natus EMU40EX User And Service Manual
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natus EMU40EX User And Service Manual

natus EMU40EX User And Service Manual

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User and Service Manual

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  • Page 1 EMU40EX ™ User and Service Manual...
  • Page 2 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.

  • Page 3: Table Of Contents

    Essential Performance ............................7 Essential Performance Degradation ........................ 7 Instructions to access the eIFU ..........................7 EMU40EX Safety and Standards Conformity ......................... 8 Standards of Compliance and Normative References .................... 8 Declaration of Compliance for IEC 60601-1-2 ......................9 Declaration of Compliance for FCC ........................12 Warnings, and Cautions ...............................
  • Page 4 Placement of the Operator and Patient ......................42 Beginning a study ............................42 Powering Down the System .......................... 42 Adding the EMU40EX Breakout Box to a Lanyard ..................42 Potential Equalization Conductor ........................43 EMU40EX Amplifier System Description ........................44 EMU40EX Breakout Box to Base Unit Data Link ....................

  • Page 5: Device Description

    The EMU40EX EEG Headbox is an electroencephalograph that works in conjunction with NeuroWorks software. The EMU40EX EEG Headbox is used to acquire, digitize, store, and transmit physiological signals (such as EEG, pulse and oximetry signals) for EEG studies in research and clinical environments.

  • Page 6: Indications For Use

    Recording EEG with the EMU40EX amplifier does not directly affect outcome; the collected EEG activity will allow the physician to decide on treatment. Treatment directed by data recorded with the EMU40EX may result in better outcomes than treatment informed solely by data from clinical assessment.

  • Page 7: Essential Performance

    Search for “EMU40EX User and Service manual” and choose the version for your local language for the Instructions For Use. The files can be printed, saved, or searched using Adobe Reader. A copy of Adobe Reader can be downloaded directly from Adobe Systems (www.adobe.com).

  • Page 8: Emu40Ex Safety And Standards Conformity

    Mode of operation: Continuous Environmental Conditions : Normal : 10-40°C, 30-75% rH, 700-1060hPa The EMU40EX and its accessories have been designed to comply with the following national and international standards. Table 1 – Safety Standard of Compliance and Normative References CAN /CSA-C22.2 No.

  • Page 9: Declaration Of Compliance For Iec 60601-1-2

    Table 1 - Electromagnetic Emissions Guidance and manufacturer’s declaration – electromagnetic emissions The EMU40EX is intended for use in the electromagnetic environment specified below. The customer or the user of the EMU40EX should assure that it is used in such an environment.
  • Page 10 Table 2 - Electromagnetic Immunity Guidance and manufacturer’s declaration – electromagnetic immunity The EMU40EX is intended for use in the electromagnetic environment specified below. The customer or the user of the EMU40EX should assure that it is used in such an environment.
  • Page 11 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the EMU40EX is used exceeds the applicable RF compliance level above, the EMU40EX should be observed to verify normal operation. If abnormal operation is observed, additional measures may be necessary, such as re-orienting or relocating the EMU40EX.

  • Page 12: Declaration Of Compliance For Fcc

    EMU40EX™ User and Service Manual Table 4 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test Band Service Maximum Distance IMMUNITY Modulation frequency Power TEST LEVEL (MHz) (MHz) (V/m) Pulse 380 –390 TETRA 400 modulation 18 Hz GMRS 460, 430 –...

  • Page 13: Warnings And Cautions

    Caution device. Any serious incident that has occurred in relation to the Natus EMU40EX system must be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. NOTE: It is recommended that all data be stored using redundant storage capabilities. This can help to minimize data loss in the event of a failure of the primary drive.

  • Page 14: Electrical Warnings And Cautions

    Do NOT position Medical Electrical equipment in such a way as to make it difficult to operate the disconnection device. Do not dispose of this medical product as unsorted municipal waste. At the end of an EMU40EX's life, please contact Natus at 1-800-303-0306 in order to arrange return shipping for your EMU40EX amplifier.
  • Page 15 When replacing the fuse for the EMU40EX, 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: Patient Environment Warnings And Cautions

    Check areas of use to avoid using the system in the presence of flammable gases. 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 17: Pulse Oximeter Warnings And Cautions

    As with all medical equipment, there is a risk of injury if the lanyard/belt and pouch(es) are used without ensuring they are secured to the patient properly. Refer to the Adding the EMU40EX breakout box to a lanyard or belt section for details.

  • Page 18: Wireless Option Warnings

    The EMU40EX Amplifier system does NOT include SpO2 or Pulse Rate alarms. Wireless Option Warnings NOTE: The EMU40EX contains FCC ID: SQGBT700 which complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation.

