EEG-1200K Electrocephalograph

Transcription

1 NEUROLOGY EEG-1200K Electrocephalograph Product Features & Technical Data

2 PRODUCT FEATURES General The EEG-1200 Electroencephalograph is designed for both clinical and research use. Fields of application are: Routine EEG with common provocation tests like photic stimulation and/or hyperventilation EEG monitoring on intensive care units incl. emergency EEG and brain death diagnostic Long term monitoring e.g. for epilepsy diagnostics Polysomnography Typical configuration of EEG-1200K for clinical use: Main unit incl. isolation transformer Shuttle PC with minimum Intel Core 2 Duo, 3.0 GHz 2 GB RAM 500 GB HDD 38 channel amplifier JE-921A incl. Stand Photic stimulation incl. control unit and Xenon flash lamp 19 TFT screen Accessory kit Software package for acquisition and review of EEG waveforms Polaris-one database Digital video option with camera Cart with optional screen and camera mounting Typical configuration of EEG-1200K for intensive care use: Fanless medical grade Panel PC with17 touch screen display Dual Core CPU, 1.5 GHz 2 GB RAM 160 GB HDD 38 channel amplifier JE-921A with build in SpO2 and CO2 Polaris.one database Light weight cart designed for ICU environment Video option available QP-160AK Trend Program with aeeg is recommended for neonatal ICU (For details of the composition in regards of standard and optional equipment please see technical data section) 2

3 Acquistion Amplifiers for every requirement EEG-1200 can be delivered with a wide range of amplifiers, from a 32 channel routine amplifier to a 256 channel amplifier for intracranial long term recordings. Multifunction junction box for clinical routine The electrode junction box JE-921A has 25 EEG, 14 bipolar (7 pairs), 4 DC, SpO 2 and CO 2 connectors. Its sibling JE-910A comes with 25 EEG, 4 Extra and 3 bipolar connectors. PSG junction box (option) The PSG amplifier JE-912AK with comfortable mini junction box JE-915A is an easy to use and flexible solution for polysomnographic recordings. Multi-channel amplifier (option) The multi channel amplifier JE-120A with up to 256 channels and high speed sampling rates of up to 10 khz is the ideal solution for long term recordings or research purposes. Standard amplifier PSG amplifier Mini junction boxes for JE-921A JE-912AK incl. JE-915A multichannel amplifier Input box converter (standard with multi channel amplifier) The input box converter QI-122AK provides LAN connectivity so it is easy to expand your EEG system. It connects all amplifiers to the EEG-1200 via standard CAT5 Ethernet cabling. QI-122AK provides 16 additional DC inputs (multi channel amplifier only) and connection for photic stimulator. Wireless input unit, Air-EEG WEE-1000K (option) Up to 64 channels EEG data can be sent to the EEG unit by wireless transmission. Wireless reduces stress to the patients and lets physicians monitor the EEG data while the patients are moving freely. All options (including digital video) of the EEG-1200 are available with the wireless input unit. Innovative roaming functions and an optional SpO2 probe that can be connected directly to the telemetry unit makes it suitable for all kind of EEG- and PSG recordings. EEG Recording Navigation You can set several measurements as one routine in advance and record the series of EEG data automatically. You can program the pattern, recording time, photic stimulation mode and other items for each stage. 3

4 Data review during acquisition Comparison mode: The EEG Scope function lets you look back into and review previous epochs of EEG while simultaneously monitoring current EEG acquisition. One side of a split screen shows previous EEG epochs and the other side shows the current EEG. On-line frequency mapping The EEG data can be shown as a frequency map during acquisition, so you can easily check the frequency distribution. Review Easy to use software interface EEG-1200 software has an easy to operate graphical user interface which can be adapted to user requirements. Standard settings provide an intuitive software layout making it easy to learn even for beginners. Individual configuration of the software layout allows adapting EEG to every need: flexible arrangement of menu bars colouring of waveforms individual montage settings Review of EEG waveforms Waveforms can be displayed in a variety of methods. 40 individual montages with up to 250 traces Pre-defined or individual high / low cut filters. Manual or automatic paging forwards and backwards is the standard way of reviewing EEG waveforms. Other ways are the event bar or DSA trend graph to navigate to interesting parts of the EEG recording. Several measurement tools help to go into details. A part of the waveforms can be copied into the note waveform window to compare them to the current waveforms. DSA trend graphs Frequency components of EEG waveforms and the amplitudes of each frequency are displayed as a DSA (Density Spectral Array) trend graph on the review screen and EEG Scope. The DSA lets you find epileptic seizures of a specific EEG frequency band over a long period of time at a glance. Up to 8 trend graphs can be displayed, each with its own settings in regards of the electrodes shown. 4

