GE Logiq 9 User Manual
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Safety Precautions LOGIQ E9 User Guide 4-19 Direction 5180302-100 Rev. 1 EMC (Electromagnetic Compatibility) (continued) NOTE: Do not use devices which intentionally transmit RF Signals (cellular phones, transceivers, or radio controlled products) other than those supplied by GE (wireless microphone, broadband over power lines, for example) 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 4-20 LOGIQ E9 User Guide Direction 5180302-100 Rev. 1 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), other than those supplied by GE (wireless microphone, broadband over power lines, for example) unless intended for use with this system, in the vicinity of this equipment as it may cause performance outside the published specifications. 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 4-5: 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 E9 User Guide 4-21 Direction 5180302-100 Rev. 1 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 4-22 LOGIQ E9 User Guide Direction 5180302-100 Rev. 1 General Notice 1. Designation of Peripheral Equipment Connectable to This Product. The equipment indicated in Chapter 18 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 E9 User Guide 4-23 Direction 5180302-100 Rev. 1 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 E9 to image recording and other devices or communication networks. The LOGIQ E9 has been verified for overall safety, compatibility and compliance with the following on-board image recording devices: • Sony UP-D897 Digital Printer • Sony UP-D23 Digital Printer • Sony UP-D55 Digital Printer • Canon PIXMA MP610 Digital Printer • DVR • Drive Bay (for Tru3D and Volume Navigation) • USB Flash Drive (Memory Stick) • Hard Disk Drive The LOGIQ E9 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. The LOGIQ E9 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 4-24 LOGIQ E9 User Guide Direction 5180302-100 Rev. 1 Peripheral Update for EC countries (continued) Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (i.e., IEC60950 for data processing equipment and IEC60601-1 for medical equipment). Furthermore, all complete configurations shall comply with the valid version of the system standard IEC60601-1-1. Everyone who connects additional equipment to the signal input part or signal output part of the LOGIQ E9 system configures a medical system, and is therefore responsible to ensure that the system complies with the requirements of the valid version of IEC60601-1-1. If in doubt, consult the technical service department or your local GE Healthcare representative. 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 E9 and are used simultaneously, must be less than or equal to the rated supply of the LOGIQ E9. 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 60601-1-1. 6. Electromagnetic emissions and immunity of the combination must conform to IEC/EN 60601-1-2.
Safety Precautions LOGIQ E9 User Guide 4-25 Direction 5180302-100 Rev. 1 Peripheral Update for EC countries (continued) 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 4-26 LOGIQ E9 User Guide Direction 5180302-100 Rev. 1 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 4-6: Declaration of Emissions Guidance and manufacturer’s declaration - electromagnetic emissions The system is intended for use in the electrmagnetic environment specified below. The user of the system should assure that it is used in such an environment. Emission TypeComplianceElectromagnetic Environment RF Emissions CISPR 11 Group 1 This system uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF Emissions CISPR 11 Class A This system 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, provided the following warning is heeded: WARNING: This system is intended for use by healthcare professionals only. This system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the system or shielding the location. Harmonic Emissions IEC 61000-3-2Class A Voltage Fluctuations/Flicker Emissions IEC 61000-3-3Complies
Safety Precautions LOGIQ E9 User Guide 4-27 Direction 5180302-100 Rev. 1 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.
Safety 4-28 LOGIQ E9 User Guide Direction 5180302-100 Rev. 1 Declaration of Immunity (continued) Table 4-7: Declaration of Immunity Immunity Type Equipment CapabilityRegulatory Acceptable LevelEMC Environment and Guidance IEC 61000-4-2 Static discharge (ESD) ± 9 kV contact ± 12 kV air± 9 kV contact ± 12 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 field6 A/m 6 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 IEC 61000-3-2 Harmonic Disturbance EmissionsIEC Limits 230Vac IEC 61000-3-3 Voltage Fluctuations EmissionsIEC Limits 230Vac 50Hz, 100Vac 50Hz NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. If noise generated from other electronic equipment is near the probe’s center frequency, noise may appear on the image. Good power line isolation is required.