Nihon Kohden ZB-102AA Telemetry Unit User Manual Manual 1

Nihon Kohden Corporation Telemetry Unit Manual 1

Contents

Manual 1

OPERATOR’S MANUALWIRELESS INPUT UNITWEE-1000A
CONTENTSOperator's Manual WEE-1000 C.1ContentsGENERAL HANDLING PRECAUTIONS ....................................................................... iWARRANTY POLICY ................................................................................................... iiFCC Part 15 Subpart B Class B .................................................................................. iiiIndustry Canada: RSS-210 (Category I) .......................................................................vEMC RLATED CAUTION ............................................................................................. viConventions Used in this Manual and Instrument....................................................... viiDangers, Warnings, Cautions and Notes .......................................................... viiPrecautions for Input Jack Use .................................................................................. viiiSection 1 General ...................................................................................1C.1Introduction ......................................................................................................................... 1.1Composition ........................................................................................................................ 1.4General Safety information ................................................................................................. 1.5Panel Descriptions ............................................................................................................ 1.15ZB-101AA/ZB-102AA Telemetry Unit ...................................................................... 1.15ZR-101AA Access Point ......................................................................................... 1.17JE-011A/JE-012A/ZB-103A Electrode Junction Box............................................... 1.18SC-101A Isolator .................................................................................................... 1.19Section 2 Installation/Preparation .........................................................2C.1System Location ................................................................................................................. 2.1Installation Flowchart .......................................................................................................... 2.3Installing the Access point .................................................................................................. 2.4Attaching the Access Point to the Wall ...................................................................... 2.5Attaching the Access Point to the Rack .................................................................... 2.5Cable Connection ............................................................................................................... 2.6Connecting the Access point and Electroencephalograph........................................ 2.6Connecting the Power Cord ................................................................................................ 2.7Connecting the Power Cord ...................................................................................... 2.7Equipotential Grounding ........................................................................................... 2.7Upgrading the EEG System Program ................................................................................. 2.8Preparing the Telemetry Unit .............................................................................................. 2.9General ..................................................................................................................... 2.9Using a Battery ......................................................................................................... 2.9Inserting the Battery ............................................................................................... 2.11Charging the Lithium-ion Rechargeable Battery ........................................... 2.12Remaining Battery Power ............................................................................. 2.13Connecting the Telemetry unit to the Access point with the Isolator ....................... 2.14Power On/Off Procedure ................................................................................................... 2.15Power On Procedure .............................................................................................. 2.15Power Off Procedure .............................................................................................. 2.17General Requirements for Connecting in Medical Electrical Systems .............................. 2.18
CONTENTSC.2 Operator's Manual WEE-1000Section 3 EEG/PSG Measurement.........................................................3C.1General ............................................................................................................................... 3.1EEG Waveform Acquisition ....................................................................................... 3.4About Polysomnography ........................................................................................... 3.4Flowchart of Waveform Measurement ...................................................................... 3.5Attaching the Electrodes (EEG Measurement) ................................................................... 3.6Guidelines for Input Jack Use ................................................................................... 3.6Required Electrodes ....................................................................................... 3.6Input Jack Z .................................................................................................... 3.6Input Jacks C3 and C4 ................................................................................... 3.6Input Jacks A1 and A2 .................................................................................... 3.6Checking Original Electrode Potentials for All Active Electrodes .................... 3.6Introduction to Electrode Position, Derivation and Montage ..................................... 3.7Electrode Position ........................................................................................... 3.7Derivation ....................................................................................................... 3.7Monopolar Derivations (Referential Derivation) .............................................. 3.7Bipolar Derivation ........................................................................................... 3.8Montage (Pattern) ........................................................................................... 3.8Attaching the Electrodes to the Patient ..................................................................... 3.9EEG Scalp Disk Electrodes .......................................................................... 3.10Electrode Positions ....................................................................................... 3.10Earlobe Electrodes ....................................................................................... 3.11Attaching the Electrodes and Sensors (PSG Measurement) ............................................ 3.12Measurement Parameters and Attachment Sites ................................................... 3.12Electroencephalogram (EEG) ....................................................................... 3.12Electrooculogram (EOG) .............................................................................. 3.12Electromyogram (EMG) ................................................................................ 3.12Electrocardiogram (ECG) ............................................................................. 3.12Attaching the Electrode ................................................................................ 3.13Respiration (Airflow, Chest, Abdomen) ......................................................... 3.15Snore ............................................................................................................ 3.16Body Position ................................................................................................ 3.16Periodic Limb Movements (PLM) .................................................................. 3.16Oxygen Saturation (SpO2) ............................................................................ 3.17Connecting the Electrodes and Sensors to the Electrode Junction Box ........................... 3.19EEG Measurement ................................................................................................. 3.20PSG Measurement ................................................................................................. 3.20Attaching the Telemetry Unit to the Patient ............................................................. 3.21Changing the Measurement Settings ................................................................................ 3.22Measuring Waveforms ...................................................................................................... 3.23
Operator's Manual WEE-1000 iGENERAL HANDLING PRECAUTIONSThis device is intended for use only by qualified medical personnel.Use only Nihon Kohden approved products with this device. Use of non-approved products orin a non-approved manner may affect the performance specifications of the device. Thisincludes, but is not limited to, batteries, recording paper, pens, extension cables, electrodeleads, input boxes and AC power.Please read these precautions thoroughly before attempting to operate the instrument.1. To safely and effectively use the instrument, its operation must be fully understood.2. When installing or storing the instrument, take the following precautions:(1) Avoid moisture or contact with water, dust, extreme atmospheric pressure, excessive humidity and temperatures,poorly ventilated areas, and saline or sulphuric air.(2) Place the instrument on an even, level floor. Avoid vibration and mechanical shock, even during transport.(3) Avoid placing in an area where chemicals are stored or where there is danger of gas leakage.(4) The power line source to be applied to the instrument must correspond in frequency and voltage to productspecifications, and have sufficient current capacity.(5) Choose a room where a proper grounding facility is available.3. Before Operation(1) Check that the instrument is in perfect operating order.(2) Check that the instrument is grounded properly.(3) Check that all cords are connected properly.(4) Pay extra attention when the instrument is in combination with other instruments to avoid misdiagnosis or otherproblems.(5) All circuitry used for direct patient connection must be doubly checked.(6) Check that battery level is acceptable and battery condition is good when using battery-operated models.4. During Operation(1) Both the instrument and the patient must receive continual, careful attention.(2) Turn power off or remove electrodes and/or transducers when necessary to assure the patient’s safety.(3) Avoid direct contact between the instrument housing and the patient.5. To Shutdown After Use(1) Turn power off with all controls returned to their original positions.(2) Remove the cords gently; do not use force to remove them.(3) Clean the instrument together with all accessories for their next use.6. The instrument must receive expert, professional attention for maintenance and repairs. When the instrument isnot functioning properly, it should be clearly marked to avoid operation while it is out of order.7. The instrument must not be altered or modified in any way.8. Maintenance and Inspection:(1) The instrument and parts must undergo regular maintenance inspection at least every 6 months.(2) If stored for extended periods without being used, make sure prior to operation that the instrument is in perfectoperating condition.
ii Operator's Manual WEE-1000(3) Technical information such as parts list, descriptions, calibration instructions or other information is available forqualified user technical personnel upon request from your Nihon Kohden distributor.9. When the instrument is used with an electrosurgical instrument, pay careful attention to the application and/orlocation of electrodes and/or transducers to avoid possible burn to the patient.10. When the instrument is used with a defibrillator, make sure that the instrument is protected against defibrillatordischarge. If not, remove patient cables and/or transducers from the instrument to avoid possible damage.WARRANTY POLICYNihon Kohden Corporation (NKC) shall warrant its products against all defects in materials and workmanship for one yearfrom the date of delivery. However, consumable materials such as recording paper, ink, stylus and battery are excluded fromthe warranty.NKC or its authorized agents will repair or replace any products which prove to be defective during the warranty period,provided these products are used as prescribed by the operating instructions given in the operator’s and service manuals.No other party is authorized to make any warranty or assume liability for NKC’s products. NKC will not recognize any otherwarranty, either implied or in writing. In addition, service, technical modification or any other product change performed bysomeone other than NKC or its authorized agents without prior consent of NKC may be cause for voiding this warranty.Defective products or parts must be returned to NKC or its authorized agents, along with an explanation of the failure.Shipping costs must be pre-paid.This warranty does not apply to products that have been modified, disassembled, reinstalled or repaired without NihonKohden approval or which have been subjected to neglect or accident, damage due to accident, fire, lightning, vandalism,water or other casualty, improper installation or application, or on which the original identification marks have beenremoved.In the USA and Canada other warranty policies may apply.CAUTIONUnited States law restricts this device to sale by or on the order of a physician.
