to be a medical system. It is your responsibility to comply with IEC 60601-1
and test the system to those requirements. If you have questions, contact
your Philips representative.
• Do not use nonmedical peripherals, such as report printers, within 1.5 m
(5 ft) of a patient, unless the nonmedical peripherals receive power from
an isolated power outlet on the Philips ultrasound system, or from an
isolation transformer that meets medical safety standards, as defined by
standard IEC 60601-1.
• The system and patient-applied parts meet the standard IEC 60601-1.
Applied voltages exceeding the standard, although unlikely, may result in
electrical shock to the patient or operator.
• Connection of optional devices not supplied by Philips Ultrasound could
result in electrical shock. When such optional devices are connected to
your ultrasound system, ensure that the total system earth leakage current
does not exceed 500 µA, or in the United States, 300 µA.
• To avoid risk of electrical shock, do not use any transducer that has been
immersed beyond the specified cleaning or disinfection level. See the
"Transducer Care" section.
• To avoid risks of electrical shock and fire hazards, inspect the system power
cord and plug regularly. Ensure that they are not damaged in any way.
• Operating the system with physio input signals that are below the specified
minimum levels may cause inaccurate results. See the "Specifications" section.
• Electrosurgical units (ESUs) and other devices intentionally introduce radio
frequency electromagnetic fields or currents into patients. Because imaging
ultrasound frequencies are coincidentally in the radio frequency range,
ultrasound transducer circuits are susceptible to radio frequency
interference. While an ESU is in use, severe noise interferes with the
black-and-white image and completely obliterates the color image.
Concurrent failures in an ESU or other device and in the outer layer of the
TEE transducer shaft can cause electrosurgical currents to return along the
transducer conductors. This could burn the patient, and the ultrasound
system and the transducer could also be damaged. Be aware that a disposable
transducer cover provides no protective electrical insulation at ESU
frequencies.
31
iU22 User Manual
4535 614 45861
2
Safety
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