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Summary of Contents for BIOPAC Systems B-ALERT X10
- Page 1 User Manual 42 Aero Camino Goleta, CA 93117 805 685‐0066 http://www.biopac.com/ Distributed by BIOPAC Systems, Inc. Manufactured by Advanced Brain Monitoring, Inc.
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Page 2: Table Of Contents
Post‐session Clean‐up ....................... 15 Common Headset and Sensor Issues................17 Chapter 4: Specifications...............19 B‐Alert X10 ........................19 Environmental Conditions ....................20 Chapter 5: Compliance ................21 FCC ............................ 21 General Compliance......................23 Software License Agreement.................... 24 Product Limited Warranty ....................24 Returns and Service ......................25 Trademark Acknowledgements ..................25 2 BIOPAC Systems, Inc. B-Alert X10 User Manual ... -
Page 3: Chapter 1: Introduction And Safety Information
(for artifact) are exceeded. EEG Power Spectral Densities, EEG classifications, and Heart rate measures can be generated in real‐time or off‐line. B. Intended Use The B‐Alert X10 system is intended for use in clinical and research settings, by trained technicians, to measure and record the electrical activity originating from the brain (EEG), the 3 BIOPAC Systems, Inc. B-Alert X10 User Manual ... -
Page 4: Safety
ALERT rechargeable batteries. EEG Leads, Strips and Sensor interfaces are not protected against the effects of defibrillation. Damage to the device is possible if worn during defibrillation. Not Defibrillator Proof. Additional equipment connected to the patient must comply with the requirements of IEC 60601‐1‐1. B‐ X10 The PC used with must be placed outside the patient/client environment ALERT (more than 3 meters or 10 feet), or the PC must comply with IEC 60601‐1.1 4 BIOPAC Systems, Inc. B-Alert X10 User Manual ... - Page 5 . Contact ALERT BIOPAC Customer Support (pg. 24) for repair or replacement. CAUTIONS – Batteries Do not charge the batteries while wearing the Sensor Headset. Do not recharge batteries that have been fully charged. Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device components, including batteries. Batteries may leak or explode if used or disposed of improperly. The internal Li‐Polymer batteries should only be replaced by the service department! 5 BIOPAC Systems, Inc. B-Alert X10 User Manual ...
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Page 6: Minimum System Requirements
D. Minimum System Requirements Personal computer (PC) with minimum Pentium 2.4 GHz processor; Minimum of 1 GB of installed RAM memory and 4 MB virtual memory; Windows XP or Windows 7 operating system; .NET framework version 3.5 installed; Minimum of 50 MB hard disk space per 5‐hour session; One CD‐ROM drive; VGA or higher resolution video adapter; One available USB port. Monitor size between 15” and 21” required for Baseline acquisition. 6 BIOPAC Systems, Inc. B-Alert X10 User Manual ... -
Page 7: Items Required For Use
Cleaning Tools ‐ Tweezers & Foam Sensors Synapse Gel Bottle 12cc Syringe Electrode Brush & Tube ABM USB Host device ECG Leads (left) Disposable Electrodes B‐Alert Dongle (left) Mastoid (right) Optional ESU‐MC (right) Zip‐Linq Wall Charger & Tape Measure Neoprene Strap X10 Cable Adapter 7 BIOPAC Systems, Inc. B-Alert X10 User Manual ... -
Page 8: Chapter 2: Sensor Headset Use
Note: This chapter presents a detailed, written process of a standard subject setup. For an additional demonstration, refer to the instructional videos provided with the included software. Brain map of a 9‐electrode strip. Front Back Charging The B‐Alert Sensor Headset should arrive fully charged and ready for use. For ongoing usage, it is recommended that you charge the headset the night before using. Fully charged headsets can record for at minimum 8hrs. It takes 2‐3hrs to fully charge a headset. To recharge the Headset follow the steps below. 1. Verify the Headset is in the off position. Insert the X10 cable adapter into the sensor headset. 2. Plug the Mini‐B connector into the X10 cable adapter and Cable Adapter the USB‐A connector into your computer’s USB port Mini‐B 3. Once power is recognized, the sensor headset will automatically begin charging, confirmed by a double blinking green LED pattern on the front of the headset. 4. Charging will automatically terminate once the batteries are fully charged, confirmed by a single blinking green LED pattern. LED Indicator 8 BIOPAC Systems, Inc. B-Alert X10 User Manual ... -
Page 9: Preparation
1. Preparing Sensor Headset a. Ensure that the fuzzy side of the Neoprene is facing out, and the strip connector triangle is Fuzzy side of neoprene Triangle Strip Connector pointing up. b. Using a clean Neoprene Strap, feed the Strap ends through each side of the Sensor Headset strap holders and fasten the Velcro. Do this equally to both sides, but leave loose for easy application to subject later. c. Verify that the Mastoid Leads are plugged into the system. Mastoid Leads 2. Preparing Strip a. Inspect the Strip and verify there are no rips or hard creases on the Strip itself. Check the entire strip, paying special attention to spots (circled in red) prone to rips and creases. 9 BIOPAC Systems, Inc. B-Alert X10 User Manual ... - Page 10 ii. The gel can also be dispensed into the foam from the sides by pushing the tip into either side of the foam until it begins to fill the center. i. d. Make sure to completely fill foam piece. Each sensor will hold 0.4‐0.6 cc of synapse gel. e. The foam should be saturated with gel and the center hole should be filled to the top. Size ium ‐ Inion Medium >34.5 cm Small 32.0 – 34.5 cm 10 BIOPAC Systems, Inc. B-Alert X10 User Manual ...