Operator's Manual WEE-1000 iiiFCC Part 15 Subpart B Class BNOTICEThis equipment has been tested and found to comply with the limits for a Class B digital device,pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protectionagainst harmful interference in a residential installation.This equipment generates, uses and can radiate radio frequency energy and, if not installed and usedin accordance with the instructions, may cause harmful interference to radio communications.However, there is no guarantee that interference will not occur in a particular installation. If thisequipment does cause harmful interference to radio or television reception, which can be determinedby turning the equipment off and on, the user is encouraged to try to correct the interference by one ormore of the following measures:• Reorient or relocate the receiving antenna.• Increase the separation between the equipment and the receiver.• Connect the equipment into an outlet on a circuit different from that to which the receiver isconnected.• Consult the dealer or an experienced radio/TV technician for help.FCC WARNINGChanges or modifications not expressly approved by the party responsible for compliance could voidthe user’s authority to operate the equipment.Properly shielded an grounded cables and connectors must be used for connection to host computer and/orperipherals in order to meet FCC emission limits.
iv Operator's Manual WEE-1000This device complies with Part 15 of the FCC Rules. Operation is subject tothe following two conditions:(1) this device may not cause harmful interference, and (2) this device mustaccept any interference received, including interference that may causeundesired operation.FCC Radiation Exposure StatementTelemetry Unit (ZB-101AA/ZB-102AA):The available scientific evidence does not show that any health problems areassociated with using low power wireless devices. There is no proof, however, thatthese low power wireless devices are absolutely safe. Low power Wireless devicesemit low levels of radio frequency energy (RF) in the microwave range while beingused. Whereas high levels of RF can produce health effects (by heating tissue),exposure to low level RF that does not produce heating effects causes no knownadverse health effects. Many studies of low level RF exposures have not found anybiological effects. Some studies have suggested that some biological effectsmight occur, but such findings have not been confirmed by additional research.The Telemetry Unit (ZB-101AA/ZB-102AA) has been tested and found to complywith the Federal Communications Commission (FCC) guidelines on radiofrequency energy (RF) exposures. The maximum SAR levels tested for theTelemetry Unit (ZB-101AA/ZB-102AA) has been shown to be 0.736 W/kg at Body.Use of other installation may not ensure compliance with FCC RF exposureguidelines.Access Point (ZR-101AA):CAUTIONThis equipment complies with FCC radiation exposure limits set forth for anuncontrolled environment.This equipment should be installed and operated with minimum distance 20cmbetween the radiator and body (excluding extremities: hands, wrists and feet) andmust not be co-located or operated with any antenna or transmitter.
Operator's Manual WEE-1000 vIndustry Canada: RSS-210 (Category I)“Operation is subject to the following two conditions; (1) this device may notcause interference, and (2) this device must accept any interference, includinginterference that may cause undesired•@operation of the device.”
vi Operator's Manual WEE-1000EMC RELATED CAUTIONThis equipment and/or system complies with the International Standard IEC 60601-1-2 for electromagneticcompatibility for medical electrical equipment and/or system. However, an electromagnetic environmentthat exceeds the limits or levels stipulated in the IEC 60601-1-2, can cause harmful interference to theequipment and/or system or cause the equipment and/or system to fail to perform its intended function ordegrade its intended performance. Therefore, during the operation of the equipment and/or system, ifthere is any undesired deviation from its intended operational performance, you must avoid, identify andresolve the adverse electromagnetic effect before continuing to use the equipment and/or system.The following describes some common interference sources and remedial actions:1.Strong electromagnetic interference from a nearby emitter source such as an authorized radio station orcellular phone:Install the equipment and/or system at another location if it is interfered with by an emitter source suchas an authorized radio station. Keep the emitter source such as cellular phone away from the equipmentand/or system.2.Radio-frequency interference from other equipment through the AC power supply of the equipment and/or system:Identify the cause of this interference and if possible remove this interference source. If this is notpossible, use a different power supply.3.Effect of direct or indirect electrostatic discharge:Make sure all users and patients in contact with the equipment and/or system are free from direct orindirect electrostatic energy before using it.4.Electromagnetic interference with any radio wave receiver such as radio or television:If the equipment and/or system interferes with any radio wave receiver, locate the equipment and/orsystem as far as possible from the radio wave receiver.If the above suggested remedial actions do not solve the problem, consult your Nihon KohdenCorporation subsidiary or distributor for additional suggestions.The CE mark is a protected conformity mark of the European Community. The products herewith complywith the requirements of the Medical Device Directive 93/42/EEC.The CE mark is only applied to the WEE-1000K Wireless Input Unit.This equipment complies with EUROPEAN STANDARD EN 60601-1-2 (1993) which requires EN 55011, classA. Class A EQUIPMENT is allowed in domestic establishments when used under the jurisdiction of a healthcare professional.
Operator's Manual WEE-1000 viiConventions Used in this Manual and InstrumentDangers, Warnings, Cautions and NotesWarnings, cautions and notes are used in this manual to alert or signal the reader to specific information.DANGERA danger is used to alert the user to a hazardous situation which will cause death or serious injury.WARNINGA warning alerts the user to possible injury or death associated with the use or misuse of the instrument.CAUTIONA caution alerts the user to possible injury or problems with the instrument associated with its use ormisuse such as instrument malfunction, instrument failure, damage to the instrument, or damage to otherproperty.NOTEA note provides specific information, in the form of recommendations, prerequirements, alternativemethods or supplemental information.
viii Operator's Manual WEE-1000Precautions for Input Jack UseNOTEChecking electrode potentials for all active electrodesCheck the original electrode potential for all active electrodes by programming a montage with the system referenceelectrode (Use the pattern VA (factory default setting) or select the 0 V button for reference electrode on the Montagedialog box). Refer to “Programming Patterns” in Section 4 of the operator’s manual of the electroencephalograph.The digital EEG displays the EEG waveform in each channel by subtracting two electrode potentials selected to amontage. The subtracted result will be incorrect if the electrode attachment is incorrect, the original electrode potentialis flat or unstable, or artifact is superimposed on the original electrode potential. Omit the measurement result if thedisplayed EEG waveform is incorrect.Do not perform EEG measurement without the Z, C3, C4, A1 and A2 electrodes.Use of input jack ZConnect the lead from the electrode (Z electrode) attached on the patient’s nasion to the input jack Z on the electrodejunction box. The purpose of this input jack is to eliminate AC interference positively.NOTEThe input jack Z is also used for checking electrode impedance.Use of input jacks C3 and C4Connect the leads from the electrodes attached on the positions C3 and C4 to the input jacks C3 and C4 respectively.NOTE• The C3 and C4 electrodes are the system reference electrodes for EEG measurement.• The input jacks C3 and C4 must be attached for EEG measurement even when the C3 and C4 are notprogrammed in any montage.Use of input jacks A1 and A2, C3 and C4 during skin-electrode impedance checkWhen checking each electrode impedance, connect the leads from the electrode attached on the positions A1, A2, C3and C4 to the input jacks A1, A2, C3 and C4 respectively.NOTE• The A1 and A2 electrodes are the reference electrodes for skin-electrode impedance check.• The input jacks A1 and A2 in addition to the Z, C3 and C4 must be attached for the electrode impedancecheck.
