natus Nicolet V Series Information For Use
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natus Nicolet V Series Information For Use

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Nicolet Systems
Nicolet™ V Series Amplifier
Information For Use
August 11, 2016
018964 Rev 01
© 2016 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 Incorporated,
its subsidiaries or affiliates. All other trademarks are the property of their respective owners.

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  • Page 1 © 2016 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 Incorporated,...

  • Page 3: Table Of Contents

    Table of Contents Introduction Intended use..............................1-3 Intended readers............................1-3 Important ..............................1-3 Manufacturer..............................1-4 Natus EU Authorized Representative .......................1-4 CE mark...............................1-4 Technical support ............................1-4 Regulatory notices............................1-5 Equipment classifications ..........................1-5 Safety Summary ............................1-6 Warnings ..............................1-7 Additional Warnings and EMC information....................1-9 Read the safety reference guide.........................1-9 Electromagnetic Compatibility (EMC) .....................1-9...
  • Page 4 Nicolet VSeries Amplifiers Cabling diagrams ............................3-9 v32 EEG amplifier system.........................3-9 v44 sleep amplifier system #1 .........................3-10 v32 or v44 sleep amplifier system #2 ......................3-12 Set up the host computer ..........................3-13 Configure the NicoletOne software ......................3-13 V-Series IP address setup.........................3-14 NetWork Interface Card (NIC) IP address setup ..................3-15 Operation Introduction ..............................4-3 Patient safety..............................4-3...
  • Page 5 Introduction 8/11/16...
  • Page 6 Nicolet V Series Amplifiers Blank page. August 11, 2016...

  • Page 7: Intended Use

    (Sp02) is available. Intended readers The Nicolet V Series amplifiers facilitate the recording, review, and reporting of electroneurophysiological data. This manual has been produced for those experienced in this field – technologists, physicians, administrative staff, nurses who will be using this application.

  • Page 8: Manufacturer

    Nicolet V Series Amplifiers 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 Natus EU Authorized Representative Natus Manufacturing Limited IDA Business Park Gort, Co.Galway, Ireland CE mark Compliant to Medical Device Directive 93/42/EEC...

  • Page 9: Regulatory Notices

    Introduction Regulatory notices This device has been designed and certified to comply with the requirements of the international standard IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-6, IEC 60601-2-26 the United States standard UL60601-1, and the Canadian standard CAN/CSA22.2 No.601.1. The device is classified: CLASS IIA, Type BF 100-250 VAC, 50/60 Hz, 80 VA The above classification is based on the condition that this device is installed and...

  • Page 10: Safety Summary

    V Series Amplifier operation. IMPORTANT: Read and follow all WARNINGS, CAUTIONS and NOTES provided in the Additional Information and Safety Notes for Assorted Natus Neurology Incorporated Products Reference Guide 269-594705 on CD part number 482-638702. To avoid the possibility of injury, damage to your system components or lost data, always observe these safety precautions during operation.

  • Page 11: Warnings

    The V Series Amplifier is not defibrillator proof. The Headbox and amplifier (electrode input device) should be disconnected before using a defibrillator. If repair or replacement becomes necessary, call or write to request service advice from Natus Neurology. August 11, 2016...
  • Page 12 This product must not be altered without the prior written approval of Natus Neurology. The user of this product shall have the sole responsibility for any malfunction that results from improper use, faulty maintenance, improper repair, unauthorized service, or alteration by anyone other than Natus Neurology.

  • Page 13: Additional Warnings And Emc Information

    Safety information before applying power to and using your V Series Amplifier. Electromagnetic Compatibility (EMC) Please refer to the Electromagnetic Compatibility Reference Guide 269-596201 on CD part number 482-638702 furnished with your Nicolet V Series Amplifier for information concerning your Nicolet system. August 11, 2016...

  • Page 14: Labels And Symbols

    Nicolet V Series Amplifiers Labels and symbols The following labels and symbols may be affixed to the system: When applied on device: Attention: Consult Accompanying Documentation. (ISO 7000-0434A) When used in documentation: Caution, Warning or Precaution follows. Consult Operating Instructions. Failure to follow operating instructions could place the patient or oper- ator at risk.

  • Page 15: 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 16 Nicolet V Series Amplifiers Blank page. 1-12 August 11, 2016...

  • Page 17: Product Description

    Product Description 8/11/16...
  • Page 18 Nicolet V Series systems Blank page. 8/11/16...
  • Page 19 The V-Series systems are designed specifically for the EEG and PSG monitoring lab. These systems feature the v32 or v44 amplifier with headbox and Natus software. The V- Series amplifiers are compact AC amplifier units with up to 32 (v32) or 44 (v44) channels for EEG and PSG recording applications.