5 3D voltage mapping Whole head maps provide a complete overview and a better interpretation of the topography of EEG abnormalities. Just click on a detected pattern to obtain 3D maps of the whole head. Click on a particular view to obtain a series of maps showing the change over time. EEG mapping The EEG mapping module QP-220AK provides amplitude and frequency mapping of EEG waveforms Real-time mapping during acquisition Off-line mapping during review for selected intervals Up to eight frequency maps (seven power/voltage maps at seven different frequency bands and one map of all frequency bands) Power/Voltage spectra for up to 32 channels of EEG waveform data Edge frequency, average frequency, median frequency or peak frequency for each spectrum is indicated with a mark. Potential mapping Spectral analysis Frequency mapping Reporting NeuroReport is the common reporting tool for all neurological systems from Nihon Kohden. Various predefined templates can be used to create customized reports for different examination types, physicians or other criteria. You can also create an EMU examination report which has screen comments automatically assigned to seizure events. A powerful auto-text function helps to create individual reports. Saved within the database in a license free format, the reports will be automatically converted into PDF after finalizing. 5

6 Digital video system (option) Patient image including sound can be recorded and reviewed synchronized with the EEG waveform. A wide range of different video formats (MPEG1 and MPEG4) and resolutions (up to 720*576 pixel) are available. Real time and fast forward mode (up to 20 times) for reviewing the video Comfortable clipping and snapshot functions allow reducing the video data by creating new video EEG clips or attaching the clipped video file to the original EEG recording. BESA Epilepsy (option) BESA Epilepsy is a software for fast detection, visualization, and evaluation of epileptiform EEG activities recorded noninvasively from the human scalp. Automated detection and clustering of brief epileptiform discharges in 2 h epochs It allows a very fast evaluation of long-term EEG data using a new hyperclustering technique Evaluation and reporting can be done within 5 minutes for a 24 h interval Advanced software options On-line and off-line Spike- and seizure detection software QP-251AK based on Persyst EEG Examination Software QP-150AK including spike- and seizure detection, voltage mapping of intracranial recordings, and EEG TrendScope for remote review of recordings Polysmith sleep analysis software QP-251AK QP-150AK Polysmith 6

7 Data integration and management Polaris.one Polaris.one allows you to easily manage EEG data and examination schedules. SQL based database for EEG, EMG/EP, and ECG data User interface can be scaled according to user needs Calendar view and to-do lists Copies of EEG data can be stored for personal or global use Presentation functionality for case conferences Auto-proposing for text input fields Manual, semi-automatic, and automatic transfer and archive as background service Integrated NeuroReport incl. PDF conversion Offline functionality for acquisition and review stations Multi-client-capability with user-related filtering of patients Extensive user rights management (via groups) Activity log records all changes to medical data Integrated DVD/CD burning EEG PortaView EEG PortaView integrates review software into EEG data files and saves them on a portable storage device, so you can review the EEG data on any Windows PC without special software. Just carry the EEG data and you can review anytime and anywhere. 7

