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Neuron-Spectrum (Technical Manual)

10

Safety and Electromagnetic Compatibility

Electromagnetic compatibility (EMC) is provided by IEC 60601-1-2:2007 requirements

fulfillment.

The devices are intended for operation in electromagnetic environment, which special
features are specified in Appendix 1.

Portable and mobile RF communication equipment can affect the system operation.

The use of the equipment not listed in tables 2 - 6 of the present technical manual
may result in increased emission and system decreased immunity.

As for safety, each digital EEG system satisfies IEC 60601-
1:1988+A1:1991+A2:1995, IEC 60601-1-1:2000 and IEC 60601-2-26:2002. The

electronic units of digital EEG systems are supplied by regulated power supply
through USB interface, it has double isolation and BF type work parts according to
IEC 60601-1.

Interpretation of symbols on the electronic EEG unit:

  -

Attention: consult user and technical manuals.

 

-

Work parts of BF type according to IEC 60601-1.

 

-

Mark of conformance to Russian standards requirements.

 

-

Mark of measuring device conformance to Russian standards
requirements.

 

-

Mark of conformance to 93/42/EEC “Concerning Medical Devices”
directive.

 

-

Mark of conformance to 2002/96/EC “On waste electrical and electronic
equipment (WEEE)” directive.

Содержание CloudEEG

Страница 1: ...Technical Manual Neuron Spectrum 1 Neuron Spectrum 2 Neuron Spectrum 3 Neuron Spectrum 4 Neuron Spectrum 4 P CloudEEG Digital Neurophysiological Systems TM015 03 002 000 24 03 2020...

Страница 2: ...n Spectrum 4 P CloudEEG EEG channels 1 Neuron Spectrum 1 Neuron Spectrum 2 Neuron Spectrum 3 and Neuron Spectrum 4 or up to 4 polygraphic channels Neuron Spectrum 4 P CloudEEG ECG EOG 1 respiratory ch...

Страница 3: ...the Systems 27 3 4 Actions in Emergency 28 4 Servicing 28 4 1 General Requirements 28 4 2 Servicing 28 4 3 Conservation 28 5 Current Repair 29 5 1 General Requirements 29 5 2 EEG ECG Cables Adapters...

Страница 4: ...are guaranteed by the manufacturer Do not start working with the systems before you have read this manual Because of the continuous improvements of the digital EEG systems its construction could be m...

Страница 5: ...ystems can be used in the patient care institutions diagnostics centers neurosurgical hospitals and experimental laboratories of the research institutions to Record review and analyze EEG Record revie...

Страница 6: ...h frequency equipment to patient it can lead to burns in places of electrode attachment or system damage to connect another equipment not included in delivery set to electrode slots to open the units...

Страница 7: ...0 3 V Input impedance not less than 400 M Patient leakage current not more than 50 nA Polygraphic Channels Number of channels 1 4 Input range 0 2 100 mV Ratio error of voltage measurement in the range...

Страница 8: ...ation of stimulus duration within 10 Maximal brightness of LED stimulator FS 1 16000 1600 cd m 2 Stimulation frequency 0 1 100 Hz Relative deviation of stimulation frequency within 1 Left right two si...

Страница 9: ...ronic unit power consumption not more than 2 8 V A Electronic unit dimensions 140 200 45 mm Electronic unit weight not more than 0 9 kg Delivery set weight without computer and printer not more than 1...

Страница 10: ...ety each digital EEG system satisfies IEC 60601 1 1988 A1 1991 A2 1995 IEC 60601 1 1 2000 and IEC 60601 2 26 2002 The electronic units of digital EEG systems are supplied by regulated power supply thr...

Страница 11: ...al EEG system Table 2 Base Delivery Set Name Document code of main specifications Quantity per configuration pcs 1 2 3 4 5 6 Neuron Spectrum 1 electronic unit 1 NS015201 028 NS015201 028 001 1 Neuron...

Страница 12: ...user manual AU999 01 005 000 1 1 1 1 1 1 Software on CD Neuron Spectrum NET software without additional modules 1 1 1 1 1 1 Package Cardboard package set 002901 001 1 1 1 1 1 1 Notes 1 The accessorie...

Страница 13: ...rap for electrode cap3 ELECTRO CAP Electro CAP USA 46 50 XSM 50 54 SM 54 58 M 58 62 L pediatric 1 1 1 1 1 1 Electrode cap extension cable NS007103 023 30 1 1 1 1 1 1 Special needle for filling electro...

Страница 14: ...1 1 1 1 1 1 with Neuron Spectrum NET PSG additional module 1 1 1 1 1 1 with Neuron Spectrum NET Video additional module 1 1 1 1 1 1 Electronic Equipment Isolation transformer 4 NS036999 001 TM 630M 1...

Страница 15: ...l CNB SC100 1 Control cable for video camera NS015103 032 1 USB extension cable Omix 20 m UniqueICs Ltd Russia 1 Extension cable NS015103 035 1 IR projector NS015302 004 1 Patient microphone NS015355...

