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XLTEK EEG32U

User and Service Manual

Summary of Contents for XLTEK EEG32U

Page 1: ...XLTEK EEG32U User and Service Manual...

Page 2: ...l rights reserved This manual contains proprietary information which is protected by copyright and may not be copied in whole or in part except with the prior written permission of Natus Medical Incor...

Page 3: ...CC 14 Warnings and Cautions 15 General Warnings 15 Electrical Warnings and Cautions 16 Patient Environment Warnings and Cautions 17 Transportation Warnings 18 Conducted Immunity Warnings 18 Procedures...

Page 4: ...Isolation Transformer Details 31 Maintenance Cleaning Disposal 32 Recommendations 32 Disposal 33 Troubleshooting 34 Theory of Operation 35 Introduction 35 System Overview 35 Features of the EEG32U Sy...

Page 5: ...sed in conjunction with Natus NeuroWorks software to acquire scalp electroencephalographic EEG signals The EEG32U Amplifier is intended to be used by trained medical professionals and is designed for...

Page 6: ...onvention Description Function This symbol denotes a warning or important information that should not be missed Read all warnings and cautions carefully before starting the system for the first time A...

Page 7: ...0 1Hz 70 Hz bandwidth EEG Channel Hardware Gain 125 Maximum Differential AC Input Before Clipping Referential 20 mV Maximum Operational DC Input Voltage Electrode Offset 1000 mV Input Bias Current 20...

Page 8: ...USB 2 0 USB 2 0 Full Speed 12Mbit sec Amplifier Mechanical Interface Cable USB 2 0 cable maximum 3m Approximate Size 160 mm l x 97mm w x 29mm d Environmental Conditions for Use Operating Environmental...

Page 9: ...2011 ANSI AAMI ES60601 1 2005 R 2012 C1 2009 R 2012 and A2 2010 R 2012 IEC 60601 1 2005 C1 2006 and C2 2007 Third Edition CENELEC EN 60601 1 2006 A1 2013 Medical electrical equipment Part 1 General re...

Page 10: ...bility EMC Part 4 6 Testing and Measurement Techniques Immunity to Conducted Disturbances Induced by Radio frequency Fields IEC 61000 4 8 2009 ed 2 0 Electromagnetic Compatibility EMC Part 4 8 Testing...

Page 11: ...t Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 The EEG32U uses RF energy only for its internal function Therefore its RF emissions are very low and not likely to cause...

Page 12: ...ould be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode Complies Mains power quality should be that of a typical commercial or hospital...

Page 13: ...the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site1 should be less than the compliance level in each frequency2 Interfe...

Page 14: ...800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation b 217 Hz 2 0 3 28 1 845 1 970 2 450 2 400 2 570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation b 217 Hz 2 0 3 28...

Page 15: ...ted in a commercial environment This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instruction manual may cause harmful interfere...

Page 16: ...sions or decreased immunity of the equipment and may cause the system to be non compliant with the requirements of IEC 60601 1 2 2007 The computer and the peripherals used with the EEG32U headbox and...

Page 17: ...han 30 cm 12 inches to any part of the EEG32U System including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result Electrical Warnings and Caut...

Page 18: ...ied via MPSO with a separating transformer Do NOT connect electrical equipment which has not been supplied as a part of the system to the MPSO Patient Environment Warnings and Cautions NOTE The patien...

Page 19: ...transports carts or operating surfaces Natus is not responsible for any injury or damage that may result from improper cable storage during transport TIPPING HAZARD During transport the user should g...

Page 20: ...atic electricity to damage the product components Avoid carpets in cool dry areas If provided leave the product components in their anti static packaging until ready to be installed Take care when con...

Page 21: ...e is present on the EEG waveforms try to identify possible culprits by disconnecting nearby equipment from the common power source Lay out the interconnection cables as far as possible from the cables...

Page 22: ...NTION Consult Accompanying Documents and Consult Accompanying Documents Protective Earth Ground Type BF Equipment Dangerous Voltage Alternating Current Direct Current 5VDC 0 2A Power On Power Off EU o...

