XLTEK EMU40 and EMU40EX User and Service Manual Rev H

Publisher’s Notice 105098X Rev H XLTEK EMU40 / EMU40EX Natus Medical Incorporated Excel-Tech Ltd. (XLTEK) 2568 Bristol Circle Oakville, Ontario, L6H 5S1 Canada Tel: 905-829-5300 or Fax: 905-829-5304 Toll Free (US & Canada): 800-303-0306 Technical Support Email: [email protected] Customer Service Email: [email protected] Website: www.natus.com EUROPEAN AUTHORIZED REPRESENTATIVE: Natus Europe GmbH Robert-Koch-Str 1 82152 Planegg Germany

ISO 13485 Certified Copyright © 2011 by Excel-Tech Ltd. (XLTEK) The information in this publication is provided for reference only. All information contained in this publication is believed to be correct and complete. Excel-Tech Ltd. shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance, or use of this material. All product specifications, as well as the information contained in this publication, are subject to change without notice. This publication may contain or reference information and products protected by copyrights or patents and does not convey any license under the patent rights of Excel-Tech Ltd., nor the rights of others. Excel-Tech Ltd. does not assume any liability arising out of any infringements of patents or other rights of third parties. All rights reserved. This document contains confidential or proprietary information of Excel-Tech Ltd. No part of this document may be reproduced or transmitted in any form or by any means without the written permission of Excel-Tech Ltd. Excel-Tech Ltd. makes no warranty of any kind with regard to this material, including but not limited to the implied warranties of merchantability and fitness of a particular purpose.

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Table of Contents INTRODUCTION

6

PRODUCT INTENDED USE USING THE MANUAL MANUAL CONVENTIONS

6 7 7

EMU40EX SAFETY AND STANDARDS CONFORMITY

8

STANDARDS OF COMPLIANCE AND NORMATIVE REFERENCES DECLARATION OF COMPLIANCE FOR IEC 60601-1-2 DECLARATION OF COMPLIANCE FOR FCC

8 10 14

WARNINGS AND CAUTIONS

15

GENERAL WARNINGS ELECTRICAL WARNINGS AND CAUTIONS PATIENT ENVIRONMENT WARNINGS AND CAUTIONS MASIMO PULSE OXIMETER WARNINGS MASIMO PULSE OXIMETER SENSOR WARNINGS WIRELESS OPTION WARNINGS AND CAUTIONS

15 16 16 17 18 19

DESCRIPTION OF SYMBOLS

20

SPECIFICATIONS: EMU40EX AMPLIFIER

21

PRODUCT IMAGES

24

EMU40EX SYSTEM EMU40EX BASE UNIT EMU40EX BREAKOUT BOX

24 25 28

UNPACKING

29

SETTING UP

29

USB-STYLE CONNECTION ETHERNET-STYLE CONNECTION

29 31

EMU40EX HEADBOX SYSTEM DESCRIPTION

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Introduction The XLTEK EMU40 EEG amplifier system is ideal for making EEG/LTM recordings. EMU40 has 46 input channels – including an integrated Masimo SET® pulse oximeter – and both TCP/IP and USB connectivity for quick and easy installation. This rugged device was designed with extensive clinical input to meet the workflow and application needs of the EEG/LTM Lab. EMU40EX is equipped with a more powerful wireless transmitter when compared to EMU40, allowing it to be used over extended distances. The content in this manual applies equally to both EMU40 and EMU40EX devices unless explicitly stated. The differences are explained in the Specifications section. EMU40 features include: •

40 referential channels, 4 DC channels, 1 pulse rate and 1 oximeter channel

•

Ability to initiate an impedance test, change the threshold, and view the results in the patient room

•

Operation in ambulatory mode for up to two hours (powered by a rechargeable battery pack)

•

Wireless data acquisition and monitoring over a wireless Bluetooth connection during ambulatory operation

•

A small and lightweight breakout box – 364 cm3 and 300g

•

Ruggedness and durability

•

TCP/IP and USB connectivity

•

DC inputs on base unit for fixed devices

•

Patient-event switch interface on both the breakout box and base units

•

Photic stimulator interface for EEG applications WARNING: We strongly recommend that you read the Warnings and Cautions section of this manual before operating this amplifier.

Product Intended Use • •

•

The EMU40EX EEG headbox is an electroencephalograph that works in conjunction with Natus NeuroWorksTM 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. The EMU40EX EEG headbox requires competent user input, and its output must be reviewed and interpreted by trained medical professionals who will exercise professional judgment in using this information.

