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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

Labels and symbols ...................................................................................................................................1-10
Copyright ................................................................................................................................................... 1-11

Product Description

Product description.....................................................................................................................................2-3
Functional components...............................................................................................................................2-4

Amplifiers..................................................................................................................................................2-5
Headboxes .................................................................................................................................................2-7
PSU-v32 power supply..............................................................................................................................2-9

Installation

Locating the system.....................................................................................................................................3-3
Warnings ......................................................................................................................................................3-4

Electric shock hazard.................................................................................................................................3-4
Explosion hazard .......................................................................................................................................3-4
Patient safety .............................................................................................................................................3-5

Installation ...................................................................................................................................................3-6

Cabling ......................................................................................................................................................3-6
Isolation transformer .................................................................................................................................3-6
Network interface card ..............................................................................................................................3-6
PSU-v32 power supply..............................................................................................................................3-6
v32/v44 amplifier ......................................................................................................................................3-7
Headbox.....................................................................................................................................................3-7

Summary of v32/v44 amplifier functions..................................................................................................3-8

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Содержание Nicolet V Series

Страница 1: ...porated 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 trademark...

Страница 2: ......

Страница 3: ...ety reference guide 1 9 Electromagnetic Compatibility EMC 1 9 Labels and symbols 1 10 Copyright 1 11 Product Description Product description 2 3 Functional components 2 4 Amplifiers 2 5 Headboxes 2 7...

Страница 4: ...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 Controls 4 4 Indicato...

Страница 5: ...8 11 16 1 1 1 Introduction...

Страница 6: ...Nicolet V Series Amplifiers 1 2 August 11 2016 Blank page...

Страница 7: ...ield technologists physicians administrative staff nurses who will be using this application As Nicolet Systems are designed for the Microsoft Windows operating system you will need to be familiar wit...

Страница 8: ...ntative 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 Incorporat...

Страница 9: ...ding to the instructions supplied In order for the complete system to maintain compliance with the relevant standards the host computer must be approved to the Nationally Recognized Testing Laboratory...

Страница 10: ...could result in damage to the equipment NOTE Notes help you identify areas of possible confusion and avoid potential problems during V Series Amplifier operation IMPORTANT Read and follow all WARNING...

Страница 11: ...The V Series Amplifier is NOT intended for use with High Frequency Surgical Equipment To avoid possible safety hazards caused by the summation of leakage currents when several system components are in...

Страница 12: ...for any malfunction that results from improper use faulty maintenance improper repair unauthorized service or alteration by anyone other than Natus Neurology The safety reliability and performance of...

Страница 13: ...5 on CD part number 482 638702 furnished with your Nicolet system thoroughly paying special attention to the Safety information before applying power to and using your V Series Amplifier Electromagnet...

Страница 14: ...Instructions ISO 7000 1641 Protective earth European Authorized Representative Alternating current Manufacturer On only for a part of the equipment When the equipment comes to the end of its operatin...

Страница 15: ...opyright use extend to all media in which this information 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...

Страница 16: ...Nicolet V Series Amplifiers 1 12 August 11 2016 Blank page...

Страница 17: ...8 11 16 2 1 2 Product Description...

Страница 18: ...Nicolet V Series systems 2 2 8 11 16 Blank page...

Страница 19: ...v32 or 44 v44 channels for EEG and PSG recording applications The easy to use Natus software provides data acquisition recording and review capabilities in one flexible package NOTE Styles models sho...

Страница 20: ...HB 4 clinical non OR headbox with impedance check display no headcap adapter x HB 5 OR headbox x V44 clinical non OR headbox impedance check display with headcap adapter x PSU 32 Medical grade power s...

Страница 21: ...priate software sets the sample rate starts and stops the data transmission monitors the digital data and stores it to hard disk The amplifiers can be mounted to a cart arm on a wall next to a patient...

Страница 22: ...rnational 10 20 placement layout Integrated control for a photic stimulator Pulse oximeter option support provided via the Nonin X Pod pulse rate SpO2 Patient event button option The v44 amplifier req...

Страница 23: ...tether cable for easy positioning next to a patient bed The HB 3 headbox is designed for the v32 amplifier It provides up to 32 AC channels of operation A complete 10 20 EEG system can be setup using...

Страница 24: ...p using this headbox Bedside impedance check is not available with the HB 5 headbox The V44 headcap headbox is designed for the v44 amplifier It provides up to 32 AC channels of operation It includes...

Страница 25: ...Product Description PSU v32power supply Power is supplied to the v32 v44 amplifiers via a medical grade 15V power supply Only certified Nicolet regulated power supplies may be used with the v32 or v44...

Страница 26: ...Nicolet V Series systems 2 10 8 11 16 Blank page...

