Stereotaxy - Operator Manual - UM - 5262169-8-1EN - 3

Senographe Essential Stereotaxy
Operator manual
5262169-8-1EN
Revision 3
© 2008-2017 by General Electric Company
All Rights Reserved.
Senographe Essential Stereotaxy 5262169-8-1EN
Operator manual Revision 3
This page is intentionally left blank.
Page no. 2 Cover-Ess.fm

IMPORTANT...X-RAY PROTECTION
CAUTION
If not properly used, x-ray equipment may cause injury. Accordingly, it is your obligation to
confirm that the instructions herein contained are thoroughly read and understood by everyone
who will use the equipment before you attempt to place this equipment in operation. The General
Electric Company, Healthcare Technologies, will be glad to assist and cooperate in placing this
equipment in use.
Although this apparatus incorporates a high degree of certain protections against x-radiation
other than the useful beam, no feasible design of equipment can provide complete protection
from all potential injury. Nor can any feasible design force the operator to take adequate
precautions to prevent the possibility of any persons carelessly exposing themselves or others to
radiation.
It is important that anyone having anything to do with x-radiation be properly trained and fully
knowledgeable about the recommendations of the National Council on Radiation Protection and
Measurements as published in NCRP Reports available from NCRP Publications, 7910
Woodmont Avenue, Room 1016, Bethesda, Maryland 20814, and of the International
Commission on Radiation Protection. It is your obligation and responsibility to take adequate
steps to protect against injury.
The equipment is sold with the understanding that the General Electric Company, Healthcare
Technologies, its agents, and representatives have no responsibility for injury or damage, which
may result from improper use of the equipment. Various protective materials and devices are
available. It is urged that such materials or devices be used in accordance your site’s clinical
practice.
radiation warning.fm Page no. 3

Page no. 4 radiation warning.fm

Table of Contents
Table of Contents
IMPORTANT...X-RAY PROTECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Table of Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Chapter 1. Publication presentation

1. Applicability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2. How to use the manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3. Conventions for this manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4. Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Chapter 2. Standards and regulations

1. Standards compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2. Installation requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3. Usage requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
4. Operator profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
5. Training program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
6. De-installation and Recycling requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
7. Meaning of symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Chapter 3. The Stereotaxy Application

1. Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
2. Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3. Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4. Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Chapter 4. Stereotaxy components

1. Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
2. Stereotactic Positioner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
3. Accessories supplied with the Stereotactic Positioner . . . . . . . . . . . . . . . . . . . . . . . . . . 29
4. Parts contained in the Vertical Holder Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
5. Parts contained in the Lateral Holder Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
6. Needle guides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Chapter 5. The Stereotactic Positioner

1. Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
2. The Stereotactic Positioner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
3. The stereo compression paddle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Chapter 6. Installation of the Stereotactic Positioner

1. Installing the Stereotactic Positioner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
TOC.fm Page no. 5

Table of Contents
2. Removing the Stereotactic Positioner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Chapter 7. Procedure Steering Guide

1. Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
2. Quick reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
3. Pre-examination check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
4. Cleaning, disinfection, and sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
5. Patient examination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Chapter 8. Installation for Vertical Approach

1. Installing needles and biopsy devices for vertical approach . . . . . . . . . . . . . . . . . . . . . . 53
2. Installing the biopsy device support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
3. Fitting a vertical approach biopsy device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Mammotome ST or Biopsys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
SenoRx EnCor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
BARD Magnum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
BARD Vacora. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Suros ATEC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Chapter 9. Installation for Lateral Approach

1. Installing needles and biopsy devices for lateral approach . . . . . . . . . . . . . . . . . . . . . . . 65
2. Installing the lateral approach tool support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
3. Installing the lateral needle guide holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
4. Fitting the lateral approach biopsy device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Suros ATEC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Mammotome ST or Biopsys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
SenoRx EnCor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
BARD Magnum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
BARD Vacora. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Chapter 10. Preparation for examinations

1. Preparation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
2. Arm Positioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
3. Preparation for an examination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Chapter 11. Needle Setup

1. Needle parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
2. Needle Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
3. Needle and biopsy device dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
4. Biopsy device measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Page no. 6 TOC.fm

Table of Contents
Chapter 12. Stereotaxy Image Acquisition

1. Starting the Stereotaxy application. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
2. Stereotaxy viewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
3. Making Stereotaxy exposures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
Chapter 13. Stereotaxy Punctures

1. Defining punctures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
2. Sending Puncture information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
3. Positioning the Needle Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
4. Performing the puncture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
5. Additional punctures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
6. Completion of puncture procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Chapter 14. Image Printing and Review

1. Printing Images. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
2. Image Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
Chapter 15. System Hygiene

1. Cleaning, disinfection, and sterilization - Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
2. Definitions of part categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
3. Hygiene practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
Chapter 16. Planned Maintenance

1. Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
2. Field Engineer Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
3. QC Tests for the Radiologic Technologist or Medical Physicist . . . . . . . . . . . . . . . . . . . 161
QC Test 1 - Needle Path Block Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
QC Test 2 - Localization Accuracy - Vertical Approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
QC Test 3 - Accuracy check before using new CB or VAD needles in vertical approach . . 168
QC Test 4 - Accuracy check before using new FNA/Hook-wire needles in vertical approach 172
QC Test 5 - Localization Accuracy - Lateral Approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176
QC Test 6 - Accuracy check before using new CB or VAD needles in lateral approach . . . 180
Test results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185
4. Test Result Record sheets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185
QC Test Chart 1- NeedlePath Block Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186
QC Test Chart 2 - Stereotactic Localization Accuracy: Vertical Approach. . . . . . . . . . . . . . 187
QC Test Chart 3 - Accuracy check before using new CB or VAD needles in vertical approach 188
QC Test Chart 4 - Accuracy check before using new FNA needles in vertical approach . . 189
QC Test Chart 5 - Localization Accuracy: Lateral Approach . . . . . . . . . . . . . . . . . . . . . . . . 190
QC Test Chart 6 - Accuracy check before using new CB or VAD needles in lateral approach 191
TOC.fm Page no. 7

Table of Contents
Chapter 17. Operator messages

1. Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193
2. Operator messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193
Chapter 18. Specifications

1. Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207
2. Senographe Stereotaxy functional specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207
3. Physical specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208
4. Trademark information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208
Page no. 8 TOC.fm

Publication presentation
Chapter 1 Publication presentation
1 Applicability
This manual is provided for operators using a Senographe Essential Acquisition System for Stereotaxy.
The manual has been written to describe the use of the system in its most complete configuration. If any
of the options described in this manual are not included in your system, skip the corresponding chapter
or section.
See your GE Representative for the options available with the Senographe Essential Acquisition
System.
2 How to use the manual

2-1 Types of chapter
In general, information in this manual is arranged in chapters, each of which contains one type of
information:
• Physical description chapters.
Intended to answer the question: “What is it?”.
Usually arranged according to physical location of the various parts.
• Functional description chapters.
Intended to answer the question: “How does the system behave?”.
• Procedural description chapters.
Intended to answer the questions: “How do I …?”, or “What do I do now?”.
Arranged according to context, i.e., according to the situation in which the Operator is operating,
following the sequence of an examination.
2-2 Links between different chapters

Each type of information may refer to another. For example, a procedural chapter describing how to use
a particular function may contain instructions which require the Operator to know how to find some piece
of software or hardware (referring to a physical description), and to understand how the function works
(referring to a functional description).
Physical description
chapters.
Procedural description
chapters.
Functional description
chapters
Chapters are arranged in an order which is intended to suit the learning requirements of a new Operator.
This means that similar types of chapter are not necessarily grouped together.
Publication-Presentation.fm Page no. 9 Chapter 1

2-3 List of chapters classified by type

Physical description
- 4 Stereotaxy components on page 27
- 5 The Stereotactic Positioner on page 39
- 18 Specifications on page 207
Functional description
- 3 The Stereotaxy Application on page 19
- 17 Operator messages on page 193
Procedural description
- 6 Installation of the Stereotactic Positioner on page 43
- 7 Procedure Steering Guide on page 45
- 8 Installation for Vertical Approach on page 53
- 9 Installation for Lateral Approach on page 65
- 10 Preparation for examinations on page 93
- 11 Needle Setup on page 103
- 12 Stereotaxy Image Acquisition on page 125
- 13 Stereotaxy Punctures on page 135
- 14 Image Printing and Review on page 157
- 15 System Hygiene on page 159
- 16 Planned Maintenance on page 161
Chapter 1 Page no. 10 Publication-Presentation.fm

3 Conventions for this manual

3-1 Mouse and trackball buttons
This document contains many references to the use of mouse buttons (left, middle, and right buttons). In
case of problems, you should check with your system documentation.
Trackball Mouse buttons

Mouse Equivalent Mouse
buttons trackball buttons
buttons 3 4
Left 3 and 4 1
1 6
1 3
Middle 2 and 5 2
2 5 2
Right 1 and 6 3
(on the side
of the
trackball)
3-2 Typographical
• In text describing the Operator interface, italic and bold characters are used to differentiate between
body text and on-screen or hardware captions and labels, entered text, etc.:
- Italics are used for references to hardware items and text which appears on-screen (e.g., menu
titles, button labels, on-screen messages, etc.).
- Bold face is used when specific instructions are given for the entry of text or selection of a menu
option, etc. If the operation or text entry includes the use of a keyboard or mouse button, its name
is shown between angle brackets, to distinguish it from entered text, e.g., 123<Enter> would be
written for an instruction to type 123 followed by the Enter or Return key.
• In other text:
- Italics are used when a specific concept is introduced.
- Italic and bold characters may also be used for local emphasis.
- In electronic versions of the document, cross-references appear in blue italics.

3-3 Definitions of different types of Warnings

The various safety and cautionary notes throughout this manual are defined as follows:
DANGER
Indicates an imminently hazardous situation that, if not avoided, will result in death or serious
injury.
WARNING
Indicates a potentially hazardous situation that, if not avoided, could result in death or serious
injury.
CAUTION
Indicates a potentially hazardous situation that, if not avoided, may result in minor or moderate
injury.
! Notice:
Used for instructions to the Operator to prevent damage to property.
Note:
Used to draw attention to information that is important for the Operator to know.

4 Revision History
This table is intentionally left in English.
Date Reference Revision Main modifications

2017-11 5262169-8-1EN 3 Resolution of SPR:
Senographe Essential -HCSDM00484124: removal of ISO
Stereotaxy Operator Manual compliance statement
-HCSDM00484139: statement for the date of
the initial CE marking year
2015-01 5262169-8-1EN 2 HCSDM00332051 resolved: updated page
Senographe Essential numbering translation for BG, CS, DA, ET, FI,
Stereotaxy Operator Manual HR, HU, LT, LV, NL, NO, PL, RO, RU, SK,
SR, SV and TR.
HCSDM00332056 resolved: corrected second
paragraph in frequency of QC test 6 in BG,
CS, DA, DE, EL, ES, ET, FI, FR, HR, HU, IT,
JA, KO, LT, LV, NL, NO, PL, PT-PT, RO, RU,
SK, SR, SV, TR and ZH-CN.
No change in the manual content.
2014-05 5262169-8-1EN 1 HCSDM00264027 resolved:
Senographe Essential CE marking removed from Cover page.
Stereotaxy Operator Manual CE marking information updated chapter 2,
section 2.1 "Standards compliance".
HCSDM00284096 resolved:
- Harmonized wording and frequency of QC
test 6 and QC test 3 titles
- Harmonized frequency of QC test 5 and QC
test 2
- Modified test frequency in chapter 7, section
3 "Pre-examination check"
2013-11 5262169-7-1EN 2 HCSDM00247250 resolved: Updated page
Senographe Essential numbering for FR, HR and JA.
Stereotaxy Operator Manual No change in the manual content.

2013-08 5262169-7-1EN 1 CFDA release:

Senographe Essential HCSDM00200200 resolved: GE Buc address
Stereotaxy Operator Manual changed on last page and on p15.
HCSDM00188711 resolved: China service
agent address changed on last page.
HCSDM00172839 resolved: Turkey importer
address added on last page.
HCSDM00196150 resolved: radiation warn-
ing updated.
HCSDM00168746 resolved: typos corrected.
HCSDM00226099 resolved: "Imagination at
work" and "GE Healthcare" removed.
HCSDM00227456 resolved: levels of safety
messages updated.
HCSDM00227804 resolved: trademark
information added.
2011-01 5262169-6-1EN 1 Compatibility between needles and needle
Senographe Essential guides on chapter 3 paragraph 4 and minor
Stereotaxy Operator Manual modifications.

Standards and regulations
Chapter 2 Standards and regulations
1 Standards compliance
This product complies with the regulatory requirements of the following:
• If the 0459 label is affixed to the product, it complies with Council Directive 93/42/EEC concerning
medical devices.
European registered place of business:
GE MEDICAL SYSTEMS SCS
283, RUE DE LA MINIERE
78530 BUC France
• The first year of CE marking of this product is 2009.
• Code of Federal Regulations Title 21, Subchapter J - Radiological health.
• Underwriters' Laboratories, Inc. (UL), an independent testing laboratory.
• Canadian Standards Association (CSA).
• International Electrotechnical Commission (IEC), international standards organization, when
applicable, in particular IEC 60601-2-45:2001 compliance notice.
• USA/HHS: United States Federal law restricts this device to use by or on the order of a physician.
• The original document was written in English.
Use within the patient environment
All components of the Senographe Essential Stereotaxy system are designed to be suitable for use
within the patient environment, and are compliant with the relevant standards.
regulatory.fm Page no. 15 Chapter 2

2 Installation requirements
Packing materials
The materials used to pack our equipment are recyclable. They must be collected and processed in
accordance with the regulations in force for the country where the machines or accessories are
unpacked.
Use in the presence of flammable gases
The Stereotactic Positioner must not be used in the presence of flammable gases.
Electromagnetic Compatibility (EMC)
This equipment complies with the IEC 60601-1-2 Edition 2 EMC standard for medical devices.
This equipment generates, uses, and can radiate radio frequency energy. The equipment may cause
radio frequency interference to other medical and non-medical devices and radio communications.
To provide reasonable protection against such interference, this product complies with emissions
limits for a Group 1, Class A Medical Devices Directive as stated in EN60601-1-2. However, there is
no guarantee that interference will not occur in a particular installation.
If this equipment is found to cause interference (which may be determined by turning the equipment
on and off), the user (or qualified service personnel) should attempt to correct the problem by one or
more of the following measure(s):
- Reorient or relocate the affected device(s).
- Increase the separation between the equipment and the affected device.
- Power the equipment from a source different from that of the affected device.
- Consult the point of purchase or service representative for further suggestions.
The manufacturer is not responsible for any interference caused by using other than recommended
interconnect cables or by unauthorized changes or modifications to this equipment. Unauthorized
changes or modifications could void the users' authority to operate the equipment.
To comply with the regulations on electromagnetic interference for a Class A FCC Device, all
interconnect cables to peripheral devices must be shielded and properly grounded. Use of cables not
properly shielded and grounded may result in the equipment causing radio frequency interference in
violation of the FCC regulations.
Do not use devices which intentionally transmit RF Signals (Cellular Phones, Transceivers, or Radio
Controlled Products) in the vicinity of this equipment as it may cause performance outside the
published specifications. Keep the power to these types of devices turned off when near this
equipment.
The medical staff in charge of this equipment is required to instruct technicians, patients, and other
people who may be around this equipment to comply fully with the above requirement.
Chapter 2 Page no. 16 regulatory.fm

3 Usage requirements
• The equipment includes a function IMAGE ANNOTATIONS, which allows the physician to store
information on the patient.
• Note that the European Directive regarding “the protection of the people with regard of data
management on their private life and to the free circulation of these data” requests the users of
computerized files (radiologists, physicians) not to store data related to:
- race,
- philosophical opinions,
- religious opinions,
- political opinions,
- etc.
4 Operator profile
The use of the Senographe Essential Stereotaxy positioning system requires specific technical and
medical knowledge and skills. As a minimum, operators must have acquired knowledge and skill in the
areas of:
• radiation protection,
• safety procedures,
• patient safety.
through approved training and professional education.
5 Training program
Before using the Senographe Essential Stereotaxy system to work with patients, it is mandatory that all
users have received adequate training. Contact your GE Representative for information on suitable
training programs.
For systems subject to Mammography Quality Standards Act (MQSA) rules, the Radiologist, Interpreting
Physician, and the Medical Physicist are each required to obtain eight hours of new-modality training for
full-field digital mammography.
Additional information can be found on the Food and Drug Administration’s (FDA's) website:
http://www.fda.gov
in the Mammography pages.
6 De-installation and Recycling requirements

Machines or accessories at end-of-life
The elimination of machines and accessories must be in accordance with national regulations for
waste processing.
All materials and components that could pose a risk to the environment must be removed from the
end-of-life machines and accessories (examples: dry and wet cell batteries, transformer oil, etc.).
Please consult your local General Electric Medical Systems representative before discarding these
products.
regulatory.fm Page no. 17 Chapter 2

7 Meaning of symbols
Protective ground (earth)
Ground (earth)
Dangerous voltage
Type B equipment
This symbol indicates that waste electrical and electronic equipment must not be disposed
of as unsorted municipal waste and must be collected separately. Please contact an
authorized representative of the manufacturer for information concerning the
decommissioning of your equipment.
Name and address of the manufacturer
Date of manufacture
Manufacturer’s catalogue number
Medical device serial number
Consult instructions for use
This symbol on the console indicates that you must have read and understood the
operator manual before taking any action.
Chapter 2 Page no. 18 regulatory.fm

The Stereotaxy Application
Chapter 3 The Stereotaxy Application
1 Intended Use
Senographe Stereotaxy is an optional accessory for the Senographe full field digital system. It is
designed to allow the accurate location of lesions in the breast in three dimensions, using information
extracted from stereotactic pairs of two-dimensional images. It is intended to provide guidance for
interventional purposes (such as biopsy, pre-surgical localization or FNA).
Senographe Stereotaxy includes the Senographe Stereotactic Positioner with adaptors for vertical and/
or lateral approach biopsies, and the Stereotaxy software application.
2 Overview
It is assumed that the reader of this manual is familiar with the Senographe Essential Acquisition System
Operator manual.
• The Stereotaxy application is entered automatically when the Stereotactic Positioner is installed. It is
used to perform a stereotactic exam, to locate breast masses or micro-calcifications in three
dimensions. When it has been located, information of coordination is sent to the Stereotactic
Positioner, where it is used to accurately position a suitable needle to perform cytology/histology or
hook wire placement.
• Standard X-ray images are made with the X-ray beam
perpendicular to the image receptor; only 2-dimensional
information (X and Y coordinates) is available. In
Stereotaxy, the Senographe tube arm can be angled
independently of the image receptor, allowing the
calculation of 3-dimensional information (X, Y, Z) from
images taken at ±15° with respect to a line perpendicular
to the plane of the image receptor. This information is
then sent to the Stereotactic Positioner.
• The Stereotactic Positioner is a self-contained unit which
is mounted on the Senographe image receptor, in place
of the Bucky. It includes a compression paddle
(independent of the main compression system), used to
immobilize the breast during the procedure. The paddle
used for vertical approach procedures has an aperture to
allow the passage of needles; a paddle without aperture
is used for lateral approach procedures. The unit
includes a needle holder which accepts interchangeable
needle guides for accurate positioning of various types
of needles. Provision is made for the use of spring-
loaded and vacuum assisted biopsy devices.
• When an area of interest has been identified, and
located by the software, its 3-dimensional coordinates
are sent to the positioner, finally the needle holder is manually operated or motorized driven to the
exact required position which depends on the needle and device to be used . The needle is then
introduced through the needle guides, in the breast.
Stereotaxy.fm Page no. 19 Chapter 3

3 Principles
3-1 General
Stereotaxy is a process which allows you to determine the location (X, Y and Z coordinates) of an object
of interest (such as a suspected lesion), using a stereo pair of X-ray images. It is then possible to
accurately perform a puncture at this location.
0°
0°
+15° -15°
A B
• A single image (such as the scout image) taken with the tube arm at the 0° position, perpendicular to
the plane of the image receptor, can only show the X and Y coordinates of the projection of an object
on the image plane. See illustration A.
• If an image of the same object is taken with the tube arm at a different angle with respect to the
image receptor, the object appears to shift along a line called epipolar line. The shifted distance
along the epipolar line depends on the tube arm angle, and is proportional to the height (Z) of the
object above the image plane. See illustration B.
• Stereotaxy uses a stereo pair of images, taken with the tube arm angled to +15° and -15° with
respect to a line perpendicular to the image receptor.
• By measuring the position of the object on each of the two images of the stereo pair, its position in all
three dimensions (X, Y, and Z) can be computed.
• A scout view and an associated stereo pair may be referred to as a stereo triplet.
3-2 Biopsy devices

A number of biopsy devices may be used with the Stereotactic Positioner. They include spring-loaded
core biopsy devices which fire, specially designed core extraction needles, at high speed for efficient
extraction of core material, and vacuum assisted needle biopsy devices (VAD) which use vacuum
suction to obtain tissue samples.
Refer to section 4 Compatibility on page 24 for a summary of biopsy devices with which the system is
designed to be compatible.
Chapter 3 Page no. 20 Stereotaxy.fm

3-3 Types of Examination

3-3-1 Fine needle aspiration (FNA)
In an FNA cytology exam, a fine needle is inserted into a suspect area in the breast to take a sample of
cells. The needle is usually inserted manually (no biopsy device). Two different techniques are typically
used to obtain a sufficient quantity of cells: either aspiration through the needle by a syringe, or by
leaving the needle inserted in the suspect area for a few minutes, to allow cells to move up the needle by
capillary action.
An anatomo-pathology examination is made on the sample obtained, to determine the type of cells and
their pathological character.
3-3-2 Core Biopsy (CB)
In a CB histology exam, a larger needle is fired into the breast tissue by a spring-loaded biopsy device.
The needle is designed to extract a core sample of tissue from the suspect area in the breast. Typically,
one sample of tissue is removed per needle insertion.
An anatomo-pathology examination is made on the sample obtained, to determine the type of cells and
3-3-3 Vacuum assisted device (VAD)
Vacuum assisted biopsy devices may be used in histology exams to extract sample tissue from a
suspect area by using vacuum aspiration to draw material through the needle. The needle may then be
rotated before obtaining additional samples, allowing the collection of multiple samples during one
needle insertion.
When used in vertical approach, some vacuum assisted devices require a holder (VAD with holder),
while others are hand-held (VAD without holder).
An anatomo-pathology examination is made on the samples obtained, to determine the type of cells and
3-3-4 Marker clip placement
After a biopsy (FNA, CB, or VAD), a biopsy device may be used to insert a marker clip (a small
radiopaque marker), allowing the biopsy area to be located precisely during later exams or surgery.
3-3-5 Hook wire placement
For pre-surgical localization, a special needle containing a radiopaque hook wire is inserted through the
skin and into the breast. The needle is usually inserted manually (no biopsy device). The hook wire is a
metal wire having a hook at its distal point, so that it remains in place when the needle is removed from
the breast. The presence of the hook wire allows the surgeon to accurately locate the lesion in the
breast, localization may be preceded by a cytological or histological puncture.

3-4 Vertical vs. Lateral Approach

The Stereotaxy solution on Senographe allows punctures to be performed following two different
approaches: vertical and lateral.
• In vertical approach biopsy the needle is introduced perpendicularly to the detector.
• In lateral approach biopsy the needle is introduced laterally to the breast, horizontally to the detector.
a a
As shown in the drawing, the lateral arm (b) simulates a needle having a length of (a) when
introduced vertically.
• It is the responsibility of the physician to decide which access is most suitable for each procedure,
depending on the position of the lesion and the biopsy device that will be used.

3-5 Examination types and identification

The following table summarizes the main types of examination performed using the stereotaxy system,
and indicates the needle category which must be selected (in the Create needle menu, described in
Chapter 11 Needle Setup) when setting up or modifying a needle.
Examination Biopsy device to be used Selection in Create needle menu

Device Description Vertical approach Lateral approach
FNA No specific 0.9 mm or smaller FNA LAT
(Fine Needle
Aspiration)
Core Biopsy BARD Magnum Spring loaded CB LAT
Mammotome ST
Biopsy using a Mammotome Vacuum assisted VAD with holder LAT
vacuum assisted Biopsys
device SenoRx EnCor
BARD Vacora Vacuum assisted VAD without holder LAT
Suros ATEC
Marker clip Any biopsy device According to According to LAT
placement biopsy device in biopsy device in
use use
Hook wire No specific 0.9 mm, 1 mm and FNA LAT
placement 1.2 mm

4 Compatibility
• The Stereotaxy option has been designed to be compatible with the needles and biopsy devices
listed below.
• Where appropriate, installation instructions for biopsy devices listed here are given in this manual.
• For the full operating instructions of biopsy devices, you must refer to the manufacturer’s instructions
for use. Contact the biopsy device manufacturer for ordering information.

4-1 Vertical and lateral approach

Needle or Needle or Needle guide manufacturer Needle and needle guide dimensions
device device
manufacturer
FNA No specific - Disposable plastic needle - Needle: 20G and 21G and
guide manufactured by greater.
Perouse Medical (*). - Needle guide: 20G and 21G (1
- Sterilizable metal needle mm and 0.9 mm).
guide distributed by GE.
Hook wire No specific - Disposable plastic needle - Needle: 19G, 20G and 21G.
guide manufactured by - Needle guide: 19G, 20G and 21G
Perouse Medical (*). (1.2 mm, 1 mm and 0.9 mm).
- Sterilizable metal needle
guide distributed by GE.
Suros ATEC Hologic (**) Sterilizable metal needle guide - Needle: 9G and 12G.
(**) distributed by GE. - Needle guide: 9G and 12G (3.9
mm and 2.9 mm).
Mammotome Devicor (**) Sterilizable metal needle guide - Non-circular needle: 8G,11G and
ST (**) distributed by GE. 14G.
(non-circular - Needle guide for non-circular
needle) needle: 8G, 11G and 14G (6.2
mm, 4.8 mm and 3.3 mm).
Mammotome Devicor (**) Sterilizable metal needle guide - Non-circular needle: 11G and
Biopsys (**) distributed by GE. 14G.
(non-circular - Needle guide for non-circular
needle) needle: 11G and 14G (4.8 mm
and 3.3 mm).
SenoRx BARD/ For compatible needle guide, - Needle: 7G and 10G.
EnCor (**) SenoRx (**) please refer to manufacturer - Plastic and metal needle guides :
user documentation of needle 7G and 10G.
or device.
BARD BARD (**) - Disposable plastic needle - Needle: 11G, 12G, 14G, 16G
Magnum (**) guide manufactured by and 18G.
Perouse Medical (*). - Needle guide: 11G, 12G, 14G,
- Sterilizable metal needle 16G and 18G (3.2 mm to 1.4
guide distributed by GE. mm).

Needle or Needle or Needle guide manufacturer Needle and needle guide dimensions
device device
manufacturer
BARD Vacora BARD (**) For compatible needle guide , - Needle: 10G.
(**) please refer to manufacturer - Plastic needle guides for metallic
user documentation of needle coaxial cannula (4 mm).
or device. - Plastic needle guides for plastic
coaxial cannula (4.5 mm).
- Other needles/gauges may be available.
(*) Perouse medical is not a distributor. For distribution informations, contact your GE Sales and
Service representative.
(**) See Trademark information on page 208.

