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.