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natus Nicolet User Manual

Cortical stimulator
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Nicolet System
Nicolet™ Cortical Stimulator
User Guide
November 29, 2018
269-621500 Rev 07
© 2018 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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  • Page 1 © 2018 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-...

  • Page 3: Table Of Contents

    Table of Contents Table of contents About the Nicolet Cortical Stimulator.......................1-i About the Acquisition systems ...........................1-i Natus EU authorized representative.........................1-ii CE mark ................................1-ii Technical support ...............................1-ii Labels and symbols ............................1-iii Copyright ................................1-iv General Information Intended readers..............................1-3 Intended use ................................1-3 Amplifier terminology............................1-4 C64-OR Amplifier ............................1-4...
  • Page 4 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 using the Nicolet system......................3-18 To start a stimulation using NeuroWorks ......................3-18...
  • Page 5 Table of Contents Electromagnetic Compatibility (EMC) Nicolet Cortical Stimulator..........................4-3 Safety and standards conformity ........................4-4 Essential performance ............................4-4 Safety standards..............................4-4 Declaration of compliance 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 –...
  • Page 6 Nicolet Cortical Stimulator Blank page. Revised 11/21/18...

  • Page 7: About The Nicolet Cortical Stimulator

    Preface About the Nicolet Cortical Stimulator The Nicolet Cortical Stimulator can be used as an independent device or as an option for use with the Nicolet system. It is used to support brain mapping procedures. The Nicolet Cortical Stimulator enhances a physician’s ability to conduct cortical stimulation studies during surgical evaluations for epilepsy and tumors.

  • Page 8: Natus Eu Authorized Representative

    Nicolet Cortical Stimulator Natus EU authorized representative Natus Manufacturing Limited IDA Business Park Gort, Co.Galway, Ireland CE mark Compliant to Medical Device Directive 93/42/EEC Technical support Domestic International Natus Neurology Incorporated Natus Neurology Incorporated 3150 Pleasant View Road Phone: 0049 (0) 180 501 5544...

  • Page 9: Labels And Symbols

    Preface Labels and symbols The following labels and symbols may be affixed to the Nicolet Cortical Stimulator: When applied on device: Attention: Consult Accompanying Docu- mentation. (ISO 7000-0434A) When used in documentation: Caution, Warning or Precaution fol- lows. Consult Operating Instructions. Failure to follow operating instructions could place the patient or operator at risk.

  • Page 10: Copyright

    Natus Neurology Incorporated. The copyright and the foregoing restrictions on the copyright use extend to all media in which this information is preserved.

  • Page 11: General Information

    General Information Revised 11/21/18...
  • Page 12 Nicolet Cortical Stimulator Blank Page Revised 11/21/18...

  • Page 13: Intended Readers

    General Information Intended readers The Nicolet Cortical Stimulator can be used as an independent device or as an option for use with the Nicolet or Xltek System. The Nicolet or Xltek System facilitates the capture and review of electroneurophysiological data. This manual has been written for those experienced in this field –...

  • Page 14: Amplifier Terminology

    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) via a hand held bipolar probe.

  • Page 15: Basic Organization

    Chapter 2 provides an overview of the Stimulus Control Unit (SCU), Stimulus Switching Unit (SSU), Natus Quantum and C64-OR Amplifier as well as general information on the software and Nicolet/Xltek System. Also included in this chapter is a block diagram showing a possible example configuration scenario.

  • Page 16: Safety Summary

    IMPORTANT: Read and follow all WARNINGS, CAUTIONS and NOTES provided in Additional Information and Safety Notes for Assorted Nicolet Brand Products Reference Guide 269-594705 on CD part number 482-638702 as well as the NeuroWorks 9 Reference Manual (023933) and Natus Quantum User and Service Manual (014556).

  • Page 17: Cautions And Warnings

    Use of the Nicolet Cortical Stimulator product is restricted to medical professionals trained in the use of cortical stimulation. It is strongly recommended that users be trained in the use of the Nicolet Cortical Stimulator product prior to initial use.
  • Page 18 Nicolet Cortical Stimulator The applicable stimulation probe is the Natus Neurology Incorporated Bipolar Stimulation Probe with 2.2mm diameter tips. The applicable stimulation electrodes are any commercially available 2.3mm diameter Strip and Grid Electrodes. In the United States only, the stimulation electrodes and stimulation probes must have been cleared to market by the Food and Drug Administration (FDA).