Stereotaxy components
Chapter 4 Stereotaxy components
1 Overview
This chapter gives an introduction to components used in the Senographe Essential Stereotaxy system.
• The standard configuration of Senographe Stereotaxy includes:
- The Stereotactic Positioner, shown in section 2 Stereotactic Positioner on page 28, and fully
described in Chapter 5 The Stereotactic Positioner.
- Accessories provided with the Stereotactic Positioner, shown in section 3 Accessories supplied
with the Stereotactic Positioner on page 29. They include the aperture paddle, metal needle guide
adaptors for vertical and lateral approach, the calibration needle for vertical approach and a
phantom used for calibration and verification of accuracy, in vertical approach (FNA and Hook
wire needles). Some other service tools are also included in this kit.
- The Vertical Holder kit; components of the kit are shown in section 4 Parts contained in the
Vertical Holder Kit on page 31. This kit, supplied in a carrying case, provides parts required for
mounting interventional tools (needles, biopsy devices, etc.) to be used in vertical approach.
- The Lateral Holder kit; components of the kit are shown in section 5 Parts contained in the Lateral
Holder Kit on page 33. This kit, supplied in a carrying case, contains components required for
mounting interventional tools (needles, biopsy devices, etc.) to be used in lateral approach. It
includes the non-aperture paddle, and a phantom used for calibrating lateral approach tools and
verifying accuracy in vertical and lateral approach.
• Typical needle guides are shown in section 6 Needle guides on page 38. According to the biopsy
device in use, and the type of intervention, needle guides may be provided by GE or by the
manufacturer of the biopsy device.
DS_Ess_Stereo_Parts.fm Page no. 27 Chapter 4

2 Stereotactic Positioner
Part name Code Comment Illustration
Stereotactic Positioner SP The Stereotactic Positioner is a
self-contained unit which is
mounted on the Senographe
image receptor, in place of the
Bucky. A compression paddle
fitted to the positioner is used,
independently of the main
compression system, to
immobilize the breast during
stereotactic procedures. The
paddle used for vertical approach
procedures has an aperture to
allow the passage of needles; a
paddle without aperture is used for
lateral approach procedures. The
unit includes a needle holder
which accepts interchangeable
needle guides for accurate
positioning of various types of
needle
Chapter 4 Page no. 28 DS_Ess_Stereo_Parts.fm

3 Accessories supplied with the Stereotactic Positioner

3-1 Adaptors
Metal needle guide VA1 Fits in the SP needle holder upper
adaptor for vertical support, to hold a needle guide for
approach (upper): use in vertical approach
procedures.
Metal needle guide VA2 Fits in the SP needle holder lower

adaptor for vertical support, to hold a needle guide for
approach (lower): use in vertical approach
procedures.
Metal needle guide Reusable, to be disinfected before use. Supplied in packs of 3

adaptors for vertical
approach (upper or
lower):
Metal guide for the LG Fits in the SP needle holder upper
lateral arm securing rod, support. Used in lateral approach
also used as a metal procedures to hold the securing
needle guide adaptator rod L2 on lateral arm. It is also
for vertical approach : used in vertical approach with
specific devices.
Metal guides for the Reusable, to be disinfected before use. Supplied in packs of 3
lateral arm securing rod: 8 mm axis.
3-2 Aperture paddle

Compression paddle AP Fits to the SP to apply breast
with aperture. compression during vertical
approach procedures. For lateral
approach procedures it is replaced
by the non-aperture paddle L6.

3-3 Vertical approach phantom

Vertical approach VAP The vertical approach phantom is
phantom used with FNA and hook wire
needles for vertical approach
accuracy tests.
Its use is described in Chapter 16
Planned Maintenance, section
QC Test 2 - Localization Accuracy
- Vertical Approach on page 165
3-4 Calibration tools

Calibration tools (for the SPT Tools for use by the FE during
FE) initial setup of the SP.
Calibration needle The 120 mm Calibration needle is

120mm used to calibrate the SP, and for
the Accuracy QC test in Vertical
Approach.
Its use is described in Chapter 16
Planned Maintenance, section
QC Test 2 - Localization Accuracy
- Vertical Approach on page 165.

4 Parts contained in the Vertical Holder Kit

• The parts described below are required for use with biopsy devices used in vertical approach. They
are contained in the Vertical Holder kit, which is supplied in a carrying case,
• For information on installing kit components, refer to Chapter 8 Installation for Vertical Approach

Biopsy device support V1 Clips over the SP head to support
biopsy devices in vertical
approach.
Mammotome Biopsys V2 Holder fitted to Mammotome

holder Biopsys devices for use in vertical
approach. Slides onto the Biopsy
device support V1.
Mammotome ST holder V3 Holder fitted to Mammotome ST

devices for use in vertical
approach. Slides onto the Biopsy
device support V1.
BARD Magnum guide V4 Clips over the SP head to guide

BARD Magnum devices when
used in vertical approach.
Securing rods V5 Used with the securing plate V6 to

secure the biopsy device support
V1 in place on the SP.


Securing plate V6 Used with the securing rods V5 to
secure the biopsy device support
V1 in place on the SP.
Knurled securing screw V7 Used to secure a Mammotome

biopsy device to its holder V2 or
V3.

5 Parts contained in the Lateral Holder Kit

• The parts described below are required for use with biopsy devices used in lateral approach. They
are contained in the Lateral Holder kit, which is supplied in a carrying case.
• For information on installing the kit components, refer to Chapter 9 Installation for Lateral Approach,
• A Pin Phantom (L19) is included in the kit for use in vertical and lateral approach accuracy tests. Its
use is described in Chapter 16 Planned Maintenance, section QC Test 5 - Localization Accuracy -
Lateral Approach on page 176.
Lateral approach tool L1 Clips over the SP head when the
support lateral approach adaptor bar L4 is
used. The securing rod L2 passes
through the support.
Securing rod L2 Acts as a pivot for the lateral

adaptor bar L4. It passes through
the tool support L1, the adaptor
bar L4, and the metal guide for
lateral approach LG, and screws
into securing plate L3.
Securing plate L3 Fits under the SP vertical carrier to
hold the securing rod L2.
Lateral adaptor bar with L4 + Used to support biopsy devices

positioning cursor L5 and associated needle guide
holders during lateral approach
procedures.
The adaptor bar L4 pivots on the
securing rod L2.
The cursor L5 can be moved
along the adaptor bar to provide a
locating point.


Non-aperture L6 Fits to the SP to apply breast
compression paddle. compression. Used in place of the
aperture paddle during lateral
approach procedures.
Rigidity bar support L7 When required, one of these ball

joint supports is secured to the
side of the SP, using the support
screws L9. The rigidity bar L10
can then be clipped to the ball joint
on the support. Used for DS
systems only; ball joints are fitted
permanently to the sides of the
Essential SP.
Key (hex wrench) L8 Used to install or remove the See paragraph :
support screws L9. Contents of the lateral holder
kit on page 67
Rigidity bar support L9 Used to secure the rigidity bar See paragraph :
screws support L7 in place on the side of Contents of the lateral holder
the SP. kit on page 67
Rigidity bar L10 Clips between the permanently
attached support and the lateral
needle guide holder or support
(L13, L15, or L18), to prevent
movement. Its length is adjustable
as required.


Biopsy device support L11 Fitted to several VAD (senoRx
EnCor, Mammmotome ST,
Mammototme Biopsys, Suros
ATEC) . The assembly can then
be attached to the lateral adaptor
bar L4. The lateral lock (spring clip
A) is for use with the Mammotome spring clip A
Biopsys; it is removed when the removed
support is fitted to the
Mammotome ST, SenoRx EnCor,
Suros ATEC.
spring clip A
Biopsy device support L12 Used to secure the biopsy device

screw support L11 to Mammotome,
SenoRx EnCor, Suros ATEC
biopsy devices.
Guide holder support L13 Slides on the lateral adaptor bar
L4. A needle guide holder L14 or
L16 is attached to the bottom of
the support.The rigidity bar L10
clips to one of the two ball joints.
Used for BARD Vacora (when
mounting the lateral kit on the left
side).
Needle guide holder for L14 Fits to the guide holder support
lateral approach: 6 mm L13 or L15 to hold a 6 mm needle
dia guide for use in lateral approach.
Needle guide holder for Reusable, to be disinfected before use. Supplied in packs of 5
lateral approach: 6 mm axis.


Guide holder support L15 Slides on the lateral adaptor bar
L4. A needle guide holder L14 or
L16 is attached to the bottom of
the support.The rigidity bar L10
clips to the ball joint.
Used for Mammotome ST,
Mammotome Biopsys, SenoRx
EnCor, Suros ATEC, BARD
Vacora.
Needle guide holder for L16 Fits to the guide holder support
lateral approach: 8 mm L13 or L15 to hold an 8 mm
dia needle guide for use in lateral
approach.
Needle guide holder for Reusable, to be disinfected before use. Supplied in packs of 5
lateral approach: 8 mm axis.
BARD Magnum holder L17 Slides on the lateral adaptor bar
L4 to hold the BARD Magnum
biopsy device for use in lateral
approach.
Needle guide holder L18 Slides on the lateral adaptor bar

L4 to hold two needle guides for
use with the BARD Magnum
device in lateral approach. The
rigidity bar L10 clips to the ball
joint,
May also be used with the
calibration needle L20 during the
lateral arm length measurement
procedure,and localization
accuracy test in lateral appproach.


Pin phantom (calibration L19 Tool used for localization accuracy
tool) tests and lateral arm length
measurement.
Calibration needle 70mm L20 Mounted in the needle guide

holder L18, for use with the Pin
Phantom L19 during the lateral
arm length measurement
procedure, and for the Accuracy
QC tests in Lateral Approach.

6 Needle guides
Note:
Needle guides may also be referred to as bushings. The term needle guide is used throughout this
manual for consistency.
• Needle guides may be provided by GE or by biopsy device manufacturers, and exist in many sizes
and forms for different uses. The information provided here is indicative only.
Plastic needle guide NGP To be inserted in
metal needle guide adaptors
(upper and lower) to position the
needle.
Plastic needle guides: Supplied sterilized, for one-time use, in packs of 10 (5 pairs).
Diameters (mm): 0.9, 1.0, 1.2, 1.4, 1.8, 2.25.
Plastic needle guide with HWG To be inserted in metal needle
slot, for use with hook guides adptators (upper and
wires. lower) to position the needle for a
hook wire localization exam.The
needle passes through the holes
in the needle guides, and the slot
in the front of the guides allow the
wire to be disengaged after Plastic needle guide
withdrawal of the needles.

Plastic needle guides Supplied sterilized, for one-time use, in packs of 10 (5 pairs).
with slot: Diameters (mm): 0.9, 1.0, 1.2.
Metal needle guide. NGM To be inserted in metal needle
guide adptators (upper and lower)
to position the needle.
Metal needle guides: Reusable, to be sterilized before use. Supplied in packs of 4 (2 pairs).
Diameters (mm): 0.9, 1.0, 1.2, 1.4, 1.8, 2.25, 2.55*, 2.9*, 3.2* (* = without
retaining catch).
Metal needle guides for NG Fits in upper and lower SP needle
VAD. holder :
- Available for 8G,11G and 14G
Mammotome needles (non-
circular needles).
- Available for 9 G and 12 G
circular needles.
Metal needle guides. - Reusable, to be sterilized before use. Supplied in packs of 5.
Available for 8G, 11G And 14G Mammotome needles.
- Reusable, to be sterilized before use. Available for 9G and 12 G circular
needles.

The Stereotactic Positioner
Chapter 5 The Stereotactic Positioner
1 Introduction
This chapter provides information on the Stereotactic Positioner and the Stereo Compression Paddle.
• The main positioner components are described in section 2 The Stereotactic Positioner on page 39.
• Installation and removal of the stereo compression paddle is described in section 3 The stereo
compression paddle on page 41.
2 The Stereotactic Positioner

The illustration below shows the Stereotactic Positioner unit on its table support.It is followed by a brief
description of each of the components and controls provided. Refer to Chapter 6 Installation of the
Stereotactic Positioner, section 1 Installing the Stereotactic Positioner on page 43 for information on
installing the unit.
Display panel
Rotation/Angulation button
Needle path block lever Movement control buttons
Needle holder
Compression knob
Stereo compression
paddle Movement control knobs
(X, Y, Z)
Table support
Breast support
• Display panel. This panel displays positioning information. When not in use, the panel is stored in
its holder on top of the unit, as shown. In use, it may be placed on the side of the unit, held in
place by its magnetic back.
• Stereo compression paddle and compression knobs. The compression paddle is used to
immobilize the breast during the exposure and puncture procedures. An aperture in the paddle
allows the needle to penetrate the breast in vertical approach. A non-aperture paddle is provided
for use in lateral approach. Refer to section 3 The stereo compression paddle on page 41 for
information on paddle installation and removal.
Compression is applied manually, using one of the two compression knobs (one on each side of
the unit).
• Breast support. The breast support forms part of the Stereotactic Positioner assembly. The
assembly is mounted on the Image Detector in the same way as other breast supports (Bucky
and Magnification Stands). Four crosses are engraved on the breast support to indicate the limits
of the biopsy window.
• Movement control knobs. Three knobs are provided to allow manual positioning of the needle
holder on the three axes, X, Y, and Z. These knobs are duplicated on each side of the SP.
• Movement control buttons. Two sets of three buttons (one set on each side of the unit) are
provided to control motorized movement of the needle holder: Go to Park P , Go to Target
Stereotaxy positioner.fm Page no. 39 Chapter 5

, and Next Target . A light next to each Go to Target button becomes green to
indicate that the target position has been reached, or flashes green to indicate that the needle
holder is in the Park position.
• Rotation/Angulation buttons. Two buttons (one on each side of the
unit) are provided to enable switching between rotation and
angulation modes when positioning the gantry for stereotactic
exposures. A green light next to each button is lit when the
angulation mode is in use. Refer to Chapter 10 Preparation for
examinations, section 2 Arm Positioning on page 94.
• Needle path block lever. Motorized movement is not allowed

unless this lever has been pushed to the right to block the needle
path and prevent needle insertion.
• Needle holder. The holder provides two supports for removable

needle guide adaptors, which hold needle guides for use in vertical
approach procedures.
When using some biopsy devices in vertical approach, the adaptors
may be removed or replaced. Refer to the biopsy device installation
instructions.
For lateral approach procedures, both adaptors are removed, and an
adaptator for the lateral arm securing rod is placed in the upper
support. Refer to the installation instructions for lateral approach.
Vertical movement of the upper support allows precise positioning of the puncture tool. Movement
may be motorized or manual (by turning the Z control knob).
The lower support may be moved up and down manually as required.
Chapter 5 Page no. 40 Stereotaxy positioner.fm

3 The stereo compression paddle

The stereo compression paddle is used to immobilize the breast
during the exposure and puncture procedures. B
An aperture in the paddle allows the needle to penetrate the breast
in vertical approach. A non-aperture paddle is provided for use in
lateral approach.
The stereo compression paddle assembly includes two components,
the paddle support (A), and the plastic paddle itself (B).
3-1 Installation and removal of the paddle support

• The paddle support may be installed on or removed from the
Stereotactic Positioner with or without the plastic paddle in place.
CAUTION
To avoid risk of damage to the paddle when installing or removing

the paddle support, take care to press only on the metal of the
support. Do not apply pressure to the plastic paddle.
• To install the support on the positioner, hold it under the mounting slot
at the front of the positioner as shown.
Press the support firmly upwards until it clicks into place.
• To remove the support, reverse the procedure. Press the support
firmly downwards to release and remove it.
3-2 Removal and installation of the plastic paddle

• Follow the sequence shown in the illustrations below to remove the plastic paddle from its support:
1. Paddle shown locked in its normal position on the metal support.
2. Keeping your thumbs on the paddle to prevent it from falling, release it by turning the two locking
levers to the vertical position.
3. Pull the paddle forwards.
4. Lift the front of the paddle slightly. It can now be pulled away from the support
1 2 3 4
• Reverse the procedure to install the plastic paddle. On completion, remember to lock the paddle in
position by turning the two locking levers to the horizontal position.
Stereotaxy positioner.fm Page no. 41 Chapter 5

Chapter 5 Page no. 42 Stereotaxy positioner.fm

Installation of the Stereotactic Positioner
Chapter 6 Installation of the Stereotactic Positioner
1 Installing the Stereotactic Positioner

For a description of the Stereotactic Positioner, refer to Chapter 5 The Stereotactic Positioner.
WARNING
The rear of the Stereotactic Positioner assembly is very heavy. Take great care when installing or
removing the assembly. It is important to hold it using both metal rods, to ensure the best
possible grip. Especially, do not try to hold the assembly using the compression knobs, the
carbon cover, or any attached parts (e.g., the lateral approach tool if it is mounted).
If the Stereotactic Positioner assembly falls on the detector, or is allowed to slide at an angle on
the detector, it can cause irreparable damage.
When not installed, the assembly should be placed on its special table stand. If it is placed on a
flat surface without support, its own weight may cause it to tip over and cause damage.
Note:
Installation of the Stereotactic Positioner is easiest when the Arm angle is 0°, and the operator is
directly facing the Image Detector. Adjust the Arm elevation as required for comfort and ease of
installation.
• To install the Stereotactic Positioner on the Senographe Arm:
1. Remove Senographe accessories:
- Face shield
- Compression paddle
- Bucky or magnification platform
2. Move the compression paddle holder on the Senographe arm to the
maximum height, using the footpedal and manual controls.
Note:
If the compression paddle holder on the gantry is not in its upper
position, angulation will not be allowed.
3. Hold the Stereotactic Positioner and breast support assembly by the
metal rods as shown. Carefully align the assembly with the rails, and
slide it onto the rails as shown. Press on the front of the breast
support until motor noise is heard, indicating the start of the locking
phase. You should hear a click (as for Bucky installation). The display
panel then displays Communcation not established, followed by
Ready.
After Stereotactic Positioner locking has been completed, the red line on the rear cover must not be
visible. If it is visible, the breast support has not been inserted correctly. Remove it and insert it
correctly, sliding it along the rails until motorized locking begins.
4. Attach the Display Unit to the positioner housing so that it is easily visible, held in position by its
magnetic base.
5. Use the manual control knobs to move the stereo compression paddle to its highest position.
6. Press and hold the Go to Park button P to move the needle holder out of the field of view. The
display panel should now display position coordinates for the upper needle holder support.
Install stereotactic positioner.fm Page no. 43 Chapter 6

Installation of the Stereotactic Positioner
! Notice:
The knobs at the sides of the Senographe compression paddle holder (used for manual
compression in standard mammography) must not be operated once the Stereotactic Positioner is
in place.
• The Senographe can now be positioned for the projection required as described in Chapter 10
Preparation for examinations, section 2 Arm Positioning on page 94.
2 Removing the Stereotactic Positioner
WARNING
The rear of the Stereotactic Positioner assembly is very heavy. Take great care when installing or
removing the assembly. It is important to hold it using both metal rods to ensure the best possible
grip, as described above (section 1). Especially, do not try to hold the assembly using the
compression knobs, the carbon cover, or any attached parts (e.g., the lateral approach tool if it is
mounted).
Take great care, and be prepared to take the weight when removing the assembly. If it falls on
the detector, or is allowed to slide at an angle on the detector, it can cause irreparable damage.
After removal, the assembly should be placed on its special table stand. If it is placed on a flat
surface without support, its own weight may cause it to tip over and cause damage.
To remove the Stereotactic Positioner assembly, press the two breast
support unlocking buttons (located underneath the Image Detector)
simultaneously. It is only necessary to press them briefly to start the
unlocking phase. Do not pull the assembly; unlocking takes place
automatically. Motor noise is heard during the entire unlocking phase.
When the unlocking movement stops (after about three seconds),
remove the assembly by manually sliding it along the rails.
Breast support
unlocking buttons
Chapter 6 Page no. 44 Install stereotactic positioner.fm

Procedure Steering Guide
Chapter 7 Procedure Steering Guide
1 Introduction
This chapter provides a step-by-step guide to stereotaxy examination procedures.
Section 3 Pre-examination check on page 45 refers to procedures required to make needle path tests
and accuracy tests for vertical and lateral approaches using a stereotaxy phantom.
Section 5 Patient examination on page 46 describes the normal procedures required for use with a
patient.
2 Quick reference
Section 3 Pre-examination check on page 45
Section 4 Cleaning, disinfection, and sterilization on page 45
Section 5 Patient examination on page 46
5-1 Preparation on page 46
5-2 Stereotaxy exposures on page 47
5-3 Define puncture on page 48
5-4 Send the puncture set and move the Stereotatic Positioner to the target position on page 49
5-5 Puncture on page 50
5-6 Secondary targets (if required) on page 50
5-7 Completion on page 51
3 Pre-examination check
• The following tests are described in Chapter 16 Planned Maintenance section 3 QC Tests for the
Radiologic Technologist or Medical Physicist on page 161.
- QC Test 1 - Needle Path Block Test on page 163.
- QC Test 2 - Localization Accuracy - Vertical Approach on page 165.
- QC Test 5 - Localization Accuracy - Lateral Approach on page 176.
For information on the frequency of the above listed tests, refer to the description of each test.
If no stereotactic exams are carried out, the tests should be carried out at least once a month to
ensure continued accuracy:
• Record the test results as instructed in Chapter 16 Planned Maintenance section 4 Test Result
Record sheets on page 185.
• Refer to local rules and regulations for the required frequency of geometrical accuracy tests using the
phantoms.
4 Cleaning, disinfection, and sterilization

The room and all equipment must be kept in a clean condition.
Before and after each exam, carry out appropriate disinfection and sterilization procedures on all
equipment surfaces.
Refer to Chapter 15 System Hygiene.
Procedures.fm Page no. 45 Chapter 7

5 Patient examination
5-1 Preparation
1. Switch on the Senographe and install the Stereotactic Positioner as described in Chapter 6
Installation of the Stereotactic Positioner, section 1 Installing the Stereotactic Positioner on page 43.
After pushing the Go to Park button P as instructed in Chapter 6 Installation of the Stereotactic
Positioner, the display panel should display position coordinates for the upper needle holder support.
2. For biopsy devices in vertical approach, refer to Chapter 8 Installation for Vertical Approach:
- If required, install the vertical adaptor or other parts as described.
3. For biopsy devices in lateral approach, refer to Chapter 9 Installation for Lateral Approach:
- If required, install the lateral adaptor or other parts as described.
- Depending on the position of the targeted lesion, the puncture should be performed from the side
(right or left) that allows the shortest route. Check the Accessibility:
- Any lesion located at the Right part of the Scout (0°) image should be accessed from the Right
Any lesion located at the Left part of the Scout (0°) image should be accessed from the Left.
- Any lesion located within 2 cm of the center of the Scout (0°) image can be accessed from
either Left or Right, if the distance between the lesion and the entrance point in the breast is
less than the useful needle length.
4. Prepare the biopsy device to be used, with its mounting bracket if required.
5. Ensure that the needle or biopsy device to be used is specified in the Needle Panel Refer to
Chapter 11 Needle Setup for more information.
6. Open the Worklist window and verify that the selection for the type of exam is Stereo.
7. Select the patient’s name/ID in the Patients list on the Worklist by clicking on it.
If the Patient has not yet been defined, select New Patient... in the Worklist, and complete the new
Medical Procedure Card as required, before starting image acquisition. Refer to Chapter 12
Stereotaxy Image Acquisition section 1 Starting the Stereotaxy application on page 125.
8. Click the Start Exam button. The Stereotactic Viewer appears, with the Viewer area at the right of the
screen remaining black until an exposure is taken.
9. Move the compression paddle on the Stereotatic Positioner to its highest position.
10. Press the rotation buttons to set the gantry at the selected incidence.
11. Press and hold the Go to Park button P to move the needle holder out of the field of view.
Image acquisition is allowed only when the display shows parking.
12. Position the patient as described in Chapter 10 Preparation for examinations section 3-3 Positioning
the Patient on page 99. Ensure that the area of interest is in the field of view and compress the breast
to immobilize it. Note that the system does not recognize the presence of a breast unless the
compressed thickness is less than10 cm.
13. Press the Rotation/Angulation button on the Stereotactic Positioner to switch from rotation mode to
angulation mode. The gantry readout now displays the stereo angle, not the gantry angle. Refer to
Chapter 10 Preparation for examinations, section 2 Arm Positioning on page 94.
Chapter 7 Page no. 46 Procedures.fm

5-2 Stereotaxy exposures

Note:
The procedure described here creates a set of three images, a scout image and two stereo
images. This set of images may be referred to as a Stereo triplet.
1. Select the exposure mode (AOP or manual). See Chapter 12 Stereotaxy Image Acquisition section
3-2 Exposure Modes on page 132.
2. Make the scout exposure. The scout image appears in the Viewer area.
3. Adjust the window width and level if necessary for best viewing level.
4. Verify that the area of interest appears inside the projection of the compression paddle aperture, or
within the four engraved crosses. If not, release compression and reposition the patient.
5. Move the cursor onto the center of one of the two Reference Markers . Press and hold the left
mouse button until the cursor icon becomes a pencil, then drag the Reference Marker to place it
exactly on top of one of the images of the inverted T reference marks, as described in Chapter 13
Stereotaxy Punctures section 1 Defining punctures on page 135. Repeat the procedure to drag the
other Reference Marker and place it on top of the image of the other inverted T reference mark.
Use the invert function (Chapter 12 Stereotaxy Image Acquisition, section 2-4 Control Panels on
page 130) to confirm the positioning.
6. Make the two stereo exposures, with the tube angled first to +15°, then to -15°.
See Chapter 10 Preparation for examinations section 2 Arm Positioning on page 94 for a description
of tube arm movements.
See Chapter 12 Stereotaxy Image Acquisition, section 3 Making Stereotaxy exposures on page 132
for an explanation of the exposure sequence.
7. The stereo images are displayed in the monitor Viewer area in Stereo mode (the images in lower half
of the viewing area are zoomed images of the top half; see Chapter 12 Stereotaxy Image Acquisition
section 2 Stereotaxy viewer on page 126).
8. Use the right mouse button to click on the area of interest on each of the top images, to center the
lower zoomed images on the area of interest.

5-3 Define puncture
1. Click (left mouse button) on the Stereotaxy selection tab to open the Stereotaxy Panel
2. Click the New Primary button to define a new puncture set, then select the puncture marker and
drag it over the exact area of interest on each of the zoomed images. Use the Show/Hide Epipolar
buttons to view the epipolar line if necessary. Refer to Chapter 13 Stereotaxy Punctures section 1-
4 Placing the Primary Puncture Marker on page 136.
Note:
You must accurately select the same point seen on the two images. Inaccuracies may lead to
deviations when the needle is being inserted in the breast.
CAUTION
Before starting a puncture, make sure that the Z value of the target is greater than the specified
minimum accessible value for the biopsy device in use. If not, the breast must be repositioned for
access to the lesion.
3. Click the Check on scout button to display the scout image in the top half of the screen. This allows
you to check that the correct puncture site has been selected.
See Chapter 12 Stereotaxy Image Acquisition section 2-3 Viewing Area on page 127 for more
information on this feature.
4. Click the Back to Pair button to return to Stereo Mode.
5. If you wish to define Secondary puncture sites, click the Secondary button. See
Chapter 13 Stereotaxy Punctures section 1-5 Placing the Secondary Puncture 5.5
Markers on page 138 for more information on this feature.
To change the distance of the secondary markers from the primary site, click on the Secondary
up/down arrows to adjust the value displayed in the offset window (the value can be
changed by increments of 0.5 mm to the maximum of 20.0 mm).

5-4 Send the puncture set and move the Stereotatic Positioner to the target position
1. Click the Needle & Puncture button to open the Needle & Puncture panel. Note that this panel opens
only if the puncture set is within the puncture volume. Puncture volume is the volume in which the
Stereotactic Positioner can physically reach the defined puncture target position.(see Chapter 13
Stereotaxy Punctures for more information).
2. Select a pre-programmed needle or biopsy device, or define the needle if it does not already exist.
3. Click the Send button.
If this button is inactive, the cause is given in the status field below the button. Device-target
incompatibility may be caused by
- an unsuitable needle length,
- a risk of collision with the breast support,
- a puncture target outside the puncture volume, or
- because a correction to the Z target is needed to reach the lesion.
If a correction is required, click the Correction button to acknowledge and accept any required
changes (the correction is made automatically; if you make the correction manually you risk
missing the target). Now check at the bottom of the panel to see if there are any active warnings
present. Click Send if you still want to perform the puncture. Refer to Chapter 13 Stereotaxy
Punctures, section 2-2 Correction on page 145 for more information.
4. Angle the tube arm to either of the parking positions as required, (or +/-33°) to ease insertion of the
needle.
5. Press and hold the Go To Target button (or manually adjust the X, Y and Z knobs) on the
Stereotactic Positioner until the target position is reached; the light will now be green; the display
indicates TARGET REACHED and 0-0-0.
See Chapter 13 Stereotaxy Punctures section 4 Performing the puncture on page 151 for more
information.
Note:
Motorized movement is allowed only when the needle path is closed.
6. When the target has been reached, press the Go To Target button again to display the
programmed needle. Check that the correct needle or biopsy device has been chosen.
7. Install the required needle guides.
For the Lateral Arm, see Chapter 9 Installation for Lateral Approach, section 4-2-2 Install needle
guide holders and needle guides on page 81.

