Part Ii; Limited Warranty - Medtronic Xomed Hydrodebrider Bedienungsanleitung

Part II

The Xomed® Hydrodebrider® System is intended for use in the electromagnetic environment specified below.
The customer or the user of the Xomed® Hydrodebrider® System should assure that it is used in such an environment.
Immunity test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the Xomed® Hydrodebrider® System is used exceeds the
applicable RF compliance level above, the Xomed® Hydrodebrider® System should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the Xomed® Hydrodebrider™.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Limited Warranty

A. This Limited Warranty provides the following assurance for the customer who purchases a Xomed® Hydrodebrider® Console (hereinafter
referred to as a "System Component") or any of its related handpiece(s), control cables, irrigation tubing, and irrigation with suction tubing
(hereinafter referred to as "Single Use Component"). The System Component and the Single Use Component(s) are jointly referred to as the
Xomed® Hydrodebrider® System, unless specifically noted otherwise. This Limited Warranty is extended only to the buyer purchasing the System
Component or Single Use Component directly from Medtronic or from its affiliate or its authorized distributor or representative.
(1) Should a System Component fail to function to Medtronic's published specifications during the term of this Limited Warranty (one year from
the date of sale of a new System Component or 90 days from the date of sale of a refurbished or used System Component), Medtronic will
either repair or replace the System Component or any portion thereof.
(2) Should a Single Use Component fail to function to Medtronic's published specifications prior to its "use by" date Medtronic will replace the
Single Use Component.
B. To qualify for this Limited Warranty, the following conditions must be met:
(1) The Xomed® Hydrodebrider® System must be used on or before its "Use By" or "Use Before" date, if applicable.
(2) The Xomed® Hydrodebrider® System must be used in accordance with its labeling and may not be altered or subjected to misuse, abuse,
accident or improper handling.
(3) Medtronic must be notified in writing within thirty (30) days following discovery of a defect.
(4) The Xomed® Hydrodebrider® System must be returned to Medtronic within thirty (30) days of Medtronic receiving notice as provided for in
(3) above.
(5) Upon examination of the Xomed® Hydrodebrider® System by Medtronic, Medtronic shall have determined that: (i) the Xomed®
Hydrodebrider® System was not repaired or altered by anyone other than Medtronic or its authorized representative, (ii) the Xomed®
Hydrodebrider® System was not operated under conditions other than normal use, and (iii) the prescribed periodic maintenance and services,
if applicable, have been performed on the Xomed® Hydrodebrider® System.
C. This Limited Warranty is limited to its express terms. THIS LIMITED WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED
OR IMPLIED WHETHER STATUTORY OR OTHERWISE, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE. In no event shall Medtronic be liable for any consequential, incidental, prospective or other similar
damage resulting from a defect, failure, or malfunction of the Xomed® Hydrodebrider® System, whether a claim for such damage is based upon the
warranty, contract, negligence or otherwise.
D. The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene mandatory provisions of
applicable law. Users may benefit from statutory warranty rights under legislation governing the sale of consumer goods. If any part or term of this
Limited Warranty is held by any court of competent jurisdiction to be illegal, unenforceable, or in conflict with applicable law, the validity of the
remaining portion of the Limited Warranty shall not be affected, and all rights and obligations shall be construed and enforced as if this Limited
Warranty did not contain the particular part or term held to be invalid.
10
IEC/EN60601-1-2 test level Compliance level
3 Vrms
150 kHz to 80 MHz
3 V / m
80 MHz to 2.5 GHz
Electromagnetic environment - guidance
Portable and mobile RF communications equipment should
be used no closer to any part of the Xomed® Hydrodebrider®,
including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
3 Vrms d = 1.2 √P
3 V / m d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2.5 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation distance
in meters (m).
Field strengths from fixed RF transmitters, as determined
by an electromagnetic site survey,a should be less than the
compliance level in each frequency range.b
Interference may occur in the vicinity of equipment marked
with the following symbol:
Xomed® Hydrodebrider® System