U.S. And International Safety Standards - VQ OrthoCare BioniCare Hand System Manual De Instrucciones

U.S. and International Safety Standards

When traveling with the BioniCare Hand 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 Hand System, is a FDA Class II Medical Device prescribed
by a licensed physician or other medical professional for the treatment of
rheumatoid arthritis of the hand. This Device has been cleared by the U.S.
Food and Drug Administration under 510(k) K030332.
The BioniCare Hand 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
• IEC 60601-1-2:2001 + A1:2004 Medical electrical equipment. General
requirements for safety. Collateral standard. Electromagnetic compatibility.
Requirements and tests.
Further information regarding this medical device may be obtained directly
from VQ OrthoCare at 1.949.266.6969.
BioniCare Hand System
®
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