OPERATOR’S MANUAL WIRELESS INPUT UNIT WEE-1000A
CONTENTS Contents GENERAL HANDLING PRECAUTIONS ....................................................................... i WARRANTY POLICY ................................................................................................... ii FCC Part 15 Subpart B Class B .................................................................................. iii Industry Canada: RSS-210 (Category I) ....................................................................... v EMC RLATED CAUTION .......................
CONTENTS Section 3 EEG/PSG Measurement .........................................................3C.1 General ............................................................................................................................... 3.1 EEG Waveform Acquisition ....................................................................................... 3.4 About Polysomnography ........................................................................................... 3.
GENERAL HANDLING PRECAUTIONS This device is intended for use only by qualified medical personnel. Use only Nihon Kohden approved products with this device. Use of non-approved products or in a non-approved manner may affect the performance specifications of the device. This includes, but is not limited to, batteries, recording paper, pens, extension cables, electrode leads, input boxes and AC power. Please read these precautions thoroughly before attempting to operate the instrument. 1.
(3) Technical information such as parts list, descriptions, calibration instructions or other information is available for qualified 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/or location of electrodes and/or transducers to avoid possible burn to the patient. 10.
FCC Part 15 Subpart B Class B NOTICE This 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 protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. FCC Radiation Exposure Statement Telemetry Unit (ZB-101AA/ZB-102AA): The available scientific evidence does not show that any health problems are associated with using low power wireless devices.
Industry Canada: RSS-210 (Category I) “Operation is subject to the following two conditions; (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired•@operation of the device.
EMC RELATED CAUTION This equipment and/or system complies with the International Standard IEC 60601-1-2 for electromagnetic compatibility for medical electrical equipment and/or system. However, an electromagnetic environment that exceeds the limits or levels stipulated in the IEC 60601-1-2, can cause harmful interference to the equipment and/or system or cause the equipment and/or system to fail to perform its intended function or degrade its intended performance.
Conventions Used in this Manual and Instrument Dangers, Warnings, Cautions and Notes Warnings, cautions and notes are used in this manual to alert or signal the reader to specific information. DANGER A danger is used to alert the user to a hazardous situation which will cause death or serious injury. WARNING A warning alerts the user to possible injury or death associated with the use or misuse of the instrument.
Precautions for Input Jack Use NOTE Do not perform EEG measurement without the Z, C3, C4, A1 and A2 electrodes. Use of input jack Z Connect the lead from the electrode (Z electrode) attached on the patient’s nasion to the input jack Z on the electrode junction box. The purpose of this input jack is to eliminate AC interference positively. NOTE The input jack Z is also used for checking electrode impedance.
Section 1 General Introduction ......................................................................................................................... 1.1 Composition ........................................................................................................................ 1.4 General Safety information .................................................................................................. 1.5 Panel Descriptions ....................................................................
1. GENERAL Introduction The WEE-1000A Wireless Input Unit lets you compose a wireless EEG/PSG measuring system with an EEG-1100/9100/9200 Series Electroencephalograph. The wireless input unit consists of an electrode junction box, telemetry unit, access point and isolator. The telemetry unit measures EEG waveforms, ECG waveforms, EMG waveforms, respiration waveforms, SpO2 and other parameters and transmits them to the access point by wireless transmission (IEEE 802.
1. GENERAL • Easy skin-electrode contact impedance check The skin-electrode contact impedance check can be performed on both the telemetry unit and electroencephalograph. The impedance check result is displayed on the LCD display on the telemetry unit or on the screen on the electroencephalograph. • LCD display The LCD display on the telemetry unit displays the operation status, communication status and remaining battery power. • Limited roaming function One telemetry unit can use up to 3 access points.
1. GENERAL Frequency Band and Channels The WEE-1000A Wireless Input Unit is a radio wave transmission method used in small wireless devices such as a PHS or cellular telephone. It uses the 2.4 GHz radio frequency band and transmits data up to 11 Mbps. This band is internationally assigned for wireless LAN IEEE 802.11b standard. The frequency band is divided into 11 channels every 5 MHz. Each channel uses about 22 MHz frequency bandwidth.
