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Table of Contents
Related Manuals for natus neuro Embla Dx Series
Summary of Contents for natus neuro Embla Dx Series
- Page 2 The copyright and the foregoing restrictions on the copyright 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 Medical Incorporated or its distributors. Natus Medical Incorporated makes no representations or warranties of any kind whatsoever with respect to this document.
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Page 3: Table Of Contents
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Table of Contents Introduction..............................5 Intended Use ............................. 5 System Components ..........................6 Essential Performance ..........................6 Essential Performance Degradation ...................... 6 Operating Principle of the Amplifier ......................6 Using the Manual ............................ - Page 4 Adding the Breakout Box to a Pouch ...................... 36 Potential Equalization Conductor ......................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 Pressure Sensor ..................
- Page 5 Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Pulse Oximeter Precautions and Warnings ..................... 45 Maintenance, Cleaning, & Disposal ......................46 Brain Monitor & Embla Dx Series Amplifiers Pouch ................46 Recommendations ........................... 46 Disposal ..............................47 Troubleshooting ............................
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Page 6: Introduction
16 DC inputs. This rugged device was designed with extensive clinical input to meet the workflow and application needs of the EEG, LTM, or PSG Lab. A “+” logo on the front of the Natus Base unit indicates that the base unit is a 2 generation Natus base. -
Page 7: System Components
Operating Principle of the Amplifier The Natus Brain Monitor & Embla Dx Series amplifiers are comprised of a base unit and a breakout box. The variation of the amplifier and feature subset is defined by the model of breakout that is connected to the base unit. -
Page 8: Using The Manual
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Using the Manual This manual describes the theory, features, set up, operation, and maintenance of the Natus Brain Monitor & Embla Dx Series Amplifiers. It also provides information on specifications, troubleshooting, and getting help. -
Page 9: Safety & Standards Conformity
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Safety & Standards Conformity Standards of Compliance and Normative References Multichannel Sleep/EEG Headbox System, Models: Brain Monitor, Embla NDx, Embla SDx Amplifiers, detachable cord connected, portable 100-230Vac, 50/60Hz, 80VA. -
Page 10: Declaration Of Compliance For Iec 60601-1-2
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Declaration of Compliance for IEC 60601-1-2 Table 1 - Electromagnetic Emissions Guidance and manufacturer’s declaration – electromagnetic emissions The amplifier is intended for use in the electromagnetic environment specified below. The customer or the user of the amplifier should ensure that it is used in such an environment. - Page 11 Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Table 2 - Electromagnetic Immunity Guidance and manufacturer’s declaration – electromagnetic immunity The Brain Monitor & Embla Dx Series Amplifiers are intended for use in the electromagnetic environment specified below. The customer or the user of the Brain Monitor & Embla Dx Series Amplifiers should assure that they are used in such an environment.
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Page 12: Supporting
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Table 3 - Electromagnetic Immunity – for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacturer’s declaration – electromagnetic immunity The Brain Monitor & Embla Dx Series Amplifiers are intended for use in the electromagnetic environment specified below. - Page 13 Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Table 4 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test Band Service Modulation Maximum Distance IMMUNITY frequency Power TEST LEVEL (MHz) (MHz) (V/m) 380 –390...
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Page 14: Declaration Of Compliance For Fcc
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Declaration of Compliance for FCC Note: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. -
Page 15: Contraindications, Warnings, & Cautions
To ensure the validity of signals, do not operate the device near any sources of electromagnetic interference. Natus systems are not AP or APG rated. DO NOT USE a Natus system in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. -
Page 16: Electrostatic Discharge (Esd) Precautions
Natus approved cold sterilizing agent. It is important to dry off the unit quickly. Avoid letting liquid seep into any of the internal electronics of the system. Do not use any abrasive cleaner on the system. -
Page 17: Electrical Warnings And Cautions
Do not connect items which are not specified as part of the Brain Monitor & Embla Dx Series Amplifier system to the system. Electrical Warnings and Cautions Natus systems are intended for connection to a properly grounded electrical outlet only. Conductive parts of electrodes and their connectors are not to contact other conductive parts and earth. -
Page 18: Patient Environment Warnings And Cautions
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual The current rating of the isolation transformer must be sufficient to operate all of the devices powered by it. Refer to the current ratings of the isolation transformer and current rating for each individual device connected. -
Page 19: Transportation Warnings
Natus is not responsible for any injury or damage that may result from inadequate, poorly constructed, or unapproved transports, carts, or operating surfaces. Natus is not responsible for any injury or damage that may result from improper cable storage during transport. -
Page 20: Conducted Immunity Warnings
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Wireless Option Warnings and Cautions Mobile RF communications can affect the operation of this medical equipment.. Conducted Immunity Warnings In environments where parasitic electrical noise interferes with the electrical biologic signal, there is no risk of misinterpretation of EEG waveforms or ancillary data. -
Page 21: Procedures And Warnings
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Procedures and Warnings Electrostatic Discharge (ESD) Handling Before performing any setup or placement procedures, read the precautions outlined in this section. WARNING: Be sure to take the appropriate Electrostatic Discharge (ESD) precautions. -
Page 22: Conducted Immunity Procedures And Warnings
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Conducted Immunity Procedures and Warnings Conducted immunity is defined as the ability of an electronic product to tolerate the influence of electrical energy from other electronic products or electromagnetic phenomena. -
Page 23: Description Of Symbols
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual 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... - Page 24 Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Symbol Description ESD Sensitive Static Sensitive Base to Breakout Cable Body Position Connector Patient Event Button Connector Nonin Pulse Oximeter Sensor SpO2 Connector LAN Connection USB Connection Manufacturer Information...
