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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 o 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 sta 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 0.0014 V/meter).
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