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GE Logiq 9 User Manual

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    							Safety Precautions
    LOGIQ E9 User Guide 4-9
    Direction 5180302-100 Rev. 1
    Related Hazards (continued)
    CAUTIONThis equipment provides no special means of protection from 
    high frequency (HF) burns that may result from using an 
    electrosurgical unit (ESU).  To reduce the risk of HF burns, 
    avoid contact between the patient and ultrasound transducer 
    while operating the ESU.  Where contact cannot be avoided, as 
    in the case of TEE monitoring during surgery, make sure the 
    transducer is not located between the ESU active and 
    dispersive electrodes and keep the ESU cables away from the 
    transducer cable.
    Electrical
    HazardTo avoid injury:
    •  Do not remove protective covers. No user serviceable 
    parts are inside. Refer servicing to qualified service 
    personnel.
    •  To assure adequate grounding, connect the attachment 
    plug to a reliable (hospital grade) grounding outlet (having 
    equalization conductor   ).
    •  Never use any adaptor or converter of a three-prong-to-
    two-prong type to connect with a mains power plug. The 
    protective earth connection will loosen.
    •  Do not place liquids on or above the console. Spilled liquid 
    may contact live parts and increase the risk of shock.
    •  In North America a 220V installation requires the use of a 
    center-tapped AC source. 
    CAUTIONDo not use this equipment if a safety problem is known to exist. 
    Have the unit repaired and performance verified by qualified 
    service personnel before returning to use.
    Smoke &
    Fire HazardThe system must be supplied from an adequately rated 
    electrical circuit. The capacity of the supply circuit must be as 
    specified. 
    						
    							Safety
    4-10 LOGIQ E9 User Guide
    Direction 5180302-100 Rev. 1
    Related Hazards (continued)
    Biological
    HazardFor patient and personnel safety, be aware of biological 
    hazards while performing invasive procedures. To avoid the 
    risk of disease transmission:
    •  Use protective barriers (gloves and probe sheaths) 
    whenever possible. Follow sterile procedures when 
    appropriate.
    •  Thoroughly clean probes and reusable accessories after 
    each patient examination and disinfect or sterilize as 
    needed. Refer to  Probes and Biopsy for probe use and 
    care instructions.
    •  Follow all infection control policies established by your 
    office, department or institution as they apply to personnel 
    and equipment.
    CAUTIONContact with natural rubber latex may cause a severe 
    anaphylactic reaction in persons sensitive to the natural latex 
    protein. Sensitive users and patients must avoid contact with 
    these items. Refer to package labeling to determine latex 
    content and FDA’s March 29, 1991 Medical Alert on latex 
    products.
    CAUTIONAllowing the machine to transmit acoustic output with the probe 
    not in use (or in its holder) can cause the transducer to build up 
    heat. Always turn off lower acoustic output or freeze the image 
    when not in use. The system’s acoustic output remains 
    transmitting when the user controls are being used.
    The system is equipped with an Auto Freeze feature which 
    disables acoustic output and freezes the image when the 
    machine is not in use.  
    						
    							Safety Precautions
    LOGIQ E9 User Guide 4-11
    Direction 5180302-100 Rev. 1
    Related Hazards (continued)
    CAUTIONWhen you move the Control Panel up/down with the monitor, 
    place BOTH hands on the Control Panel.  Touching other 
    moving parts other than the Control Panel may cause personal 
    injury.
    CAUTIONTo avoid injury or system damage, NEVER place any object or 
    liquid on the operator panel.
    CAUTIONArchived data is managed at the individual sites. Performing 
    data backup (to any device) is recommended.
    CAUTION•  Make sure to verify the media after writing of data, such as 
    EZBackup, SaveAs or Export.     
    •  Before deleting a patient or image from the patient screen, 
    make sure you have saved the data by EZBackup/Backup 
    or Export and verify that the media transfer of data was 
    successful.  
    CAUTIONDo not unpack the LOGIQ E9. This must be performed by 
    qualified service personnel only. 
    						
    							Safety
    4-12 LOGIQ E9 User Guide
    Direction 5180302-100 Rev. 1
    Related Hazards (continued)
    Material Safe Data
    Rubber partMaterial: EPDM
    Where Used: Probe holder/Gel holder/Keyboard bumper/Front 
    and Rear Foot Pedal/System bumper at the four corners
    CAUTIONTo minimize accidental loss of data, perform EZBackup and 
    Backup on a regular basis.
    1.  First, perform EZBackup to save the images.
    2.  Next, perform Backup at Utility -> Backup/Restore. Enable 
    the following checkboxes under Backup:
    • Patient Archive
    • Report Archive
    • User defined configuration
    • Service
    CAUTIONDO NOT load non-system software on the system computer.  
    						
    							Safety Precautions
    LOGIQ E9 User Guide 4-13
    Direction 5180302-100 Rev. 1
    Related Hazards (LCD Monitor)
    Related Hazards (Volume Navigation)
    CAUTION• DO NOT place a finger, hand or any object on the joint of 
    the monitor or monitor arm to avoid injury when moving the 
    monitor and monitor arm.
    •  To avoid result of injury or system damage, NEVER place 
    any object or liquid on the monitor, whether in the home or 
    flip down/transport position.
    • DO NOT scratch or press on the panel with any sharp 
    objects, such as a pencil or pen, as this may result in 
    damage to the panel.
    •  To avoid injury or damage, make sure nothing is within the 
    range of motion before moving the monitor and monitor 
    arm. This includes both objects and people.
    •  Pay attention to the monitor arm position to avoid hitting it 
    against anyone or anything.
    •  Before moving the system to another location, be sure to 
    lock LCD/LCD arm in transport position. 
    •  The LCD screen may have defective pixels. These pixels 
    may appear as a slightly light or dark area on the screen. 
    This is due to the characteristics of the panel itself, and not 
    the product. 
    •  The backlight of the LCD panel has a fixed life span. When 
    the screen becomes dark or begins to flicker, contact a 
    qualified Service Representative for information. 
    WARNINGDO NOT use the Volume Navigation feature on any patient 
    relying on life-sustaining electronic equipment, such as a 
    pacemaker or defibrillator. 
    						