8 TECHNICAL DATA DATA ACQUISITION JE-921A/AG electrode junction box Number of input jacks EEG input jacks: 25 Extra inputs: 4 Bipolar input jacks (pairs): 7 The extra jacks (X1-X4) can be used as bipolar jacks. To select extra jack or bipolar jack, refer to Section 5 System Programs. DC input jacks: 4 SpO 2 connector: 1 CO 2 connector: 1 Input impedance EEG input/extra input: 100 MΩ DC input: 1.5 MΩ Input circuit current: 5 na or less Internal noise level EEG input/extra input: 1.5 μvp-p or less (0.53 to 60 Hz) DC input: 10 mvp-p or less CMRR EEG input/extra input: 105 db or greater (60 Hz) Bipolar input: 100 db or greater (60 Hz) Low-cut filter: 0.08 Hz (Time constant: 2 s) High-cut filter: 300 Hz (-18 db/oct) Offset tolerance: ±600 mv AD conversion: 16 bits (97 nv/lsb) Sampling and hold: All electrodes at the same time Sampling frequency 100, 200, 500, 1000, selectable 8

9 JE-910A/AG electrode junction box Number of input jacks EEG input jacks: 25 Extra inputs: 4 Bipolar input jacks (pairs): 3 Input Impedance EEG input/extra input: 100 MΩ Input circuit current: 5 na or less Internal noise level EEG input/extra input: 1.5 μvp-p or less (0.53 to 60 Hz) CMRR EEG input/extra input: 105 db or greater (60 Hz) Low-cut filter: 0.08 Hz (Time constant: 2 s) High-cut filter: 300 Hz ( 18 db/oct) Offset tolerance: ±600 mv A/D conversion: 16 bits (97 nv/lsb) Sampling and hold: All electrodes at the same time Sampling frequency: 100, 200, 500, 1000 Hz, selectable JE-120A electrode junction box (option) Number of input jacks The JE-120A electrode junction box must be used with the following mini junction box combinations. Mini junction box (Number of input jacks) Total number of input jacks JE-208A (64) or JE-225A (64) JE-210A (128) or JE-225A (64) and JE-226A (64) JE-225A (64) and JE-226A (64) and JE-227A 192 JE-225A (64) and JE-226A (64) and JE-227A (64) and JE-228A (64) 256 Bipolar inputs 4 provided with JE-125A (alternative to JE-225A) or JE-208A DC inputs 16 Additional inputs SpO 2 and etco 2 9

10 Maximum number of recorded referential electrodes and sampling frequency (clinical line) Maximum number of recorded referential electrodes and sampling frequency (extended line for research) Input range: Input impedance: Internal noise level: CMRR: Time constant: High-cut filter: Offset tolerance: A/D conversion: Sampling and hold: Sampling frequency: 256 (2 khz), 128 (5 khz), 64 (10 khz) 256 (10 khz) ±3.2mV or ±12,8mV (selectable) 200 MΩ Less than 1.5 μvp-p (0.53 to 120 Hz) 110 db or greater (60 Hz) (EEG inout) 2 or 10 s, selectable 3000 Hz ( 18 db/oct), depending on the sampling frequency ±1000 mv 24 bits All electrodes at the same time Hz (max) Number of input jacks (for all amplifiers / input boxes): Model /Inputs EEG EXTRA (X1-) Bipolar Respiration Reference (Z) DC JE-208A (4ch) 1 JE-213A / JE-214A 64 1 JE-215A / JE-226A / JE-227A / JE-228A 64 1 JE-921A/AG (7ch) * 3 (X5, X6, X7) 1 6 ** JE-910A/AG * X1(+) to X4(+) inputs jacks can be used as unipolar inputs **4 x DC + 1 x SpO 2 input + 1 x CO 2 input Note: The extra jacks and the RESP jack for each item cannot be used simultaneously. DATA PROCESSING Sensitivity EEG INPUT: DC INPUT: Time constant (Low-cut filter): OFF, 1, 2, 3 (2.5), 5, 7, 10, 15, 20, 30, 50, 75, 100, 150, 200 μ V/mm OFF, 10, 15, 20, 30, 50, 75, 100, 150, 200 mv/mm 0.001, 0.003, 0.03, 0.1, 0.3, 0.6, 1.0, 2.0, 5.0, 10.0 s 0.016, 0.03, 0.08, 0.16, 0.27, 0.53, 1.6, 5.3, 53, 159 Hz ( 6 db/oct) 10

