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Revised 11/21/18

4-3

Electromagnetic Compatibility (EMC)

Nicolet Cortical Stimulator

The Natus Neurology Incorporated Nicolet Cortical Stimulator needs special
precautions regarding EMC and needs to be installed and put into service
according to the Electromagnetic Compatibility (EMC) information provided in
the following Manufacturer’s Declaration.

Portable and mobile Radio Frequency (RF) communications equipment can
affect the operation of the Nicolet Cortical Stimulator.

The following is a list of the cables and other accessories that are used as part of
the Nicolet Cortical Stimulator that comply with sections 201.17 and 202 of IEC
60601-2-40, Ed. 2.0:

•

SSU Interface Cable - 5m (Control Unit to SSU)

•

SSU Interface Cable - 1m (1st to 2nd SSU)

•

Serial Interface Cable - 5m (Control 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 internal components, may result in increased
EMISSIONS or decreased IMMUNITY of the Nicolet Cortical Stimulator.

This Nicolet Cortical Stimulator is intended for use by healthcare
professionals only. This system may cause radio interference or may disrupt
the operation of nearby equipment. It may be necessary to take mitigation
measures, such as reorienting the Nicolet Cortical Stimulator or shielding
the location

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Summary of Contents for Nicolet

Page 1: ...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 ...

Page 2: ......

Page 3: ...afety Reference guides 1 5 Additional manuals available 1 5 Safety summary 1 6 Contraindications 1 6 Cautions and Warnings 1 7 Product specifications 1 9 Nicolet customers 1 9 Xltek customers 1 9 System configuration disclaimers 1 9 Weight and dimensions 1 10 Input requirements 1 10 Output specifications 1 10 Environmental considerations operating 1 11 Environmental considerations non operating 1 ...

Page 4: ...3 Cortical Stimulator cabling diagrams 3 4 OR Probe Biphasic Mode 3 5 Electrode Mode Nicolet Desktop 3 6 Probe Mode Nicolet Desktop 3 8 Connect the options accessories 3 10 Apply power to the Stimulus Control Unit SCU 3 11 Using the Nicolet Cortical Stimulator to set the Cortical Stimulator parameters 3 12 Using the Nicolet system to set the Cortical Stimulation parameters 3 16 Start the study usi...

Page 5: ...liance for IEC 60601 1 2 Ed 4 0 2014 4 5 Table 1 Electromagnetic emissions 4 5 Table 4 Immunity Test Levels Enclosure Port 4 5 Table 5 Immunity Test Levels Input A C Power Port 4 6 Table 7 Patient Coupling Port 4 6 Table 8 Immunity Test Levels Signal Input Output Parts Port 4 7 Table 9 Test specifications for Enclosure Port Immunity to RF wireless communications equipment 4 8 Error Codes Error cod...

Page 6: ...Nicolet Cortical Stimulator 4 Revised 11 21 18 Blank page ...

Page 7: ...es or using a hand held bipolar stimulator probe The acquisition system records EEG signals directly from the cortex via intracranial electrodes By observing the patient in person or through reviewing of video and analyzing the recorded EEG and clinical behavior the physician can evaluate the epileptiform focus as well as cortical structures and brain function near tumors About the Acquisition sys...

Page 8: ...and CE 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 helpdesk natus com www Natus com Natus Neurology Incorporated Phone 0049 0 180 501 5544 Fax 0049 0 89 83942777 service europe natus com www Natus com ...

Page 9: ... 1641 European Authorized Representative Manufacturer Natus Neurology Incorporated 3150 Pleasant View Road Middleton WI USA 53562 608 829 8500 1 800 356 0007 Fax 608 829 8589 www natus com Disposal at end of operating life instructions When the equipment comes to the end of its operating life it should be disposed of in accordance with local waste regulation authority which is typically within the...

Page 10: ...is 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 representations or warranties of any kind whatsoever with respect to this document Natus Neurology Incorporated disclaims all liabilities for loss or damage arising out of the possession sale or use of this ...

Page 11: ...Revised 11 21 18 1 1 1 General Information ...

Page 12: ...Nicolet Cortical Stimulator 1 2 Revised 11 21 18 Blank Page ...

