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APPENDIX

INTELECT

RPW 2 USER MANUAL

ELECTROMAGNETIC COMPATIBILITY
(EMC)

The Intelect

RPW 2 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.

The guidelines below are intended to help promote
electromagnetic compatibility (EMC) in the identified use
environment for the Intelect

RPW 2.

• Make use of available resources such as EMC

professionals and publications and Internet web
pages on the subject of medical device EMC;

• Assess the electromagnetic environment of the

facility (e.g., identify radio transmitters in around
the facility) and identify areas where critical medical
devices are used;

• Manage the electromagnetic environment, RF

transmitters and all electrical and electronic
equipment, including medical devices, to reduce the
risk of medical device electromagnetic interference
(EMI) and achieve EMC;

• Coordinate the purchase, installation, service,

and management of all electrical and electronic
equipment used in the facility to achieve EMC;

• Educate healthcare facility staff, contractors, visitors,

and patients about EMC and EMI and how they can
recognize medical device EMI and help minimize
associated risks;

• Establish and implement written policies and

procedures that document the intentions and
methods of the healthcare institution for reducing
the risk of medical device EMI and achieving EMC;

• Report EMI problems to the US FDA MedWatch

program and communicate EMI/EMC experiences to
colleagues in open forums such as medical/technical
publications and conferences.

More information is contained within a comprehensive
guidance document for EMC in healthcare facilities,
developed, with FDA participation, by the Association for the
Advancement of Medical Instrumentation (AAMI): Technical
Information Report (TIR) 18, Guidance on Electromagnetic

Compatibility of Medical Devices for Clinical/Biomedical
Engineers. AAMI TIR 18-1997. Arlington, Virginia: Association
for the Advancement of Medical Instrumentation; 1997.

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 ultrasound 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 re-orient interfering equipment.
• Increase distance between interfering equipment and

your ultrasound system.

• Manage use of frequencies close to ultrasound

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).