11 High-cut filter: AC filter: Calibration waveform Waveform shape: Voltage: ECG elimination filter: Impedance check Indication on the screen: Indication on LED: Impedance threshold: Pattern: Reference electrode selector: Marking signal: JE-921A electrode junction box 15, 30, 35, 60, 70, 120 ( 12 db/oct), 50 (RAPID), 300 Hz ( 18 d B/oct) JE-120A electrode junction box (option) 15, 30, 35, 60, 70, 120, 300, 600, 1200 ( 12 db/oct), 50 (RAPID), 3000 Hz ( 18 db/oct) 50 or 60 Hz, (rejection ratio: 1/25 or more) 0.25 Hz step wave or 10 Hz sine wave 2, 5, 10, 20, 50, 100, 200, 500, 1000 μv ( 1000 for DC input signal) Available in acquisition and review programs All electrodes are displayed on the screen in electrode position layout. Impedance for each electrode is displayed and electrodes with impedance higher than the preset impedance threshold are highlighted. LEDs on the electrode junction box with impedance higher than the preset impedance threshold light. 2, 5, 10, 20 and 50 kω 36 sets of programmable montages combined with programmable individual amplifier settings A1 A2, A1 A2, A1 A2, A1 + A2, VX, AV (with unsuitable electrode deletion function), Aav, Org, SD, BN and OFF Photic stimulation mark, Hyperventilation mark DISPLAY Display resolution: Number of display channels: Display modes: Waveform display color: Waveform display on/off: Waveform position adjustment: Up to 1600 dots 1200 lines Up to 64 and one mark channel When multi-channel electrode junction box and mini junction boxes are used: Up to 250 and one mark channel Overwrite and page-by-page 16 colors Provided Provided 11

12 Waveform freeze: Patient image display: Waveform sweep speed: Timing mark: Time scale: Event mark: EEG scale: Dual display: Provided Available when the optional QI-120A Camera Capture Unit and video camera are used. 0.1, 0.2, 0.5, 1, 2, 5, 10, 15, 20, 30, 60 s or 5 min/page 0.1, 1 s off, 0.2, 1 s Displays at the bottom of the screen Provided Available ACQUISITION PROGRAM Timer function: Data storage device: Manual timer, recording timer, HV timer Hard disk drive (standard) PHOTIC SIMULATOR Optional photic control unit: LS-120A Flash lamp: LS-703A Maximum flash energy: 1.28 J/Single Stimulation modes: 3 automatic (30 steps, programmable), manual, and single Mode of operation: Continuous operation with intermittent loading Duty cycle: Max. 5 minutes continuous operation in 30 minutes Automatic stimulation Stimulus rate: 0.5, 1 to 33 (1 Hz steps), 50 and 60 Hz Stimulation period: 1 to 99 seconds in 1 second steps Pause period: 1 to 30 seconds in 1 second steps Manual stimulation Manually set frequency and stimulation period Photic frequency: 0.5 Hz, 1 to 33 Hz in 1 Hz steps, 50 and 60 Hz Stimulation time: 1 to 99 s in 1 second steps and continuous stimulation (FREE: Max. 5 min) Pulse mode: Normal, random, and double Random stimulation: 1 to 33 Hz in 1 Hz steps within ± 50% Single stimulation: Manual key operation single stimulation or automatic single stimulation by external trigger signal Trigger input: TRIGGER IN connector (1 to 5 V) Trigger output: TRIGGER OUT connector (3 V or more) 12

