Manuale d’uso / di manutenzione del prodotto TA9217 del fabbricante Leica
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Page 1 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 Leica HER2 FISH System - 30 T est Instructions For Use For use on Leica Biosystems’ BOND-MAX and BOND-III System.
English Page 2 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 Contents Intended Use .................................................................................................
Page 3 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 English Intended Use For in vitro diagnostic use The Leica HER2 FISH System .
English Page 4 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 The characteristic morphology of the tissue and the spatial distribution of oncogene copies in individual uncultured primary breast carcinomas are retained.
Page 5 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 English The Leica HER2 FISH System - 30 T est is for use only on the Leica BOND-MAX and BOND-III System.
English Page 6 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 T issue sections mounted on charged slides (Leica BOND Plus Slides S21.21 13) can be held for up to 12 months at 2–8 °C before staining.
Page 7 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 English bandpass uorescence microscope lter sets optimized for use with the Leica HER2 FISH System - 30 T est are available for most microscope models.
English Page 8 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 5. T urn on the PC attached to the Leica BOND-MAX and BOND-III System.
Page 9 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 English Signal Assessment and Enumeration T o assess the signal quality and enumerate the HER2 and CEP17 signals follow the process below: 1.
English Page 10 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 Recommended Method for LSI HER2 to CEP17 Ratio Determination T o determine the LSI HER2 to CEP17 ratio, use the following method: 1.
Page 1 1 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 English Figure 1: Interpretation Guide Leica HER2 FISH S ystem - 30 T est Interpretation Guide Count as 2 orange signals and 1 green signal Do not count.
English Page 12 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 Leica HER2 FISH S ystem - 30 T est Score Sheet 20 Nuclei Signal Cou.
Page 13 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 English Quality Control Use of Control Slides It is recommended that a Leica HER2 FISH Control Slide is included in each test run to monitor assay performance and to assess the accuracy of signal enumeration.
English Page 14 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 Unexpected FISH staining, or variations in the staining, may be a result of alterations in the expression levels of the encoding genes.
Page 15 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 English 2x2 Concordance Results Leica BOND-MAX System Data was grouped as negative (<2.
English Page 16 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 2x2 Concordance Results Leica BOND-III System Data was grouped as negative (<2.
Page 17 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 English Precision T esting – Leica BOND-MAX System A. Within Run Precision Study The within run precision study was performed in a randomized and blinded fashion.
English Page 18 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 F . Lot-to-Lot Precision Study The lot-to-lot precision study was performed in a randomized and blinded fashion.
Page 19 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 English K. Between Observer Precision Study The between observer precision study was performed in a randomized and blinded fashion.
English Page 20 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 denaturation time is recommended.
Page 21 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 English T roubleshooting Problem Probable C ause Remedial Action No or weak.
English Page 22 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 Problem Probable C ause Remedial Action Nonspecic background uorescent signal/staining Inadequate post hybridization washing Increase post hybridization wash incubation time.
Page 23 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 English References 1. Bargmann CI, Hung MC, Weinberg RA. The neu oncogene encodes an epidermal growth factor related protein. Nature 1986;319:226–30.
Page 24 of 24 English Leica Biosystems Leica HER2 FISH System - 30 T est Instructions for Use T A9217 EN-CE-Rev_D 08/04/2013 License Agreement This product contains PathV ysion FISH probes supplied by Abbott Molecular Inc. PathV ysion, LSI and CEP are a trademark of Abbott Molecular Inc.
Un punto importante, dopo l’acquisto del dispositivo (o anche prima di acquisto) è quello di leggere il manuale. Dobbiamo farlo per diversi motivi semplici:
Se non hai ancora comprato il Leica TA9217 è un buon momento per familiarizzare con i dati di base del prodotto. Prime consultare le pagine iniziali del manuale d’uso, che si trova al di sopra. Dovresti trovare lì i dati tecnici più importanti del Leica TA9217 - in questo modo è possibile verificare se l’apparecchio soddisfa le tue esigenze. Esplorando le pagine segenti del manuali d’uso Leica TA9217 imparerai tutte le caratteristiche del prodotto e le informazioni sul suo funzionamento. Le informazioni sul Leica TA9217 ti aiuteranno sicuramente a prendere una decisione relativa all’acquisto.
In una situazione in cui hai già il Leica TA9217, ma non hai ancora letto il manuale d’uso, dovresti farlo per le ragioni sopra descritte. Saprai quindi se hai correttamente usato le funzioni disponibili, e se hai commesso errori che possono ridurre la durata di vita del Leica TA9217.
Tuttavia, uno dei ruoli più importanti per l’utente svolti dal manuale d’uso è quello di aiutare a risolvere i problemi con il Leica TA9217. Quasi sempre, ci troverai Troubleshooting, cioè i guasti più frequenti e malfunzionamenti del dispositivo Leica TA9217 insieme con le istruzioni su come risolverli. Anche se non si riesci a risolvere il problema, il manuale d’uso ti mostrerà il percorso di ulteriori procedimenti – il contatto con il centro servizio clienti o il servizio più vicino.