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A Total Service Solution

Standing behind every XLTEK product is Natus Medical Incorporated, an internationally respected
innovator of medical products and services.

Our Neurology systems are backed up by an in-house support team staffed 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 include preventative maintenance visits
and computer upgrades.

Natus Medical Incorporated

DBA Excel-Tech Ltd. (XLTEK)

2568 Bristol Circle

Oakville, Ontario

L6H 5S1 Canada

T: +1 905.829.5300

F: +1 905.829.5304

P/N 022571, REV 02

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Содержание neuro Embla Dx Series

Страница 1: ......

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

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

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

Страница 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...

Страница 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...

Страница 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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