Q6F-600B-Alert System

Advanced Brain Monitoring, Inc. B-Alert System User Guide Table of Contents Chapter 1: Introduction About B-Alert TM System.................................................. 1 Package Contents.......................................................... 2 Minimum System Requirements.......................................... 2 Chapter 2: Installing Software and System Set-Up Installing B-Alert Software ............................................... 3 Preparing the Host Unit for Use............................................ 4 Preparing the Head Unit for Use........................................... 5 Using the Head and Host Units............................................. 5 Recharging Batteries on the Head & Host Units......................... 6 Preparing the Sensors for Use .............................................. 7 Applying the Sensor Headset ............................................... 8 Care for the Sensor Headset ................................................. 8 Chapter 3: Recording and Viewing Physiological Data Introduction to the B-Alert Software.................................... 9 Main Screen................................................................... 10 Setting Menu Options........................................................ 10 Selecting File Name........................................................ 12 Impedance Monitoring...................................................... 13 Acquiring Signals and Off-Line Viewing ................................. 13 Viewing Decontaminated Signals........ ................................. 14 Chapter 4: Generating Output Files Selecting Channels and Processing Options .................................... 16 Specifications Sheet................................................................ 18 FCC Compliance................................................................... 20 Trademark Acknowledgements................................................ 20 Software License Agreement ................................................... 21 Software Limited Warranty ..................................................... 22 Product Limited Warranty ........................................................23 Returns .............................................................................. 23 Customer Support ................................................................ 24 BALERT603-REV1 1 Advanced Brain Monitoring, Inc. B-Alert System User Guide Chapter 1: Introduction About B-Alert TM System The B-Alert System provides an integrated approach for wireless acquisition and recording of electroencephalographic (EEG) and electrooculargraphic (EOG) signals. The B-Alert System utilized the patented Sensor Headset and patent-pending disposable EEG sensors to acquire high quality EEG recordings. The Sensor Headset can be self-applied in less than five-minutes with no scalp preparation. The wireless technology allows the user to be untethered and move around the home or clinic while real time data is collected, displayed, and analyzed. The B-Alert System Model 603, which provides three channels of bi-polar recordings and three channels of monopolar recordings, is recommended for use with ABM’s patented B-Alert analysis software, ERP analysis software, and Alertness and Memory Profiler TM software to quantify alertness, drowsiness, memory and/or mental workload. The B-Alert System Model 603 consists of: Head and Host Units for bi-directional transmission of digitized physiological signals, a Sensor Headset that locates EEG sensors at Fz, Cz, and POz, linked mastoids for the monopolar channels, bi-polar EOG signals, 30 disposable EEG sensors, 20 disposable EEG electrodes, conductive gel, batteries, B-Alert acquisition program, and users manual. The Head Unit collects signals from the sensors attached to the user, performs analog-to-digital conversion, encoding, formatting and transmitting of all signals. The signals are communicated using a 902-928 MHz radio transmitter. The B-Alert software utilizes the bi-directional capabilities of the system to initiate scalp-electrode impedance monitoring, monitor battery capacity in the Head and Host Units, and select transmission frequencies. Up to five systems can be used in the same area without interference with one another. The B-Alert acquisition program consists of several modules that allow the user to acquire, store, view, and analyze physiological signals acquired by the wireless system. The software provides a simple graphical interface for establishing and controlling data acquisition. Patented algorithms can be selected to monitor artifacts that impact signal quality in real time and sound an alarm when thresholds are exceeded. Event marks can be superimposed on the signals during data acquisition to identify in real time the presentation and response of the user to stimuli generated by the Alertness and Memory Profiler software. This Device is not FDA approved to market and is available for non-medical use only unless it is to be used in an IRB approved program. BALERT603-REV1 2 Advanced Brain Monitoring, Inc. B-Alert System User Guide Package Contents Before starting, please check to make sure your kit contains the following components:
Sensor Headset with Sensor Strip (one medium size)
Head Unit
Host Unit with nine-pin serial interface
Four AAA NiMH rechargeable batteries.
30 EEG sensors
20 disposable EEG/EOG electrodes
Conductive cream
EEG Sensor pry tool.
Radio Shack Battery Charger with Adapter Cable
B-Alert Software CD
User’s Guide
Warranty Form (separate from User Guide) Minimum System Requirements
Personal computer with minimum Pentium TM 450 MHz processor (recommend Pentium TM 750 MHz or higher when using technician monitoring features);
Microsoft® Windows 98, Windows NT 4.0, Windows 2000, or Windows XP or higher;
Minimum of 64 MB (recommend 128 MB) of installed memory for use with Windows operating system;
Minimum 50 MB free hard disk…

