natus Nicolet SCU User Manual
  1. Manuals
  2. Brands
  3. natus Manuals
  4. Medical Equipment
  5. Nicolet SCU
  6. User manual
natus Nicolet SCU User Manual

natus Nicolet SCU User Manual

Cortical stimulator
Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
Nicolet System
Nicolet™ Cortical
Stimulator User Guide
March, 2010
269-621500 Rev 03
© 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.

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the Nicolet SCU and is the answer not in the manual?

Questions and answers

Related Manuals for natus Nicolet SCU

Summary of Contents for natus Nicolet SCU

  • Page 1 © 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-...

  • Page 3: Table Of Contents

    Table of Contents About the Nicolet Cortical Stimulator..............i About the Nicolet system..................i European authorized representative..............ii CE mark ........................ii Technical support ....................ii Labels and symbols ....................iii Copyright........................ iv General Information Intended readers ....................1-3 Intended use ......................1-3 C64-OR amplifier terminology ................1-3 Basic organization ....................1-4 Read the Safety Reference guides ..............1-4...
  • Page 4 Nicolet Cortical Stimulator Nicolet Cortical Stimulator Overview The Nicolet Cortical Stimulator components............2-3 Stimulus Control Unit (SCU) ................2-4 Nicolet Cortical Stimulator symbols ..............2-8 Stimulus Switching Unit (SSU)..............2-10 C64-OR amplifier...................2-10 Hand-held stimulating probes ................ 2-11 Nicolet system ....................2-11 Block diagrams ....................2-12 OR probe biphasic mode ................2-12 OR probe biphasic mode - Nicolet desktop............2-13 Electrode biphasic modes ................2-14...

  • Page 5: About The Nicolet Cortical Stimulator

    About the Nicolet system The Nicolet range of Multimedia EEG systems has been designed and manufactured by Natus Neurology Incorporated, which has always had an enviable reputation for innovation and quality of its products. Natus Neurology Incorporated quality management system has been certified by Kema to comply with ISO 13485:2003.

  • Page 6: European Authorized Representative

    Nicolet Cortical Stimulator European authorized representative Natus Europe GmbH Robert-Koch-Str. 1 82152 Planegg Germany 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 7: Labels And Symbols

    Image on blue background. (ISO 7010 M002) Consult Operating Instructions. (ISO 7000-1641) 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...

  • Page 8: 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 9: General Information

    General Information Revised 8/27/13...
  • Page 10 Nicolet Cortical Stimulator Blank Page Revised 8/27/13...

  • Page 11: 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 System. The Nicolet System facilitates the capture and review of electroneurophysiological data. This manual has been written for those experienced in this field –...

  • Page 12: Basic Organization

    Nicolet Cortical Stimulator Basic organization This manual covers all aspects of using the system for day-to-day operations. Chapter 1 provides general introductory information, including preventive maintenance. Chapter 2 provides an overview of the Stimulus Control Unit (SCU), Stimulus Switching Unit (SSU), and C64-OR Amplifier as well as general information on the software and Nicolet System.

  • Page 13: Safety Summary

    General Information Safety summary In this manual, two labels identify potentially dangerous or destructive conditions and procedures: The WARNING label identifies conditions or practices that may present danger to the patient and/or user. The CAUTION label identifies conditions or practices that could result in damage to the equipment.

  • Page 14: Cautions And Warnings

    Nicolet Cortical Stimulator 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. When in use, the Nicolet Cortical Stimulator must be attended at all times by medical professionals trained in cortical stimulation.

  • Page 15: Product Specifications

    Use only stimulus probes and electrodes that are specifically designed for direct contact with brain tissue. 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 16: System Configuration Disclaimers

    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 Incorporated equipment which will be secure without the use of active or normal scanning.

  • Page 17: Weight And Dimensions

    General Information Weight and dimensions Stimulus Control Stimulus C64-OR Unit (SCU) Switching Unit Amplifier (SSU) Weight Less than 2.2lb (1kg) 0.25 b (0.1 kg) Dimensions 9in (230mm) 2in (51mm) 4.5in (115mm) • Length: 5in (130mm) 5.5in (138mm) 3in (76mm) • Width: 3in (75mm) 1in (25mm)

  • Page 18: Environmental Considerations (Operating)

    Nicolet Cortical Stimulator Environmental considerations (operating) 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) Environmental considerations (non-operating) 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) Regulatory standards...