1. GENERAL Composition Electrode junction box, JE-011A/JE-012A/JE-013A Telemetry unit, ZB-101AA/ZB-102AA Event marker SpO2 adapter Isolator, SC-101A Pouch, strap, belt Video camera Digital video unit Access point, ZR-101AA Electroencephalograph, EEG-1100 EEG-9100/9200 1.
1. GENERAL General Safety information DANGER • Never use the wireless input unit in a flammable atmosphere (i.e. areas with flammable anesthetics, concentrated oxygen, hyperbaric oxygen) or in an environment in which an electrical arc could ignite an explosion. Otherwise, the unit will explode or catch fire. • Never use the wireless input unit in a high-pressure oxygen medical care tank. Otherwise, the unit will explode or catch fire.
1. GENERAL Warning - continued • Before defibrillation, all persons must keep clear of the bed and must not touch the patient or any equipment connected to the patient. Failure to follow this warning may cause serious electrical burn, shock or other injury. Installation WARNING • Do not install the EEG System Program into a personal computer which is not specified by Nihon Kohden and connect it to the access point.
1. GENERAL Warning - continued Connecting to a Local Area Network • When connecting the access point and electroencephalograph with a local area network, connect the access point and electroencephalograph so that the access point and electroencephalograph are electrically separated from the local area network 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”.
1. GENERAL Battery DANGER • 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 up and rusts and the battery liquid leaks out. • Never use a battery which is damaged, discolored or has leakage. A damaged battery explodes if used. If the battery is damaged and the battery liquid contacts the eyes or skin, wash immediately and thoroughly with water and see your physician.
1. GENERAL Caution - continued • Before turning the telemetry unit on, make sure that the battery holder is firmly attached to the telemetry unit. If any static electricity enters the telemetry unit, it may cause malfunction. • When the telemetry unit is not used, remove the battery from the telemetry unit. • When replacing the battery, while the telemetry unit is connected to the access point with the isolator, do not touch the metal part of the connector.
1. GENERAL Electrode Attachment/ Cable Connection WARNING • Do not connect the Z electrode lead plug on the electrode junction box to a ground or equipotential ground. Otherwise, leakage current from another instrument cause electrical shock to the patient. • Only connect a BF type instrument to the DC connector on the telemetry unit. Otherwise, leakage current from the other instrument causes electrical shock to the patient.
1. GENERAL Operation WARNING When using the NE-224S Sub-dermal Straight Needle Electrode • Do not use the NE-224S sub-dermal straight needle electrode as a measurement electrode for the EEG or evoked potential measurement for any longer than one hour. When measuring the EEG or evoked potential for over one hour, use the EEG disk electrode. • Do not check the skin-electrode impedance when using a needle electrode or intracranial electrode.
1. GENERAL Caution - continued • Do not shake or swing the electrode junction box holding the cable or EEG lead connected to the electrode junction box. The electrode junction box may come off and it may injure somebody or damage surrounding instruments. SpO2 Measurement WARNING • Measurement may be incorrect in the following cases.
1. GENERAL CAUTION • Only use the specified probes and JL-101A SpO2 Adapter. Otherwise SpO2 cannot be monitored properly and instrument performance may be 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 not reuse the disposable probe for another patient. It will cause cross infection.
1. GENERAL Caution - continued • While a patient is on medication which causes vasodilation, the pulse waveform may change and in rare case SpO2 value may not be displayed. Disinfecting or Sterilizing CAUTION Before cleaning or disinfecting, turn off the power of the telemetry unit and access point, remove the battery from the telemetry unit and disconnect the AC power cord from the access point. Otherwise you may get an electrical shock or the instrument may malfunction.