13 DIGITAL VIDEO UNITS (OPTOIN) MPEG4 encoding: Video resolution: Digital video software: Software encoded MPEG4: Camera capture unit: Video storage device: External USB video capture unit: USB I/F: Video input: Audio input: Power: NF-QV4/STD up to pixels (NTSC), up to pixels (PAL) QP-110AK Windows Media 9 Time delay between EEG waveform and video image: within 100 ms in still mode QI-120A usage of existing system/data hard disk QI-120A USB 2.0 high speed Composite 1 ch RCA pin jack S-Video 1 ch MINI-DIN 4-pin jack , 50 fields/s (PAL) Data transfer speed 23.1 MB/s maximum 2 ch (stereo mini jack 1) 16 bit sampling 44,100 Hz Data transfer speed 177 kb/s maximum 5 V ± 5%, less than 500 ma (using USB bus power) Data compression and required disk space (Windows Media 9 encoding): Resolution Frames File Size Audio Capture Frame 2 320x240 pixels (NTSC/PAL) 2 frames/s 0.8 MB/min Monaural, 48 kbps, 44kHz sample rate Frame x240 pixels (NTSC/PAL} 15frames/s 1.2 MB/min Monaural, 48 kbps, 44kHz sample rate Low 320x240 pixels (NTSC/PAL) frames/s (NTSC) 25 frames/s (PAL) 1.5 MB/min Monaural, 48 kbps, 44kHz sample rate Medium 320x240 pixels (NTSC/PAL} frames/s (NTSC) 25 frames/s (PAL) 2.25 MB/min Monaural, 48 kbps, 44kHz sample rate High 320x240 pixels (NTSC/PAL) frames/s (NTSC) 25 frames/s (PAL) 10 MB/min Stereo, 192 kbps, 44kHz Extra High 320x240 pixels (NTSC/PAL) frames/s (NTSC) 25 frames/s (PAL) 20 MB/min Stereo, 192 kbps, 44kHz High Res 640x480 pix (NTSC) 720x576 pix (PAL) frames/s (NTSC) 25 frames/s (PAL) 24 MB/min Stereo, 192 kbps, 44kHz 13

14 REVIEW PROGRAM Changeable items: Jump functions: Display modes: Display information: Montage, sensitivity, high-cut filter, time constant, reference electrode, and display speed Specified event, page by page, and specified time Continuous, high speed, high speed with pause, manually pageby-page, manually second-by-second and manually waveform centering Event, channel number, montage and comment ELECTROMAGNETIC COMPATIBLITY IEC : 2001 IEC Amendment 1: 2004 CISPR11 GROUP 1 CLASS B: 2003 CAN/CSA C22.2 No POWER REQUIREMENTS Line voltage: Line frequency: Power consumption: SM-120AK isolation unit: AC 220 to 240 V 50/60 Hz 750 VA (for PC unit and display) 1 kva (PC unit, display, photic stimulator control unit and analog output unit) SAFETY Safety standard IEC : 1988 IEC Amendment 1: 1991 IEC Amendment 2: 1995 CAN/CSA C22.2 No.601.1B-90 CAN/CSA C22.2 No (R2002) CAN/CSA C22.2 No IEC : 2000 EN : 1990 IEC : 2001 IEC Amendment 1: 2004 EN Amendment 1: 1993 EN Amendment 2:

15 Type of protection against electric shock: Degree of protection against electric shock (JE-921A) Type BF applied part: EN IEC : 2002 Amendment 13: 1996 CAN/CSA C22.2 EN : 2001 No M90: 1990 CAN/CSA C22.2 EN :2003 No S1-94 Class I Electrode jacks, bipolar jacks, SpO 2 connector, CO 2 connector Degree of protection against electric shock (JE-207A/209A/212A) Type CF applied part: Degree of protection against harmful ingress of water: Degree of safety of application in the presence of a flammable anaesthetic mixture with air or oxygen or nitrous oxide: Mode of operation: Electrode jacks, bipolar jacks Non-protected (IPX0) Not suitable for use in the presence of a flammable anaesthetic mixture with air or oxygen or nitrous oxide Continuous DIMENSIONS AND WEIGHT JE-921A, electrode junction box: PC unit: SM-120AK, isolation unit: LS-120A/AG, photic stimulator control unit: QD-120A, analog output unit: NF-KD1200/1, cart: 185 (W) 72 (D) 167 (H) mm, 1.0 kg 200 (W) 300 (D) 185 (H) mm, 6.5 kg The dimensions and weight differ according to model. Refer to the Operator s manual of the PC unit. 181 (W) 320 (D) 140 (H) mm, 13 kg 155 (W) 300 (D) 75 (H) mm, 4.10 kg 155 (W) 300 (D) 75 (H) mm, 2.32 kg 565 (W) 625 (D) 830 (H) mm, 44 kg 15