  • Page 19: Preventive Maintenance

    General Information Preventive maintenance Preventive maintenance does not require access to the interior of the components and may be performed by the user. Preventive maintenance consists of periodically cleaning and inspecting the exterior of the instrument as well as inspect all cables. It is recommended that you develop a schedule for these purposes.

  • Page 20: Cleaning The System

    Nicolet Cortical Stimulator Cleaning the 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 system 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.

  • Page 21: Nicolet Cortical Stimulator Overview

    Nicolet Cortical Stimulator Overview Revised 8/27/13...
  • Page 22 Nicolet Cortical Stimulator Blank Page Revised 8/27/13...

  • Page 23: The Nicolet Cortical Stimulator Components

    Overview The Nicolet Cortical Stimulator components The Nicolet Cortical Stimulator consists of the following items: N i c r t i c o l e a l S t i m u l a t o r S t a t u s S e t l s e...

  • Page 24: Stimulus Control Unit (Scu)

    Nicolet Cortical Stimulator Stimulus Control 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 Unit (SCU) the Acquisition system via a Serial port on the Desktop, Laptop, or Panel PC computer.
  • Page 25 Overview N i c r t i c o l e a l S t i m u l a t o r S t a t u s t u p l s e F r e l s e r a t i o n T r a...
  • Page 26 Nicolet Cortical Stimulator LEGEND Bottom View LEGEND Status Shows current status of the stimulator: Set-up, Ready, Stim On. Setup 1, 2 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 Adjust Contrast...
  • Page 27 Displays parameter options you can choose after pressing one of the parameter buttons. Isolated Stimulation Allows use of approved Natus Neurology Incorporated Hand-held, Bipolar Stimulating Outputs, Probe Probes without the Stimulus Switching Unit (SSU). This is referred to as the Probe Biphasic mode.

  • Page 28: Nicolet Cortical Stimulator Symbols

    Nicolet Cortical Stimulator Nicolet Cortical Stimulator Symbol Description symbols Show current status of the Nicolet Cortical Stimulator. Change the Stimulus Control Unit (SCU) parameters. Choose the rate at which pulses are delivered. Choose the duration. Choose the train duration. Select which electrodes will receive the stimulus. &...
  • Page 29 Overview Symbol Description Standby. Power Supply Input. PSU-v32 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. Revised 8/27/13...

  • Page 30: Stimulus Switching Unit (Ssu)

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

  • Page 31: Hand-Held Stimulating Probes

    Overview Hand-held Use only the Natus Neurology Incorporated Bipolar Stimulating Probe with a 2.2 mm diameter tip. stimulating probes Nicolet system The Stimulus Control Unit (SCU) may be connected to a Nicolet system Desktop, Laptop, or Panel PC computer via an RS-232 port. The stimulation...

  • Page 32: Block Diagrams

    Nicolet Cortical Stimulator Block diagrams Following are five possible connection configurations for the Nicolet Cortical Stimulator option: OR Probe Biphasic Mode 2. OR Probe Biphasic Mode - Nicolet Desktop 3. Electrode Switching Mode - Nicolet Desktop 4. Electrode Switching Mode - Nicolet Laptop 5.

  • Page 33: Or Probe Biphasic Mode - Nicolet Desktop

    Overview OR probe biphasic In this configuration, you set up stimulus parameters and control delivery of stimulus from the Stimulator Control Unit control panel or computer control. mode - Nicolet Stimulus to the patient is delivered from the Stimulus Control Unit (SCU) via a desktop hand held bipolar probe.

  • Page 34: Electrode Biphasic Modes

    Nicolet Cortical Stimulator Electrode biphasic In the following three configurations, you set up the stimulus parameters and control delivery from the Stimulus Control Unit (SCU) control panel or by modes computer control. Stimulus to the patient is delivered from the Stimulus Control Unit (SCU) to the Electrodes through the Stimulus Switching Unit (SSU).

  • Page 35: Electrode Biphasic Switching Mode - Nicolet Laptop

    Overview Electrode biphasic switching mode - Nicolet Laptop Electrode Biphasic Switching Mode - Nicolet Laptop Electrodes C64 Headbox Stimulus Switching Unit (SSU) Stimulus Control Unit (SCU) Medical Power Supply Stimulus Control Unit (SCU) Laptop - Nicolet Acquisition Computer Medical Power Supply IBox C64-OR SSU 2-15...

