natus Embla Dx Series User And Service Manual
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natus Embla Dx Series User And Service Manual

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Natus
Part Number: 022571 Rev 04
System Model Numbers: PK1274, PK1270, PK1245
© 2018 - 2023 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.
Brain Monitor &
®
Embla Dx Series
User and Service Manual
2023/01/27
™

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Summary of Contents for natus Embla Dx Series

  • Page 1 © 2018 - 2023 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...
  • Page 2 User and Service Manual Natus ® Brain Monitor & Embla Dx Series ™ Arazy Group Switzerland GmbH Natus Medical Incorporated Bruderholzallee 53 DBA Excel-Tech Ltd. (XLTEK) 4059 Basel 2568 Bristol Circle Oakville, Switzerland Ontario L6H 5S1 Canada Swiss.ar@arazygroup.com Tel: 905-829-5300 Fax: 905-829-5304 Toll Free (US &...

  • Page 3: Table Of Contents

    Natus ® Brain Monitor & Embla Dx Series ™ User and Service Manual Table of Contents Introduction ...................................... 5 Device Description ..................................5 Intended Use, Intended User and Patient Groups ........................5 Clinical Benefit ....................................5 Medical Conditions ..................................6 Residual Risks and Side Effects ..............................
  • Page 4 Adding the Breakout Box to a Pouch ............................. 41 Potential Equalization Conductor ............................... 41 Connection Mode ..................................42 Connecting the Natus Base Unit and Brain Monitor & Embla Dx Series Breakout Boxes ............43 Removing the Connections ................................. 43 Connecting to the Body Position Pod ............................44 Connecting to the Luer Lock Pressure Sensor ..........................
  • Page 5 Pulse Oximeter Accessories ................................ 48 Available Nonin Oximetry Sensors ............................49 Pulse Oximeter Precautions and Warnings ..........................49 Maintenance, Cleaning, & Disposal ..............................50 Brain Monitor & Embla Dx Series Amplifiers Pouch ........................50 Warnings ....................................50 Disposal ...................................... 51 Troubleshooting ....................................52 Troubleshooting Checklist ................................

  • Page 6: Introduction

    Brain Monitor & Embla Dx Series amplifiers are designed for the acquisition of EEG and Polysomnographic (PSG) data. The amplifiers design consists of a Natus Base unit and an amplifier breakout box. The Natus Base is common for all variations of the amplifier and the breakout box varies depending on the amplifier model. There are three variations of the Natus Brain Monitor &...

  • Page 7: Medical Conditions

    Isolation transformers are intended to provide power for all system components while ensuring the safety of the operators and the patients. Carts are intended to support and facilitate the use of the Brain Monitor & Embla Dx Series Amplifiers while keeping the system mobile.

  • Page 8: General And Network Security Measures

    User and Service Manual Natus ® Brain Monitor & Embla Dx Series ™ General and Network Security Measures Utilize best practice security measures in your clinical environment including the following: General Security Policies Prevent physical access to the system from unauthorized persons.

  • Page 9: Operating Principle Of The Amplifier

    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. It is part of a system that is made up of a personal computer, a photic stimulator, an isolation transformer, video and audio equipment, networking equipment, and mechanical supports.

  • Page 10: Safety & Standards Conformity

    Mode of operation: Continuous Environmental Conditions: Normal: 10-30°C, 30-75% rH, 700-1060hPa The Brain Monitor & Embla Dx Series Amplifiers and accessories have been designed to comply with the following national and international standards. Safety Standard of Compliance and Normative References •...

  • Page 11: Declaration Of Compliance For Iec 60601-1-2

    Electromagnetic Environment - Guidance RF emissions Group 1 The Brain Monitor & Embla Dx Series Amplifiers use RF energy CISPR 11 only for its internal function. Therefore, their RF emissions are very low and not likely to cause any interference in nearby...
  • Page 12 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.
  • Page 13 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.

  • Page 14: Declaration Of Compliance For Fcc

    User and Service Manual Natus ® Brain Monitor & Embla Dx Series ™ 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...

  • Page 15: Contraindications, Warnings, & Cautions

    Inaccurate measurements may be caused by incorrect application or use. When replacing the fuse for the Brain Monitor & Embla Dx Series Amplifiers, it must be replaced by a fuse with the same type and rating as the original fuse. Replacement fuses should be purchased from Natus directly.

  • Page 16: Electrostatic Discharge (Esd) Warnings

    Refer to the Recommended Separation Distances table in the Safety & 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.