    							Safety
    4-14 LOGIQ E9 User Guide
    Direction 5180302-100 Rev. 1
    Device Labels
    Label Icon Description
    The following table describes the purpose and location of safety 
    labels and other important information provided on the 
    equipment.
    Table 4-2:  Label Icons
    Label/IconPurpose/MeaningLocation
    Identification and Rating Plate • Manufacturer’s name and country of 
    origin
    • Date of manufacture
    • Model and serial numbers
    • Electrical ratings (Volts, Amps, 
    phase, and frequency)See ‘Warning Label Locations’ 
    on page 4-34 for more 
    information.
    Type/Class Label Used to indicate the degree of safety 
    or protection.Rear panel
    Type BF Applied Part (man in the box) 
    symbol is in accordance with IEC 
    60417-5333.Probe
    Type BF Applied Part (man in the box 
    with paddle) symbol is in accordance 
    with IEC 60417-5334.Probe
    Type CF Applied Part (heart in the 
    box) symbol is in accordance with IEC 
    60878-02-03.Probe
    Type CF Defib-Proof Applied Part 
    (heart in the box with paddle) symbol 
    is in accordance with IEC 60878-02-
    06.Probe
    “ATTENTION” - Consult 
    accompanying documents” is intended 
    to alert the user to refer to the operator 
    manual or other instructions when 
    complete information cannot be 
    provided on the label.Control panel and inside of 
    console
    “General Warning Sign” Rear panel and UPS battery 
    						
    							Safety Precautions
    LOGIQ E9 User Guide 4-15
    Direction 5180302-100 Rev. 1
    “Warning” - Dangerous voltage” (the 
    lightning flash with arrowhead) is used 
    to indicate electric shock hazards.Rear panel and inside of 
    console
    “Mains OFF” indicates the power off 
    position of the mains power breaker.See the Console Overview 
    section for location 
    information.
    “Mains ON” indicates the power on 
    position of the mains power breaker.See the Console Overview 
    section for location 
    information.
    “ON” indicates the power on position 
    of the power switch.
    CAUTION: This Power Switch DOES 
    NOT ISOLATE Mains Supply.
    “Standby” indicates the power standby 
    position of the power switch.
    CAUTION: This Power Switch DOES 
    NOT ISOLATE Mains Supply.See the Console Overview 
    section for location 
    information.
    “Protective Earth” indicates the 
    protective earth (grounding) terminal.Internal
    “Equipotentiality” indicates the 
    terminal to be used for connecting 
    equipotential conductors when 
    interconnecting (grounding) with other 
    equipment.
    Connection of additional protective 
    earth conductors or potential 
    equalization conductors is not 
    necessary in most cases and is only 
    recommended for situations involving 
    multiple equipment in a high-risk 
    patient environment to provide 
    assurance that all equipment is at the 
    same potential and operates within 
    acceptable leakage current limits.  An 
    example of a high-risk patient would 
    be a special procedure where the 
    patient has an accessible conductive 
    path to the heart such as exposed 
    cardiac pacing leads. IEC60417-5021Rear of console
    Alternating Current symbol is in 
    accordance with IEC 60878-01-14.Rear Panel, Rating Plate, 
    Circuit breaker label of console 
    and front panel (if applicable).
    Table 4-2:  Label Icons (Continued)
    Label/IconPurpose/MeaningLocation 
    						
    							Safety
    4-16 LOGIQ E9 User Guide
    Direction 5180302-100 Rev. 1
    This symbol indicates that waste 
    electrical and electronic equipment 
    must not be disposed of as unsorted 
    municipal waste and must be collected 
    separately. Please contact an 
    authorized representative of the 
    manufacturer for information 
    concerning the decommissioning of 
    your equipment.Rear Panel
    DO NOT place a finger, hand or any 
    object below the operator panel on the 
    top cover of the console to avoid injury 
    while you’re moving it up and down.On the movable up/down 
    operator control panel to 
    caution users to not place their 
    hands in this location while 
    lowering the operator panel.
     
    GOST Symbol. Russia Regulatory 
    Country Clearance. Rear Panel
    This product consists of devices that 
    may contain mercury, which must be 
    recycled or disposed of in accordance 
    with local, state, or country laws. 
    Within this system the backlight lamps 
    in the monitor display contain mercury. Rear Panel
    ETL Listing Mark Monogram Rear Panel
    ISO 7010 - P007
    Volume Navigation Pacemaker 
    WarningV Nav Trasmitter
    Table 4-2:  Label Icons (Continued)
    Label/IconPurpose/MeaningLocation 
    						
    							Safety Precautions
    LOGIQ E9 User Guide 4-17
    Direction 5180302-100 Rev. 1
    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)
    Continuous Operation
    System is Ordinary Equipment (IPX0)
    *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 BF 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 4-3:  Type BF Equipment
    Normal Mode Single fault condition
    Patient leakage current Less than 100 microA Less than 500 microA
    Table 4-4:  Type CF Equipment
    Normal Mode Single fault condition
    Patient leakage current Less than 10 microA Less than 50 microA 
    						
    							Safety
    4-18 LOGIQ E9 User Guide
    Direction 5180302-100 Rev. 1
    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. 
    						
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