Compliance Statements; Electromagnetic Compatibility (Emc) - CMF OL1000 SC Manual De Instrucciones

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 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 func-
tioning . 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 Stan-
dards (3V/meter EMI immunity, limit interference level to 0 . 0 014 V/
meter) .
18