  • Page 19: Electromagnetic Interference (Emi) Warnings

    EMU40EX™ Electromagnetic Interference (EMI) Warnings Only use the EMU40EX system in conjunction with approved devices and accessories. Use of cables other than those specified or sold by the manufacturer on the equipment, may result in increased emissions or decreased immunity of the equipment and may cause the system to be non-compliant with the requirements of IEC 60601-1-2:2007.
  • Page 20 Use cleaning solution sparingly. Excessive solution can flow into the amplifier and cause damage to internal components. Disconnect all cables from the EMU40EX before cleaning. Use a lint-free cloth. Do not use cleaners on any system component. Do NOT use petroleum-based or acetone solutions, or other harsh solvents, to clean the amplifier. These substances attack the device's materials and device failure can result.

  • Page 21: Procedures And Warnings

    User and Service Manual EMU40EX™ Procedures and Warnings Electrostatic Discharge (ESD) Handling Before performing any setup or placement procedures, read the precautions outlined in this section. Some semiconductor (solid state) devices can be easily damaged by static electricity. Such components are commonly called Electrostatically Sensitive Devices (ESD).

  • Page 22: Glossary Of Symbols

    EMU40EX™ User and Service Manual Glossary of Symbols Symbol Title Standard Standard Title of as per Symbol Explanation Reference Symbol Referenced Standard ISO 15223-1 Medical devices — An indication of This product is a Symbol 5.7.7 Symbols to be used Medical Device medical device.
  • Page 23 User and Service Manual EMU40EX™ Symbol Title Standard Standard Title of as per Symbol Explanation Reference Symbol Referenced Standard IEC 60601-1, Part 1: General Type BF applied To identify a type BF Reference no. requirements for basic part applied part complying Table D.2,...
  • Page 24 EMU40EX™ User and Service Manual Symbol Title Standard Standard Title of as per Symbol Explanation Reference Symbol Referenced Standard Medical devices — Importer Indicates the entity ISO 15223-1 Symbols to be used importing the medical Symbol 5.1.8 with medical device device into the locale.
  • Page 25 User and Service Manual EMU40EX™ Symbol Title Standard Standard Title of as per Symbol Explanation Reference Symbol Referenced Standard Medical devices — Consult Indicates an instruction ISO 15223-1 Symbols to be used Instruction for to consult an electronic Symbol 5.4.3...
  • Page 26 EMU40EX™ User and Service Manual Symbol Title Standard Standard Title of as per Symbol Explanation Reference Symbol Referenced Standard Graphical symbols for Protective earth; Identifies any terminal ISO 7000 / use on equipment protective ground which is intended for IEC 60417...
  • Page 27 User and Service Manual EMU40EX™ Symbol Title Standard Standard Title of as per Symbol Explanation Reference Symbol Referenced Standard Graphical symbols for Alarm inhibit Identifies the alarm inhibit IEC 60417 use on equipment on control equipment. Symbol 5319 Graphical symbols for...

  • Page 28: System Symbols

    EMU40EX™ User and Service Manual Symbol Title Standard Standard Title of as per Symbol Explanation Reference Symbol Referenced Standard Medical devices — Not made with Indicates a medical device Based on ISO Symbols to be used with Natural Rubber Latex...

  • Page 29: Specifications: Emu40Ex Amplifier

    User and Service Manual EMU40EX™ Specifications: EMU40EX Amplifier Specification Value(s) Analog Specifications Channels Referential Channels Differential Input Impedance > 50 MOhms Common Mode Input Impedance > 25 MOhms Common Mode Rejection Ratio 116 dB @ 60 Hz Input Noise (peak to peak) 3.9 µV @ 0.1~70 Hz bandwidth...
  • Page 30 100 – 230V, 50/60Hz Storage Capacity 4 GB Internal Compact Flash Card Mains Power Requirement (Base Unit) 100-230VAC; 50-60Hz 70VA Power Consumption (EMU40EX Breakout Box) 1 W @12 V Battery Rechargeable 2 x AAA Ni-Mh battery Battery Life 1 to 1.5 hrs. (depending on features enabled: wireless,...
  • Page 31 User and Service Manual EMU40EX™ Specification Value(s) Dimensions Size (length x width x height) Natus Base Unit 292.5mm x 266.6mm x 51.5mm (11.52” x 10.5” x 2.03”) 100mm x 158mm x 23mm EMU40EX Breakout (3.94’’ x 6.22’’ x 0.91’’) Weight Natus Base Unit 2.14kg (4.72lb)

  • Page 32: Product Images

    EMU40EX™ User and Service Manual Product Images EMU40EX System EMU40EX System: Base Unit, Breakout Box and Battery Pack...

