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Natus® Brain Monitor &

Embla Dx Series™

User and Service Manual

22

Description of Symbols

Symbol

Description

ATTENTION:

Consult Accompanying Documents

Consult Accompanying Documents

Consult Operating Instructions

Pushing Prohibited

Protective Earth (Ground)

Type BF Equipment

Dangerous Voltage

Alternating Current

Direct Current

Power On

Power Off

EU only:

Do Not Dispose as Unsorted Municipal Waste

CE Mark

Class II Equipment (non-grounded enclosure)

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Summary of Contents for neuro Embla Dx Series

Page 1: ......

Page 2: ...8 by Natus Medical Incorporated All rights reserved This manual contains proprietary information which is protected by copyright and may not be copied in whole or in part except with the prior written...

Page 3: ...nity 10 Table 3 Electromagnetic Immunity for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING 11 Table 4 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment 12 De...

Page 4: ...37 Connection Mode 37 Connecting the Natus Base Unit and Brain Monitor Embla Dx Series Breakout Boxes 38 Removing the Connections 38 Connecting to the Body Position Pod 39 Connecting to the Luer Lock...

Page 5: ...9 Accessories Replacement Parts List 50 Getting Help 52 Step 1 Document the Incident 52 Step 2 Search NeuroWorks Online Documentation 52 Step 3 Restart the Computer 52 Step 4 Shut Down the Computer 52...

Page 6: ...plifier features include Up to 64 AC inputs 40 referential and 24 referential differential configurable Up to 16 DC channels 12 on Natus Base unit 4 on Brain Monitor Embla NDx Breakouts Integrated Pul...

Page 7: ...f SpO2 accuracy by controlled desaturation study to be covered by the manufacturer of the pulse oximeter probe or sensor used Essential Performance Degradation Professional healthcare trained personne...

Page 8: ...refully Manual Conventions Various symbols and typographical conventions are used throughout the manual The following table illustrates them and describes their meanings and functions Symbol Conventio...

Page 9: ...Normative References IEC 60601 1 2012 General Safety Third Edition CAN CSA C22 2 No 60601 1 08 R2013 C2 2011 IEC 60601 1 6 2010 Usability Third Edition IEC 62366 2007 Edition 1 0 IEC 60601 2 26 2012 E...

Page 10: ...ic Environment Guidance RF emissions CISPR 11 Group 1 The Brain Monitor Embla Dx Series Amplifiers use RF energy only for its internal function Therefore their RF emissions are very low and not likely...

Page 11: ...uality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode Complies Mains power quality should be that of a typical commercial or...

Page 12: ...d d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site 1 should be less than the compliance level in each frequency...

Page 13: ...GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation b 217 Hz 2 0 3 28 1 845 1 970 2 450 2 400 2 570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation b 217 Hz 2 0...

Page 14: ...operated in a commercial environment This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instruction manual may cause harmful int...

Page 15: ...on of this equipment with input signals in excess of a range of 10mV may cause incorrect results Warnings and Cautions General Warnings NOTE It is recommended that all data be stored using redundant s...

Page 16: ...fere with the operation of the Natus software Please consult Natus Technical Support before installing third party software on the computer WARNING No modification of this equipment is allowed Electro...

Page 17: ...y Standards Conformity section for minimum recommended separation distances Do not connect items which are not specified as part of the Brain Monitor Embla Dx Series Amplifier system to the system Ele...

Page 18: ...rodes to any other device or external outlet may result in personal injury If a computer is located in the patient environment and is connected to a network a network isolator MUST be used The patient...

Page 19: ...hould only be used in conjunction with the Modular Pouch If a computer is located in the patient environment it must be 60601 1 approved or 60950 1 approved and powered by a 60601 1 approved isolation...

Page 20: ...o risk of misinterpretation of EEG waveforms or ancillary data Any abnormal pattern or out of range value is confirmed by trained medical professionals performing the test In addition to ancillary dat...

Page 21: ...y static electricity Immediately before handling any product components assemblies drain the electrostatic charge from your body by touching a known earth ground Minimize body motions when handling un...

Page 22: ...ation on the EEG waveforms which are coupled together with off the scale values for auxiliary sensors Follow these techniques to help identify the sources and to increase the immunity towards parasiti...

