FujiFilm Sonosite PX System, Руководство по обслуживанию

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16 Chapter 3: Safety
Clinical safety
WARNING:
To avoid injury, inspect all fasteners and connections.
WARNING:
Fujifilm Sonosite does not recommend the use of high-frequency
electromedical devices in proximity to its systems. Fujifilm Sonosite equipment
has not been validated for use with high-frequency electrosurgical devices or
procedures. Use of high-frequency electrosurgical devices in proximity to its
systems may lead to abnormal system behavior or shutdown of the system. To
avoid the risk of a burn hazard, do not use the transducer with high frequency
surgical equipment. Such a hazard may occur in the event of a defect in the
high frequency surgical neutral electrode connection.
WARNING: The maximum temperature of the transducer scan head may be greater than
41 °C (105.8 °F), but is less than 43 °C (109.4 °F) when in contact with the
patient. Special precautions should be considered when using the transducer
on children or on other patients who are sensitive to higher temperatures.
WARNING:
Do not use the system if it exhibits erratic or inconsistent behavior.
Discontinuities in the scanning sequence are indicative of a hardware failure
that must be corrected before use.
WARNING: Some transducer sheaths contain natural rubber latex and talc, which can
cause allergic reactions in some individuals. Fujifilm Sonosite recommends
identifying your latex- and talc-sensitive patients and being prepared to treat
allergic reactions promptly.
WARNING: Perform ultrasound procedures prudently. Use the ALARA (as low as
reasonably achievable) principle and follow the prudent use information
concerning MI and TI.
WARNING: Fujifilm Sonosite does not currently recommend a specific brand of acoustic
standoff. If an acoustic standoff is used, it must have a minimum attenuation
of .3dB/cm/MHz.
WARNING: Use market-cleared, sterile transducer sheaths and sterile coupling gel for
transrectal, transvaginal, or guided-needle procedures. Do not apply the
transducer sheath and coupling gel until you are ready to perform the
procedure. After use, remove and discard the single-use sheath, and clean and
disinfect the transducer using a Fujifilm Sonosite recommended disinfectant.
WARNING: To avoid injury or reduce the risk of infection to the patient, observe the
following:
• Follow Universal Precautions when inserting and maintaining a medical
device for interventional procedures.
• Appropriate training in interventional procedures as dictated by current
relevant medical practices as well as in proper operation of the ultrasound
system and transducer is required. During vascular access, the potential
exists for serious complications including without limitation the following:
pneumothorax, arterial puncture, and guidewire misplacement.
WARNING:
To avoid applying unsafe voltage levels to the patient while a device is
connected to the digital video out port, do not touch the ultrasound system
and the patient simultaneously. Check the electrical safety of your system with
a trained biomedical engineer.