  • Page 19: Product Specifications

    General Information Product specifications Nicolet customers Refer to Nicolet with LTM Module Product Specification Sheet (P/N 169- 432900) for a complete set of technical specifications. Xltek customers Refer to Natus Quantum Product Specification Sheet (P/N 015467E) and the NeuroWorks 9 Reference Manual (023933) and for a complete set of technical specifications.

  • Page 20: Weight And Dimensions

    1.0 mA to 15 mA (±20% or 0.05mA, whichever is larger). 15 mA maximum current limit at 1K load. Note: The Nicolet Cortical Stimulator is calibrated at the factory, and then is self- monitoring. If the unit is out of calibration, it will display an error code and must be replaced.

  • Page 21: Environmental Considerations (Operating)

    10% - 90% (non-condensing) Altitude 0-12 km (0-40,000 ft) Regulatory standards The Nicolet Cortical Stimulator meets the following safety standards set by domestic and international regulatory agencies for Medical Electrical Equipment. Type BF applied device. UL 60601-1 Medical Electrical Safety Standard (USA) CAN/CSA-C22.2 no.

  • Page 22: Preventive Maintenance

    Use a brush to dislodge any dirt on or around the connectors and panel edges. Storage Store the Nicolet Cortical Stimulator components in a cool, dry place. Instructions for disposal at end of operating life 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 local government office.

  • Page 23: Nicolet Cortical Stimulator Overview

    Nicolet Cortical Stimulator Overview Revised 11/21/18...
  • Page 24 Nicolet Cortical Stimulator Blank Page Revised 11/21/18...

  • Page 25: The Nicolet Cortical Compatible Amplifiers

    Overview The Nicolet Cortical compatible amplifiers The Nicolet Cortical Stimulator consists of the following items: C64-OR Amplifier Stimulus Switching Unit (SSU) C64-OR Amplifier - Headbox Natus Base Unit Quantum Main Breakout Box Quantum Secondary Breakout Box Revised 11/21/18...

  • Page 26: Stimulus Control Unit (Scu)

    Nicolet Cortical Stimulator Stimulus Control Unit The Stimulus Control Unit (SCU) is equipped with built-in controls and a display. It provides isolated constant current stimulation and may be connected to (SCU) the Acquisition system via a Serial port on the Desktop, Laptop, or Panel PC computer.
  • Page 27 Overview PSU-v32 LEGEND Power Switch 15VDC Power In from Medical Power Supply Bottom View Revised 11/21/18...
  • Page 28 Nicolet Cortical Stimulator LEGEND Status Shows current status of the stimulator: Set-up, Ready, Stim On. Setup Changes the Stimulus Control Unit (SCU) parameters. Change Mode Probe Biphasic Electrode Biphasic Select Label Set Numeric Montage Delete Label Set Select Language A list of available languages appears...
  • Page 29 Displays parameter options you can choose after pressing one of the parameter buttons. W Isolated Stimulation Allows use of approved Natus Neurology Incorporated Hand-held, Bipolar Outputs, Probe Stimulating Probes without the Stimulus Switching Unit (SSU). This is referred to as the Probe Biphasic mode.

  • Page 30: Nicolet Cortical Stimulator Symbols

    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 be recorded. This is a result of the timing of opening the Switch Matrix Relays while the stimulator is still sending the stimulus and measuring the delivered output.
  • Page 31 Overview Symbol Description Press button to mark the selected channels. Start. Deliver stimulation pulse. Deliver a single stimulus pulse. Stop stimulation. Not used Start/Stop. Trigger Synchronization. SYNC Trigger Input. Trigger Output. Isolated Stimulator Outputs. Type BF Equipment. Output. Standby. Power Supply Input. PSU-v32 Serial.

  • Page 32: Stimulus Switching Unit (Ssu)

    Nicolet Cortical Stimulator Stimulus Switching The Stimulus Switching Unit (SSU) interfaces with the C64-OR amplifier and the Stimulus Control Unit (SCU). It provides an electronic method of selecting Unit (SSU) electrode pairs to stimulate the patient without disconnecting the electrodes from the amplifier.

