VQ OrthoCare BIONICARE KNEE SYSTEM, Руководство по эксплуатации

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U.S. and International Safety Standards
When traveling with the BioniCare Knee System, 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 BioniCare Knee System, is a FDA Class II Medical Device prescribed
by a licensed physician or other medical professional for the treatment of
osteoarthritis of the knee. This Device has been cleared by the U.S. Food
and Drug Administration under 510(k) K030332.
The BioniCare Knee System 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: Electro-
magnetic 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).