  • Page 17: Electrical Warnings And Cautions

    ELECTRICAL SHOCK HAZARD: Do NOT service the system. Refer servicing to qualified personnel only. Do NOT use repaired components without proper testing. Do not use the MPSO with the Brain Monitor & Embla Dx Series Amplifiers system for supplying power to any equipment that is not part of the system.
  • Page 18 Brain Monitor & Embla Dx Series ™ The Brain Monitor & Embla Dx Series Amplifiers are NOT designed to work with defibrillators. The Brain Monitor & Embla Dx systems could be damaged when used with this device. When using the Brain Monitor & Embla Dx Series Amplifiers together with electrosurgical units (cautery devices) it is recommended to connect to the acquisition PC using the TCP/IP interface.

  • Page 19: Transportation Warnings

    Make sure that any platform, table, cart, or other surface used during the operation, transport, or temporary or permanent storage of the system and its components is adequate, sturdy, and safe. Natus is not responsible for any injury or damage that may result from inadequate, poorly constructed, or unapproved transports, carts, or operating surfaces.

  • Page 20: Conducted Immunity Procedures And Warnings

    User and Service Manual Natus ® Brain Monitor & Embla Dx Series ™ Be sure to take the appropriate Electrostatic Discharge (ESD) precautions. Disconnect the cables before moving, cabling, or performing any set up procedures. Some semiconductor (solid state) devices can be easily damaged by static electricity. Such components are commonly called Electrostatically Sensitive Devices (ESD).

  • Page 21: Description Of Symbols

    Natus ® Brain Monitor & Embla Dx Series ™ User and Service Manual Description of Symbols Symbol Title Standard Title as per Symbol Standard Reference Explanation of Symbol Referenced Standard ISO 15223-1 Medical devices An indication This product is a Symbol 5.7.7...
  • Page 22 User and Service Manual Natus ® Brain Monitor & Embla Dx Series ™ Symbol Title Standard Title as per Symbol Standard Reference Explanation of Symbol Referenced Standard 21 CFR 801.109(b)(1) Labeling- Device is Indicates that the Prescription cleared for the...
  • Page 23 Natus ® Brain Monitor & Embla Dx Series ™ User and Service Manual Symbol Title Standard Title as per Symbol Standard Reference Explanation of Symbol Referenced Standard ISO 15223-1 Medical devices Legal Indicates the Symbol 5.1.1 — Symbols to be...
  • Page 24 User and Service Manual Natus ® Brain Monitor & Embla Dx Series ™ Symbol Title Standard Title as per Symbol Standard Reference Explanation of Symbol Referenced Standard ISO 15223-1 Medical devices Humidity limit Indicates the range Symbol 5.3.8 — Symbols to be...
  • Page 25 Natus ® Brain Monitor & Embla Dx Series ™ User and Service Manual Symbol Title Standard Title as per Symbol Standard Reference Explanation of Symbol Referenced Standard IEC 60601-1 Medical electrical Follow Refer to instruction Table D.2 #10 equipment – Part Instructions for manual/Booklet.
  • Page 26 User and Service Manual Natus ® Brain Monitor & Embla Dx Series ™ Symbol Title Standard Title as per Symbol Standard Reference Explanation of Symbol Referenced Standard Graphical symbols Protective earth; Identifies any terminal IEC 60601-1 for use on protective which is intended for Table D.1 #6...
  • Page 27 Natus ® Brain Monitor & Embla Dx Series ™ User and Service Manual Symbol Title Standard Title as per Symbol Standard Reference Explanation of Symbol Referenced Standard Graphical symbols "OFF" (power) Indicates disconnection IEC 60601-1 for use on from the mains, at Table D.1 #13...
  • Page 28 User and Service Manual Natus ® Brain Monitor & Embla Dx Series ™ Symbol Title Standard Title as per Symbol Standard Reference Explanation of Symbol Referenced Standard Classification of Ingress Protection from IEC 60529 degrees of Protection dripping water from...

  • Page 29: 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 inputs...
  • Page 30 User and Service Manual Natus ® Brain Monitor & Embla Dx Series ™ Specifications Brain Monitor & Embla NDx Embla SDx Atmospheric Pressure: 70 kPa–106 kPa Transport and Storage -25°C to 60°C Temperature Range (-13°F to 140°F) Transport and Storage Humidity Range 10%–95%...

  • Page 31: Product Images

    Natus ® Brain Monitor & Embla Dx Series ™ User and Service Manual Product Images Brain Monitor Embla NDx Embla SDx...

  • Page 32: 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 33: 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 34: Embla Ndx

    User and Service Manual Natus ® Brain Monitor & Embla Dx Series ™ 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. Labeled with .

  • Page 35: 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. Labeled with .

