Arthrex Angel, Operator'S Manual

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Other Commercial Matters
Angel ® cPRP System Operator’s Manual
8-1
Chapter 8: Other Commercial Matters
This is not a warranty document. For all warranty information, including disclaimers, exclusions, terms,
conditions and related provisions refer to the “ Arthrex U.S. Product Warranty ” section of the Arthrex, Inc.
website, found at www.arthrex.com whose provisions are incorporated herein by reference.
Limitation of Liability
NEITHER ARTHREX, INC. NOR THE MANUFACTURER WILL HAVE ANY
RESPONSIBILITY FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES,
WHETHER FOR BREACH OF WARRANTY OR OTHER CONTRACT,
NEGLIGENCE OR OTHER TORT OR ON ANY STRICT LIABILITY THEORY.
Technical documentation
a) Products are always supplied complete with adequate documentation, including, inter alia,
instructions for correct use, as well as the list of routine care activities. Other details may
concern any disposables needed for correct use of the device.
b) All the documentation and information, drawings and descriptions contained in the manual
or, for whatever reason, provided to the user, shall be considered as confidential and as
belonging exclusively to Arthrex, Inc. These shall not therefore be revealed, distributed,
copied or reproduced by any means and for whatever purpose, nor given out for
consultation, total or partial, to anyone, without specific prior authorization being formally
given by the manufacturer.
c) The manufacturer reserves the right to make, without prior notice, amendments or updates
to the contents of previously distributed documentation.
Technical safety standards
a) The safety standards applicable to the manufacture of the Angel System shall be those
enforced in the Country where the device is addressed by the Manufacturer at the time of
marketing of such device.
b) In Europe, safety with regard to electrical and mechanical hazards, explosions and fires,
relative to medical electrical equipment, is defined by the following harmonized standard:
EN 60601-1: Medical electrical equipment - Part 1: general requirements for safety which
implements the requirements of the International Standard
IEC 601-1: Safety of medical electrical equipment-Part 1: general requirements issued by
I.E.C., International Electrotechnical Committee, and already transposed by C.E.I.,
Comitato Elettrot ecnico Italiano, such as: CEI 62-5: Apparecchi elettromedicali-Parte 1:
nor me generali per la sicurezza
Such standards apply to medical electrical equipment intended for use by or under the
control of qualified personnel in the immediate proximity of the patient and in relation to the
patient him/herself (in this context, proximity means the area within 2.5 m from the patient).