Page 23: ...t Accompanying Documents Consult Accompanying Documents Consult Operating Instructions Pushing Prohibited Protective Earth Ground Type BF Equipment Dangerous Voltage Alternating Current Direct Current...

Page 24: ...nector Patient Event Button Connector Nonin Pulse Oximeter Sensor SpO2 Connector LAN Connection USB Connection Manufacturer Information Non Waterproof Device Equipotential stud Fragile IPX0 No protect...

Page 25: ...ram Pulse Quality Input Impedance Common Mode 1 Gohm Differential Mode 40 Mohm 280pF 20 Common Mode 1 Gohm Differential Mode 40 Mohm 280pF 20 Input Noise 3 2 uV pk to pk 0 1Hz to 70 Hz 40nVsqrt Hz wid...

Page 26: ...rature 10 C to 30 C Relative Humidity 30 75 Atmospheric Pressure 70 kPa 106 kPa Transport and Storage Temperature Range 25 C to 60 C Transport and Storage Humidity Range 10 95 Transport and Storage At...

Page 27: ...Natus Brain Monitor Embla Dx Series User and Service Manual 26 Product Images Brain Monitor Embla NDx Embla SDx...

Page 28: ...Labeled with 5 Ground equipotential terminal 6 Connects to the Natus Base Unit to the mains power supply 7 Fuse Compartment Labeled above with Fuse T1 6A 250V 80VA 100 230VAC 8 Labeled with 9 Can be u...

Page 29: ...e to Breakout Main Cable Connection Labeled with 3 Luer Lock Connection Labeled with 4 Body Position Pod Connection Labeled with 5 Patient Event Button Connection Labeled with 6 Headcap Connection 7 L...

Page 30: ...kout Main Cable Connection Labeled with 3 Luer Lock Connection Labeled with 4 Body Position Pod Connection Labeled with 5 Patient Event Button Connection Labeled with 6 Headcap Connection 7 Light Sens...

Page 31: ...ase to Breakout Main Cable Connection Labeled with 3 Luer Lock Connection Labeled with 4 Body Position Pod Connection Labeled with 5 Patient Event Button Connection Labeled with 6 Light Sensor 7 Handl...

Page 32: ...to the acquisition computer using a network or via USB The base unit can be connected to a standard switched gigabit network jack recommended or to a secondary gigabit network interface card on the a...

Page 33: ...button on the touchscreen to access the IP Configuration NOTE The amplifier supports both DHCP and static TCP IP address configuration Selecting DHCP will allow the amplifier to receive TCP IP address...

Page 34: ...the Info button to view the information screen 7 On the information screen ensure that the IP address is set as intended and that the connection information related to the breakout and pin boxes show...

Page 35: ...but the software has not established a connection with the headbox If it is TRANSPARENT then no network cable is plugged in NOTE If a USB connection is used the above connection will be shown until t...

Page 36: ...atient At no point should the system be leaned against or rested upon Refer to the Transport System Specifications and Maintenance section for placement details and cautions for the different cart tra...

Page 37: ...ch Neither the Amplifier pouch nor the breakout box should be covered by blankets or any other material Failure to follow these instructions could raise the temperature of the Brain Monitor Embla Dx S...

Page 38: ...em is used Connection Mode The following section describes how the Brain Monitor Embla Dx Series Amplifiers system is connected When the Natus base unit is physically connected to the breakout box usi...

Page 39: ...or ease of connecting To Connect the Natus base unit to the Amplifier 1 Locate the Patient Cable from Amplifier to Base p n 013348 which was included with your purchase and connect it to the Natus Bas...

Page 40: ...the pod cable to the left side of the amplifier breakout in the position connector labeled with Connecting to the Luer Lock Pressure Sensor The Brain Monitor and Embla Dx Series amplifiers each inclu...

Page 41: ...ortation System setup and installation should be performed by Natus qualified personnel only XLTEK Trolley Specifications Mounting Location Default Equipment Equipment Weight lbs Maximum Load lbs incl...

Page 42: ...PC Specifications Mounting Location Default Equipment Equipment Weight lbs Maximum Load lbs including equipment A1 Video Camera 4 4 A2 IR Illuminator 2 2 B Amplifier Mount 5 5 C Storage Bin 0 10 D Is...

