration required for detection. Maximum Event Duration is the maximum LM duration allowed for event detection. Minimum Series Length is the minimum number of LM events required for a PLM Series. Minimum Period Length is the minimum amount of time allowed between any two LM events in a PLM series. If a LM event is too close to the previous event, it will not be included in the PLM series count, however the PLM series may continue if another LM event meets the minimum period length setting. Maximum Period Length is the maximum amount of time allowed between any two LM events in a PLM series. A PLM series will be broken if a LM is greater than 90 seconds away from a previous LM event. Threshold Multiplier is used to detect more or less LM events. The default threshold is 6. Set the threshold lower to detect more events, set the threshold higher to detect fewer events. LM Low and High Cut Filter Settings. When artifact is encountered, use these settings as necessary to change LM detector results. Oximetry Event Detector To enable the Oximetry Event Detector, click on the Oximetry Event Detector. Place a check mark in the Oximetry Event Detector check box. Note that the Oximetry Event Detector setting will display True in the column on the left side of the menu. This will indicate that the event detector has been set to detect oximetry events. Oximetry Channel selection allows the user to select the Cadwell EasyNet SpO2 oximeter

(SpO2) or any other oximeter calibrated and identified within the Easy III system (SpO2-

1, SpO2-2, etc.). Minimum Event Duration is the minimum time (seconds) required to detect a desaturation event. Maximum Event Duration is the maximum time (seconds) allowed for desaturation events. This duration should be increased if the patient is having events greater than 60 seconds. Percentage Change from Baseline is the minimum percentage change in SpO2 level from the baseline SpO2 required to detect an oximetry event. Respiratory Event Detector Note the Obstructive Apnea event below. The detector has marked the event as a 13.8 second obstructive apnea. 1. Placing the mouse/cursor on the red event bar will display the event details. The details are as follows:

- Duration = 13.8 seconds

- Airflow Signal Drop = 86%

- Minimum SpO2 associated with the event = 93%

- Total SpO2 drop associated with the event = 3% *

- Minimum pulse rate associated with the event = 36 bpm 2. Note the associated oximetry desaturation event. The patients saturation dropped from 96%

to 93%. 136 Respiratory Event Bar Colors Obstructive = Red Central = Yellow Mixed = Black Hypopnea = Green To enable the Respiratory Event Detector, click on the Respiratory Event Detector. Place a check mark in the Respiratory Event Detector check box. Note that the Respiratory Event Detector setting will display True in the column on the left side of the menu. This will indicate that the event detector has been set to detect respiratory events. Airflow Channel ID. Set this to Auto-Detect to have Easy III automatically detect an airflow sensor. Select a specific channel if you would like Easy III to use a specific channel for respiratory event detection. Minimum Event Duration. This is the minimum duration (seconds) for respiratory events (apneas, hypopneas). Maximum Event Duration. This is the maximum duration allowed for respiratory events. Extend this duration if the patient is have events greater than one minute in duration. Post Event SpO2 Interval. This is the period of time after a respiratory event that Easy III will look for the lowest saturation associated with the respiratory event. Respiratory Effort Threshold. This threshold will increase or decrease the types of apneas detected. Lower this threshold to detect more central apneas, increase this threshold to detect more central apneas. Apnea Airflow Threshold. This setting will increase or decrease the number of apneas detected. Decrease this setting to decrease the number of apneas events detected. Hypopnea Airflow Threshold. This setting determines the airflow amplitude drop required to detect a hypopnea. Central, Obstructive, Mixed, and Hypopnea Desaturation Threshold. This setting requires that the specified respiratory event have a corresponding desaturation event. Airflow and Respiratory Effort Low and High Cut Filter Settings. When artifact is encountered, use these settings as necessary to change respiratory event detector results. NOTE: It is important to realize that the computerized process of event detection is only an aid for the physician in the establishment of a diagnosis. It does not replace the physician or diminish the requirement to use sound professional judgment when reviewing and marking events. Snore Event Detector To enable the Snore Event Detector, click on the Snore Event Detector. Place a check mark in the Snore Event Detector check box. Note that the Snore Event Detector setting will display True in the column on the left side of the menu. This will indicate that the event detector has been set to detect snore events. Snore Channel ID. Use the Auto Detect setting to have Easy III detect the presence of a snore channel. Select a specific snore channel if you want Easy III to detect events on a specific channel. Minimum Event Duration. This is the minimum duration required to detect a snore event. Maximum Event Duration. This is the maximum duration for a snore event. A snore event will not be marked if it exceeds this duration. Threshold Multiplier. The default threshold is 4. Set this threshold lower to detect more events. Set this threshold higher to detect fewer events. Snore Low and High Cut Filter Settings. When artifact is encountered, use these settings as necessary to change snore event detector results. NOTE: It is important to realize that the computerized process of event detection is only an aid for the physician in the establishment of a diagnosis. It does not replace the physician or diminish the requirement to use sound professional judgment when reviewing and marking events. 138 Selecting a Protocol Protocols are used for data collection. A protocol is typically configured for specific modality or recording type. Protocols define the default layout that will be used for data collection and review. Selecting a Protocol for use with the Record Data buttons 1. When the user clicks on New Patient or Select Patient, the default recording protocol will be user. 2. To select a default protocol, click on the Protocols button. 3. Click on the drop down arrow in the Preferred Protocol column. Select the protocol you would like to use. Click on Done to save your setting. The selected protocol will now be used when the user clicks on the New Patient or Select Patient button. Note: The default protocol setting is specific to the User Name. Each user can select his/her default recording protocol. Editing Protocols The Easy III software allows the user to define a laboratory specific layouts (workspaces) for data recording and review. The workspace can consist of multiple views. For example, the first view will contain a recording trace window only, however a second view will contain the same recording trace window, a Q-Video patient window, and a event list. A Recording Protocol Contains the following:

Default Screen Layout/Workspace (for recording and review) Default Event Buttons (specified by the user) Default Instrument (Easy III, Easy II, or Ambulatory Amplifier) Default Impedance Measurement Time Out duration Default Calibration Montage Default Page Width Default Flash Program Creating a New Protocol Click on Protocols 140 Click on Edit Protocols Click on Add protocol Note the Edit Protocol Dialog below. General Tab Settings Owner ID - This is the name of the user that created the protocol. If you are logged in under your name, your Easy user name should be displayed in this window. Protocol Name - This is the name of the protocol that will be displayed in the protocol list. Description - The user can create a short description about the protocol. For example, the user could enter 'Dual Monitor w/Q-Video'. Default Instrument - Use this option to select the amplifier you would like to use with this particular protocol. The options include:

Easy 3 Easy 2 Ambulatory Default - Use this option if you are likely to use different amplifiers on multiple Easy III computer systems SynthHardware Server - Do not use. This is a configuration setting for system evaluation. EEGSynthHardware Server - Do not use. This is a configuration setting for system evaluation. Impedance Duration (minutes) - This option determines the length of time the impedance measurement will run. After the user specified duration has been met, the impedance measurement process will stop. Data Map - A default data map can be selected for the protocol. This allows the user to use specific channel types, colors, and settings for the protocol selected. Default Calibration Montage - This setting determines how the calibration montage will be displayed with the protocol. Current Montage - The trace window will show only those inputs used in the current montage. 1 - 32 Channels - The trace window will show inputs 1 - 32. 1 - 64 Channels - The trace window will show inputs 1 - 64. 1 - 128 Channels - The trace window will show inputs 1 - 128. 10-20 + Active/Reference Pairs - The trace window will show all 10-20 inputs and the Active Reference Inputs. 142 Default Page Width - The user can select the default page width that will be used when a record is recorded or reviewed. 1 sec/page - 300 mm/sec 2 sec/page - 150 mm/sec 5 sec/page - 60 mm/sec 10 sec/page - 30 mm/sec 15 sec/page - 20 mm/sec 20 sec/page - 15 mm/sec 30 sec/page - 10 mm/sec 60 sec/page - 5 mm/sec 120 sec/page - 2.5 mm/sec 300 sec/page - 1 mm/sec 600 sec/page - 0.5 mm/sec Display Paper Speed as sec/page - Place a check mark in this check box if you prefer the paper speed units to be displayed as seconds per page. Flash Program 1 & 2 - Click on the Select button to select the default flash program for buttons 1 and 2 in the flash program control (used for EEG activation). Editing User Events, Default Montages, and Default Reports User Events Click on the User Events Tab. 1. Type in an event that you would like displayed in the user event list. 2. Type in an abbreviation that will be placed on the Event Button. Note the Event Buttons below. Montage and Report Buttons Click on the Button Assignments Tab. Click on the Drop down arrow for each button (M1-M6). Select the six montages you would like to associate with the Montage buttons. Select the three reports you would like to associate with the Report Buttons. 144 Note the Montage and Report Buttons below. Editing Workspace Click on the Edit Workspace button. Adding a Window to the Workspace Add a Basic Trace Window by clicking on the Basic Trace Window option in the Available Windows Box. Note the illustration below:

1. Left click and highlight the Basic Trace Window 2. Drag the Basic Trace Window into the workspace area 3. Reposition and size the window in workspace area. This will determine the exact location of the window when you collect and review data. 146 Configuring a Workspace View Note the illustration below. 1. Drag the Position Bar option in the Available Windows Box into the workspace area 2. Position and size the Position Bar under the trace window 3. Note the Basic Trace windows that are now included in the workspace are listed in the Existing Windows box 4. Add a custom name to the workspace view you have created. In the sample below 'Standard View' has been entered. 5. Verify the Basic Trace Window is correctly aligned in the workspace. Setting Defaults for Windows Used in a Workspace Each available window added to the workspace will need to be setup correctly. After a window is added, right click on the window to determine if any default settings are available. Adjust the settings as required. Right Click in the Basic Trace Window, Select Setup. (Note the illustration below) The Trace Window Setup will be displayed. (Note the illustration below) 1. Select the default settings for this trace window. These settings will be used for every recording collected with this specific protocol. Show Grid Lines - Add a check box to this item to show grid lines in the background of the trace window. Always Show Live Data - Add a check box to this item to force the window to always show live data during data collection. If the user clicks on the position bar at the bottom of the trace window during data collection, the displayed page will not change. However; after data collection the user can click on the position bar and reposition to the location selected. Show Page Grid Lines - Add a check mark to this option to show grid lines Show Page Number - Add a check mark to this option to show the page number in the trace window 148 Show Time of Day - Add a check mark to this option to show time of day in the trace window Show Satellite View -Add a check mark to this option to have the trace window display data in a Satellite View. The number of pages displayed will be determined by the Satellite View Settings. Background Color - Click on the background color option to select a different color for the trace window background. Satellite View Settings - Click on this option to select the page count used when a satellite view is used. The page counts options include the following grid views:

Trace Label Interval (SpO2, Body Position, Pulse Rate) - Select the interval to display digital values on the trace data during review. The digital trace values will not be displayed on the live trace data during data collection. If you look back, or review recorded data during data collection, the trace labels will be displayed. 2. Select the default montage that will be used with the protocol. Adding another View Click on the Add View button and repeat the steps listed above to customize your second view. Important Details When Creating or Editing Views 1. When you are creating additional views, try to reuse windows from the Existing Windows box. 2. If you are creating views for multiple monitors, drag the available window over to the second monitor. The location you placed the window will be used when the protocol is used. 3. Provide useful names when additional views are created. For example, Q-Video View, or Satellite View. 4. When creating workspaces, maximize the edit workspace dialog to a full screen view to more clearly view the workspace. Setting up Workspace Windows Basic Trace Window Setup To Add the Basic Trace window to the workspace, click and drag the Basic Trace Window option from the Available Windows. Right click in the Basic Trace window to enter the setup options.

(Note the illustration below) 1. The following setup options are available for the Basic Trace Window. These settings will be used for every recording collected with this specific protocol. Show Grid Lines - Add a check box to this item to show grid lines in the background of the trace window Always Show Live Data - Add a check box to this item to force the window to always show live data during data collection. If the user clicks on the position bar at the bottom of the trace window during data collection, the displayed page will not change. However; after data collection the user can click on the position bar and reposition to the location selected. Show Page Grid Lines - Add a check mark to this option to show grid lines Show Page Number - Add a check mark to this option to show the page number in the trace window Show Time of Day - Add a check mark to this option to show time of day in the trace window 150 Show Satellite View -Add a check mark to this option to have the trace window display data in a Satellite View. The number of pages displayed will be determined by the Satellite View Settings. Background Color - Click on the background color option to select a different color for the trace window background. Satellite View Settings - Click on this option to select the page count used when a satellite view is used. The page counts options include the following grid views:

Trace Label Interval (SpO2, Body Position, and Pulse Rate) - Select the interval to display digital values on the trace data during review. The digital trace values will not be displayed on the live trace data during data collection. If you look back, or review recorded data during data collection, the trace labels will be displayed. 2. Select the default montage that will be used. Click OK to save. Digital Value Panel Setup The digital value panel is used during a polysomnogram. 1. To add the panel to a view, drag the Digital Value Panel option from the Available Trace Windows box. 2. Right click on the Digital Value Panel to adjust the setup configuration. 3. Select the font, font size, and color for each channel type. Select the background color and determine if you want the digital value panel to always show live data during data collection. If you do not add a check box to this option, the digital value panel will no longer display live data when reviewing previously collected data. Click on OK to save. 152 Event Detection Status Window Display this dialog if you would like to see the status of all detectors during data collection. Note: Most users will not add this dialog to a workspace. The dialog can be viewed by adding it during data collection or review. There are no setup options for this window. Event List Window Display this window if you would like to view the event list. There are no setup options for this window. Multi-Page Trace Window If you are using a dual monitor configuration, you can take advantage of the Multi-Page Trace Window option. Note the illustration below:

1. Click, highlight, and drag the Multi-Page Window option into the workspace area. 2. Note the trace window (number 2) displayed below. Reposition and size this window in the workspace area. 3. Note trace window 3 below. Drag this window over to the second monitor. 4. Right click in the trace window (number 2 in the illustration above). The dialog below will be displayed. Note the number of Page Windows highlighted below. If you would like to add additional trace windows, enter the total number of windows you would like to use. Click on OK to save. 154 Persyst Magic Marker To add Magic Marker to a workspace, click and drag the Persyst Magic Marker option to the workspace window. There are no setup options for this window. Persyst Tools To add Persyst Tools to a workspace, click and drag the Persyst Tools option to the workspace. There are no setup options for this window. Position Bar To add the Position Bar to a workspace, click and drag the Position Bar option to the workspace. Right click on the Position Bar to set up the default configuration. Note the Position Bar Setup options below. Add a check mark to those items you would like to display in the position bar. Click on OK to save. 156 PSG All Night Summary Window (see below) To add the All Night Summary Window to a workspace:

1. Click and drag the PSG All Night Summary Window to the workspace 2. Note the outline of the window will be displayed in the workspace. Right click in the box and select Setup. 3. Highlight the graphs you would like to use in the Available Graphs box. Click on insert to move the graphs to the Graph Layout box. Highlight a graph and click on the up, down, or delete option. Click on the Show hour labels on the x-axis if you want to display a time marker below the summary graphs. Click OK to save. PSG Trace Window To Add the PSG Trace window to the workspace, click and drag the PSG Trace Window option from the Available Windows. The PSG Trace window has a unique toolbar at the top of the trace window that allow the user to enter sleep stages and other sleep events. Right click in the PSG Trace window to enter the setup options. (Note the illustration below) The following setup options are available for the Basic Trace Window. These settings will be used for every recording collected with this specific protocol. Show Grid Lines - Add a check box to this item to show grid lines in the background of the trace window Always Show Live Data - Add a check box to this item to force the window to always show live data during data collection. If the user clicks on the position bar at the bottom of the trace window during data collection, the displayed page will not change. However; after data collection the user can click on the position bar and reposition to the location selected. Show Page Grid Lines - Add a check mark to this option to show grid lines Show Page Number - Add a check mark to this option to show the page number in the trace window Show Time of Day - Add a check mark to this option to show time of day in the trace window Show Satellite View -Add a check mark to this option to have the trace window display data in a Satellite View. The number of pages displayed will be determined by the Satellite View Settings. Background Color - Click on the background color option to select a different color for the trace window background. Satellite View Settings - Click on this option to select the page count used when a satellite view is used. The page counts options include the following grid views:

158 Trace Label Interval (SpO2, Body Position, Pulse Rate) - Select the interval to display digital values on the trace data during review. The digital trace values will not be displayed on the live trace data during data collection. If you look back, or review recorded data during data collection, the trace labels will be displayed. Select a default montage that will be used. Highlight a montage in the Montage list and click on OK. Q-Video To Add the Q-Video window to the workspace, click and drag the Q-Video Window option from the Available Windows. Right click in the Q-Video window to enter the setup options. (Note the illustration below) Q-Video Options (Click on Advanced to see all options) Video Source - Q-Video currently requires a video to USB adapter. If you are using a USB camera, you will see the name of the camera in the drop down menu. Audio Source - Typically the audio from the microphone in on the computer will be used. You can also use audio from your USB camera if it is available. Image Size - The image size is the resolution used for video. The higher the resolution, the larger the video files. Video Compression - Cadwell requires that you use Microsoft MPEG-4 Video Codec V2 Audio Compression - Cadwell requires that you use Windows Media Audio V2 Image Type - Cadwell recommends using I420 compression. It is more efficient and reliable than RGB compression. Audio Properties - Cadwell recommends Channels; Rate 11025; Bits 16 160 Record Audio Checkbox - Add a check mark to this box if you want to record audio (by default) with video. If you do not add this check mark, the user can add a check mark to a Record Audio option during data collection. Video Frame Rate - Set this option to a default frame rate between 1-30 fps. NOTE: Some computers (laptop computers) may experience difficulty recording 30 fps. Set the frame rate below 30 if required. Start Video Recording When Recording Starts - Add a check mark to this option if you want video to concurrently start when a recording starts. Maximum Video Clip Size (MB) - This option will determine when the Easy software will start a new video file. If the present file reaches this level (650 MB), the Easy software will create an additional video file. Record Edit 1. To add the Record Edit window to the workspace, click and drag the Record Edit Window option from the Available Windows. 2. Right click in the Record Edit window to enter the setup options. (Note the illustration below) 3. Click on the E1 button to edit the default settings for the E1 button. 4. Note the setup options below. The user can pre-configure the edit button to save or delete data when selected. Record Edit Setup Options E1, E2, and E3 Buttons - Each button can be pre-configured. Left click on the button to review the default settings (see number 4 above). Note the Button Label can be user configured. Enter a name that will help you understand the default settings for the displayed button. For example, you could name the button 'Save 1.25'. From Event - This option will assist the user in automatically clipping waveform and video data adjacent Easy events. Place a check mark adjacent to the events you would like to mark. The Waveform, Video, and Audio check boxes will determine what concurrent data will be marked. The Minutes to Mark settings will determine the amount of time before and after an event that will be marked. Video Compression - Cadwell requires that you use Microsoft MPEG-4 Video Codec V2 Audio Compression - Cadwell requires that you use Windows Media Audio V2 Deletion Warning Levels - These settings will warn the user if less than 25% (user specified) data will be saved. 162 Report Token Window To add the Report Token window to the workspace, click and drag the Report Token Window option from the Available Windows. There are no setup options for this window. Note the window displayed below. The window should be placed and sized to fit in the workspace. Select Inputs to Enable or Disable Inputs that are not used during data collection can be disabled. Disabling inputs will reduce file size. Reducing file size will shorten the total amount of time required to archive, move, and copy data files. Some improvement will also be noticed when reading files over a remote connection. 1. Click on Select Inputs 2. Remove the check mark on the inputs you would like to disable. Note: If a recording is started with the wrong inputs selected, a new recording must be started after the correct inputs have been enabled. Adding, Modifying, and Calibrating DC Devices Adding and Calibrating DC Devices Before an external DC device is used for a recording, it must be assigned to an input that will be used in your recording montage. The DC device should be calibrated to the particular amplifier it will be connected to. Each DC device has unique voltage outputs, even two identical devices of the same brand and model. A unique device definition (calibration) is needed for each combination of DC device, amplifier and input you will use. Calibrating a New DC Device 1. Connect the DC device to the Easy III Amplifier DC input. Note the DC input number. 2. Select System Setup from the Easy III Start menu. 3. Click the Data Map button. Highlight the Data Map used by your facility. In most cases, the default PSG map (EEG/PSG) can be used. Click Edit to view the data map. 164 4. This drop down is highlighted blue in the illustration above). Select the channel data type you are looking for. For example, if you are adding a CPAP leak channel, select the CPAP leak flow data type. 5. Look for the Input(s) cell. In the displayed menu illustration above, note the CPAP Leak Flow-2 channel has been added. The Input(s) cell is in the second column of the CPAP Leak Flow-2 row. Click in the Input(s) cell. The cell should now be highlighted. 6. Click on the Device tab in the upper left hand corner of the Edit Data Map dialog. Note the illustration above. The eight DC input buttons displayed on this tab correspond to the eight DC inputs on the Easy III amplifier. Select the DC input (DC1 - DC8) your device is currently connected to. The DC input should be the same input connected in step 1 above. 7. Click on 'Add' (note the illustration above) to add your new DC device. 8. Enter the Name of the channel you are calibrating. Select the 'Read voltage from attached device for each calibration value' option. Now select the DC input that the DC device is connected to. In the example below, the DC8 input has been selected by clicking on the Device Input button. Note the cool yellow and red mouse cursor displayed below on this button. Verify you are selecting the correct amplifier and DC input. 166 9. To Calibrate the Low Value - Set the DC device (in this example the DC device is a ResMed flow channel) to the lowest flow/calibration setting. Click on the -400 lpm button. Proceed forward until the following prompt is displayed. If you would like to specify a different low calibration value (the default was -400) you can enter it in the calibration value field. In the example below, the calibrated value (-400) will be manually modified to -200. Click on Update to continue. 10. Note the illustration below. The low value button is now displayed with the new calibration value. The low calibration value also has a green check mark box displayed adjacent to the low value. This indicates the new low calibration value has been recorded. 11. To Calibrate the High Value - Set the DC device (in this example the DC device is a ResMed flow channel) to the highest flow/calibration setting. Click on the 400 lpm button. Proceed forward until the following prompt is displayed. If you would like to specify a different low calibration value (the default was 400) you can enter it in the calibration value field. In the example below, the calibrated value (400) will be manually modified to 200. Click on Update to continue. 12. Note the illustration below. The high value button is now displayed with the new calibration value. The high calibration value also has a green check mark box displayed adjacent to the high value. This indicates the new high calibration value has been recorded. Click on Update to save the new calibration. 13. The new DC calibration should now be displayed in you list of DC input calibrations. (Note the illustration below) 14. Highlight the new DC calibration and click on Select. 168 15. Note the illustration below. The calibration has now been added to your default data map. All data maps on all synchronized Easy III systems will now be updated. If you have another Easy III system that will use the same device, or same type of device, you will need to perform another calibration on each specific system. Note: After the calibration has been record for each specific system, the calibration does not need to be repeated unless the DC device, DC device cable, or Easy III amplifier have been replaced. 16. Click on OK to save the new calibration in the data map. Verify that your new DC input is correctly configured in your recording montages. Review the information below to verify your configuration is correct. Verifying the Correct DC Calibration and Input are Used in Recording Montages 1. Click the Montages button in the System Settings window. 2. Select the PSG montage from the montage list. Click the Edit button. 3. To add a new DC input channel to an existing montage, right click in the location where you would like to insert the channel. In the illustration above, the insert option is selected to add another channel to the bottom of the displayed montage. 4. Click in the Input(s) box adjacent to the channel. In the illustration above, the channel is added to row 18. 5. Click on the Data Type tab located on the left side of the Edit Montage dialog (note the illustration below). 6. Verify you are using the correct data map. In the example above, the data map with the new DC device channel is EEG/PSG. 170 7. Look for the new DC device channel you would like to add to the montage. Click on the channel. 8. Note (below) that the new channel will be displayed in your montage. 9. Click on OK to save your changes. The edited montage will be synchronized with other Easy III system Re-calibrating DC Devices Re-calibration needs to be performed when an existing hardware configuration has been modified. Devices will need to be re-calibrated when the following occur:

An existing DC device is exchanged for another DC device of the same type. An existing DC device is replaced with a different device that provides the same data type (CPAP flow, CPAP pressure). A new DC input cable from the DC device to the Easy III amplifier is used. A new Easy III amplifier is used. Re-calibration Steps 1. Verify the DC device is connected to the Easy III Amplifier DC input. Note the DC input number. 2. Select System Setup from the Easy III Start menu. 3. Click the Data Map button. Highlight the Data Map used by your facility. In most cases, the default PSG map (EEG/PSG) can be used. Click Edit to view the data map. 4. Look for the channel you would like to re-calibrate. If the channel is not in the data map, you may be in the wrong data map. If the device needs to be added to the data map, proceed to the Adding and Calibrating a New DC Device section of this Help File. 5. If the channel is in the data map, click on the Edit DC Input Calibrations button. 172 6. Look for the input you would like to re-calibrate in the DC Input Calibrations dialog. Highlight the channel and click on Calibrate. 7. Verify the name of the channel you are calibrating is correct. Select the 'Read voltage from attached device for each calibration value' option. Verify the correct DC input is being used. 8. To Calibrate the Low Value - Set the DC device (in this example the DC device is a Respironics Synchrony pressure channel) via the PC Direct software to the minimum pressure/calibration setting. Click on the O cm H20 button in the Device Calibration dialog. Proceed through the calibration, clicking on Update to complete the minimum calibration. 9. To Calibrate the High Value - Set the DC device (in this example the DC device is a Respironics Synchrony pressure channel) via the PC Direct software to the maximum pressure/calibration setting. Click on the 30 cm H20 button in the Device Calibration dialog. Proceed through the calibration, clicking on Update to complete the maximum calibration. The calibration has now been updated with the new calibration. Adding a Event Button to a Data Map 1. Select the Data Map you would like to edit. Click on Edit. 2. Click on the Data Type drop down. Select Event Button. 3. Click on the Device Tab. Click on the DC input you would like to use for the Event Button. The DC Input Calibration dialog will be displayed. 4. Look for the Event Button in the list. If the event button is not displayed, click on Add. 5. Type in a name 'Event Button'. 6. Click on the Device Input button. Select the Amplifier and DC input you would like to use. Click on Update. 7. Click on Read Voltages from the Attached Device. 8. Click on the '0' button in the upper right hand corner. Select OK when you are ready. The input voltage should read 15V. 9. Hold the button down on the Event Button. Click on the '1' button in the upper right hand corner. Select OK. The voltage should equal 0V. Click on Update. 10. The '0' button and the '1' button should now have a green check mark next to each button. This indicates that both have been calibrated. Click on Update. 174 11. Edit the Event Button in the Data Map. Select a trace color. Add trace clipping if you want to restrict the Event Button signal amplitude. Click on OK and close the System Setup dialog. 12. Edit Montages from the System Settings dialog. Add the Event Button channel to selected montages by clicking on the Data Type tab. Verify that the correct Data Map is being used. 13. Click on the channel row in the montage where you would like to add the Event Button. Click on the Event Button item in the list displayed on the left side. After clicking on the Event Button, the channel should now be displayed in the selected montage displayed in the right hand panel. Click on OK. Close the Montage Editor. 14. The Event Button is now ready for use. When the event button is depressed, the Easy III software will detect the event. The event will be added to the trace window and the Event List. Record Manager Record Manager Options (note illustration below) 1. Select a location to copy or move your selected files. Click on Browse button to select a location. Click on the drop down arrow in the path to select previous paths used. 2. Select Records you would like to move or copy. Note: Several records can be selected at the same time. 3. All records selected will be displayed in this window. File size will be displayed adjacent to each record. Waveform data will be displayed with red checkmark adjacent to the waveform file. If Q-Video data was recorded with patient data, each video file will be listed in this window. Remove the check box from the video file segment(s) if you do not want to copy or move the file. 4. Record Manager Controls Archive - The archive feature will move the selected file(s) to the specified target (number 1 in the illustration above). After the file has been archived, the original file will be deleted from the data folder. The file will be placed in the Windows Recycle Bin. Note: The Recycle Bin must configured to save deleted data and have adequate space available. If you are archiving data from a network location to an archive media, data will not be placed in the Recycle Bin. The name of the selected patients will be placed in the Archive Database. Note: The date, time, and user name that archived the file will remain in the record history file. 176 Move - This feature will move the selected files to another Easy III system selected in the Target options (number 1 in the illustration above). Note: The file will be moved to the new target. After the file is removed from the local machine, it will not be placed in the Recycle Bin. Note:

The date, time, and user name that moved the file will be placed in the record history file. Copy - This feature will copy the selected files to another Easy III system selected in the Target options (number 1 in the illustration above). Note: The date, time, and user name that copied the file will be placed in the record history file. Share by eMail - This feature will launch your local email client (if available). The selected patient files will be placed as an attachment to the email. Note: The date, time, and user name that emailed the patient files will be placed in the record history file. Delete - This feature will delete the selected files. The files will be placed in the Windows Recycle Bin. Note: The Recycle Bin must configured to save deleted data and have adequate space available. If you are deleting data from a network location, data will not be placed in the Recycle Bin. Note: The date, time, and user name that deleted the file will remain in the record history file. Export - This option will allow the user to copy the file to the selected target. If the target is a DVD or CD, an autorun file (Add Easy III Data to My Computer) will be copied to the media

(note image below). When the media is placed in another computer with Easy III software, the utility below will automatically run. 5. Click on the Import button to copy a file from another media to the local computer. Remove the check mark from the 'Include Video Files When Moving From CD' if you do not want to import video data along with waveform data. Click on 'Add One Record' if you want to browse to one record to import. Click on 'Add Multiple Records' to copy all records from the selected target. Note: The utility will prompt you with a message with a message confirming all records have been imported. 6. To review a list of archived records, click on the Find Record button for the Archive Database. Record Manager Notes Easy III does not support re-writable CD and DVD media. You must use CD-R and DVD-R media. Write the Media Label on the topside of the DVD/CD using a felt-tip pen. International customers: The Easy DVD/CD Archiving does not support the use of large extended language character sets, such as in Asian and Arabic languages, in the Patient Information dialog. 178 Prepare a Patient for Data Collection Required Equipment To prepare for data collection, verify the following equipment is available:

Easy III PC Easy Amplifier & Cables Power/Com Module & Cables Photic Stimulator & Cable (if required) Setup Supplies: Skin Prep, Electrode Paste, Gauze Verify System Hardware Setup See Setup System Hardware for more information. Place Electrodes and Sensors Follow your laboratory protocols for applying electrodes to the patient. Cadwell recommends adherence to the International 10-20 standards for EEG electrode placement:

1. Attach electrodes to the patient. 2. Verify that the patient will be comfortable and not become entangled in wires. 3. Route the electrode cables to the Remote Input Box. 4. Plug the electrodes into the Remote Input Box. (Do not pull electrode wires when removing electrodes from the Remote Input Box. Remove each electrode carefully to avoid damaging the electrode connector). 5. Place respiratory, body position, snoring and SpO2 sensors if required. See EasyNet Modules for more information. Start Easy III Procedure 1. Prepare your patient according to laboratory protocol. 2. Verify electrodes are in the correct jacks. 3. Verify the amplifier is connected and ready for use. 4. Start a record by selecting New Patient or Select Patient from the Easy III Start Page. New Patient Window 180 Select Patient 5. The patient information dialog will be displayed next. (see next page) 6. Click on OK to close the patient information dialog. 7. To start a recording, click on the start button (see next page). 182 Start Button for PSG Recording Start Button for EEG Recording Easy III Toolbar Options Record EEG Record PSG Checking Impedance during Data Collection The Easy III software will evaluate all inputs displayed in the impedance dialog during impedance measurement. When the impedance dialog is opened, Easy III will test the EEG inputs, then the reference inputs, ground electrodes, and active reference pairs. NOTE: It is important that the user wait at least 10 seconds when the impedance menu is opened. This will allow the program to adequately check all inputs. NOTE: Waveform data is not recorded during impedance measurement. Check impedance and promptly return to data collection after evaluating impedance levels. Checking Impedance from the Easy III Amplifier On the amplifier, press the 20K button while recording to check impedances greater than 20 kilohms. Press the 10K button to check impedances between 5 and 20 kilohms. Press the 5K button to check impedances below 5 kilohms. Each time an impedance button is pressed, the impedance LEDS on the amplifier that correspond to the kilohm level of the button pushed will light up. The Impedance-Live window will open in the Easy III software. Press the OFF button on the amplifier to stop impedance measurement. If the OFF button is not pressed, the Easy III software will stop measuring impedance when the maximum impedance measurement interval to obtained. The maximum impedance measurement duration is set in the recording protocol. Checking Impedance from the Easy III Software Note the illustration below. Impedance levels that are good will be displayed with green background color in the input. In the sample below, the impedance is greater than 20K, therefor the background color is red. 184 Click in the Easy III software toolbar. 1. Auto-Reference Select - Place a check mark in this box if you would like the Easy software to find the lowest impedance reference electrode for use as a reference electrode. Note: The evaluation and selection of the lowest impedance electrode is only done during impedance measurement. After the reference electrode has been selected and the impedance measurement option is closed, the reference electrode will not be changed unless the impedance measurement option is opened again. The reference electrode can be manually selected by clicking on the drop down Recording Reference option. 2. Note the reference electrode is marked with a blue oval ring around the input. Available Reference Inputs: A1, T3, C3, Cz, C4, T4, or A2. Marking Events The Event List window summarizes all events associated with a recording. Click on a tab to select a specific category. Click on a specific event to reposition to the selected event. Click on an event and click the Delete button to remove it from the Event List. See Event List Window Setup in Modify Window Settings for setup information. Marking PSG Events Hold the mouse cursor over any trace in a running procedure to show the option Respiratory Events Place the mouse over a respiratory channel, then click and drag across to mark a respiratory event. As shown below, the Easy III software will instantaneously provide the event criteria:

Duration;

Percentage Drop in Signal Amplitude;

Minimum Sp02;

Percentage Drop in Sp02; and Minimum Pulse Rate. 186 Marking Events by Event Type When you mark a respiratory event on the flow channel, a pop-up window will appear asking you to select a respiratory event type. Moving the mouse below the airflow channel will allow the user to select an event type before marking a respiratory event. This simulated image demonstrates the different events that can be marked on a channel by moving your mouse up or down:

Real-Time Feedback Marking Events Easy III will display duration and amplitude or range while marking events. Arousal PLM Snore Respiratory EKG Event Details Clicking on any previously marked event will display the Edit Channel Event window, which displays event type, event details, and the User's name. The event may be erased by clicking on the Delete button. Easy Stamp Easy III allows users to mark any event, at any time, in any window. Quickly stamp a sleep event on a particular channel in a trace window. Place the mouse over a sleep channel and right-

click to stamp an event start. To extend the duration of the stamped event, right-click on the event bar again. The duration will increase each time you right-click the event. Some events will automatically pull up an Edit Channel Event window, in which you can select a more specific Event Type, review the event details, and add a comment. The Event will also appear in the Event List window. Click on the Event to review the trace where it occurred. 188 Easy Stamp Options Menu Easy Stamp - Check mark to enable. Easy Stamp Duration - Default duration of Easy Stamp event. Use arrows to adjust. Easy Stamp Tap Extender - Determines additional duration added to an event when the event bar is right-clicked. Auto Associate Arousal - Check mark to automatically associate an EEG arousal with the Easy Stamp Event. User Events 1-10 - Configure custom user events assigned to specific channels in a montage in the System Setup/User Defined PSG Events menu. Sleep Events Enter Sleep Events The basic trace window and PSG trace window support marking and editing of PSG channel events. You may mark the channel, start time and duration of the event. When a new event is marked, the event type is set to the type specified in the Linked Event attribute of the associated display channel. If the Linked Event is a group name, the event type shall be set to a default event type which is a member of the specified group. If a new event is marked that overlaps the time span of an existing event, the two will merge if the types match, or if the two are of the same group. When events are merged, the time span of the new event will be the union of the time span of the individual events. If they are not of the same event type, the type of the merged event will match the type of the newly marked event. Easy Stamp Each user may set up their own EasyStamp data. EasyStamp works for Respiratory, PLM, Snore, arousal, O2 Desaturation, Arrhythmia, Seizure, and User 1-10 events. Click on the EasyStamp button to initiate. Manually Mark User-Defined Events See EasyStamp to set User-Defined Events. See Mark Events for more information on the types of events that are marked. A separate set of PSG channel events exist for each scoring session in the PSG recording session. Each PSG channel event is stored persistently with the PSG recording session data. Manually Mark Session PSG Events Click on a button in the PSG events toolbar to add a session event. See Lights, CPAP, O2 for more information. 190 1. Lights Out - Click on this toolbar to enter a Lights Out event. Lights out will be placed at the first second of the present epoch. 2. Light On - Click on this toolbar to enter Light On. Lights out will be placed at the last second of present epoch. 3. Sleep Onset - Click on this toolbar to mark an epoch as sleep onset. Sleep onset will be placed at the first second of the present epoch. 4. CPAP/BiLevel Pressure - Click on this toolbar to place a CPAP event in the trace window. 5. Optimal Pressure - Click on this toolbar to place an Optimal Pressure event in the trace window. 6. Body Position - Click on this toolbar to enter a Body Position Change. If you are using a body position sensor, you can use this option to over-ride or resume using the body position sensor. 7. Supplemental O2 - Click on this option to enter a supplemental O2 level. Edit CPAP/BiLevel Pressure, Body Position Events or Supplemental Oxygen When you add a session event, windows will open asking you to enter event type, levels, and body positions. Change Event Length Once you have clicked and dragged to capture an event, right-click within the rectangle to add a second to its length. Modify or Delete Event Information Click on an event to open the Edit Channel Event window. View the event data or add a comment. Click the Delete button to remove the event from the Event List. 192 Sleep Summary Events Lights Out Lights On Sleep Onset CPAP/Bilevel Pressure The CPAP/Bilevel Pressure settings determine the range for continuous, inhale and exhale positive airway pressures that will be tabulated in Easy Sleep reports. o Click on the CPAP button. A vertical line marker will appear; place it at the point of pressure change on the waveform. Enter a pressure level for CPAP between 1 and 30 cm H2O by typing a level in or using the up and down arrows. Enter a pressure level for IPAP and EPAP between 1 and 45 cm H2O. Click the OK button to finish. Optimal CPAP/Bilevel Pressure o The Optimal CPAP/Bilevel Pressure searches the study for a specific pressure level. o Select an optimal CPAP pressure between +1 and +30 cm H2O. Select optimal pressures for IPAP and EPAP between 1 and 45. The IPAP must be between the value of the EPAP and 45. Click the OK button to finish. Body Position o Click on the Body Position button. A vertical line marker will appear; place it at the point of movement on the waveform. Select Left, Right, Prone, Supine, Upright and click the OK button. The body position will be noted as an event in the Events list. O2 Titration o Click on the O2 Titration button. A vertical line marker will appear; place it at the point of titration on the waveform. Enter an O2 level between 1 and 12 using the up or down arrows, and then press the OK button. Computer Assisted PSG Event Detectors The PSG Real-Time Analyzer has two primary functions:

To compute a comprehensive set of statistical measures for the PSG recording;

To assist the user in locating sleep events (i.e. APNEA, PLM and SNORE events). Easy III allows the Real-Time Analyzer to operate in real-time as PSG data is recorded so that preliminary results are available to the report generator and view windows shortly following the acquisition of the data. Event Control and Status Right-click within the trace window, hover your cursor over, PSG Event Detection and click the left mouse button. The PSG Event Detection Status window will open. The Event Detection window will display the pages that have been analyzed. Easy III event detectors perform event detection during data collection. Typically, the event detectors are detecting events within 1 minute of real time data during data collection. A check mark must be displayed in the Event Detector, PSG Event Detector check box for event detection to be enabled. Event detectors that also have a check mark will be detected during data collection. To change the events that will be detected, click on the Detection Settings option (refer to PSG Event Detection section of this manual for information related to the detection settings). NOTE: It is important to realize that the computerized process of event detection is only an aid for the physician in the establishment of a diagnosis. It does not replace the physician or diminish the requirement to use sound professional judgment when reviewing and marking events. If the detection settings are modified from their original settings, the Easy III will prompt the user that changes have been detected. 194 Re-scanning Channels Right click in the trace window, select PSG Event Detection. 1. Click on Detection Settings 2. Event Detection must be enabled. Verify the PSG Event Detector is set to True (on). 3. In the sample above, the Low Cut filter setting has been highlighted in the Snore Event Detector values. 4. The Snore Event Detector settings are displayed in the right hand column. Click on a value to modify the current settings. When you have completed modifying the present settings, click on OK. 5. If any setting in the Detection Settings has been modified, the 'Changes Detected' dialog will appear (note the illustration above) If you select the 'Re-scan all channels', all previously 'auto-

detected events for the selected event type will be re-scanned. This option will delete all manual and computer assisted events. The current detection settings will be used to scan all channels with event detectors enabled. If you select 'Re-scan only modified channels, only modified detectors will be used. 6. Delete Manually-marked Events - If a check mark is placed in this option, all manually marked events will be deleted. The auto-detector will re-scan the channel to detect events with the new settings. 196 Bookmarks A bookmark marks a segment of the recording, noting its current montage, filter, sensitivity and paper speed settings. Bookmarks allow users to quickly review notable sections of the EEG record, and are also used for including segments of the EEG in reports. Review a Bookmark Use the right/left arrows to scroll through bookmarks within a trace window. Click the flagged button to view a list of bookmarks. Select a bookmark from the list and click the Go To button to see the bookmark in the trace. Add a Bookmark Bookmarks are on a per-trace window basis. To specify the trace window to bookmark, open the Montage Toolbar and click the Add a Bookmark button. Enter a title and adjust the elapsed times as desired. Bookmark1, Bookmark2, etc. are default titles, but are not dependent on elapsed times. If you move backward and place a new bookmark, the default title will contain the next sequential number. The default times correspond with the beginning and ending times of the page being viewed on the screen. The length of the bookmark segment may be increased or decreased. The current montage, filter, sensitivity and paper sped will be saved with the bookmark. More than one bookmark may be created at the same location if they have different settings. Delete a Bookmark Click the flagged button to view a list of bookmarks. Select a bookmark from the list and click the Delete button to remove the bookmark from the trace. Print a Bookmark Click the flagged button to view a list of bookmarks. Select a bookmark from the list and click the Print button to print a bookmark. Q-Video Q-Video as a Trace Q-Video is enabled with a motion detection algorithm that detects and quantifies movement from a video signal. By adjusting the Color options on Q-Video, movement can be accentuated with color and displayed in the video picture to assist clinicians in detecting subtle movements which reviewing data faster than the speed of data collection. When Video Motion is selected as a channel, patient movement caught on camera is turned into a trace. As shown here, the Left Leg motion is quantified by both the anterior tibialis EMG signal and the Video Motion trace. Both Video Motion and Video Noise may be set up as channels and recorded as traces within the recording montage. This feature allows users to review epochs of data without video, when video movement is detected, the Q-Video player can be viewed for patient observation. Set Q-Video as a Trace Open the trace settings of a blank channel. Open the drop-down Channel Type menu and select Video Motion. Select a trace color to set it apart from the other traces. Q-Video Record Setup Window Access Q-Video Record Setup Within a procedure file, select a view with Q-Video. Right-click within the Q-Video screen and select Setup, or When you Edit a Workspace, access Workspace Setup Options. Set Up Q-Video Video Source Select a camera. Audio Source Select a microphone. Image Size Choose a resolution. The lower the resolution, the smaller the file size but the grainier the image. The higher the resolution, the larger the file size but the clearer the image. Record Audio Check this box to automatically record audio when video is being recorded. It can also be checked or unchecked from the Advanced button in the Q-Video window within a procedure. Video Frame Adjust the frame rate in frames per second (fps). The lower the fps, the smaller the file size because the record is gathering less information. The higher the fps, the larger the file size because the record is gathering more information. Easy III defaults to 30 fps. Advanced Increase your preference changes to include the following:

Video Compression Only use the Microsoft MPEG-4 Video Codec V2. Audio Compression Only use the Microsoft Windows Media Audio V2. Image Type Choose I420 for color preferences. Audio Properties Select the Channel, Rate and Bits for the audio file. Start video recording when EEG recording starts Check this box to automatically record video when data collection begins. Maximum Video Clip Size Set a limit to the size of a Q-Video file (for archiving/storage space purposes). Easy III will create multiple video clips during data collection. The maximum file size per clip will be determined by this setting. OK Save your changes and close. Cancel Close without saving changes. Use Q-Video Setup Q-Video in Edit Workspace. Open a procedure, and select a view that includes Q-Video. Zoom. Click and drag the mouse over the Q-Video image data subset that you wish to enlarge. When you release the click, a floating Zoom window will appear. Move and resize the Zoom window as necessary during a procedure or review. Snapshot. Click Snapshot to capture a still photo from the video. Enter a comment, such as an event associated with the action in the photo. The snapshot will appear as an event in the event list. Record/Stop. Press the Record button to begin recording video feed. It will turn into a Stop button. Press the Stop button to end recording video feed. Volume. Adjust the speaker output volume in a range of one (1) to ten (10) using the up and down arrows. To further adjust speaker volume, double click on the speaker icon in the system tray on your computer desktop. To record video audio, click the Advanced button. Modes. Q-Video collects and displays video data in a standard view. At any time during data collection or review, enable motion controls to accentuate movement in the video. This assists clinicians in quantifying movement during sleep studies or EEG recordings. Click through the Mode up and down arrows to choose color accentuation. Normal Dark Gray Light Gray Black and White Motion Highlight 200 Advanced. Click the Advanced button to select Record Audio, view or change the video frame rate (in frames per second) at any time during a recording, or use the sliders to adjust the brightness and saturation of the image. Advanced also displays disk status: real time memory space used to store Q-Video files, the memory capacity of the hard drive, and the remaining memory space. Review Q-Video In Read Data, you can access Q-Video data files in the Event List Window under the All tab or the Image tab. Double-click on the file to open. Play Press the Play button to watch the recorded Q-Video. During the review, you may:

Take a snapshot, Use the Volume control arrows to adjust speaker output from within Easy III software, Adjust the Mode to change the color accentuation of movement within the Q-Video file, Adjust the Rate of playback between 10 and 200% of real time, and Use the Zoom feature to enlarge sections of the Q-Video file. Q-Video Record Edit To efficiently edit video data, you must add the Q-Video window and the editor to your workspace. If you need to configure the Q-Video settings, enter the Protocol editor to configure Q-Video settings. 1. Click and drag the Q-Video Window option from the Available Windows. 2. Right click in the Q-Video window to enter the setup options. (Note the illustration below) 3. Configure the Q-Video Record Setup Settings. Q-Video Options (Click on Advanced to see all options) Video Source - Q-Video currently requires a video to USB adapter. If you are using a USB camera, you will see the name of the camera in the drop down menu. Audio Source - Typically the audio from the microphone in on the computer will be used. You can also use audio from your USB camera if it is available. Image Size - The image size is the resolution used for video. The higher the resolution, the larger the video files. Video Compression - Cadwell requires that you use Microsoft MPEG-4 Video Codec V2 Audio Compression - Cadwell requires that you use Windows Media Audio V2 202 Image Type - Cadwell recommends using I420 compression. It is more efficient and reliable than RGB compression. Audio Properties - Cadwell recommends Channels; Rate 11025; Bits 16 Record Audio Checkbox - Add a check mark to this box if you want to record audio (by default) with video. If you do not add this check mark, the user can add a check mark to a Record Audio option during data collection. Video Frame Rate - Set this option to a default frame rate between 1-30 fps. NOTE: Some computers (laptop computers) may experience difficulty recording 30 fps. Set the frame rate below 30 if required. Start Video Recording When Recording Starts - Add a check mark to this option if you want video to concurrently start when a recording starts. Maximum Video Clip Size (MB) - This option will determine when the Easy software will start a new video file. If the present file reaches this level (650 MB), the Easy software will create an additional video file. Record Edit Settings 1. To add the Record Edit window to the workspace, click and drag the Record Edit Window option from the Available Windows. 2. Right click in the Record Edit window to enter the setup options. (Note the illustration below) 3. Click on the E1 button to edit the default settings for the E1 button. 4. Note the setup options below. The user can pre-configure the edit button to save or delete data when selected. 204 Record Edit Setup Options E1, E2, and E3 Buttons - Each button can be pre-configured. Left click on the button to review the default settings (see number 4 above). Note the Button Label can be user configured. Enter a name that will help you understand the default settings for the displayed button. For example, you could name the button 'Save 1.25'. From Event - This option will assist the user in automatically clipping waveform and video data adjacent Easy events. Place a check mark adjacent to the events you would like to mark. The Waveform, Video, and Audio check boxes will determine what concurrent data will be marked. The Minutes to Mark settings will determine the amount of time before and after an event that will be marked. Video Compression - Cadwell requires that you use Microsoft MPEG-4 Video Codec V2 Audio Compression - Cadwell requires that you use Windows Media Audio V2 Deletion Warning Levels - These settings will warn the user if less than 25% (user specified) data will be saved. Generate a Report Reports Overview Easy III reports allow you to print patient information, record information, and pages of EEG specified by bookmarks. Reports can also include technician comments, impedance history, file access history, and Q-Video snapshots. The Report Generator can be launched during data collection and review. Click on the Report Toolbar to access reports. Click on a report template to generate a report. 206 Select Report 1. Click on the plus sign to access the list of available report templates. 2. Click on a template to view the Description. A blue ball with a yellow arrow will designate which template is selected. 3. Click the Show All Users' Reports box to access the list of all report templates available. 4. Click the OK button. 5. Wait while the Report loads and collects its tokens. QuickReport Document The QuickReport document will open in a Word formatted file. From here, you may edit data, change headers and footers, view automatic spell check, run grammar check, change font colors, etc. Save or Print report using the Word tools. Click the Finish button to save or close before exiting. Save the Report From the Document view, perform one of the following. Click the diskette icon to save to the default location. Select Save from the File menu to save to the default location. Reports will be automatically saved to the following destination: C:\Cadwell\Easy III\Reports File Names The filename of the report document is automatically created based on the patient's last name, first name, the date of the exam, and the patient's birth date. The report will be saved to the C:/Cadwell/Easy III/Reports. Save the reports to C:/Cadwell/Easy III/Data if you would like the reports to be archived with the patient data. Note: Do not rename the report file names. When reports are copied to the Data folder, the Easy III software will specifically look for system generated (patient specific) report file names. Close QuickReport From the Document view, perform one of the following. Select Exit from the File menu. Click the Finish button at the bottom right of the screen. Click the Red X in the top right-hand corner. If the report has not been saved, you will be prompted to save the report before exiting. Report Header The Report Header is the information that appears at the top of the first page of the report document. The report header is named Easy III Report Header.doc. The report can be found in the C:\Cadwell\Easy III folder. To modify the report header, open and edit the report. You must modify the report header on each Easy III system. 208 Persyst Tools Click on Show Window Click on Persyst Tools Three separate programs are available from Persyst. 1. Spike Review 2. Reveal Spike Detector 3. Voltage Plot Magic Marker Magic Marker can trend physiological monitoring data simultaneously with EEG. A single trend panel can be displayed concurrently with EEG data. Magic Marker Trends Rhythmic Run Detection and Display EEG Asymmetry (absolute and relative) Relative Alpha Variability Alpha/Delta Ratio Spectral edge trends Power Ratio (any bands) Power Difference (any bands) Amplitude (amplitude-integrated, DC average, zero-crossing frequency) Coherence Event Density (e.g., spike density functions from Reveal on-line spike and seizure detection) Compressed Spectral Array (CSA), Coherence CSA, Peaks CSA Trend relationships between EEG changes vs. physiological trends (MAP, HR, etc.) Multi-Epochcompare foreground to background with optional lag and apply Standard Deviation, Maximum or Minimum, Average Ratio, TStat, and more Typical Magic Marker Trend 210 Magic Marker Menu Options Configuring Magic Marker 1. Click one Magic Marker Menu to configure default settings. The settings selected in the Magic Marker Menu will be retained the next time Magic Marker is used. AutoStart - Use this option to automatically start trending Magic Marker data when a new recording is started. Auto-Scroll with Analysis - Use this option to display trend analysis data during data collection. Web Update - Use this option to stream trend and waveform data to a folder. Remote users can remotely access the web folder to review recorded data. Web Options & Web Snapshot Options - Use these options to pre-configure trend and waveform data display. 2. Click on the Settings tab to configure trend panel settings. Panel Tab - Use this tab to select the Instruments you would like to use in the Magic Marker panel. Instruments Tab - Use this tab to select or create custom trends (instruments) that can be displayed in the Magic Marker panel. Channels Tab - Use this tab to select or configure channel lists. For example, you can create a custom channel group called 'Frontal Sleep', including F3, Fz, and F4 in a group. Range Tab - Select the Range Tab to determine the duration of time to display in the Magic Marker panel. 212 Reveal Spike Detector Reveal Spike Detector from Persyst. 1. Click on the Reveal button from the Persyst Tools dialog. 2. Click on process to begin detecting events. 3. To modify the detection montage click on the Settings menu option. 4. Click on Protocol to select a different scanning montage. 5. After detecting events, click on the Spike Review button from the Persyst Tools dialog. Spike Review Click on the Spike Review button from the Persyst Tools dialog. Spike Review will allow the user to highlight, review, confirm or delete detected events. Review Records Select Record Review or Append to a Patient File by clicking the Read Data button or the Append button on the Start Page. The Select Record window will open. Select a Patient by Name Organize the lists by Last Name, First Name, Patient ID, Date, Description, Status, Type or Instrument by clicking on the column header. Narrow down the search results by entering in Patient name or ID. By Date Narrow down the search options by entering Patient information in the Last Name, First Name or ID fields, by narrowing the Select Date Range, or by entering descriptive information in Selection fields. By Filter Selection the Type in descriptors and select Status, Study Type, Instrument and Details to narrow down the search results. Filter Details: Edit Details To set the Details, click the Edit Details button. 214 Add a filter by typing in a Name, setting the Date range and details, and then clicking the Add button. Repeat for additional filters. Click the Update button to return to the Select Record window. In the Selection section, select the filter from the Details drop-down menu, and then checkmark the Details On box to turn the filter on. Summary of Selected Record The summary for each patient file records the patient ID, description of procedure, status and computer on which the procedure took place. The History will show when the file was created, when recording began and ended, when the file was closed, and which user performed each event. Scroll through Records Adjust Parameter Toolbar Adjust the Channel Group, Low and High Filters, Sensitivity, and Notch Filter Frequency, Scroll Through Records From the position bar The position bar can be configured in differently as needed by the user. Right click on the position bar and enter the setup dialog menu to change the configuration of the position bar. The position bar can be configured with and without the auto paging controls. The position bar displayed above shows the auto paging tools. Click on the red auto paging button to enable auto paging. The gold up and down arrows determines if the paging tool will skip pages during the paging process. The green LED bar shows the current paging speed. Increase the number of bright green LEDs to increase the paging speed. Click on one of the left or right arrow buttons to automatically page through the recording. Press the space bar to stop the auto paging process. The position bar displayed above is configured without the auto paging tools. Click the yellow arrow buttons to move back or forward one page at a time, or click and drag along the position bar to manually move through pages. During recordings, click the View live data button to return to live recording. From the waveform display To scroll through the pages using only the mouse, position your cursor between channels. The horizontal placement of the cursor determines the scroll commands:

,

, or space bar To last event in Event list or To first event in Event list From the keyboard Forward one page Back one page 216 From the Events dialogue box Click on an event in the Events List to jump to that event in the trace. Click the View Live Data button to return to live data. Event Definitions Sleep Epoch Categories Sleep Stages are

(W) Wake, N1, N2, N3, N, & REM based on the May, 2007 AASM Guidelines. The older sleep stage categories are (A)Awake,

(M) Movement, Stage 1, Stage 2, Stage 3, Stage 4, REM based on R & K Guidelines

(1967). An epoch can also be marked as unscored if it has no staging. Arousal 3- (or more) second event marked LM (formerly called a PLM or PLM burst) An EMG burst occurring on a limb movement channel. Concurrent LMs that occur on both legs are scored as one LM. If the LMs are 5 seconds apart, they can be scored as 2 LMs. PLM Series (formerly called PLM Episode) A series of LM events that occur rhythmically during sleep. Sleep Onset or Sleep Latency - Always the start of the first epoch scored as any stage other than Wake (W) after Lights Out. Snore A burst of high frequency data recorded from a snore microphone or nasal pressure signal. SPT Sleep Period Time - The elapsed time between Sleep Onset and the end of the last epoch marked as sleep, before Lights On. TIB Time in Bed - Lights Out to Lights On. TRT Total Recording Time Total amount of time from Lights Out to Lights On. TST Total amount of sleep time during TIB