  • Page 33: Natus Quantum Amplifier

    Overview Natus Quantum The Natus Quantum Amplifier acquires the electrical signals from the brain to the system for recording and display. See Quantum amplifier terminology in amplifier Chapter 1 for definitions of the Natus Quantum amplifier. Natus Base Unit Quantum Main Breakout Box...

  • Page 34: Hand-Held Stimulating Probes

    Stimulus Control Unit (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.

  • Page 35: System Components

    Quantum Natus Quantum Breakout to Base Cable, 10m 013348 Quantum Natus Quantum Breakout to Breakout Cable 013415 Quantum Natus Quantum REF Jumper Cable, 3ft 014883 Quantum Natus Quantum Stim Daisy Chain Cable, 1 to 2, 013769 41in 2-13 Revised 11/21/18...

  • Page 36: Block Diagrams

    OR probe biphasic 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 mode configuration. In this configuration, you set up stimulus parameters and control delivery of stimulus from the Stimulator Control Unit (SCU) control panel.

  • Page 37: Or Probe Biphasic Mode - Nicolet Desktop

    EEG data is collected and amplified by the 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.

  • Page 38: Electrode Biphasic Modes

    Stimulus to the patient is delivered from the Stimulus Control Unit (SCU) to the Electrodes through the Stimulus Switching Unit (SSU). Electrode biphasic switching mode - Nicolet desktop Electrode Biphasic Switching Mode - Nicolet Desktop Electrodes C64 Headbox...
  • Page 39 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. Electrode Biphasic Switching Mode - Nicolet Desktop Desktop - NeuroWorks Acquisition Computer Natus Base Unit...
  • Page 40 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. Electrode Biphasic Switching Mode - Nicolet Desktop Desktop - NeuroWorks Acquisition Computer Natus Base Unit...
  • Page 41 Overview Blank page. 2-19 Revised 11/21/18...
  • Page 42 Nicolet Cortical Stimulator 2-20 Revised 11/21/18...

  • Page 43: Performing A Cortical Stimulation Study

    Performing a Cortical Stimulation Study Revised 11/21/18...
  • Page 44 Nicolet Cortical Stimulator Blank Page Revised 11/21/18...

  • Page 45: Introduction

    Performing a Cortical Stimulation Study Introduction The Cortical Stimulator enhances a physician’s ability to conduct cortical stimulation studies during surgical evaluations for epilepsy and tumors. During a study, the physician applies an electrical current directly to the cortex using paired, intracranial electrodes or using a hand-held bipolar stimulator probe. An EEG technician operates the computer, which may be in a separate (non-sterile) control room.

  • Page 46: Cortical Stimulator Cabling Diagrams

    Nicolet Cortical Stimulator Cortical Stimulator cabling diagrams The following pages illustrate the components and cabling schemes for the Nicolet Cortical Stimulator. NOTE: The Stimulating Probe and cable connectors styles may vary from those shown. The Stimulating Probe is optional with Electrode Stimulus Switching.

  • Page 47: Or Probe Biphasic Mode

    Performing a Cortical Stimulation Study OR Probe Biphasic Mode Part Number Description 222-496100 Stimulator Probe - Use only the Natus Neurology Incorporated Bipolar Probe with 2.2 mm diameter tips 515-005500 Stimulus Control Unit (SCU) 113-405500 Hospital Grade Power Supply Red connector...

  • Page 48: Electrode Mode - Nicolet Desktop

    Nicolet Cortical Stimulator Electrode Mode - Nicolet Desktop The applicable stimulation electrodes are any commercially available 2.3mm electrodes or equivalent. In the United States, these electrodes must have been cleared by the Food and Drug Administration (FDA). Electrode Mode Components...
  • Page 49 Performing a Cortical Stimulation Study Electrode Mode Cables Description Part Number Nic1 C64SSU Compact Amp Single Pigtail Cable with ferrite 085-480100 Nic1 C64SSU Compact Amp Double Pigtail Cable with ferrite 085-480000 Cortical Stimulator Interface Cable 3M 085-476800 C64 Amplifier Cable, 10m 085-461202 Cortical Stimulator Interface Cable 5M 085-476900...

