U60 Diagnostic Ultrasound System User Manual Safety Guidance
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WARNING
37. EDAN makes every effort to manufacture safe and effective probes. You must take
all necessary precautions to eliminate the possibility of exposing patients, operators,
or third parties to hazardous or infectious materials. These precautions should be
considered in the use of any application that may indicate the need for such care and
during endocavity scanning.
38. If the liquid crystal material leaks from the panel, it should be kept away from the eye
or mouth. In case of contact with hands, skin or clothes, it has to be washed away
thoroughly with soap.
39. EMI Limitations
Ultrasound machines are susceptible to Electromagnetic Interference (EMI) from
radio frequencies, magnetic fields, and transients in the air of wiring. Ultrasound
machines also generate EMI. The U60 complies with limits as stated on the EMC
label. However, there is no guarantee that interference will not occur in a particular
installation.
Possible EMI sources should be identified before the unit is installed.
Electrical and electronic equipment may produce EMI unintentionally due to one of
the following defects: High frequency electrotome, Transformer, Defibrillator,
Wireless LAN equipment, Medical lasers, Scanners, Cauterizing guns, Computers,
Monitors, Fans, Gel warmers, Microwave ovens, Light dimmers, Portable phones
The presence of a broadcast station or broadcast van may also cause interference.
If you find strong interference shows on the screen, please check the sources.
40. Ultrasound may be harmful to the human body. This device should be used for valid
reasons, for the shortest period of time, and at the lowest mechanical and thermal
indices necessary to produce clinically acceptable images. According to the ALARA
(As Low As Reasonably Achievable) principles, the acoustic output should be set to
the lowest level required to satisfactorily perform the examination. Long time
exposure should be avoided. For the parameters of sound output, please refer to
appendix II. The U60 complies with the requirements of applicable International
Electrotechnical Commission (IEC) standards in terms of safety and acoustic output
levels.
41. Contact with natural rubber latex may lead to a severe anaphylactic reaction in
persons sensitive to the natural latex protein. Sensitive users and patients must
avoid contact with these items. EDAN strongly recommends that health-care
professionals identify their latex-sensitive patients, and refer to the March 29, 1991
Medical Alert on Latex products. Be prepared to treat allergic reactions immediately.
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