EEG32U User and Service Manual Rev O Jan 2019

User and Service Manual

XLTEK EEG32U Amplifier

Publisher’s Notice 105491 Rev O XLTEK EEG32U Natus Medical Incorporated DBA 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] Website: www.natus.com

EUROPEAN AUTHORIZED REPRESENTATIVE Natus Manufacturing Limited IDA Business Park Gort, Co. Galway Ireland

ISO 13485 Certified

Copyright © 2019 by Natus Medical Incorporated. Issued in January 2019. All rights reserved. This manual contains proprietary information, which is protected by copyright and may not be copied in whole or in part except with the prior written permission of Natus Medical Incorporated. 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. Natus Medical Incorporated disclaims all liabilities for loss or damage arising out of the possession, sale, or use of this document.

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XLTEK EEG32U Amplifier

User and Service Manual

Table of Contents Introduction ... 4 Product Intended Use ...4 Essential Performance ...4 Using the Manual ...4 Manual Conventions ...5

Specifications: EEG32U Amplifier ... 6 EEG32U Safety and Standards Conformity ... 8 Standards of Compliance and Normative References ...8 Declaration of Compliance for IEC 60601-1-2 ... 10 Declaration of Compliance for FCC ... 14

Warnings and Cautions ... 15 General Warnings ... 15 Electrical Warnings and Cautions ... 16 Patient Environment Warnings and Cautions... 17 Transportation Warnings... 18 Conducted Immunity Warnings ... 18

Procedures and Warnings ... 19 Electrostatic Discharge (ESD) Handling ... 19 Conducted Immunity Procedures and Warnings ... 19

Description of Symbols ... 21 Product Images... 23 EEG32U Headbox ... 23

Unpacking ... 24 Setting Up ... 25 Placement of the Operator and Patient ...25 Beginning a study ...25 Powering Down the System ...25

Connecting to a Computer ... 26 Testing the EEG32U Amplifier ... 26 Calibration and Verification ...27

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Channel Test ...27 Impedance Check ...28

Transport System Specifications and Maintenance ... 30 XLTEK Trolley Specifications ... 30 Maintenance ... 31 Warnings and Cautions ... 31 Electrical Input and Isolation Transformer Details... 31

Maintenance, Cleaning, & Disposal ... 32 Recommendations ... 32 Disposal ... 33

Troubleshooting ... 34 Theory of Operation: ... 35 Introduction ... 35 System Overview ... 35 Features of the EEG32U System ...35 Components of the Communications Link ...35 Power Sources to the Headbox ...35

Circuit Board Assemblies inside the Headbox ... 35 A. B.

Analog Board ...35 Digital Board ...36

Getting Help ... 37 EEG Accessories & Replacement Parts... 38 Index... 39

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XLTEK EEG32U Amplifier

User and Service Manual

Introduction The XLTEK EEG32U amplifier offers advanced signal acquisition capabilities for accurate data acquisition with 1kHz sampling rates and 16 bit analog-to-digital data conversion. The highest signal-tonoise ratios and fast recovery from saturation for stable baselines are available with the EEG32U. This rugged device was designed with extensive clinical input to meet the workflow and application needs of the basic EEG Lab. EEG32U features include: •

USB connectivity to XLTEK Desktop or Laptop

•

32 referential channels

•

Patient-event switch interface

•

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 EEG32U Amplifier is intended to be used as an electroencephalograph to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks™ software to acquire scalp electroencephalographic (EEG) signals. The EEG32U Amplifier is intended to be used by trained medical professionals, and is designed for use in clinical environments such as hospital rooms and epilepsy monitoring units. It can be used with patients of all ages, but is not designed for fetal use.

Essential Performance Essential performances of the EEG32U amplifier are identified in the standard IEC 60601-2-26:2012. Essential performance relates to the quality of the signal recorded from the amplifier. Specific essential performances are: (1) (2) (3) (4) (5)

accuracy of signal reproduction dynamic range and differential offset voltage input noise level frequency response common mode rejection

The definition of these essential performances can be found in the standard.

Using the Manual This manual describes the theory, features, set up, operation and maintenance of the EEG32U amplifier. It also provides information on specifications, troubleshooting and getting help. When reviewing the procedures, we recommend you read the entire section first, before beginning a sequence. Please follow the instructions carefully.

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XLTEK EEG32U Amplifier

Manual Conventions Various symbols and typographical conventions are used throughout the manual. The following table illustrates them and describes their meanings and functions. Symbol/ Convention

Description/Function 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. A note that contains 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.