Page 13: ...s field administrative staff nurses technicians physicians Neurosurgeons and Neurophysiologists who will be using this application Because Nicolet and Xltek Systems are designed for the Microsoft Windows operating system you will need to be familiar with its basic features Refer to the documentation supplied with Microsoft Windows Intended use The Nicolet Cortical Stimulator is intended for use in...

Page 14: ...lifier NOTE For simplicity the amplifier will be referred to hereafter as the C64 OR Amplifier The stimulus can be delivered from the Stimulus Switching Unit SSU independent of the Nicolet System This is referred to as the Electrode Biphasic Mode on the SCU Setup field Natus Quantum The Natus Quantum Amplifier may be used when stimulus to the patient is delivered from the Stimulus Control Unit SCU...

Page 15: ... use the Cortical Stimulator equipment during a Cortical Stimulation Study Read the Safety Reference guides Please read the Additional Information and Safety Notes in the Natus Quantum User and Service Manual 014556 and the NeuroWorks 9 Reference Manual 023933 thoroughly paying special attention to the Safety information before applying power to and using your NeuroWorks system and its options acc...

Page 16: ...ence Manual 023933 and Natus Quantum User and Service Manual 014556 To avoid the possibility of injury damage to your system or lost data always observe these safety precautions during system operation Contraindications DO NOT operate in the presence of flammable anesthetics DO NOT plug in or unplug power cord in the presence of combustible gas DO NOT operate in close proximity to radio transmitti...

Page 17: ... stimulation Any device connecting to the Trigger Output port must maintain the IEC 60601 1 approvals of the Nicolet Cortical Stimulator Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the Nicolet Cortical Stimulator including cables specified by the manufacturer Otherwise degradati...

Page 18: ... 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 neural tissue before starting the stimulation pulse train and stop the stimulation pulse train before removing the stimulator probe This will ensure the effective surface area of the stimulator probe will not be reduced DO NOT touch stimulatio...

Page 19: ...us Software is not recommended on any Natus Neurology Incorporated instrument Active and Normal scanning are not allowed during acquisition of patient data Anti Virus 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 configurations for Natus Neurology ...

Page 20: ...pter 5 for error codes and actions Stimulus Control Unit SCU Weight Less than 2 2lb 1kg Dimensions Length Width Height Maximum 3 3in 75mm System Power 15V 3A 45W Frequency Range 47 63Hz AC Voltage Current 100 240VAC 1 35A Current output Bi phasic constant current of up to 15 mA Stimulus levels 0 to 15 mA Train durations 0 1 to continuous Secs 20 in Bipolar Probe mode 0 1 to 30 Secs 20 in Electrode...

Page 21: ...tem was in use SSU mode this system will also power back up normally and can be used normally Temperature 15 6 C to 32 2 C 60 F to 90 F Relative 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 Safety Standard USA CAN CSA C22 2 no 601 1 M90 Medical Elec...

Page 22: ...l ethyl solution The Nicolet Cortical Stimulator product should be cleaned by medical professionals who are trained in techniques to prevent cross contamination and infection Cleaning the system Turn OFF the system power before cleaning the instrument Do not permit solutions to seep into the electronic portions of the components Take special care around controls connectors and panel edges Do not u...

Page 23: ...Revised 11 21 18 2 1 2 Nicolet Cortical Stimulator Overview ...

Page 24: ...Nicolet Cortical Stimulator 2 2 Revised 11 21 18 Blank Page ...

Page 25: ...plifier B Stimulus Switching Unit SSU C C64 OR Amplifier Headbox D Natus Base Unit E Quantum Main Breakout Box F Quantum Secondary Breakout Box 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 58 59 60 61 62 63 64 A B B C A D E F ...

Page 26: ...ted to the Acquisition system via a Serial port on the Desktop Laptop or Panel PC computer The Stimulus Control Unit SCU delivers trains of bi phasic constant current electrical pulses for direct cortical electrical stimulation procedures One pair of electrodes are selected to deliver the chosen stimulus Figure 1 Example Bi phasic stimulus pulse Legend A Train Duration B Stimulus Level ma C Pulse ...

Page 27: ...Revised 11 21 18 2 5 Overview LEGEND 1 Power Switch 2 15VDC Power In from Medical Power Supply 3 Bottom View PSU v32 1 2 3 ...

Page 28: ...numbers These are disabled in the Probe Biphasic mode Probe will be displayed when in the Probe Biphasic mode 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 the Set Stim button to select the least significant value and then enter by using the Selector knob Repeat as n...