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Page 11: Application
Measure the distance from the nasion to the inion (occipital bone). b. Use an alcohol swab to wipe down areas where the sensors will be placed. Also clean Mastoid and ECG locations with an alcohol swab. c. Place the Sensor Headset onto the subject’s Nasion Inion head and tighten the Neoprene Strap to provide a snug fit. d. Verify that the Neoprene Strap is centered on the subject and that it is not resting on the ears. e. While holding the strip in front of the subject, with the foam pieces facing away from the face, attach the Strip to the front of the Neoprene Strap by feeding triangular tip through the hole adjacent to site Fz. f. Carefully bring the Strip over the top of the subject’s head, verifying that the Strip is centered and that the subject’s inion is below the alignment hole. (See picture on next page). 11 BIOPAC Systems, Inc. B-Alert X10 User Manual ... - Page 12 While holding the Strip in place over the inion, take the two Strip Arms closest to the inion and attach them to the Neoprene Strap. h. Tighten the remaining Strip Arms in pairs, from the back of the head to the front, so that the Strip sits flat against the subject’s head, while maintaining the correct alignment on the scalp. h. i. Verify that all sensor sites are contacting the head and adjust straps if necessary. j. Gently plug connector on the back of the Strip into the Sensor Headset. The connection between headset and strip is snug; be gentle when plugging/unplugging. k. If the subject complains about discomfort from any electrode, loosen individual Strip Arms. 12 BIOPAC Systems, Inc. B-Alert X10 User Manual ...
- Page 13 4. Mastoids and ECG Leads 13 BIOPAC Systems, Inc. B-Alert X10 User Manual ...
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Page 14: Additional Ecg Placements
2. Verify the Sensor Headset is synced to the B‐Alert Dongle by switching on the Sensor Headset and viewing the indicator lights on the front of the Sensor Headset. The Sensor Headset has established connection when the green indicator light turns solid after 5‐ seconds. If the red indicator light stays on while the green indicator light is blinking, the headset is not properly connecting. Refer to the Operations section in Chapter 7 of the B‐Alert Software Manual for details on how to re‐sync a Headset to the USB Host Device. Connected Not Connected 3. Maintaining BT Signal Quality: a. Make sure the Sensor Headset and B‐Alert Dongle are within 25 feet of each other. 14 BIOPAC Systems, Inc. B-Alert X10 User Manual ... -
Page 15: Post-Session Clean-Up
Minimize the number of obstructions (and avoid metal objects) in the line‐of sight of the head and host units. Post‐session Clean‐up 1. Removal of Sensor Headset and Electrodes 15 BIOPAC Systems, Inc. B-Alert X10 User Manual ... - Page 16 2. Cleaning the Sensor Strip and Neoprene Strap CLEANING CAUTIONS: For optimal recordings, clean the strip immediately after use. Do not reuse foam sensors. Strips are recommended for 25‐30 uses. Do not aggressively scrub the Sensor pads when cleaning. If Sensor pad is removed from strip discontinue use of strip. When removing the sensor strip from the headset, DO NOT pull or jerk the connector. 16 BIOPAC Systems, Inc. B-Alert X10 User Manual ...
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Page 17: Common Headset And Sensor Issues
Chapter 3: Acquisition Troubleshooting Common Headset and Sensor Issues The following topics describe critical troubleshooting methods to undertake when encountering problems during the setup session of a subject. Hands should be away from Face! Part thick hair and add cream. 17 BIOPAC Systems, Inc. B-Alert X10 User Manual ... - Page 18 NOTE: The recommendations are not necessarily listed in a logical sequence. Use best judgment to determine which trouble‐shooting tips are most relevant to the problem(s). 18 BIOPAC Systems, Inc. B-Alert X10 User Manual ...
