King VISION Bedienungsanleitung Seite 16

The King Vision Display and Video Adapter are designed for multiple patient uses when properly cleaned
and disinfected between patients.
The King Vision aBlades are designed for Single Use and cannot be reprocessed or sterilized.
RISK OF REUSE (as required for Single Use devices):
U.S. and International Laws/Regulations require the original device manufacturer to warrant that the
product sold is fit for use according to the scope of its Instructions for Use and is capable of being tracked
back to its original assembly. If an issue were to arise during use, this requirement allows for the product to
be properly tracked and acted upon in accordance with all applicable laws.
Any reuse of a device labeled as a Single Use Device (SUD) invalidates the manufacturer's requirement to
track the product back to its original assembly. As such, any facility that reuses a SUD assumes the role of a
manufacturer and must test and verify the suitability of this (reused) device. This includes, but is not
limited to, the proper level of cleaning, disinfection and/or sterilization necessary to warrant the reused
device's fitness for use. In the USA, any facility that re-processes a SUD must register with the Food and
Drug Administration under Code of Federal Regulations Title 21 as a device manufacturer and abide by all
applicable federal and state laws regulating device manufacturers. Outside the USA other laws may apply.
Manufactured By:
King Systems
15011 Herriman Blvd., Noblesville, IN 46060
317-776-6823
800-642-5464
www.kingsystems.com
Made in U.S.A. of US and imported parts
US and International Patents Pending
Copyright 2013 King Systems, all rights reserved
King Vision is a trademark of King Systems Corporation
The King Vision product line meets the requirements of the European Directive 93/42/EEC for medical
devices and carries the CE mark.
INFM-84 V02.2015/10
European Representative
MPS
Medical Product Service GmbH
Borgasses 20
35619 Braunfels Germany
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