Operator's Manual WEE-1000 1C.1Section 1 GeneralIntroduction .........................................................................................................................1.1Composition ........................................................................................................................1.4General Safety information .................................................................................................. 1.5Panel Descriptions ............................................................................................................. 1.15ZB-101AA/ZB-102AA Telemetry Unit ....................................................................... 1.15ZR-101AA Access Point.......................................................................................... 1.17JE-011A/JE-012A/JE-013A Electrode Junction Box ............................................... 1.18SC-101A Isolator ..................................................................................................... 1.19
1. GENERALOperator's Manual WEE-1000 1.1IntroductionThe WEE-1000A Wireless Input Unit lets you compose a wireless EEG/PSGmeasuring system with an EEG-1100/9100/9200 Series Electroencephalograph.The wireless input unit consists of an electrode junction box, telemetry unit, accesspoint and isolator. The telemetry unit measures EEG waveforms, ECG waveforms,EMG waveforms, respiration waveforms, SpO2 and other parameters and transmitsthem to the access point by wireless transmission (IEEE 802.11b compliant) or bycable transmission through the isolator. The access point is connected to theelectroencephalograph by LAN. The electroencephalograph displays and saves themeasurement data.• Compact and lightweight electrode junction box/telemetry unitThe telemetry unit can be worn by the patient in a pouch and electrode junctionbox is contained in the shoulder strap so that the patient is free from anelectroencephalograph and examination room.• Up to 64 channels of waveforms can be measured.JE-011A Electrode Junction Box and ZB-101AA Telemetry Unit:30 channels of EEG waveforms or 22 channels of EEG waveforms, 8 channels ofbipolar signals and 2 channels of DC input signalsJE-013A Electrode Junction Box and ZB-102AA Telemetry Unit:62 channels of EEG waveforms and 2 channel of DC input signals• SpO2 measurementAn optional SpO2 probe can directly be connected to the telemetry unit with theJL-101A SpO2 Adapter (option).• JE-012A Electrode Junction Box for polysomnogram (PSG) measurement• Battery operationThe telemetry unit can operate on battery power for 24 hours or more on alithium-ion rechargeable battery.• Backup of transmitted dataThe transmitted data is backed up in the telemetry unit to guard againstaccidental signal loss• Communication with the ElectroencephalographThe access point communicates with the electroencephalograph through LAN(10/100Base T). The measurement data from the telemetry unit can betransferred to a distant electroencephalograph by LAN.• Direct connection with the SC-101A Isolator.The telemetry unit can also be directly connected to the access point with an SC-101A Isolator. The isolator is useful when there is a lot of radio frequencyinterference or to save battery power when the patient is sleeping. DC power issupplied to the telemetry unit from the access point through the isolator.Features
1. GENERAL1.2 Operator's Manual WEE-1000• Easy skin-electrode contact impedance checkThe skin-electrode contact impedance check can be performed on both thetelemetry unit and electroencephalograph. The impedance check result isdisplayed on the LCD display on the telemetry unit or on the screen on theelectroencephalograph.• LCD displayThe LCD display on the telemetry unit displays the operation status,communication status and remaining battery power.• Limited roaming functionOne telemetry unit can use up to 3 access points. Each access point covers onearea. The 3 areas covered by the access points should overlap so that the patientcan walk around the ward within the 3 areas without interruption or loss inconnectivity. When this function is used, the multi receiving function is notavailable.• Multi receiving functionEach access point can communicate with up to 3 telemetry units simultaneously.The measurement data can be transferred via LAN to the electroencephalographassigned to each telemetry unit. When this function is used, the limited roamingfunction is not available.• PouchThe pouch contains the telemetry unit, electrode junction box and isolator forstable measurement. It reduces the patient burden and during measurement, thepatient can freely move around while wearing the telemetry unit.NOTEUse only Nihon Kohden recommended parts and accessories to assuremaximum performance from your instrument.TrademarkWindows is a registered trade mark of Microsoft Corporation.
1. GENERALOperator's Manual WEE-1000 1.3WARNINGThe wireless input unit complies with radio frequency standards.• Do not disassemble, repair or modify the wireless input unit.• Do not peel off the radio frequency standard certification label. If thelabel is peeled off, this may result in illegal modification.Frequency Band and ChannelsThe WEE-1000A Wireless Input Unit is a radio wave transmission method used insmall wireless devices such as a PHS or cellular telephone. It uses the 2.4 GHzradio frequency band and transmits data up to 11 Mbps. This band isinternationally assigned for wireless LAN IEEE 802.11b standard. The frequencyband is divided into 11 channels every 5 MHz. Each channel uses about 22 MHzfrequency bandwidth. However, all channels cannot be used at the same timebecause overlapping channels interfere each other.The WEE-1000 Wireless Input Unit covers channels 1 to 11 and uses up to threenon-overlapping channels (for example, channel 1, channel 6 and channel 11) atthe same time.The 2.4 GHz frequency band, which is called ISM (Industry Science Medical), isused for medical devices, ham radio and microwave ovens in addition to wirelessLAN. To prevent radio interference, the wireless input unit uses a spread spectrumtechnology.Channel 1(2.412)Channel 5(2.432)Channel 9(2.452)Channel 2(2.417)Channel 6(2.437)Channel 10(2.457)Channel 3(2.422)Channel 7(2.442)Channel 11(2.462)Channel 4(2.427)Channel 8(2.447)2.400 2.410 2.420 2.430 2.440 2.450 2.460 2.470 2.480 GHz( ): Center frequency
1. GENERAL1.4 Operator's Manual WEE-1000CompositionTelemetry unit, ZB-101AA/ZB-102AAElectrode junction box,JE-011A/JE-012A/JE-013AAccess point,ZR-101AADigital video unitEEG-9100/9200Electroencephalograph, EEG-1100Event markerPouch, strap, beltVideo cameraIsolator,SC-101ASpO2 adapter
1. GENERALOperator's Manual WEE-1000 1.5General Safety informationDANGER• Never use the wireless input unit in a flammable atmosphere (i.e.areas with flammable anesthetics, concentrated oxygen, hyperbaricoxygen) or in an environment in which an electrical arc could ignitean explosion. Otherwise, the unit will explode or catch fire.• Never use the wireless input unit in a high-pressure oxygen medicalcare tank. Otherwise, the unit will explode or catch fire.WARNINGUsing with an electrical surgical unit (ESU)• Never use the wireless input unity near the ESU. The unit maymalfunction due to high-frequency noise from the ESU.• When using wireless input unit with an ESU, refer to the instructionmanual for the ESU. Before measurement, check that the return plateis correctly attached to the patient and that the unit operates correctlywhen using with the ESU. If the return plate is not attached correctly,it may burn the patient’s skin where the electrodes are attached.• Before using the ESU, remove all needle electrodes and silver ballelectrodes from the patient. Failure to follow this warning may causeburn on the patient.MRI examination• Do not install the wireless input unit in an MRI examination room.The unit may not operate properly due to high-frequency magneticnoise from the MRI.• When performing MRI tests, remove all electrodes and transducersfrom the patient which are connected to the electrode junction boxand telemetry unit. Failure to follow this warning may cause seriouselectrical burn on the patient due to local heating caused by dielectricelectromotive force. For details, refer to the instruction manual for theMRI.When performing defibrillation• Before defibrillation, remove from the patient all electrodes andtransducers which are connected to connectors that do not have a“” or “ ” mark. Otherwise, the discharged energy may causeserious electrical burn or shock to the operator.• Before defibrillation, remove all electrodes, transducers and medicalagents from the patient. If the defibrillator paddle directly contactsthese materials or medical agents, the discharged energy may causeserious electrical burn to the patient.
1. GENERAL1.6 Operator's Manual WEE-1000InstallationWarning - continued• Before defibrillation, all persons must keep clear of the bed and mustnot touch the patient or any equipment connected to the patient.Failure to follow this warning may cause serious electrical burn,shock or other injury.WARNING• Do not install the EEG System Program into a personal computerwhich is not specified by Nihon Kohden and connect it to the accesspoint.- If the personal computer does not satisfy the performancespecifications and safety standards which are required by NihonKohden, the patient and operator may get electrical shock.- Nihon Kohden does not warrant if hardware and/or softwarebecomes defective after installation.• Only use the provided power cords. If different power cord is used, itmay cause electrical shock.• For electrical safety, equipotential grounding is required. Consult aqualified biomedical engineer.• Connect only the specified instruments to the connectors or socketmarked with , by following the specified procedure. Otherwise,electrical leakage current may harm the patient and operator.Access Point• When attaching the access point to a wall or rack, you must have aqualified builder to attach the access point. Show the builder thismanual.• Attach the access point securely enough to withstand external force orvibration caused by an earthquake.• Tell the builder the size and weight of the access point. Both size andweight of the access point affect safety.Dimensions and weight: 240 (W) ××××× 55 (D) ××××× 200 (H) mm, 1.5 kg (withoutantenna).• Do not install the access point near a microwave oven. Themicrowaves from the microwave oven may interfere with the radiowave communication between the telemetry unit and access point.