Page 29: ...e use R Future use Future use S Serial Interface For Nicolet system interface T Not used Not used U Future use Future use V Display Displays parameter options you can choose after pressing one of the parameter buttons W Isolated Stimulation Outputs Probe Allows use of approved Natus Neurology Incorporated Hand held Bipolar Stimulating Probes without the Stimulus Switching Unit SSU This is referred...

Page 30: ... being applied Applies the selected stimulus to an internal load to verify correct operation The LED lights when this feature is enabled The actual current that is delivered is displayed in the Delivered Stimulation display field see Figure 1 below When stimulation is initiated and stopped from the Nicolet Cortical Stimulator software it is possible that only half of the stimulation amplitude will...

Page 31: ...ynchronization Trigger Input Trigger Output Isolated Stimulator Outputs Type BF Equipment Output Standby Power Supply Input 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 consult accompanying documents Symbol Description SYNC PSU v32 ...

Page 32: ...er 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 Amplifier B Cable Connector Connects to the Stimulus Control Unit SCU for 1 64 channels operation C Cable Connector Connects to second Stimulus Switching Unit SSU Amplifier when 65 to 128 channels ca...

Page 33: ...Amplifier acquires the electrical signals from the brain to the system for recording and display See Quantum amplifier terminology in Chapter 1 for definitions of the Natus Quantum amplifier A Natus Base Unit B Quantum Main Breakout Box C Quantum Secondary Breakout Box A B C ...

Page 34: ...SCU or through the Nicolet system software which provides you with a more versatile user interface The Nicolet system also is used for electrode labels and marking annotations on the recorded EEG NeuroWorks system The Stimulus Control Unit SCU may be connected to a NeuroWorks Quantum system via an RS 232 The stimulation delivered to the patient can be controlled from the Stimulus Control Unit SCU ...

Page 35: ...rt Stim Interface 128 Ch 085 476800 SSU Cable 5M Cort Stim Interface 64 Ch and 128 Ch 085 476900 SSU NIC1 C64 SSU Amp w Cable Holder No Low Pass Filter 672 610800 SSU NIC CSC64 SSU Amp w Cable Holder 140KHz Low Pass Filter 672 612500 SSU Cable 1M NIC Compact Amp Dbl w Bead 128 Ch 085 480000 SSU Cable 0 5M NIC Compact Amp w Bead 64 Ch 085 480100 SSU Cable NIC1 Compact Amp 10M 64 Ch and 128 Ch 085 4...

Page 36: ...e 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 configuration In this configuration you set up stimulus parameters and control delivery of stimulus from the Stimulator Control Unit SCU control panel Stimulus to the patient is delivered from the Stimulus Control Unit SCU via a...

Page 37: ...ers 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 Desktop computer can be replaced with a Laptop or Panel PC without the Video option A OR Probe Biphasic Mode Nicolet Desktop B Electrodes C C64 Headbox D C64 OR E Stimulus Control Unit SCU Medical Power Supply F Stimulus Cont...

Page 38: ...mulus Control Unit SCU to the Electrodes through the Stimulus Switching Unit SSU Electrode biphasic switching mode Nicolet desktop A Electrode Biphasic Switching Mode Nicolet Desktop B Electrodes C C64 Headbox D Stimulus Switching Unit SSU E Stimulus Control Unit SCU Medical Power Supply F Stimulus Control Unit SCU G Desktop Nicolet Acquisition Computer H USB Interface Board Used to connect C Seri...

Page 39: ...l delivery from the Stimulus Control Unit SCU control panel or by NeuroWorks Acquisition system Stimulus to the patient is delivered from the Stimulus Control Unit SCU to the Electrodes through the Quantum Breakout Box A Electrode Biphasic Switching Mode Nicolet Desktop B Desktop NeuroWorks Acquisition Computer C Natus Base Unit D Quantum Breakout E Stimulus Control Unit SCU E C D B A F ...

Page 40: ...m the Stimulus Control Unit SCU control panel or by NeuroWorks Acquisition system Stimulus to the patient is delivered from the Stimulus Control Unit SCU to the Electrodes through the Quantum Breakout Boxes A Electrode Biphasic Switching Mode Nicolet Desktop B Desktop NeuroWorks Acquisition Computer C Natus Base Unit Primary Breakout Box A D Secondary Breakout Box B E Stimulus Control Unit SCU G E...