  • Page 50: Probe Mode - Nicolet Desktop

    Nicolet Cortical Stimulator Probe Mode - Nicolet Desktop Probe Mode Components Part Description Number Dual C64-OR amplifiers shown for Probe stimulation 672-610800 Stimulus Control Unit (SCU) 515-005500 Hospital Grade Power Supply 113-405500 Cort Stim Bipolar Probe 222-496100 Desktop PC Revised 11/21/18...
  • Page 51 Performing a Cortical Stimulation Study Probe Mode Cables Part Description Number Nic1 C64SSU Compact Amp single pigtail cable with ferrite 085-480100 Nic1 C64SSU Compact Amp double pigtail cable with ferrite 085-480000 C64 Amplifier cable, 10m 085-461202 Cortical Stimulator RS232 cable 085-479400 Cortical Stimulator Bipolar cable 222-496100...

  • Page 52: Connect The Options/Accessories

    Connect the options/accessories Description Stimulus Control Unit (SCU) - Top View Stimulus Control Unit (SCU) - Side View Stimulator Probe - Use only the Natus Neurology Incorporated Bipolar Probe with 2.2 mm diameter tips. Stimulus Switching Unit (SSU) Interface. Future use Future use RS232 interface for Nicolet Desktop/Panel PC.

  • Page 53: Apply Power To The Stimulus Control Unit (Scu)

    Performing a Cortical Stimulation Study Apply power to the Stimulus Control Unit (SCU) Description Stimulus Control Unit (SCU) - Bottom View The green Power On LED illuminates when on. 3-11 Revised 11/21/18...

  • Page 54: Using The Nicolet Cortical Stimulator To Set The Cortical Stimulator Parameters

    Nicolet Cortical Stimulator Using the Nicolet Cortical Stimulator to set the Cortical Stimulator parameters Description Selector knob NOTE: Use the Selector knob to choose the desired parameter from the display. Press the Parameter button for the parameter you want to set up.
  • Page 55 If you are currently stimulating the patient, press the Stop button on the Stimulus Control Unit (SCU) before changing any parameters. The following parameters can also be set through the Nicolet system PC when the Stimulus Control Unit (SCU) and PC are connected via the RS232 port.
  • Page 56 Selector knob until the desired electrode number or label appears and then press the Selector knob. The applicable stimulation probe is the Natus Neurology Incorporated Bipolar Stimulation Probe with 2.2mm diameter tips. The applicable stimulation electrodes are any commercially available 2.3mm diameter Strip and Grid Electrodes.
  • Page 57 Performing a Cortical Stimulation Study 10. Set Stim - At startup, the stimulation current level is set to 0 mA. • Press the Set Stim button a single time to select the desired stimulation current level: 0 - 15 mA (8 mA or less is typical) in 1 mA increments using the Selector knob.

  • Page 58: Using The Nicolet System To Set The Cortical Stimulation Parameters

    Stop button prior to making any changes other than the Stimulation level (Set Stim parameter). With the Nicolet system running in the Recorder mode, click on View > Panel > Cortical Stim to display the Cortical Stim panel at the right side of the screen display.
  • Page 59 Performing a Cortical Stimulation Study 6. Pulse Freq - To check the Pulse Frequency, click on the Pulse Freq. show menu button and then select the desired pulse frequency rate (50 Hz, typical). The last selected setting becomes the startup default setting. 7.

  • Page 60: Start The Study Using The Nicolet System

    Nicolet Cortical Stimulator Start the study using the Nicolet system NOTE: You can periodically verify the stimulator is operating properly by pressing the Check Stim button. This delivers a single bi-phasic pulse to an internal dummy load and displays the requested current Stimulus Level.

  • Page 61: Using The Neuroworks System To Set The Cortical Stimulation Parameters

    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).
  • Page 62 Nicolet Cortical Stimulator 3. Click on (check) the Use Nicolet cortical stimulator checkbox. 3-20 Revised 11/21/18...

  • Page 63: Display The Cortical Stimulation Window

    Status of cortical stimulator control interface DSM control - Manual selection of electrodes to stimulate Settings for Nioolet Cortical Stimulator DSM operating mode and status Nicolet Cortical Stimulator internal stimulation test Start stimulation Manually stop stimulation before preset train duration 3-21...
  • Page 64 Nicolet Cortical Stimulator Description Press to send a single pulse attempting to block seizure onset. Manual DSM relay control in Semi-automatic or Manual modes. Confirmation of stimulation current applied to the electrodes. Refer to Warning below. DSM control - Preset selection of electrodes to stimulate. Right-click in this area to configure presets.

