Cautions
Note
6
Medical electrical equipment requires special precautions regarding EMC and
must be installed and operated according to these instructions. Portable RF
communications equipment (including peripherals, such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part
of the ultrasound system, including cables specified by FUJIFILM SonoSite.
Portable and mobile RF communications equipment can affect the ultrasound
system. Electromagnetic interference (EMI) from other equipment or interference
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).
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
devices susceptible to EMI.
Share relevant EMI information with others, particularly when evaluating new
equipment purchases which may generate EMI.
Purchase medical devices that comply with IEC 60601-1-2 EMC Standards.
Do not stack other equipment on the ultrasound system or use other equipment
in close proximity and adjacent to the ultrasound system. If stacking or using
other equipment in close proximity is unavoidable, then you must observe the
system to verify normal operation.
The emissions characteristics of the SonoSite M-Turbo ultrasound system make it
suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a
residential environment (for which CISPR 11 class B is normally required), the
ultrasound system might not offer adequate protection to radio-frequency
communication services. It may be necessary to take mitigation measures, such as
relocating or reorienting the equipment.
Electromagnetic compatibility