Page 41: ...Revised 11 21 18 2 19 Overview Blank page ...

Page 42: ...Nicolet Cortical Stimulator 2 20 Revised 11 21 18 ...

Page 43: ...Revised 11 21 18 3 1 3 Performing a Cortical Stimulation Study ...

Page 44: ...Nicolet Cortical Stimulator 3 2 Revised 11 21 18 Blank Page ...

Page 45: ...es or using a hand held bipolar stimulator probe An EEG technician operates the computer which may be in a separate non sterile control room A nurse or other medical professional may also be present in the operating room The EEG recording system records EEG signals directly from the cortex via intracranial electrodes By observing the patient in person and reviewing video and analyzing the recorded...

Page 46: ...h Electrode Stimulus Switching Table 1 Amplifiers Key Description A First amplifier for 1 64 channel operation Probe Biphasic Stimulation B Second amplifier for 65 128 channel operation Probe Biphasic Stimulation C First amplifier for 1 64 channel operation Electrode Biphasic Stimulus Switching D Second amplifier for 65 128 channel operation Electrode Biphasic Stimulus Switching E Natus Base Unit ...

Page 47: ...obe Biphasic Mode Key Part Number Description A 222 496100 Stimulator Probe Use only the Natus Neurology Incorporated Bipolar Probe with 2 2 mm diameter tips B 515 005500 Stimulus Control Unit SCU C 113 405500 Hospital Grade Power Supply Red connector Black connector ...

Page 48: ...odes must have been cleared by the Food and Drug Administration FDA Electrode Mode Components NOTE Each SSU has two ports A B to interface to the SCU or another SSU Key Description Part Number A Dual C64 OR amplifiers shown with Stimulus Switching Unit SSU s See Note below 672 610800 B Stimulus Control Unit SCU 515 005500 C Hospital Grade Power Supply 113 405500 D Cort Stim Bipolar Probe 222 49610...

Page 49: ...e with ferrite 085 480100 Nic1 C64SSU Compact Amp Double Pigtail Cable with ferrite 085 480000 2 Cortical Stimulator Interface Cable 3M 085 476800 3 C64 Amplifier Cable 10m 085 461202 4 Cortical Stimulator Interface Cable 5M 085 476900 5 Cortical Stimulator RS232 Cable 085 479400 6 Cortical Stimulator Bipolar cable 222 496100 Red connector Black connector ...

Page 50: ... Nicolet Desktop Probe Mode Components Key Description Part Number A Dual C64 OR amplifiers shown for Probe stimulation 672 610800 B Stimulus Control Unit SCU 515 005500 C Hospital Grade Power Supply 113 405500 D Cort Stim Bipolar Probe 222 496100 E Desktop PC ...

Page 51: ...mber 1 Nic1 C64SSU Compact Amp single pigtail cable with ferrite 085 480100 Nic1 C64SSU Compact Amp double pigtail cable with ferrite 085 480000 2 C64 Amplifier cable 10m 085 461202 3 Cortical Stimulator RS232 cable 085 479400 4 Cortical Stimulator Bipolar cable 222 496100 Red connector Black connector ...

Page 52: ...Stimulus Control Unit SCU Top View 2 Stimulus Control Unit 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 Future use D Future use E RS232 interface for Nicolet Desktop Panel PC F Future use G Future use H Trigger Out ...

Page 53: ...ed 11 21 18 3 11 Performing a Cortical Stimulation Study Apply power to the Stimulus Control Unit SCU A B Key Description A Stimulus Control Unit SCU Bottom View B The green Power On LED illuminates when on ...

Page 54: ... through the options 3 Press the Selector knob or Parameter button to select the desired option NOTE To choose the desired parameter from the Setup menu use the Selector knob to navigate the sub menus 1 Press the Setup button 2 Turn the Selector knob to scroll through the available sub menus 3 Press the Selector knob to select the desired sub menu 4 Turn the Selector knob to scroll through the sub...

Page 55: ... to flash 2 Change Mode Press the Selector knob to select Change Mode You can choose from two options in the Change Mode function Change Mode Probe Biphasic Electrode Biphasic 3 Selector Knob Rotate the Selector knob to choose Probe Biphasic stimulus if using the probe or Electrode Biphasic if using the Stimulus Switching Unit SSU Press the Selector knob to make your selection 4 Other Functions To...