  • Page 20: Functional Components

    Nicolet V Series systems Functional components The amplifier systems consist of the following main functional components. Main component description Used with: HB-3 clinical headbox HB-4 clinical non-OR headbox with impedance check display, no headcap adapter HB-5 OR headbox V44 clinical, non-OR headbox, impedance check display with headcap...

  • Page 21: Amplifiers

    Product Description Amplifiers The V-Series systems provide for patient safety isolation, signal conditioning (physiological signal amplification and filtering), digitization and data transfer to a single host host computer using TCP/IP protocol over an Ethernet network or dedicated cable. A host computer, using the appropriate software, sets the sample rate, starts and stops the data transmission, monitors the digital data, and stores it to hard disk.
  • Page 22 Nicolet V Series systems The v32 amplifier has an integrated headbox with a LED impedance display. You can initiate an impedance check and monitor the results from the LED impedance display located on the headbox. Also available on the v32 amplifier are connectors for an optional event pushbutton as well as other optional external connections (pulse-oximeter probe, photic stimulator, etc.).

  • Page 23: Headboxes

    Product Description Headboxes The patient connection module or electrode input box is referred to as a headbox, which connects to the v32/v44 amplifiers. • The headboxes provide SAFETY LEAD electrode connections. • Attaches to the v32/v44 through a tether (cable) for easy positioning next to a patient bed.
  • Page 24 Nicolet V Series systems The HB-5 headbox is designed specifically for the OR and provides for up to 32 AC channels of operation. A complete 10-20 EEG system can be setup using this headbox. Bedside impedance check is not available with the HB-5 headbox.

  • Page 25: Psu-V32 Power Supply

    Product Description PSU-v32 power Power is supplied to the v32/v44 amplifiers via a medical-grade +15V power supply. supply Only certified Nicolet regulated power supplies may be used with the v32 or v44 amplifiers. 8/11/16...
  • Page 26 Nicolet V Series systems Blank page. 2-10 8/11/16...

  • Page 27: Installation

    Installation 8/11/16...
  • Page 28 Nicolet V-Series systems Blank page. 8/11/16...

  • Page 29: Locating The System

    The headbox is tethered to the V-Series amplifiers to allow it to be located next to the patient. Natus provides a full line of mobile carts and mounting brackets. Please consult Natus Customer Support for further details. Take care to locate the system components away from dirt, dust, high- temperatures, and liquid spill hazards.

  • Page 30: Warnings

    Measure the system’s leakage current after completion of installation, after disconnect/ reconnection of parts of the system, and at regular periodic intervals. For instructions on how to perform this test please contact Natus Neurology Technical Support. Forward and reverse polarity: 500 microamperes The oximeter port is only rated for ESD (Electrostatic Discharge) immunity when the oximeter is connected.

  • Page 31: Patient Safety

    Installation Patient safety The patient should be disconnected from the V-Series amplifier when high frequency surgical equipment is used. To prevent patient injury or equipment damage, use only accessories and electrodes identified for use with this device (see instructions for the electrodes you are using). If an electrode/sensor is damaged in any way, discontinue use immediately.

  • Page 32: Installation

    NOTE: Component and connector models/styles may vary from those shown on the following pages. Cabling Natus recommends that all cabling, network, video cabling, intercom cabling, and any other cabling for auxiliary instrumentation be run by qualified personnel under hospital supervision and according to local standards and regulations.

  • Page 33: V32/V44 Amplifier

    Installation v32/v44 The v32 or v44 may be located remotely or locally to the host computer. The setup will require a network connection. The connection can be either option below: amplifier • TCPiP via direct connection to the host PC or switch. •...

  • Page 34: Summary Of V32/V44 Amplifier Functions

    Nicolet V-Series systems Summary of v32/v44 amplifier functions NOTE: For questions regarding the compatibility of any device with the v32 or v44 amplifiers, please contact Natus Neurology Technical Support. v32 amplifier v44 amplifier Legend Function Legend Function Headbox input Not used...

  • Page 35: Cabling Diagrams

    Installation Cabling diagrams v32 EEG amplifier system Legend Description Keyboard HB-3 headbox NONIN SPO2 XPOD with sensor (option) Patient event button (option) Isolated power system (option) PC (Connector locations may vary. Refer to PC manual) v32 amplifier Monitor Mouse V32-PSU medical grade power supply LED photic stimulator (option) Photic power supply (option) for lamp photic Lamp photic stimulator (option)

  • Page 36: V44 Sleep Amplifier System #1

    Nicolet V-Series systems v44 sleep amplifier system #1 Legend Description Keyboard HB-4 Headbox, Clinical, with impedance check (option) or Clinical with headcap adapter and impedance check HB-5 Headbox, OR, (option) NONIN SPO2 sensor (option) Patient event button (option) Isolated power system (option) PC (Connector locations may vary.
  • Page 37 Installation Legend Description v32-PSU medical grade power supply Photic power supply for lamp photic stimulator (option) LED photic stimulator (option) Lamp photic stimulator (option) Medical grade power supply DC inputs To hospital grade wall outlet 3-11 8/11/16...

