U.S. And International Safety Standards - VQ OrthoCare BioniCare Manual De Instructiones

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 and osteoarthritis of the hand. This Device has been
cleared by the U.S. Food and Drug Administration under 510(k) K052625
and K142236.
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 1.949.261.3000.
ENGLISH | 23