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.