1. GENERALOperator's Manual WEE-1000 1.7Connecting to a Local Area Network• When connecting the access point and electroencephalograph with alocal area network, connect the access point andelectroencephalograph so that the access point andelectroencephalograph are electrically separated from the local areanetwork according to the IEC 60601-1-1 “Medical electrical equipment -Part 1-1: General requirements for safety - Collateral standard: Safetyrequirements for medical electrical systems”. Failure to follow thiswarning may cause electrical shock to the patient and operator.• Check that there is no damage on the surface of the network cable. Ifit is damaged, it may cause electrical shock to the patient andoperator.CAUTION• When connecting the cables, make sure that all components of thewireless input unit turned off.• Only install the specified software in the electroencephalograph.Otherwise the electroencephalograph may malfunction.• Do not install the telemetry unit and access point in a place where isblocked by metal or concrete, or do not install the access point withits antenna bent. Decreased radio wave causes frequent signal lossbetween the telemetry unit and access point.• Do not give impact to the antenna. This may damage the access pointor cause access point malfunction.• Use the provided ZR adapter when installing the access point.Otherwise, the access point may fall off and cause injury.• After installing the telemetry unit and access point, check that thecommunication between the telemetry unit and access point iscorrectly performed without any interference.Warning - continued
1. GENERAL1.8 Operator's Manual WEE-1000BatteryDANGER• Keep the battery away from fire. Do not heat the battery. Otherwise,the battery explodes.• Do not immerse the battery in water or seawater. The battery heats upand rusts and the battery liquid leaks out.• Never use a battery which is damaged, discolored or has leakage. Adamaged battery explodes if used. If the battery is damaged and thebattery liquid contacts the eyes or skin, wash immediately andthoroughly with water and see your physician. Never rub your eyes,otherwise you may lose your eyesight.• Never disassemble, modify or give impact to the battery. The batteryshort-circuits and the battery liquid leaks out.• Never short-circuit the + and – terminals on the battery with a wire.• Do not leave the battery where patients can reach it. If a battery isswallowed, see your physician immediately.• Do not expose the battery to direct sunlight or leave it in a hightemperature place, such as in a car or near heater . The lifetime of thebattery may be shortened, the performance of the battery may bedegraded and the battery liquid may leak out.WARNING• Only charge the CGR-B/242 rechargeable lithium-ion battery with theprovided DE-158UA Battery Charger.• Charge the rechargeable lithium-ion battery at the surroundingtemperatures of 10 to 40°C (50 to 104°F). If the battery is chargedbelow 10°C or over 40°C, it may leak or heat up. This may damage thebattery.CAUTION• Battery replacement should only be done by the operator. Duringmeasurement, when replacing the battery, be careful not to touch thepatient.• Do not charge a deteriorated battery. Otherwise, the instrument cannotoperate on battery power.
1. GENERALOperator's Manual WEE-1000 1.9Caution - continued• Before turning the telemetry unit on, make sure that the battery holderis firmly attached to the telemetry unit. If any static electricity entersthe telemetry unit, it may cause malfunction.• When the telemetry unit is not used, remove the battery from thetelemetry unit.• When replacing the battery, while the telemetry unit is connected tothe access point with the isolator, do not touch the metal part of theconnector. Otherwise the telemetry unit may malfunction due toelectrostatic energy.• Before disposing of the battery, check with your local solid wasteofficials for details in your area for recycling options or properdisposal. The battery is recyclable. At the end of its useful life, undervarious state and local laws, it may be illegal to dispose of this batteryinto the municipal waste stream.The lithium-ion rechargeable battery can be used for approximately 300 fullcharging cycles. When the battery is charged more than 300 times, the batteryoperation time may be reduced.
1. GENERAL1.10 Operator's Manual WEE-1000Electrode Attachment/Cable Connection WARNING• Do not connect the Z electrode lead plug on the electrode junctionbox to a ground or equipotential ground. Otherwise, leakage currentfrom another instrument cause electrical shock to the patient.• Only connect a BF type instrument to the DC connector on thetelemetry unit. Otherwise, leakage current from the other instrumentcauses electrical shock to the patient.• Before disconnecting or connecting the cable from/to a connecter onthe telemetry unit, while the telemetry unit is turned on, dischargeelectrostatic charge from your body. Otherwise, the telemetry unitmay malfunction due to electrostatic energy.• When connecting the electrode junction box cable to the electrodejunction box, align the marks on the electrode junction box cableconnector and electrode junction box. Otherwise, leakage current maycause electrical shock to the patient.CAUTIONUsing a collodion electrode or EEG paste• If rash, redness or itch appears on the patient skin from the use ofcollodion or EEG paste, immediately remove the collodion or EEGpaste from the skin and perform medical treatment.• Never allow collodion or acetone to get in the patient’s eyes. Ifcollodion or acetone accidentally gets in the eyes, immediately andthoroughly wash eyes with clean water and perform medical treatmentimmediately.• If chemical solution is swallowed, have the person drink water andvomit the chemical solution. Perform medical treatment immediately.• Collodion is a volatile solvent. Both patients and medical staff musttake extreme care not to inhale collodion. When using collodion,make sure there is adequate ventilation. If too much collodion isinhaled, have the person lie quietly and keep warm in fresh air.Perform medical treatment immediately.
1. GENERALOperator's Manual WEE-1000 1.11OperationWARNINGWhen using the NE-224S Sub-dermal Straight Needle Electrode• Do not use the NE-224S sub-dermal straight needle electrode as ameasurement electrode for the EEG or evoked potential measurementfor any longer than one hour. When measuring the EEG or evokedpotential for over one hour, use the EEG disk electrode.• Do not check the skin-electrode impedance when using a needleelectrode or intracranial electrode. Failure to follow this warninginjures the patient because these electrodes will be damaged byelectrolyzation inside the body.• When measuring the patient with the implantable pacemaker, leave theinstrument (telemetry unit and access point) more than 22 cm from thepatient. Otherwise, the radio wave from the telemetry unit or accesspoint may interfere with the pacemaker.• Do not delete any system file in the hard disk of theelectroencephalograph. Otherwise the electroencephalograph maymalfunction.• Periodically back up the EEG data files to prevent loss of data if thehard disk or MO disk is damaged.CAUTION• Do not use a device which uses Bluetooth® wireless technology andwireless LAN device which complies with IEEE 802.11b near thewireless input unit at the same time. If they are used together, theradio waves interfere with each other. This may prevent thecommunication between the telemetry unit and access point byreducing transmission speed and transmission distance.• Do not give impact to the telemetry unit. Spike noise may besuperimposed on the waveform.• Use the provided pouch to hold the telemetry unit, electrode junctionbox and/or isolator when they are attached to the patient.• When moving the patient, make sure that the cable connected betweenthe isolator and access point is disconnected. Otherwise, the patientmay fall over the cable, or the cable may be broken.• Do not shake or swing the telemetry unit holding the cable connectedto the telemetry unit. The telemetry unit may come off and it mayinjure somebody or damage surrounding instruments.