  • Page 36: Electrode Biphasic Switching Mode - Nicolet Panel Pc

    Nicolet Cortical Stimulator Electrode biphasic switching mode - Nicolet Panel PC Electrode Biphasic Switching Mode - Nicolet Panel PC Electrodes Headbox Stimulus Switching Unit (SSU) Stimulus Control Unit (SCU) Medical Power Supply Stimulus Control Unit (SCU) Panel PC - Nicolet Acquisition Computer USB Interface Board C64-OR SSU 2-16...

  • Page 37: Performing A Cortical Stimulation Study

    Performing a Cortical Stimulation Study Revised 8/27/13...
  • Page 38 Nicolet Cortical Stimulator Blank Page Revised 8/27/13...

  • Page 39: Cortical Stimulator Cabling Diagrams

    Performing a Cortical Stimulation Study Cortical Stimulator cabling diagrams The following six 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. C64-OR Amplifiers First amplifier for 1 - 64 channel operation - Probe Biphasic Stimulation Second amplifier for 65 - 128 channel operation - Probe Biphasic Stimulation...

  • Page 40: Or Probe Biphasic Mode

    D is ru p S to 1 - 3 Cable Connections Use only the Natus Neurology Incorporated Bipolar Probe with 2.2 mm diameter tips Stimulator Probe - Stimulus Control Unit (SCU) Hospital Grade Power Supply - Provided Red connector Black connector...

  • Page 41: Electrode Mode - Nicolet Desktop

    Dual C64-OR amplifiers shown with Stimulus Switching Unit (SSU)s Stimulus Control Unit (SCU) Hospital Grade Power Supply - Provided Use only the Natus Neurology Incorporated Bipolar Probe with 2.2 mm diameter tips Optional Stimulator Probe - Desktop PC Red connector...

  • Page 42: Electrode Biphasic Mode - Nicolet Laptop

    Dual C64-OR amplifiers shown with Stimulus Switching Unit (SSU)s Stimulus Control Unit (SCU) (side view). Hospital Grade Power Supply - Provided Use only the Natus Neurology Incorporated Bipolar Probe with 2.2 mm diameter tips Optional Stimulator Probe - I-Box Hospital Grade Power Supply - Provided...

  • Page 43: Probe Mode - Nicolet Desktop

    Cable Connections Dual C64-OR amplifiers shown for Probe stimulation Stimulus Control Unit (SCU) Hospital Grade Power Supply - Provided Use only the Natus Neurology Incorporated Bipolar Probe with 2.2 mm diameter tips Stimulator Probe - Desktop PC Red connector Black connector...

  • Page 44: Probe Stimulation System - Nicolet Laptop

    Dual C64-OR Amplifiers shown for Probe stimulation Stimulus Control Unit (SCU) (side view). Hospital Grade Power Supply - Provided Use only the Natus Neurology Incorporated Bipolar Probe with 2.2 mm diameter tips Stimulator Probe - I-Box Hospital Grade Power Supply - Provided...

  • Page 45: Connect The Options/Accessories

    Performing a Cortical Stimulation Study Connect the options/accessories Stimulus Control Unit (SCU) - Top View Stimulus Control Unit (SCU) - Side View Use only the Natus Neurology Incorporated Bipolar Probe with Stimulator Probe - 2.2 mm diameter tips. Stimulus Switching Unit (SSU) Interface.

  • Page 46: Apply Power To The Stimulus Control Unit (Scu)

    Nicolet Cortical Stimulator Apply power to the Stimulus Control Unit (SCU) Stimulus Control Unit (SCU) - Bottom View The green Power On LED illuminates when on. 3-10 Revised 8/27/13...

  • Page 47: Using The Nicolet Cortical Stimulator To Set The Cortical Stimulator Parameters

    Performing a Cortical Stimulation Study Using the Nicolet Cortical Stimulator to set the Cortical Stimulator parameters N ic rt ic o le a l S C ... ti m u la S ta to r tu s S e tu ls e F re ls e...
  • Page 48 Nicolet Cortical Stimulator 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. Setup - Press the Setup button; Change Mode appears on the display and begins to flash.
  • Page 49 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 50 Nicolet Cortical Stimulator 10. Set Stim - At startup, the stimulation current level is set to 0 mA. Press the Set Stim button and then select the desired stimulation current level: 0 - 15 mA (8 mA or less is typical) using the Selector knob. NOTE: If Electrode + or Electrode - are changed, the stimulation current level will reset to 0 mA.