5-5 Puncture
1. If using a biopsy device, prepare the device and the adaptator (if needed).
- For a biopsy device in vertical approach, see Chapter 8 Installation for Vertical Approach.
- For a biopsy device in lateral approach, see Chapter 9 Installation for Lateral Approach.
2. Position the patient.
3. Perform the stereo triplet.
4. Mark the target, select the needle/device that will be used.
5. Clean/disinfect the breast.
6. Move the needle holder to target position.
7. Insert a fine needle through the sterile needle guides to check correct location to perform anesthesia
and inject anesthesic.
8. When the anesthesic is injected, remove the needle in use.
9. Move the needle holder back to make an incision, if necessary.
10. Move the needle holder back to target position.
11. Place the biopsy device in the cocked position and insert the needle through the sterile needle
guides.
Note:
Performing an incision and injecting anesthesic depends on the device in use so, the application
of the previous procedures is the decision of the performing physician.
12. Take pre-fire images (if CB or VAD). Take needle tip check images (if hook wire or FNA).
CAUTION
Pre-fire stereo images allow the needle position to be checked in the X and Y axes.
To check the Z position of the needle, it is recommended that you define a new target at the tip of
the needle, and compare the Z value with the Z value of the lesion.
13. Confirm needle placement. You can compare the pre-fire and the stereo pair by using the Pairs
Comparison feature (see Chapter 12 Stereotaxy Image Acquisition section 2-3 Viewing Area on
page 127).
14. Proceed to the sample collection as described in the Biopsy Device User Manual (if CB or VAD); get
the cellls sample (suction or capillarity if FNA).
15. A stereo pair can be taken after the sample collection, to check if more samples are needed, in case
of CB or VAD. A stereo pair could be performed to check the wire tip position in case of hook wire
exam.
16. Proceed with secondary targets if defined (Chapter 5-6 Secondary targets (if required)).
17. Remove the needle / device when all the necessary samples are obtained.
18. Marker clip insertion : for core biopsy, it might be useful to perform a marker clip insertion to mark the
targeted area for additional procedures. Follow the instructions provided by the clip manufacturer for
correct insertion and placement.
5-6 Secondary targets (if required)

1. If secondary targets have been defined, press the Next Target button until the desired target
is displayed.

2. Press the Go To Target button again to move the needle holder over the selected target (only
if the needle path was closed between sampling; otherwise move the holder manually).
3. Proceed with the remaining secondary targets.
5-7 Completion
1. Before releasing compression:
You may want to make a final image at 0° to check that affected tissue has been removed. To do this,
close the needle path and drive the needle holder to parking position.
2. Specimen imaging:
If another mammography system is available, leave the patient compressed and use the other
system to image the specimen. If no other system is available, release the patient from compression
before imaging specimens.
3. Slowly relase patient compression and proceed with appropriate patient after-care.
4. Print or archive the image(s) for permanent documentation.
Refer to Chapter 14 Image Printing and Review.
5. Specimen imaging after target completion:
- If the samples image (s) are performed on the Stereotatic Positioner, the compression paddle
holder must be moved to a height smaller than 10 cm to allow exposures.
- Samples image(s) can also be taken using the magnification stand.
6. Set the arm angulation to 0.0° (scout position), removal of the Stereotactic Positioner is allowed if
the compression paddle holder is moved to a height over 10 cm.


Installation for Vertical Approach
Chapter 8 Installation for Vertical Approach
1 Installing needles and biopsy devices for vertical approach

CAUTION
When a biopsy device is installed:

- Make sure that all securing screws are tightened to avoid unexpected movements,
- To avoid damage to the equipment and/or injury to the patient, it is recommended that the Z
knob should NOT be turned after installation of a biopsy device.
- Adjustments of the X and Y knobs must be performed with extreme care to avoid injury to the
patient.
1-1 Installation procedure - summary

• The Stereotactic Positioner must have been previously installed.
• Parts commonly required for the installation of biopsy devices for vertical approach are contained in
the vertical holder kit described in section 1-2 Contents of the vertical holder kit on page 55. When
additional adaptors are required, they are supplied by the manufacturer with the biopsy device.
• Refer to the diagram overleaf for an overview of the mechanical installation required.
• Parameters for the needle and biopsy device to be used must have been previously set up in the
Needle Panel, as described in Chapter 11 Needle Setup, section 2 Needle Setup on page 104
• If you are to make a puncture manually, with no biopsy device, install the correct size of needle
guides in the needle holder upper and lower supports. The puncture is made by passing the needle
through the guides.
• If you are using one of the following biopsy devices, first fit the biopsy device support V1. Refer to
section 2 Installing the biopsy device support on page 56:
- Mammotome ST.
- Mammotome Biopsys.
- SenoRx EnCor.
• If you are using the BARD Magnum biopsy device, first fit the biopsy device support V4, supplied in
the vertical holder kit.
• When the BARD Vacora and Suros ATEC biopsy devices are used in vertical approach, no support is
available. However, they may be positioned manually as “hand held” devices.
• Fit the desired biopsy device. Refer to section 3 Fitting a vertical approach biopsy device on page 58.
Install and use the biopsy device according to the manufacturer’s instructions.
Install vertical adaptors.fm Page no. 53 Chapter 8

Install the Stereotactic Positioner.
See 1 Installing the Stereotactic Positioner on page 43. Stereotactic Positioner SP
Chapter 8
Operator manual
Parts contained in the vertical holder kit:

Install the biopsy device support if
required.
See section 2 Installing the biopsy
device support on page 56. Biopsy device support V1
Fit the biopsy device.

See section 3 Fitting a vertical Mammotome Mammotome BARD Magnum
approach biopsy device on page 58. ST holder Biopsys holder guide
Overview installation for vertical approach
V3 V2 V4
Needle guides in Needle guide in Needle guide in Adaptor and Needle guides in
SP needle holder SP needle holder SP needle holder needle guide in SP needle holder
Page no. 54
upper and lower lower support lower support SP needle holder upper and lower
supports lower support supports
SenoRx EnCor
Hand held biopsy devices holder
Puncture to be Suros Atec BARD Vacora Mammotome ST Mammotome SenoRx EnCor BARD Magnum
made manually biopsy device biopsy device biopsy device Biopsys biopsy device biopsy device
No biopsy device biopsy device
Needle Needle Needle Needle Needle Needle Needle

5262169-8-1EN
Revision 3
Install vertical adaptors.fm

1-2 Contents of the vertical holder kit

V1 V4
V6
V5
V7
V2 V3
Refer to Chapter 4 Stereotaxy components (section 4 Parts contained in the Vertical Holder Kit on
page 31) for an overview and illustrations of parts contained in the kit.
Note:
It is strongly recommended that all kit components are returned to the carrying case after use.
Parts contained in the kit are listed in the following table:
Part Reference Quantity
Biopsy device support V1 1
Mammotome Biopsys holder V2 1
Mammotome ST holder V3 1
BARD Magnum guide V4 1
Securing rods V5 2
Securing plate V6 1
Knurled securing screw V7 1
Note:
Different biopsy devices require different parts from the kit. Refer to the installation instructions in
this chapter.

2 Installing the biopsy device support

• This support must be installed if you are using one of the following biopsy devices:
- Mammotome ST.
- Mammotome Biopsys.
- SenoRx EnCor.
• Install the biopsy device support as described below.
Parts which are required from the vertical holder kit are shown here:
Biopsy device support V1
Securing rods V5
Securing plate V6
1. Remove the stereo compression paddle. Refer

to Chapter 5 The Stereotactic Positioner,
section 3 The stereo compression paddle on
page 41.
Chapter 8 Page no. 56 Install vertical adaptors.fm

2. Clip the support V1 over the Stereotactic

Positioner head.
3. Pass both securing rods V5 through the holes

of the support V1.
4. Position the securing plate V6 so that it fits

snugly under the bottom of the Z travel carrier.
Secure it in position by screwing the two
securing rods V5 into it.
5. Re-install the compression paddle (removed in step 1).

3 Fitting a vertical approach biopsy device
WARNING
The use of Plexiglas or other material to build up the breast for a vertical approach procedure
may cause:
- Image quality degradation, so the lesion may therefore be missed.
- Risk of needle damage or breast perforation because the system is not aware of the thickness
of the breast as compared to the thickness of the supporting material.
It is the user’s responsability to ensure that no injury to the patient or damage to the equipment
results from the procedure.
Follow the instructions supplied for the biopsy device to be used:
• Mammotome ST
Refer to section 3-1 Fitting the Mammotome ST or Mammotome Biopsys biopsy device (vertical
approach) on page 59.
• Mammotome Biopsys
Refer to section 3-1 Fitting the Mammotome ST or Mammotome Biopsys biopsy device (vertical
approach) on page 59.
• SenoRx EnCor
Refer to section 3-2 Fitting the SenoRx EnCor biopsy device (vertical approach) on page 61.
• BARD Magnum
Refer to section 3-3 Fitting the BARD Magnum biopsy device (vertical approach) on page 62.
• BARD Vacora
Refer to section 3-4 Using the BARD Vacora biopsy device (vertical approach) on page 63.
• Suros ATEC
Refer to section 3-5 Using the Suros ATEC biopsy device (vertical approach) on page 64.

Installation for Vertical Approach Mammotome ST or Biopsys
Mammotome ST or Biopsys
3-1 Fitting the Mammotome ST or Mammotome Biopsys biopsy device (vertical

approach)
• First install the biopsy device support as described in section 2 Installing the biopsy device support
on page 56.
• Install the biopsy device as described below.
Parts which may be required from the vertical holder kit are shown here:
Mammotome Biopsys V2
holder
Mammotome ST holder V3
Knurled securing screw V7
3-1-1 Install the holder onto the biopsy device

Place the Mammotome holder V2 (for
Mammotome Biopsys) or V3 (for Mammotome ST)
on the back of the Mammotome biopsy device. The
two pins of V2/V3 should fit exactly into the two
holes of the Mammotome driver. Tighten the
knurled screw V7 to secure the holder in position.

Installation for Vertical Approach Mammotome ST or Biopsys
3-1-2 Install the needle guide

1. Remove the adaptor from the 2. Remove the adaptor from the 3. Install a Mammotome needle
needle holder upper support. needle holder lower support guide in place of the adaptor
(turn it and lift). in the lower support.
3-1-3 Install the biopsy device

1. If firing is desired, cock the biopsy device
before installation.
2. Carefully slide the Mammotome holder V2 or
V3, with its attached biopsy device, into the
guides of the Mammotome support V1, so that
the needle passes through the needle guide.
CAUTION
The biopsy device must not be left

unattended when installed.

Installation for Vertical Approach SenoRx EnCor
SenoRx EnCor
3-2 Fitting the SenoRx EnCor biopsy device (vertical approach)

• First install the biopsy device support as described in section 2 Installing the biopsy device support
on page 56.
3-2-1 Install the needle guide
1. Remove the adaptor from the 2. Remove the adaptor from the 3. Install the SenoRx EnCor
needle holder upper support. needle holder lower support metal adaptor and the correct
(turn it and lift). size of needle guide (7 or 10
gauge) in the needle holder
lower support.
3-2-2 Fit the SenoRx EnCor device to the biopsy device support
Note:
A sterile disposable needle guide is provided
with the SenoRx EnCor device.
1. Fit the SenoRx EnCor biopsy device to the
adaptor supplied. Follow the instructions
provided with the adaptor.
• When the needle holder is at the target

position, carefully slide the adaptor, with the
attached SenoRx EnCor, into the guides of the
biopsy device support V1, so that the needle
passes through the needle guide.
CAUTION
The biopsy device must not be left


Installation for Vertical Approach BARD Magnum
BARD Magnum
3-3 Fitting the BARD Magnum biopsy device (vertical approach)

Parts required from the vertical holder kit are shown here:
BARD Magnum guide V4
• Clip the BARD Magnum guide V4 over the

Stereotactic Positioner head.
3-3-1 Install the needle guides

• Install the metal needle guide adaptators and
correct size of needle guides in the needle
holder upper and lower supports.

position, insert the BARD Magnum biopsy
device through the opening in the BARD
Magnum guide V4 so that it rests on the upper
needle, with the needle passing through the
two needle guides.
• Make sure that the correct throw of the biopsy
device (15 mm or 22 mm throw) has been
selected, corresponding to the needle length
and notch length set up in the Needle Panel.
CAUTION
The BARD Magnum biopsy device is not

secured in its position. It must not be left

Installation for Vertical Approach BARD Vacora
BARD Vacora
3-4 Using the BARD Vacora biopsy device (vertical approach)

• Install the metal needle guide adaptators and
correct size of needle guides in the needle
holder upper and lower supports.

• Select the pre-defined needle matching the
needle and notch length, and send the required
target.
• Prepare the breast for the puncture.
position, hold the body of the biopsy device and
pass the needle through the needle guides until
the biopsy device rests on the upper needle
guide.
CAUTION
The BARD Vacora biopsy device is not

unattended when installed..
Note:
The BARD Vacora device is always used with a coaxial cannula, a spacer may also be added.It
changes the needle length value as well as notch and device’s. Be sure to select the pre-defined
needle corresponding to the configuration in use.

Installation for Vertical Approach Suros ATEC
Suros ATEC
3-5 Using the Suros ATEC biopsy device (vertical approach)

• The Suros ATEC biopsy device can be used in the vertical approach by manual insertion only. A
firing mechanism is not available for this approach.
• The Suros ATEC biopsy device is delivered with its needle in the post-fire position. Remove the
device from its sterile packaging, measure the required dimensions, and create a new Suros ATEC
device, as described in Chapter 11 Needle Setup.
• Install the biopsy device as described below
• Install metal needle guide (for lateral arm) in
the upper support and the correct size of
needle guide in the upper and lower supports.

• Select the pre-defined needle matching the
needle length, and send the required target.
• Prepare the breast for the puncture.
position, hold the body of the biopsy device and
pass the needle through the needle guides until
the biopsy device rests on the upper needle
guide holder.
CAUTION
The Suros ATEC biopsy device is not


Installation for Lateral Approach
Chapter 9 Installation for Lateral Approach
1 Installing needles and biopsy devices for lateral approach

CAUTION
When a biopsy device is installed:

- Make sure that all securing screws are tightened to avoid unexpected movements,
- To avoid damage to the equipment and/or injury to the patient, it is recommended that the the Z
knob should NOT be turned after installation of a biopsy device.
- Adjustments of the X and Y knobs must be performed with extreme care to avoid injury to the
patient.
WARNING
The Use of Plexiglas or other material to build up the breast for a lateral approach procedure may
cause:
- Image quality degradation so the lesion may therefore be missed.
- Risk of needle damage or unnecessary skin perforation, because the system is not aware of the
presence of the supporting material.
It is the responsibility of the user to ensure that no injury to the patient or damage to the
equipment results from the procedure.
1-1 Installation procedure - summary

• Parts commonly required for the installation of biopsy devices for lateral approach are contained in
the lateral holder kit shown in section 1-2 Contents of the lateral holder kit on page 67. When
additional adaptors are required, they are provided by the biopsy device manufacturer.
• Refer to the diagram overleaf for an overview of the mechanical installation required.
• The installation procedure is performed in three stages:
1. Install the lateral approach tool support and adaptor bar. Refer to section 2 Installing the lateral
approach tool support on page 68.
2. Select and install the appropriate lateral needle guide holder. Refer to section 3 Installing the
lateral needle guide holder on page 71.
3. Select and install the appropriate needle guide(s) and the desired biopsy device:
- If the puncture is to be made manually, with no biopsy device, install the needle guide(s). The
puncture is made by passing the needle through the guides.
- If you are to use a biopsy device, install the needle guides and the desired biopsy device.
Refer to section 4 Fitting the lateral approach biopsy device on page 73
Mammotome ST,
Mammotome Biopsys,
BARD Magnum,
BARD Vacora,
Suros ATEC,
SenoRx EnCor.
Install and use the biopsy device according to the manufacturer’s instructions.
Install lateral adaptors.fm Page no. 65 Chapter 9

Install the Stereotactic Positioner.
See section 1 Installing the Stereotactic Positioner on Stereotactic Positioner SP
page 43.
Chapter 9
Install the lateral approach tool support
Operator manual
and adaptor bar.

Parts contained in the lateral holder kit:
See section 2 Installing the lateral
approach tool support on page 68. Lateral approach tool support L1
and adaptor bar L4
Install the needle guide holder.

See section 3 Installing the lateral needle Needle guide holder L14, L16, or L18, with
guide holder on page 71. support L13 or L15 as required
Fit the biopsy device, with holder if Biopsy device holder BARD Magnum holder
Overview of installation for lateral approach
required. L11 L17

See section 4 Fitting the lateral approach
biopsy device on page 73.
Page no. 66
SenRx EnCor BARD Vacora rail
holder holder and
adaptor
Needle guides Needle guides Needle guides Needle guides Needle guides Needle guides Needle guides
Suros Atec Mammotome ST Mammotome SenoRx EnCor BARD Magnum BARD Vacora Puncture to be
biopsy device biopsy device Biopsys biopsy device biopsy device biopsy device made manually
biopsy device No biopsy device
Needle Needle Needle Needle Needle Needle Needle

5262169-8-1EN
Revision 3
Install lateral adaptors.fm

1-2 Contents of the lateral holder kit

Refer to Chapter 4 Stereotaxy components (section 5 Parts contained in the Lateral Holder Kit on
page 33) for an overview and illustrations of parts contained in the kit.
L2L2 L20 L20 L5 L4
L12 L4
L11 L5
L10 L15
L12
L10
L7 + L9
L3
L3 L11 L6 L19 L13
L15
L8
L1
L9
L7
L1
L17
L13
Note:
It is strongly recommended that all kit components are returned to the carrying case after use
Parts contained in the kit are listed in the following table:.
Part Ref. Qnty Part Ref. Qnty
Lateral approach tool support L1 1 Biopsy device support L11 1
Securing rod L2 1 Biopsy device support screw L12 1
Securing plate L3 1 Guide holder L13 1
Lateral adaptor bar L4 1 Needle guide 6 mm dia. L14 5
(delivered in a separate envelope)
Positioning cursor L5 1 Guide holder L15 1
Non-aperture paddle L6 1 Needle guide 8 mm dia. L16 5
(delivered in a separate envelope)
Rigidity bar supports L7 2 BARD Magnum holder L17 1
(not used for Essential)
Key (hex wrench) L8 1 Guide Holder (BARD Magnum) L18 1
Rigidity bar support screws L9 4 Pin Phantom L19 1
(in plastic bag)
Rigidity bar L10 1 Calibration needle L20 1

Note:
Different biopsy devices require different parts from the kit. Refer to the installation instructions in
this chapter.
2 Installing the lateral approach tool support

CAUTION
The lateral approach tool support and adaptor bar are provided to position and guide biopsy
devices used in lateral approach. Biopsy devices must be hand-held when in use.
• Install the lateral approach tool support and adaptor bar as described below.
Parts required from the lateral holder kit are shown here:
Lateral approach L1 Securing rod L2
tool
support
Securing plate L3 Lateral adaptor L4 +

bar with L5
positioning
cursor
Non-aperture L6
compression
paddle.
Biopsy device L12

support screw
Chapter 9 Page no. 68 Install lateral adaptors.fm

1. If present, remove the compression paddle with aperture used for vertical approach. Refer to
Chapter 5 The Stereotactic Positioner.
2. Make sure that the needle path is closed, then press the Go to Park button to move the needle
holder out of the field of view.
3. Clip the lateral approach tool support L1 over the
Stereotactic Positioner head.
4. On the Stereotactic Positioner, push down the needle

holder lower support. Open the needle path (push the
lever to the left).
Note:
With the lateral adaptor installed, the needle path
remains open; it is not possible to perform any
motorized motion (Go to Park, Go to Target) on
the Stereotactic Positioner. The targeted position
should be reached by manually turning the knobs
before installing the biopsy device on the lateral
arm.
5. Remove the adaptor from the needle holder lower
support (turn it and lift).
6. Install a metal needle guide adaptator LG (see 3-

1 Adaptors on page 29) for the lateral arm securing
rod (8 mm aperture) in place of the upper needle
holder. The securing rod L2 will pass through it to
secure the lateral arm.
7. Position the lateral adaptor bar L4 as shown below:
- The central opening in the adaptor bar must fit over the metal guide for the securing rod as
shown.
- The holes in the bar and guide must be aligned.
- The engraved mark “OK” must face the patient when the bar is turned to the side from which
the lateral approach will be made.

CAUTION
With the bar on the side to be used, make sure that the “OK” engraved mark is facing the
patient, otherwise the targeted lesion won’t be reached even if the needle holder is in the target
position.
Correct Not correct
Metal guide
for securing
rod
8. Hold the bar in position by sliding the securing rod L2

through the holes in the lateral approach tool holder
L1, the bar L4, and the metal guide for the securing
rod.
9. Push up the lower needle holder.

Position the securing plate L3 so that it fits snugly
under the bottom of the Z travel carrier. Secure it in
position by screwing the rod L2 into it.
10. Install the non-aperture compression paddle L6.

3 Installing the lateral needle guide holder

• Install the lateral needle guide holder as described below.
Parts which may be required from the lateral holder kit are shown here:
Rigidity bar L10
Guide holder support L13
Guide holder support L15
Needle guide holder L18

1. Select the guide holder support L13 or L15, or

needle guide holder L18, corresponding to the
⃝ ⃞
biopsy device to be used. The engraved marks
may be used for reference:
⃟
- L13 ⃞ Used for BARD Vacora.
- L15 ⃝ Used for Mammotome ST,
Mammotome Biopsys, SenoRx EnCor,
Suros ATEC, BARD Vacora.
- L18 ⃟ Used for BARD Magnum.
2. Snap the rigidity bar L10 onto the lateral support ball (fitted to the side of the breast support), on the
side (left or right) from which the biopsy will be performed.
3. Snap the ball of the selected needle guide holder or support (L13, L15, or L18) into the socket on
the other end of the rigidity bar L10.
Note:
A second ball is provided on the holder L13, to allow the bar to be positioned at a greater angle
when using the BARD Vacora with the lateral arm mounted on the left side of the breast support
(entering the breast from the left side of the stereo positioner).
WARNING
L13 must never be used with the lateral arm mounted on the right side of the breast support.
The protruding second ball may impact the patient’s chest wall.
4. Slide the selected lateral needle guide holder or support (L13, L15, or L18) onto the lateral adaptor
bar L4.The engraved arrow must point towards the Stereotactic Positioner (note that when the
approach is from the left, the arrow is found at the rear of the holder).
5. Rotate the adaptor bar towards the rear, to be sure that the holder and the bar are far enough from
the 0 position to prevent them from appearing on images.
6. Tighten the screw of the rigidity bar L10 to lock the assembly in position; be sure that the assembly
can NOT rotate freely.
Ensure that the guide or holder and the adaptor bar are outside the field of view.

4 Fitting the lateral approach biopsy device

Follow the instructions supplied for the biopsy device to be used:
• Suros ATEC
Refer to section 4-1 Fitting the Suros ATEC biopsy device (lateral approach) on page 74.
• Mammotome ST
Refer to section 4-2 Fitting the Mammotome ST or Biopsys biopsy device (lateral approach) on
page 79.
• Mammotome Biopsys
Refer to section 4-2 Fitting the Mammotome ST or Biopsys biopsy device (lateral approach) on
page 79.
• SenoRx EnCor
Refer to section 4-3 Fitting the SenoRx EnCor biopsy device (lateral approach) on page 84.
• BARD Magnum
Refer to section 4-4 Fitting the BARD Magnum biopsy device (lateral approach) on page 87.
• BARD Vacora
Refer to section 4-5 Fitting the BARD Vacora biopsy device (lateral approach) on page 90.

Installation for Lateral Approach Suros ATEC
Suros ATEC
4-1 Fitting the Suros ATEC biopsy device (lateral approach)
WARNING
When the Suros ATEC is used with a needle length of 90 mm or 120 mm, the target area must be
at least 23 mm above the breast support. For target areas below this height, use the140 mm
needle, to allow the biopsy device to be positioned to the side of the breast support.
• First install the lateral approach adaptor and needle guide holder as described in sections 2 Installing
the lateral approach tool support on page 68 and 3 Installing the lateral needle guide holder on
page 71.
• The guide holder support used must be L15.
• Install the biopsy device as described in the instructions which follow.
Additional parts required from the lateral holder kit are shown here:
Biopsy device support L11
Needle guide holder for L16

lateral approach: 8 mm
dia

4-1-1 Fit the Suros ATEC device to the biopsy device support
Fit the Suros ATEC biopsy device to the adaptor supplied. Follow the instructions provided with the
adaptor.
1. Remove the lateral lock spring clip A (see L11
in the table in Chapter 4 Stereotaxy
components, Section 5 Parts contained in the
Lateral Holder Kit on page 33); it is not required
for use with the Suros ATEC device.
2. Place the biopsy device support L11 on the

back of the Suros ATEC assembly.
The two pins of the support should fit exactly
into the two holes of the Suros ATEC adaptor.
3. Use the biopsy device support screw L12 to
secure the biopsy device support L11 in
position on the Suros ATEC adaptor.
4. The engraved arrow on the holder L11 must
point towards the Suros ATEC needle tip.
5. Cock the biopsy device. This should be done
now to avoid the possibility of moving the
biopsy device if it is cocked after it has been
positioned on the adaptor bar.

4-1-2 Installation of guides and needle guides for the Suros ATEC in lateral approach
1. Install one of the five metal needle guide
holders L16, by sliding the holder into the guide
holder support L15.
2. Secure the holder in position by tightening the
knurled screw on the support.
WARNING
The metal needle guide holders L14 and L16 are supplied non-sterile. They MUST be
disinfected before use. Refer to Chapter 15 System Hygiene,.
3. Install the needle guide:
Select the appropriate size of sterile needle
guide supplied by GE, and introduce it into the
needle guide holder L16.
WARNING
Biopsy devices should never be used without either disposable needle guides supplied by the
biopsy device manufacturer or sterilizable needle guides supplied by GE.
Always make sure that the size of the needle guide corresponds to the diameter of the needle to
be used.

4-1-3 Position the Suros ATEC biopsy device

1. Rotate the lateral adaptor bar to obtain the
correct puncture direction
2. Tighten the screw of the rigidity bar L10 to
secure the assembly in position. Make sure that
the arm can NOT rotate freely.
WARNING
When a biopsy device is installed on the lateral approach adaptor bar, the use of the rigidity bar
L10 is mandatory. To avoid unexpected rotation of the bar while the needle is in the patient
breast, the securing screw of the rigidity bar L10 must not be released.
CAUTION
devices used in lateral approach. They must not be considered as a firm support: biopsy devices
should be supervised and hand-held when in use.
The target position should be reached before installing the biopsy device on the lateral arm.
! Notice:
To avoid damage to the equipment, the Z positioning knob must NOT be turned after a biopsy
device has been installed on the lateral approach adaptor bar. If it is necessary to move the Z axis,
the biopsy device must first be removed, or it must be held so as to prevent its weight from being
applied to the adaptor assembly during movement.
3. Release the securing screw of the biopsy
device support L11. Fit the support, together
with the attached Suros ATEC assembly, on to
the lateral adaptor bar L4, so that the needle of
the biopsy device passes through the needle
guide. Note that the biopsy device must be held
perfectly parallel to the bar for ease of
mounting.

4. Slide the support L11, together with the

attached Suros ATEC assembly on the adaptor
bar L4 so that it contacts the holder L15.
5. Determine the L5 ruler positiion according to
the needle parts used : the fired needle length,
the sample notch and the throw. Make sure that
no space is left between the cursor L5, the
guide holder support L15 , and the biopsy
device support L11. Securely tighten the
securing screw of the holder L11; ensure that
the holder is now unable to slide on the bar.
Note:
The position used should be verified after installation, using the pin phantom and the biopsy device
in use. Refer to Chapter 16 Planned Maintenance, section QC Test 6 - Accuracy check before
using new CB or VAD needles in lateral approach on page 180. The required position of cursor L5
is obtained if the tip of the pin phantom is in the middle of the notch (center of B) at the end of the
procedure.

Installation for Lateral Approach Mammotome ST or Biopsys
Mammotome ST or Biopsys
4-2 Fitting the Mammotome ST or Biopsys biopsy device (lateral approach)
WARNING
The Mammotome ST and Biopsys biopsy devices cannot be used for biopsies on patients with
target areas less than 13 mm above the breast support.
page 71.
Biopsy device support L11

dia
dia

4-2-1 Fit the Mammotome device to the biopsy device support

1. If you are using the Mammotome ST biopsy
device, remove the lateral lock spring clip A
(see L11 in the table in Chapter 4 Stereotaxy
components, Section 5 Parts contained in the
Lateral Holder Kit on page 33).
If you are using the Mammotome Biopsys
biopsy device, the lock must be installed (see
step 4, below).
2. Place the biopsy device support L11 on the

back of the Mammotome ST or Mammotome
Biopsys biopsy device.
The two pins of the support should fit exactly
into the two holes of the biopsy device.
3. Use the biopsy device support screw L12 to

secure the biopsy device support L11 in
position on the Mammotome device.
Check that the engraved arrow on the holder
shows the direction of the needle tip (the arrow
is on the side of the support not seen in this
illustration).
4. For Mammotome Biopsys only, check that the

lateral lock (see L11 in the table in Chapter 4
Stereotaxy components, Section 5 Parts
contained in the Lateral Holder Kit on page 33)
is present and secures the needle loading flap
correctly, so that the flap does not open when
using the biopsy device in the reverse position.
5. Cock the biopsy device. This should be done
now to avoid the possibility of moving the
biopsy device if it is cocked after it has been
positioned on the adaptor bar.