1. GENERAL1.12 Operator's Manual WEE-1000SpO2 Measurement• Do not shake or swing the electrode junction box holding the cable orEEG lead connected to the electrode junction box. The electrodejunction box may come off and it may injure somebody or damagesurrounding instruments.WARNING• Measurement may be incorrect in the following cases.- When the patient’s carboxyhemoglobin or methemoglobin increasesabnormally- When dye is injected in the blood- When using an electrical surgery unit- During CPR- When there is body movement- When there is vibration- When measuring at a site with venous pulse- When the pulse wave is small (insufficient peripheral circulation)- When using an IABP (intra-aortic balloon pump)• When the SpO2 probe is used on a neonate, low birth weight infant orpatient with a fever or peripheral circulation insufficiency, a slightburn may result from the probe increasing the skin temperature at theattached site by 2 or 3°C (4 or 5°F). Periodically check the attachedstate of the probe and change the attachment site.• To avoid poor circulation, do not wrap the tape too tight when fixingthe probe with surgical tape. Check the blood circulation condition byobserving the skin color and congestion at the skin peripheral to theprobe attachment site. Even for short-term monitoring, there may beburn or pressure necrosis from poor blood circulation.• When using the probe on the following patients, take extreme careand change the measurement site more frequently according tosymptoms and degree.- A patient with a fever- A patient with a peripheral circulation insufficiency- Neonate or low birth weight infant with delicate skinFor a patient with a peripheral circulation insufficiency, themeasurement result may be incorrect.• When not measuring SpO2, disconnect the SpO2 adapter cable fromthe telemetry unit. Otherwise, noise from the probe sensor mayinterfere and incorrect data is displayed on the screen.Caution - continued
1. GENERALOperator's Manual WEE-1000 1.13CAUTION• Only use the specified probes and JL-101A SpO2 Adapter. OtherwiseSpO2 cannot be monitored properly and instrument performance maybe degraded.• Do not use a probe which is past the expiration date on the package.• Do not use a damaged or disassembled probe.• Disposable probes are not sterilized.• Use the disposable probe only once and for one patient only. Do notreuse the disposable probe for another patient. It will cause crossinfection.• When the attachment site is wet with blood or when the patient hasnail polish on, remove the dirt and nail polish before attaching theprobe. The transmitted light may decrease due to the blood or nailpolish and the measurement data may be incorrect.• Turn off the power of cellular telephones, small wireless devices andother devices which produce strong electromagnetic interference.Otherwise, the waveforms and measurements are affected byinterference and the displayed data may be incorrect.• Under normal conditions, normal light has negligible effect on thisprobe. However, when measuring under strong light (surgical light,bilirubin light, sunlight, etc.), cover the probe with a blanket or cloth.Otherwise, the measurement result may be incorrect.• If the skin gets irritated or redness appears on the skin by the probe,change the attachment site or stop using the probe.• For long term monitoring, check the circulation condition byobserving the skin color of the measuring site. To avoid circulationinsufficiency and skin burn, change the measurement site everyspecified number of hours. Refer to the operator’s manual of theprobe.• Do not pull or bend the probe cable, and do not let caster feet run overthe probe cable. Do not immerse the probe cable in chemicalsolutions or water. Failure to follow these cautions may cause cablediscontinuity, short circuit, skin burn on the patient and incorrectmeasurement data. Replace any broken probe with a new one.• When removing a probe that is taped to the skin, do not pull the cablepart of the probe because this can damage the probe’s cableconnection.
1. GENERAL1.14 Operator's Manual WEE-1000Disinfecting or Sterilizing CAUTIONBefore cleaning or disinfecting, turn off the power of the telemetryunit and access point, remove the battery from the telemetry unit anddisconnect the AC power cord from the access point. Otherwise youmay get an electrical shock or the instrument may malfunction.WARNINGThe wireless input unit complies with radio frequency standards.• Do not disassemble, repair or modify the wireless input unit. If thereis any damage or the unit is suspected to be faulty, attach an“Unusable” or “Repair request” label to the unit and contact yourNihon Kohden distributor or representative.• Do not peel off the radio frequency standard certification label. If thelabel is peeled off, this may result in illegal modification.CAUTIONWhen upgrading the system program, contact your NK distributor orrepresentative. When the upgrading fails, the electroencephalographmay malfunction.CAUTIONBefore disposing of a component of the wireless input unit, checkwith your local solid waste officials for details in your area forrecycling options or proper disposal. When disposing of thetelemetry unit, remove the battery from the telemetry unit.NOTE• If any static electricity enters the electrode junction box, spike noisemay be superimposed on the waveform.MaintenanceDisposingCaution - continued• While a patient is on medication which causes vasodilation, the pulsewaveform may change and in rare case SpO2 value may not bedisplayed.
1. GENERALOperator's Manual WEE-1000 1.15Floppy Disk/CD-ROM DiskHandling and Storing WARNINGThe EEG System Program is protected by copyright law andinternational treaties. Unauthorized reproduction or distribution ofthis software, or any portion of it, may result in severe civil andcriminal penalties, and will be prosecuted to the maximum extentpossible under law.CAUTION• Keep floppy disks away from strong magnetic objects such as amagnet, TV set or speaker. Otherwise, data in the disk may be lost.• During measurement, do not insert or remove a CD-R or CD-RW diskinto or from the CD-RW drive. Otherwise, the Acquisition programmay malfunction.• Do not touch the disk surface of the recorded side (CD-ROM: oppositeside of the label side). If the surface of the disk becomescontaminated with any foreign substances such as fingerprints,reading data may be impossible.• Keep the disk away from direct sunlight and high temperature.Otherwise, the disk may become deformed.• Do not handle the disk while smoking or eating.• Do not get the disk wet.• Do not put a label on top of another label. Remove the old labelbefore applying a new label.• Do not write on the label after the label is attached on the disk.Otherwise, the disk may be damaged and reading may be impossible.• Do not bend the disk, put heavy material on the disk, or give a strongimpact to the disk.• Clean the disk with a disk cleaner. Do not use organic solvents suchas acetone.• This CD–ROM is not an audio CD and cannot be played with an audioCD player.
1. GENERAL1.16 Operator's Manual WEE-1000Name Functions1. Battery holder Contains the battery. Two types of battery holder are provided. One is for the 9 Vlithium-ion rechargeable battery, the other is for the 9 V 006P lithium battery andalkaline battery. When setting the battery, make sure that the battery is in the samedirection shown by the figure on the holder.2. Battery holder release lever Releases the battery holder.3. LCD display Displays the operation status, communication status and remaining battery power.Battery mark: Displayed in battery operation. When the isolator is con-nected, the battery mark goes off.SpO2 mark: Displays the SpO2 mark when the JL-101A SpO2 Adapter isconnected.Status display: Displays the result of the selected operation or function andthe supplemental information for each function.4. FUNCTION key Selects the operation item.ZB-101AA/ZB-102AA Telemetry UnitWARNINGConnect only the specified instruments to the connectors or socket marked with , by following thespecified procedure. Otherwise, electrical leakage current may harm the patient and operator.1345678910112Top panelFront panel Right side panelPanel Descriptions
1. GENERALOperator's Manual WEE-1000 1.17Name Functions5. START/OK key The START/OK key works as follow.• Turns on the power of the telemetry unit when the power is off.• Performs the operation selected by the FUNCTION key.6. MARK/kΩ key Adds event marks or changes the impedance threshold• While acquiring the EEG waveforms, adds event marks (annotations) on thewaveforms.• When checking the skin-electrode contact impedance, changes the impedancethreshold.7. Electrode junction box Connects to the electrode junction box. connector8. DC connector Inputs analog signals from an external instrument.WARNINGOnly connect a BF type instrument to the DC connector on thetelemetry unit. Otherwise, leakage current from the other instrumentcauses electrical shock to the patient.9. MARK connector Connects the event marker.10. SpO2 connector Connects an SpO2 probe by way of the optional JL-101A SpO2 Adapter.11. ISOL connector Connects to the access point by way of the SC-101A Isolator for direct wiredconnection.