  • Page 36: Brain Monitor Spo2 Sensor Cable Clip

    User and Service Manual Natus ® Brain Monitor & Embla Dx Series ™ Brain Monitor SpO2 Sensor Cable Clip Natus Brain Monitor breakout boxes come with a removeable wire clip connector retainer that holds the oximeter cable in place. P/N 036850...

  • Page 37: Setup

    Connect the power cable, base to breakout cable, patient event button, and any additional accessories (XactTrace belts, cannula, thermistor, snoring sensor, pulse oximeter probe, DC inputs cables etc.) as required. NOTE: Setup and Installation of the Brain Monitor & Embla Dx Series Amplifiers System should be performed by Natus qualified personnel only.

  • Page 38: Setting The Ip Address

    ® Brain Monitor & Embla Dx Series ™ 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 39: Touchscreen Icons

    Touchscreen Icons When properly installed and connected to the PC, the Brain Monitor & Embla Dx Series Amplifiers displays several icons at the bottom of the touchscreen which indicate the connectivity status of the breakout boxes, the headbox, and the base units. The following table shows the different connection status indicators.
  • Page 40 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 41: 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 42: Adding The Breakout Box To A Pouch

    Potential Equalization Conductor The Natus base unit provides a potential equalization conductor for optional use. To install, connect a bus cable from the potential equalization conductor to the potential equalization busbar of the electrical insulation in the room where the system...

  • Page 43: 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 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 44: 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 45: Connecting To The Body Position Pod

    Connecting to the Luer Lock Pressure Sensor The Brain Monitor and Embla Dx Series amplifiers each include a stainless steel luer lock located at the bottom end of each breakout. This luer lock allows the connection of a cannula to allow recording of airflow via pressure sensor.

  • Page 46: 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. NOTE: Trolley and cart availability varies by region.

  • Page 47: 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 always secured tight.

  • Page 48: Transportation System Specifications And Maintenance Warnings And Cautions

    Transportation System Specifications and Maintenance Warnings and Cautions WARNING: Only use Natus approved equipment on the trolley/cart. Non-approved equipment may compromise the function and safety of the system. WARNING: Do not tilt the trolley/cart more than 10° incline as this will compromise the stability of the trolley/cart.

  • Page 49: 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 & Embla Dx Series Amplifiers. The Brain Monitor & Embla Dx Series Amplifiers provides power and isolates the oximeter from the main power and ground.

  • Page 50: Available Nonin Oximetry Sensors

    User and Service Manual Natus ® Brain Monitor & Embla Dx Series ™ Available Nonin Oximetry Sensors Model Number Description 8000SS Sensor, Reusable, Soft, Small, 1 m (3 ft) cable 8000SS-3 Sensor, Reusable, Soft, Small, 3m (9.8ft) cable 8000SM Sensor, Reusable, Soft, Medium, 1 m (3 ft) cable 8000SM-3 Sensor, Reusable, Soft, Medium, 3 m (9.8 ft) cable...

  • Page 51: Maintenance, Cleaning, & Disposal

    Electrodes and accessories The Brain Monitor & Embla Dx Series Amplifiers and their components 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 AIC Wedge Wipes to wipe all surfaces, cables and accessories.

  • Page 52: Disposal

    Equipment) Directive 2012/19/EU. These regulations state that electrical and electronic waste must be separately collected for the proper treatment and recovery to ensure that WEEE is reused or recycled safely. In line with that commitment Natus Medical Incorporated may pass along the obligation for take back and recycling to the end user unless other arrangements have been made.

  • Page 53: 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 54: 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 55 Breakout Box Holster, Arm & Roll Stand 036850 Wire Clip, Connector Retainer 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...

  • Page 56: Getting Help

    Brain Monitor & Embla Dx Series ™ Getting Help Natus is committed to providing support to operate the Brain Monitor & Embla Dx Series Amplifier. Follow these steps to find a solution: Step 1: Document the Incident Carefully document the incident. If possible, note error messages, dialog box names and what you did before the problem occurred.

  • Page 57: 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 58: Headcap Connector Wiring

    User and Service Manual Natus ® Brain Monitor & Embla Dx Series ™ 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. The following shows the layout of the bulk connector pin box inputs.

  • Page 59: 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 60: Sample Rate: 1024Hz

    User and Service Manual Natus ® Brain Monitor & Embla Dx Series ™ Sample Rate: 1024Hz Sample Rate: 2048Hz...

  • Page 61: Sample Rate: 4096Hz

    Natus ® Brain Monitor & Embla Dx Series ™ User and Service Manual Sample Rate: 4096Hz...
  • Page 62 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.

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