4-2-2 Install needle guide holders and needle guides

holders L14 (if using Ethicon disposable needle
guides) or L16 (if using GE sterilizable metal
needle guides).
Slide the guide into the guide holder support
L15.
2. Secure the guide in position by tightening the
knurled screw on the support.
WARNING
The metal needle guide holders L14 and L16 are supplied non-sterile. They MUST be
disinfected before use. Refer to Chapter 15 System Hygiene.
Introduce a disposable needle guide supplied
by the manufacturer into the needle guide
holder L14, or a GE sterilizable metal needle
guide into the needle guide holder L16. The
size of needle guide must be chosen according
to the needle to be used.
WARNING
manufacturer or sterilizable needle guides supplied by GE.
be used.

4-2-3 Position the Mammotome biopsy device

WARNING
CAUTION
! Notice:
To avoid damage to the equipment, the Z positioning knob should not be turned after a biopsy
the biopsy device must be removed, or it must be held so as to prevent its weight from being
applied to the adaptator assembly during movement.
3. Slide the guide holder support L15 along the

bar until it touches the cursor L5.
4. If the fire function is to be used, cock the biopsy
device. This should be done now to avoid the
possibility of moving the biopsy device if it is
cocked after it has been positioned on the
adaptor bar.
5. Release the securing screw of the biopsy

device support L11 and fit the support on to the
lateral adaptor bar L4, so that the needle of the
biopsy device passes through the needle
guide. Note that the biopsy device must be held
mounting.

6. Slide the biopsy device support L11 along the

bar until it touches the guide holder support
L15.
7. Ensure that the slot of the white plastic needle
guide is aligned with the triangle sign of the
needle dial (if the needle guide from the
manufacturer is used).
8. Determine the L5 ruler stop posiiton according

to the needle parts used : the fired needle
length, the sample notch and the throw. Make
sure that no space is left between the cursor
L5, the guide holder support L15, and the
biopsy device support L11. Securely tighten the
securing screw of the holder L11; ensure that
the holder is now unable to slide on the bar.
Note:
procedure.

Installation for Lateral Approach SenoRx EnCor
SenoRx EnCor
4-3 Fitting the SenoRx EnCor biopsy device (lateral approach)
WARNING
The SenoRx EnCor biopsy device cannot be used for biopsies on patients with target areas less
than 15 mm above the breast support.
page 71.

dia
4-3-1 Fit the SenoRx EnCor device to the biopsy device support
1. Fit the SenoRx EnCor biopsy device to the
EnCor adaptor supplied. Follow the instructions
provided with the adaptor.

4-3-2 Install a needle guide holder

holders L14, by sliding the guide into the guide
holder support L15.
2. Secure the guide holder in position by
tightening the knurled screw on the holder
support.
WARNING
The metal needle guide holders L14 are supplied non-sterile. They MUST be disinfected before
use. Refer to Chapter 15 System Hygiene.
Select the appropriate size of sterile needle
guide supplied by the manufacturer, and
introduce it into the needle guide holder L14.
WARNING
manufacturer or sterilizable needle guides supplied by GE.
be used.
4-3-3 Position the SenoRx EnCor biopsy device

WARNING
breast, the securing screw of the rigidity bar L10 must NOT be released.

CAUTION
! Notice:
the biopsy device must first be removed, or it must be hand-held so as to prevent its weight from
being applied to the adaptor assembly during movement.
3. Release the securing screw of the SenoRx
EnCor assembly. Fit the assembly on to the
lateral adaptor bar L4, so that the needle of the
biopsy device passes through the needle
guide. Note that the device must be held
mounting.
4. The biopsy device support L11 must be
positioned on the adaptor bar L4 so that the
position cursor L5 contacts the holder L15.
Determine the L5 ruler stop position according
to the needle parts used: the fired needle
length, the sample notch and the throw. When
the correct position has been attained, tighten
the securing screw of the holder L11 securely;
ensure that the holder is now unable to slide on
the bar.
Note:
procedure.

Installation for Lateral Approach BARD Magnum
BARD Magnum
4-4 Fitting the BARD Magnum biopsy device (lateral approach)
WARNING
The BARD Magnum biopsy device cannot be used for biopsies on patients with target areas less
than 8 mm above the breast support.
• First install the lateral approach adaptor and needle guide as described in sections 2 Installing the
lateral approach tool support on page 68 and 3 Installing the lateral needle guide holder on page 71.
• The needle guide holder used must be L18.
Additional parts required from the lateral holder kit are shown here:
BARD Magnum holder L17
4-4-1 Install needle guides

- Introduce two plastic or metal needle guides
(supplied by GE) into the needle guide holder
L18, one from each side.
WARNING
Metal needle guides are supplied non-sterile. They MUST be sterilized before use. Refer to
Chapter 15 System Hygiene.
WARNING
Biopsy devices should never be used without either disposable needle guides or sterilizable
needle guides.
be used.

4-4-2 Position the BARD Magnum biopsy device

1. Rotate the lateral adaptor bar L4 to obtain the
correct puncture direction.
WARNING
CAUTION
! Notice:
To avoid damage to equipment, the Z positioning knob must NOT be turned after a biopsy device
has been installed on the lateral approach Biopsy adaptor. If it is necessary to move the Z axis, the
biopsy device must first be removed, or it must be hand-held so as to prevent its weight from being
applied to the adaptor assembly during movement.
3. Position the cursor L5 on adaptor bar L4, using the scale engraved on the bar.
Determine the L5 ruler stop position according to the needle parts used: the fired needle length, the
sample notch, the throw and coax.
Note:
procedure.
4. Slide the needle guide holder L18 onto the bar
L4, until it contacts cursor L5.
5. Slide the BARD Magnum holder L17 over the
bar L4, and secure it in position, using the
upper screw of the holder.

6. Introduce the BARD Magnum in its cocked

state (pre-fire) into the BARD Magnum holder
L17, so that the needle passes through the
needle guide and the biopsy device is in
contact with the needle guide.
If necessary, adjust the position of the holder
L17 on the bar L4 so that the biopsy device is
well supported in its correct position, then
tighten the upper and lateral screws of the
holder L17 to secure the biopsy device in
position.
Note:
Depending on the fired length of the needle
used, the throw and coax, the positions of
the cursor L5, needle guide holder L18, and
BARD Magnum holder L17 may need to be
adjusted. Adjustments are made after initial
setup as stated above.

Installation for Lateral Approach BARD Vacora
BARD Vacora
4-5 Fitting the BARD Vacora biopsy device (lateral approach)
WARNING
When the BARD Vacora is used with a needle length of 118 mm, the target area must be at least
15 mm above the breast support. When it is used with a needle length of 140 mm, the target area
must be at least 13 mm above the breast support. Lower targets cannot be accessed using the
BARD Vacora device in lateral approach.
• Install the lateral approach adaptor and needle guide holder as described in sections 2 Installing the
lateral approach tool support on page 68 and 3 Installing the lateral needle guide holder on page 71.
• The guide holder support used must be L15 when entering the breast from the right side of the
needle positioner.
Note:
A second ball is provided on the holder L13, to allow the bar to be positioned at a greater angle
when using the BARD Vacora with the lateral arm mounted on the left side of the breast support
(entering the breast from the left side of the needle positioner).
CAUTION
L13 must never be used with the lateral arm mounted on the right side of the breast support. The
protruding second ball may impact the patient’s chest wall.
4-5-1 Install the needle guide holder and needle guide
1. Fit the needle guide holder supplied with the
Vacora biopsy device onto the guide holder
support L15 or L13. Secure it in place by
tightening the lower screw of L15 or L13.
2. Introduce the sterile needle guide (4 mm for
metallic coaxial cannula, 4.5 mm for plastic
coaxial cannula) through the opening on the
needle guide holder.
WARNING
biopsy device manufacturer or sterilizable needle guides supplied by GE.
be used.

4-5-2 Position the BARD Vacora biopsy device

correct puncture direction.
WARNING
breast, the securing screw of the rigidity bar L10 must NOT be released.
CAUTION
! Notice:
the biopsy device must first be removed, or it must be supported so as to prevent its weight from
being applied to the adaptor assembly during movement.
3. The cursor L5 must be positioned on the adaptor bar L4, using the scale engraved on the bar.
Determine the L5 ruler stop position according to the needle parts used: the fired needle length, the
sample notch, the throw and coax (if a spacer is used, this should be considered also).
Note:
procedure.
4. Slide the cursor L5 to the chosen position on
the adaptor bar L4. Lock it in position by
tightening its screw.
5. Move the needle guide holder L15 or L13 up to
the cursor L5. Lock it in position by tightening
its screw.

6. Slide the BARD Vacora rail holder support over

the bar L4 until it is close to the guide holder
support L15 or L13. Lock it in position, using
the upper screw of the holder.
4-5-3 Fit the coaxial cannula

1. Select the coaxial cannula to be used:
- Metal cannula for the 4 mm needle guide.
- Plastic cannula for the 4.5 mm needle
guide.
- Select the length of the cannula to match
that of the needle to be used.
2. Insert the selected cannula into the needle
guide. Use the needle guide holder clip to lock
it in position.
4-5-4 Install the BARD Vacora biopsy device

1. Cock the Vacora biopsy device.
2. Fit the BARD Vacora adaptor over the back of
the biopsy device. The two pins of the adaptor
should fit exactly over the two holes in the
biopsy device. Clip the plastic hook (on the
holder) over the biopsy device to lock the two
together.
3. Remove the axial needle trocar from the
cannula.
4. Slide the BARD Vacora assembly (adaptor and
biopsy device) onto the rail holder.
5. Introduce the puncture needle into the needle
guide and slide the assembly forward until the
biopsy device touches the cannula.

Preparation for examinations
Chapter 10 Preparation for examinations
1 Preparation
1-1 Preparing the Senographe
The Senographe is switched on and used in the usual way as described in the Senographe Essential
Acquisition System Operator manual.
1-2 Centering light duration

For routine (non-stereo) operation, switching the centering light on gives light for 45 seconds. This period
is often too short when positioning a patient for stereotactic procedures.
• When the stereotaxy application is active (i.e., when the stereotactic positioner is installed), the
duration of the light is selected on the X-ray Console Medical Menu, accessed by using the Setup
button as described in the X-ray Console chapter in the Senographe Essential Acquisition System
Operator manual.
• To view or change the current setting press the Set-up button , then select in succession
MEDICAL, STEREO and LIGHT.
• The factory default setting for light duration in stereotaxy is 5 minutes. It can be changed in steps of
1 minute between the minimum of 1 minute and the maximum of 10 minutes.
1-3 Check the stereotaxy paddle and the breast support

The breast support and compression paddle must be checked regularly to ensure that they have no
sharp edges or corners that might cut, pinch, or otherwise hurt a patient.
Preparation.fm Page no. 93 Chapter 10

2 Arm Positioning
2-1 Rotation and Angulation Modes
• The term rotation is used to describe the rotation of the
complete Arm assembly, with the tube head arm
remaining at its current angle with respect to the image
receptor. The illustration shows rotation of the arm from
CC to MLO. Rotation
• The term angulation is used to describe rotation of the

tube arm with respect to the image receptor, changing
the angle at which the X-ray beam reaches the image
receptor. The illustration shows angulation of the tube
arm from 0° to -15°. Angulation
• When the Stereotactic Positioner has been installed, the

operator can choose between Rotation mode and Angulation mode
by pressing the Rotation/Angulation button on the positioner:
- Rotation mode is used while positioning the patient and to select
the view. It allows rotation and up/down movement of the Arm
assembly. When rotation mode is active, the light adjacent to
the button is OFF.
- Angulation mode is used when the patient has been positioned
and the breast has been compressed. It allows angular
movement of the tube arm for stereotactic exposures. When
angulation mode is active, the light adjacent to the button is ON.
Press the Rotation/Angulation button on the Stereotactic Positioner to switch from rotation to
angulation mode. The gantry readout display changes from rotation mode to angulation mode.
Rotation mode display Angulation mode display
Chapter 10 Page no. 94 Preparation.fm

2-2 Movement control buttons

• Four similar sets of five buttons (two sets on the head, two sets near the handles at either side of the
detector) are used to control rotation and angulation, and up/down movement.
Arm elevation
Left of Arm control buttons Right of Arm
1 4 5 5 4
1
2 2
3 3
Arm rotation
control buttons
• When the Stereotactic Positioner is installed:
- Buttons shown with reference 4 in the illustration are used to control rotation or angulation,
according to the current mode of operation. Note that in angulation mode only one speed of
movement is available; additional pressure does not change the speed of movement.
- Buttons shown with reference 5 are used for up/down (lift) movement.
- Buttons with references 1, 2, and 3 (used for preset movements in routine mammography) are not
operational.
2-3 Rotation mode

• In rotation mode, rotation movement of the Arm is allowed; angulation is not allowed.
To use rotation mode with the Stereotactic Positioner installed:
- The Stereotactic Positioner compression paddle must be set to the parking (upper) position (over
100 mm; refer to section 3-3-6 Compression on page 100).
- The Rotation/Angulation light on the Stereotactic Positioner must be OFF. If it is ON (indicating
angulation mode), it can be turned off by pressing the Rotation/Angulation button, provided that
no compression is applied to the breast and the angulation is 0°.
Rotation mode may be forbidden if the stereo angle is not close enough to 0.0°. If this happens,
angle the arm slightly to approach 0.0° and verify that "0" is highlighted in the central panel of the
gantry readout display before requesting rotation mode again.
2-3-1 Rotation movement
- Rotation movement is allowed only when rotation mode has been selected (the Rotation/
Angulation light on the Stereotactic Positioner must be OFF) and no compression is applied.
- When the stereo positioner is installed, rotation movement is allowed between -90° and +90°,
only (horizontal position of the arm on either side).

2-4 Angulation mode

• In angulation mode the Arm can be angled with respect to the image receptor; no rotation of the Arm
is allowed.
• To use the angulation mode:
- The Stereotactic Positioner must be correctly installed.
- The patient must be correctly positioned, and the breast must be compressed, using the
Stereotactic Positioner compression paddle.
- Press the Rotation/Angulation button on the Stereotactic Positioner to switch the system into
angulation mode. The Rotation/Angulation light switches ON to show that angulation mode has
been accepted.
• When the system is in angulation mode:
- Rotation movement of the Senographe positioning arm is not allowed.
- Up/down (lift) movement of the Senographe positioning arm is not allowed.
CAUTION
When the patient is in position, take great care when angulating to avoid any possibility of hitting
the patient with the arm assembly.
Note:
While compression is applied to the breast, all rotation and lift movements are inhibited. Only
angulation movement is possible.
2-4-1 Angulation movement for stereotaxy
• When in angulation mode, only the buttons shown with reference 4 (in the illustration in section 2-
2 Movement control buttons on page 95) are operational. They are used to move the tube head arm
between the five permitted positions as shown in the diagram below.
+33 to +25° -25 to -33°
1. Press the top or bottom of the button to cause angular movement of the tube head arm in the
direction indicated by the arrow on the button.

2. Continue to press the button until angulation stops automatically, at the next permitted position.
For example, if the angulation is now 0°, press and hold the top of button 4 on the left hand side of
the arm, to move the tube head arm clockwise, until it stops automatically at the -15° position.
Press and hold the same button again to move the arm to the -Park position.
3. If the button is released during movement, the movement stops immediately.
4. The +Park and -Park positions are preset at ±33°, but the user can choose to stop the gantry at
any position.
Note:
With the Stereotactic Positioner installed, exposure is only
possible with the tube arm at a nominal angulation of +15°,
-15°, or 0°, as shown on the gantry readout (note that the
numeric display may show a slightly different value, for
example -15.3° instead of -15.0°, as shown here).
In all other cases, exposure is inhibited and a warning
message appears on the Senographe X-ray Console.
2-5 Angulation interlock

2-5-1 Risk of collision between tube head covers and the biopsy device.
When angulation movement with the selected needle may cause a risk of collision between the tube
head covers and the biopsy device, the user can send the target and perform the puncture, but
angulation in the range +15° to -15° towards 0° is not allowed. The warning message Angulation motion
limited is displayed.
2-5-2 To override the angulation interlock.
• Under some circumstances, it may be possible to temporarily remove the biopsy device, to allow
angulation without danger of collision. However, the system is not aware of the configuration change,
because the needle path remains open, and the interlock continues to prevent angulation towards 0°
in the range +15° to -15°.
• When you have removed the biopsy device, and are satisfied that angulation is possible without risk
of collision, the interlock can be overridden as follows:
- Press the appropriate angulation button (right or left, top or bottom), as required
to move in the desired direction.
There is no movement, because of the presence of the interlock.
- Within five seconds, press the 0° button. The interlock is temporarily removed.
- Again within five seconds, press the angulation button again.

The Arm angulates towards the 0° position.
- The angulation interlock is reimposed, and further movement is blocked, when

the 0° position is reached, or if the movement is reversed before the 0° position is
reached.

2-6 Lift movement

• Up/down (lift) movements are not possible when angulation mode has been selected.
Up/down (lift) movements are not possible when compression is applied, i.e., when the Stereotactic
Positioner paddle is positioned less than 10 cm from the breast support.
• The range of lift movement is the same as for routine mammography.
3 Preparation for an examination

• This section provides a check list of accessories which should be available during typical stereotaxy
examinations.
The lists can be adapted to the requirements and techniques of each user.
• Decision to apply local anaesthetic before the puncture is to be taken by the performing physician.
• Concerning fine needle aspiration (FNA) procedures, samples preparation is to be performed by the
performing physician.
WARNING
- If metal needle guides (reusable) are in use, ensure that they have been sterilized before use.
- The internal diameter of needle guides must always be one size larger than the external
diameter of the needle in use; e.g., a needle of 0.8 mm should be used with needle guides of
0.9 mm.
3-1 Suggested accessories checklist

1. Biopsy device with needle(s) appropriate to the technique to be used.
2. Suitable mounting adaptor(s) if required. According to the biopsy device in use, adaptors may be
provided by the manufacturer of the biopsy device or in the GE vertical or lateral adaptor kit. Refer to
the instructions given in Chapter 8 Installation for Vertical Approach or Chapter 9 Installation for
Lateral Approach.
3. Sterile needle guides. These accessories may be provided by the manufacturer of the biopsy device,
by Perouse Medical or as GE optional accessories. If using GE supplied needle guides, select the
appropriate size from the following list :
Circular Needle Guide Description Mammotome Non-circular Needle Guide
Description
9 G / 3.9 mm 8 G / 6.2 mm
11 G / 3.2 mm 11 G / 4.8 mm
12 G / 2.9 mm
14 G / 2.25 mm 14 G / 3.3 mm
16 G / 1.8 mm
18 G / 1.4 mm
19 G / 1.2 mm
20 G / 1.0 mm
21 G / 0.9 mm

3-2 Positioning the Senographe

• Refer to section 2 Arm Positioning on page 94 for an explanation of tube rotation and angulation.
• Depending on the position of the suspect area on the standard mammography image, the operator
decides the rotation of the Senographe examination arm. For example, if the lesion is visible and
accessible at an oblique angle of 60°, the operator rotates the examination arm to 60° so that the
patient can be positioned to approach the lesion in the most adequate projection; it also depends on
the biopsy device to be used.
Note:
In pre-operative localization, patient positioning may also depend on the incision to be made by
the surgeon. Radiologist and surgeon should agree on a suitable patient positioning for the hook
wire localization exam.
• Rotate the column to the selected position, using the rotation buttons located below the handles and
on the tube head of the Senographe.
Note:
The Stereotactic Positioner compression paddle must be in the park (high) position. Otherwise, up/
down movement and positioning arm rotation of the Senographe are inhibited.
3-3 Positioning the Patient

3-3-1 Patient reception
Women undergoing a mammography examination often feel apprehensive because of the examination
and the ensuing diagnosis. To reassure the patient, receive her in a warm room and provide a simple but
precise explanation of the procedure.
3-3-2 Patient comfort and support
The examination room should be well ventilated and at a comfortable temperature.
Breast biopsies and localizations using the Stereotactic Positioner should be carried out with the patient
in a seated or recumbent position.
CAUTION
The patient must be comfortably seated, or otherwise well supported (e.g., on a stretcher or a
suitable table), to ensure that she remains motionless, and that there is no danger of falling if she
is unwell during the examination. She should be supervised at all times.
CAUTION
While the images are being processed on the workstation, it is recommended that an operator
should remain with the patient to ensure that she does not move. If the patient moves between
the +15° and - 15° exposures, the scout and stereo images should be repeated (see Chapter 13
Stereotaxy Punctures section 1 Defining punctures on page 135).
3-3-3 The seated patient
Use a suitable examination chair, with adjustable height and locking wheels.
To adjust the chair (functions of the chair vary according to the model):
• Set chair height and depth of back of chair so that the patient is sitting comfortably with her back
straight and firmly supported.
• Set the height of the foot support so that the patient’s feet are resting comfortably.
• Set the height of the arm rests to support the patient’s arms comfortably.

Note:
1. The patient should be seated in a comfortable position, in which she can remain motionless for
the duration of the exam. This condition is essential for the accuracy of the puncture.
2. Be sure that the patient’s arms or hands do not rest on any of the Stereotactic Positioner
controls, such as the X, Y, Z knobs or the compression knobs.
3-3-4 Recumbent Patient Position
The patient should be positioned in a lateral decubitus position. She should be secured on the stretcher
and have good back support. Bending the knees with a pillow between them often makes the patient
more comfortable. The arms should be positioned so that the patient is not lying on them or restricting
the blood flow by being bent abnormally. The patient’s hand(s) may be directed to hold onto a handle on
the system if convenient. The breast can then be positioned into a LM/ML position or a CC or FB
position, making sure to check tube rotation/angulation prior to the start of the procedure. If the selected
projection for the exam is CC, FB or LM, the patient lies on the unaffected breast side, however if the
selected projection is ML, the patient lies on the affected breast side and the opposite breast side needs
to be positioned so that it is not included in the FOV. Refer to the Senographe Essential Acquisition
System Operator manual for information on selection of view names for recumbent patients.
3-3-5 Positioning the Breast
• Position the breast under the compression paddle so that the area to be examined is in the center of
the aperture in the paddle, or in the area defined by the four engraved crosses on the breast support
plate if using a non-aperture paddle.
CAUTION
For maximum accuracy, it is essential that the area of interest is as close to the center of the
compression paddle as possible.
3-3-6 Compression
• Compress the breast by using the manual compression knobs on the Stereotactic Positioner.
Compression must be firm to prevent movement of the breast, but not so firm as to cause discomfort
or to cause the breast to protrude through the paddle aperture.
WARNING
The Senographe Essential Acquisition System was designed for patient breast thicknesses of
less than 100 mm when under compression. The system is not recommended for use with patient
breast thickness exceeding 100 mm under compression.
• The system assumes that compression is applied when the distance between the Stereotactic
Positioner paddle and the breast support is reduced to less than 100 mm. It assumes that
compression has been removed, and therefore require the acquisition process to be restarted, when
the distance is increased to more than 105 mm.
• The system monitors breast thickness. When the operator defines targets, the system will give a
warning if the breast thickness has changed during the exam. See Chapter 13 Stereotaxy Punctures.

3-4 Operating Recommendations

3-4-1 X-Ray Image
The physician must be able to accurately determine the same point to be punctured on each of the two
stereo exposures. Any deviations in the X, Y, or Z axes may lead to errors in accuracy when inserting the
needle into the breast.
3-4-2 Equipment
All necessary equipment should be prepared before the start of the examination and placed for easy
access near the patient (see section 3 Preparation for an examination on page 98).


Needle Setup
Chapter 11 Needle Setup
1 Needle parameters
• This chapter describes Needle Setup procedures. These
procedures require the entry of biopsy device and needle
Tube head
dimensions.
• It is important to obtain and enter these measurements correctly,
Risk of collision
so that the system can accurately position the needle, and can
take all dimensions into account when calculating permissible
movements and access to the target area.
Biopsy device
• Use of incorrect needle and biopsy device dimension can cause:
- Risk of collision between the angulating tube head and the
biopsy device.
- Risk of skin tear.
- Risk of collision with the breast support.
- Risk of missing the target (needle too long or too short).
• For information on the Needle Management function for creation and modification of needle
parameters, refer to section 2 Needle Setup on page 104.
• For information on measurements required for needle management, refer to section 3 Needle and
biopsy device dimensions on page 108.
• For specific information on the measurement of biopsy devices for use in vertical approach, refer to
section 4 Biopsy device measurements on page 114.
WARNING
All needles and biopsy devices to be used should be programmed in the system before a patient
procedure is started.
All needle measurements (needle and biopsy device parameters) must be entered in millimeters
in the Needle Panel.
Needle setup.fm Page no. 103 Chapter 11

Needle Setup
2 Needle Setup
2-1 The Needle Panel
The needle to be used for a puncture is selected from a list of available needles.
To manage the needle list, i.e., to declare and specify a new needle, modify the specification of an
existing needle, or delete one that is no longer used, open the Needle Panel and use the Needle
Management function.
To open the Needle Panel window:
• Click the Needle or Needle & Puncture button in the Stereotaxy Viewer Needle & Puncture
Control Panel (see Chapter 12 Stereotaxy Image Acquisition section
2 Stereotaxy viewer on page 126). If a valid puncture target is currently
selected, the legend on the button is Needle & Puncture, and a puncture control panel is displayed
below the needle description.
Or:
• Click the Tools icon, and then select Needle Setup from the drop down menu.
The Needle Panel is displayed:
Needle Panel
Needle Management Needle description
Type FNA
Fna72
Name FNA72
Core92
Hook107
Needle (A) 110 mm
VacuumDevice
Needle guide (n) 4.0 mm
Modify Delete
Create needle
Quit
Note:
Buttons for OK and Cancel are displayed only after a function (Create needle, Modify, or Delete)
has been selected.
Chapter 11 Page no. 104 Needle setup.fm

Needle Setup
2-2 To create a new needle (with or without a biopsy device)

To create a new needle specification:
1. Click the Create needle button. Create needle
2. In the list displayed, select the type of needle to be created.
• For a needle to be used in vertical approach, select from: FNA
CB
Fine Needle Aspiration (FNA) Hook
Core Biopsy (CB) VAD with holder
Pre-surgical hook (Hook) VAD without holder

LAT
Vacuum Assisted Device with vertical holder (VAD with holder)
Vacuum Assisted Device without vertical holder (VAD without holder).
• For a needle to be used in lateral approach (with or without a biopsy device), select Lateral
Approach Tool (LAT).
3. The Needle description window opens to display the selected needle type and the specification fields
to be completed.
When entering a name for the needle, select an easily-identified name, e.g. “Hook_72_mm”.
Note:
When entering a name exceeding 10 characters, it will be truncated on the SP display:
only the first 10 characters will be accessible on the SP display when targets are sent with this
needle.
• Enter the required data as shown in the window.
For information on measurements required for needle management, refer to section 3 Needle
and biopsy device dimensions on page 108.
• For specific information on the measurement of biopsy devices for use in vertical approach, refer
to section 4 Biopsy device measurements on page 114. Measurements are described for the
following biopsy devices:
BARD Magnum.
BARD Vacora.
Suros ATEC.
Mammotome ST.
Mammotome Biopsys.
SenoRx EnCor.
For assistance in setting up one of these biopsy devices, contact your local GE Application
Specialist, who will give you instructions for setting up the required biopsy devices.You can then
set up new needles for the biopsy device, using the function Create needle/same device.
4. When all the required data has been entered, click OK. If the entered data are acceptable, the needle
specification is added to the displayed Needle list. Click Cancel if you wish to annul the operation.
5. If there is any error or incompatibility in the entered data, a pop-up message informs you of the
problem. Click the OK button in the window to acknowledge the message, then correct the data and
click OK again. Click Cancel if you wish to cancel the operation.