1. GENERAL1.18 Operator's Manual WEE-1000Name Functions1. Antenna Diversity antenna2. PHOTO UNIT connector Connects to the optional LS-901A Photo Control Unit.3. ISOLATOR connector Connects to the telemetry unit by way of the SC-101A Isolator for direct wiredconnection. DC power is supplied to the telemetry unit through the isolator.4. DV UNIT connector Connects to the optional DV-101A Digital Video Unit through wired LAN.5. PC connector Connects to the electroencephalograph through wired LAN.6. POWER lamp Lights while AC power is supplied to the access point.7. TX lamp Lights while in contact with the telemetry unit.8. RX lamp Lights while receiving the data from the telemetry unit.9. Protective ground terminal Use this terminal when protective grounding is required.10. Equipotential ground Connects this terminal to the equipotential ground terminal on the wall with the terminal ground lead when the equipotential grounding is required to ensure electricalsafety.11. AC SOURCE socket Connects the power cord to supply AC power to the access point. When AC poweris supplied, the access point is turns on and the POWER lamp lights.ZR-101AA Access PointWARNINGConnect only the specified instruments to the connectors or socket marked with , by following thespecified procedure. Otherwise, electrical leakage current may harm the patient and operator.Left side panel Front panel Right side panel1234567891110
1. GENERALOperator's Manual WEE-1000 1.19JE-011A/JE-012A/JE-013A Electrode Junction BoxName Function1. Electrode jack (DIN type) Connects the EEG disk electrode.2. Extra jack (DIN type) Inputs biological signals other than EEG waveforms.The following extra jacks can be used as bipolar jacks. To select extra jack orbipolar jack, refer to the System Programs.• JE-011A Electrode Junction Box: X2 to X9• JE-012A Electrode Junction Box: X17 to X243. Z jack (DIN type) Reduces the artifact when the electrode for Z on the patient is connected to the Zjack. Be sure to attach the Z electrode to the patient during measurement4. Electrode junction box Connects to the telemetry unit. connectorBottom panelFront panel Right side panel1243Example: JE-011A
1. GENERAL1.20 Operator's Manual WEE-1000SC-101A IsolatorName Function1. ISOL connector Connects the telemetry unit.2. Access point connector Connects to the access point with the connection cable.12
Operator's Manual WEE-1000 2C.1Section 2 Installation/PreparationSystem Location ................................................................................................................. 2.1Installation Flowchart .......................................................................................................... 2.3Installing the Access point ..................................................................................................2.4Attaching the Access Point to the Wall ...................................................................... 2.5Attaching the Access Point to the Rack .................................................................... 2.5Cable Connection ................................................................................................................2.6Connecting the Access point and Electroencephalograph .........................................2.6Connecting the Power Cord .................................................................................................2.7Connecting the Power Cord ....................................................................................... 2.7Equipotential Grounding ............................................................................................2.7Upgrading the EEG System Program .................................................................................. 2.8Preparing the Telemetry Unit................................................................................................2.9General ......................................................................................................................2.9Using a Battery .........................................................................................................2.9Inserting the Battery ............................................................................................... 2.11Charging the Lithium-ion Rechargeable Battery ............................................. 2.12Remaining Battery Power .............................................................................. 2.13Connecting the Telemetry unit to the Access point with the Isolator ........................ 2.14Power On/Off Procedure ..................................................................................................2.15Power On Procedure ............................................................................................... 2.15Power Off Procedure ............................................................................................... 2.17General Requirements for Connecting in Medical Electrical Systems ............................... 2.18
2. INSTALLATION/PREPARATIONOperator's Manual WEE-1000 2.1System LocationThis wireless input unit measures very small electrical potential changes (5 to 200µV). Ideally the instrument should be installed in a shielded room which providesconstant environmental conditions. Select the examination locations as follows andalso refer to “GENERAL HANDLING PRECAUTIONS”.DANGER• Never use the system in a flammable atmosphere (i.e. areas withflammable anesthetics, concentrated oxygen, hyperbaric oxygen) orin an environment in which an electrical arc could ignite anexplosion. Otherwise, the system will explode or catch fire.• Never use the system in a high-pressure oxygen medical care tank.Otherwise, the system will explode or catch fire.WARNING• Do not install the EEG System Program into a personal computerwhich is not specified by Nihon Kohden and connect it to the system.- If the personal computer does not satisfy the performancespecifications and safety standards which are required by NihonKohden, the patient and operator may get electrical shock.- Nihon Kohden does not warrant if hardware and/or softwarebecomes defective after installation.• Only use the provided power cords. If another power cord is used, itmay cause electrical shock or other injury.• For electrical safety, equipotential grounding is required. Consult aqualified biomedical engineer.• Connect only the specified instruments to the connectors or socketmarked with , by following the specified procedure. Otherwise,electrical leakage current may harm the patient and operator.Connecting to a Local Area Network• When connecting the access point and electroencephalograph with alocal area network, connect the access point andelectroencephalograph so that the access point andelectroencephalograph are electrically separated from the local areanetwork according to the IEC 60601-1-1 “Medical electrical equipment- Part 1-1: General requirements for safety - Collateral standard:Safety requirements for medical electrical systems”. Failure tofollow this warning may cause electrical shock to the patient andoperator.• Check that there is no damage on the surface of the network cable. Ifit is damaged, it may cause electrical shock to the patient andoperator.
2. INSTALLATION/PREPARATION2.2 Operator's Manual WEE-1000CAUTION• Select a room with a 3-prong outlet with a ground third contact.• Do not install the system near equipment with a high powerconsumption, such as large X-ray equipment.• Do not install the system near a power line, dynamo or motor whichhas electromagnetic induction.• Do not install the wireless input unit near an electrosurgical unit orRF therapeutic equipment.• Select a room with no excessive noise, vibration, sunlight, highhumidity or water splashes.• When connecting the cables, make sure that each instrument isturned off.• Only install the specified software in the electroencephalograph.Otherwise the electroencephalograph may malfunction.• Make sure that there is no influence from a cellular phone.• Avoid locations where the wireless input unit may receive strongelectromagnetic interference such as radio or TV stations, cellularphones or mobile two-way radios.• A sudden loss of power or extreme power surge can damage data.To assure an uninterrupted power supply, use an uninterruptablepower supply (UPS).• Do not install the wireless input unit where it will be exposed towater or chemical solutions. Avoid direct sprinkling, spray or moistair from the nebulizer or humidifier. These cause malfunction andshorten the life of the unit.• After installing the telemetry unit and access point, check that thecommunication between the telemetry unit and access point iscorrectly performed without any interference.For external instrument connection and local area network connection, refer to“General Requirements for Connecting Medical Electrical Systems” in this section.NOTE• Do not place blankets or cloth over the access point.• Do not install the wireless input unit in dusty area.• Connect the power cable to an AC outlet which can supply enoughAC current to the access point. The access point cannot functionproperly with low current.For electroencephalograph installation, refer to the operator’s manual for theelectroencephalograph.
2. INSTALLATION/PREPARATIONOperator's Manual WEE-1000 2.3Installation Flowchart1. Install the access point.2. Connect the access point to the electroencephalograph.3. Turn on the access point and electroencephalograph.4. Upgrade the EEG system program to version 05-10 or later.5. Prepare the telemetry unit.The network configuration settings of the telemetry unit and access point canbe set on the Acquisition screen.
2. INSTALLATION/PREPARATION2.4 Operator's Manual WEE-1000Installing the Access pointWARNING• When attaching the access point to a wall or rack, you must have aqualified builder attach the access point. Show the builder thismanual.• Attach the access point securely enough to withstand external forceor vibration caused by an earthquake.• Tell the builder the size and weight of the access point. Both sizeand weight of the access point affect safety.Dimensions and weight: 240 (W) ××××× 55 (D) ××××× 200 (H) mm, 1.5 kg(without antenna).• Do not install the access point near a microwave oven. Themicrowaves from the microwave oven may interfere with the radiowave communication between the telemetry unit and access point.CAUTION• Use the provided ZR adapter when installing the access point.Otherwise, the access point may fall off and cause injury.• Use appropriate screws according to the material and structure ofthe wall or rack.• Make sure that there is enough space between the access point andthe wall for adequate ventilation. Leave more than 1 cm of spacebetween the wall and vent holes on the rear panel of the accesspoint. Otherwise the internal temperature of the access point rises,which leads to inaccurate operation and shortens the access pointlife.• Install the access point at least 20 cm away from the operator.• Do not install the telemetry unit and access point in a place where isblocked by metal or concrete, or do not install the access point withits antenna bent. Decreased radio wave causes frequent signal lossbetween the telemetry unit and access point.• Do not install the access point and telemetry unit near a devicewhich uses Bluetooth® wireless technology or wireless LAN devicewhich complies with IEEE 802.11b near the wireless input unit at thesame time. If they are used together, the radio waves interfere witheach other. This may prevent the communication between thetelemetry unit and access point by reducing transmission speed andtransmission distance.• Do not give impact to the antenna. This may damage the accesspoint or cause access point malfunction.NOTESelect a place where the POWER lamp, TX lamp and RX lamp can bechecked.
