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Nicolet System

Nicolet™ Cortical

Stimulator User Guide

March, 2010

Nicolet Cortical Stimulator

User Guide

269-621500 Rev 0

3

© 2013 Natus

Medical Incorporated or one of its subsidiaries. All rights reserved.

Natus is a registered trademark of Natus Medical Incorporated. All product names appearing on this document
are trademarks or registered trademarks owned, licensed to, promoted or distributed by Natus Medical Incorpo-
rated, its subsidiaries or affiliates. All other trademarks are the property of their respective owners.

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Summary of Contents for Nicolet SCU

Page 1: ...ne of its subsidiaries All rights reserved Natus is a registered trademark of Natus Medical Incorporated All product names appearing on this document are trademarks or registered trademarks owned lice...

Page 2: ......

Page 3: ...ce guides 1 4 Additional manuals available 1 4 Safety summary 1 5 Cautions and Warnings 1 6 Product specifications 1 7 System configuration disclaimers 1 8 a Antivirus and third party software and har...

Page 4: ...mode Nicolet Panel PC 2 16 Performing a Cortical Stimulation Study Cortical Stimulator cabling diagrams 3 3 OR Probe Biphasic Mode 3 4 Electrode Mode Nicolet Desktop 3 5 Electrode Biphasic mode Nicol...

Page 5: ...sing a hand held bipolar stimulator probe The Nicolet system records EEG signals directly from the cortex via intracranial electrodes By observing the patient in person or through reviewing of video a...

Page 6: ...mark Compliant to Medical Device Directive 93 42 EEC Technical support Domestic International Natus Neurology Incorporated 3150 Pleasant View Road Middleton WI USA 53562 1 800 356 0007 madison helpdes...

Page 7: ...t or operator at risk Image on blue background ISO 7010 M002 Consult Operating Instructions ISO 7000 1641 European Authorized Representative Manufacturer Natus Neurology Incorporated 3150 Pleasant Vie...

Page 8: ...preserved This copy of the User Manual shall be used only in accordance with the conditions of sale of Natus Neurology Incorporated or its distributors Natus Neurology Incorporated makes no represent...

Page 9: ...Revised 8 27 13 1 1 1 General Information...

Page 10: ...Nicolet Cortical Stimulator 1 2 Revised 8 27 13 Blank Page...

Page 11: ...ing stimulation via electrode pairs or a hand held bipolar probe C64 OR amplifier terminology The C64 OR Amplifier my be used when stimulus to the patient is delivered from the Stimulus Control Unit S...

Page 12: ...pter 3 provides instructions on how to use the Cortical Stimulator equipment during a Cortical Stimulation Study Read the Safety Reference guides Please read the Additional Information and Safety Note...

Page 13: ...practices that could result in damage to the equipment NOTE Notes help you identify areas of possible confusion and avoid potential problems during system operation IMPORTANT Read and follow all WARNI...

Page 14: ...timulator product prior to initial use When in use the Nicolet Cortical Stimulator must be attended at all times by medical professionals trained in cortical stimulation The Nicolet Cortical Stimulato...

Page 15: ...with a low current level and increase in small increments When stimulating with a hand held probe keep the probe in firm contact with cortical tissue Place the stimulator probe in contact with the neu...

Page 16: ...software will interrupt the recording resulting in complete or partial inability to record patient data Natus Neurology Incorporated network consultants can recommend network and antivirus software co...

Page 17: ...ons Length Width Height 3in 75mm 1in 25mm 4 5in 115mm 3in 76mm 1 7in 45mm System Power 15V 3A 45W Frequency Range 47 63Hz AC Voltage Current 100 240VAC 1 35A Current output Bi phasic constant current...

Page 18: ...Humidity 20 80 non condensing Altitude 0 3 km 0 10 000 ft Temperature 17 7 C to 55 C 0 F to 132 F Relative Humidity 10 90 non condensing Altitude 0 12 km 0 40 000 ft UL 60601 1 Medical Electrical Saf...

Page 19: ...ng the system Routinely check the components for exterior damage Periodically check the system ground integrity the system leakage current and the patient leakage current Follow your medical facilitie...

Page 20: ...are around controls connectors and panel edges Do not use any abrasive cleaners The proper cleaning method for non critical medical devices permits the use of 70 isopropyl ethyl solution Remove any du...