  • Page 33: Base Unit

    Box is connected. Used to connect the Patient Breakout Box for the EMU40EX. Labeled with NOTE: Only one type of breakout box should be used at a given time. You cannot use an EMU40EX breakout in conjunction with another breakout box.

  • Page 34: Emu40Ex Breakout Box

    EMU40EX™ User and Service Manual EMU40EX Breakout Box EMU40EX Breakout Box Standard 10-20 Channel Inputs Patient Event Connection (on side) Base Unit or External Battery Pack Connection (on side) Status LEDs 8 Additional Channels Pulse Oximeter Connection...

  • Page 35: Unpacking

    EMU40EX Battery Pack NOTE: The EMU40EX breakout box inputs use standard DIN42802 touchproof connectors; however, Natus cannot guarantee that all electrodes and sensors with touch proof connectors are compatible with the EMU40EX breakout box. Please contact Natus for recommended electrodes and sensors.

  • Page 36: Setting Up

    If a Photic Stimulator is needed, insert the Photic Stimulator into the Photic Stimulator connection on the Base Unit. When you are ready to run a study, connect the patient leads and transducers to the EMU40EX Breakout Box. USB-Style Hardware Connections for an EMU40EX System Ethernet-Style Connection Connect the computer to the LAN (Local Area Network).
  • Page 37 User and Service Manual EMU40EX™ Connect the power cable, Base Unit to EMU40EX Breakout Cable, patient event switch, and any additional accessories as required. NOTE: Setup and Installation of the EMU40EX amplifier system should be performed by Natus qualified personnel only.

  • Page 38: Setting The Ip Address

    EMU40EX™ User and Service Manual Setting the IP Address To power-up the Base unit, 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. NOTE: The amplifier supports both DHCP and static TCP/IP address configuration. Selecting DHCP will allow the amplifier to receive TCP/IP addresses automatically from the DHCP server.
  • Page 39 User and Service Manual EMU40EX™ Select On or Off for Audio Alerts. Select DHCP under Network Settings otherwise, the DNS server will enable manual entry of the IP address and DNS server for the Base Unit. Press Save to finalize changes to the IP configuration.
  • Page 40 EMU40EX™ User and Service Manual From the Main Screen, confirm system setup by pressing the Info button to view the information screen. On the information screen, ensure that the IP address is set as intended, and that the connection information related to the Breakout show that all components are recognized by the system.

  • Page 41: Touchscreen Icons

    Touchscreen Icons When properly installed and connected to the PC, the Natus Base 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 42: Amplifier Usage And Features

    Amplifier units are patient-worn. Refer to the section Adding the EMU40EX Breakout Box to a Harness or Belt for details on the placement of the Breakout Box on the patient.

  • Page 43: Potential Equalization Conductor

    The 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 EMU40EX system is used.

  • Page 44: Emu40Ex Amplifier System Description

    EEG electrode impedance testing in the patient room. The EMU40EX Breakout Box can be connected to the Base Unit with a cable or can connect wirelessly through a secure Bluetooth link. Using the EMU40EX amplifier system in its various operational modes is described in detail below.

  • Page 45: Feature Description Of Emu40Ex With Wireless Option Disabled

    Feature Description of EMU40EX with Wireless Option Disabled When the Base Unit is physically connected to the Breakout Box, i.e., with the Breakout Box Data Cable, the EMU40EX is 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 46 User and Service Manual When the Base Unit is physically disconnected from the Breakout Box, the EMU40EX is referred to as being in Physical Disconnection Mode. In this mode, the Breakout Box uses compact flash memory to store the study data (see below).
  • Page 47 EMU40EX™ When the Breakout Box is reconnected to the Base Unit, the EMU40EX is referred to as being in Physical Reconnection Mode. In this mode, any data stored in the Breakout Box is transferred to the computer via the Base Unit and merged with the recorded study (see below).

  • Page 48: Feature Description Of Emu40Ex With Wireless Option

    EMU40EX™ User and Service Manual Feature Description of EMU40EX with Wireless Option The wireless option has no effect on wired operation. During Physically Connected Mode, data is transmitted over the wired connection to the Base Unit and then transmitted to the computer.
  • Page 49 User and Service Manual EMU40EX™ When the Base Unit is physically disconnected from the Breakout Box, the Breakout Box uses compact flash memory to store the study data and simultaneously transmits a down-sampled version of this data over the wireless connection (see below).