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Using the Manual This manual provides basic information and instructions that will enable you set up and operate the EMU40EX amplifier. When going through the procedures, we recommend that you read the whole section first, before starting the sequence. Please follow the instructions carefully. In addition to reading this manual, we encourage you to explore the online Help to enable you to take advantage of everything that XLTEK has designed the EMU40EX amplifier to do. More detailed instructions relating to the operation and customization of the system are provided in the online Help.

Manual Conventions This symbol denotes a warning or important information that should not be missed. Read all warnings and cautions carefully before starting the system for the first time. This note symbol denotes important supplemental information.

Bold

Names of control keys, function keys, options, and labels are shown in bold. Bold text is also used to emphasize important names or ideas.

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EMU40EX Safety and Standards Conformity Standards of Compliance and Normative References Multichannel Sleep/EEG Headbox System, Model EMU40EX, detachable cord connected, portable 115/230Vac, 50/60Hz, 30W. 1. 2. 3. 4.

Type of protection against electric shock: Class I Degree of protection against electric shock: Type BF Degree of protection against ingress of water: IPX0 Degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. 5. Mode of operation: Continuous 6. 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 601.1-M90 CAN/CSA C22.2 601.1S1-94

CAN/CSA C22.2 601.1B-90

CAN/CSA-C22.2 No. 60601-2-26-04

UL 60601-1 (1st Ed)

Medical Electrical Equipment Part 1: General Requirements for Safety adopted IEC 601-1 2ed (90) Supplement No 1-94 to CAN/CSA C22.2 601.1-M90 Medical Electrical Equipment Part 1: General Requirements for Safety adopted IEC 601-1 2ed (90), amendment 1 (91) Amendment 2 to CAN/CSA C22.2 601.1-M90 Medical Electrical Equipment Part 1: General Requirements for Safety adopted IEC 601-1 2ed, amendment 2 (95) Medical Electrical Equipment Part 2-26: Particular Requirements for the Safety of Electroencephalographs, adopted IEC 60601-2-26 Ed.2 (02). Medical Electrical Equipment Part 1: General Requirements for Safety

IEC 60601-1:1990 (2nd Ed)

Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance

IEC 60601-2-26: 2002 (2nd Ed)

Medical Electrical Equipment Part 2-26: Particular requirements for the safety of electroencephalographs

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Table 2 – EMC Standard of Compliance and Normative References EN 60601-1-2:2001 (2nd Ed)

Medical Electrical Equipment Part 1-2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests

IEC 61000-4-2:1995 / EN 61000-42:2001

Electromagnetic Compatibility (EMC) Part 4-2: Testing and Measurement Techniques - Electrostatic Discharge Immunity Test

IEC 61000-4-3:2002 / EN 61000-43:2002 +A1:2002 +IS1:2004

Electromagnetic Compatibility (EMC) Part 4-3: Testing and Measurement Techniques - Radiated, Radio-frequency, Electromagnetic Field Immunity Test

IEC 61000-4-4:2004 / EN 61000-44:2004

Electromagnetic Compatibility (EMC) Part 4-4: Testing and Measurement Techniques - Electrical Fast Transient/Burst Immunity Test

IEC 61000-4-5:1995 / EN 61000-45:2001

Electromagnetic Compatibility (EMC) Part 4-5: Testing and Measurement Techniques - Surge Immunity Test

IEC 61000-4-6:1996 / EN 61000-46:1996 +IS1:2004

Electromagnetic Compatibility (EMC) Part 4-6: Testing and Measurement Techniques - Immunity to Conducted Disturbances, Induced by Radio-frequency Fields

IEC 61000-4-8 / EN 61000-4-8

Electromagnetic Compatibility (EMC) Part 4-8: Testing and Measurement Techniques - Power Frequency Magnetic Field Immunity Test

IEC 61000-4-11:2004 / EN 61000-411:2004

Electromagnetic Compatibility (EMC) Part 4-11: Testing and Measurement Techniques - Voltage Dips, Short Interruptions and Voltage Variations Immunity Tests

IEC 61000-3-2:1995 / EN 61000-32:2001

Electromagnetic Compatibility (EMC) Part 3-2: Limits - Limits for Harmonic Current Emissions

IEC 61000-3-3:1994 / EN 61000-33:1998

Electromagnetic Compatibility (EMC) Part 3-3: Limits Limitation of Voltage Changes, Voltage Fluctuations and Flicker in Public Low-voltage Supply Systems

CISPR 11:2004 / EN 55011:1998 +A1:1999 +A2:2002 Class A, Group 1

Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment - Electromagnetic Disturbance Characteristics Limits and Methods of Measurement