Text truncated - open the document above for the full version.

5.5cm 4.0cm Advanced Brain Monitoring Inc. 2850 Pio Pico Drive #A Phone760-720-0099/Fax 760-720-0094 B-Alert System S/N 925006/000025 FCC ID: Q6F-600 This device complies with 1 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. 2 AAA Batteries 1.2 Volts

Head Unit Host Unit RF Board – Top View Head Unit Host Unit RF Board – Bottom View Head Unit 6Channel Board – Top View Head Unit 6Channel Board – Bottom View Host Unit Serial Board – Top View Host Unit Serial Board – Bottom View Inside of Head Unit Enclosure – Bottom Inside of Head Unit Enclosure – Top Battery Door – Inside Inside of Host Unit Enclosure – Top Inside of Host Unit Enclosure – Bottom

TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 Report No. SC301556-03 Page 1 of 17 Rev.No 1.0 MEASUREMENT AND TECHNICAL REPORT ADVANCED BRAIN MONITORING SYSTEMS 2850 Pio Pico Drive, Suite A Carlsbad, CA 92008 DATE: 09 April 2003 This Report Concerns: Original Grant: X Class II Change: Equipment Type: EEG Acquisition System, Model B-Alert Deferred grant requested per 47 CFR 0.457(d)(1)(ii)? Yes: Defer until: No: X Company Name agrees to notify the Commission by: N/A of the intended date of announcement of the product so that the grant can be issued on that date. Transition Rules Request per 15.37? Yes: No: X* (*) FCC Part 15, Paragraph(s) 15.209(a), 15.249 Report Prepared by: TÜV AMERICA, INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 546 3999 Fax: 858 546 0364 TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 Report No. SC301556-03 Page 2 of 17 Rev.No 1.0 TABLE OF CONTENTS Pages 1.0 GENERAL INFORMATION 3 - 5 1.1 Product Description 3 - 4 1.2 Related Submittal Grant 5 1.3 Tested System Details 5 1.4 Test Methodology 5 1.5 Test Facility 5 1.6 Part 2 Requirements 5 2.0 SYSTEM TEST CONFIGURATION 6 2.1 Justification 6 2.2 EUT Exercise Software 6 2.3 Special Accessories 6 2.4 Equipment Modifications 6 2.5 Configuration of Test System 6 3.0 RADIATED EMISSIONS EQUIPMENT/DATA 7 - 16 4.0 ATTESTATION STATEMENT 17 TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 Report No. SC301556-03 Page 3 of 17 Rev.No 1.0 1.0 GENERAL INFORMATION 1.1 Product Description CUSTOMER INFORMATION COMPANY NAME: Advanced Brain Monitoring COMPANY ADDRESS: 2850 Pio Pico Dr. #A Carlsbad, CA 92008 PHONE NUMBER: 760-720-0099 FAX NUMBER: 760-720-0094 CUSTOMER CONTACT: Daniel J. Levendowski PRODUCT DESCRIPTION NAME, MODEL, SERIAL # OF EUT: B-Alert System, Model 603 DESCRIPTION OF EUT: 6 channel EEG Acquisition system Components of EUT Description Model Number (s) Serial Number FCC ID Number Head and Host Unit 57-8, and 57S respectively 925006, and 000025 OPERATING MODE(S): Normal EUT CONFIGURATIONS: POWER INTERFACE FREQUENCY/AC/DC VOLTAGE: 2 AAA Internal NiMH batteries 2*1.2V PHASES (f)/CURRENT (amps): OSCILLATOR FREQUENCIES: POWER SUPPLY DESCRIPTION: Internal MANUFACTURER, MODEL #, S/N # SWITCHING FREQUENCY: 300kHz +-40kHz POWERLINE FILTER: MODEL #: DESCRIPTION OF ENCLOSURE: ABS Plastic CRITICAL EMI COMPONENTS: TRF6900A, Crystal HE-MCC-125-B-26-E SAW filter SAFCH915MAL0N00 INTERFACING AND/OR SIMULATORS PERIPHERAL EQUIPMENT: Description Model # Serial # FCC