How Supplied - Devicor Mammotome elite Manual Del Usuario

How Supplied

• The Mammotome® elite Holster is supplied non-sterile.
• The Mammotome® elite Probes are supplied sterile for single patient use and sold separately. Discard after use.
Warranty
Devicor® Medical Products, Inc. warrants this product to be free from defects in material and workmanship under normal
use for the respective warranty period shown below.
Devicor® Medical Products, Inc. ' s obligation under this warranty is limited to the replacement, at its option, of any
product, or part thereof, which has been returned to Devicor® Medical Products, Inc. or its Distributor within the
applicable time period shown below and which examination disclosed, Devicor® Medical Products, Inc. ' s satisfaction, to
be defective. This warranty does not apply to any product, or part thereof, that has been: (1) adversely affected due to
use with devices manufactured or distributed by parties not authorized by Devicor® Medical Products, Inc. (2) repaired or
altered outside Devicor® Medical Products, Inc. ' s factory in a way so as to, in Devicor® Medical Products, Inc. ' s judgment,
affect its stability or reliability, (3) subjected to improper use, negligence or accident, or (4) used other than in accordance
with the design and use parameters, instructions and guidelines for the product or with functional, operational or
environmental standards for similar products generally accepted in the industry. Devicor® Medical Products, Inc. ' s
products are warranted for the following periods after delivery to the original purchaser:
Mammotome® elite Holster Six (6) Month, Replacement
Charging Base with AC accessories Six (6) Month, Replacement
UNLESS SUPERCEDED BY APPLICABLE LOCAL LAW, THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR
IMPLIED, INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, AND OF ALL
OTHER
OBLIGATIONS OR LIABILITIES ON THE PART OF DEVICOR® MEDICAL PRODUCTS, INC. AND IS A PURCHASER'S
EXCLUSIVE REMEDY. IN NO EVENT SHALL DEVICOR® MEDICAL PRODUCTS, INC. BE LIABLE FOR SPECIAL, INCIDENTAL OR
CONSEQUENTIAL DAMAGES INCLUDING, WITHOUT LIMITATION, DAMAGES RESULTING FROM LOSS OF USE, PROFITS,
BUSINESS OR GOODWILL OTHER THAN AS EXPRESSLY PROVIDED BY A SPECIFIC LAW.
Devicor® Medical Products, Inc. neither assumes nor authorizes any other person to assume for it any other liability in
connection with the sale or use of any of Devicor® Medical Products, Inc. products. There are no warranties that extend
beyond the terms hereof. Devicor® Medical Products, Inc. reserves the right to make changes to products built and/or
sold by them at any time without incurring any obligation to make the same or similar changes on products previously
built and/or sold by them.
CAUTION:
Federal (USA) law restricts this device to sale by or on the order of a physician.
Consult a MAMMOTOME Sales Representative for details regarding replacement options.
Indications
Le Système de biopsie Mammotome® elite est indiqué pour l'obtention d'échantillons de tissus mammaires ou de
ganglions axillaires lymphatiques pour le diagnostic d'anomalies mammaires.
• Le Système de biopsie Mammotome® elite permet d'obtenir des tissus mammaires en vue d'un examen histologique
ainsi que le prélèvement partiel ou complet de l'anomalie visualisée.
• Le Système de biopsie Mammotome® elite permet d'obtenir des tissus mammaires en vue d'un examen histologique
ainsi que le prélèvement partiel de l'anomalie visualisée.
L'étendue d'une anomalie histologique ne peut pas être déterminée de façon fiable d'après son aspect
mammographique. Par conséquent, l'étendue du prélèvement d'une anomalie palpée ou visualisée ne prédit pas
l'étendue du prélèvement d'une anomalie histologique, c'est-à-dire d'une malignité. Lorsque l'histologie de l'anomalie
prélevée présente des résultats malins, il est essentiel d'examiner les marges de la lésion pour s'assurer de l'ablation
complète au moyen de méthodes chirurgicales standard.
Quand un patient présente une anomalie palpable qualifiée de bénigne selon des critères cliniques et/ou radiologiques
(par ex. adénofibrome, lésion fibrokystique), le système de biopsie mammaire Mammotome® elite peut aussi servir
à effectuer l'exérèse partielle de ces lésions palpables. Lors de prélèvements de tissus mammaires, l'évaluation
histologique des tissus est une bonne pratique. Lorsque l'histologie de l'anomalie prélevée présente des résultats
malins, il est essentiel d'examiner les marges de la lésion pour s'assurer de l'ablation complète au moyen de méthodes
chirurgicales standard.
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