ANSI C63.4:2004

American National Standard for Methods of Measurement of Radio-noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9KHz to 40 GHz

CISPR 16-1-1:2003

Specification for Radio Disturbance and Immunity Measuring Apparatus and Methods. Part 1-1: Measuring Apparatus

CISPR 16-2-1:2004

Specification for Radio Disturbance and Immunity Measuring Apparatus and Methods. Part 2-1: Conducted Disturbances Measurement

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FCC 47 CRF Part 15:2005, Subpart B Class A

Federal Communications Commission (FCC) - Unintentional Radiators

CISPR 22:2003 +A1:2004 / EN 55022:2003

Information Technology Equipment - Radio Disturbance Characteristics - Limits and Methods of Measurement

Declaration of Compliance for IEC 60601-1-2 Table 1 - Electromagnetic Emissions Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The EMU40 is intended for use in the electromagnetic environment specified below. The customer or the EMU40EX should assure that it is used in such an environment.

Emissions Test RF emissions

Compliance Group 1

The EMU40EX uses RF energy only for its internal function. Therefore, its RF emissions are very low and not likely to cause any interference in nearby electronic equipment

Class A

The EMU40EX is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

CISPR 11 RF emissions

Electromagnetic Environment - Guidance

CISPR 11 Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/ flicker emissions

Complies

IEC 61000-3-3

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Table 2 - Electromagnetic Immunity Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The EMU40 is intended for use in the electromagnetic environment specified below. The customer or the user of the EMU40 should assure that it is used in such an environment.

Immunity Test Electrostatic Discharge (ESD)

IEC 60601 Test Level ±6 kV contact

Compliance Level Complies

Electromagnetic Environment - Guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

±8 kV air

IEC 61000-4-2 Electrostatic fast transient/burst IEC 61000-4-4

Surge IEC 61000-4-5

±2 kV for power supply lines ±1 kV for input/output lines ±1 kV differential mode

Mains power quality should be that of a typical commercial or hospital environment.

Complies Complies

Complies

Mains power quality should be that of a typical commercial or hospital environment.

Complies

Mains power quality should be that of a typical commercial or hospital environment. If the user of the EMU40EX requires continued operation during power mains interruption, it is recommended that the EMU40EX to be powered from an suitable uninterruptible power supply or a battery.

Complies

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

±2 kV common mode Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

<5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 250ec

Power frequency (50/60 Hz) magnetic field

3 A/m

IEC 61000-4-8 NOTE: UT is the AC supply voltage prior to application of the test level.

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Table 3 - Electromagnetic Immunity– for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The EMU40 is intended for use in the electromagnetic environment specified below. The customer or the user of the EMU40 should assure that it is used in such an environment

Immunity test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment - Guidance Portable and mobile RF communications equipment should be used no closer to any part of the EMU40, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Conducted RF

3 Vrms

IEC 61000-4-6

150 kHz to 80 MHz

Radiated RF

3 V/m

IEC 61000-4-3

80 MHz to 2.5 GHz

Recommended separation distance Complies 150kHz to 80MHz

80MHz to 800MHz

800MHz to 2.5GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic sitea should be less than the compliance level in each frequencyb. Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed 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.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Table 4 - Recommended Separation Distances Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the EMU40EX. The EMU40 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the EMU40 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the EMU40 as recommended below, according to the maximum output power of the communications equipment.

Rated Maximum Output Power of Transmitter (W)

Separation Distance according to Frequency of Transmitter (m) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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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. 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 interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. Warning: Changes or modifications not expressly approved by the manufacturer could void the user's authority to operate the equipment.

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Warnings and Cautions General Warnings Proper use of this device depends on the careful reading of all instructions and labels that come with or on the system. Inaccurate measurements may be caused by incorrect application or use. The amplifier is classified as an IP0 – ordinary degree of protection against ingress of water according to IEC 529. The computer used with a EMU40EX amplifier must either be approved by XLTEK and supplied as part of an IEC 601 approved system, or it must be approved to IEC 950 or similar and kept outside of the patient environment (that is, the area within 1.5 meters of the patient laterally and within 2.5 meters of the floor in the area occupied by the patient). To ensure the validity of signals, do not operate the device near any sources of electromagnetic interference. Turn off system power before cleaning. Prevent detergent solution or cold sterilization agents from seeping into the electronics of the system. Be careful around all connectors and edges. Do not use abrasive agents. The EMU40EX cannot be cleaned of bio-contaminate. Attempts to remove biocontaminate will damage the unit. XLTEK systems are not AP or APG rated. Device accessories may include several kinds of disposable, sterile needle electrodes. These needles are labeled as STERILE, and the method of sterilization is documented on the packaging. These electrodes should not be used if the sterile packaging has been tampered with. The sale, distribution, or use of this device is restricted to, by, or on order of a physician. Printers and/or peripherals used with XLTEK devices should be marked and approved for use in their appropriate medical environment in accordance with the regulations of the country in which they are used. Do not attempt to connect any third-party devices to the patient breakout box except those approved by XLTEK.