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Page 25: Specifications: Brain Monitor & Embla Dx Series Amplifiers
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Specifications: Brain Monitor & Embla Dx Series Amplifiers Specifications Brain Monitor & Embla NDx Embla SDx AC Channels 64 AC channels, 6 Sensor inputs 20 AC Channels + 6 Sensor... - Page 26 Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Specifications Brain Monitor & Embla NDx Embla SDx Environmental Conditions for Use Operating Environmental Limits Temperature: 10°C to 30°C Relative Humidity: 30%–75% Atmospheric Pressure: 70 kPa–106 kPa – 25°C to 60°C...
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Page 27: Product Images
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Product Images Brain Monitor Embla NDx Embla SDx... -
Page 28: Natus Base Unit
Power Button. Labeled with Reserved for future use. Labeled with Can be used to connect the Natus Base Unit directly to a PC and/or Laptop. Labeled with Can be used to connect the Natus Base Unit to a system network. Labeled with Ground equipotential terminal. -
Page 29: Breakout Boxes
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Breakout Boxes Brain Monitor Nonin Oximeter Connection. Labeled with Base to Breakout Main Cable Connection. Labeled with Luer Lock Connection. Labeled with Body Position Pod Connection. Labeled with Patient Event Button Connection. -
Page 30: Embla Ndx
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Embla NDx Nonin Oximeter Connection. Labeled with Base to Breakout Main Cable Connection. Labeled with Luer Lock Connection. Labeled with Body Position Pod Connection. Labeled with Patient Event Button Connection. -
Page 31: Embla Sdx
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Embla SDx Nonin Oximeter Connection. Labeled with Base to Breakout Main Cable Connection. Labeled with Luer Lock Connection. Labeled with Body Position Pod Connection. Labeled with Patient Event Button Connection. -
Page 32: Setup
User and Service Manual Setup Connections The Brain Monitor & Embla Dx Series Amplifiers are designed to work with a Natus computer system running Natus NeuroWorks/SleepWorks software. Confirm the base unit is mounted via the Quick Disconnect Bracket to either a system cart or wall mount track. -
Page 33: Setting The Ip Address
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Setting the IP Address Once the Natus base unit has been powered up, press and hold power button for 3 seconds. The following user interface appears. Press the Settings button on the touchscreen to access the IP Configuration. - Page 34 Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Press Save all to finalize changes, and press Close to return to the main screen. From the Main Screen, confirm system setup by pressing the Info button view the information screen.
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Page 35: Touchscreen Icons
With the Cycle feature set to ON in the NeuroWorks/SleepWorks User interface, the system will automatically measure and display impedances for each channel. Displays the information about the Breakout connected. Sends the selected note to the NeuroWorks/SleepWorks Software from the Natus Base unit. -
Page 36: Amplifier Usage And Features
Beginning a study Once the equipment has been installed by your Natus qualified representative and a patient has been connected to the system, a new EEG or Sleep study can be started. For details on beginning a new EEG or Sleep study, consult the NeuroWorks/SleepWorks reference manuals directly. -
Page 37: Powering Down The System
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Powering Down the System Utilize the following steps to ensure your system is powered down completely and safely. Close any active studies in the NeuroWorks/SleepWorks software. Shut the computer down; ensuring to follow the proper shut down procedure. -
Page 38: Potential Equalization Conductor
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 using the patient cable, the Brain Monitor & Embla Dx Series amplifiers are referred to as being in Physical Connection Mode. In this mode, the data is transmitted over the wired connection to the base unit, which then transmits the data to the computer. -
Page 39: Connecting The Natus Base Unit And Brain Monitor & Embla Dx Series Breakout Boxes
To Connect the Natus base unit to the Amplifier: Locate the Patient Cable from Amplifier to Base (p/n 013348) which was included with your purchase and connect it to the Natus Base unit at the connection labeled with (#1 on the image above). -
Page 40: Connecting To The Body Position Pod
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Connecting to the Body Position Pod The Brain Monitor & Embla Dx Series amplifiers use a proprietary 3 dimensional body position pod to gather and generate position and activity data from the patient. -
Page 41: Transport System Specifications And Maintenance
Refer to the corresponding Instructions for Use for all system components prior to use. This should include, but is not limited to: cameras, computers, stimulators, and software. NOTE: Transportation System setup and installation should be performed by Natus qualified personnel only. -
Page 42: Neurowand Cart (No Pc) Specifications
