Leica TA9217の取扱説明書

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  • Leica TA9217 - page 1

    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. T A9217 is a uorescence in situ hybridization product designed to stain 30 tests (30 slides stained with LS ...

  • Leica TA9217 - page 2

    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 ............................................................................................................................................................................... 3 For in vitro diagn ...

  • Leica TA9217 - page 3

    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 - 30 T est is designed to detect amplication of the HER2/neu gene via uorescence in situ hybridization (FISH) in formalin-xed, parafn-embe ...

  • Leica TA9217 - page 4

    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. Aberrations in chromosome 17 copy number (aneusomy) are also ...

  • Leica TA9217 - page 5

    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. Components Provided The materials listed below (T able 1) are sufcient to stain 30 tests (30 slides stained with LSI H ...

  • Leica TA9217 - page 6

    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. Following sectioning, it is recommended that slides are incubated at 60 °C fo ...

  • Leica TA9217 - page 7

    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. The recommended lter sets for the Leica HER2 FISH System - 30 T e ...

  • Leica TA9217 - page 8

    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. 6. Open the Leica BOND software. 7. For a new Leica HER2 FISH System - 30 T est kit, scan the reagent tray barcode with the handheld scanner to ent ...

  • Leica TA9217 - page 9

    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. Assessment of Slide Quality Evaluate slide quality using the following criteria: • ...

  • Leica TA9217 - page 10

    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. Record and determine the number of LSI HER2 and CEP17 signals in 20 nuclei (see Figu ...

  • Leica TA9217 - page 11

    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. Nuclei with no signals or with signals of only 1 color should not be s ...

  • Leica TA9217 - page 12

    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 Count Nucleus # HER2 Copy Number CEP17 Copy Number Nucleus # HER2 Copy Number CEP17 Copy Number 1 11 2 12 3 13 4 14 5 15 6 16 7 17 8 18 9 19 10 20 T otal ...

  • Leica TA9217 - page 13

    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. Control slides s ...

  • Leica TA9217 - page 14

    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. Any change in expected staining patterns should be interpreted in association wit ...

  • Leica TA9217 - page 15

    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 (<2.00) or positive (≥2.00) for a 2x2 analysis The observed agreement for 300 samples between the two tests in a 2x2 analysis show a conc ...

  • Leica TA9217 - page 16

    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 (<2.00) or positive (≥2.00) for a 2x2 analysis The observed agreement for 300 samples between the two tests in a 2x2 analysis show a conc ...

  • Leica TA9217 - page 17

    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. Within run precision testing of the Leica HER2 FISH System - ...

  • Leica TA9217 - page 18

    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. Lot-to-Lot precision was determined on three independently manufactured lots of the Leica HER2 FISH Syst ...

  • Leica TA9217 - page 19

    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. Between observer reproducibility testing of the Leica HER2 FISH System - 30 T est was evaluat ...

  • Leica TA9217 - page 20

    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. • No difference in amplication status was observed when the hybridization time was performed for 9 hours and 15 hours when compared to the default Leica HER2 FISH System - 30 T e ...

  • Leica TA9217 - page 21

    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 uorescent signal/staining Inappropriate xation or processing of test specimen Ensure a formalin-based xativ e is used and that processing sc ...

  • Leica TA9217 - page 22

    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 Nonspecic background uorescent signal/staining Inadequate post hybridization washing Increase post hybridization wash incubation time. Inappropriate bulk reagents dispense ...

  • Leica TA9217 - page 23

    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. 2. Lonardo F , Di Marco E, King CR, Pierce JH, Segatto O, Aaronson SA, et ...

  • Leica TA9217 - page 24

    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. All Rights Reserved. Used under License. Amendments to Previo ...

メーカー Leica カテゴリー Oxygen Equipment

Leica TA9217のメーカーから受け取ることができるドキュメントは、いくつかのグループに分けられます。その一部は次の通りです:
- #BRANDの図面#
- TA9217の取扱説明書
- Leicaの製品カード
- パンフレット
- またはLeica TA9217の消費電力シール
それらは全部重要ですが、デバイス使用の観点から最も重要な情報は、Leica TA9217の取扱説明書に含まれています。

取扱説明書と呼ばれる文書のグループは、Leica TA9217の取り付け説明書、サービスマニュアル、簡易説明書、またはLeica TA9217のユーザーマニュアル等、より具体的なカテゴリーに分類されます。ご必要に応じてドキュメントを検索しましょう。私たちのウェブサイトでは、Leica TA9217の製品を使用するにあたって最も人気のある説明書を閲覧できます。

関連する取扱説明書

Leica TA9217デバイスの取扱説明書はどのようなものですか?
取扱説明書は、ユーザーマニュアル又は単に「マニュアル」とも呼ばれ、ユーザーがLeica TA9217を使用するのを助ける技術的文書のことです。説明書は通常、全てのLeica TA9217ユーザーが容易に理解できる文章にて書かれており、その作成者はその分野の専門家です。

Leicaの取扱説明書には、基本的な要素が記載されているはずです。その一部は、カバー/タイトルページ、著作権ページ等、比較的重要度の低いものです。ですが、その他の部分には、ユーザーにとって重要な情報が記載されているはずです。

1. Leica TA9217の説明書の概要と使用方法。説明書にはまず、その閲覧方法に関する手引きが書かれているはずです。そこにははLeica TA9217の目次に関する情報やよくある質問、最も一般的な問題に関する情報を見つけられるはずです。つまり、それらはユーザーが取扱説明書に最も期待する情報なのです。
2. 目次。Leica TA9217に関してこのドキュメントで見つけることができる全てのヒントの目次
3. Leica TA9217デバイスの基本機能を使うにあたってのヒント。 Leica TA9217のユーザーが使い始めるのを助けてくれるはずです。
4. トラブルシューティング。Leica TA9217に関する最も重要な問題を診断し、解決するために役立つ体系化された手続き
5. FAQ。よくある質問
6. 連絡先。一人では問題を解決できない場合に、その国におけるLeica TA9217のメーカー/サービスへの連絡先に関する情報。

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