  • Page 65: To Start A Stimulation

    Performing a Cortical Stimulation Study To start a stimulation Select the electrodes either using the drop down lists or using the presets. For bipolar stimulation, select a pair of active electrodes. For monopolar stimulation, select one active electrode and GND. 2.

  • Page 66: Recommended Workflow

    Cortical stimulation automatically prior to starting procedure from stimulation and opened after NeuroWorks software, stimulation end. not from Nicolet Cortical In this mode, buttons on stimulator device stimulator are deactivated to prevent starting/stopping stimulation from the device. This is because when pressing...
  • Page 67 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 stimulation in an emergency, push the Power button on the stimulator unit.

  • Page 68: Stopping/Interrupting Stimulation

    • 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.

  • Page 69: Electromagnetic Compatibility (Emc)

    Electromagnetic Compatibility (EMC) Revised 11/21/18...
  • Page 70 Nicolet Cortical Stimulator Blank Page Revised 11/21/18...

  • Page 71: Nicolet Cortical Stimulator

    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: •...

  • Page 72: Safety And Standards Conformity

    Nicolet Cortical Stimulator Safety and standards conformity Essential performance In normal operational mode, the essential performance is defined as the performance as required by IEC 60601-1-2 edition 4.0 and particular standard IEC 60601-2-40 edition 2.0. Basic Safety and Essential Performance must be maintained throughout testing.

  • Page 73: Declaration Of Compliance For Iec 60601-1-2: Ed. 4.0 (2014)

    Declaration of compliance for IEC 60601-1-2: Ed. 4.0 (2014) The Nicolet Cortical Stimulator is intended for use in the electromagnetic environment specified below. The customer or the user of the Nicolet Cortical Stimulator should assure that it is used in such an environment. Table 1 - Electromagnetic emissions...
  • Page 74 Nicolet Cortical Stimulator Table 5 – Immunity Test Levels – Input A.C. Power Port Immunity Test Levels - Professional Phenomenon Basic EMC Standard Healthcare Facility Environment ± 2 kV Electrical Fast Transients / Bursts IEC 61000-4-4 100 kHz repetition frequency...
  • Page 75 Electromagnetic Compatibility (EMC) Table 8 – Immunity Test Levels - Signal Input / Output Parts Port Immunity Test Levels - Professional Healthcare Phenomenon Basic EMC Standard Facility Environment ± 8 kV contact Electrostatic Discharge IEC 61000-4-2 ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air ±...
  • Page 76 Nicolet Cortical Stimulator Table 9 - Test specifications for Enclosure Port Immunity to RF wireless communications equipment Test Maximum Immunity Band Distance Frequency Service Modulation Power Test Level (MHz) (MHz) (V/m) 380 – 390 TETRA 400 Pulse modulation 18 Hz GMRS 460,...

  • Page 77: Error Codes

    Error Codes Revised 11/21/18...
  • Page 78 Nicolet Cortical Stimulator Blank Page Revised 11/21/18...
  • Page 79 General Information Error codes Error Code Error Message Action Error 20 Phase A pulse width too short Press Stop. Reset stim value. Press Start. If error repeats, replace control unit. Error 21 Phase B pulse width too short Press Stop. Reset stim value. Press Start. If error repeats, replace control unit.
  • Page 80 Nicolet Cortical Stimulator Error Code Error Message Action Error 35 Unexpected monophasic pulse was Press Stop. Reset stim value. Press Start. If error repeats, replace delivered control unit. Error 40 CSCU processor failed to refresh Press Stop. Reset stim value. Press Start. If error repeats, replace watchdog control unit.
  • Page 81 Table 8 – Immunity Test Levels - Signal Input / Output Parts Port 4-7 About the Acquisition systems i Table 9 - Test specifications for Enclosure Port Immunity About the Nicolet Cortical Stimulator i to RF wireless communications equipment 4-8 Additional manuals available 1-5 Declaration of compliance for IEC 60601-1-2 Amplifier terminology 1-4 Ed.
  • Page 82 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 using the Nicolet system 3-18 Revised 11/21/18...

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