2. INSTALLATION/PREPARATIONOperator's Manual WEE-1000 2.51. Attach the ZR adapter to the rear of the accesspoint and secure it with four M4×8 pan screws withspring washers.Attaching the Access Point to the Wall1. Attach the ZR adapter to the bottom of the accesspoint and secure it with four M4×8 pan screws withspring washers.Attaching the Access Point to the Rack2. Attach the ZR adapter to the rack and secure theZR adapter with the four pan screws with springwashers.2. Attach the ZR adapter to the wall and secure theZR adapter with the four pan screws with springwashers.AccesspointZR adapterM4×8 pan screw withspring washerExample:M4 pan screw withspring washerAccess pointZR adapterM4×8 pan screw withspring washerExample:M4 pan screw withspring washer
2. INSTALLATION/PREPARATION2.6 Operator's Manual WEE-1000Cable ConnectionWARNING• When connecting the cables, make sure that all components of thewireless input unit are turned off.• Connect only the specified instruments to the connectors or socketmarked with , by following the specified procedure. Otherwise,electrical leakage current may harm the patient and operator.Connecting to a Local Area Network• When connecting the access point and electroencephalograph with alocal area network, connect the access point andelectroencephalograph so that the access point andelectroencephalograph are electrically separated from the local areanetwork according to the IEC 60601-1-1 “Medical electrical equipment- Part 1-1: General requirements for safety - Collateral standard:Safety requirements for medical electrical systems”. Failure to followthis warning may cause electrical shock to the patient and operator.• Check that there is no damage on the surface of the network cable. Ifit is damaged, it may cause electrical shock to the patient andoperator.1. Connect the provided network cable to the PC connector on the left side panelof the access point.Connecting the Access pointand Electroencephalograph2. Connect the other side of the network cable to the network connector on the PCunit of the electroencephalograph.PC connector
2. INSTALLATION/PREPARATIONOperator's Manual WEE-1000 2.7Connect the provided power cord to the AC SOURCE socket on the right side panelof the access point and plug the cord into a 3-prong AC outlet.CAUTIONOnly use the provided power cords. If another power cord is used, itmay cause electrical shock.WARNINGFor patient safety, equipotential grounding may be required. Consultwith a qualified biomedical engineer.When more than one electrical instrument is used, there may be electrical potentialdifference between the instruments. Potential difference between instruments maycause current to flow to the patient connected to the instruments, resulting inelectrical shock (micro shock). Never use any medical equipment in patienttreatment without proper grounding.Always perform equipotential grounding when required. It is often required in theoperating room, ICU room, CCU room, cardiac catheterization room and X-rayroom. Consult with a biomedical engineer to determine if it is required.When Equipotential Grounding is RequiredConnect the equipotential ground terminal on the right side panel of the accesspoint to the equipotential ground terminal on the wall with the ground lead.Connecting the Power CordConnecting the PowerCordEquipotential Grounding
2. INSTALLATION/PREPARATION2.8 Operator's Manual WEE-1000NOTEWhen the system program version of the electroencephalograph is05-01 or earlier, the access point can not be connected. Upgrade thesystem program with the provided system disk.1. Insert the EEG system program CD-ROM into the CD-ROM drive.2. From the Start menu, select Run. The Run dialog opens.3. Type X:\Software\Setup.exe in the Open text box and click the OK button (Xis the CD-ROM drive). The EEG setup program starts copying the files.4. Follow the instructions on the screen.5. When the setup is complete, restart the computer.Upgrading the EEG System Program
2. INSTALLATION/PREPARATIONOperator's Manual WEE-1000 2.9Preparing the Telemetry UnitThe telemetry unit communicates with the access point by wireless transmission(IEEE 802.11b compliant). The telemetry unit can also be directly connected to theaccess point with an SC-101A Isolator. The isolator is useful when there is a lot ofradio frequency interference or to save battery power when the patient is sleeping.The telemetry unit can operate on battery power with the following batteries• CGR-B/242 lithium-ion (LiON) rechargeable battery ×1 (option)• 006P 9V lithium battery ×1 (U9VL: recommended)• 006P 9V alkaline battery ×1Battery operation time (at surrounding temperature: 25°C (77°F))• Lithium- ion rechargeable battery: 24 hours or more(10 seconds intermittent transmission)• 9V lithium battery: About 12 hours• 9V alkaline battery: About 5 hoursThe lithium-ion rechargeable battery can be used for approximately 300 fullcharging cycles. When the battery is charged more than 300 times, the batteryoperation time may be reduced.WARNING• Keep the battery away from fire. Do not heat the battery. Otherwise,the battery explodes.• Do not immerse the battery in water or seawater. The battery heatsup and rusts and the battery liquid leaks out.• Never use a battery which is damaged, discolored or has leakage. Adamaged battery explodes if used. If the battery is damaged and thebattery liquid contacts the eyes or skin, wash immediately andthoroughly with water and see your physician. Never rub your eyes,otherwise you may lose your eyesight.• Never disassemble, modify or give impact to the battery. The batteryshort-circuits and the battery liquid leaks out.• Never short-circuit the + and – terminals on the battery with a wire.• Do not leave the battery where patients can reach it. If a battery isswallowed, see your physician immediately.• Do not expose the battery to direct sunlight or leave it in a hightemperature place. The lifetime of the battery may be shortened, theperformance of the battery may be degraded and the battery liquidmay leak out.• Only charge the CGR-B/242 rechargeable lithium-ion battery with theprovided DE-158UA Battery Charger.• Charge the battery at the surrounding temperatures of 10 to 40°C (50to 104°F). If the battery is charged below 10°C or over 40°C, it mayleak or heat up. This may damage the battery.GeneralUsing a Battery
2. INSTALLATION/PREPARATION2.10 Operator's Manual WEE-1000CAUTION• Battery replacement should only be done by the operator. Duringmeasurement, when replacing the battery, be careful not to touch thepatient.• Do not charge a deteriorated battery. Otherwise, the instrumentcannot operate on battery power.• Before turning the telemetry unit on, make sure that the batteryholder is firmly attached to the telemetry unit. If any static electricityenters the telemetry unit, it may cause malfunction.• When the telemetry unit is not used, remove the battery from thetelemetry unit.• When replacing the battery, while the telemetry unit is connected tothe access point with the isolator, do not touch the metal part of theconnector. Otherwise the telemetry unit may malfunction due toelectrostatic energy.• Before disposing of the battery, check with your local solid wasteofficials for details in your area for recycling options or properdisposal. The battery is recyclable. At the end of its useful life, undervarious state and local laws, it may be illegal to dispose of thisbattery into the municipal waste stream.NOTEUse a fully charged lithium-ion rechargeable battery, a new 006P 9Vlithium battery or new 006P 9V alkaline battery for everymeasurement.
2. INSTALLATION/PREPARATIONOperator's Manual WEE-1000 2.112. Insert the battery into the battery holder. Two types of battery holder areprovided. One is for the lithium-ion rechargeable battery, the other is for the9V 006P lithium battery and alkaline battery. Use the appropriate batteryholder according to the battery. When setting the battery, make sure that thebattery is in the same direction shown by the figure on the holder.Inserting the Battery 1. Press the battery holder release lever and remove the battery holder from thetelemetry unit.Battery holderBattery holderrelease lever3. Attach the battery holder to the telemetry unit.Battery holder forlithium-ion batteryBattery holder for 006P lithiumbattery and alkaline battery
2. INSTALLATION/PREPARATION2.12 Operator's Manual WEE-1000Charging the Lithium-ion Rechargeable BatteryThe lithium-ion rechargeable battery can be used for approximately 300 fullcharging cycles with the DE-158UA Battery Charger. When the battery is chargedmore than 300 times, the battery operation time may be reduced.WARNING• Only charge the CGR-B/242 Lithium-ion rechargeable battery with theprovided DE-158UA Battery Charger.CAUTION• Battery replacement should only be done by the operator. Duringmeasurement, when replacing the battery, be careful not to touch thepatient.• When replacing the battery, while the telemetry unit is connected tothe access point with the isolator, do not touch the metal part of theconnector. Otherwise the telemetry unit may malfunction due toelectrostatic energy.• Do not charge the battery inside the patient environment (IEC 60601-1-1 2.204*)* Patient environmentAny area in which intentional or unintentional contact between PATIENT andparts of SYSTEM or some other persons touching of the SYSTEM can occur.The two rechargeable batteries can be set in the battery charger at the same timebut the charging is performed for only one battery.• When the second battery is set in the charger, while a battery is being charged,the second battery is charged after the first battery charging is complete.• When two batteries are set in the battery charger before AC power is supplied, thebattery which is set in the channel 1 is charged first.1. Connect the battery charger to the AC outlet and turn the power on. The powerlamp lights in red.2. Set the rechargeable battery in the battery charger. Make sure that the batteryis set in the direction shown by the mark. When the batteries is correctlyset in the battery charger, charging starts.The battery charge lamp (green) indicates the battery charging status:Lit : The battery is being chargedBlinking: The battery is fully charged.Off: The battery is too hot (After while, if the battery charge lamp doesnot light or blink, the battery may be damaged.The rechargeable battery can be fully charged in about 100 minutes.