Страница 16: ...capture card USB 1 Patient s microphone NS015355 003 1 IR projector NS015302 004 1 Electrode cap for 19 channel EEG recording 1 ELECTRO CAP Electro CAP USA 46 50 XSM 50 54 SM 54 58 M 58 62 L 34 38 38...

Страница 17: ...lifier module controls measurement calibration impedance measurement and internal diagnostics modes The power supply of the amplifier module is performed through electrically isolated DC converter SU1...

Страница 18: ...marked as FP1 O2 A1 A2 polygraphic channels are marked as 1 2 3 4 The slot is used to attach the ground electrode The operation indicator glows yellow at the electronic unit connection to the compute...

Страница 19: ...r visual stimulator attachment the connector for the auditory stimulator attachment Fig 3 Fig 3 The external view of the top side panel The bottom side panel contains the connector for electrode cap a...

Страница 20: ...ins is not less than 3 meters Do not place the electronic unit in the immediate vicinity less than 5 meters to short wave or microwave therapeutic equipment it can lead to its unstable operation Place...

Страница 21: ...ground contact Before the digital EEG system setting the electrician must check the quality of standard tripolar sockets and the integrity of the protective ground circuit In case the system componen...

Страница 22: ...EEG electronic unit PU notebook PC power unit which corresponds to IEC 60601 1 C patient chair Kb keyboard M monitor Nb notebook PC P printer Ph photic stimulator PS pattern stimulator monitor SU sys...

Страница 23: ...with the computer the equipment is delivered with installed and configured software If you purchase the digital system separately please install the software from the compact disk included in the del...

Страница 24: ...m the electric mains The connection to the USB connectors on the monitor or keyboard does not provide the correct device operation The connection to passive USB splitter without supply from electrical...

Страница 25: ...was done incorrectly without following this manual instructions To connect digital EEG system and surgical HF equipment to the patient it can cause patient s flash burn in the places of electrode pla...

Страница 26: ...ont panel do not glow Incorrect PC connection to the mains Check the PC connection accuracy to the mains PC operational system load is not carried out properly Faultiness of PC hardware or software Ma...

Страница 27: ...blems with electronic unit 1 Check the quality of electrode set ting by impedance measurement 2 Replace the electrode 3 Consult Neurosoft Ltd 3 3 Exams Performing Using the Systems Before EEG exams ca...

Страница 28: ...ducted according to user and technical manuals or typical rules When detecting the troubles it is recommended to use the information given in Troubleshooting section If the troubles can t be eliminate...

Страница 29: ...k or ground it is necessary to replace or cut it if the cable length is sufficient 5 3 Computer Interface Cable Repair USB cable Computer interface cable Fig 10 is examined externally and the circuit...

Страница 30: ...in Fig 12 by the device for LED check It is necessary to open cable jack unit and check the montage If the failure is not detected open the photic stimulator unit and measure the resistance of each c...

Страница 31: ...is impossible It is necessary to open cable jack unit and check the montage If the failure is not detected open the jack unit from the monitor side and measure the resistance of each cable If the cabl...

Страница 32: ...ng to rules of goods transportation for each mode of transport The digital EEG system portage by sea transport should be done according to Safety Regulations for Sea Transport of General Cargoes The s...

Страница 33: ...TC 9441 014 13218158 2006 Package report number _______________________ Package report date _______________________ The detailed information about the delivery set is described in the package report...

Страница 34: ...the requirement of the present technical manual Information about the system storage before and in the process of operation is registered in Table 7 Table 7 Storage Data Date of Storage conditions Po...

Страница 35: ...iod free of charge The repair is carried out in the service center of Neurosoft Ltd 5 Voronin str Ivanovo 153032 Russia only if this registration certificate is provided 14 Reclamation Data 14 1 In ca...

Страница 36: ...t the following rules should be observed it should be packed so to exclude the possibility of its damage during the transportation the notice see item 14 1 and the present manual must be added to the...

Страница 37: ...Reclamation Data 37 Table 8 Reclamation Data The date of failure or trouble appearance Brief description of the trouble The date of reclamation sending Taken measures Note...

Страница 38: ...al 38 15 Repair Data Table 9 Repair Data Name and code of faulty unit Degree of imperfection Date Name of repair works Position name signature of person completion of repair arrival Carried out the re...

Страница 39: ...l function Therefore its RF emissions are very low and not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The digital system is suitable for use in all e...

Страница 40: ...d be that of typical commercial or hospital environment 2 kV common mode 2kV 2 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for...

Страница 41: ...range 2 Interference may occur in the vicinity of equipment marked with the following symbol 1 Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and...

Страница 42: ...on distance according to frequency of transmitter m 150 kHz up to 80 MHz outside ISM bands P d 17 1 80 MHz to 800 MHz P d 17 1 800 MHz to 2 5 GHz P d 23 2 0 01 0 117 0 117 0 233 0 1 0 369 0 369 0 738...

Страница 43: ...ing pulse parameters are described on Fig 14 If the trigger input is used then negative polarity pulse TTL not less than 5 s must be at the input Pulse droop will be considered as the beginning of syn...

Страница 44: ...ot differ from the one described in the corresponding chapters of the given manual The external stimulators connected to the trigger output must be used in the following order 1 Connect the external s...

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