ID/Other Host Computer I/O PORTS: Name of Line Type of Line Length of Cable Status of Line Kind of Transmission EEG input 1.7 oShielded X Unshielded 10” o Passive X Active X Analog o Digital Reference oShielded X Unshielded 10” X Passive o Active X Analog o Digital RS232 receive oShielded X Unshielded 3’ o Passive X Active o Analog X Digital Rs232 transmitt oShielded X Unshielded 3’ o Passive X Active o Analog X Digital CTS control oShielded X Unshielded 3’ o Passive X Active o Analog X Digital Ground oShielded X Unshielded 3’ X Passive o Active o Analog X Digital TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 Report No. SC301556-03 Page 4 of 17 Rev.No 1.0 MAJOR SUBASSEMBLIES OR INTERNAL DEVICES Description Model # Serial # FCC ID # Head Unit 57-8 925006 Host Unit 57-S 000025 BLOCK DIAGRAM: TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 Report No. SC301556-03 Page 5 of 17 Rev.No 1.0 1.2 Related Submittal Grant None 1.3 Tested System Details The FCC ID’s for all equipment, plus descriptions of all cables used in the tested system are: None 1.4 Test Methodology Purpose of Test: To demonstrate compliance with the following tests. TEST FCC CFR 47# PASS/FAIL Radiated Emissions Radiated Emissions 15.209(a) 15.249 Pass Pass Both Conducted and Radiated testing were performed according to the procedures in FCC/ANSI C63.4 and CSA 108.8-M1983. Radiated testing was performed at an antenna-to-EUT distance of 3 meters (1 - 25 GHz). 1.5 Test Facility The open area test site and conducted measurement data were tested by: TÜV AMERICA, INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 546 3999 Fax: 858 546 0364 The Test Site Data and performance comply with ANSI C63.4 and are registered with the FCC, 7435 Oakland Mills Road, Columbia Maryland 21046. All Measurement Data is acquired according to the content of FCC Measurement Procedure and ANSI C63.4, unless supplemented with additional requirements as noted in the test report. TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 Report No. SC301556-03 Page 6 of 17 Rev.No 1.0 2.0 SYSTEM TEST CONFIGURATION 2.1 Justification The EUT was initially tested for FCC emissions in the following configuration: See Block Diagram 2.2 EUT Exercise Software None 2.3 Special Accessories None 2.4 Equipment Modifications None 2.5 Configuration of Test System See Block Diagram TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 Report No. SC301556-03 Page 7 of 17 Rev.No 1.0 3.0 RADIATED EMISSIONS EQUIPMENT/DATA See following page(s). TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 Report No. SC301556-03 Page 8 of 17 Rev.No 1.0 Test Conditions: RADIATED EMISSIONS: FCC Part 15.209(a) and Part 15.249 The RADIATED EMISSIONS measurements were performed at the San Diego Testing Facility: oo - Test not applicable Test Equipment Used: n - Canyon #2 (3- and 10-Meter Open Area Test Site), Carroll Canyon, San Diego, 3 meters Model No. Prop. No. Description Manufacturer Serial No. Date Cal’ed LPB 2520/A 739 Antenna, Bilog Antenna Research 1170 05/02 ESVS 30 427 EMI Test Receiver Rohde & Schwarz 830350/006 12/02 n - Roof (Small Open Area Test Site), 3 meters Mo…

Text truncated - open the document above for the full version.