2. INSTALLATION/PREPARATIONOperator's Manual WEE-1000 2.13Remaining Battery PowerDuring battery operation, the battery mark appears on the LCD display. You cancheck the remaining battery power on the LCD.1. When the battery is inserted in to the battery holder, press the START/OK key.The telemetry unit is turned on and the version information is displayed on theLCD display.2. Check the battery operation power by pressing the FUNCTION key. Thebattery operation power is displayed on the status display.The battery voltage is shown as follows.BH: The battery voltage is about 7 V or more.BL: The battery voltage is less than about 7 V.Eb: The battery voltage is less than about 6 VReplace the battery when “BL” or “Eb” is displayed on the LCD display.When the battery voltage becomes less than 6 V, the beep sounds and amessage to replace the battery is displayed on the Acquisition screen of theelectroencephalograph.To turn the power off, select “OF” by pressing the FUNCTION key and pressthe START/OK key.Turn the power off, when you detach the battery holder.
2. INSTALLATION/PREPARATION2.14 Operator's Manual WEE-1000Connecting the Telemetryunit to the Access pointwith the IsolatorThe telemetry unit can also be directly connected to the access point with an SC-101A Isolator. DC power is supplied to the telemetry unit from the access pointthrough the isolator.CAUTION• When connecting the isolator to the telemetry unit, make sure thattelemetry unit is turned off.• When using the isolator, do not remove the battery holder.Otherwise, the telemetry unit may malfunction due to static energy.• When moving the patient, make sure that the cable connectedbetween the isolator and access point is disconnected. Otherwise,the patient may fall over the cable, or the cable may get broken.• When connecting or disconnecting the connection cable to/from theisolator, hold the connectors. If you hold the cable, the cable mayget broken.1. Disconnect the connection cable from the isolator which connects the isolatorand access point.2. Connect the cable from the isolator to the telemetry unit and secure theconnector with the two screws. Use the provided flat-blade screwdriver tosecure the connector.3. Connect the connection cable to the access point and secure the connector withthe two screws.4. Connect the AC power cord of the access point to the AC outlet.5. Connect the other side of the connection cable to the isolator. DC power issupplied to the telemetry unit and the telemetry unit is turned on. The LCDdisplay displays the version information, then displays “CL”.To turn off the telemetry unit, disconnect the connection cable from theisolator. When the battery is set in the battery holder, the telemetry unitcontinues to operate on battery power.
2. INSTALLATION/PREPARATIONOperator's Manual WEE-1000 2.15Power On/Off ProcedureCAUTION• When connecting the isolator to the telemetry unit, make sure thattelemetry unit is turned off.• When using the isolator, do not remove the battery holder.Otherwise, the telemetry unit may malfunction due to static energy.1. Before turning the power on, check the following items. If there is any damageor the instrument is suspected to be faulty as a result of checking, attach an“Unusable” or “Repair required” label to the instrument and contact your NKdistributor or representative.Check items before turning the power onOverview:•Telemetry unit, access point and isolator are not dirty, damaged or in contactwith liquid.•Power cord is not damaged.•No key on the telemetry unit is broken.•No electrode is dirty or damaged.•No electrode lead is frayed or damaged.•No connection cable is frayed or damaged.Connection and Setting:Telemetry unit•Fully charged lithium-ion battery, a new lithium battery or a new alkalinebattery is inserted.•Battery is inserted in the correct direction.•Battery holder is attached to the telemetry unit firmly.•Isolator is firmly connect to the telemetry unit.•Electrode junction box is properly connected to the telemetry unit.Access point•Power cord and ground lead are properly connected to the access point.•Access point is properly connected to the electroencephalograph with thenetwork cable.Environment•There is no obstruction between the telemetry unit and access point.•Bluetooth device or other wireless LAN device is not used near the wirelessinput unit.Power On Procedure
2. INSTALLATION/PREPARATION2.16 Operator's Manual WEE-1000Accessories:•Enough electrodes.•Enough EEG paste.•A second battery.2. Turn the power onWireless communication:1) Connect the AC power cord of the access point to the AC outlet.2) Press the START/OK key on the telemetry unit.Wired communication:1) Connect the telemetry unit and access point with the isolator.2) Connect the AC power cord of the access point to the AC outlet.3. After turning the power on, check the following items.Check items after turning the power onOverview:•No fire, smoke or smell.•No electrical shock when touching the telemetry unit or access point.•Telemetry unit and access point are not too hot.•Telemetry unit and access point do not affect surrounding equipment.Telemetry unit•No beep sounds.•No error code is displayed on the LCD screen.•All keys operate correctly.Access point•The power lamp lights.•TX and RX lamps blinks•All operation indicators light.Electroencephalograph•The communication between the telemetry unit and access point isestablished with or without the isolator.•The message to replace the battery of the telemetry unit is not displayed.•There is no error message on the screen or malfunction.•The screen display is correct.•The time and date display is correct.•All programs operate correctly.•All settings (such as montage and amplifier settings) are correct.•Calibration waveform is properly displayed.•No noise on the calibration waveform.•Amplitude of the calibration waveform is correct.
2. INSTALLATION/PREPARATIONOperator's Manual WEE-1000 2.17Power Off Procedure 1. Check the following before turning the power off.Check items before turning the power off•All necessary files are saved.•All programs are closed.2. Turn the power off.1) On the telemetry unit, select “OF” by pressing the FUNCTION key, thenpress the START/OK key.2) Disconnect the AC power cord of the access point from the AC outlet.Check the following items for the next use•Power of all external instruments are turned off.•Telemetry unit and access point is not dirty, damaged or in contact withliquid.•Power cord is not damaged.• Telemetry unit is turned off•No key on the telemetry unit is broken.•Battery is removed from the battery holder.•Lithium battery or alkaline battery is correctly disposed of.•No electrode is dirty or damaged.•No electrode lead is frayed or damaged.•No connection cable is frayed or damaged.•Electrodes and leads are cleaned and disinfected.•Enough electrodes.•Enough EEG paste.
2. INSTALLATION/PREPARATION2.18 Operator's Manual WEE-1000General Requirements for Connecting in Medical Electrical SystemsWhen more than one electrical instrument is used, there may be electrical potentialdifference between the instruments. Potential difference between instruments maycause current to flow to the patient connected to the instruments, resulting in electricalshock (micro shock). Therefore, electrical instruments must be appropriately installedas specified in IEC 60601-1-1.The following is an excerpt from IEC 60601-1-1 “Medical electrical equipment - Part1-1: General requirements for safety - Collateral standard: Safety requirements formedical electrical systems”. For details, refer to IEC 60601-1-1 and consult with abiomedical engineer.Examples of combinations of MEDICAL ELECTRICAL EQUIPMENT and non-medical electrical equipmentIEC 60601/B = IEC 60601-1 EQUIPMENT of TYPE B with PATIENT connectionIEC 60601/F = IEC 60601-1 EQUIPMENT of TYPE BF or TYPE CF (or TYPE Bwithout PATIENT connection)IEC 60601/X = IEC 60601-1 EQUIPMENT of TYPE B or TYPE BF or TYPE CFIEC XXXXX = Equipment complying with, e.g. IEC 348, IEC 950 etc.P: additional protective earthQ: additional separating transformerR: floating power supplyS: separationSituation No. Equipment A Equipment B Solution1 IEC 60601/X OK1a IEC XXXXXOK, if ENCLOSURE LEAKAGECURRENT is less than 0.5 mA. Ifthe ENCLOSURE LEAKAGECURRENT is more than 0.5 mA:Solution Q (separating transformers).2a IEC 60601/X IEC 60601/B OK2b IEC 60601/F IEC XXXXX for B any one of P, Q, R2c IEC 60601/B IEC XXXXX for A solution P for B any one of P,Q, R3a IEC 60601/X IEC 60601/B OK3b IEC 60601/F IEC XXXXX OK3c IEC 60601/B IEC XXXXX for A solution P4 see 3a, 3b, 3c5a IEC 60601/X IEC 60601/B for A solution P or S (groundlooppossible)5b IEC 60601/X IEC XXXXX for A solution P or S (groundlooppossible)6a IEC 60601/X IEC 60601/X OK (with S)6b IEC 60601/X IEC XXXXX OK (with S)
2. INSTALLATION/PREPARATIONOperator's Manual WEE-1000 2.19Legend:(V) = Potential difference between different localities> < = SEPARATION DEVICEPE = Protective earth123456Situation No. PATIENT ENVIRONMENT Medical-use room Non-medical use roomAPEABPE PEABPE PEABPEPEABPEPE(V)ABPEPE(V)

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