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Compliance Statements
Electromagnetic Compatibility (EMC)
The VenaFlow Elite 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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