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Do not dispose of this medical product as unsorted municipal waste. At the end of an EMU40EX’s life, please contact XLTEK at 1-800-303-0306 in order to arrange return shipping for your EMU40EX amplifier.

Electrical Warnings and Cautions XLTEK systems are intended for connection to a properly grounded electrical outlet only. ELECTRICAL SHOCK HAZARD: Do NOT turn on the system power until all cables have been connected, verified and visually inspected for any damage. Failure to inspect the cables may result in electrocution. ELECTRICAL SHOCK HAZARD: Do NOT connect electrode inputs to earth ground. The patient breakout box contains warning symbols reminding you that the connections are intended for isolated patient connections only. Connecting to an earth ground might result in electrocution. ELECTRICAL SHOCK HAZARD: Do NOT service the system. Refer servicing to qualified personnel only. For the use of an ELECTROENCEPHALOGRAPH without protective means to prevent burning of the PATIENT, information on the location of the ELECTRODES is provided. When the EMU40EX EEG Headbox is used in an end-use system, the system shall be evaluated using 60601-1-1. The EMU40EX amplifier is NOT designed to work with defibrillators or electrocautery devices. The EMU40EX could be damaged when used with these devices.

Patient Environment Warnings and Cautions NOTE: The patient environment is defined as the area within 1.5 meters of the patient laterally and within 2.5 meters of the floor in the area occupied by the patient. Connect all patient electrodes to fully electrically isolated devices only. Connecting patient electrodes to any other device or external outlet may result in personal injury. The patient breakout box accepts only touch-proof style electrode inputs. Do NOT attempt to use any other style of patient electrode input. The patient event switch attached to the EMU40EX base or breakout unit is NOT intended for critical patient-safety-related incidents.

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Patient connections are NOT intended for direct cardiac contact. Route patient cabling carefully to reduce the possibility of patient entanglement or strangulation. Do not use EMU40EX in the vicinity of MRI or CT systems.

Masimo Pulse Oximeter Warnings ®

The Masimo SET pulse oximeter is to be operated by qualified personnel only. This manual, accessory directions for use, all precautionary information, and specifications should be read before use. Explosion hazard. Do not use the MS board pulse oximeter in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide. A pulse oximeter should NOT be used as an apnea monitor. A pulse oximeter should be considered an early warning device. As a trend towards patient deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter to completely understand the patient’s condition. Significant levels of dysfunctional hemoglobins (HbCO or MetHb) may cause inaccurate measurements. Intravascular 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 cause inaccurate measurements. Venous pulsations may cause inaccurate measurements. Carboxyhemoglobin may erroneously increase readings. The level of increase is approximately equal to the amount of carboxyhemoglobin present. Dyes, or any substance containing dyes, that change usual arterial pigmentation may cause erroneous readings.

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Loss of pulse signal can occur when the patient has hypotension, severe vasoconstriction, severe anemia or hypothermia. Loss of pulse signal can occur when there is arterial occlusion proximal to the sensor. Loss of pulse signal can occur when the patient is in cardiac arrest or is in shock. Tissue damage can occur due to incorrect placement of sensor. Do not immerse the sensor in water, solvents, or cleaning solutions. Do not sterilize the sensor by irradiation, steam or ethylene oxide. Do not immerse patient cables in water, solvents, or cleaning solutions (the patient cable connectors are not waterproof). Do not sterilize patient cables by irradiation, steam or ethylene oxide.