Page 56: ...ast 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 appears and then press the Selector knob 9 Negative Electrodes Press the Electrode Cathode button and turn the Selector knob until the desired electrode number or label appears and then press the Selector kno...

Page 57: ...ypical in 0 1 mA increments using the Selector knob NOTE If Electrode or Electrode are changed the stimulation 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 stimulation press the Mark Channel button 12 Check Stim Press the Check Stim button to check the integrity...

Page 58: ...nit 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 Electrodes Click on the Electrode Anode show menu button and then click on the desired electrode number or label 5 Negative Electrodes Click on the Electrode Cathode show menu button and then click on the desi...

Page 59: ...es the startup 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 is typical If any parameter is changed other than the Stimulation level the stimulation level will reset to 0 0 mA 9 Begin with a lowest current level and increase in small increments 10 If you...

Page 60: ...20 or more higher than the selected level stimulation is stopped automatically and an error report is generated 2 If you wish during surgery when using the Bipolar Probe you can select the Continuous mode by pressing the Train Duration button and selecting Continuous using the Selector knob NOTE If you change any parameters on the Stimulus Control Unit SCU stimulation will stop being delivered to ...

Page 61: ...al Stimulator The feature for software controlled cortical stimulation needs to be activated in the acquisition profile used for starting the study If Use Nicolet Cortical stimulator is not selected the DSM Stimulation window will only control the relays from the DSM Digital Switch Matrix in the Breakout s 1 From the Edit Settings window select the Acquisition tab Figure 1 2 Click on the Advanced ...

Page 62: ...Nicolet Cortical Stimulator 3 20 Revised 11 21 18 3 Click on check the Use Nicolet cortical stimulator checkbox ...

Page 63: ...lay the Cortical Stimulation control window Key Description 1 Status of cortical stimulator control interface 2 DSM control Manual selection of electrodes to stimulate 3 Settings for Nioolet Cortical Stimulator 4 DSM operating mode and status 5 Nicolet Cortical Stimulator internal stimulation test 6 Start stimulation 7 Manually stop stimulation before preset train duration ...

Page 64: ...empting to block seizure onset 9 Manual DSM relay control in Semi automatic or Manual modes 10 Confirmation of stimulation current applied to the electrodes Refer to Warning below 11 DSM control Preset selection of electrodes to stimulate Right click in this area to configure presets 12 Operating mode ...

Page 65: ...imulation current NOTE The stimulation current is reset automatically to 0mA when any of the other stimulation parameters are changed 4 Click on the Automatic button 5 Set the desired Relay Control mode Figure 2 Figure 2 Relays control mode window Optional Relay Control modes available are Automatic mode Software controls relays Device controls are disabled Semiautomatic mode When device controls ...

Page 66: ...omatic Semi automatic Semi automatic plus or Manual 7 Click OK to close the dialog Mode Use Case Operating Mode Automatic mode Used in case of full Cortical stimulation procedure from NeuroWorks software not from Nicolet Cortical stimulator device DSM relays are closed automatically prior to starting stimulation and opened after stimulation end In this mode buttons on stimulator are deactivated to...

Page 67: ... immediately on the stimulator When Nicolet Cortical Stimulation is initiated from NeuroWorks software the manual Stop button on the Stimulator unit is disabled To stop the stimulation use one of the following three methods Using Stop in NeuroWorks software Pressing Esc key on the keyboard Pressing first the Start and then the Stop buttons on a Nicolet Cortical Stimulator To quickly stop stimulati...

Page 68: ...of the following methods Select Stop in the software Press the Esc key on the keyboard Press the Start button first and then the Stop button on the Nicolet Cortical Stimulator To quickly stop stimulation in an emergency switch the Power button off on the Nicolet Cortical Stimulator unit Reviewing the recorded EEG Please refer to the Nicolet Information for Use guide 269 604503 and or the Nicolet S...

Page 69: ...Revised 11 21 18 4 1 4 ElectromagneticCompatibility EMC ...

Page 70: ...Nicolet Cortical Stimulator 4 2 Revised 11 21 18 Blank Page ...