  • Page 50: Testing The Emu40Ex Amplifier

    Calibration and Verification There is no need to calibrate the software or the EMU40EX amplifier. All calibration is done at the factory before the system is shipped. To verify that the EMU40EX amplifier is correctly calibrated, perform the following procedure:...

  • Page 51: Channel Test

    User and Service Manual EMU40EX™ Connect the Base Unit to an acquisition computer and turn on the system. Start Natus Database. To start a new study, click New EEG or Sleep. Choose Edit > Settings > Acquisition. On the Acquisition tab, set the Reference Electrode to Common.

  • Page 52: Impedance Check

    EMU40EX™ User and Service Manual Impedance Check An impedance check is performed to ensure that the electrode contact with the patient is satisfactory. You can perform an impedance check at any time during a study. Running an Impedance Check from the Software When an impedance check is initiated, the software scans all channels (in auto scan mode).

  • Page 53: Pulse Oximeter

    ® board that is built into the EMU40EX. The board connects to sensors and provides oxygen saturation, pulse rate, pulse waveform, and other output information via the NeuroWorks software. The EMU40EX provides power and isolates the board from the main power and ground. The NeuroWorks/SleepWorks software currently provides two types of SpO2 data: a 4 beat averaged pulse rate based on the previous four continuous acceptable pulse rates, and a beat to beat pulse rate value which is calculated based on the previous beat.
  • Page 54 EMU40EX™ User and Service Manual The Masimo SET ® pulse oximeter as well as traditional pulse oximetry determines SpO by passing red and infrared light into a capillary bed and measuring changes in light absorption during the pulsatile cycle. Red and infrared light-emitting diodes (LEDs) in oximetry sensors serve as the light sources, a photodiode serves as the photodetector.

  • Page 55: Pulse Oximeter Accessories

    Pulse Oximeter Accessories The Pulse Oximeter Accessories, PC Series Cable and LNCS series Oximetry sensors are sold separate from the EMU40EX System. PC Series Cable: Connects the pulse oximeter module to the oximetry sensors. Transfers LED drive power to the •...

  • Page 56: Oximeter Specifications

    EMU40EX™ User and Service Manual 1863 Masimo LNCS DCI Reusable Adult Finger Clip Sensor with 3ft Cable 1864 Masimo LNCS DCIP Reusable Pediatric Finger Clip Sensor with 3ft Cable Masimo LNCS Y1 Reusable Multisite Sensor 2258 Requires disposable wraps, standard and petite sizes available...

  • Page 57: Causes Of Loss Of Pulse Signal

    User and Service Manual EMU40EX™ Causes of Loss of Pulse Signal Sensor is too tight. • • Excessive illumination from light sources such as a surgical lamp, a bilirubin lamp, or sunlight. • Blood pressure cuff is inflated on the same extremity as the one with a SpO sensor attached.

  • Page 58: Transport System Specifications And Maintenance

    Natus Photic Stimulator Mount Tray for Acquisition DT Isolation Transformer Base Cart Weight Total Weight * Optional Items Natus ErgoJust Cart Specifications For specifications and details on the ErgoJust cart, please refer to the Natus ErgoJust Installation & Functionality Guide (p/n: 019667).

  • Page 59: Transportation Maintenance

    EMU40EX. Your EMU40EX should be cleaned after each use using a cleaning solution of 70% isopropyl alcohol and a lint-free cloth. Prior to any cleaning, disconnect power and all cables from the EMU40EX before wiping. Do not use cleaners on any system component.

  • Page 60: Troubleshooting

    Ask the patient to relax. Inspect your cables. Make sure all cables are connected properly between the EMU40EX and the computer. If using a LAN, make sure the hardware and software are configured correctly. Make sure the patient electrodes are connected to the correct channels in the Breakout Box.

  • Page 61: Getting Help

    User and Service Manual EMU40EX™ Getting Help Natus is committed to providing you with support so you can operate the EMU40EX amplifier 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 62: Accessories & Replacement Parts List

    Natus Photic Stimulator 10368 EMU40EX Wall Mount Kit EEG accessories which can be used with the EMU40EX Amplifier System are available for you to browse in the www.natus.com Natus Accessories Catalog online at or via Natus Sales and Support at 1-800-303-0306.
  • Page 63 Natus Medical Incorporated DBA Excel-Tech Ltd. () 2568 Bristol Circle Oakville, Ontario L6H 5S1 Canada T: +1 905.829.5300 F: +1 905.829.5304 P/N 023528, REV 03 www.natus.com...

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