Page 43: ...ase refer to the Natus ErgoJust Installation Functionality Guide p n 019667 Maintenance 1 Regularly inspect the trolley to ensure that casters bolts equipment mounting and shelf fasteners are secured...

Page 44: ...damage that may result from improper cable storage during transport WARNING Do not tilt the trolley cart more than 10 incline as this will compromise the stability of the trolley cart TIPPING HAZARD D...

Page 45: ...to 321 beats per minute BPM Pulse Oximeter Instruction for use The indication of a signal inadequacy and or probe faults for the SP02 sensor is alarmed through the Neuroworks 9 0 software and is disp...

Page 46: ...t cable 8000Q2 Sensor Reusable Ear Clip 8000R Sensor Reusable Reflectance 6000C Sensor Disposable Cloth Series 6500 Sensor Disposable Durafoam Series 7000 Sensor Disposable Flexi Form III Series Pulse...

Page 47: ...ents should not be immersed in water or any other fluid To clean use a damp cloth or cleaning disinfecting products such as isopropyl alcohol PDI Sani Wipes AF3 PDI Sani Cloth Plus Metrex CaviWipes or...

Page 48: ...when disposing of the Brain Monitor Embla Dx Series Amplifiers and its components it is recommended that federal state and local laws be followed for proper disposal of printed circuit boards plastics...

Page 49: ...lectrodes fit properly into the headbox not loosely Make sure that there are no apparent breaks in the patient electrode cables Are any of the electrodes touching If so they are causing a short circui...

Page 50: ...st control bar appears above the waveform display 3 Point to the first menu on the Channel Test control bar and click Sine or Square The Sine wave setting is good for general use A low frequency Squar...

Page 51: ...ft 3m W8194X USB 2 0 Hi Speed Gold Cable 6ft 1 8m W8128F CAT5e Network Cable 15ft 4 6m 007310 USB to Ethernet Adaptor 013931 Quantum Nonin Oximeter Adapter Cable 105592 Nonin Reusable Soft Sensor Medi...

Page 52: ...or Thorax for Pre Sized Single Use Belt 013224 XactTrace Snap Sensor Cable Abdomen 78 cable for Pre Sized Single Use Belt 013225 XactTrace Snap Sensor Cable Thorax 78 cable for Pre Sized Single Use Be...

Page 53: ...ndows taskbar 2 Navigate to the Excel Tech Documentation folder Step 3 Restart the Computer Often restarting the computer will solve a problem 1 Close all applications 2 Click the Start button on the...

Page 54: ...ain Monitor Embla Dx Series 53 Appendix A Digital Trigger Input Port Wiring Diagram Pin Definition Note 1 TRG1 Digital Trigger in 0 5V 2 TRG2 3 TRG3 4 TRG4 5 TRG5 6 TRG6 7 TRG7 8 TRG8 9 LT Digital Tri...

Page 55: ...tch connector is required This should come from the manufacturer of the pre wired headset or assembly or a 3rd party vendor The following shows the layout of the bulk connector pin box inputs Pin on 2...

Page 56: ...User and Service Manual Natus Brain Monitor Embla Dx Series 55 Appendix C Frequency Response Curves Sample Rate 256Hz Sample Rate 512Hz...

Page 57: ...Natus Brain Monitor Embla Dx Series User and Service Manual 56 Sample Rate 1024Hz Sample Rate 2048Hz...

Page 58: ...User and Service Manual Natus Brain Monitor Embla Dx Series 57 Sample Rate 4096Hz...

Page 59: ...pliance for FCC 13 Declaration of Compliance for IEC 60601 1 2 9 Description of Symbols 22 Digital Trigger Input Port Wiring 53 Disposal 46 47 E Electrical Input and Isolation Transformer Details Tran...

Page 60: ...hooting 49 Specifications Brain Monitor 24 Embla NDx 24 Embla SDx 24 Natus Base 24 Standards of Compliance and Normative References 8 Symbols Description 22 System Components 6 T Touchscreen Icons 34...

Page 61: ...affed with technical and clinical experts 24 7 support remote support via WebEx or VPN the largest clinical and technical field support network in Neuro Sleep and customized service contracts that inc...

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