Needle Setup
2-3 To modify a needle

! Notice:
For needles specified with a biopsy device (CB, VAD with holder, VAD without holder), only the
needle and needle guide description fields (needle name, and dimensions A, B, C, and n) can be
modified.
The device length (D) and vertical holder distance (E) can not be modified.
If there is an error in either of these fields, use the Create needle function (section 2-2, above). to
make a new entry with the correct measurement(s). All needle entries created for the biopsy device
with wrong D and/or E values must then be manually deleted and introduced with the correct
values.
To modify data for an existing needle:
1. Click the name of the needle in the Needle list to select it.
The Needle description window displays the current specification of the selected needle.
2. Click the Modify button. Modify
3. Move the mouse pointer into the appropriate data fields in the window, and enter the
specification of the new needle or modify the existing one.
4. Confirm each entry by pressing the Enter key on the keyboard.
5. When you have entered all the required data, click OK. If the entered data are acceptable, the needle
specification is updated in the displayed Needle list.
2-4 To delete a needle

To delete a needle from the list:
1. Click the name of the needle in the Needle list to select it.
The Needle description window displays the current specification of the selected needle.
2. Click the Delete button, then click the OK button to confirm the deletion, or click the Cancel Delete
button to annul the operation. Deletion of a needle specified with a biopsy device does not
delete the values (D) and (E) used by other needles using the same biopsy device.

Needle Setup
2-5 To create a new needle for a specified biopsy device

1. Select an existing needle which uses the biopsy device.
A new button Create needle/same device is displayed above the Create needle button.
It is not displayed if the needle selected is of type FNA, Hook, or LAT.
2. Click the button Create needle/same device to display a new window, in which the values for the
biopsy device length (D) and vertical holder distance (E) (if applicable) are displayed, but cannot be
edited.
3. Enter the required data (needle name, and dimensions A, B, C, and n), then click OK.
4. If there is any error or incompatibility in the entered data, a pop-up message informs you of the
problem. Click the OK button in the window to acknowledge the message, then correct the data and
click OK again. Click Cancel if you wish to annul the operation.
Needle Panel

Needle list Type: VAD without holder
Core92 Name: VADtestwithout

Fna72
Hook107
Needle post-fire (A): 128 mm
VADtestwithout
Notch (B): 20 mm
Tip (C): 20 mm
Needle guide (n): 3.5 mm

Modify Delete
Device (D): 200.0 mm
Create needle/same device
Create needle OK Cancel
Quit

Needle Setup
3 Needle and biopsy device dimensions

3-1 Required dimensions
• Dimensions which must be measured for entry in the workstation Needle Panel when creating or
modifying a needle entry are described below, in sections 3-3 to 3-6.
• Measurements for biopsy devices must be made on the device in the configuration to be used,
including cannulas and spacers where appropriate.
• For specific information and illustrations showing how these measurements are made and entered
for biopsy devices used in vertical approach, refer to section 4 Biopsy device measurements on
page 114.
3-2 Limitations on needle dimensions

• To prevent the entry of excessively large dimensions, the following limits are applied to entries in the
Needle Panel:
Dimension or value Limit
Needle or Needle post-fire (A) must be less than 1000 mm
Notch (B) must be less than (A-C)
Tip (C) must be less than (A-B)
Needle guide (n) must be less than 500 mm
Device (D) must be less than 1000 mm
Vertical Holder (E) must be less than 500 mm
(D+ E) must be less than 1000 mm
(D + n) must be less than 1000 mm
3-3 FNA and Hook wire in vertical approach

Measure and enter the following dimension when
creating or modifying a needle of type Fine Needle
Aspiration (FNA) or a Pre-surgical hook (Hook): n
• Needle (A):
Length from the tip to the hub of the needle.
A
• Needle guide (n):
Thickness of the needle guide.

Needle Setup
3-4 Core Biopsy or Vacuum Assisted Device without holder in vertical approach
Measure and enter the following dimensions when creating or modifying either a core biopsy device
(CB), or a vacuum assisted device without holder (VAD without holder) for use in vertical approach.
Refer to section 4 Biopsy device measurements on page 114 for more information:
• Needle post-fire (A):
Post-fire length from the tip of the needle to the
bottom of the body of the biopsy device (see
drawing). The needle length must be measured in a
D
post-fire position (i.e. with the biopsy device not
cocked)
• Notch (B):
Length of the collection chamber.
n
• Tip (C):
Distance from the end of the collection chamber to
the tip of the needle.
• Needle guide (n):
Thickness of the needle guide.
A
• Device (D):
Length of the biopsy device body. Measure from the
top of the biopsy device to the bottom of the body. B
This length is taken into account when calculating the
clearance available for angulation: you must include
any protruding buttons. If tubes are present, include C
an allowance for the vertical part of the tubes (to the
point where their flexibility allows them to bend).

Needle Setup
3-5 Vacuum Assisted Device with holder in vertical approach

Measure and enter the following dimensions when creating or modifying a vacuum assisted device with
vertical holder (VAD with holder) in vertical approach. Refer to section 4 Biopsy device measurements
on page 114 for more information:
• Needle post-fire (A):
Post-fire length from the tip of the needle to the bottom of the body of the biopsy device (see
drawing). The needle length must be measured in a post-fire position (i.e. with the biopsy device not
cocked).
• Notch (B):
Length of the collection chamber.
• Tip (C):
Distance from the end of the collection chamber to the tip of the needle.
• Device (D):
Length of the biopsy device body. Measure from the top of the biopsy device to the bottom of the
body. This length is taken into account when calculating the clearance available for angulation: you
must include any protruding buttons. If tubes are present, include an allowance for the vertical part of
the tubes (to the point where their flexibility allows them to bend).
• Vertical Holder (E):
Distance from the bottom of the biopsy device to the 0 level reference point used by the software. To
obtain this dimension, measure the distance e from the top of the SP upper needle holder support to
the bottom of the biopsy device, and add 3 mm (the value of 3 mm is the distance between the
reference point and the measuring point at the top of the holder). The value of (E) may be negative,
as explained below.

Needle Setup
Note:
When using a vacuum assisted biopsy device with vertical holder, the bottom of the body of the
biopsy device may be above the top of the needle holder support (Mammotome ST or Biopsys), or
may be below it (SenoRx EnCor). In the latter case, the measured distance e is negative, and the
value E may be negative. The two conditions are shown here:
D
+
+
e
E
0 3 mm
3 mm 0 e
E
-
-
B A
C B
C
The bottom of the biopsy device is above the The bottom of the biopsy device is below the
holder; e is positive. holder; e is negative.
E = measured distance e + 3 mm E = 3 mm - |measured distance e|

Needle Setup
3-6 Lateral Approach adaptor
WARNING
Regardless of the type of needle used, do not enter the
actual needle length for Needle (A)
Instead, use the dimension shown in the diagram, measured
as described below.
A
To measure the lateral arm length:

Perform the following steps:
1. Using the Pin Phantom L19, simulate a puncture as described in the lateral approach accuracy test
(Chapter 16 Planned Maintenance, steps 3-5 Procedure on page 176 to 3-5-3 Define puncture on
page 177).
2. Open the Needle & Puncture panel and define a new lateral biopsy device (LAT).
3. In the length field, set the value to 107.2 mm, click on OK and select the new biopsy device. Send the
target to the Stereotactic Positioner.
4. Using the X, Y, and Z knobs of the Stereotactic Positioner, adjust
the Lateral Arm position coordinates to 0,0,0.
XX= 0.0
+ 0.0mm
mm
Y = 0.0 mm
Z = 0.0 mm
5. Make sure that the positioning cursor L5 is pushed up to the stop

on the lateral adaptor bar L4. Engage the needle guide holder L18
over the adaptor bar, and push it along the bar to touch the cursor
L5.
6. Insert the calibration needle L20 fully into the needle guide holder
L18.The tip of the X calibration needle L20 should be close to the
tip of the pin of the Pin Phantom L19.

Needle Setup
7. Using the X, Y, Z knobs of the Stereotactic Positioner, adjust

X, Y, and Z so that the tip of the X calibration Bar is at the tip of
the phantom pin. Record the Z value ∆Z.
8. Open the Needle Panel again, select the previous lateral arm and click on Modify. Change the value
in field Length (A) to be equal to A + Z, where A is the current value (e.g., 107.2 mm) and ∆Z is the
value obtained in step 7.
Example: (A) = 107.2 mm, ∆Z = +1.0 mm
New value (A) = 108.2 mm
Needle Panel
Needle description
Needle Management
Needle list Type LAT
Core92 Name CalibTest

Fna72
Hook107 Length (A): 108.2 mm
CalibTest
OK Cancel
Modify Delete
Create needle
Puncture
Quit Send

Needle Setup
4 Biopsy device measurements

• To create a new needle using a biopsy device in vertical approach, first follow the steps described in
section 2-2 To create a new needle (with or without a biopsy device) on page 105.
• Section 3 Needle and biopsy device dimensions on page 108 describes dimensions to be entered for
each type of needle and biopsy device.
• The following sections (4-1 through 4-4) describe the measurement of dimensions required for
specific biopsy devices when used in vertical approach.
4-1 Measure and enter biopsy device dimensions

• When creating a new needle, you are required to measure the needle dimensions and biopsy device
dimensions (in mm) for the biopsy device to be set up, and then enter these values in the Needle
description window.
• Refer to the information and illustrations given in the appropriate section listed below to identify the
required measurements.
- Core Biopsy: section 4-2
BARD Magnum - Measurements for core biopsy device - BARD Magnum on page 116.
- VAD without vertical holder: section4-3
BARD Vacora - Measurements for VAD without vertical holder - BARD Vacora on page 118.
Suros ATEC - Measurements for VAD without vertical holder - Suros ATEC on page 119.
- VAD with vertical holder section: 4-4
Mammotome ST - Measurements for VAD with vertical holder - Mammotome ST on page 121.
Mammotome Biopsys - Measurements for VAD with vertical holder - Mammotome Biopsys on
page 122.
SenoRx EnCor - Measurements for VAD with vertical holder - SenoRx EnCor on page 123.
Note:
If you do not specify values for the needle (A,B, and C) then you can not submit the configuration
for the biopsy device.
Note:
For biopsy devices that require measurement of the Vertical Holder (E) distance, add 3 mm to the
measured dimension e (identified in the illustrations and detailed in section 3-5 Vacuum Assisted
Device with holder in vertical approach on page 110). This value of 3 mm accounts for the distance
between the measuring point (the top of the upper needle holder support) and the 0 reference point
used by the system.
Note:
When the position of the Vertical Holder is above the top of the needle (as in the case of the
SenoRx EnCor), the measured dimension e is negative, and the value for (E) may be negative.
• When all of the required measurements have been entered, click OK to submit the completed
configuration for the biopsy device.
The new biopsy device is now listed in the Needle Management section of the Needle Panel window.

Needle Setup
4-2 Core Biopsy (CB)

4-2-1 Needle Description for Core Biopsy Device (CB)
• Before any stereotactic procedure, the required dimensions must have been carefully measured and
entered in the Needle Description for each needle and each configuration to be used.
Needle Panel
Needle list Type CB

Name Core92
Fna72
Hook107 Needle post-fire (A): 92.0 mm
Core92
Notch (B): 10.0 mm
Tip (C): 10.0 mm

Modify Delete
Device (D): 130.0 mm
Quit

Needle Setup
4-2-2 Measurements for core biopsy device - BARD Magnum

Biopsy device alone Biopsy device with
cannula
A
B
C
Device (D) Device (D)
The presence of a cannula

reduces the value of (A) and
increases the value of (D).
Needle guide
(n)
Needle post-fire Needle post-fire

length (A) length (A)
Changing the throw length

changes the value of (A)
and of (B).
Notch (B)
Tip (C)
Before any stereotactic procedure, the required dimensions must have been carefully measured and
Note:
The BARD Magnum biopsy device has two possible throw lengths, 15 mm and 22 mm.
It may also be used with a coaxial cannula.
The throw length in use affects dimensions for needle length (A) and notch length (B).
Be sure to measure A and B after firing with the throw length to be used (15 mm or 22 mm).
Using the cannula reduces the value of (A) and increases the value of (D).
If the cannula is to be used, be sure to measure A and D with the cannula in place.

Needle Setup
4-3 VAD without vertical holder

4-3-1 Needle Description for VAD without vertical holder
Needle Panel

Needle list Type: VAD without holder
Core92 Name: VADtestwithout

Fna72
Hook107
Needle post-fire (A): 128 mm
VADtestwithout
Notch (B): 20 mm
Tip (C): 20 mm

Modify Delete
Device (D): 240 mm
Quit

Needle Setup
4-3-2 Measurements for VAD without vertical holder - BARD Vacora

Allow space for tubes to bend when measuring the length of the Device (D).
Biopsy device alone Biopsy device with Biopsy device with
cannula cannula and spacer
D
A
B
C
D D Device (D)
Needle guide (n)

n
n
n
Needle post-fire
length (A)
A A
Notch (B)
B B
B Tip (C)
C C C
Note:
The BARD Vacora biopsy device is normally used with a coaxial cannula which enables insertion and
removal of the biopsy device several times to collect samples.
It may also be used with a spacer to reduce the effective length of the notch.
The presence of a cannula reduces the value of (A) and increases the value of (D).
The presence of a spacer reduces the value of (A) and (B), and increases the value of (D).
Any cannula and spacer to be used must be in position on the device when making the measurements.

Needle Setup
4-3-3 Measurements for VAD without vertical holder - Suros ATEC

Allow space for tubes to bend
when measuring the length of
the Device (D). D
A
B
C
Device (D)
Needle guide
(n)
Needle post-fire
(A)
Notch (B)
Tip (C)

Needle Setup
4-4 VAD with vertical holder

4-4-1 Needle Description for VAD with vertical holder
Needle Panel
Needle list
Type VAD with holder
Fna72
Name VADwith2
VADwith1
VADwithout1
Hook107 Needle post-fire (A) 132.0 mm
VADwith2 Notch (B) 22.0 mm
Tip (C) 10.0 mm

Modify Delete Device (D) 250.0 mm
Vertical Holder (E) 50.0 mm

Create needle
OK Cancel
Quit

Needle Setup
4-4-2 Measurements for VAD with vertical holder - Mammotome ST
D
+
E
0
-
A
B
C
Device (D)
Measured distance (e)

E = (e) + 3 mm
See section 3-5
Needle post-fire (A)
Notch (B)
Tip (C)
Needle dimensions: In the needle dimension fields for (A), (B), and (C), enter the measured dimensions
(in mm) for the needle in use with the biopsy device.
Device dimensions: In the biopsy device dimension fields (D) and (E), enter the measured dimensions
(in mm) of the biopsy device (E = e + 3 mm).

Needle Setup
4-4-3 Measurements for VAD with vertical holder - Mammotome Biopsys
D
+
E
0
-
A
B
Device (D)
C
Measured distance (e)

(E) = (e) + 3 mm
See section 3-5
Needle post-fire
(A)
Notch (B)
Tip (C)

Needle Setup
4-4-4 Measurements for VAD with vertical holder - SenoRx EnCor
D
Device (D) +
E
0
-
A
B
C
Distance measured (e)

(E) = (e) + 3 mm
See below and section 3-5
Note: When the top of the needle holder support is

above the top of the needle, as shown here, the
value for the distance measured (e) is negative. The
value for the Vertical Holder dimension (E) becomes:
(E) = 3 - e mm.
(E) may be negative.
Needle post-fire
(A)
Notch (B)
Tip (C)

Needle Setup

Stereotaxy Image Acquisition
Chapter 12 Stereotaxy Image Acquisition
1 Starting the Stereotaxy application

The Stereotaxy application is started from the Worklist. Refer to the Worklist chapter in the Senographe
Essential Acquisition System Operator manual for more information.
The stereotaxy viewer can be recognized by the presence of three control panel buttons, including the
Stereotaxy panel button , in the Viewer Command Window. Refer to section 2-4 Control
Panels on page 130.
Note:
The stereotaxy viewer is available only for acquisition, not for review. Refer to Chapter 14 Image
Printing and Review, section 2 Image Review on page 158.
1-1 Image Acquisition - New Patient

To start an exam for a new patient:
• Install the Stereotactic Positioner on the Senographe arm.
• Verify in the Worklist window that the selection for Type of Exam is Stereo.
• If patient data are received directly from a Hospital or Radiology Information System, the patient data
should already be present in the Worklist. If not, patient data must be entered manually; click the
New Patient... button in the Worklist to display the Medical Procedure Card window and enter the
required information.
Note:
Be sure to complete the Procedure Description field with sufficient information to allow the series
to be recognized later.
Refer to the Worklist chapter in the Senographe Essential Acquisition System Operator manual for
information on entering information in the Medical Procedure Card.
Note:
A patient must have unique identifiers (name and ID are mandatory, first name is optional).
• When the card has been completed, click the Start Exam button. The Medical Procedure Card
window closes, and the Stereotaxy Viewer is displayed (see section 2 Stereotaxy viewer on
page 126).
• Check the information displayed. If it is not correct, do not proceed; click Cancel to close the Viewer
and return to the Worklist. Select the correct patient and click Edit.... Make any changes required,
then click Start Exam again to open the Viewer with the Medical Procedure Card displayed. If the
information is now correct, begin the first acquisition.
1-2 Image Acquisition - New Exam

To add an exam for an existing patient:
• Install the Stereotactic Positioner on the Senographe arm.
• Verify in the Worklist window that the selection for Type of Exam is Stereo.
• Select the required patient entry in the Patient list in the Worklist by clicking on it.
• Click the Start Exam button.
The remaining procedure is the same as for a new patient, except that the patient information fields in
the Medical Procedure Card are already completed and cannot be modified (displayed in grey).
Exposures.fm Page no. 125 Chapter 12

2 Stereotaxy viewer
2-1 Overview
The Stereotactic Viewer, shown below, includes two main areas:
• The Image Window or Viewing Area, in which images are displayed.
• A Command window at the left of the Viewer window. It contains:
- The Mosaic Image Browser (top).
- Control Panels (center);
- Middle mouse button function panel (bottom).
Command window
Mosaic Image
Browser
Control Panel Viewing area

(varies according to
selection)
Middle mouse button

function panel
Chapter 12 Page no. 126 Exposures.fm

2-2 Mosaic Image Browser

The Mosaic Image Browser, at the top of the command window,
displays the content of the current exam in the form of reduced-size
images. Scout images are shown as a single image in a row, stereo
images are shown as two images side-by-side.
If the exam contains more images than can be displayed at once,
you can scroll through the full set image by image, using the image
up/down arrow buttons in the Mosaic Image Browser.
Click on the desired scout image or stereo pair in the Mosaic Image
Browser to display it in the viewing area.
A white dot on the reduced image(s) in the Mosaic Image Browser
identifies the current scout image or stereo pair displayed.
2-3 Viewing Area

Images are displayed in the viewing area. For information on selecting images for display, refer to
Chapter 13 Stereotaxy Punctures section 1 Defining punctures on page 135.
The format changes according to the viewing mode in use:
• Scout mode
When a scout view is displayed by itself, it is
centered in the viewing area with zoom mode
1 : 1 (each pixel on the screen corresponds to
a pixel on the Digital Detector).

• Stereo mode
When the stereo images are used for placing
puncture markers, the images are shown at
two different resolutions.
The complete left and right images are shown
side by side in the upper half of the viewing Complete -15° image Complete +15° image
area, in “fit-to-view” format.
Portions of the same images are shown side
by side as high-resolution visualizers in the
lower half of the viewing area. The zoom
mode used is 1 : 1 (as used for Scout Mode).
The high-resolution visualizers are scrollable
to allow regions of interest to be shown. High resolution High resolution
-15° image +15° image

• Check on Scout Mode

This mode displays a stereo pair and the
scout view simultaneously. It allows the
validity of the pairing defined on a stereo pair
to be checked by projecting a selected target
onto the scout view. The target position can
be adjusted using the mouse or trackball.
Refer to Chapter 13 Stereotaxy Punctures,
section 1-4 Placing the Primary Puncture
Marker on page 136.
Enter the mode from Stereo mode by clicking
the Check on Scout button. The legend on the
button changes to Back to Pair.
The images previously displayed in the upper
visualizers disappear. They are replaced by
the most recent scout image which
corresponds to the stereo pair shown in the
lower visualizers.
All three images are displayed with a zoom mode of 1 : 1, and all three images are scrollable.
Click the Back to Pair button to return to Stereo mode.
• Pairs Comparison Mode
This mode displays two different stereo pairs
simultaneously, allowing comparison of
stereo pair images captured at different
instants of the procedure (e.g., pre-fire and
post-fire).
Enter the mode from Stereo mode by clicking
the Pairs Comparison button.
The stereo pair previously displayed becomes
the Main stereo pair, and is displayed in the
lower part of the screen. At this point the
upper visualizers are blank.
Select the Second stereo pair to be viewed
by clicking on it in the Mosaic Image Browser.
The new pair is displayed in the upper part of
the screen. This pair can be changed at any
time by clicking on another pair in the Mosaic Image Browser.
All four images are displayed with a zoom mode of 1 : 1, and all four images are scrollable.
Click the Back to Pair button to return to Stereo mode.
• Shutter command (F10)
To allow clearer viewing of the images in the viewing area, it is possible to hide the command window
at the left of the screen by placing a “shutter” (mask) over it.
To apply the shutter, press the F10 function key (in the top row on the keyboard). Press F10 again to
bring the command window back into view.

2-4 Control Panels

Control panels are located in the center of the command window (see section 2-1 Overview on
page 126).Three panels are available in stereotaxy: the View panel, the Annotation panel, and the
Stereo panel. They are arranged as a stack of index cards; only one is displayed at a time. Click the
appropriate selection button (at the top of each panel, shown below) to display the corresponding panel
as shown below. Use of the panels is described in the following sections:
Selection buttons:
View panel Annotation Stereotaxy panel

panel
Primary Secondary
Annotation Level
Full Partial None Custom
Coordinates (mm)
Graphics & Meas.
Secondary
Display Parameters New Primary Delete Primary

Erase all
Hide Marker Hide Epipolar
Check on Scout
Pairs Comparison
Needle & Puncture

Inv. Standard
2-4-1 The View Control panel

The View control panel is used to set brightness & contrast display and to invert the grey
levels. Refer to the Viewer chapter in the Senographe Essential Acquisition System
Operator manual for more information.
2-4-2 The Annotation Control panel
The Annotation control panel is used to add user annotations and perform measurements
on images. Refer to the Viewer chapter in the Senographe Essential Acquisition System
Operator manual for more information.
WARNING
Measurements shown in the Annotation control panel are valid only for images taken with the X-
ray beam perpendicular to the detector; they are not valid in angulation. When angulation is in
use, annotations may be used as relative values for comparison, but not as absolute
measurements.

Note:
Annotations added to the images are local only; they are not sent with the images to review
workstations or archiving devices.
2-4-3 The Stereotaxy Control panel
The Stereotaxy Control panel is used to define primary and secondary punctures, and to
access the Puncture window and Needle Management window. Refer to Chapter 13
Stereotaxy Punctures section 1 Defining punctures on page 135 for more information.
2-5 Middle Mouse Button Panel

This panel is used to select the function of the middle button of the
mouse or trackball (also referred to as the Multi-Function mouse
button): magnifying glass, image scroll or brightness/contrast control.
Refer to the Viewer chapter in the Senographe Essential Acquisition System Operator manual for more
information. Refer to current system documentation for the correspondence between mouse and
trackball buttons.

3 Making Stereotaxy exposures

3-1 Configuration
For stereotactic exposures, the large focal spot is selected by default The small focal spot cannot be
selected.
Check on the X-ray control panel display that the focal spot selection is shown as Large.
3-2 Exposure Modes

Two exposure modes are available when performing a stereotactic exam: AOP (automatic optamization
of parameters) and manual. The exposure mode can be selected for the first exposure of an exam.
If the first image has been taken in manual mode, the operator cannot make exposures in AOP mode
unless a new serie is started.
If the first image has been taken in AOP mode, the operator has the possibility to switch to manual mode
for following exposures.
If you wish to switch back to AOP mode after the first scout image has been acquired in manual mode,
you must first start a new series by selecting the button New Series in the AWS interface (placed under
the Print button). The previous acquired images will be stored in the Browser and will disappear from the
view. The exam must be restarted from the first scout image.

3-3 AOP mode (automatic optamization of parameters)

3-3-1 Introduction
In AOP mode, the system automatically controls radiation and selects the main parameters to produce
images optimized for stereotactic exams.
When AOP mode is selected, a brief absorption measurement exposure is made during the scout
acquisition that follows last patient positioning. This absorption measurement determines the
characteristics of the breast being examined to optimize exposure parameters (track/filter/kV/mAs).
All the following exposures of the series will then be performed using these optimized parameters to give
the best image quality. Moreover, the mAs value will be adjusted to compensate for angulation and
possible thickness change.
In AOP mode for stereotactic exams the X-ray Console displays AUTO in place of the parameter values
until the absorption measurement exposure is performed. From this moment on, the exposure
parameters of the last acquisition will be displayed with a letter "X" at the left of the kV value.
Note:
The mAs compensated value is refreshed upon Prep button being depressed.
Note:
AOP mode is not recommended for specimen imaging. Use manual mode instead (for example:
24-28 kVp and 10-40 mAs). The technique may vary depending on the sample container and on
the mode (contact vs magnification).
3-3-2 AOP Classic Table versus Profile Table
AOP mode is configured at installation time to use one of two sets of optimized exposure parameters:
the Classic Table and the Profile Table.
Compared to the Classic Table, the Profile Table provides an increased Contrast to Noise Ratio (CNR)
for all types of breast.
It is important to understand that any improvement in CNR is made at the cost of an increase in Average
Glandular Dose (AGD) and vice versa; a reduction in AGD yields a reduction in CNR.
It is the radiologist's responsibility to make the choice between use of the Classic Table or the Profile
Table.
3-3-3 AOP configuration
By default, AOP mode in stereotaxy is configured to use the Profile Table.
It can be changed at installation time to use the Classic table, if required.
After installation, please contact your Field Engineer if you wish to know which table is in use, or to
change the table.
3-4 Manual mode

In manual mode, you must select all exposure parameters manually: Track, Filter, kV, and mAs. In this
mode, the exposure parameters can be changed at any moment during the exam.

3-5 Exposure Sequence

• First ensure that the Stereotactic Positioner is in place, the system is prepared for stereotaxy with the
needle holder in the parking position, the arm assembly is rotated to the desired position, and the
patient is correctly positioned.
• Follow the procedure described below. Refer to Chapter 10 Preparation for examinations section
2 Arm Positioning on page 94 for information on positioning the tube arm:
1. Select the breast laterality.
2. Select the exposure mode (AOP or manual).
3. If the exposure mode is manual, set the exposure parameters.
4. First exposure of the stereo triplet (scout image):
- Position the tube arm at 0° angulation.
- Ensure that the needle holder is in the parking position; if not, the scout exposure will not be
allowed.
- Make the exposure, and wait until the image is displayed on the workstation screen; do not move
the mouse or trackball.
5. Second exposure of the stereo triplet (first stereo image):
- Angle the tube arm to +15° (or to -15°).
6. Third exposure of the stereo triplet (second stereo image)
- Angle the tube arm to -15° (or to +15°).
7. Leave the tube arm in a suitable parking position while the images are analyzed and the subsequent
procedures are prepared:
Minimize the number of tube passes through the zero position.
- If the last exposure was a +15° image, go to +P,
- If the last exposure was a -15° image, go to -P.
CAUTION
While the images are being analyzed on the workstation, the patient MUST remain motionless. It
is recommended that the patient should be supervised at all times.
In particular, patient motion between successive exposures (scout image, and left and right
images of the stereo pair) may result in clearly perceptible differences in position of the same
anatomical feature on the different images.
8. If more exposures are required (e.g., check exposures), set the tube arm to the required angulation
(0°, -15°, or 15°) and make the exposure as for the previous images.