Italic

Italic text is used for captions.

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Specifications: EEG32U Amplifier Specification

Value(s)

Analog Specifications Channels Referential Channels

32

Differential Input Impedance

≥ 100 MOhms

Common Mode Input Impedance

≥ 50 MOhms

Common Mode Rejection Ratio

- 110 dB @ 60 Hz

Channel Bandwidth

0.1 Hz to 400 Hz

Input Noise (peak to peak)

3.0 µV @ 0.1Hz~70 Hz bandwidth

Input Noise (RMS)

0.65 μV @ 0.1Hz~70 Hz bandwidth

EEG Channel Hardware Gain

125

Maximum Differential AC Input Before Clipping (Referential)

± 20 mV

Maximum Operational DC Input Voltage Electrode Offset

± 1000 mV

Input Bias Current

≤ 20 pA

Channel Crosstalk

 70 dB

Photic Stim Interface Photic Stim Output

1 (TTL level, active high)

Photic Stim Input

1 (TTL level, active high)

User Interface Push Buttons

1 (Impedance Check)

Event Switch Connection

1 on board

LED Indication

68 on board.

Digital Specifications Sampling Frequency

256, 512 and 1024 Hz

Sampling Resolution - EEG Channels

16 bits

Sampling Quantization - EEG Channels

600 nV

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User and Service Manual

Specification

XLTEK EEG32U Amplifier

Value(s)

Modes of Operation Power Consumption

<1 W @ 5 V

Impedance Check

< 2.5, < 5, < 10, < 25 KOhms

Channel Test Signal

Programmable Sine: 16-32 Hz, 158-10110 μV peak-to-peak Square: 0.25-0.5 Hz, 50-6400 μV peak-topeak

Host Interface USB 2.0

USB 2.0 Full Speed (12Mbit/sec).

Amplifier Mechanical Interface Cable

USB 2.0 cable, maximum 3m

Approximate Size

160 mm (l) x 97mm (w) x 29mm (d)

Environmental Conditions for Use Operating Environmental Limits

Temperature: 10° to 40°C Relative Humidity: 30%-75% Atmospheric Pressure: 700 hPa-1060 hPa

Transport and Storage Temperature Range

- 25°C to 60°C

Transport and Storage Humidity Range

10-95%, including condensing

Transport and Storage Atmospheric Pressure Range

500 hPa to 1060 hPa

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EEG32U Safety and Standards Conformity Standards of Compliance and Normative References 32 Channel Electroencephalograph (EEG) Headbox; model EEG32U; rated 5Vdc,0.2A 1. 2. 3. 4.

5. 6.

Type of protection against electric shock: Class II 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. Mode of operation: Continuous Environmental Conditions: Normal: 10-40°C, 30-75% rH, 700-1060hPa

The EEG32U 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. 60601-1: 08(R2013) + C2:2011

Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

ANSI/AAMI ES60601-1:2005/(R)2012 + C1:2009/(R)2012 and A2:2010/(R)2012 IEC 60601-1:2005 + C1:2006 and C2:2007, Third Edition CENELEC EN 60601-1:2006 + A1:2013 IEC 60601-1-6:2010, Edition 3.0

Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability

IEC 62366:2007, Edition 1.0

Medical devices – Application of usability engineering to medical devices

IEC 60601-2-26:2012, Edition 3

Medical electrical equipment – Part 2-26: Particular requirements for the safety of electroencephalographs

CENELEC EN 60601-2-26L2003, Edition 2 EN ISO 80601-2-61:2011, Edition 1

Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

Table 2 – EMC Standard of Compliance and Normative References

IEC 60601-1-2, Edition 4.0, February 1, 2014

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Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance– collateral standard: electromagnetic compatibility – requirements and tests

User and Service Manual

XLTEK EEG32U Amplifier

IEC 61000-4-2:2008, ed 2.0

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

IEC 61000-4-3 ed 3.0 with A1:2007+A2:2010

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

IEC 61000-4-4:2012, ed 3.0

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

IEC 61000-4-5:2014, ed 3.0

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

IEC 61000-4-6 ed 2.0 with A1:2004 + A2:2006

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

IEC 61000-4-8:2009, ed 2.0

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

IEC 61000-4-11:2004, ed 2.0

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

IEC 61000-3-2:2014, ed 4.0

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

IEC 61000-3-3:2013, ed 3.0

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

CISPR 11 ed 5.0 with A1:2010

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

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Declaration of Compliance for IEC 60601-1-2 Table 1 - Electromagnetic Emissions Guidance and manufacturer’s declaration – electromagnetic emissions The EEG32U is intended for use in the electromagnetic environment specified below. The customer or the user of the EEG32U should assure that it is used in such an environment. Emissions Test RF emissions