User and Service Manual Natus® Brain Monitor & Embla Dx Series™ Neurowand Cart (No PC) Specifications Maximum Equipment Load [lbs] Mounting Weight (including Location Default Equipment [lbs] equipment) Video Camera IR Illuminator Amplifier Mount Storage Bin Isolation Transformer Base Cart Weight... -
Page 43: Breakout Box Holster With Roll Cart
User and Service Manual Breakout Box Holster with Roll Cart Natus ErgoJust Cart Specifications For specifications and details on the ErgoJust cart, please refer to the Natus ErgoJust Installation & Functionality Guide (p/n: 019667). Maintenance Regularly inspect the trolley to ensure that casters, bolts, equipment mounting and shelf fasteners are secured tight at all times. -
Page 44: Warnings And Cautions
Natus is not responsible for any injury or damage that may result from inadequate, poorly constructed, or unapproved transports, carts, or operating surfaces. Natus is not responsible for any injury or damage that may result from improper cable storage during transport. -
Page 45: Pulse Oximeter
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Pulse Oximeter NOTE: Refer to the Instructions for Use for any pulse oximeter sensors prior to use. The following topic lists the specifications for the Nonin Oximeter sensor that is used with the Brain Monitor &... -
Page 46: Pulse Oximeter Precautions And Warnings
User and Service Manual Natus® Brain Monitor & Embla Dx Series™ Model Number Description 8000SM Sensor, Reusable, Soft, Medium, 1 m (3 ft) cable 8000SM-3 Sensor, Reusable, Soft, Medium, 3 m (9.8 ft) cable 8000SL Sensor, Reusable, Soft, Large, 1 m (3 ft) cable... -
Page 47: Maintenance, Cleaning, & Disposal
Regular maintenance performed by the user does not involve access to the interior of the amplifier and components. For service problems that require corrective maintenance and/or internal component service, call Natus Technical Support at 1-800-303- 0306 or OTS@natus.com, or contact your local Natus representative. -
Page 48: Disposal
At the end of the expected service life, 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, and metal parts. For disposal of non-Natus accessories, please follow the instructions provided with these items. -
Page 49: Troubleshooting
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Troubleshooting If the acquired waveforms are flat, do not appear, or do not appear correctly (or as expected), try shutting down the computer for at least 10 seconds, and then set up the test again from the beginning. Shutting down and starting over resets the headbox and sometimes solves the problem. -
Page 50: Problems With Signal Quality
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Problems with Signal Quality If there is a missing or bad signal, first try swapping cables to the Breakout Box. If you are still experiencing problems, try running a channel test. -
Page 51: Accessories & Replacement Parts List
Natus Brain Monitor Breakout 021919 Natus Embla NDx Breakout 021920 Natus Embla SDx Breakout 013348 Natus Quantum Breakout to Base Cable, 33ft (10m) 013414 Natus Quantum Breakout to Base Cable, 16ft (5m) 015170 Replacement Fuse, Natus Base Unit 010893 Medical Network Isolator with 10in (25cm) Patch Cable... - Page 52 023445 Breakout Box Holster, Arm & Roll Stand EEG/PSG accessories which can be used with the Brain Monitor & Embla Dx Series Amplifiers are available for you to browse in the Natus Neurology Accessories Catalog online at www.natus.com or call...
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Page 53: Getting Help
User and Service Manual Getting Help Natus is committed to providing you with support so you can operate the Brain Monitor & Embla Dx Series Amplifiers with ease and confidence. If you need help, follow these steps to find a solution: Step 1: Document the Incident Carefully document the incident. -
Page 54: Digital Trigger Input Port Wiring Diagram
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Appendix A Digital Trigger Input Port Wiring Diagram Pin# Definition Note TRG1 Digital Trigger in (0~5V) ‘’ TRG2 ‘’ TRG3 ‘’ TRG4 ‘’ TRG5 ‘’ TRG6 ‘’ TRG7 ‘’... -
Page 55: Headcap Connector Wiring
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Appendix B Headcap Connector Wiring To connect a pre-wired headcap or assembly to the headcap connector a 25 pin female type latch connector is required. This should come from the manufacturer of the pre-wired headset or assembly or a 3rd party vendor. -
Page 56: Frequency Response Curves
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Appendix C Frequency Response Curves Sample Rate: 256Hz Sample Rate: 512Hz... -
Page 57: Sample Rate: 1024Hz
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Sample Rate: 1024Hz Sample Rate: 2048Hz... -
Page 58: Sample Rate: 4096Hz
Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Sample Rate: 4096Hz... -
Page 59: Index
Connecting to the Body Postion Pod ......39 Connecting to the Luer Lock Pressure Sensor ....39 Head Cap Connector Connecting to the Natus Base Unit ......38 Wiring ................54 Removing connection to Natus Base Unit ....38 Help ................48, 52 Breakout Boxes .............. - Page 60 Natus® Brain Monitor & Embla Dx Series™ User and Service Manual Symbols Description ..............22 Operating Principle of the Amplifier ........6 System Components ............6 Placement of the Operator and Patient ......35 Touchscreen Icons ............34 Potential Equalization Conductor ........37 Transport System .............
- Page 61 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.