Stereotaxy Punctures
Chapter 13 Stereotaxy Punctures
1 Defining punctures
1-1 Overview
After acquiring one or more scout images and stereo pairs, you can define one or more puncture targets
using the Stereotaxy Viewer, as described in the following sections.
You can define several puncture sets (each consisting of a primary puncture and optional secondary
punctures) within the same exam.
You can at any time during the procedure add or delete graphic and text annotations, or make
adjustments to the contrast and brightness settings and invert function (to better see the
microcalcifications), using the Viewer command window. The magnifying glass, scroll, and contrast/
brightness functions of the Multi-Function mouse button are also available at all times.
Note:
Annotations added on the Acquisition Workstation are local, and are lost during image transfer to
a Review Workstation.
1-2 Image Selection

To work on an image in the main viewing area, it must be selected (active). More than one image may be
displayed at one time in the viewing area (e.g., Check on Scout display mode, where the stereo triplet is
displayed), but only one image can be selected at one time.
All displayed images are identified in the Mosaic Image Browser by a white dot in the upper left corner of
the corresponding reduced-size image.
The single selected image is identified in the Viewing area by a large white dot in the upper left corner.
• To select an image, click anywhere on it in the Mosaic Image browser, using the left mouse button.
• To display a scout image in Scout mode:
Click on the corresponding scout image (single image) in the Mosaic Image Browser.
• To display a stereo pair of images in Stereo mode:
If the current mode is Pairs Comparison first click the Back to Pair button.
Click on the corresponding pair (two images side-by-side) in the Mosaic Image Browser.
Full-content views are displayed on the upper half of the screen and partial (zoomed) views on the
lower half of the screen, with the -15° images on the left and the +15° images on the right.
Click with the right mouse button on the region of interest in the upper view to center the lower
(zoom) view on the same region of interest.
• To display the images in a stereo triplet:
If the current mode is Stereo, click Check on Scout.
Most of the time, this is transparent to the user. For instance, when positioning puncture markers, you
can move from one image to another. As soon as you click on a marker to start moving it, the
corresponding image is selected automatically.
Punctures.fm Page no. 135 Chapter 13

1-3 Placing the Reference Markers

Two lead markers, shaped like an inverted T, are permanently embedded in the Bad positioning:
breast support of the Stereotactic Positioner, and their shadows appear on the Lead marke
images. On the scout view, two Reference Markers (with the same shape) are
positioned on the image at the approximate positions of the two lead marker
shadows.
• In the Mosaic Image Browser, select the scout image.
• Use the left mouse button to select each of the two Reference Markers in Reference Marker
turn and drag them exactly on top of the corresponding lead marker shadow. Correct positioning:
It may be helpful to use the Invert tool when positioning the markers.
This provides the Stereotaxy application with the necessary data to perform
the transformation from Stereotactic Positioner coordinates to image
coordinates.
CAUTION
Correct positioning of the Reference Markers is essential for the

successful performance of the procedure. The Reference Markers MUST have been positioned
correctly before sending the puncture data to the Stereotactic Positioner.
The system will not send puncture target data if both Reference Markers have not been
repositioned first.
If you acquire more than one scout image and stereo pair during an exam, the Reference Markers on the
subsequent scout images are initially positioned using the data from the preceding scout image.
CAUTION
Check coincidence between Reference Markers and lead marker shadows on each scout image.
If necessary, correct the Reference Marker positions on the final scout image used for the
procedure.
1-4 Placing the Primary Puncture Marker

Markers
• In the Mosaic Image Browser, select the stereo pair.
New Primary
• To define a new puncture set (primary puncture and optional secondary
punctures), click the New Primary button on the control panel. Primary
The new puncture set number is displayed in the Primary puncture selection
window.
The New Primary button is inactive when:
- a stereo triplet has not been acquired, and
- when you have chosen to acquire a new stereo triplet for next target
creation. See Chapter 17 Operator messages Table 3 Patient position status
change messages displayed on the AWS on page 199.
Chapter 13 Page no. 136 Punctures.fm

• Define the puncture position. On each of the two images of the stereo pair, use the trackball or
mouse to select the Puncture Marker (a cross) and drag it until it is centered exactly over the
structure of interest (suspected lesion). Use the lower views for final positioning because of their
greater accuracy. If the position defined is within the puncture volume (accessible by the Stereotactic
Positioner), the legend OK or OK? is displayed beside the puncture number. If not, no text is
displayed beside the number. See section 1-8 Puncture set marker status on page 141.
Note:
If the system detects that the Stereo triplet used to define the puncture set may not correspond to
the position of the targeted area, it warns the operator with a pop-up message (this is due to a
thickness change, for instance) .
See Chapter 17 Operator messages Table 3 Patient position status change messages displayed
on the AWS on page 199. The message suggests that a new triplet must be acquired for the next
target creation.
- If the operator chooses to acquire a new triplet, the New Primary button becomes disabled
until a new triplet is acquired. The primary markers already set will show OK?
- If the operator chooses to continue the procedure when the system has detected a change in
breast compression, the legend of accessible puncture set is OK? The New Primary button is
still enabled. See section 1-8 Puncture set marker status on page 141.
CAUTION
The user must accurately select the same point on the two images. Inaccuracies may lead to
deviations when the needle is inserted in the lesion.
• The computed X, Y, and Z coordinates of the selected puncture target are displayed continuously in
the Coordinates (mm) window of the control panel.
Coordinates (mm)
X= X:
- 2.3
- 2.3
Y=26.37
y: 26.37
Z=23.28
Y z: 23.28
Z
X
Epipolar line
0
• The epipolar line display shows the location of the puncture target in relation to the
Show Epipolar
breast support. It should display the same value as the Z value in the Coordinates
window.
• By default, the epipolar line is hidden on the view. To show the epipolar line associated with the
marker, click the Show Epipolar button on the control panel.

The graduations along the epipolar line are in half centimeters of depth in the Z direction. The 0 indicates
the bottom, i.e., the breast support end (Z = 0).
When you move a marker up or down away from the epipolar line (in the Y direction) on one of the two
views, the corresponding marker on the other view will follow this movement as soon as you release the
mouse button. Both markers are displayed with the same Y coordinates, since for any structure of
interest (suspected lesion) the Y coordinates are the same on the left and right view.
Note:
The Y coordinate may vary from one image to another if the patient has moved between
exposures, or if it relates to two separate areas within the breast.
When you move a marker left or right along the epipolar line on one of the views, the corresponding
marker on the other view does not move. You will note, however, that the epipolar line moves relative to
the marker, to show the newly computed height (Z) that corresponds to the shift in the X direction
Show/hide markers and epipolar line
To view the image without the markers or the epipolar line:
• Click the Hide Marker or Hide Epipolar button on the control panel.
Hide Marker
The button legend changes to Show Marker or Show Epipolar.
• A second click on the button brings the markers, or the epipolar line, back into
Show Epipolar
view.
Delete markers
To delete any of the primary puncture markers you have defined previously:
• Select (highlight) the number of the puncture in the Primary puncture selection window by clicking on
it.
• Click the Delete Primary button.
Delete Primary
Note that deletion is not possible if the puncture information has already been sent to
the Stereotactic Positioner (status shown as S).
1-5 Placing the Secondary Puncture Markers
CAUTION
Be careful to superimpose the inverted T reference markers precisely before defining the
coordinates to the stereo positioner. The accuracy of the biopsy targets depends on the correct
positioning of these reference markers over the inverted Ts.
You can define a set of secondary markers, to perform sampling around the B
target area defined by the Primary Puncture Marker, at the same height (Z) as the
primary, but with an offset in X and Y.
The purpose is to provide a sample at a given offset around the primary. A C
Y
CAUTION D
The user should NOT attempt to position the secondary markers

accurately on structures in the images. X
The illusion may occur that a secondary marker points to a structure which
in reality is not located in the same plane, and hence not even in the path
of the needle.

• To add secondary markers, click the Secondary button. The secondary markers are
displayed around the primary marker on all displayed images. 5.5
• To cancel the definition of secondary markers, click again on the Secondary button.
Secondary
The secondary markers disappear from the display.
• The value of the X and Y offsets is shown in mm in the offset window above the
Secondary button. Minimum offset is 0.5 mm and maximum offset is 20.0 mm. To change the value
(by 0.5 mm steps), click the up or down arrow at the side of the window.
Note:
If the system detects that the Stereo triplet used to define the puncture set may not correspond to
the current position of the target area, it warns the operator with a pop-up message (for instance
due to a tickness change).
See Chapter 17 Operator messages Table 3 Patient position status change messages displayed
on the AWS on page 199. The message suggests that a new triplet be acquired for the next target
creation.
If the system has detected a change in breast compression, the legend displayed beside the
accessible secondary points is OK?. See section 1-8 Puncture set marker status on page 141.
1-6 Check on Scout

The Stereotaxy application uses the X, Y and Z coordinates, obtained on the stereo pair, to compute and
display the location of the Primary Puncture Marker on the scout (0°) view. To display the scout image
with the Puncture Marker:
• Click the Check on Scout button. The legend on the button changes to Back to
Check on Scout
Pair.
If the Primary Puncture Marker was placed accurately on the same structure of
interest on each of the views of the stereo pair, the computed marker displayed Back to Pair
on the scout image will also point to this same structure.
If a mistake was made (and in particular if on the stereo pair the primary marker was not placed on
the same structure) this will be obvious on the scout image, because the computed marker will be
pointing elsewhere, and not on the structure of interest.
• In that case, the corrections can be done in Check on Scout mode, but only on the stereo pair
images.
Note:
Patient motion between the acquisition of the scout image and of the two images of the stereo pair
can also result in unsatisfactory results. In this case the procedure should be repeated (see also
the Warning in section 1-4 Placing the Primary Puncture Marker on page 136).

1-7 Adding and Modifying Puncture Sets

You can define several puncture sets (primary puncture and optional secondary punctures) during the
same exam.
To add a puncture set:
• Click the New Primary button.
New Primary
A puncture set number is added in the Primary puncture selection window. You
can now proceed as described above (sections 1-4 Placing the Primary Puncture
Marker on page 136 through 1-6 Check on Scout on page 139) to define the new puncture set.
Note:
If the system detects that the Stereo Triplet used to define the puncture set may not correspond to
the current position of the targeted area, it warns the operator with a pop-up message (this is due
to a tickness chang, for instance). See Chapter 17 Operator messagesTable 3 Patient position
status change messages displayed on the AWS on page 199. which suggests that a new triplet be
acquired for next target creation.
- If the operator chooses to acquire a new triplet, the New Primary button becomes disabled
and it is no longer possible to modify the location of puncture sets until a new triplet is
acquired.The primary markers already set will show OK?
- If the operator chooses to continue the procedure when the system has detected a change in
breast compression, the legend of accessible puncture set is OK? The New Primary button is
still enabled. See section 1-8 Puncture set marker status on page 141.
To modify an existing puncture set:
• Select (highlight) its number in the Primary puncture selection window. Primary
The markers belonging to the selected set are displayed again on the views, and
can be moved as required.
The markers can not be moved if they have already been sent (status S) See
section 1-8 Puncture set marker status on page 141.
The marker can not be moved when you have chosen to acquire a new stereo
triplet for next target creation, after a thickness change for instance (when the
"New Primary" button is disabled) (See Chapter 17 Operator messages Table 2 Operator Messages
displayed on the AWS monitor on page 196.)
To re-use a sent puncture set (status S):
• Select (highlight) its number in the Primary puncture selection window, and click the New Primary
button. A new puncture set is created, having the same co-ordinates as the selected puncture set,
and can be modified as required.
To relocate a puncture set with the OK? status in the current breast position (see section 1-8 Puncture
set marker status on page 141):
• Acquire a new Stereo Triplet and move the existing puncture set markers labeled OK?. OK will
replace OK?

1-8 Puncture set marker status

Using the Stereotaxy application, a puncture marker can be placed anywhere within the biopsy volume,
which is the 3D volume located between the compression paddle and the positioner breast support, and
bounded by the stereo images. However, a puncture set is defined only if its position is within the
puncture volume (where it can be physically reached by the Stereotactic Positioner).
When the system has detected a change in breast thickness that may impair the puncture set definition,
the Stereo Triplet used to define the puncture set does not conform to the current patient position. If no
change in breast thickness is detected, the Stereo Triplet conforms to the current patient position.
Table 1 - Possible status indications
Puncture set position Status indicated
Stereo Triplet conforms to relative to Puncture
Before sending to Sent to Stereotactic
current patient position Volume
Stereotactic Positioner Positioner(1)
Yes or No Outside Blank Not possible
Yes Inside OK S
No Inside OK? S
(1) A puncture set can only be transferred to the Stereotactic Positioner (see section Secondary
2 Sending Puncture information on page 142) if the primary puncture is inside the
puncture volume and its status is shown as OK or OK? .
Secondary puncture points’ status are defined using the same rules as for the primary
puncture point: it is blank when it is outside the puncture volume, OK or OK? according
to whether or not the Stereo Triplet conforms to the current patient position, and S
when it is sent.
When a puncture set is sent to the Stereotactic Positioner, only secondary targets
inside the puncture volume are sent with the primary target.
When the puncture set marker status is OK?, a warning message "Reminder: thickness has changed by
xx.x mm." Is displayed in the Warning(s) field of the Needle & Puncture panel, indicating the thickness
variation value compared with the scout view of the Stereo Triplet used to define the target. In this state,
the puncture set no longer conforms to the actual target position.
To return a puncture set to conformance with the current breast position (see section 1-8 Puncture set
marker status on page 141), acquire a new Stereo Triplet and move the existing puncture set markers
labeled OK?. OK will replace OK?

2 Sending Puncture information

2-1 Selection of Puncture Set and Needle
To perform a puncture, first select the desired puncture set in the Primary puncture selection window:
1. Click on the number of the desired puncture set to highlight it. If the puncture is inside the puncture
volume, the legend on the Needle button becomes Needle & Puncture.
2. Check to make sure the intended target is the one displayed. Click on the Primary Target window to
highlight each target positioned before selecting Needle & Puncture, to be sure that the correct
primary has been selected for the biopsy.
3. Click the Needle & Puncture button to open the Needle & Puncture panel, with the Puncture window
displayed below the Needle description window:
Needle & Puncture
Needle description
Needle Management
Needle list
Type FNA
Core92
Fnatest Name FNA132
FNA132
Needle (A): 120.0 mm
Modify Delete
Create needle
Puncture
Quit Send
Warning(s)
Target List ready to send
4. Select the needle to be used for the puncture by clicking on its name in the list of predefined needles
shown in the Needle list.
The description of the selected needle is displayed in the Needle description window. A status field at
the bottom of the Needle & Puncture panel indicates whether or not the puncture is authorized, and a
message giving additional information may be displayed in the Warning(s) field.
WARNING
Always verify that the needle selected is indeed the needle that is in use.
Note:
It is highly recommended that the operator configures all needle characteristics (length, notch
width for a biopsy needle, etc.) BEFORE starting the exam (from the Tool menu of the Main
Browser or during the accuracy test procedure).
However, the operator can still create a new needle or modify an existing one during the
procedure.

2-1-1 Change of thickness during an the exam

When the Needle & Puncture is opened to send a puncture set which has the marker status OK? (see
section 1-8 Puncture set marker status on page 141) the Send button is available, but the warning
message "Reminder: thickness has changed by xx.x mm." is displayed in the Warning(s) field indicating
the variation thickness value compared with the scout view of the Stereo Triplet used to define the target.
Target List ready to send: Reminder: thickness has changed by xx.x mm.
Needle & Puncture
Needle list
Core92 Type FNA

Fna72
Name FNA120
FNA132
Fna72
FNA120 Needle (A): 120.0 mm
Modify Delete
Create needle
Puncture
Quit Send
Warning(s)
Reminder: thickness has changed by xx.x mm.
CAUTION
It is the responsibility of the operator to decide whether the thickness variation is acceptable for
the definition of the stereotactic puncture(s) to be performed, or whether the acquisition of new
images is required.

2-1-2 Core biopsy and Vacuum Assisted Device compatibility

Although there is ample room to work between the Stereotactic Positioner and the tube
head, there are some interlocks to ensure safety when using Core biopsy or Vacuum
Assisted Devices with or without a holder:
• Breast support collision interlock. Puncture targets close to the breast support may
cause a risk of collision between the needle and the breast support. The system will
not allow such targets to be sent to the Stereotactic Positioner.
• Stereo angulation interlock. The combination of a large compression thickness and a
target placed at a high Z coordinate can be unsafe, and may produce a collision
between the tube head and the biopsy device. To avoid this, stereo angulation motion
is inhibited in these cases.
Under some circumstances, it may be possible to override the interlock, after
temporarily removing the biopsy device to avoid the danger of collision. Refer to
Chapter 10 Preparation for examinations, section 2-5 Angulation interlock on page 97.
CAUTION
When using a Core biopsy or Vacuum Assisted Device VAD in vertical approach,
there can be a risk of collision between the tube head when angling the tube arm
to perform the pre-fire and post-fire images. The operator must take great care to avoid this risk.
The risk of collision with the tube head is especially great when trying to puncture a target with a
high Z. The system recognizes this situation and warns the operator by displaying the following
message in the Warning(s) panel: Angulation motion limited. Angulation from -15° to 0° and from
+15° to 0° is forbidden.
Needle Panel

Needle list
Type: VAD with holder
Hook107
Fna72 Name: cbDeviceTooLong
cbDeviceTooLong
VacuumDevice
Needle post-fire (A): 120.0 mm
Notch (B): 10.0 mm
Tip (C): 10.0 mm

Modify Delete
Create needle/same device Device (D): 600.0 mm
Create needle Vertical Holder (E) 50.0 mm
Puncture
Quit Send
Warning(s)
Angulation motion limited

• The two conditions described above combine to limit punctures with a Mammotome in vertical
approach to puncture targets in a range of Z coordinates. The limits of these ranges are:
Zmin Zmax
Mammotome Biopsys 11G 13 mm 43mm
Mammotome ST 11G 13 mm 67mm
• When an interlock is required, it is activated as soon as the needle path is opened. The interlock is
then released as soon as the needle path is closed.
2-2 Correction
The combination of a puncture target position too close to the breast Before After
support (in the “danger zone”) and the use of a core biopsy needle correction correction
or a VAD in vertical approach is not accepted by the system,
because of the risk of the tip of the needle hitting the breast support.
In this case the Send button is inactive.
The “puncture target position” corresponds to the center of the notch Puncture
of the core biopsy needle. If the puncture can be performed with the target
structure to be punctured still located within the lower part of the
notch, the Needle Status display shows Corrective action possible
and the Correction button is active.
In this case, clicking the Correction button will move the puncture
target position upwards, so that the puncture is accepted by the
system. Click on Undo to remove the correction.
It is the operator’s responsibility to decide whether the nature of the
Breast support Danger zone
structure to be punctured, and the width of the notch of the core
biopsy needle, allow a satisfactory puncture under these conditions.
CAUTION
1. When corrective action is accepted by clicking the Correction button, clicking Send performs
the corrective action automatically. Do not also make the correction manually (e.g., by moving the
positioner Z knob), or you will miss the target.
2. Corrective action is not proposed if the target is too low (i.e., if the target defined is lower than
the tip of the needle plus the danger zone height).

2-3 Transfer of Puncture Data

The current status of the Stereotactic Positioner is shown by messages on the Stereotactic Positioner
Status display (below the Needle description window).
If the combination of puncture target data and selected needle characteristics is not correct and
acceptable for puncture, this is indicated by a message on the Needle Status display (below the Needle
description window), and the Send button is inactive.
If for any reason you want to close the Puncture panel and return to the Stereotaxy application screen
without transferring the puncture data, click the Cancel button at the left of the Puncture panel.
When you have selected the needle, and Stereotactic Positioner status and Needle status are correct:
1. Click the Send button on the puncture panel.
Note:
This button is disabled when creating, modifying, or deleting a needle.
Puncture
Send
2. The puncture data is transferred to the Stereotactic Positioner, and the Puncture panel closes.
3. The needle holder can now be positioned ready for the puncture as described in section
3 Positioning the Needle Holder on page 147.

3 Positioning the Needle Holder

3-1 Needle Path block
Push the needle path block lever to

the left to open the needle path
Needle holder
• The Stereotactic Positioner is equipped with a needle path block. Its purpose is to prevent any
motorized movement of the Stereotactic Positioner when a needle is being inserted or already in the
breast or phantom.
The needle path block is controlled by the small lever next to the Z manual adjustment knob. When
this is pushed to the right, a plastic disk between the two needle holder supports blocks the needle
path.
• For patient safety, the motorized movement of the Stereotactic Positioner can only be used if the
needle path is blocked. In this position it is not possible to insert a needle in the holder.
• To open the needle path for the insertion of a needle, push the lever to the left.
• When the needle path is open, all motorized movement of the positioner is inhibited.
Note:
The needle path is always blocked when using the lateral arm. Only manual movement is allowed
when the lateral arm is in use.
WARNING
The needle path block does not prevent manual movement of the positioner using the X, Y, Z
knobs.
It is the responsibility of the operator to ensure that the positioner manual controls are not moved
after the needle is inserted.
WARNING
Needle path block test:
The needle path block must be tested on each day that stereotactic exams are performed, before
the first exam of the day.
If the needle path block is broken, the Stereotactic Positioner must NOT be used.

3-2 Motorized Positioning

Motorized needle holder movement is controlled by means of three Go to Park
buttons on the Stereotactic Positioner: Go To Park, Go To Target,
and Next Target. These buttons and their use are described below.
For ease of access, the three buttons are duplicated on the left and Go to Target
right side; their functions are the same on either side.
Next target
3-2-1 Go To Park P
The Go To Park button is used to move the needle holder out of the field of view, to obtain the best view
of the area of interest.
1. Press and hold the Go To Park button.
The needle holder starts moving to the park position, i.e., centered left-right (X), maximum
displacement towards the rear (Y), and centered height (Z).
2. Hold the button down until the needle holder has reached this position and stops, then release the
button.
When the needle holder is at the park position, the light beside the control buttons on the Stereotactic
Positioner will blink green.
During the operation, the display unit shows the distances X,Y,
and Z between the current position and the park position. parking X=+01.3
Z=+012.3 Y=-08.5
3-2-2 Go To Target
The Go To Target button is used to move the needle holder directly over the target.
1. Press and hold the Go To Target button.
The needle holder starts moving to the target position. The distances X, Y, and Z between the current
position of the needle holder and the target position are displayed continuously on the Display Unit.
2. Hold the button down until the needle holder has reached the target position and stops, then release
the button.
3. During the operation, the display unit continues to show the distances
X,Y, and Z between the current position and the destination position, P3 X=+00.0
until the three coordinates become zero at the destination position. Z=+002.3 Y=-00.0

4. When the needle holder is at the destination position, the light beside
the Go To Target button illuminates green, and the display unit shows TARGET REACHED
the message TARGET REACHED.
5. To confirm that the correct needle is in use:
Press the Go To Target button again when the needle holder is at the
destination position. FNA: N1
NL = 110.0
The display unit now shows the programmed needle characteristics:
- Needle type:
Display Declared needle type
FNA Fine Needle Aspiration FNA
CORE Core Biopsy CB
HOOK Pre-surgical hook Hook
VAD Vacuum Assisted Device with vertical holder VAD with holder
VADN Vacuum Assisted Device without vertical holder VAD without holder
LAT Lateral Approach Tool LAT
- Needle name
- Needle dimension.
The example shows the display for an FNA needle named N1, having a length of 110 mm.
Note:
If the needle holder is moved/located to a position where the tip of the needle would enter the
“danger zone” (i.e., it would reach a position close to the breast support plate, where it may touch
the plate), the light next to the Go To Target button illuminates red, warning you that there is a risk
of the needle hitting the plate.
3-2-3 Next Target

The Next Target button is used to select the next secondary target.
1. Press the Next Target button to step through the targets (primary target and associated secondary
targets) until the desired puncture target is displayed.
When the desired target has been selected, use the Go To Target button to move the needle holder
over the target as described above.
Note:
When the puncture data are transferred to the positioner, the primary target is selected by default,
so that normally you can go directly to the primary target, then select secondary targets as
required.
2. The Display Unit shows the reference of the puncture target, and the distance in X, Y, and Z between
the current position of the needle holder and the coordinates of the target. See examples below.
This example shows a primary puncture target corresponding to a
third puncture set defined using the stereotaxy application, named P3 X= + 00.0
P3. Z= + 00.0 Y= + 00.0
This example shows a secondary target. The four secondary targets

of a puncture set are named SA, SB, SC, and SD (corresponding to SC X= + 03.0
Z = + 00.0 Y = + 03.0

the four positions A, B, C, D, shown in section 1-5 Placing the Secondary Puncture Markers on
page 138).
To cycle through the targets, press the button repeatedly. After the last target, the display
automatically wraps around, back to the first puncture target.
An asterisk (*) is displayed in front of the puncture target reference
when the target (primary or secondary) has been reached. *P3 X=00.0
Z=000.0 Y=00.0
3-3 Manual Positioning
Manual positioning of the needle holder of the Stereotactic Positioner can be used in the following cases:
• To perform fine tuning of the X, Y and Z coordinates to make slight changes from the values
computed on the workstation. For instance, when placing of a hook wire for pre-surgical localization.
Final adjustment of the Z coordinate is done manually.
Note:
If the needle holder is moved/located to a position where the tip of the needle would enter the
“danger zone” (i.e., it would reach a position close to the breast support plate, where it may touch
the plate), the light next to the Go To Target button illuminates red, warning you that there is a risk
of the needle hitting the plate.
• When using the lateral approach arm accessory (only manual positioning is possible, in this case).
• To correct the position of the biopsy device after viewing pre-fire or post-fire images, when the biopsy
device is still in place.

4 Performing the puncture

4-1 Overview
After defining the puncture(s) on the workstation, you can perform the puncture(s) using the Stereotaxy
Viewer and Stereotactic Positioner, as described in the following sections.
During the procedure you can perform check exposures (such as pre-fire and post-fire exposures during
core biopsy, or to ascertain correct positioning of a pre-surgical localization hook).
If you have defined more than one puncture set for the same patient, they can be performed in
succession, by repeating the sequence of operations.
4-2 Performing the Primary Puncture

• After moving the needle holder to the primary puncture position using
the Go To Target button or manually using the X, Y and Z knobs as *P3 X=00.0
described above, the X, Y, and Z values indicated on the display unit Z=000.0 Y=00.0
should all be zero.
Note:
The primary target is selected by default when the puncture data are transferred to the positioner.
Tube arm angled to

the + 15° position
Needle holder
• Move the tube arm to the right hand or left hand side Park position (see Chapter 10 Preparation for
examinations section 2 Arm Positioning on page 94).
This frees the space above the needle holder, to facilitate the installation of needle guides and
needles.
Note:
At the Park positions, exposure is inhibited; a warning message appears on the Senographe
Control Console read-out if exposure is attempted.

4-2-1 FNA, Pre-Surgical Hook or Core Biopsy Needle

If an FNA, Pre-Surgical Hook, or Core Biopsy needle was selected in the needle list:
1. Open the needle path by moving the knob to the left.
2. Check that the appropriate needle guide (with adaptor and/or holder if needed) is in place.
3. Insert a pair of sterile needle guides of the correct diameter for the needle in the needle holder.
4. The radiologist disinfects the skin of the patient.
Note:
The tray containing equipment required for the puncture must be ready and beside the radiologist.
See Chapter 10 Preparation for examinations, section 3 Preparation for an examination on
page 98.
5. Insert the needle into the needle guides. When it reaches the surface of the skin, push it firmly into
the breast. The bottom of the needle-guard should touch the upper edge of the needle guide.
6. Perform check exposures as described in section 4-3 Check Exposures on page 152.
7. If a biopsy device is in use, fire it to reach the desired target.
4-2-2 Lateral Approach Tool (LAT)
If the Lateral Approach Tool (LAT) was selected in the needle list for a lateral approach puncture:
• Insert sterile needle guides of suitable diameter in the needle guide holder before proceeding with
the puncture. See Chapter 9 Installation for Lateral Approach, section 4-2-2 Install needle guide
holders and needle guides on page 81.
4-3 Check Exposures
CAUTION
Whatever the type of puncture performed, check exposures must be made with the needle in
place in the breast.
CAUTION
Angulating to the opposite side when the biopsy device is in place is not possible if a risk of
collision between the biopsy device and the tube head covers has been detected. In that case,
only a check in the current angulation is enabled. It is the responsibility of the user to determine
whether this check is sufficient to accept the puncture or not.
Under some circumstances, it may be possible to override the interlock, after temporarily removing the
biopsy device to avoid the danger of collision. Refer to Chapter 10 Preparation for examinations, section
2-5 Angulation interlock on page 97.
4-3-1 Performing Check Exposures
As soon as the puncture data is transferred to the Stereotactic Positioner by pressing the Send button,
the Senographe workstation returns to the Stereotaxy application screen, ready for further exposures,
such as pre-fire and post-fire check exposures during core biopsy, or exposures to verify correct
positioning of a pre-surgical localization hook.
To perform check exposures:
• Reposition the tube arm as required (angulation +15°, -15°, or 0°).
• Make the check exposures as described in Chapter 12 Stereotaxy Image Acquisition, section
3 Making Stereotaxy exposures on page 132.

• The radiologist inspects the image:

- For an FNA puncture the tip of the needle should be at the center of the suspected lesion.
- Similarly, for a core biopsy or VAD, the notch of the needle (on the post-fire image) should be at
the center of the suspected lesion.
- When placing a pre-surgical hook, it should be placed just under the suspected lesion.
CAUTION
If there is a perceptible difference between the needle position and the puncture target (for
example, due to patient motion), it is the responsibility of the operator to either accept the needle
position or to define a new puncture set.
4-3-2 Pairs Comparison Function
The display mode Pairs Comparison shows two different stereo pairs simultaneously, allowing
comparison of stereo pair images captured at different instants of the procedure, e.g., pre-fire and post-
fire images.
1. Select the stereo pair to be used as the main stereo pair for reference (e.g., the pre-fire or post-fire
images), by clicking on it in the Mosaic Image Browser. The selected pair is displayed in Stereo
mode.
2. Click the Pairs Comparison button. The legend on the button changes to Back to Pair.
3. Select the stereo pair to be used as the second stereo pair for comparison, by clicking on it in the
Mosaic Image Browser.
4. The selected pair is displayed in the upper half of the screen, with the main stereo pair shown in the
lower half.
information.

