Electrical Safety - FujiFilm SonoSite M-Turbo User Manual

Electrical safety

This system meets EN60601‐1, Class I/internally‐powered equipment requirements and Type
BF and Type CF isolated patient‐applied parts safety requirements.
This system complies with the applicable medical equipment requirements published in the
Canadian Standards Association (CSA), European Norm Harmonized Standards, and
Underwriters Laboratories (UL) safety standards. See Chapter 8, "Specifications."
For maximum safety observe the following warnings and cautions.
WARNING:
98
To avoid discomfort or minor risk of patient injury, keep hot surfaces away from the
patient.
Under certain circumstances, the transducer connector and back of the display
enclosure can reach temperatures that exceed EN60601-1 limits for patient contact,
therefore only the operator shall handle the system. This does not include the
transducer face.
To avoid discomfort or minor risk of operator injury when handling the transducer
connector, the system should not be operated for more than 60 minutes
continuously in a live-scan mode (as opposed to freeze or sleep modes).
To avoid the risk of injury, do not operate the system in the presence of flammable
gasses or anesthetics. Explosion can result.
To avoid the risk of electrical shock or injury, do not open the system enclosures. All
internal adjustments and replacements, except battery replacement, must be made
by a qualified technician.
To avoid the risk of electrical shock, do not allow any part of the system (including
the bar code scanner, external mouse, power supply, power supply connector,
external keyboard, and so on), except for the transducer or ECG leads, to touch the
patient.