Masimo Pulse Oximeter Sensor Warnings ®

Before using, carefully read the LNOP sensor directions for use. Use only Masimo oximetry sensors for SpO2 measurements. Other oxygen transducers (sensors) may cause improper pulse oximeter performance. ®

Tissue damage can be caused by incorrect application or use of an LNOP sensor; for example, by wrapping the sensor too tightly. Inspect the sensor site as directed in the sensor directions for use to ensure skin integrity and correct positioning and adhesion of the sensor. Do not use Masimo pulse oximetry sensors during MRI scanning as this could potentially cause burns. The Masimo pulse oximeter may affect the MRI image, and the MRI unit may affect the accuracy of the oximetry measurements. Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line may cause inaccurate measurements. Loss of pulse signal can occur when the sensor is too tight. ®

®

Do not use damaged LNOP sensors. Do not use an LNOP sensor with exposed optical components. Do not immerse the sensor in water, solvents or cleaning solutions (the sensors and connectors are not waterproof). Do not sterilize by irradiation, steam, or ethylene oxide. See the cleaning instructions 18

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®

in the directions for use for reusable Masimo LNOP sensors. Do not use damaged patient cables. Do not immerse the patient cables in water, solvents, or cleaning solutions (the patient cable connectors are not waterproof). Do not sterilize by irradiation, steam, or ethylene oxide. See the cleaning instructions in the directions for use for reusable Masimo patient cables.

Wireless Option Warnings and Cautions The wireless feature of this headbox presents a passive visualization of the EEG signal. This feature is not a substitute for other means of patient monitoring and supervision. Like other wireless devices, this feature is limited in operating range. The range will also be reduced substantially if there is any physical interference between the Base unit and the Breakout box. In either of these situations, the wireless data will not be received by the acquisition computer. The EMU40 (only) contains FCC ID: ED9LMX9838 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. Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. The EMU40EX (only) contains FCC ID: R47F2M03GX 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. Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. The EMU40 (only) contains IC: 1520A-LMX9838 which complies with RSS 210 of Industry Canada. 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. The EMU40EX (only) contains F2M03GXA which has passed the Bluetooth Qualification/Certification process as specified within the Bluetooth Specifications and as required within the PRD 2.0. QDID: B012540.

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Description of Symbols Symbol

Description ATTENTION: Consult Accompanying Documents Consult Accompanying Documents Protective Earth (Ground) Type BF Equipment Dangerous Voltage Alternating Current Direct Current Power On Power Off

EU only: Do Not Dispose as Unsorted Municipal Waste

CE Mark

Class II Equipment (non-grounded enclosure) ESD Sensitive or Static Sensitive

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Specifications: EMU40EX Amplifier Specification

Value(s)

Analog Specifications Channels Referential Channels

40

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

Input Noise (RMS)

0.65 µV @ 0.1~70 Hz bandwidth

EEG Channel Hardware Gain

250

Maximum Differential AC Input Before Clipping ± 10 mV pk-to-pk (Referential) Maximum Operational DC Input Voltage Electrode Offset

± 200 mV

Input Bias Current

< 20 pA

Channel Crosstalk

-87 dB

Analog Specifications – DC Channels DC Channels (patient side)

4 non-isolated

DC Input Range

±5V

Photic Stim Interface Photic Stim Output

1 (TTL level, active high)

Photic Stim Input

1 (TTL level, active high)

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EMU40EX Amplifier Specifications, cont. User Interface Push Buttons

4 (Impedance Check and Threshold, Up and Down)

Event Switch Connection

2 – 1 on Base unit and 1 on Breakout

LED Indication

3 on Base unit and 4 on Breakout box.

Display

Color LCD on Base unit

Digital Specifications Sampling Frequency

256 Hz, 512, 1024 Hz

Sampling Resolution – EEG Channels 16 bits Sampling Quantization – EEG Channels

300 nV

Sampling Resolution - DC Channels

16 bits

Sampling Quantization – DC Channels 150 µV Modes of Operation Base Unit Electrical Ratings

115/230 V AC, 50/60 Hz, 30 W

Base Unit Fuse Type and rating

T 0.5 A / 250 V

Breakout Box Storage Capacity

1 GB Internal Compact Flash Card

Breakout Box Power Consumption

1 W @12 V

Breakout Box Battery

Rechargeable 2 x AAA Ni-Mh battery

Breakout Box Battery 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 µV pk-to-pk Square: 0.25–1 Hz, 50–200 µV pk-to-pk

Wireless Specifications (Optional Feature)

10405/10406 002932/002933 EMU40 Gennum EMU40 LMX

Operating Frequency

006550/006562 EMU40EX F2M

2.400 – 2.4835 GHz

RF Output Power

4 mW (+6dBm)

2 mW (+3dBm)

6 mW (+8dBm) 64 mW (+18dBm) 1

Maximal distance range between transmitter / receiver (according to EMC environmental conditions).

Up to 10 meters

Up to 10 meters

Up to 30 meters

1

Maximum radio power can be adjusted for each EMU40EX unit using provided software utility

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