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Page 19: Chapter 4: Specifications
Delta A/D converter Noise 3.2 mV peak to peak out to 100 Kohms resistance On‐line Impedance Monitoring Initiated by host computer using bi‐directional link for EEG Channels only Input Impedance 100 Gohm Connector Interface 22‐pin JST connector for Sensor Headset Head Unit Dimensions 5” long x 2.25” wide x 1” deep Head Unit Weight 4.0 ounces with batteries Case Material ABS Bluetooth Dongle Host Unit Bluetooth Version 2.0, class 1 B‐Alert dongle Software Personal computer with 1.5 MHz or higher processor 1 GB of RAM Compatibility running Windows XP Estimated File Size per Minute ~ 30 KB/Min/channel Recharging Batteries on Head Unit Provided by USB Port on Host 500 mA @ 5 Volts Workstation 19 BIOPAC Systems, Inc. B-Alert X10 User Manual ... -
Page 20: Environmental Conditions
F Altitude ‐390 m to 3012 m ‐390m to 3012 m ‐390m to 3012 m ‐1254 ft. to 9,882 ft. ‐1254 ft. to 9,882 ft ‐1254 ft. to 9,882 ft Atmospheric 70 kPa to 106 kPa 70 kPa to 106 kPa 70 kPa to 106 kPa Pressure 20.6 in. Hg to 31.3 in. Hg 20.6 in. Hg to 31.3 in. Hg 20.6 in. Hg to 31.3 in. Hg Relative Humidity 15% to 95% non‐condensing to be compliant with IEC 15% to 95% non‐ 15% to 95% non‐ 60601‐1, sub‐clause 44.5 condensing condensing Note: Preliminary Specifications, subject to change. 20 BIOPAC Systems, Inc. B-Alert X10 User Manual ... -
Page 21: Chapter 5: Compliance
Emissions Test Compliance Electromagnetic environment ‐ guidance The X10 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby Group 1 RF emissions electronic equipment. CISPR 11 RF emissions The X10 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low‐voltage Class B CISPR 11 power supply network that supplies buildings used for domestic purposes. Harmonic emissions N/A IEC 61000‐3‐2 Voltage fluctuations/ flicker emissions IEC 61000‐3‐3 21 BIOPAC Systems, Inc. B-Alert X10 User Manual ... - Page 22 4‐3 to 2.5 GHz Field strengths from fixed RF transmitters, as determined by an a should be less than the compliance level electromagnetic site survey, in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the X10 is used exceeds the applicable RF compliance level above, the X10 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re‐orienting or relocating the X10. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 22 BIOPAC Systems, Inc. B-Alert X10 User Manual ...
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Page 23: General Compliance
Safety Standards: IEC 60601‐1, CSA 601.1, EN865, EN/IEC Equipment classification 60601‐1‐2 2 edition Type of protection Internally powered by battery Degree of protection against electrical Type BF – Applied part shock Mode of operation Continuous Degree of protection against ingress of IEC 60601‐1, sub‐class 44.6 IPXO water/liquids Degree of Safety in presence of flammable IEC 60601‐1, sub‐clause 5.5, Not suitable mixtures Applied sensor label to indicate Type BF IEC 60601‐1 Symbol 2 of Table DII of Appendix D applied part Attention Symbol, consult accompanying IEC 60601‐1 Symbol 9 of Table DI of Appendix D documentation External case made with non‐conductive IEC 60601‐1, sub‐clause 16(b) plastic Case mechanically strong IEC 60601‐1 23 BIOPAC Systems, Inc. B-Alert X10 User Manual ... -
Page 24: Software License Agreement
No warranty claim will be allowed for Sensor Headset products damaged by improper use, operation or handling after delivery of the Sensor Headset product. Purchaser must file all claims resulting from damage in transit with the carrier or carrier’s agent. Expenses incurred in connection with claims for which Advanced Brain Monitoring, Inc. is not liable may be charged to the Purchaser. Upon submission of a warranty claim, Purchaser is deemed to have waived any and all other claims against Advanced Brain Monitoring, Inc. Advanced Brain Monitoring, Inc. shall in 24 BIOPAC Systems, Inc. B-Alert X10 User Manual ... -
Page 25: Returns And Service
Monitoring, Inc., Carlsbad, CA. Synapse is a registered trademark of Med‐Tek/Synapse, Arcadia, CA. All other products or brand names are trademarks or registered trademarks of their respective companies. Copyright © 2010 Advanced Brain Monitoring, Inc. All rights reserved. 25 BIOPAC Systems, Inc. B-Alert X10 User Manual ...
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