GE Logiq P5 User Manual
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Safety Precautions LOGIQ 5 Basic User Manual 2-3 Direction 2300002-100 Rev. 2 Hazard Symbols Icon Description Potential hazards are indicated by the following icons: Table 2-1: Potential Hazards IconPotential HazardUsageSource • Patient/user infection due to contaminated equipment.• Cleaning and care instructions • Sheath and glove guidelinesISO 7000 No. 0659 • Electrical micro-shock to patient, e.g., ventricular• Probes • ECG • Connections to back panel • Console, accessories or optional storage devices that can fall on patient, user, or others. • Collision with persons or objects may result in injury while maneuvering or during system transport. • Injury to user from moving the console.• Moving • Using brakes • Transporting • Patient injury or tissue damage from ultrasound radiation.• ALARA, the use of Power Output following the ‘as low as reasonably achievable’ principle • Risk of explosion if used in the presence of flammable anesthetics.• Flammable anesthetic • Patient/user injury or adverse reaction from fire or smoke. • Patient/user injury from explosion and fire.• Replacing fuses • Outlet guidelines
Safety 2-4 LOGIQ 5 Basic User Manual Direction 2300002-100 Rev. 2 Important Safety Considerations The following topic headings (Patient Safety, and Equipment and Personnel Safety) are intended to make the equipment user aware of particular hazards associated with the use of this equipment and the extent to which injury can occur if precautions are not observed. Additional precautions may be provided throughout the manual. The equipment user is obligated to be familiar with these concerns and avoid conditions that could result in injury. CAUTIONImproper use can result in serious injury. The user must be thoroughly familiar with the instructions and potential hazards involving ultrasound examination before attempting to use the device. Training assistance is available from GE Medical Systems if needed.
Safety Precautions LOGIQ 5 Basic User Manual 2-5 Direction 2300002-100 Rev. 2 Patient Safety Related Hazards Patient identificationAlways include proper identification with all patient data and verify the accuracy of the patients name or ID numbers when entering such data. Make sure correct patient ID is provided on all recorded data and hard copy prints. Identification errors could result in an incorrect diagnosis. Diagnostic informationEquipment malfunction or incorrect settings can result in measurement errors or failure to detect details within the image. The equipment user must become thoroughly familiar with the equipment operation in order to optimize its performance and recognize possible malfunctions. Applications training is available through the local GE representative. Added confidence in the equipment operation can be gained by establishing a quality assurance program. WARNINGThe concerns listed can seriously affect the safety of patients undergoing a diagnostic ultrasound examination. 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 acoustic output or freeze the image when not in use. The system’s acoustic output remains transmitting when the user controls are being used.
Safety 2-6 LOGIQ 5 Basic User Manual Direction 2300002-100 Rev. 2 Related Hazards (continued) Mechanical hazardsThe use of damaged probes or improper use and manipulation of intracavity probes can result in injury or increased risk of infection. Inspect probes often for sharp, pointed, or rough surface damage that could cause injury or tear protective barriers. Never use excessive force when manipulating intracavity probes. Become familiar with all instructions and precautions provided with special purpose probes. The use of damaged probes can result in injury or increased risk of infection. Inspect probes often for sharp, pointed, or rough surface damage that could cause injury or tear protective barriers. Become familiar with all instructions and precautions provided with special purpose probes. Electical HazardA damaged probe can also increase the risk of electric shock if conductive solutions come in contact with internal live parts. Inspect probes often for cracks or openings in the housing and holes in and around the acoustic lens or other damage that could allow liquid entry. Become familiar with the probes use and care precautions outlined in Probes and Biopsy. CAUTIONUltrasound transducers are sensitive instruments which can easily be damaged by rough handling. Take extra care not to drop transducers and avoid contact with sharp or abrasive surfaces. A damaged housing, lens or cable can result in patient injury or serious impairment or operation. CAUTIONUltrasound can produce harmful effects in tissue and potentially result in patient injury. Always minimize exposure time and keep ultrasound levels low when there is no medical benefit. Use the principle of ALARA (A s Low As Reasonably A chievable), increasing output only when needed to obtain diagnostic image quality. Observe the acoustic output display and be familiar with all controls affecting the output level. See the Bioeffects section of the Acoustic Output chapter in the Advanced Reference Manual for more information. CAUTIONDo not use with Defibrillator. This equipment does not have a defibrillator approved applied part.
Safety Precautions LOGIQ 5 Basic User Manual 2-7 Direction 2300002-100 Rev. 2 Related Hazards (continued) TrainingIt is recommended that all users receive proper training in applications before performing them in a clinical setting. Please contact the local GE representative for training assistance. ALARA training is provided by GE Application Specialists. The ALARA education program for the clinical end-user covers basic ultrasound principles, possible biological effects, the derivation and meaning of the indices, ALARA principles, and examples of specific applications of the ALARA principle.
Safety 2-8 LOGIQ 5 Basic User Manual Direction 2300002-100 Rev. 2 Equipment and Personnel Safety Related Hazards WARNINGThis equipment contains dangerous voltages that are capable of serious injury or death. If any defects are observed or malfunctions occur, stop operating the equipment and perform the proper action for the patient. Inform a qualified service person and contact a Service Representative for information. There are no user serviceable components inside the console. Refer all servicing to qualified service personnel only. WARNINGOnly approved and recommended peripherals and accessories should be used. All peripherals and accessories must be securely mounted to the LOGIQ 5. DANGERThe concerns listed below can seriously affect the safety of equipment and personnel during a diagnostic ultrasound examination. Explosion HazardRisk of explosion if used in the presence of flammable anesthetics. Electical 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. • Plug any peripherals into the LOGIQ 5 AC power outlet.
Safety Precautions LOGIQ 5 Basic User Manual 2-9 Direction 2300002-100 Rev. 2 Related Hazards (continued) 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, See ‘Before the system arrives’ for more information. 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 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 2-10 LOGIQ 5 Basic User Manual Direction 2300002-100 Rev. 2 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. CAUTIONNever put any device onto the monitor. CAUTIONArchived data is managed at the individual sites. Performing data backup (to any device) is recommended. CAUTIONDo not unpack the LOGIQ 5. This must be performed by qualified service personnel only. CAUTIONDo not use the LOGIQ 5 Ultrasound system ECG wave for diagnosis and monitoring.
Safety Precautions LOGIQ 5 Basic User Manual 2-11 Direction 2300002-100 Rev. 2 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 2-2: Label Icons Label/IconPurpose/MeaningLocation Identification and Rating Plate • Manufacture’s name and address • Date of manufacture • Model and serial numbers • Electrical ratings (Volts, Amps, phase, and frequency)See Figure 2-4 for location information. Type/Class Label Used to indicate the degree of safety or protection. IP Code (IPX8) Indicates the degree of protection provided by the enclosure per IEC60 529. Can be used in operating room environment.Footswitch Type BF Applied Part (man in the box) symbol is in accordance with IEC 878- 02-03.Probe and PCG marked Type BF Type CF Applied Part (heart in the box) symbol is in accordance with IEC 878-02-03.ECG marked Type CF “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.Various “CAUTION” - Dangerous voltage” (the lightning flash with arrowhead) is used to indicate electric shock hazards.Inside of console “Mains OFF” indicates the power off position of the mains power breaker.See Figure 3-16 for location information. “Mains ON” indicates the power on position of the mains power breaker.See Figure 3-16 for location information.
Safety 2-12 LOGIQ 5 Basic User Manual Direction 2300002-100 Rev. 2 “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 Figure 3-11 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.Rear of console Table 2-2: Label Icons Label/IconPurpose/MeaningLocation