1. GENERAL Floppy Disk/CD-ROM Disk Handling and Storing WARNING The EEG System Program is protected by copyright law and international treaties. Unauthorized reproduction or distribution of this software, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under law. CAUTION • Keep floppy disks away from strong magnetic objects such as a magnet, TV set or speaker. Otherwise, data in the disk may be lost.
1. GENERAL Panel Descriptions ZB-101AA/ZB-102AA Telemetry Unit WARNING Connect only the specified instruments to the connectors or socket marked with , by following the specified procedure. Otherwise, electrical leakage current may harm the patient and operator. 7 Top panel 6 Front panel Right side panel 3 8 1 9 4 10 11 5 2 Name Functions 1. Battery holder Contains the battery. Two types of battery holder are provided.
1. GENERAL Name Functions 5. 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 the waveforms. • When checking the skin-electrode contact impedance, changes the impedance threshold. 7.
1. GENERAL ZR-101AA Access Point WARNING Connect only the specified instruments to the connectors or socket marked with , by following the specified procedure. Otherwise, electrical leakage current may harm the patient and operator. Front panel Left side panel Right side panel 1 2 9 3 10 4 11 5 6 1.18 7 8 Name Functions 1. Antenna Diversity antenna 2. PHOTO UNIT connector Connects to the optional LS-901A Photo Control Unit. 3.
1. GENERAL JE-011A/JE-012A/JE-013A Electrode Junction Box Front panel Right side panel Example: JE-011A 2 1 3 4 Bottom panel Name Function 1. 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 or bipolar jack, refer to the System Programs. • JE-011A Electrode Junction Box: X2 to X9 • JE-012A Electrode Junction Box: X17 to X24 3.
1. GENERAL SC-101A Isolator 1 2 1.20 Name Function 1. ISOL connector Connects the telemetry unit. 2. Access point connector Connects to the access point with the connection cable.
Section 2 Installation/Preparation System Location ................................................................................................................. 2.1 Installation Flowchart .......................................................................................................... 2.3 Installing the Access point .................................................................................................. 2.4 Attaching the Access Point to the Wall ......................................
2. INSTALLATION/PREPARATION System Location This wireless input unit measures very small electrical potential changes (5 to 200 µV). Ideally the instrument should be installed in a shielded room which provides constant environmental conditions. Select the examination locations as follows and also refer to “GENERAL HANDLING PRECAUTIONS”. DANGER • Never use the system in a flammable atmosphere (i.e.
2. INSTALLATION/PREPARATION CAUTION • Select a room with a 3-prong outlet with a ground third contact. • Do not install the system near equipment with a high power consumption, such as large X-ray equipment. • Do not install the system near a power line, dynamo or motor which has electromagnetic induction. • Do not install the wireless input unit near an electrosurgical unit or RF therapeutic equipment. • Select a room with no excessive noise, vibration, sunlight, high humidity or water splashes.
2. INSTALLATION/PREPARATION Installation Flowchart 1. 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 can be set on the Acquisition screen. Operator's Manual WEE-1000 2.
2. INSTALLATION/PREPARATION Installing the Access point WARNING • When attaching the access point to a wall or rack, you must have a qualified builder attach the access point. Show the builder this manual. • Attach the access point securely enough to withstand external force or vibration caused by an earthquake. • Tell the builder the size and weight of the access point. Both size and weight of the access point affect safety. Dimensions and weight: 240 (W) × 55 (D) × 200 (H) mm, 1.5 kg (without antenna).
2. INSTALLATION/PREPARATION Attaching the Access Point to the Wall ZR adapter Access point 1. Attach the ZR adapter to the rear of the access point and secure it with four M4×8 pan screws with spring washers. M4×8 pan screw with spring washer 2. Attach the ZR adapter to the wall and secure the ZR adapter with the four pan screws with spring washers. Example: M4 pan screw with spring washer Attaching the Access Point to the Rack 1.
2. INSTALLATION/PREPARATION Cable Connection WARNING • When connecting the cables, make sure that all components of the wireless input unit are turned off. • Connect only the specified instruments to the connectors or socket marked with , by following the specified procedure. Otherwise, electrical leakage current may harm the patient and operator.