Page 21: ...Revised 8 27 13 2 1 2 Nicolet Cortical Stimulator Overview...

Page 22: ...Nicolet Cortical Stimulator 2 2 Revised 8 27 13 Blank Page...

Page 23: ...U D C64 OR Amplifier Headbox 1 2 R R N N 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 5...

Page 24: ...ant current stimulation and may be connected to the Acquisition system via a Serial port on the Desktop Laptop or Panel PC computer The Stimulus Control Unit SCU can deliver the following stimuli Bi p...

Page 25: ...from Medical Power Supply Nicolet Cortical Stimulator Status Setup Pulse Frequency Pulse Duration Electrode Electrode Train Duration Delivered Stim Set Stim Check Stim Ictal Disrupt Mark Channel Start...

Page 26: ...the channel numbers H Set Stim 1 2 Sets the current level applied to the patient measured from baseline to peak 8 mAmps or less typical Enter the most significant value using the Selector Knob Press...

Page 27: ...For service diagnostics and optionally for computer interface U Remote Start Stop Future use V Display Displays parameter options you can choose after pressing one of the parameter buttons W Isolated...

Page 28: ...t the current level applied to the patient Display the stimulation level being applied Applies the selected stimulus to an internal load to verify correct operation The LED lights when this feature is...

Page 29: ...Serial Date of Manufacture CE Mark Medical device listing mark for U S and Canada by Intertek Testing Service Special Recycling Required Do not dispose in landfill Electrostatic sensitive Attention co...

Page 30: ...r acquires the electrical signals from the brain to the system for recording and display See C64 OR amplifier terminology in Chapter 1 for definitions of the C64 OR and C64 OR SSU amplifiers A C64 OR...

Page 31: ...Control Unit SCU may be connected to a Nicolet system Desktop Laptop or Panel PC computer via an RS 232 port The stimulation delivered to the patient can be controlled from the Stimulus Control Unit S...

Page 32: ...let Panel PC OR probe biphasic mode In this configuration the Stimulus Control Unit SCU is an independent device and does not require the Nicolet application EEG data is not collected in this configur...

Page 33: ...C64 OR EEG amplifiers Cortical stimulation results along with EEG data are viewed on the Nicolet Acquisition Computer in the operating room which also acquires and stores the EEG data Note The Deskto...

Page 34: ...ivered from the Stimulus Control Unit SCU to the Electrodes through the Stimulus Switching Unit SSU Electrode biphasic switching mode Nicolet desktop A Electrode Biphasic Switching Mode Nicolet Deskto...

Page 35: ...trode Biphasic Switching Mode Nicolet Laptop B Electrodes C C64 Headbox D Stimulus Switching Unit SSU E Stimulus Control Unit SCU Medical Power Supply F Stimulus Control Unit SCU G Laptop Nicolet Acqu...

Page 36: ...Panel PC A Electrode Biphasic Switching Mode Nicolet Panel PC B Electrodes C Headbox D Stimulus Switching Unit SSU E Stimulus Control Unit SCU Medical Power Supply F Stimulus Control Unit SCU G Panel...

Page 37: ...Revised 8 27 13 3 1 3 Performing a Cortical Stimulation Study...

Page 38: ...Nicolet Cortical Stimulator 3 2 Revised 8 27 13 Blank Page...

Page 39: ...nnel operation Electrode Biphasic Stimulus Switching 1 2 R R N N 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 5...

Page 40: ...n Electro de Electro de Train Duration Delivered Stim Se t Stim Ch eck Stim Ictal Disrup t Ch an ne l Mark Start Stop B A C 1 2 3 1 3 Cable Connections A Stimulator Probe Use only the Natus Neurology...

Page 41: ...porated Bipolar Probe with 2 2 mm diameter tips E Desktop PC Red connector Black connector 1 2 R R N N 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37...

Page 42: ...2 mm diameter tips E I Box F Hospital Grade Power Supply Provided G Laptop Computer Red connector Black connector 1 2 R R N N 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29...

Page 43: ...u ratio n De livered Stim Se t Stim Ch eck Stim Ictal Disrup t Ch an ne l Mark Start Stop 1 2 R R N N 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37...

