U.S. And International Safety Standards - VQ OrthoCare Avid IF2 Manual Para El Paciente Y Para El Médic

U.S. and International Safety Standards

When traveling with the Avid IF2, users may be requested to provide
documentation identifying it as a medical device and substantiating its
electrical safety. The following facts are provided for this purpose.
The Avid IF2, is a FDA Class II Medical Device prescribed by a licensed
physician or other medical professional. This Device has been cleared by
the U.S. Food and Drug Administration under 510(k)K183692.
The Avid IF2 meets or exceeds federal and international standards for
electrical safety, including:
• IEC 60601-1 : 1988 Standards for Medical Electrical Equipment; Part 1:
General Requirements for Safety, Amendment A1 : 1991, Amendment
A2 : 1995
• IEC 60601-2-10 : 1987 Standards for Medical Electrical Equipment; Part 2:
Particular Requirements for the Safety of Nerve and Muscle Stimulators,
Amendment A1 : 1991
• ANSI/AAMI NS4-1985 American National Standards for Transcutaneous
Electrical Nerve Stimulator; Environmental Testing
• IEC60601-1-2:2007 Medical electrical equipment - General requirements
for basic safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and tests
• IEC60601-1-11:2010 General requirements for basic safety and essential
performance - Collateral Standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare
environment
Further information regarding this medical device may be obtained directly
from VQ OrthoCare at 800.444.1456 (inside the US) or 949.261.3000
(outside of the US).
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