Electromagnetic Compatibility (Emc) - CMF OL1000 Instructions D'utilisation

EN
Compliance Statements

Electromagnetic Compatibility (EMC)

The Bone Growth Stimulator has been tested and found to comply
with the electromagnetic compatibility (EMC) limits for medical de-
vices to IEC 60601-1-2 . These limits are designed to provide reasonable
protection against harmful interference in a typical medical installa-
tion .
Caution: 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 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 of disruption, and
take the following actions to eliminate the source(s) .
• Turn equipment in the vicinity off and on to isolate disruptive equip-
ment .
• Relocate or reorient interfering equipment .
• Increase distance between interfering equipment and your system .
• Manage use of frequencies close to the system frequencies .
• Remove devices that are highly susceptible to EMI .
• Lower power from internal sources within the 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 evalu-
ating new equipment purchases which may generate EMI .
• Purchase medical devices that comply with IEC 60601-1-2 EMC
Standards (3V/meter EMI immunity, limit interference level to 0 .0014
V/meter) .
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