2. INSTALLATION/PREPARATION Connecting the Power Cord Connecting the Power Cord Connect the provided power cord to the AC SOURCE socket on the right side panel of the access point and plug the cord into a 3-prong AC outlet. CAUTION Only use the provided power cords. If another power cord is used, it may cause electrical shock. Equipotential Grounding WARNING For patient safety, equipotential grounding may be required. Consult with a qualified biomedical engineer.
2. INSTALLATION/PREPARATION Upgrading the EEG System Program NOTE When the system program version of the electroencephalograph is 05-01 or earlier, the access point can not be connected. Upgrade the system 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 (X is the CD-ROM drive).
2. INSTALLATION/PREPARATION Preparing the Telemetry Unit General The telemetry unit communicates with the access point by wireless transmission (IEEE 802.11b compliant). 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 frequency interference or to save battery power when the patient is sleeping.
2. INSTALLATION/PREPARATION CAUTION • Battery replacement should only be done by the operator. During measurement, when replacing the battery, be careful not to touch the patient. • Do not charge a deteriorated battery. Otherwise, the instrument cannot operate on battery power. • Before turning the telemetry unit on, make sure that the battery holder is firmly attached to the telemetry unit. If any static electricity enters the telemetry unit, it may cause malfunction.
2. INSTALLATION/PREPARATION Inserting the Battery 1. Press the battery holder release lever and remove the battery holder from the telemetry unit. Battery holder Battery holder release lever 2. Insert the battery into the battery holder. Two types of battery holder are provided. One is for the lithium-ion rechargeable battery, the other is for the 9V 006P lithium battery and alkaline battery. Use the appropriate battery holder according to the battery.
2. INSTALLATION/PREPARATION Charging the Lithium-ion Rechargeable Battery The lithium-ion rechargeable battery can be used for approximately 300 full charging cycles with the DE-158UA Battery Charger. When the battery is charged more than 300 times, the battery operation time may be reduced. WARNING • Only charge the CGR-B/242 Lithium-ion rechargeable battery with the provided DE-158UA Battery Charger. CAUTION • Battery replacement should only be done by the operator.
2. INSTALLATION/PREPARATION Remaining Battery Power During battery operation, the battery mark appears on the LCD display. You can check 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 the LCD display. 2. Check the battery operation power by pressing the FUNCTION key. The battery operation power is displayed on the status display.
2. INSTALLATION/PREPARATION Connecting the Telemetry unit to the Access point with the Isolator The telemetry unit can also be directly connected to the access point with an SC101A Isolator. DC power is supplied to the telemetry unit from the access point through the isolator. CAUTION • When connecting the isolator to the telemetry unit, make sure that telemetry unit is turned off. • When using the isolator, do not remove the battery holder.
2. INSTALLATION/PREPARATION Power On/Off Procedure Power On Procedure CAUTION • When connecting the isolator to the telemetry unit, make sure that telemetry 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.
2. INSTALLATION/PREPARATION Accessories: • Enough electrodes. • Enough EEG paste. • A second battery. 2. Turn the power on Wireless 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.
2. INSTALLATION/PREPARATION Power 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, then press 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.
2. INSTALLATION/PREPARATION General Requirements for Connecting in Medical Electrical Systems When more than one electrical instrument is used, there may be electrical potential difference between the instruments. Potential difference between instruments may cause current to flow to the patient connected to the instruments, resulting in electrical shock (micro shock). Therefore, electrical instruments must be appropriately installed as specified in IEC 60601-1-1.
2. INSTALLATION/PREPARATION Situation No. PATIENT ENVIRONMENT 1 A PE 2 A PE 3 A PE 4 A PE Medical-use room Non-medical use room B PE B PE B PE 5 A PE B (V) PE 6 A PE B (V) PE Legend: (V) = Potential difference between different localities > < = SEPARATION DEVICE PE = Protective earth Operator's Manual WEE-1000 2.