  • Page 38: V32 Or V44 Sleep Amplifier System #2

    Nicolet V-Series systems v32 or v44 sleep amplifier system #2 v32 Amplifier v44 Amplifier Legend Description HB-3 headbox HB-4 headbox, Clinical, with impedance check or with head cap (Option) HB-5 headbox, OR, (Option) v32 amplifier v44 amplifier v32-PSU medical grade power supply To ethernet connection (recording PC or hospital network) To hospital grade wall outlet 3-12...

  • Page 39: Set Up The Host Computer

    Installation Set up the host computer Power up the V-Series amplifier to connect the amplifier to the host computer. The host computer should have the recording application software installed and configured to work with the IP address to control the amplifier. See the next page for more information. Refer to the software manual for details on the operation of the system.

  • Page 40: V-Series Ip Address Setup

    4. Click Refresh. 5. All the amplifiers/headboxes connected to the network will be listed in the Headbox Configuration area. 6. Click OK to exit the Natus Database Options window. 7. Click Database > Exit to close the main software application. 3-14...

  • Page 41: Network Interface Card (Nic) Ip Address Setup

    Installation NetWork This section provides instructions on configuring the computer’s NIC with an IP address. The IP address used for this section is different than the one entered in the hardware Interface Card configuration setup on the previous page. (NIC) IP NOTE: If applicable, it is possible to choose an IP address that is consistent with the address setup existing networking scheme of the hospital.
  • Page 42 Nicolet V-Series systems Blank page. 3-16 8/11/16...

  • Page 43: Operation

    Operation 8/11/16...
  • Page 44 Nicolet V Series Amplifiers Blank page. 8/11/16...

  • Page 45: Introduction

    Operation Introduction The V Series amplifiers require a host computer with the appropriate software to be attached via a network cable to setup the amplifier parameters. This section is an overview of the controls, indicators, and other features available for use on the unit. Patient safety The patient must be disconnected from the V Series amplifier when high frequency surgical equipment is used.

  • Page 46: Controls

    Nicolet V Series Amplifiers Controls Check impedances NOTE: Check impedances is available only when connected to application software on the host computer. The controls integrated into the V32 amplifier include two buttons associated with impedance check. When an impedance check is initiated from the V32 amplifier the results are displayed on the V32 via LED indicator lights.

  • Page 47: Indicators

    Operation Indicators There are four indicator functions on the v32 amplifier and two on the v44 amplifier. v32 amplifier. v44 amplifier. Selected impedance tolerance threshold LEDs. Impedance check failed indicators. Power on LED Sending data LED (Ethernet connection) - A flashing green LED indicates a successful connection and data is being transmitted.

  • Page 48: Calibration

    Nicolet V Series Amplifiers Calibration The V Series amplifiers include a built-in calibration signal generator and the means to connect this generator to the amplifier inputs at the first stage preamplifier. The generator outputs a 5 Hz, 500 μV peak-to-peak square wave. Gain calibration and correction is critical to the accurate creation of bipolar montages from the referentially recorded data.

  • Page 49: Maintenance

    Maintenance 8/11/16...
  • Page 50 Nicolet VSeries Amplifiers Blank page. 8/11/16...

  • Page 51: Cleaning

    Maintenance Maintenance There is no routine maintenance required for the V Series Amplifier other than normal periodic checks for unusual wear, cable abrasion, and routine cleaning. Cleaning Perform cleaning as needed. Main system modules and Event pushbutton Electric Shock Hazard. Before cleaning the AC power supply or any AC line powered equipment, always turn off the power and disconnect the power cord from the AC power supply.

  • Page 52: Storage And Transportation

    For disposal of non-Natus accessories, please follow the instructions included with those items. Calibration The V Series amplifiers include a built-in calibration signal source for verifying proper operation and to simplify cross-channel gain correction and offset adjustment.
  • Page 53 Index Configure the NicoletOne software 3-13 NetWork Interface Card (NIC) IP address Additional Warnings and EMC information setup Amplifiers 3-15 V-Series IP address setup 3-14 v32/v44 amplifier 3-7 Introduction Cabling diagrams v32 EEG amplifier system 3-9 v32 or v44 sleep amplifier system #2 3-12 v44 sleep amplifier system 3-10 Labels and symbols 1-10...
  • Page 54 Nicolet V Series Amplifiers Explosion hazard 3-4 Patient safety 3-5 8/11/16...

This manual is also suitable for:

Nicolet v32Nicolet v44

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