Electrical Safety
WARNING:
Biological Safety
WARNING:
Electromagnetic Compatibility (EMC)
The ultrasound system has been tested and found to comply with the electromagnetic compatibility
(EMC) limits for medical devices to IEC 60601-1-2:2001. These limits are designed to provide
reasonable protection against harmful interference in a typical medical installation.
Caution:
• Turn equipment in the vicinity off and on to isolate disruptive equipment.
• Relocate or re-orient interfering equipment.
• Increase distance between interfering equipment and your ultrasound system.
• Manage use of frequencies close to ultrasound system frequencies.
• Remove devices that are highly susceptible to EMI.
• Lower power from internal sources within facility control (such as paging systems).
• Label devices susceptible to EMI.
• Educate clinical staff to recognize potential EMI-related problems.
• Eliminate or reduce EMI with technical solutions (such as shielding).
• Restrict use of personal communicators (cell phones, computers) in areas with
• Share relevant EMI information with others, particularly when evaluating new
• Purchase medical devices that comply with IEC 60601-1-2 EMC Standards.
2
Chapter 2: Safety
To avoid the risk of electric shock and fire hazard, a multiple portable socket outlet
(MPSO) or extension cord should not be connected to the auxiliary mains socket
outlets on the SiteStand.
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.
Medical electrical equipment requires special precautions regarding EMC and must
be installed and operated according to these instructions. It is possible that high
levels of radiated or conducted radio-frequency electromagnetic interference (EMI)
from portable and mobile RF communications equipment or other strong or nearby
radio-frequency sources, could result in performance disruption of the ultrasound
system. Evidence of disruption may include image degradation or distortion, erratic
readings, equipment ceasing to operate, or other incorrect functioning. If this
occurs, survey the site to determine the source of disruption, and take the following
actions to eliminate the source(s).
devices susceptible to EMI.
equipment purchases which may generate EMI.