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GE Logiq P5 User Manual

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    							Safety Precautions
    LOGIQ 5 Basic User Manual 2-13
    Direction 2300002-100 Rev. 2
    Label Icon Description (continued)
    ClassificationsType of protection against electric shock
    Class I Equipment (*1)
    Degree of protection against electric shock
    Type BF Applied part (*2)
     (for PCG, Probes marked with BF symbol)
    Type CF Applied part (*3) (for ECG marked with CF symbol)
    Continuous Operation
    System is Ordinary Equipment (IPX0)
    Footswitch is IPX8
    *1. Class I Equipment
    EQUIPMENT in which protection against electric shock does not 
    rely on BASIC INSULATION only, but includes an earth ground. 
    This additional safety precaution prevents exposed metal parts 
    from becoming LIVE in the event of an insulation failure.
    *2. Type BF Applied Part
    TYPE B APPLIED PART providing a specified degree of 
    protection against electric shock, with particular regard to 
    allowable LEAKAGE CURRENT.
    *3. Type CF Applied Part
    TYPE CF APPLIED PART providing a degree of protection 
    higher than that for Type BF Applied Part against electric shock 
    particularly regarding allowable LEAKAGE CURRENTS.Table 2-3: Type BF Equipment
    Normal Mode Single fault condition
    Patient leakage current Less than 100 microA Less than 500 microA
    Table 2-4: Type CF Equipment
    Normal Mode Single fault condition
    Patient leakage current Less than 10 microA Less than 50 microA 
    						
    							Safety
    2-14 LOGIQ 5 Basic User Manual
    Direction 2300002-100 Rev. 2
    EMC (Electromagnetic Compatibility)
    NOTE:  This equipment generates, uses and can radiate radio 
    frequency energy. The equipment may cause radio frequency 
    interference to other medical and non-medical devices and radio 
    communications. To provide reasonable protection against such 
    interference, this product complies with emissions limits for a 
    Group 1, Class A Medical Devices Directive as stated in EN 
    60601-1-2. However, there is no guarantee that interference will 
    not occur in a particular installation.
    NOTE:  If this equipment is found to cause interference (which may be 
    determined by turning the equipment on and off), the user (or 
    qualified service personnel) should attempt to correct the 
    problem by one or more of the following measure(s):
    • reorient or relocate the affected device(s)
    • increase the separation between the equipment and the 
    affected device
    • power the equipment from a source different from that of the 
    affected device
    • consult the point of purchase or service representative for 
    further suggestions.
    NOTE:  The manufacturer is not responsible for any interference caused 
    by using other than recommended interconnect cables or by 
    unauthorized changes or modifications to this equipment. 
    Unauthorized changes or modifications could void the users’ 
    authority to operate the equipment.
    NOTE:  To comply with the regulations on electromagnetic interference 
    for a Class A FCC Device, all interconnect cables to peripheral 
    devices must be shielded and properly grounded. Use of cables 
    not properly shielded and grounded may result in the equipment 
    causing radio frequency interference in violation of the FCC 
    regulations. 
    						
    							Safety Precautions
    LOGIQ 5 Basic User Manual 2-15
    Direction 2300002-100 Rev. 2
    EMC (Electromagnetic Compatibility) (continued)
    NOTE:  Do not use devices which intentionally transmit RF Signals 
    (cellular phones, transceivers, or radio controlled products) in 
    the vicinity of the equipment as it may cause performance 
    outside the published specifications. Keep the power to these 
    type devices turned off when near this equipment.
    The medical staff in charge of this equipment is required to 
    instruct technicians, patients, and other people who maybe 
    around this equipment to fully comply with the above 
    requirement.
    EMC Performance
    All types of electronic equipment may characteristically cause 
    electromagnetic interference with other equipment, either 
    transmitted through air or connecting cables. The term EMC 
    (Electromagnetic Compatibility) indicates the capability of 
    equipment to curb electromagnetic influence from other 
    equipment and at the same time not affect other equipment with 
    similar electromagnetic radiation from itself.
    Proper installation following the service manual is required in 
    order to achieve the full EMC performance of the product.
    The product must be installed as stipulated in 4.2, Notice upon 
    Installation of Product.
    In case of issues related to EMC, please call your service 
    personnel.
    The manufacturer is not responsible for any interference caused 
    by using other than recommended interconnect cables or by 
    unauthorized changes or modifications to this equipment. 
    Unauthorized changes or modifications could void the users’ 
    authority to operate the equipment.  
    						