Page 23: ...e or Static Sensitive Manufacturer Information Reference Number This is the part number for the device The ETL mark is a safety symbol that shows the product was independently tested and certified to...

Page 24: ...uct Images EEG32U Headbox EEG32U Headbox 1 Standard 10 20 Channel Inputs 2 Impedance LEDs 3 Patient Ground 4 Additional Referential Inputs 5 Impedance Threshold LEDs 6 Impedance Button 7 Photic Stim C...

Page 25: ...EEG32U make sure the following items are included EEG32U headbox USB 2 0 cable Patient event switch Optional Accessories EEG accessory kit NOTE The EEG32U amplifier should be used only with cables tr...

Page 26: ...efer to the Transport System Specifications and Maintenance section for placement details and cautions for the different cart transportation options Refer to the corresponding Instructions for Use for...

Page 27: ...Patient Event input on the headbox 4 If a Photic Stimulator is needed insert the Photic Stimulator into the Photic Stimulator connection on the base unit 5 When you are ready to run a study connect th...

Page 28: ...crovolts peak to peak The accuracy of the gain is 1 NOTE For more information on setting up a montage consult the online Help Channel Test While you are working in the NeuroWorks live recording screen...

Page 29: ...are connected To Activate an Impedance Check Do one of the following On the keyboard press the minus key on the number pad Choose Controls Impedance Check Press the Impedance button on the headbox hol...

Page 30: ...ne of the Threshold buttons in the Threshold Group box on the right side of the Check Impedance screen To read a numerical value for the impedance in kOhms double click on the headbox picture on the s...

Page 31: ...on System setup and installation should be performed by Natus qualified personnel only XLTEK Trolley Specifications Mounting Location Default Equipment Equipment Weight lbs Maximum Load lbs including...

Page 32: ...Natus is not responsible for any injury or damage that may result from inadequate poorly constructed or unapproved transports carts or operating surfaces Natus is not responsible for any injury or da...

Page 33: ...U amplifier and its components should not be immersed in water or any other fluid To clean use a damp cloth to wipe all surfaces Taking basic care of the system and avoiding extreme physical abuse hel...

Page 34: ...life when disposing of the EEG32U amplifier and its components it is recommended that federal state and local laws be followed for proper disposal of printed circuit boards plastics and metal parts F...

Page 35: ...rly into the headbox not loosely Make sure there are no apparent breaks in the patient electrode cables Are any of the electrodes touching If so they are causing a short circuit and will develop an ar...

Page 36: ...puter Allows selection of reference signal Provides internally generated test signals sine and square for user assessment of equipment performance Components of the Communications Link Digitized wavef...

Page 37: ...tion the NeuroWorks computer calculates and transmits the channels gains to each digital board Whenever a study starts the computer uses these stored values to scale the digitized signals channel by c...

Page 38: ...3 Choose Shut Down from the Start menu 4 Select Restart the computer and click Yes Step 4 Shut Down the Computer Sometimes you need to shutdown the computer completely in order to solve a problem 1 C...

Page 39: ...Service Manual 10440 Natus Photic Stimulator 026274 4 Port USB hub 026275 12VDC power adaptor 105546 EEG32U TROLLEY MOUNT 008556 EEG32U MOUNT 102181 EEG32U Brain Monitor Breakout Box Roll Stand 10351...

Page 40: ...ons 6 Environmental Conditions for Use 7 Host Interface 7 Modes of Operation 6 Photic Stim Interface 6 User Interface 6 System Images 23 Testing the Amplifier 26 Theory of Operation MERGEFORMAT 35 EEG...

Page 41: ...C Standards of Compliance and Normative References 8 Safety Standards of Compliance and Normative References 8 Testing Calibration 27 Channel Test 27 Available Signal Settings 28 Signal Control 27 Imp...

Page 42: ...taffed with technical and clinical experts 24 7 support remote support via WebEx or VPN the largest clinical and technical field support network in Neuro Sleep and customized service contracts that in...

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