Compliance Group 1

The EEG32U 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 EEG32U 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 CISPR 11 Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/ flicker emissions

Complies

IEC 61000-3-3

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Electromagnetic Environment - Guidance

User and Service Manual

XLTEK EEG32U Amplifier

Table 2 - Electromagnetic Immunity Guidance and manufacturer’s declaration – electromagnetic immunity The EEG32U is intended for use in the electromagnetic environment specified below. The customer or the user of the EEG32U should assure that it is used in such an environment. Immunity Test

Electrostatic Discharge (ESD)

IEC 60601

Compliance

Test Level

Level

±8 kV contact

Complies

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

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.

Complies

Mains power quality should be that of a typical commercial or hospital environment. If the user of the EEG32U requires continued operation during power mains interruption, it is recommended that the EEG32U be powered from an 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.

±15 kV air

IEC 61000-4-2 Electrostatic fast transient/burst

±2 kV, 100Khz for power supply lines

IEC 61000-4-4

±1 kV, 100Khz for input/output lines

Surge

±1 kV differential mode

IEC 61000-4-5

Electromagnetic Environment - Guidance

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

<100% drop, 0/5 periods, 0°, 45°, 90°, 135°, 180°, 225°, 270°, 315° 100% dip, 1 period 30% dip, 25/30 periods 40% dip for 5 cycles

Power frequency (50/60 Hz) magnetic field

30 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 LIFESUPPORTING Guidance and manufacturer’s declaration – electromagnetic immunity The EEG32U is intended for use in the electromagnetic environment specified below. The customer or the user of the EEG32U should assure that it is used in such an environment Immunity test

Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3

IEC 60601 Test Level

Compliance Level

3 Vrms

3V

150 kHz to 80 MHz

3 V/m

3 V/m 80 MHz to 2.7 GHz

Electromagnetic Environment - Guidance

Portable and mobile RF communications equipment should be used no closer to any part of the EEG32U, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d=1.2 ×√P

150kHz to 80MHz

d=1.2 ×√P

80MHz to 800MHz

d=2.3 ×√P

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 site1 should be less than the compliance level in each frequency2. 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.

1

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 EEG32U is used exceeds the applicable RF compliance level above, the EEG32U should be observed to verify normal operation. If abnormal operation is observed, additional measures may be necessary, such as reorienting or relocating the EEG32U. 2

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

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Table 4 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test frequency (MHz)

Band a)

Service a)

Modulation b)

(MHz) Pulse modulation b) 18 Hz FM c) ± 5 kHz deviation 1 kHz sine

Maximum Power (W)

Distance (m)

IMMUNITY TEST LEVEL (V/m)

1,8

0,3

27

2

0,3

28

385

380 –390

TETRA 400

450

430 – 470

GMRS 460, FRS 460

704 – 787

LTE Band 13, 17

Pulse modulation b) 217 Hz

0,2

0,3

9

800 – 960

GSM 800/900, TETRA 800, iDEN 820, CDMA 850,LTE Band 5

Pulse modulation b) 18 Hz

2

0,3

28

1,700 – 1,990

GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS

Pulse modulation b) 217 Hz

2

0,3

28

2,400 – 2,570

Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7

Pulse modulation b) 217 Hz

2

0,3

28

5,100 – 5,800

WLAN 802.11 a/n

Pulse modulation b) 217 Hz

0,2

0,3

9

710 745 780 810

870 930 1,720 1,845 1,970

2,450

5,240 5,500

5,785 NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME 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 cycle square wave signal. c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.

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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 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. Proper use of this device depends on careful reading of all instructions and labels that come with or on the system. The EEG32U headbox is classified as an IPX0 – ordinary degree of protection against ingress of water according to IEC 529. The EEG32U is not water proof. Inaccurate measurements may be caused by incorrect application or use.

Only qualified personnel should operate this equipment. Only use the EEG32U amplifier 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 The computer and the peripherals used with the EEG32U headbox and the NeuroWorks EEG system 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 the 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 accessories of this device may include several kinds of disposable, sterile needle electrodes. These needles may be labeled as STERILE. The EEG32U is not sterile and cannot be made sterile.