    							Safety
    2-16 LOGIQ 5 Basic User Manual
    Direction 2300002-100 Rev. 2
    EMC Performance (continued)
    Portable and mobile radio communications equipment (e.g. two-
    way radio, cellular/cordless telephones, wireless computer 
    networks) should be used no closer to any part of this system, 
    including cables, than determined according to the following 
    method: 
    CAUTIONDo not use devices which intentionally transmit RF signals 
    (cellular phones, transceivers, or radio controlled products) in 
    the vicinity of this equipment as it may cause performance 
    outside the published specifications. Keep the power to these 
    type devices turned off when near this equipment.
    Keep power to these devices turned off when near this 
    equipment.
    Medical staff in charge of this equipment is required to instruct 
    technicians, patients and other people who may be around this 
    equipment to fully comply with the above regulation.
    Table 2-5: Portable and mobile radio communications equipment distance requirements
    Frequency Range: 150 kHz - 80 MHz 80 MHz - 800 MHz 800 MHz - 2.5 GHz
    Calculation Method: d=[3.5/V
    1] square root 
    of Pd = [3.5/E1] square root 
    of Pd = [7/E1] square root of 
    P
    Where: d= separation distance in meters, P = rated power of the transmitter, V
    1=compliance value for 
    conducted RF, E
    1 = compliance value for radiated RF
    If the maximum 
    transmitter power in 
    watts is ratedThe separation distance in meters should be
    5 2.6 2.6 5.2
    20 5.2 5.2 10.5
    100 12.0 12.0 24.0 
    						
    							Safety Precautions
    LOGIQ 5 Basic User Manual 2-17
    Direction 2300002-100 Rev. 2
    Notice upon Installation of Product
    Separation distance and effect from fixed radio communications 
    equipment: field strengths from fixed transmitters, such as base 
    stations for radio (cellular/cordless) telephones and land mobile 
    radios, amateur radio, AM and FM radio broadcast, and TV 
    broadcast transmitter cannot be predicted theoretically with 
    accuracy. To assess the electromagnetic environment due to 
    fixed RF transmitters, an electromagnetic site survey should be 
    considered. If the measured field strength in the location in 
    which the ultrasound system is used exceeds the applicable RF 
    compliance level as stated in the immunity declaration, the 
    ultrasound system should be observed to verify normal 
    operation. If abnormal operation is observed, additional 
    measures may be necessary, such as re-orienting or relocating 
    the ultrasound system or using an RF shielded examination 
    room may be necessary.
    1.  Use either power supply cords provided by GE Medical 
    Systems or ones designated by GE Medical Systems. 
    Products equipped with a power source plug should be 
    plugged into the fixed power socket which has the protective 
    grounding conductor. Never use any adaptor or converter to 
    connect with a power source plug (e.g. three-prong-to-two-
    prong converter).
    2.  Locate the equipment as far away as possible from other 
    electronic equipment.
    3.  Be sure to use only the cables provided by or designated by 
    GE Medical Systems. Connect these cables following the 
    installation procedures (e.g. wire power cables separately 
    from signal cables).
    4.  Lay out the main equipment and other peripherals following 
    the installation procedures described in the Option 
    Installation manuals. 
    						
    							Safety
    2-18 LOGIQ 5 Basic User Manual
    Direction 2300002-100 Rev. 2
    General Notice
    1.  Designation of Peripheral Equipment Connectable to This 
    Product.
    The equipment indicated in Chapter 13 can be hooked up to 
    the product without compromising its EMC performance.
    Avoid using equipment not designated in the list. Failure to 
    comply with this instruction may result in poor EMC 
    performance of the product.
    2.  Notice against User Modification
    The user should never modify this product. User 
    modifications may cause degradation in EMC performance.
    Modification of the product includes changes in:
    a.  Cables (length, material, wiring, etc.)
    b. System installation/layout
    c. System configuration/components
    d.  Securing system parts (cover open/close, cover 
    screwing)
    3.  Operate the system with all covers closed. If a cover is 
    opened for some reason, be sure to shut it before starting/
    resuming operation.
    4.  Operating the system with any cover open may affect EMC 
    performance. 
    						
    							Safety Precautions
    LOGIQ 5 Basic User Manual 2-19
    Direction 2300002-100 Rev. 2
    Peripheral Update for EC countries
    The following is intended to provide the users in EC countries 
    with updated information concerning the connection of the 
    LOGIQ 5 to image recording and other devices or 
    communication networks.
    The LOGIQ 5 has been verified for overall safety, compatibility 
    and compliance with the following on-board image recording 
    devices:
    •  Sony UP 895 MDW B&W Video Printer
    •  Mitsubishi P91E B&W Printer
    •  Sony UP2850P Color Video Printer
    •  Sony UP21MD Color Video Printer
    •  Sony UP51MD Color Video Printer
    •  Mitsubishi CP900E Color Video Printer
    •  Sony SVO9500MD Video Cassette Reorder
    The LOGIQ 5 has also been verified for compatibility, and 
    compliance for connection to a local area network (LAN) via the 
    rear panel Ethernet connection, provided the LAN components 
    are IEC/EN 60950 compliant. See ‘Assistance’ for more 
    information.
    Connection may also be made to a CE Marked and IEC/
    EN 60950 compliant modem using one of the serial ports at the 
    rear panel.
    The LOGIQ 5 may also be used safely while connected to 
    devices other than those recommended above if the devices 
    and their specifications, installation, and interconnection with the 
    system conform to the requirements of IEC/EN 60601-1-1. 
    						