16 OPERATION CONDITIONS Temperature: Humidity: Atmospheric pressure: 10 to 35 C (50 to 95 F) 30 to 80% (noncondensing) 70 to 106 kpa TRANSPORT AND STORAGE CONDITIONS Temperature: -20 to +60 C (-4 to +140 F) Humidity: 10 to 80% Atmospheric pressure: 70 to 106 kpa ELECTROMAGNETIC EMISSIONS The EEG-1200 s essential performances in EMC standard satisfy the following criteria. EEG-1200 is intended for use in the electromagnetic environment specified below. The customer or the user of the EEG-1200 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC Voltage fluctuations/ flicker emissions IEC Group 1 Class B* Class A Complies The EEG-1200 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The EEG-1200 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. * * When the optional JE-207A/209A/212A electrode junction box is used, the compliance for RF emission is class A. The EEG-1200 with JE-207A/209A/212A is suitable for use in all establishments excluding domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic urposes. 16

17 Electromagnetic Immunity The EEG-1200 s essential performances in EMC standard satisfy the following criteria. This Model EEG-1200 is intended for use in the electromagnetic environment specified below. The customer or the user of the EEG-1200 should assure that it is used in such an environment. Immunity test IEC test level Compliance level Electromagnetic environment - guidance Electrostatic discharge (ESD) IEC ±6 kv contact ±8 kv air ±6 kv contact ±8 kv air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Electrical fast transient / burst IEC ±2 kv for power supply lines ±1 kv for input/output ±2 kv for power supply lines ±1 kv for input/output Mains power quality should be thatof a typical commercial or hospital environment. lines lines Surge IEC ±1 kv differential mode ±2 kv common mode ±1 kv differential mode ±2 kv common mode Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines IEC <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 5 s <5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 1 cycle 70% UT (30% dip in UT) for 2 cycles (for 1 cycle*1) <5% UT (>95% dip in UT) for 5 s Mains power quality should be thatof a typical commercial or hospital environment. If the user of the EEG-1200 requires continued operation during power mains interruptions, it is recommended that the EEG-1200 be powered from an uninterruptible power supply or a battery.*2 Power frequency (50/60 Hz) magnetic field IEC A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE: UT is the AC mains voltage prior to application of the test level *1 When the QI-120A is connected to the EEG *2 It is recommended that the EEG-1200 be powered from an uninterruptible power supply or a battery if the power quality is not stable. 17

18 Immunity test IEC test Compliance Electromagnetic environment guidance level level 3 Vrms Portable and mobile RF communications 3 V/m equipment should be used no closer to any part of the EEG-1200, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of Conducted RF 3 Vrms the transmitter. IEC khz to 80 MHz Recommended separation distance Radiated RF d = 1.2 P IEC V/m 80 MHz to 2.5 d = 1.2 P 80 MHz to 800 MHz GHz d = 2.3 P 800 MHz to 2.5 GHz 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 site survey.*1, should be less than the compliance level in each frequency range. *2. 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 EEG-1200 is used exceeds the applicable RF compliance level above, the EEG-1200 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the EEG *2 Over the frequency range 150 khz to 80 MHz, field strengths should be less than for all other functions. 18