5 Additional punctures
5-1 Performing secondary punctures
If secondary punctures are required, proceed as follows for each puncture in turn:
1. After completion of the previous puncture procedure, remove the needle and close the needle path in
preparation for the next puncture (move the needle path block lever to the right, as described in
section 3-1 Needle Path block on page 147).
2. Select the next secondary puncture, using the Next Target button on the Positioner.
3. Move the needle holder to the secondary puncture position using the Go to Target button, or
manually with X, Y and Z knobs.
4. Proceed exactly as described for the primary puncture.
5-2 Performing additional puncture sets

The Stereotaxy application allows the definition of more than one puncture set for the same patient, and
allows the punctures to be performed in the same session.
1. After completion of a puncture procedure, remove the needle and, if in vertical approach, close the
needle path in preparation for the next puncture (move the needle path block lever to the right, as
described in section 3-1 Needle Path block on page 147).
2. If you have defined more than one puncture set for the same patient, return to the workstation after
completing the current puncture set, and select the next puncture site/target.
Note:
Do not send a new puncture target without completing the puncture(s) for the target already sent.
3. Select (highlight) the number of the next puncture set to be performed in the Primary
Primary puncture selection window, and click the Needle & Puncture button.
4. The subsequent procedure is identical to that described above for the first
puncture (section 2 Sending Puncture information on page 142, section
3 Positioning the Needle Holder on page 147 and section 4 Performing the
puncture on page 151).

6 Completion of puncture procedures

When all puncture procedures have been completed:
1. After completion of the last puncture procedure, remove the needle.
2. Return to the Stereotactic Positioner parking position using the Go to Park button, or manually using
the X, Y and Z knobs.
3. Acquire an image at 0° or at +15° and -15°, to verify removal of the suspect area.
4. Check the image(s) with the scout image (if the acquired image is at 0°) or with the first stereo pair (if
the acquired images are +15° and -15°).
5. If tissue was successfully removed, release the compression slowly, and proceed with appropriate
patient after-care.
If suspect tissue is still present, continue with the procedure.
WARNING
When pre-surgical localization is performed, the operator must ensure that after removal of the
needle:
1. The compression paddle is released slowly.
2. The localization wire emerging from the skin is moved carefully, so as not to move the wire
hook from the center of the lesion.


Image Printing and Review
Chapter 14 Image Printing and Review
1 Printing Images
1-1 Introduction
Print management is the same as for the screening/diagnostic application, described in the Senographe
Essential Acquisition System Operator manual.
The chapter on Printing in the Senographe Essential Acquisition System Operator manual is applicable
for the Stereotaxy Application, except for the section describing Print Annotation Models.
Note:
Printing of stereotaxy images on 10" x 12" film is not recommended. The effective image size is
too small to be useful.
1-2 Print Annotation Model

When printing stereotactic images to film, the three models described in the Senographe Essential
Acquisition System Operator manual are not applicable.
A specific template has been defined for printed stereotactic images. This mode cannot be selected for
screening/diagnostic images and is not impacted by the operator’s selection of the model in the Medical
Preferences. The Stereo Model layout is shown below:
Stereo Model:
- Top left corner:
Institution, physician, and patient data at top,
followed by a ruler indicating the image scale.
- Top right corner:
Exposure and image data, followed by view
data.
WARNING
All measurement calculations for graphical
annotations (length, surface area, etc.) are
made in a reference plane which is 2 cm
above the breast contact surface. These
values therefore do not correspond to the
true size of an object unless it is situated in
the reference plane.
It is not possible to determine in the 2D
projection image if a pathological feature is
situated in the reference plane, so these
measurement tools must not be used to
measure the size of pathological features.
Furthermore, it is not possible to duplicate
breast position from one exam to another,
so they must not be used to compare the
size of pathological features over time.
Films printed using the stereo model contain puncture information (e.g., targets, angulation, etc.).
Print Review.fm Page no. 157 Chapter 14

Image Printing and Review
2 Image Review
To review stereo images stored on the workstation image disk, return to the Browser screen.
• In the Browser screen, select the desired stereo images. First select the patient, then the exam
(study), by clicking on them.
Note:
Stereo images can be recognized in the Browser images list because the angulation (0°, +15°, -
15°) is shown in the Angulation field.
• Click the Review exam button.
• When the Review exam button is clicked after selection of a series created by the Stereotaxy
application, the Stereotaxy Viewer is launched automatically. The Viewer window opens and displays
the first selected image.
• In the Viewer Control Panel, the same functions that are available during stereo image acquisition
(refer to Chapter 12 Stereotaxy Image Acquisition, section 2-4 Control Panels on page 130) are also
available in review mode. However, the stereo puncture data defined during the procedure are
recorded as part of the exam and cannot be modified or deleted during image review.
• The following needle and target conditions are displayed when an exam is opened in review mode:
- If the status of a primary target was S (sent) at acquisition, its status appears as S in review
mode.
- If the status of a primary target was OK, OK?, or blank, at acquisition, its status appears as “--” in
review mode.
- The Needle button is enabled only if the status is S.
If the Needle button is clicked and the Needle Panel opens, the needle used for sending the
target is selected by default, and the user is not able to change this selection.
- The needle parameters shown are those of the needle at the time the target was sent.
- Whatever the status of secondary targets in acquisition mode, no status is displayed for them in
review mode (displayed as blank).
• The Mosaic Image Browser is available during stereo image review. Refer to Chapter 12 Stereotaxy
Image Acquisition, section 2-2 Mosaic Image Browser on page 127 for more information.
• The Function Panel is available during stereo image review. Refer to the Viewer chapter in the
Senographe Essential Acquisition System Operator manual for more information.
Chapter 14 Page no. 158 Print Review.fm

System Hygiene
Chapter 15 System Hygiene
1 Cleaning, disinfection, and sterilization - Introduction
WARNING
Adequate cleaning, disinfection, and sterilization is necessary to prevent disease transmission.
Be sure to keep all equipment in a clean condition.
Thoroughly clean and disinfect or sterilize all equipment surfaces that contact the patient, and all
equipment surfaces likely to become soiled during use.
The tables below indicate typical requirements, but they do not cover all situations, and should be
used only as a guide.
2 Definitions of part categories

Part category Definition
No contact Parts which do not contact the patient
Contact Parts which contact the patients:
- "Intact" skin
- "Non-intact" skin
- Mucous membranes without penetrating the skin.
Acute contact Penetrating parts which routinely penetrate the skin, and
parts which are in direct contact with those penetrating
parts
Cleaning.fm Page no. 159 Chapter 15

System Hygiene
3 Hygiene practices
Part category Example Conditions Required hygiene practice
No contact Display panel on the N/A. Cleaning :
Stereotactic Positioner Follow the instructions given in the
System Hygiene chapter in the
Senographe Essential Acquisition
System Operator Manual.
Contact Stereotactic Positioner No risk of cross Disinfection - low level:
body, including: contamination. Follow the instructions given in the
- Needle path block lever System Hygiene chapter in the
- Rotation/Angulation button Senographe Essential Acquisition
- Movement control buttons System Operator Manual.
- Manual control knobs (X,
Risk of cross Disinfection - high level:
Y, Z)
contamination Follow the instructions given in the
Compression paddles
System Hygiene chapter in the
Breast support
Senographe Essential Acquisition
All parts of the Lateral and
System Operator Manual.
Vertical Holder kits
Acute contact Metal needle guides (also N/A Sterilization:
known as metal bushings). Follow the instructions given in the
Operator Manual Sterilization of metal
components used in Stereotaxy
procedures .
Chapter 15 Page no. 160 Cleaning.fm

Planned Maintenance
Chapter 16 Planned Maintenance
1 Introduction
This chapter describes maintenance procedures intended to maintain the performance of the equipment
at the highest level, including quality control tests for the Senographe Stereotaxy.
The chapter includes the following sections:
• Section 2 Field Engineer Maintenance on page 161
• Section 3 QC Tests for the Radiologic Technologist or Medical Physicist on page 161
• Section 4 Test Result Record sheets on page 185
2 Field Engineer Maintenance

This equipment requires no planned maintenance procedures to be performed by a GEMS Service
Representative or similarly qualified and trained personnel.
3 QC Tests for the Radiologic Technologist or Medical Physicist

• QC Tests are checks which ensure that the Senographe Stereotaxy is operating to its design
standards.
• QC tests are described in the following sections:
QC Test 1 - Needle Path Block Test on page 163
QC Test 2 - Localization Accuracy - Vertical Approach on page 165
QC Test 3 - Accuracy check before using new CB or VAD needles in vertical approach on page 168
QC Test 4 - Accuracy check before using new FNA/Hook-wire needles in vertical approach on
page 172
QC Test 5 - Localization Accuracy - Lateral Approach on page 176
QC Test 6 - Accuracy check before using new CB or VAD needles in lateral approach on page 180
• All tests must be performed at least as frequently as specified.
• The tables given in section 4 Test Result Record sheets on page 185 may be copied for use in
recording the results of the tests.
• The Senographe Stereotaxy is used with the Senographe Essential Acquisition System, which also
functions as a full-field digital mammographic system for screening and diagnostic mammography.
Hence, the tests described in this section are to be performed in addition to those performed to
maintain the quality of mammography according to the Quality Mammography Standards of the
MQSA for equipment performance [21 CFR 900.12(b)] and quality control [21 CFR 900.12(e)].
Further information regarding these tests is included in the Senographe Essential Acquisition System
Quality Control Manual.
QC.fm Page no. 161 Chapter 16

Planned Maintenance
Chapter 16 Page no. 162 QC.fm

Planned Maintenance QC Test 1 - Needle Path Block Test
QC Test 1 - Needle Path Block Test
Frequency:
On each day that stereotactic exams are performed, before the first exam of the day.
If no stereotactic exams are carried out, the test should be carried out at least once a month to ensure
continued safe use.
Objective:
To ensure that motorized movement of the needle positioner is inhibited when the needle path is open
(unblocked).
CAUTION
The purpose of the needle path block is to inhibit any motorized movement of the positioner when
a needle is installed. The needle path block does not prevent manual movement of the positioner
using the X, Y, and Z knobs.
Equipment: None
Action Limit:
- The positioner must not make any motorized movement when the needle path is open.
- If it is possible to insert a needle with the needle path closed, or if motorized movement of the needle
positioner is possible when the needle path is open, the needle path block has malfunctioned, and it
is recommended that you contact your GE Service Engineer.
3-1 Procedure
1. Manually move the needle positioner so that the needle path is approximately centered in the field of
view.
2. Check that it is not possible to insert a needle when the needle path is closed (needle path block
lever to the right).
3. Open the needle path by moving the needle path block lever to the left.
4. Activate the Go To Park button on the positioner
5. Record completion of the test in section QC Test Chart 1- NeedlePath Block Test on page 186.

Planned Maintenance QC Test 1 - Needle Path Block Test

Planned Maintenance QC Test 2 - Localization Accuracy - Vertical Approach
QC Test 2 - Localization Accuracy - Vertical Approach
Frequency:
On each day that stereotactic exams using the vertical approach are to be performed, before the first
exam of the day. If no stereotactic exams are carried out, the test should be carried out at least once a
month to ensure continued accuracy. See Chapter 7 Procedure Steering Guide section 3 Pre-
examination check on page 45.
Objective:
To ensure localization accuracy in the vertical approach
Equipment:
Pin phantom L19 and calibration needle 120mm.
Action Limit:
The magnitude of the offset for any axis (X, Y, or Z) must not exceed 1 mm.
Record completion of the test in section QC Test Chart 2 - Stereotactic
Localization Accuracy: Vertical Approach on page 187.
Pin phantom
3-2 Procedure
The procedure used for the test with the phantom is similar to a normal stereotactic patient procedure.
3-2-1 Preparation
1. Prepare the Senographe and install the Stereotactic Positioner as described in Chapter 6 Installation
of the Stereotactic Positioner, section 1 Installing the Stereotactic Positioner on page 43.
2. Open the Worklist window on the Senographe AWS and
verify that the selection for Type of Exam is Stereo. Browser
3. On the Worklist, select the “Phantom” Patient or create it. Type of Exam Stereo Start Exam
4. If a “Phantom” Patient has not yet been defined for use
with the phantom accuracy tests, select New Patient... in
the Worklist, and complete the new Medical Procedure Card as required, with “Phantom” as the
Patient Name, before starting image acquisition. Refer to Chapter 12 Stereotaxy Image Acquisition
section 1 Starting the Stereotaxy application on page 125 for details.
5. Click Start Exam. The Stereotactic Viewer appears, with the Viewer area at the right of the screen
remaining black until an exposure is taken. Refer to Chapter 12 Stereotaxy Image Acquisition section
2 Stereotaxy viewer on page 126.
6. Position the Pin Phantom under the compression paddle so that the tip of the phantom rod faces the
opening in the paddle, and is approximately in the middle of the volume (Z = 30 mm).
7. Use the compression knobs on either side of the Stereotactic Positioner to apply just enough
compression to hold the phantom in place.
Note:
- When the stereotaxy compression paddle leaves the park position (i.e., it is less than 10 cm from
the breast support), the up/down and rotation movements of the Senographe Positioner Arm are
inhibited.
- After the phantom has been placed in position and compressed, it must not be moved until the
test has been completed.

9. Press the Go to Park button P on the Stereotactic Positioner to move it to the parking position.
3-2-2 Exposure
1. Select Manual exposure mode (Mo-Mo, 24kV, 4mAs) on the X-ray Console. Select laterality.
3. The scout image shows the inverted T reference marks, the projection of the phantom rod, and the
projection of the compression paddle aperture.
4. Verify that the projection of the tip of the rod appears inside the projection of the compression paddle
aperture.
7. Make the two stereo exposures, with the tube angled to +15°, then to -15°.
See Chapter 12 Stereotaxy Image Acquisition section 3 Making Stereotaxy exposures on page 132
The stereo images are displayed in the monitor Viewer area in Stereo mode (the images in lower half
Use the right mouse button to click on the area of interest on each of the top images, to center the
3-2-3 Define target
1. Click (left mouse button) on the Stereotaxy selection button to open the Stereotaxy Panel.
2. Click the New Primary button to define a new puncture set, then select the puncture
New Primary
marker and drag it over the tip of the rod on each of the zoomed images. Refer to
Chapter 13 Stereotaxy Punctures section 1-4 Placing the Primary Puncture Marker
on page 136.
Note:
deviations when the needle is being inserted in the phantom.
3. Click the Check on Scout button to display the scout image in the top half of the screen. This allows

3-2-4 Prepare needle

only if the puncture status is OK.
2. Select a pre-programmed calibration needle or program it as described in Chapter 11 Needle Setup
section 2 Needle Setup on page 104. Click the Send button (note that the n value for the dadicated
120 calibration needle is 0 mm, it must be programmed either as FNA or Hook).
3. Angle the tube arm to either of the parking positions, to ease insertion of the calibration needle. Refer
to Chapter 10 Preparation for examinations, section 2-4-1 Angulation movement for stereotaxy on
page 96.
4. With the needle path block closed, press and hold the Go to Target button on the Stereotactic
Positioner until the target position is reached; the light will now be green.
5. See Chapter 13 Stereotaxy Punctures section 4 Performing the puncture on page 151 for more
information.
Note:
When the needle path is open, all motorized movements are inhibited. Manual movement is
allowed with the needle path open.
3-2-5 Position the needle
1. Press the Go to Target button again to display the programmed needle. Check that the
correct needle has been chosen.
2. It is not necessary to install needle guides. Insert the 120 mm calibration
needle directly into the upper needle guide support.
3. The tip of the 120 mm calibration needle should just contact the tip of the
phantom rod.
- If not, adjust the X, Y, and Z positions of the calibration needle manually
until contact is established.
- Read the resulting offsets between the computed target position and the
actual needle position on the Display Unit.
- If the magnitude of any of these offsets exceeds 1.0 mm, repeat the test. If it is not possible to
reduce the magnitude of all offsets to 1.0 mm or less, call your Field Engineer.
3-2-6 Repeat for other positions
1. Decompress the Pin Phantom.
2. Reposition it on the breast support, so as to place the tip of the rod in a different position in the
puncture volume. Turn the phantom to use a different value of Z (Z=10 mm, Z=20 mm) and move it to
a different location (changing X and Y) with the tip of the rod under the paddle aperture area, away
from the center.
3. Press Go to parking till parking position is reached.
4. Carry out the procedures described above (sections 3-2-3 Define target on page 166, 3-2-4 Prepare
needle on page 167 and 3-2-5 Position the needle on page 167) for at least those two Z values.
5. To repeat the same procedure for Z= 40 mm, the dedicated 70 mm calibration needle must be used
instead of 120 mm one. This needle needs to be programmed accordingly in the needle panel,
having also an n value equal to zero since no needle guide is used.

Planned Maintenance QC Test 3 - Accuracy check before using new CB or VAD needles in vertical approach
QC Test 3 - Accuracy check before using new CB or VAD needles in vertical

approach
Frequency:
Whenever a new CB or VAD needle is defined or a new type of needle is to be used.
Note:
For needles used without a biopsy device (FNA or Hook), use the procedure described in section
page 172.
Objective:
Confirm needle definition whenever a new gauge or length needle is
introduced for an existing device.
Equipment:
Pin phantom L19, biopsy device and the new CB or VAD needle to be used.
Action Limit:
The magnitude of the offsets for the axes (X, Y, and Z) is recorded during
the check. The target must be inside the central part of the needle notch.
Record completion of the test in section QC Test Chart 3 - Accuracy check Pin phantom
before using new CB or VAD needles in vertical approach on page 188.
3-3 Procedure
3-3-1 Preparation
If a “Phantom” Patient has not yet been defined for use with
the phantom accuracy tests, select New Patient... in the
Worklist, and complete the new Medical Procedure Card as required, with “Phantom” as the Patient
Name, before starting image acquisition. Refer to Chapter 12 Stereotaxy Image Acquisition section
1 Starting the Stereotaxy application on page 125 for details.
remaining black until an exposure is taken. Refer to Chapter 12 Stereotaxy Image Acquisition
section 2 Stereotaxy viewer on page 126.
5. Position the Pin Phantom under the compression paddle so that the tip of the phantom rod faces the
opening in the paddle and is approximately in the middle of the volume (Z = 30 mm).
Note:
inhibited.

3-3-2 Exposure
1. Select Manual exposure mode (Mo-Mo, 24kV, 4mAs) on the X-ray Console, select laterality.
The scout image shows the inverted T reference marks, the projection of the phantom rod, and the

3-3-3 Define target
New Primary
marker and drag it over the tip of the rod on each of the zoomed images. Refer to
on page 136.
Note:
2. Select the new pre-programmed needle or program it as described in Chapter 11 Needle Setup
section 2 Needle Setup on page 104.
4. Angle the tube arm to either of the parking positions, to ease insertion of the needle. Refer to
Chapter 10 Preparation for examinations, section 2-4-1 Angulation movement for stereotaxy on
page 96.
5. With the needle path block closed, press and hold the Go to Target button on the Stereotactic
information.
Note:
2. Install the appropriate needle guides, and insert the needle (with the biopsy device in its pre-fire
state) through the needle guides
3. The tip of the needle must be a few millimeters above the target.
4. Acquire a pre-fire stereo pair to verify the positioning of the puncture tool.
5. Turn the Y knob slightly so as to allow the device to be fired without impacting the tip of the pin. Make
all movements very carefully, and ensure that the notch remains facing the tip of the pin.
6. Fire the device.
7. Reverse the movement of the Y knob to return to the previous position (Y = 0).
8. Check that the target is inside the notch, at a position you would accept for a puncture (usually
around the center of the notch).

9. Perform a post-fire check by acquiring a pair of stereo views. The target must be inside the notch at
an acceptable position.
3-3-6 Repeat for other test points
• Decompress the Pin Phantom.
• Reposition it on the breast support, so as to have the tip of the rod in a different position in the
puncture volume. Turn it to use a different value of Z (do not use Z = 10, as the target would then be
too low). Press Go to Parking till parking position is reached, and move to a different location
(changing X and Y), under the paddle aperture area, away from the center.
• Carry out the procedures described above (sections 3-3-3 Define target on page 170, 3-3-4 Prepare
needle on page 170 and 3-3-5 Position the needle on page 170) for at least two other positions of the
target.
Note:
Depending on the device /needle length (post fire, notch or tip length) different warnings may
appear in the Needle Panel.

Planned Maintenance QC Test 4 - Accuracy check before using new FNA/Hook-wire needles in vertical approach
QC Test 4 - Accuracy check before using new FNA/Hook-wire needles in vertical

approach
Frequency:
Whenever a new FNA/Hook-wire needle is defined or a new type of FNA/Hook-wire needle is to be used.
Note:
For needles used with a biopsy device (CB or VAD), use the procedure described in section QC
Test 3 - Accuracy check before using new CB or VAD needles in vertical approach on page 168.
Objective:
Confirm needle definition whenever a new gauge or length needle is introduced.
Equipment:
Vertical approach phantom and the new FNA needle.
Note:
The needle used must be long enough to touch
the bottom of the deepest hole of the phantom.
A needle length of at least 94-95 mm is
recommended when the phantom is
compressed to 50 mm.
• The phantom is a block measuring 50 x 100 x
72 mm (approximately 2 x 4 x 3 inches).
• Five holes of 1 mm diameter and different depths
are provided for use in accuracy tests. They are 5
positioned as shown in the diagram. The z value 3
4
for those five holes is as follows: 2
Reference 1 2 3 4 5 1
Z value 45 20 30 40 10
(mm)
Action Limit:
The magnitude of the offset for any axis (X, Y, or Z)
must not exceed 1 mm.
Record completion of the test in section QC Test
Chart 4 - Accuracy check before using new FNA needles in vertical approach on page 189.
3-4 Procedure
3-4-1 Preparation
If a “Phantom” Patient has not yet been defined for use
with the phantom accuracy tests, select New Patient... in

the Worklist, and complete the new Medical Procedure Card as required, with “Phantom” as the
Patient Name, before starting image acquisition. Refer to Chapter 12 Stereotaxy Image Acquisition
section 1 Starting the Stereotaxy application on page 125 for details.
remaining black until an exposure is taken. Refer to Chapter 12 Stereotaxy Image Acquisition section
2 Stereotaxy viewer on page 126.
5. Position the vertical approach phantom under the compression paddle so that the holes in the
phantom face the opening in the paddle.
6. Place 2cm or more of Plexiglas filtration at the rear of the phantom to prevent any possibility of ghost
images in the clinical images acquired immediately after QC tests.
Note:
inhibited.
3-4-2 Exposure
1. Select Manual exposure mode (Rh-Rh, 29 kV, 64 mAs) on the X-
ray Console.
2. Make the scout exposure. The scout image appears in the Viewer
area.
The scout image shows the inverted T reference marks, the
projection of the lead plugs contained in the phantom, and the
Verify that the projections of all lead plugs appear inside the
3. Adjust the window width and level if necessary for best viewing
Scout image
level.

-15° +15°
Inverted T Reference
Markers
Lead plugs
Stereo pair (left and right images) of phantom
3-4-3 Define target
marker and drag it over the same lead plug on each of the zoomed images. Refer to New Primary
on page 136.
Note:
2. Select a pre-programmed needle or program a new needle as described in Chapter 11 Needle Setup
section 2 Needle Setup on page 104.
Note:
- Only FNA needles should be used with the vertical approach phantom.
- The needle used must be long enough to touch the bottom of the deepest hole of the vertical
approach phantom. A needle length of at least 94-95 mm is recommended when the phantom is
compressed to 50 mm.

4. Angle the tube arm to either of the parking positions, to ease insertion of the needle. Refer to
Chapter 10 Preparation for examinations, section 2-4-1 Angulation movement for stereotaxy on
page 96.
5. With the needle block closed, press and hold the Go to Target button on the Stereotactic
information.
Note:
2. Install the appropriate needle guides, and insert the needle into the
needle guides. Needle hub
3. The needle should move easily into the hole in the phantom above
the selected target, and the tip of the needle should just contact the Needle guide
lead plug with the base of the needle hub resting on the needle
guide. Phantom
- If not, adjust the X and Y positions of the needle manually until it
is centered in the hole, and adjust the Z position until the needle Lead plug
tip just contacts the lead plug with the base of the hub resting on
the needle guide.
- Read the resulting offsets between the computed target position and the actual needle position
on the Display Unit.
• If the magnitude of any of these offsets exceeds 1.0 mm, repeat the test.
If it is not possible to reduce the magnitude of all offsets below 1.0 mm, call your Field Engineer.
3-4-6 Repeat for all test points
• Carry out the procedures described above (sections 3-4-3 Define target on page 174, 3-4-4 Prepare
needle on page 174 and 3-4-5 Position the needle on page 175) for each of the remaining holes in
the phantom.
• To be sure that the Stereotactic Positioner is operating correctly, the check should be made for at
least three of the holes in the phantom, using the same reference exposure (section 3-4-2 Exposure
on page 173).
Note:
Do not move the phantom at any time during the test. The procedure must be repeated if there has
been any movement of the phantom.

Planned Maintenance QC Test 5 - Localization Accuracy - Lateral Approach
QC Test 5 - Localization Accuracy - Lateral Approach
Frequency:
On each day that stereotactic exams using the lateral approach are to be performed, before the first
exam of the day. If no stereotactic exams are carried out, the test should be carried out at least once a
month to ensure continued accuracy. See Chapter 7 Procedure Steering Guide section 3 Pre-
examination check on page 45.
Objective:
To ensure localization accuracy in the lateral approach
Equipment:
Pin phantom L19 and calibration needle L20.
Action Limit:
The magnitude of the offset for the X or Y or Z axis must not exceed ±1.0 mm with the calibration needle.
Record completion of the test in section QC Test Chart 5 - Localization Accuracy: Lateral Approach on
page 190.
3-5 Procedure
Note:
Before beginning the procedure, the Lateral Approach Tool must have
been declared as described in Chapter 11 Needle Setup section 2-
2 To create a new needle (with or without a biopsy device) on
page 105.
The procedure used for the test with the phantom is similar to a normal
stereotactic patient procedure using the lateral arm.
Pin phantom
3-5-1 Preparation
2. Install the lateral approach tool support and adaptor bar as described in Chapter 9 Installation for
Lateral Approach.
4. On the Worklist, select the “Phantom” patient or create it. Type of Exam Stereo Start Exam
If no “Phantom” patient has been defined for use with the
phantom accuracy test, select New Patient... in the
Worklist, and complete the new Medical Procedure Card as required, with “Phantom” as Patient
Name, before starting image acquisition. Refer to Chapter 12 Stereotaxy Image Acquisition Section
1 Starting the Stereotaxy application on page 125 for details.
6. Position the phantom L19 under the compression paddle:
- With the tip of the pin within the area of the biopsy window as defined by the four engraved
crosses on the breast support.
- With the pin perpendicular to the chest wall, pointing toward the chest wall side.
The upper face of the phantom indicates the Z position of the target (10, 20, 30, or 40 mm).

Note:
- When the stereotaxy compression paddle leaves the park (high) position, the up/down and
rotation movements of the Senographe Positioner Arm are inhibited.
test has been completed
angulation mode. The gantry readout now displays the stereo angle, not the gantry angle.
9. If stereo positioner is not in parking position , turn the X, Y, and Z knobs until the parking position is
reached (green light will blink), to move the needle holder out of the field of view.
3-5-2 Exposure
1. Select the manual exposure mode with the following parameters: Mo-Mo, 24kV, 4mAs. This type of
phantom does not give a good image in AOP mode.
- Verify that the tip of the Phantom is centered within the four engraved crosses.
- Verify that both inverted T reference marks are visible and not hidden by the phantom. If not,
reposition the phantom and make the scout exposure again.
section 2 Stereotaxy viewer on page 126.
3-5-3 Define puncture
2. Click the New Primary button to define a new puncture set, then select the puncture marker and drag
it over the exact area of interest on each of the zoomed images. Refer to Chapter 13 Stereotaxy
Punctures section 1-4 Placing the Primary Puncture Marker on page 136.
Note:
deviations when the needle is being moved to the phantom position.