(from Lights Out to Lights On). WASO Wake After Sleep Onset (Stage W during TRT Sleep Onset) in minutes (this includes time that the patient may have been out of the bed). on an EEG channel. Respiratory Events:

Central Apnea A cessation of airflow with no respiratory effort. Index Count x 60/TST Lights Out This time that indicates the beginning of a recording. The exact time is associated with the first second of a 30 second epoch where the lights out event has been added. Lights On This time indicates the end of a recording. The exact time is associated with the last second of a 30 second epoch where the lights on event has been added. Minimum Respiratory Event SpO2 The lowest saturation value associated with a respiratory event. Mixed Apnea A cessation of airflow with a no respiratory effort, followed by a resumption of effort. Obstructive Apnea A cessation of airflow with continual or increasing respiratory effort. PB Periodic Breathing At least 3 episodes of central apnea separated by no more than 20 seconds of normal breathing REM Latency The elapsed time from sleep onset to the first epoch scored as REM. Sleep Efficiency (TST/TRT) x100 218 Safety Information Safety Information General Discussion The application of modern electronic technologies in medical practice has led to systems of medical and non-medical electrical equipment being used together for the diagnosis and monitoring of patients. Medical electrical equipment complying with IEC 6060-1-1 such as Cadwell equipment and accessories are often connected to other non-medical electrical equipment such as computers and printers. Non-medical electrical equipment may fully meet the requirements applicable to their specific field, but may not comply with isolation or leakage requirements for medical electrical equipment and thereby impact the safety of the entire medical electrical system. Medical electrical equipment describes electrical equipment: provided with no more than one connection to a particular supply mains; intended to diagnose, treat or monitor the patient under medical supervision; which makes physical or electrical contact with the patient, transfers energy to or from the patient, and/or detects such energy transfer to or from the patient. Medical electrical system describes the combination of items of equipment in which at least one must be medical electrical equipment and interconnected by functional connection or an isolation transformer. The following configurations ensure that combinations of Cadwell devices with non-medical electrical equipment comply with the electrical safety requirements for medical electrical systems. Allowable Cadwell System Configurations 1. All Cadwell equipment and accessories are permissible in the patient environment without incorporating a isolation transformer. Patient environment describes any volume of space (area) in which intention or unintentional contact can occur between the patient and parts of the system or between the patient and other persons touching parts of the system. This is a diameter of 1.5 meters, or 5 feet, around the patient. Isolation transformer describes a medical separating transformer designed to limit transfer of unwanted leakage current and allow non-IEC 60601-1 devices to be located in the patient environment. 2. A double-insulated laptop computer powered from Cadwell equipment is permissible in the patient environment without incorporating a isolation transformer. 3. Other computing devices such as desktop computers, monitors, printers, cameras, and Infrared illuminators are not allowed in the patient environment unless an isolation transformer is used to power such devices. 4. Non-medical devices such as those listed above may be used outside the patient environment within the medically used room with a isolation transformer, or without incorporating a isolation transformer if and only if each individual device is plugged into a fixed mains socket outlet. Medically used room describes the room in which the patient environment is located. Fixed mains socket outlet describes a permanently installed (hardwired) grounded outlet in a facility. 5. Power strips and other multiple portable socket outlets are not permitted in a medically used room unless connected to the output of a isolation transformer. Power strips describe a combination of two or more socket outlets intended to be connected to, or integral with, flexible cables or extension cords. 5. Connection to hospital networks is allowed without incorporating an isolation device if and only if the network server and the medical electrical system are connected to circuits powered from and grounded to the same electrical service entrance. Isolation device describes a component or arrangement of components with input and output parts that, for safety reasons, prevent a transfer of unwanted voltage or current between parts of the medical electrical system. System Requirements 1. Non-medical electrical equipment used in medical electrical systems must meet their respective IEC electrical safety requirements, i.e. IEC 950 for computing devices. 2. Enclosure leakage must not exceed 500uA in any single fault condition within the patient environment. Enclosure leakage a potential electrical shock hazard from contact with the enclosure of a medical device. Single fault describes the condition in which a single means for protection against a safety hazard in the system is defective, or a single external abnormal condition is present. 3. Enclosure leakage must not exceed 100uA in normal condition. 4. Earth leakage must not exceed 500uA in any single fault condition within the patient environment. Earth leakage describes the potential of an electrical shock hazard from the electrical current flowing through the ground wire of a power cord of a medical electrical system. 5. The medical electrical system must provide a minimum of 1500 volts isolation between the patient and earth. 6. The medical electrical system must provide a minimum of 4000 volts isolation between patient applied parts and mains voltage. 7. The medical electrical system must provide a minimum of 1500 volts isolation between non-

patient contact parts of the system and mains voltage. Contact the Cadwell Regulatory department at 1.800.245.3001 or 1.509.735.6481 with any questions regarding these requirements. 220 General Warnings and Precautions Federal law restricts sale of this system to, or on the order of, a physician. The operator must be trained to recognize the difference between signal artifacts and valid bio-signals caused by movements, interference, or misplacement of sensors or electrodes. This manual provides an operational summary for the Easy III system. It does not provide clinical training. It is assumed that the user has adequate clinical training. The system is not defibrillator proof. The system is not designed to operate in an explosive environment. Do not immerse the amplifier, remote input box, power-communications module, flash stimulator, and system cables in liquid. The system is designed to be used with one patient at a time. Do not connect multiple patients to one amplifier. Never place an isolation transformer on the ground. When attaching the Easy III system to a patient, verify that the subject will not become entangled in the wires. Do not allow the electrode wires to wrap around the patient's neck. Safety Information Do not try to service internal parts of the Easy III system. Only service by Cadwell, Inc. or authorized bodies. Inspect all cables before and after each use. Discard cable if insulation is damaged or if the cable or connectors are damaged in any manner. The proper use of this device, for its intended use, can only be assured once all instructions have been read and understood. Contact Cadwell with questions about operation of Easy III. Do not use the system in an MRI environment. Strictly adhere to cleaning instructions in this manual. Do not use power strips with the system unless they are connected downstream of an isolation transformer. Do not connect items which are not specified as part of or for use with the Easy III system. Do not exceed the medical isolation transformer placarded maximum load. Do not use the system isolation transformer to power non-system components. This can overload the transformer or defeat the separation by providing additional leakage sources. Do not plug non-medical electrical equipment in the patient environment directly into a wall outlet. This may cause excessive leakage current in the patient environment. Electromagnetic Compatibility The Easy III system requires special precautions regarding Electromagnetic Compatibility (EMC) and must be installed and put into service according to the EMC information provided here. Portable and Mobile RF communications equipment can affect medical electrical equipment. Easy III Cables and Accessories Remote Input Box Remote Input Box Cable Photic Stimulator Cable Isolation Transformer Use of accessories and cabling other than these specified, excepting those sold by Cadwell as replacement parts, may result in increased emissions or decreased immunity of the Easy III system. The Easy III system should not be used adjacent to or stacked with any other equipment. If such use is necessary, performance of the Easy III system should be observed to verify normal operation in the configuration in which it will be used. 222 Maintenance Warranty and Service Information Excerpted from Cadwell document Warranty & Service Information part number 829001-000 Rev 01. What is covered After the problem is diagnosed Maintenance Cadwell Inc. guarantees this unit against defects in materials and workmanship for one year from the date shipped. During the warranty period, we will repair or, at our option, replace any unit that proves to be defective. For complete warranty info, refer to your sales contract. What is not covered This warranty does not apply if the product has been damaged, abused, or misused, or if unauthorized attempts have been made to modify or repair the equipment which may impair the performance of the instrument. This warranty is non-transferable and applied to the original purchaser only. Call for help If you have a problem with your Cadwell instrument, please follow these instructions:

Have the unit, serial number and your customer identification number with you. Call Cadwell, Inc at 1.800.245.3001 or 1.509.735.6481. For applications or operational support, ask for the Clinical Applications Department. For equipment repair, ask for the Technical Service Department. Service or Applications personnel may be able to direct you through basic diagnostic procedures on the unit. If a repair part must be sent or the unit returned for repair, you will be issued a return merchandise authorization (RMA) number. You will need the RMA# when requesting info about the repair. Repair parts are shipped second-day air service. Overnight and weekend services are available for an additional charge. Exchange the part Turn the unit off and disconnect it from AC power. Exchange the part with the replacement supplied. Plug the replacement unit into AC power and turn the on to verify operation. Please return the defective part promptly using the original shipping carton. Shipping materials and instructions will be included with the replacement part. Return the unit for repair Return the unit in the original, or an appropriate, shipping container with the RMA number written on the box. Air-

freight is recommended. Second-day return air-freight cost is included on a warranty-covered repair. Repairs normally require 2-3 business days to complete. Service Warranty Equipment not covered under the original warranty or service contract will be charged from a "flat rate" schedule for repair. Billable repairs carry a 90-day service warranty (covering only those items repaired). For continued and complete coverage of your entire system, call Cadwell and ask about service contracts. Maintenance Clean the Easy III System Always disconnect all components from AC power before cleaning. Do not use acetone to clean the surface of the system components. Clean the amplifier, photic stimulator, power communications module, and remote input box with a damp cloth. Ethanol may also be used for the exterior of the system units. Do not allow direct contact of liquids to the inner parts of the Easy III system. Part Amplifier Remote Input Box Power/Com Module Photic Stimulator Amplifier Cables Photic Stimulator Cables Electrodes and Accessories EasyNet Modules Cleaning Instructions Wipe down with a damp cloth with non-conductive distilled water or electronically non-conductive inert surfactants. Wipe down with a damp cloth with Isopropyl alcohol, non-

conductive distilled water or electronically non-conductive inert surfactants. Rinse all surface electrodes with warm, soapy water or liquid sterilizing agents; ensure all pastes and gels are cleaned from the electrodes and their cables. Wipe down with a damp cloth with Isopropyl alcohol, non-

conductive distilled water, or electronically non-conductive inert surfactants. Cadwell recommends the following cleaning supplies:

Antiseptic Towelettes Alcohol Pads Envirocide Electrode Cleaner Cotton Swabs Sterile Cotton Balls While the Easy III system has been carefully designed and manufactured to be reliable and durable, regular cleaning and inspecting of the system will promote long-term trouble-free operation of the system. Avoid extremes of physical stress such as dropping the unit or exposing it to extreme temperatures. Reusable Items Clean reusable items after each use. The Easy III cables can be wiped down with a damp cloth or ethanol. Do not allow direct contact of liquids to the connectors on the EasyNet cables. The Cadwell EEG electrodes can be washed with a hospital grade cleaner such as Envirocide. Allow the electrodes to air dry prior to reuse. Technical Technical Compliances The Easy III amplifier inputs are type CF rated. CF rating ensures that no current higher than 50uA flows to or from the applied part if mains voltage is inadvertently connected to the patient. All EasyNet modules are BF rated. HIPPA Compliant access rights and auditing. Each time a patient file is accessed, the user ID is added to the user channel events. Manually entered sleep events are stamped with the user ID. Environment The Easy III system should be stored in a clean, dry place. Handle the system with care. Transport and Storage Limits (ambient conditions) Temperature:

Relative Humidity:

Atmospheric Pressure:

-20 C (-4 F) to 65 C (149 F) 10% - 90% non-condensing 500 hPa to 1060 hPa Operational Limits (ambient conditions) Temperature:

Relative Humidity:

Atmospheric Pressure:

+10 C (+50 F) to +40 C (+104 F) 30% - 75%

700 hPa to 1060 hPa Factory Calibration Regular preventative maintenance never involves access to the interior of the Easy III system. It involves regular inspection and cleaning of Easy III components. Recommended Factory Service Interval In general Cadwell recommends yearly factory service and calibration verification to help assure continued top performance from the equipment. However, the service interval may be lengthened or shortened as device performance history dictates. Refer to your facilitys in-house equipment calibration policies and procedures for further guidance on this subject. For service issues that require corrective maintenance and/or internal component service, contact Cadwell Service Department at 1.800.245.3001. Troubleshooting If you are unable to solve a technical problem, contact Cadwell Service team. If yours is a clinical or software-related call, contact Cadwell Clinical Support. Call Cadwell at 1.800.245.3001. Please provide the following when you call:

Your account name. Your account number. The device serial number. Detailed information about the issue. Customer Support Customer Support www.cadwell.com Domestic customers:

Phone: 800.245.3001 or 509.735.6481 Fax: 509-783-6503 International customers:

Please contact your distributor (listings available at www.cadwell.com) or email International@cadwell.com Support hours Service department support: Monday through Friday from 6:30 A.M. to 5 P.M. PST. Application support: Monday through Friday from 6:30 am. to 5 P.M. PST. Contact Easy III Customer Support If:

o You continue to experience difficulty after troubleshooting a problem. Cadwell Laboratories has a rapid, cost-effective method for troubleshooting and servicing equipment. Most problems can be diagnosed over the telephone, and repairs can be performed by sending in the defective part. o You wish to order optional equipment. To contact Cadwell for a problem 1. Have your customer identification number and serial number near the phone. Have a person who runs the equipment be prepared to speak to a service technician. This person should be able to provide an accurate description of the problem. It is best if the person calling is in front of the equipment when they call. 2. Call the customer support number, and ask for the service department. The Cadwell service technician will determine if an exchange or repair of parts is necessary and instruct you on appropriate shipping arrangements. Using Help Files By accessing the Easy III help files, you can get the same information about the operation, terminology, and capabilities of the Easy III as are found in the Operator's Manual. Access The help files can be accessed during operation of the Easy III software by clicking. An electronic copy of the Operator's Manual is available on the software installation CD included with your Easy III system. To access the file, insert the CD into the computer's CD-ROM . When prompted "Do you want to run the Easy III Installer," click the No button. Go to the My Computer file, right-click on the Easy III icon, and click Open. Index Index A Hardware 3, 13, 14, 16, 18, 22, 25, 26, 52, 169, 209, AASM ................................................................... 208 Amplifier3, 10, 13, 14, 16, 18, 19, 20, 21, 22, 23, 24, 214, 215 I 25, 26, 29, 31, 34, 46, 169, 211, 214, 215 Impedance ............................. 20, 22, 23, 34, 46, 196 Archive ................................................................... 84 Install ............................................ 3, 16, 83, 209, 212 B Intended Use ............................................. 3, 10, 211 Bookmark ..................................................... 187, 196 International 10-20 ................................ 10, 169, 211 C Isolation Transformer ...... 10, 25, 26, 169, 209, 211, Cables .. 10, 13, 14, 16, 18, 23, 24, 26, 29, 31, 32, 49, 50, 51, 52, 169, 209, 211, 212, 214, 215 212 L Calibration ........................................................... 215 LED ............................. 14, 20, 22, 26, 30, 34, 46, 169 Camera ....................................... 14, 16, 59, 188, 209 Log In................................................................ 85, 86 Cart ....................................................... 21, 25, 26, 29 M Channel .......... 3, 19, 20, 23, 34, 46, 52, 53, 188, 208 Memory .......................................................... 14, 190 Chest Belt ......................................................... 52, 53 Montage ............................................................... 187 Comments .............................................. 22, 190, 196 N Compliance .......................................................... 215 Network ................................. 14, 22, 23, 26, 83, 209 Configurations .............. 13, 20, 25, 34, 46, 209, 212 Network Card ........................................... 23, 26, 83 Connections .. 18, 20, 22, 23, 25, 32, 34, 46, 83, 169, O 209 Off ....................................................... 22, 23, 26, 213 Contact ......................................... 209, 210, 214, 215 On.............................. 3, 22, 26, 85, 86, 169, 188, 191 CPN .......................................................... 14, 31, 169 Operating System ................................................. 14 Customer Service ........................................ 214, 215 Oximeter .................................................... 16, 52, 53 D P DC ............................................... 3, 19, 20, 23, 34, 46 Paper Speed ......................................................... 187 E EasyNet 2, 14, 16, 19, 20, 23, 34, 46, 52, 53, 56, 214, 215 Electrodes ..................... 10, 16, 23, 50, 169, 211, 214 Events ................... 3, 19, 23, 190, 191, 204, 208, 215 F Password ................................................................ 85 Patient ....................................................... 10, 52, 211 PC ............................................................................ 14 Photic Stimulator ... 3, 14, 16, 20, 23, 25, 26, 29, 30, 31, 32, 34, 46, 169, 212, 214 Power/Com Module .. 14, 22, 23, 25, 26, 28, 29, 31, Filters .......................................... 20, 34, 46, 187, 204 169, 214 Flash Program ..................................... 29, 30, 31, 32 Preferences ..................................................... 86, 188 G Protocol ................................................................ 169 Ground ....... 10, 14, 20, 25, 26, 34, 46, 209, 210, 211 PSG ....................................... 3, 16, 52, 53, 84, 86, 97 H Hard Disk ............................................................... 14 Q Settings ........................................................... 97, 188 QVideo ............... 14, 16, 59, 188, 190, 191, 192, 196 Setup ............................... 3, 14, 16, 86, 169, 188, 190 R Sleep Events ........................................................... 84 Read Data ............................................... 86, 191, 204 Software .... 2, 3, 16, 26, 59, 83, 84, 85, 86, 188, 191, Record ... 3, 10, 19, 20, 22, 34, 46, 52, 53, 85, 86, 97, 216 188, 190, 191, 192, 196, 204, 208, 211 Support ............................................. 3, 213, 215, 216 Record Edit .......................................................... 192 T Regulations .............. 10, 14, 209, 210, 211, 212, 215 Toolbars .................................................................. 85 Remote Input Box .. 10, 16, 23, 49, 50, 51, 169, 211, Trace ............................................................. 187, 188 212, 214 Reports ..................................................... 3, 187, 196 Requirements ........................ 3, 14, 32, 59, 209, 210 Review ............................ 84, 188, 190, 191, 196, 204 Trolley ........................................................ 21, 26, 29 U USB ................................................................... 14, 59 Users ......................... 2, 3, 10, 32, 188, 204, 211, 215 Run/Stop button .................................................... 30 V S Video ............................ 14, 16, 59, 84, 188, 190, 192 Safety ............................................................ 209, 210 W Select Record ............................................... 190, 204 Sensitivity .................................................. 20, 34, 46 Warranty .............................................................. 213 228

FCC Compliance Information This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

(1) This device may not cause harmful interference, and

(2) this device must accept any interference received, including interference that may cause undesired operation. Warning: Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. Information for user Caution: Exposure to Radio Frequency Radiation This device emits radio frequency radiation. The output of this device is below acceptable FCC skin absorption rate levels if used according to manufacturers instructions. Do not place the recorder in any other pack or pouch than that supplied with or recommended by Cadwell. Use of packs or pouches other than those specified or approved by Cadwell could alter the Radio Frequency emission pattern and intensity. Wireless Performance The maximum performance for wireless is derived from IEEE Standard 802.11 specifications. Actual performance can vary, including lower wireless network capacity, data throughput rate, range and coverage. Performance depends on many factors, conditions and variables, including distance from the access point, volume of network traffic, building materials and construction, operating system used, interference and other adverse conditions.