Page 44: ...51 52 53 54 55 56 57 58 59 60 61 62 63 64 Ni colet Co r tic alStimula tor Statu s Se tup Pu lseFre qu en cy Pu lseDu rat ion Ele c tro de Ele c tro de Tra in Du rat ion De live red Stim Se tStim Ch ec...

Page 45: ...SCU Side View A Stimulator Probe Use only the Natus Neurology Incorporated Bipolar Probe with 2 2 mm diameter tips B Stimulus Switching Unit SSU Interface C Remote Start Stop Future use D For service...

Page 46: ...Nicolet Cortical Stimulator 3 10 Revised 8 27 13 Apply power to the Stimulus Control Unit SCU A B A Stimulus Control Unit SCU Bottom View B The green Power On LED illuminates when on...

Page 47: ...sired option IMPORTANT The stimulus output is stopped automatically if the current delivered exceeds the requested current level by 20 or greater The Nicolet Cortical Stimulator must be turned off and...

Page 48: ...b Rotate the Selector knob to choose Probe Bi phasic stimulus if using the probe or Electrode Bi phasic if using the Stimulus Switching Unit SSU Press the Selector knob to make your selection 4 Other...

Page 49: ...he last selected Duration setting becomes the startup default setting 8 Positive Electrodes Press the Electrode Anode button and turn the Selector knob until the desired electrode number or label appe...

Page 50: ...lation current level will reset to 0 mA Begin with the lowest current level and increase in small increments 11 Mark Channel If you want to mark the channels with ID tags prior to and after stimulatio...

Page 51: ...ng Unit SSU 3 Train Duration Click on the Train Duration button and then select the desired train duration Units of seconds 5 seconds typical or Continuous if using a stimulator probe 4 Positive Elect...

Page 52: ...tartup default setting 8 Stimulation level At startup the Stimulation level is set to 0 0 mA Click on the Set Stim show menu button and then select the desired stimulation level 0 15 mA 8 mA or less i...

Page 53: ...n is displayed on the Stimulus Control Unit SCU display Level of stimulation being delivered to the patient is displayed If the level is 20 or more higher than the selected level stimulation is stoppe...

Page 54: ...ol Unit SCU Stop button or stop from your Stimulus Control Unit SCU panel 2 To resume stimulating the patient press the Start button again Reviewing the recorded EEG Please refer to the Nicolet Inform...

Page 55: ...Revised 8 27 13 4 1 4 Electromagnetic Compatibility EMC...

Page 56: ...Nicolet Cortical Stimulator 4 2 Revised 8 27 13 Blank Page...

Page 57: ...l Unit to Computer Use of cables or accessories other than those specified with the exception of cables and accessories sold by the manufacturer Natus Neurology Incorporated as replacement parts for i...

Page 58: ...s acceptable for the Nicolet Cortical Stimulator to detect an error during EFT and ESD immunity testing as long as the user can recover by repowering the Nicolet Cortical Stimulator and or restarting...

Page 59: ...hat of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical...

Page 60: ...d separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interf...

Page 61: ...as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 k...

Page 62: ...Nicolet Cortical Stimulator 4 8 Revised 8 27 13 Blank page...

Page 63: ...Revised 8 27 13 5 1 5 Error Codes...

Page 64: ...Nicolet Cortical Stimulator 5 2 Revised 8 27 13 Blank Page...

Page 65: ...One or more of the Stimulus Switching Units SSUs are not available ready Error 26 Decoder s communication error Error 27 A decoder disconnect occurred Error 28 Stimulus current flowing when it shouldn...

Page 66: ...Nicolet Cortical Stimulator 5 4 Revised 8 27 13 Blank page...

Page 67: ...etOne Laptop 3 8 Connections Probe Mode NicoletOne Desktop 3 7 Constant current 2 4 Copyright iv Cortical Stimulator cabling diagrams 3 3 Cortical Stimulator components 2 3 Cortical Stimulator paramet...

Page 68: ...tor Knob 2 6 Serial Interface 2 6 Set Stim 2 6 3 14 Set the Cortical Stimulator parameters 3 11 3 15 Setup 2 6 Single Pulse 2 6 SSU Stimulus Switching Unit 1 3 1 4 2 14 2 15 2 16 Start 2 6 Start the s...

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