U.s. And International Safety Standards - VQ OrthoCare BioniCare Manual De Instrucciones

BioniCare Knee System
®

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 substanti-
ating 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.
In Europe, the BioniCare Hand System is a Class IIa Medical Device for
the treatment of the Rheumatoid Arthritis of the hand. This Device has
been cleared to be sold in the EU under CE certificate # 567144.
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 require-
ments 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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