Compliance Statements; Electromagnetic Compatibility (Emc) - CMF SpinaLogic Manuel

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Compliance Statements

Electromagnetic Compatibility (EMC)

The Bone Growth Stimulator has been tested and found to comply with
the electromagnetic compatibility (EMC) limits for medical devices to IEC
60601-1-2 . These limits are designed to provide reasonable protection
against harmful interference in a typical medical installation .
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
equipment .
• 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
evaluating 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 . 0 014 V/
meter) .
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