Page 71: ...that comply with sections 201 17 and 202 of IEC 60601 2 40 Ed 2 0 SSU Interface Cable 5m Control Unit to SSU SSU Interface Cable 1m 1st to 2nd SSU Serial Interface Cable 5m Control 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 internal components ma...

Page 72: ...acceptable for no current to be sent as the device is expected to fail safe as long as the result is displayed correctly by way of an error code no current delivered or current delivered less than requested The cortical stimulator design includes as a safety feature the ability to monitor the stimulus output and compare it with the stimulus parameters requested If these two results differ e g as a...

Page 73: ...irectly connected to the public low voltage power supply network that supplies buildings used for domestic purposes provided the following warning is heeded This equipment system is intended for use by healthcare professionals only This equipment system may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take mitigation measures such as reorienting ...

Page 74: ... Induced by RF Fields IEC 61000 4 6 3 V 0 15 MHz 80 MHz 6 V in ISM bands between 0 15 MHz and 80 MHz 80 AM at 1 kHz Voltage Dips IEC 61000 4 11 100 dip 0 5 cycle At 0 45 90 135 180 225 270 and 315 100 dip 1 cycle and 30 dip 25 cycles 50Hz Single phase at 0 Voltage Interruptions IEC 61000 4 11 100 dip 250 cycles 50Hz 300 cycles 60 Hz Phenomenon Basic EMC Standard or Test Method Immunity Test Levels...

Page 75: ...Healthcare Facility Environment Electrostatic Discharge IEC 61000 4 2 8 kV contact 2 kV 4 kV 8 kV 15 kV air Electrical Fast Transients Bursts IEC 61000 4 4 1 kV 100 kHz repetition frequency Surges Line to Ground Common Mode IEC 61000 4 5 2 kV Conducted Disturbances Induced by RF Fields IEC 61000 4 6 3 V 0 15 MHz 80 MHz 6 V in ISM bands between 0 15 MHz and 80 MHz 80 AM at 1 kHz ...

Page 76: ... FRS 460 FM 5 kHz deviation 1 kHz sine 2 0 3 28 710 704 787 LTE Band 13 17 Pulse modulation 217 Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation 18 Hz 2 0 3 28 870 930 1 720 1 700 1 990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 2 UMTS Pulse modulation 217 Hz 2 0 3 28 1 845 1 970 2 450 2 400 2 570 990Bluetooth WLAN 802 11 b g n RFID 2450 LTE...

Page 77: ...Revised 11 21 18 5 1 5 Error Codes ...

Page 78: ...Nicolet Cortical Stimulator 5 2 Revised 11 21 18 Blank Page ...

Page 79: ...ode but no SSU is connected Connect a properly configured C64OR SSU amplifier s If using SSU mode and C64OR SSU amplifier s are already connected Troubleshoot connection s and configuration s of C64OR SSU amplifier s Error 27 A decoder disconnect occurred SSU failed to return channel assignment verification response to SCU Troubleshoot connection and configuration of connected C64OR SSU amplifier ...

Page 80: ...lue Press Start If error repeats replace control unit Error 40 CSCU processor failed to refresh watchdog Press Stop Reset stim value Press Start If error repeats replace control unit Error 48 Stimulus Control Unit SCU Checksum incorrect Power off Power on If error repeats replace control unit Error Code Error Message Action ...

Page 81: ...mulator parameters 3 12 3 16 D Declaration of compliance Table 1 Electromagnetic emissions 4 5 Table 4 Immunity Test Levels Enclosure Port 4 5 Table 5 Immunity Test Levels Input A C Power Port 4 6 Table 7 Patient Coupling Port 4 6 Table 8 Immunity Test Levels Signal Input Output Parts Port 4 7 Table 9 Test specifications for Enclosure Port Immunity to RF wireless communications equipment 4 8 Decla...

Page 82: ... and standards conformity 4 4 Safety Reference guides 1 5 Safety summary 1 6 SCU 1 4 SCU Stimulus Control Unit 1 5 2 14 2 15 2 16 Selector Knob 2 6 Serial Interface 2 7 Set Stim 2 6 3 15 Set the Cortical Stimulator parameters 3 12 3 16 Setup 2 6 Single Pulse 2 6 SSU Stimulus Switching Unit 1 4 1 5 2 16 Standards conformity 4 4 Start 2 6 Start a stimulation using NeuroWorks 3 18 Start the study usi...

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