  • Page 51: Using The Nicolet System To Set The Cortical Stimulation Parameters

    5. Negative Electrodes - Click on the ‘Electrode -’ (Cathode) show menu button and then click on the desired electrode number or label. 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 52 Nicolet Cortical Stimulator 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 53: Start The Study

    Performing a Cortical Stimulation Study Start the study NOTE: You can periodically verify the stimulator is operating properly by pressing the Check Stim button. This delivers a single bi-phasic pulse to a load and displays the requested current Stimulus Level. When ready to begin the study, verify that the stimulus parameters are correct on the Cortical Stimulus panel and then press the Stimulus Control Unit (SCU) Start button to deliver the stimulation to the patient.

  • Page 54: Stopping/Interrupting Stimulation

    Nicolet Cortical Stimulator Stopping/interrupting stimulation To stop the stimulation, press the Stimulus Control 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 Information for Use guide 269-604503 and/or the Nicolet Software Reference guide 269-604601 for instructions on reviewing the recorded EEG.

  • Page 55: Electromagnetic Compatibility (Emc)

    Electromagnetic Compatibility (EMC) Revised 8/27/13...

  • Page 56: Nicolet Cortical Stimulator

    Nicolet Cortical Stimulator Blank Page Revised 8/27/13...
  • Page 57 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.

  • Page 58: Nicolet Cortical Stimulator With Nicolet Ltm

    Nicolet Cortical Stimulator Nicolet Cortical Stimulator 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 result of Electrical Fast Transients {EFT} or Electrical Static Discharge {ESD}) the safety checking logic will automatically abort the stimulator output and display an error message that indicates the reason for the difference.
  • Page 59 Electromagnetic Compatibility (EMC) Nicolet Cortical Stimulator Guidance and Manufacturer’s Declaration – Electromagnetic Immunity 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. Immunity test IEC 60601test level Compliance level...
  • Page 60 Nicolet Cortical Stimulator Nicolet Cortical Stimulator Guidance and Manufacturer’s Declaration – Electromagnetic Immunity 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. Immunity test IEC 60601 test Compliance...
  • Page 61 Electromagnetic Compatibility (EMC) Nicolet Cortical Stimulator Recommended separation distances between Portable and mobile RF communications equipment and the Cortical Stimulator The Nicolet Cortical Stimulator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Nicolet Cortical Stimulator can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Nicolet Cortical Stimulator as recommended below, according to the maximum output power of the communications equipment.
  • Page 62 Nicolet Cortical Stimulator Blank page. Revised 8/27/13...

  • Page 63: Error Codes

    Error Codes Revised 8/27/13...
  • Page 64 Nicolet Cortical Stimulator Blank Page Revised 8/27/13...
  • Page 65 General Information Error codes Error Code Error Message Error 20 Phase A pulse width too short Error 21 Phase B pulse width too short Error 22 Pulse frequency too short Error 23 Train duration too short Error 24 Stimulus current control voltage incorrect Error 25 One or more of the Stimulus Switching Units (SSUs) are not available / ready...
  • Page 66 Nicolet Cortical Stimulator Blank page. Revised 8/27/13...
  • Page 67 Index About the Nicolet Cortical Stimulator i Electrode - 2-6 About the NicoletOne system i Electrode + 2-6 Additional manuals available 1-4 Electrode Bi-phasic 3-12 Antivirus and third party software and hardware 1-8 Electrode biphasic switching mode - NicoletOne desktop 2- Apply power to the Stimulus Control Unit 3-10 Electrode biphasic switching mode - NicoletOne Laptop 2- Electrode biphasic switching mode - NicoletOne Panel...
  • Page 68 Nicolet Cortical Stimulator Performing a Cortical Stimulation Study 3-1 USB Connector 2-6 Power On LED 3-10 Preventive maintenance 1-11 Probe Bi-phasic 3-12 Warnings 1-6 Probe stimulation system - NicoletOne Laptop 3-8 Weight and dimensions 1-9 Product Specification 1-7 Pulse Duration 2-6 Pulse Frequency 2-6 Regulatory standards 1-10 Remote Control Start/Stop switch 2-11...

This manual is also suitable for:

Nicolet ssuNicolet c64-or

Table of Contents