19 Avoiding Electromagnetic Interference (Impedance Respiration) Impedance respiration measurement is very sensitive and affected by electromagnetic interference. Technological limitations do not allow immunity levels higher than 1 Vrms for conducted disturbances induced by RF fields. Electromagnetic fields with conducted disturbances above 1 Vrms may cause measurement error. Do not use electrically radiating equipment near the impedance respiration measurements. When the JE-921A electrode junction box is connected to the EEG-1200 electroencephalograph Immunity test IEC test Compliance Electromagnetic environment guidance level level The JE-921A that is connected to the EEG-1200 must be used only in a shielded location with a minimum RF shielding effectiveness and, for each cable that enters the shielded location, a minimum RF filter attenuation of 31 db over the frequency range 80 MHz to 2.5 GHz. Refer to the Radiated RF IEC V/m 80 MHz to 2.5 GHz 0.3 V/m note below this table. Field strengths outside the shielded location from fixed RF transmitters, as determined by an electro-magnetic site survey*, should be less than 3 V/m. Refer to the note below this table. Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection structures, objects and people. NOTE 2: It is essential that the actual shielding effectiveness and filter attenuation of the shielded location be verified to assure that they meet the minimum specification. * 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 outside the shielded location in which the JE-921A that is connected to the EEG-1200 is used exceeds 3 V/m, observe the JE-921A that is connected to the EEG-1200 to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as relocating the JE-921A that is connected to the EEG-1200 or using the shielded location with a higher RF shielding effectiveness and filter attenuation. NOTE The JE-921A that is connected to the EEG-1200 should be used in a shielded location with an RF filter attenuation of 31 db over the frequency range 80 MHz to 2.5 GHz. If the JE-921A that is connected to the EEG 1200 is used outside shielded location, use it in a location where the measured field strength is less than 0.3 V/m. To measure shielding effectiveness, consult a service engineer. 19

20 Recommended Separation Distances between Portable and Mobile RF Communications Equipment The EEG-1200 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the EEG-1200 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the EEG-1200 as recommended below, according to the maximum output power of the communications. Rated maximum output Separation distance according to frequency of transmitter (m) power of transmitter (W) 150 khz to 80 MHz d = MHz to 800 MHz d = MHz to 2.5 GHz d = 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. System Composition for EMC Test The EEG-1200 electroencephalograph is tested to comply with IEC : 2001 with the following composition. If any part which is not specified by Nihon Kohden is used, the EMC specifications may not comply. Units Electrode junction box JE-921A Photic stimulator control unit LS-120AJ/AK Flash lamp assembly LS-703A Mini electrode junction box JE-922A Camera capture unit QI-120A Analog output unit QD-120A/AK Input box converter QI-122A/AK Electrode junction box JE-212A Cable length 5.0 m 0.7 m 5.0 m 5.0 m 0.8 m 0.7 m 10 m 5.0 m 20

21 STANDARD COMPOSITION For routine study: Main unit, EEG-1200K, PC unit, Electrode junction box, JE-921A/AG or JE-910A/AG Accessory Kit (INT or GER version) For 64 channel monitoring: Main unit, EEG-1200K, PC unit, Electrode junction box, JE-207A Input box converter, QI-122AJ/K For 128 channel monitoring: Main unit, EEG-1200K, PC unit, Electrode junction box, JE-209A Input box converter, QI-122AJ/K For 192 channel monitoring: Main unit, EEG-1200K, PC unit, Electrode junction box, JE-212A Input box converter, QI-122AJ/K STANDARD ACCESSORIES German (GER) accessory kit International (INT) accessory kit Description Qty Order code Description Qty Order code Universal EEG cap 1 BE-0007 Collodion electrodes (12 pcs) 2 H527 Chin strap 1 BE-0008 Ear electrodes 3 NE-313AG Bridge electrodes 23 BE-005W Fast Clip ECG electrodes 1 H068 Electrode cable F Cable for Fast Clip 1 K512A Electrode felt pad 1 NKD-Filz Cardiocream 1 F010/1 Rubber rings Skinpure 1 F020/1 Ear electrodes 3 NE-313AG Elefix 1 F510 Fast Clip ECG electrodes 1 H068 Cable for Fast Clip 1 K512A Cardiocream 1 F010/1 Skinpure 1 F020/1 OPTIONAL SOFTWARE Spike detection and evaluation, BESA Epilepsy Spike and seizure detector software, QP-251AK, EEG examination support software, QP-150AK Trend program, QP-160AK Analysis software, EEGFocus Sleep analysis software, Polysmith 21

22 This brochure may be revised or replaced by Nihon Kohden at any time without notice. NIHON KOHDEN EUROPE GMBH Raiffeisenstrasse Rosbach Germany 22