    							Safety
    2-20 LOGIQ 5 Basic User Manual
    Direction 2300002-100 Rev. 2
    Peripheral Update for EC countries (continued)
    General precautions for installing an alternate on-board device 
    would include:
    1.  The added device must have appropriate safety standard 
    conformance and CE Marking.
    2.  The total power consumption of the added devices, which 
    connect to the LOGIQ 5 and are used simultaneously, must 
    be less than or equal to the rated supply of the LOGIQ 5.
    3.  There must be adequate heat dissipation and ventilation to 
    prevent overheating of the device.
    4.  There must be adequate mechanical mounting of the device 
    and stability of the combination.
    5.  Risk and leakage current of the combination must comply 
    with IEC/EN 60601-1.
    6.  Electromagnetic emissions and immunity of the combination 
    must conform to IEC/EN 60601-1-2.
    General precautions for installing an alternate off-board, remote 
    device or a network would include:
    1.  The added device(s) must have appropriate safety standard 
    conformance and CE Marking.
    2.  The added device(s) must be used for their intended 
    purpose having a compatible interface.
    3.  Signal or mains isolation devices and additional protective 
    earth may be needed to assure compliance with IEC/
    EN 60601-1-1. 
    CAUTIONThe connection of equipment or transmission networks other 
    than as specified in the user instructions can result in an 
    electric shock hazard or equipment malfunction. Substitute or 
    alternate equipment and connections requires verification of 
    compatibility and conformity to IEC/EN 60601-1-1 by the 
    installer. Equipment modifications and possible resulting 
    malfunctions and electromagnetic interference are the 
    responsibility of the owner. 
    						
    							Safety Precautions
    LOGIQ 5 Basic User Manual 2-21
    Direction 2300002-100 Rev. 2
    Declaration of Emissions
    This system is suitable for use in the following environment. The 
    user must assure that it is used only in the electromagnetic 
    environment as specified. 
    Table 2-6: Declaration of Emissions
    Emission TypeComplianceElectromagnetic Environment
    CISPR 11 
    RF EmissionsGroup 1 
    Class AThis system uses RF energy only for its internal function. 
    Therefore, RF emissions are very low and are not likely to cause 
    any interference in nearby electronic equipment. It is suitable for 
    use in all establishments, other than domestic establishments 
    and those directly connected to the public low-voltage power 
    supply network that supplies buildings used for domestic 
    purposes.  
    						
    							Safety
    2-22 LOGIQ 5 Basic User Manual
    Direction 2300002-100 Rev. 2
    Declaration of Immunity
    This system is suitable for use in the following environment. The 
    user must assure that the system is used according to the 
    specified guidance and only in the electromagnetic environment 
    listed.
    Table 2-7: Declaration of Immunity
    Immunity TypeTest LevelComplianceEMC Environment and Guidance
    IEC 61000-4-2
    Static discharge
    (ESD)± 6 kV contact
    ± 8 kV air± 6 kV contact
    ± 8 kV airFloors should be wood, concrete, or 
    ceramic tile. If floors are covered with 
    synthetic material, the relative humidity 
    should be at least 30%.
    Mains power quality should be that of a 
    typical commercial and/or hospital 
    environment. If the user requires 
    continued operation during power mains 
    interruptions, it is recommended that the 
    system be powered from a UPS or a 
    battery.
    NOTE: UT is the a.c. mains voltage prior 
    to application of the test level.
    Power frequency magnetic fields should 
    be at levels characteristic of a typical 
    location in a typical commercial and/or 
    hospital environment.
    Separation distance to radio 
    communication equipment must be 
    maintained according to the method 
    below. Interference may occur in the 
    vicinity of equipment marked with the 
    symbol:  IEC 61000-4-4
    Electrical fast
    transient/burst± 2 kV for mains
    ± 1 kV for SIP/
    SOP± 2 kV for mains
    ± 1 kV for SIP/
    SOP
    IEC 61000-4-5 
    Surge Immunity± 1 kV differential
    ± 2 kV common± 1 kV differential
    ± 2 kV common
    IEC 61000-4-11
    Voltage dips, 
    short interruptions 
    and voltage 
    variations on 
    mains supply< 50
    T (> 95% dip) 
    for 0.5 cycle;
    400
    T (60 0ip) for 5 
    cycles;
    700
    T (30 0ip) for 
    25 cycles;
    < 50
    T (>95% dip) 
    for 5 sec< 50
    T (> 95% dip) 
    for 0.5 cycle;
    400
    T (60 0ip) for 5 
    cycles;
    700
    T (30 0ip) for 
    25 cycles;
    < 50
    T (>95% dip) 
    for 5 sec
    IEC 61000-4-8
    Power frequency 
    (50/60 Hz) 
    magnetic field3 A/m 3 A/m
    IEC 61000-4-6
    Conducted RF3 V
    RMS150 kHz - 80 MHz3 VRMS150 kHz - 80 MHz
    IEC 61000-4-3
    Radiated RF3 V/m
    80 MHz - 2.5 GHz3 V/m
    80 MHz - 2.5 GHz
    NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by 
    absorption and reflection from structures, objects, and people. 
    						
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