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XLTEK EEG32U Amplifier

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The sale, distribution, or use of this device is restricted to, by, or on order of a physician. WARNING: Third-party software installed on the acquisition computer may interfere with the operation of the Natus software. Please consult Natus Technical Support before installing third-party software on the computer. This device does not contain any hazardous components; therefore, no special precautions are required for their disposal. WARNING: No modification of this equipment is allowed. The EEG32U system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the amplifier should be observed to verify normal operation in the configuration in which it will be used. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the EEG32U System, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Electrical Warnings and Cautions XLTEK systems are intended for connection to a properly grounded electrical outlet only.

The EEG32U is an electrically isolated, electrically floating device. The computer that is part of the system should be attached to a properly grounded electrical outlet. Conductive parts of electrodes and their connectors are not to contact other conductive parts and earth.

ELECTRICAL SHOCK HAZARD: Do NOT connect electrode inputs to earth ground. The patient headbox contains warning symbols reminding you that the connections are intended for isolated patient connections only. Connecting an earth ground might result in electrocution. 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. Verification of electrical safety should be performed routinely.

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ELECTRICAL SHOCK HAZARD: Do NOT service the system. Refer servicing to qualified personnel only. Do NOT use repaired components without proper testing. The computer attached to the EEG32U should use a three-wire power cord with a hospital grade plug. For grounding reliability, only connect the device to a hospital grade or hospital-only receptacle. Inspect the power cord often for fraying or other damage. Do NOT operate the system with a damaged power cord or plug. If there is an isolation transformer with the system, do NOT place the isolation transformer on the floor. Only plug XLTEK recommended components into the isolation transformer. Do NOT connect non-medical equipment which has been supplied as part of the system directly to the wall outlet when the system is supplied, via MPSO, with a separating transformer. Do NOT connect electrical equipment which has not been supplied as a part of the system to the MPSO.

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 physiological devices only. Connecting patient electrodes to any other device or external outlet may result in personal injury. The patient headbox accepts only touch-proof style electrode inputs. Do NOT attempt to use any other style of patient electrode input. To prevent cabling entanglement/strangulation, ensure no loose cables are accessible to the patient. No parts of the ME equipment shall be serviced or maintained while in use with a patient.

Patient connections are NOT intended for direct cardiac contact.

Do NOT touch any earth-grounded components of the EEG32U amplifier and the patient simultaneously.

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Do not use the EEG32U amplifier in the vicinity of MRI or CT systems.

Do not use the EEG32U amplifier with HF surgical equipment.

Do not allow loose electrodes to contact metal parts. The patient event switch attached to or on the EEG32U or other XLTEK device is not intended for critical patient-safety-related incidents. Do NOT use the XLDetect montage with custom channel labels.

As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.

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. Natus is not responsible for any injury or damage that may result from improper cable storage during transport. TIPPING HAZARD: During transport, the user should guide the cart using both hands, ensuring the wheel base is aligned so that a single caster leads in the direction of motion. Failure to lead the cart with one wheel could result in a tipping hazard when ascending or descending steps or thresholds.

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. Any abnormal pattern or out of range value is confirmed by trained medical professionals performing the test. In addition to ancillary data, the accompanying EEG (Electroencephalograph) amplifier’s signals will also be contaminated past the point where any clinical signal interpretation is possible. Trained electroencephalographers and technologists are well equipped to identify and disregard signals that are obscured by environmental noise.

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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. 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). Do not touch the accessible conductive parts for the Connectors marked with the ESD symbol. Follow these techniques to help reduce the incidence of component damage caused by static electricity: •

Immediately before handling any product components assemblies, drain the electrostatic charge from your body by touching a known earth ground.

•

Minimize body motions when handling unpackaged replacement ESDs. Motions such as brushing clothes together or lifting your foot from a carpeted floor can generate enough static electricity to damage the product components.

•

Avoid carpets in cool, dry areas. If provided, leave the product components in their anti-static packaging until ready to be installed.

•

Take care when connecting or disconnecting cables. When disconnecting a cable, always pull on the cable connector or strain-relief loop, not on the cable itself.

WARNING: A damaged cable can cause a short in the electrical circuit. Prevent damage to the connectors by aligning connector pins before you connect the cable. WARNING: Misaligned connector pins can cause damage to system components at power-on.

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. The electrical energy from other electronic devices located in nearby equipment are usually propagated through the connecting cables. The functionality of some Semiconductor devices and high sensitivity amplifiers (EEG, EMG ECG) may be affected by induced parasitic signals. This effect could be described as noise and/or channel saturation on the EEG waveforms, which are coupled together with off the scale values for auxiliary sensors.

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