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EMU40EX™

User and Service Manual

Symbol

Standard

Reference

Standard Title of

Symbol

Symbol Title

as per

Referenced

Standard

Explanation

Based on ISO

15223-1, Annex B

Negation of

Symbol 5.4.5

Medical devices —

Symbols to be used with

information to be supplied

by the manufacturer —

Part 1: General

requirements

Not made with

Natural Rubber Latex

Indicates a medical device

that is not made with natural

rubber latex.

ASTM F2503-20

FDA Guidance - Testing

and Labeling Medical

Devices for Safety in the

Magnetic Resonance (MR)

Environment

MR Unsafe

Identifies an item which

poses unacceptable risks to

the patient, medical staff or

other persons within the MR

environment.

System Symbols

Photic Stimulator Connector

Patient Event Button Connector

Содержание Xltek EMU40EX

Страница 1: ...EMU40EX User and Service Manual...

Страница 2: ...Kingdom Copyright 2018 2023 by Natus Medical Incorporated Issued February 17 2023 Associated product part numbers PK1072 NTB 9 021743 9 All rights reserved This manual contains proprietary information...

Страница 3: ...s 14 Patient Environment Warnings and Cautions 16 Pulse Oximeter Warnings and Cautions 17 Wireless Option Warnings 18 Electromagnetic Interference EMI Warnings 19 Transportation Warnings 19 Cleaning W...

Страница 4: ...hannel Test 51 Impedance Check 52 Pulse Oximeter 53 Masimo Patents 53 No Implied License 53 Indications for Use 53 Instruction for Use 53 How the Pulse Oximeter Works 53 Pulse Oximeter Accessories 55...

Страница 5: ...display of EEG waveforms remains available over a secure Bluetooth connection during Ambulatory Mode Data acquired on the Breakout Box while in Ambulatory Mode is transparently and seamlessly transfer...

Страница 6: ...s for performing EEG studies on patients of all ages from neonatal to adult but not fetal use Clinical Benefits The EMU40EX Amplifier aids in measuring the electrical brain activity and in diagnosing...

Страница 7: ...ealthcare trained personnel will observe essential performance degradation which includes but are not limited to Loss of EEG signal data Amplifier saturation indication on the computer monitor Intermi...

Страница 8: ...r basic safety and essential performance IEC 60601 1 6 2010 AMD1 2013 Medical electrical equipment Part 1 6 General requirements for basic safety and essential performance Collateral standard Usabilit...

Страница 9: ...in Public Low voltage Supply Systems CISPR 11 ed 5 0 with A1 2010 Industrial Scientific and Medical ISM Radio Frequency Equipment Electromagnetic Disturbance Characteristics Limits and Methods of Mea...

Страница 10: ...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 hospital enviro...

Страница 11: ...mmended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site1 should be less than the compliance level in each frequency2 Interference ma...

Страница 12: ...trical SYSTEM may be reduced to 1 m The 1 m test distance is permitted by IEC 61000 4 3 a For some services only the uplink frequencies are included b The carrier shall be modulated using a 50 duty cy...

Страница 13: ...cessories 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...

Страница 14: ...ld be damaged when used with this device EMU40EX Amplifiers are compatible with NeuroWorks SleepWorks v9 0 and newer Operation of this equipment with input signals in excess of a range of 10mV may cau...

Страница 15: ...you that the connections are intended for isolated patient connections only Connecting to an earth ground might result in electrocution Do NOT connect non medical equipment which has been supplied as...

Страница 16: ...system and the patient simultaneously Connection of a patient to high frequency surgical equipment and to electroencephalography equipment simultaneously may result in burns at the site of bio potenti...

Страница 17: ...cular dyes such as indocyanine green or methylene blue may cause inaccurate measurements Excessive illumination may cause inaccurate measurements or loss of pulse signal Excessive patient movement may...

Страница 18: ...rference with the wireless radios in this device occur relocate the devices causing the issue or contact Natus Technical Support at 1 800 303 0306 or OTS Natus com Medical Electrical Equipment needs s...

Страница 19: ...urdy 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 Natus is not responsible for any...

Страница 20: ...or bring them into contact with anything that could scratch the panel Use cleaning solution sparingly Excessive solution can flow into the amplifier and cause damage to internal components Disconnect...

Страница 21: ...op not on the cable itself 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 el...

Страница 22: ...Symbols to be used with information to be supplied by the manufacturer Part 1 General requirements Authorized representative in the European Community Indicates the Authorized representative in the E...

Страница 23: ...code Indicates the manufacturer s batch code so that the batch or lot can be identified ISO 15223 1 Symbol 5 1 6 Medical devices Symbols to be used with information to be supplied by the manufacturer...

Страница 24: ...Medical devices Symbols to be used with information to be supplied by the manufacturer Part 1 General requirements Temperature limit Indicates the temperature limits to which the medical device can be...

Страница 25: ...or basic safety and essential performance IEC 60601 1 Table D 2 10 Medical electrical equipment Part 1 General requirements for basic safety and essential performance Follow Instructions for Use Refer...

Страница 26: ...dicates that the medical device needs to be protected from moisture ISO 15223 1 Symbol 5 3 1 Graphical symbols for use on equipment Fragile handle with care Indicates that the contents of the transpor...

Страница 27: ...port or plug as meeting the generic requirements of the Universal Serial Bus USB To indicate that the device is plugged into a USB port or is compatible with a USB port IEC 60417 Symbol 5034 Graphica...

