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COMPLIANCE STATEMENTS
ELECTROMAGNETIC COMPATIBILITY (EMC)
The VenaPro 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 0.0014 V/meter).
Electromagnetic Compatibility (EMC) Tables - RF Emissions Class A
ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES - RF
EMISSIONS CLASS B
GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC EMISSIONS
The VenaPro is intended for use in the electromagnetic environment specified below. The customer or the user of the VenaPro should assure that it is used in such an
environment.
Emissions Tests
Compliance
Electromagnetic Environment Guidance
RF Emissions CISPR 11
Group 1
The
VenaPro
uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
RF Emissions CISPR 11
Class B
The
VenaPro
is suitable for use in all establishments, including domestic establishments and those directly connected to the
public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic Emissions IEC
61000-3-2
Class A
Voltage Fluctuations IEC
61000-3-3
Complies