Страница 27: ...8 11 16 3 1 3 Installation...

Страница 28: ...Nicolet V Series systems 3 2 8 11 16 Blank page...

Страница 29: ...med 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 Supp...

Страница 30: ...and undamaged The appliance coupler AC Cordset is the means for disconnecting the V Series amplifier from the power mains Measure the system s leakage current after completion of installation after di...

Страница 31: ...is to monitor and record physiological signals for EEG electroencephalography or PSG polysomnography Although this system can be used to monitor biopotentials like ECG this system should not be used a...

Страница 32: ...s of equipment to the v32 or v44 amplifier system to avoid summation of leakage currents If using an isolation transformer it should be UL60601 1 approved and rated for 115 240 VAC 50 60 Hz Network in...

Страница 33: ...be either option below TCPiP via direct connection to the host PC or switch DHCP via the hospital network NeuroWorks configuration only Headbox Plug the headbox into the v32 or v44 amplifier with the...

Страница 34: ...ifier Legend Function Legend Function 1 Headbox input 13 Not used 2 Headbox check 14 Not used 3 Pulse oximeter XPOD input 15 Not used 4 DC voltage channel 16 Not used 5 Patient event button 17 Power i...

Страница 35: ...ient event button option 5 Isolated power system option 6 PC Connector locations may vary Refer to PC manual 7 v32 amplifier 8 Monitor 9 Mouse 10 V32 PSU medical grade power supply 11 LED photic stimu...

Страница 36: ...4 Headbox Clinical with impedance check option or Clinical with headcap adapter and impedance check 3 HB 5 Headbox OR option 4 NONIN SPO2 sensor option 5 Patient event button option 6 Isolated power...

Страница 37: ...dical grade power supply 12 Photic power supply for lamp photic stimulator option 13 LED photic stimulator option 14 Lamp photic stimulator option 15 Medical grade power supply A DC inputs B To hospit...

Страница 38: ...plifier Legend Description 1 HB 3 headbox 2 HB 4 headbox Clinical with impedance check or with head cap Option 3 HB 5 headbox OR Option 4 v32 amplifier 5 v44 amplifier 6 v32 PSU medical grade power su...

Страница 39: ...section provides instructions on configuring the NicoletOne software to communicate with the V Series amplifier 1 From the desktop or Nicolet folder double click the NicVue icon 2 From the NicVue app...

Страница 40: ...programing 1 Check the box next to Obtain an IP address automatically DHCP This action will gray out the IP address Subnet mask and Default gateway 2 Click Program Device The Device is configured suc...

Страница 41: ...icon 3 Click on the Change adapter setings link in the upper left section 4 Double click on the icon that represents your NIC This may be listed as Local Area Connection 5 Click on the Properties but...

Страница 42: ...Nicolet V Series systems 3 16 8 11 16 Blank page...

Страница 43: ...8 11 16 4 1 4 Operation...

Страница 44: ...Nicolet V Series Amplifiers 4 2 8 11 16 Blank page...

Страница 45: ...f an electrode sensor is damaged in any way discontinue use immediately While connected to the amplifier the patient must not come into contact with any metal part of the V Series Amplifier or monitor...

Страница 46: ...the V44 the controls are integrated into the HB 4 and include two buttons associated with impedance check When an impedance check is initiated from the HB 4 the results are displayed on the HB 4 via L...

Страница 47: ...er and two on the v44 amplifier v32 amplifier v44 amplifier 1 Selected impedance tolerance threshold LEDs na 2 Impedance check failed indicators na 3 Power on LED 4 Sending data LED Ethernet connectio...

Страница 48: ...is recommended that a calibration procedure be performed prior to every recording as standard practice NOTE Please refer to your host application for calibration instructions Event pushbutton The opti...

Страница 49: ...8 11 16 5 1 5 Maintenance...

Страница 50: ...Nicolet VSeries Amplifiers 5 2 8 11 16 Blank page...

Страница 51: ...ply Do not autoclave or pressure sterilize any of the modules Do not soak or immerse the modules in any liquid Do not gas sterilize the modules Do not use petroleum based or acetone solutions or other...

Страница 52: ...the end of life it is recommended that federal state and local laws be followed for proper disposal of printed circuit boards and plastic parts For disposal of non Natus accessories please follow the...

Страница 53: ...ors 4 5 Installation 3 1 3 6 Cabling 3 6 Headbox 3 7 Isolation transformer 3 6 Network interface card 3 6 PSU v32 power supply 3 6 Set up the host computer 3 13 Configure the NicoletOne software 3 13...

Страница 54: ...Nicolet V Series Amplifiers 2 8 11 16 Explosion hazard 3 4 Patient safety 3 5...

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