Страница 28: ...anufacturer Part 1 General requirements Not made with Natural Rubber Latex Indicates a medical device that is not made with natural rubber latex ASTM F2503 20 FDA Guidance Testing and Labeling Medical...

Страница 29: ...ing Referential 10 mV pk to pk Maximum Operational DC Input Voltage Electrode Offset 200 mV Input Bias Current 20 pA Channel Crosstalk 87 dB Analog Specifications DC Channels DC Channels Base Unit DC1...

Страница 30: ...tery Life 1 to 1 5 hrs depending on features enabled wireless oximeter Impedance Check 2 5 5 10 25 kOhms Channel Test Signal Programmable Sine 5 20 Hz 50 200 V pk to pk Square 0 25 1 Hz 50 200 V pk to...

Страница 31: ...ication 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 EMU40EX Breakout 100mm x 158mm x 23mm 3 94 x 6 22 x 0 91 Weight Natus Base Unit 2...

Страница 32: ...EMU40EX User and Service Manual 32 Product Images EMU40EX System EMU40EX System Base Unit Breakout Box and Battery Pack...

Страница 33: ...A 8 Reserved for future use Labeled with 9 Can be used to connect DC signals from external devices Labeled with DC1 DC12 Only DC1 DC4 are available when EMU40EX Breakout Box is connected 10 Natus Phot...

Страница 34: ...4 EMU40EX Breakout Box EMU40EX Breakout Box 1 Standard 10 20 Channel Inputs 2 Patient Event Connection on side 3 Base Unit or External Battery Pack Connection on side 4 Status LEDs 5 8 Additional Chan...

Страница 35: ...proof connectors are compatible with the EMU40EX breakout box Please contact Natus for recommended electrodes and sensors Additional EEG System Components The EMU40EX amplifier system is provided with...

Страница 36: ...cal Area Network 2 Connect the Natus Base Unit to the LAN 3 Insert the Patient Event Switch into the Patient Event connection on the Base Unit or Breakout 4 If a Photic Stimulator is needed insert the...

Страница 37: ...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 perfor...

Страница 38: ...rface appears 2 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...

Страница 39: ...for Audio Alerts 4 Select DHCP under Network Settings otherwise the DNS server will enable manual entry of the IP address and DNS server for the Base Unit 5 Press Save to finalize changes to the IP co...

Страница 40: ...8 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 NOTE If DHCP...

Страница 41: ...dicates that the headbox is connected to the PC via an Ethernet cable If the color is BLUE the PC software is connected to the head box and is typically running a study If the color is BLACK the Ether...

Страница 42: ...udy consult the NeuroWorks manual NOTE To record a study the Base Unit must be connected to a PC and the Base Unit must be connected to the Breakout Box as described in EMU40EX Breakout Box to Base Un...

Страница 43: ...ctor 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 ele...

Страница 44: ...he 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...

Страница 45: ...kout 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...

Страница 46: ...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 be...

Страница 47: ...on 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 Physical Reconnection Mode without Wireless Optio...

Страница 48: ...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 The computer soft...

Страница 49: ...ically 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 connecti...

Страница 50: ...he computer via the Base Unit and merged into the recorded study see below Physical Reconnection Mode with Wireless Option Testing the EMU40EX Amplifier The EMU40EX amplifier is fully assembled tested...

Страница 51: ...ng up a montage consult the online Help Channel Test While in Acquisition mode a channel test may be performed to check whether a signal is being properly processed from the amplifier to the display A...

Страница 52: ...nto a channel Click Lock Channel Then adjust the electrode connection until satisfactory levels are achieved Proceed to a full impedance check Click Release Lock End the impedance check Click End Save...

Страница 53: ...lse oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin SpO2 and pulse rate measured by an SpO2 sensor The Masimo SE...

Страница 54: ...fluctuating absorbance by venous blood is the major component of noise during the pulse The Masimo SET pulse oximeter decomposes S 660 and S 905 into an arterial signal plus a noise component and cal...

Страница 55: ...ceives the detector signal from the oximetry sensor through the PC series cable LNCS Series Oximetry Sensors Low Noise Cabled Sensors LNCS and integrated cables are designed to provide optimal pulse o...

Страница 56: ...oximeter monitor or the pulse oximeter probe cannot be determined by using a functional tester Measurements If the accuracy of any measurement does not seem reasonable check the patient s vital signs...

Страница 57: ...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 SpO2 sensor attached Patient has hypotension severe vasoconstrictio...

Страница 58: ...cations Not available in all Markets Natus ErgoJust Cart Specifications For specifications and details on the ErgoJust cart please refer to the Natus ErgoJust Installation Functionality Guide p n 0196...

Страница 59: ...lution sparingly Excessive solution can flow into the amplifier and cause damage to internal components Do NOT touch press or rub the LCD with abrasive cleaning compounds instruments brushes rough sur...

Страница 60: ...trodes touching If so they are causing a short circuit and will develop an artifact Install a medical grade ground to make sure that your clinic has a properly grounded electrical system Check the imp...

Страница 61: ...the computer and click Yes Step 3 Shut Down the Computer Sometimes you need to shut down the computer completely to solve a problem 1 Click the Start button on the Windows taskbar 2 Choose Shut Down...

Страница 62: ...X Patient Event Switch 8 A1011X Power Cord 6 A1014X EU Power Cord W8194X USB 2 0 6ft Cable Hi Speed Gold W8128F Network Cable 15ft 015170 Fuse Glass 1 5A 250VAC 5X20mm Slow Optional Accessories List T...

Страница 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 www natus com P N 023528 REV 03...

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