See Chapter 12 Stereotaxy Image Acquisition section 2-3 Viewing Area on page 127.
3-5-4 Install and position the needle
only if the puncture status is OK
2. Select the pre-programmed lateral approach tool.
4. Angle the tube arm to either of the parking positions, to ease insertion of the needle.
5. Go to target manually by turning the X, Y, Z knobs on the
Stereotactic Positioner until the following position is reached:
X= 0.0 mm
Y= 0.0 mm
Z= 0.0 mm
This movement must be made manually because motorized
movement is not allowed with the lateral approach tool installed. X = 0.0 mm
Y = 0.0 mm
Z = 0.0 mm
6. Slide the cursor L5 up to the stop on the lateral adaptor bar L4 (position 0), and slide the needle
guide holder L18 onto the bar until it touches the cursor. Lock the cursor and holder in position by
tightening their securing screws.
7. Place the calibration needle L20 through the holes of the needle guide holder L18 (no needle guide is
required).
3-5-5 Test results
1. Check that the tip of the phantom pin touches the tip of the calibration
needle.
2. If not, use the X and Y knobs to move the needle until contact is
established between the two tips.
3. To be correct, the X, Y coordinates must be equal to or less than
±1.0 mm
• If X or Y are not within the values specified above, repeat the test. If the problem persists, call your
Field Engineer.
• If the tip of the phantom does not touch the tip of the calibration needle because of displacement on
the Z axis, refer to Chapter 11 Needle Setup and perform the procedures described in section 3-
6 Lateral Approach adaptor on page 112. Repeat the test. If the problem persists, call your Field
Engineer.


• Decompress the pin phantom.
puncture volume. Turn it to use a different value of Z, and move it to a different location (changing X
and Y). Press Go to Parking till parking position is reached.
• Carry out the procedures described above (sections 3-5-3 Define puncture on page 177, and 3-5-
4 Install and position the needle on page 178) for at least two other positions of the target.

Planned Maintenance QC Test 6 - Accuracy check before using new CB or VAD needles in lateral approach
QC Test 6 - Accuracy check before using new CB or VAD needles in lateral

approach
Frequency:
Whenever a new CB or VAD needle is defined or a new type of needle is to be used.
Note:
For needles used without a biopsy device (FNA or Hook), use the procedure described in section
page 172.
If no stereotactic exams are carried out, the test should be carried out at least once a month to ensure
continued accuracy. See Chapter 7 Procedure Steering Guide section 3 Pre-examination check on
page 45.
Objective:
To ensure localization accuracy in the lateral approach.
Equipment:
Pin phantom L19, biopsy device and the new CB or VAD needle to be used.
Action Limit:
With any biopsy device, the tip of the pin of the test phantom must be at the center of the notch of the
biopsy needle.
Record completion of the test in section QC Test Chart 6 - Accuracy check before using new CB or VAD
needles in lateral approach on page 191.
3-6 Procedure
Note:
Before beginning the procedure, the Lateral Approach Tool must have
been declared as described in Chapter 11 Needle Setup section 2-
2 To create a new needle (with or without a biopsy device) on
page 105.
The procedure used for the test with the phantom is similar to a normal
stereotactic patient procedure using the lateral arm.
Pin phantom
CAUTION
It is NOT recommended to use the firing mechanism of a biopsy device when not introduced in a
breast or a soft phantom; it could result in injury to the operator.
This procedure tests the accuracy of the system when using the lateral arm with a VAD or similar biopsy
device. The principle is to introduce the needle to a position offset by approximately 10 mm in the Y
direction from the tip of the Phantom pin, and to carefully move the needle toward the 0, 0, 0 position,
using the Y knob only.
3-6-1 Preparation
2. Install the lateral approach tool support and adaptor bar as described in Chapter 9 Installation for
Lateral Approach.

3. If required, install the mounting bracket onto the biopsy device as described in Chapter 9 Installation
for Lateral Approach section 4 Fitting the lateral approach biopsy device on page 73


Type of Exam Stereo Start Exam
5. On the Worklist, select the “Phantom” patient or create it.

If no “Phantom” patient has been defined for use with the phantom accuracy test, select New
Patient... in the Worklist, and complete the new Medical Procedure Card as required, with “Phantom”
as Patient Name, before starting image acquisition. Refer to Chapter 12 Stereotaxy Image
Acquisition Section 1 Starting the Stereotaxy application on page 125 for details.
7. Position the phantom L19 under the compression paddle:
- With the tip of the pin within the area of the biopsy window as defined by the four engraved
crosses on the breast support.
- With the pin perpendicular to the chest wall, pointing toward the chest wall side.
The upper face of the phantom indicates the Z position of the target (10, 20, 30, or 40 mm).
Note:
- When the stereotaxy compression paddle leaves the park (high) position, the up/down and
rotation movements of the Senographe Positioner Arm are inhibited.
test has been completed
angulation mode. The gantry readout now displays the stereo angle, not the gantry angle.
10. If stereo positioner is not in parking position (the green light is flashing), turn manually the X, Y, Z
knobs until the parking position is reached to move the needle holder out of the field of view.
3-6-2 Exposure
1. Select the manual exposure mode with the following parameters: Mo-Mo, 24kV, 4mAs. This type of
phantom does not give a good image in AOP mode.
- Verify that the tip of the Phantom is centered within the four engraved crosses.
- Verify that both inverted T reference marks are visible and not hidden by the phantom. If not,
reposition the phantom and make the scout exposure again.

3-6-3 Define puncture
2. Click the New Primary button to define a new puncture set, then select the puncture marker and drag
it over the exact area of interest on each of the zoomed images. Refer to Chapter 13 Stereotaxy
Punctures section 1-4 Placing the Primary Puncture Marker on page 136.
Note:
deviations when the needle is being moved to the phantom position.
See Chapter 12 Stereotaxy Image Acquisition section 2-3 Viewing Area on page 127.
3-6-4 Install and position the needle
only if the puncture status is OK
2. Select the pre-programmed lateral approach tool.
4. Angle the tube arm to either of the parking positions, to ease insertion of the needle.
5. Go to target manually by turning the X, Y, Z knobs on the
Stereotactic Positioner until the following position is reached:
X= 0.0 mm
Y= -10.0 mm
Z= 0.0 mm
This movement must be made manually because motorized
movement is not allowed with the lateral arm installed.
X = 0.0 mm
Y = -10.0 mm
Z = 0.0 mm
6. Install the appropriate needle guide holders and needle guides as described in Chapter 9 Installation
for Lateral Approach.
7. With the biopsy device in a post-fire condition (the biopsy device has already been fired), install it as
described in Chapter 9 Installation for Lateral Approach.
8. Turn the Y knob carefully to reach the 0, 0, 0 position.

3-6-5 Test results

1. Check that the tip of the phantom pin is within the center of the needle notch or collecting chamber
2. If the tip of the phantom pin is not exactly in the center of the notch, use the X and Y knobs to position
it accurately.
3. Record the new X and Y values and decide whether you find them acceptable. If not, repeat the test
to try to achieve better accuracy. If the problem persists, call your Field Engineer.
The illustrations show examples of
Correct Not correct
good and bad results.
In the "not correct" example shown,
the deviation y of 5.0 mm in the Y
axis is not considered acceptable.
• If the tip of the phantom is not within the notch because of displacement on the Z axis, refer to
Chapter 11 Needle Setup and perform the procedures described in section 3-6 Lateral Approach
adaptor on page 112. Repeat the test. If the problem persists, call your Field Engineer.
• Decompress the pin phantom.
puncture volume. Turn it to use a different value of Z, and move it to a different location (changing X
and Y). Press Go to Parking till the parking position is reached.
• Carry out the procedures described above (sections 3-6-3 Define puncture on page 183, and 3-6-
4 Install and position the needle on page 183) for at least two other positions of the target.

Planned Maintenance Test results
Test results
4 Test Result Record sheets

The following charts are included in this section:
QC Test Chart 1- NeedlePath Block Test on page 186
QC Test Chart 2 - Stereotactic Localization Accuracy: Vertical Approach on page 187
QC Test Chart 3 - Accuracy check before using new CB or VAD needles in vertical approach on
page 188
QC Test Chart 4 - Accuracy check before using new FNA needles in vertical approach on page 189
QC Test Chart 5 - Localization Accuracy: Lateral Approach on page 190
QC Test Chart 6 - Accuracy check before using new CB or VAD needles in lateral approach on page 191
They may be copied for use in recording the results of the tests described in this chapter.

Planned Maintenance QC Test Chart 1- NeedlePath Block Test
QC Test Chart 1- NeedlePath Block Test
Facility: Room:
Year Month
Date 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
Initials
Needle Path Block Test
Year Month
Date 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Initials
Needle Path Block Test
Remarks:

Planned Maintenance QC Test Chart 2 - Stereotactic Localization Accuracy: Vertical Approach
QC Test Chart 2 - Stereotactic Localization Accuracy: Vertical Approach
Observations:
As read from the Stereotactic Positioner Display Unit, x is the offset between the final needle position
and the computed target position in the X direction, y is the offset in the Y direction, and z is the offset
in the Z direction.
Date
Pin Phantom Position Pin Phantom Position Pin Phantom Position
Offset 1 2 3 1 2 3 1 2 3
Δx (mm)
Δy (mm)
Δz (mm)
Date
Offset 1 2 3 1 2 3 1 2 3
Δx (mm)
Δy (mm)
Δz (mm)
Date
Offset 1 2 3 1 2 3 1 2 3
Δx (mm)
Δy (mm)
Δz (mm)

Planned Maintenance QC Test Chart 3 - Accuracy check before using new CB or VAD needles in vertical approach
QC Test Chart 3 - Accuracy check before using new CB or VAD needles in

vertical approach
Observations:
in the Z direction.
Date
Offset 1 2 3 1 2 3 1 2 3
Δx (mm)
Δy (mm)
Δz (mm)
Date
Offset 1 2 3 1 2 3 1 2 3
Δx (mm)
Δy (mm)
Δz (mm)
Date
Offset 1 2 3 1 2 3 1 2 3
Δx (mm)
Δy (mm)
Δz (mm)

Planned Maintenance QC Test Chart 4 - Accuracy check before using new FNA needles in vertical approach
QC Test Chart 4 - Accuracy check before using new FNA needles in vertical
approach
Observations:
in the Z direction.
Date
Vertical approach phantom hole number Vertical approach phantom hole number
Offset 1 2 3 4 5 1 2 3 4 5
Δx (mm)
Δy (mm)
Δz (mm)
Date
Offset 1 2 3 4 5 1 2 3 4 5
Δx (mm)
Δy (mm)
Δz (mm)
Date
Offset 1 2 3 4 5 1 2 3 4 5
Δx (mm)
Δy (mm)
Δz (mm)
Use this figure to identify the plugs when testing Stereotactic
Localization Accuracy with an FNA needle. The view is from
the top of the test phantom.
5
4
2
1

Planned Maintenance QC Test Chart 5 - Localization Accuracy: Lateral Approach
QC Test Chart 5 - Localization Accuracy: Lateral Approach
Observations:
in the Z direction.
Date
Offset 1 2 3 1 2 3 1 2 3
Δx (mm)
Δy (mm)
Δz (mm)
Date
Offset 1 2 3 1 2 3 1 2 3
Δx (mm)
Δy (mm)
Δz (mm)
Date
Offset 1 2 3 1 2 3 1 2 3
Δx (mm)
Δy (mm)
Δz (mm)

Planned Maintenance QC Test Chart 6 - Accuracy check before using new CB or VAD needles in lateral approach
QC Test Chart 6 - Accuracy check before using new CB or VAD needles in lateral
approach
Observations:
in the Z direction.
Date
Offset 1 2 3 1 2 3 1 2 3
Δx (mm)
Δy (mm)
Δz (mm)
Date
Offset 1 2 3 1 2 3 1 2 3
Δx (mm)
Δy (mm)
Δz (mm)
Date
Offset 1 2 3 1 2 3 1 2 3
Δx (mm)
Δy (mm)
Δz (mm)

Planned Maintenance QC Test Chart 6 - Accuracy check before using new CB or VAD needles in lateral approach

Operator messages
Chapter 17 Operator messages
1 Introduction
Any operational anomalies found by the system during Senographe operation are signalled by Error
Messages. These may be displayed on the X-ray Console, in a pop-up window on the AWS monitor, or
on the Gantry Readout. They may be simple information messages requiring no action, or they may
indicate error or fault conditions requiring action from the operator and/or GE Service engineers.If you
need to call your Field Service representative about an Operator message, you should quote the entire
message or messages, complete with any identification characters.
• The following tables list error messages relating to stereotactic operation, with explanations and
recommended actions.
- Table 1 Operator Messages displayed on the X-ray Console on page 194
- Table 2 Operator Messages displayed on the AWS monitor on page 196
- Table 3 Patient position status change messages displayed on the AWS on page 199
- Table 4 Operator Messages Displayed on the Readout Panel at the foot of the Gantry on
page 201
• Only messages relating to stereotactic operation are listed here. If you see an error message which
is not listed here, and for more information about error messages, refer to the Error Messages
chapter in the Senographe Essential Acquisition System Operator manual.
2 Operator messages
• Messages displayed on the X-ray Console monitor begin with a three-character identification code,
followed by the message itself.
The first letter of each code indicates the type of message, for example:
- Exx: Error messages indicating that a non-recoverable error has been detected. The system must
be restarted by switching OFF/ON from the X-ray Console.
- Ixx: Information or warning messages indicating operational errors due to temporary fault
conditions or attempts to use non-permitted configurations. It is usually possible to continue use
of the system without restarting.
- Sxx: System exposure messages indicating conditions in which an exposure may not be possible
or has not been correctly terminated.
• Four main types of messages are displayed on the AWS monitor;
- Information messages relating to power on/off events.
- Information messages relating to boot/reset events.
- Information messages relating to disk or memory problems.
- Information messages relating to the stereotaxy interface.
• Four main types of message are displayed on the Readout panel at the foot of the Gantry:
- Information messages with no prefix: Displayed to acknowledge operator actions such as the
selection of a new field of view.
- Advisory messages with a prefix Axx: Displayed to warn the operator when a requested operation
is not possible.
- Halt messages with a prefix Hxx: Displayed to warn the operator that a non-recoverable error has
been detected. The system must be restarted by switching ON/OFF from the X-ray Console.
- Warning messages with a prefix Wxx: Displayed to warn the operator when an error has been
detected that does not prevent continued operation.
Errors.fm Page no. 193 Chapter 17

Operator messages
Table 1 - Operator Messages displayed on the X-ray Console
Message on X-ray Explanation Corrective Action

Console
I53 Scout required for Thickness has changed after 1) If you want to define a new target, acquire
valid TRIPLET acquisition of the scout and the scout image again prior to the stereo pair.
you decided to invalidate it for 2) If you do not need to define new target,
New Primary target definition. ignore this warning and continue exam as
It is now required to acquire a desired.
new scout prior to the stereo
pair.
CAUTION: If stereo angulated
images are acquired instead of
new scout, it will not be
possible to define new targets.
I56 New series is The operator requested to Acquire a new scout view when ready
being started start a new series, or the first
scout of the series has
aborted.
- As long as this warning is
displayed, it is still possible to
review current images in the
acquisition viewer.
- This warning will
automatically disappear at
next scout view acquisition.
S51 Stereotactic Stereotactic Positioner has 1) Check that the Stereotactic Positioner is
positioner not ready been detected but it is not correctly installed and switched on.
ready to start stereotactic 2) If the Stereotactic Positioner screen, does
exam. not display READY or the needle holder
parking coordinates, remove the Stereotactic
Positioner, and install it again.
3) If the problem persists, power OFF/ON from
the control console.
4) If the problem persists, shut down the
system from the AWS Browser.
5) If the problem persists, note ALL messages
and contact your Field Service representative.
S53 Needle holder First exposure is not possible if Move Stereotactic Positioner needle holder to
not in parking pos. needle holder is not in parking parking position using the Go to Park button or
position manually using the X, Y, Z knobs.
S54 Stereo First exposure is not possible if Move arm to 0° angulation to start exam.
angulation not at 0 stereo angulation is not 0°.
degrees
Chapter 17 Page no. 194 Errors.fm

Operator messages
Message on X-ray Explanation Corrective Action

Console
S55 Stereo Exposure is only possible at Move arm to one of these positions to perform
angulation not at X- 0°, +15° or -15° X-rays.
ray pos.
S62 Stereo. Stereotactic Positioner cannot 1) Check that the Stereotactic Positioner is:
positioner failure perform puncture. - correctly installed and switched on.
- in application mode (not in calibration or test
mode).
2) Check any messages displayed on the
Stereotactic Positioner screen.
3) If problem persists, note ALL messages and
contact your Field Service representative.
S63 AWS busy, The AWS is busy, and the 1) No action required; wait for the completion of
please wait… current operation may take the current operation.
some time 2) If the problem persists for more than 30
seconds, shut down the system from the ADS
browser.

Operator messages
Table 2 - Operator Messages displayed on the AWS monitor
Message on AWS Explanation Corrective Action

monitor
Angulation motion Angulating the tube towards 0° Remove the puncture tool and close the needle
limited in the [-15°, 15°] area is not path to release the angulation interlock. If the
possible due to the risk of puncture tool has been removed, but the
collision between the biopsy needle path can not be closed (because of the
device and the tube head. presence of a cannula, for example), it is
possible to override the interlock as described
in chapter 10, section 2-5 Angulation interlock
on page 97.
AWS reset completed The AWS boot or reset Click OK to close the pop-up window.
sequence has been
successfully
completed.
AWS Reset failed The AWS boot failed. System 1) Perform system shutdown and restart the
is not operational, exam is not system.
possible. 2) If the problem persists, note ALL messages
Corrective action The system has detected a Refer to Chapter 13, section 2-2 Correction on
possible risk of collision with the breast page 145. If you are satisfied that the
support, but can correct the correction is acceptable, click the Correction
target position button to proceed.
Device length is User attempted to create a Verify the values entered. If they are correct,
incorrect. Please device (in vertical approach) the tool is not compatible with the system.
enter a valid value too long to be used with the
system without a risk of
collision with the tube head.
Do you want to start a System requests confirmation 1) Answer YES if you want to start a new
new series? of an operator request for a series.
new image series. 1) Answer NO if you do not want to start a new
series.
Lateral approach tool Target is not accessible with Access the lesion using a vertical approach or
too long the lateral arm. reposition the patient.
Lateral approach tool Target is not accessible with Access the lesion using a vertical approach or
too short the lateral arm. reposition the patient.
Needle name already User attempted to create a Select a needle name which is not already in
used puncture tool with a needle use.
name already in use.
Needle name field is User attempted to create a Enter the needle name in the name field.
empty puncture tool with the needle
name field empty.

Operator messages

monitor
Needle name is Needle name field contains Delete the forbidden characters (e.g., a
incorrect forbidden characters and comma).
needle creation has been
refused.
Needle parameters User attempted to create a Correct the data fields.
are incorrect puncture tool with one or more
fields containing incorrect
information.
Needle %d mm too Target is not accessible with Select a shorter puncture tool.
long the selected puncture tool.
Needle %d mm too Target is not accessible with Select a longer puncture tool.
short the selected puncture tool.
Reposition Reference The Reference Markers Close the Needle & Puncture panel, reposition
Markers before (inverted Ts) have not been the Reference Markers on the last scout image
sending the target repositioned before trying to and try to send the target again.
send a target.
Stereotactic Stereotactic Positioner is not 1) Close the Needle & Puncture panel.
Positioner not ready ready; puncture is forbidden. 2) If no error message appears, try to send the
to receive target target again.
3) If an error message appears, perform the
corrective action for the system error displayed.
and contact Field Service Representative
Target outside the The target is located in part of Reduce the compression slightly, or move the
Puncture Area the breast above the paddle target so that it is accessible.
and cannot be reached,
Target List ready to Target list is ready to be sent. Click the “Send” button to send target set to
send Stereotactic Positioner.
Reminder: thickness Breast compression thickness If thickness has changed, it is advised to
has changed by xx.x has changed by xx.x mm acquire a new stereo triplet and define the
mm. during or since the acquisition targets again.
of the triplet used for the
primary definition. Target may
be wrong.
Target sending in Target sending is in progress, None.
progress, please wait please wait.
Target too close to The target that has been Change selected puncture tool or reposition the
the tray selected is too near the breast patient.
holder and puncture is
impossible with the selected
puncture tool.

Operator messages

monitor
Target transmission Target sending has failed. 1) Close the Needle & Puncture panel;
error 2) If no error message appears, try to send the
target again.
3) If an error message appears, perform the
corrective action of the system error displayed.
and contact Field Service Representative.
Risk of skin tear when Puncturing the target with the If you decide to continue, take great care when
firing the biopsy selected biopsy device is firing the biopsy device or insert the biopsy
device possible, but there is a risk of device in the breast not cocked. You can also
tearing the patient skin beside reposition the patient.
the paddle when firing the
biopsy device.
Vertical holder to User attempted to enter a Verify the values entered. If they are correct,
device distance is vertical holder distance too the tool is not compatible with the system
incorrect. Please long to be used with the
enter a valid value system without a risk of
collision with the tube head or
with the breast support.

Operator messages
Table 3 - Patient position status change messages displayed on the AWS
Message on Gantry Explanation Corrective Action

Readout
Breast thickness has System has detected a breast 1) If already defined targets have not been
changed by xx.x mm thickness variation which may sent, follow the steps below:
impair target definition. a) Considering the thickness variation,
CAUTION: evaluate the risk of missing the defined targets.
Target definition may When answering YES: b) Then, according to this risk, decide to send
be wrong. a) It is still possible to send or not the defined targets.
already defined targets c) Then, if first target sent is missed, it is
Do you want to keeping in mind that the recommended to acquire a New Stereo Triplet
acquire a new triplet puncture accuracy is no longer and to redefine all targets.
for the next target guaranteed. 2) For new targets definition, it is highly
creation? b) Defining a new target is recommended to answer YES to ensure
impossible until a new Stereo puncture accuracy.
Triplet* acquisition is
performed.
When answering NO:
a) It is still possible to send
already defined targets,
keeping in mind that the
puncture accuracy is no longer
guaranteed.
b) It is still possible to define
new targets but it is highly
recommended to acquire a
new Stereo Triplet first. Stereo
Triplet acquisition is a scout
view, followed by a Stereo
Pair.
*Stereo Triplet Acquisition =

Scout view followed by a
Stereo Pair

Operator messages

Readout
Gantry state has been System lost the positioner or 1) If already defined targets have not been
lost the Stereotactic positioner sent:
status. a) Send the first target
CAUTION: - Angulation and breast b) Acquire a verification view to check if the
Target definition may thickness accuracy may have target is reached. If it is missed, it is highly
be wrong. been lost, it is then recommended to acquire a New Stereo Triplet*
recommended to acquire a and to redefine all targets.
Do you want to new Stereo Triplet* before 2) For new target definitions, it is highly
acquire a new triplet defining next targets recommended to answer YES, to ensure
for the next target When answering YES: puncture accuracy.
creation? a) It is still possible to send 3) If already defined targets have been sent
already defined targets and no new target is required, answer NO
guaranteed.
b) Defining a new target is
impossible until a new Stereo
Triplet* acquisition is
performed.
When answering NO:
a) It is still possible to send
already defined targets
guaranteed.
b) It is still possible to define
new targets but it is highly
recommended to acquire a
new Stereo Triplet* first.
*Stereo Triplet acquisition =
scout view followed by a
Stereo Pair.

Operator messages
Table 4 - Operator Messages Displayed on the Readout Panel at the foot of the Gantry

Readout
A01 Angulation mode The system cannot switch to 1) To change to angulation mode, first take the
not allowed angulation mode. Possible following action, according to the cause:
causes are: A. Rotate the arm into the area allowed by the
A. The arm has been rotated Stereotaxy application.
beyond the values allowed by B. Wait for completion of the current movement
the Stereotaxy application [- and press the change mode button again.
90°, +90°]. C. Wait for completion of image acquisition and
B. Movement is currently in press the change mode button again.
progress. 2) If the problem persists, power OFF/ON from
C. Image acquisition is still in the X-ray Console.
progress. 3) If the problem persists, note ALL messages
A04 Compression A lift or a rotation movement 1) If the Stereotactic Positioner has just been
status is unknown has been requested while the installed, wait for the READY message, or for
Stereotactic Positioner was not the needle holder coordinates, on the SP
ready. display, then press the footswitch or control
movement button desired.
2) If COMMUNICATION NOT ESTABLISHED
is displayed on the SP display, unplug the
Stereotactic Positioner, connect it again .
3) If the problem persists, power off/on from the
X-ray Console.
A11 Motion stopped; Angulating the tube in the [- 1) If you already removed the puncture tool,
risk of collision with 15°, 15°] area is impossible close the needle path to release the angulation
puncture tool due to the risk of collision interlock. Otherwise remove the puncture tool
between the biopsy device and and then close the needle path.
the tube head. 2) If the problem persists, power OFF/ON from
the X-ray Console.
A13 Move up the When the Stereotactic Move the Gantry paddle holder up, using the
paddle holder Positioner is installed, the foot-pedal or the manual gantry knob (not the
gantry paddle holder must be Stereotactic Positioner knob)
at the upper position.

Operator messages

Readout
A16 Rotation limit for When the Stereotactic 1) If the Stereotactic Positioner is installed, no
Stereotaxy is reached Positioner is installed, rotation action is required.
beyond the horizontal plane is 2) If the Stereotactic Positioner is not installed,
not allowed. an error has occurred:
A. Power OFF/ON from the X-ray Console.
B. If the problem persists, note ALL messages
A17 Rotation mode The system cannot switch to 1) To change to rotation mode, first take the
not allowed rotation mode. Possible following action, according to the cause:
causes are: A. Move the compression paddle up and press
A. Breast thickness was less the change mode button again.
than 100 mm when a stereo B. Perform Angulation movement, move to the
exam was started. 0° position, and press the change mode button
B. Rotation/Angulation clutch again.
not correctly adjusted. C. Wait for completion of the current movement
C. Movement is currently in and press the change mode button again.
progress. D. Wait for completion of image acquisition and
D. Image acquisition is still in press the change mode button again.
progress. 2) If the problem persists, power OFF/ON from
the X-ray Console.
A19 Stereotactic Stereotactic Positioner has 1) Check that the Stereotactic Positioner is
Positioner is not been detected but is not ready correctly installed and switched on.
ready to start stereotactic exam. 2) If the Stereotactic Positioner screen, does
not display READY or the needle holder
parking coordinates, remove the Stereotactic
Positioner, and install it again.
3) If the problem persists, power OFF/ON from
the control console.
A20 Stereotactic System cannot continue 1) Redefine your primary and secondary target
Positioner; target list because the Stereotactic list and send it again.
full Positioner received too many 2) If the problem persists, power OFF/ON from
targets. the X-ray Console; a new series will
automatically be started.

Operator messages

Readout
A21 No Gantry Rotation, lift or angulation 1) Wait for completion of the Stereotactic
motion while movement has been Positioner movement and press the command
Stereotactic requested while a Stereotactic button again.
Positioner Motion Positioner movement is in 2) If the problem persists, power OFF/ON from
progress. the X-ray Console.
A22 Angulation limit is The angulation movement is None
reached stopped because it reached its
parking limit.
H15 Stereotactic Pos. The system is set in 1) Release and remove the Stereotactic
comm. Failure emergency mode: Positioner.
- Stereotactic Positioner is not 2) Power OFF from the X-ray Console.
able to perform puncture, the 3) Reinstall the Stereotactic Positioner; check
system is set in the “halt” state. that it is correctly locked.
-It is not possible to perform 4) Power ON from the X-ray Console; check
any movement or image that the Stereotactic positioner is correctly
acquisition. installed and switched on (“READY” or needle
holder parking coordinates are displayed on
the Stereotactic positioner LCD).
H16 Stereotactic Pos The system is set in 1) Check that the Stereotactic Positioner is:
control failed emergency mode: - correctly installed and switched on (“READY”
- The system is not able to is displayed on the Stereotactic positioner
control the Stereotactic LCD).
Positioner, the system is set in - in application mode (not in calibration or test
the “halt” state. mode).
-It is not possible to perform 2) Check any messages displayed on the
any movement or image Stereotactic Positioner screen (refer to section
acquisition. xxx)
H26 Stereotactic The system is set in 1) Power OFF from the X-ray Console.
Positioner failure emergency mode: 2) Unplug the Stereotactic Positioner.
- Stereotactic Positioner is in 2) Reinstall the Stereotactic Positioner: check
fault state, the system is set in that it is correctly installed and switched on.
“halt” state. 3) Power ON from the X-ray Console.
-It is not possible to perform 4) If problem persists, note ALL messages and
any movement or image contact your Field Service representative.
acquisition.

Operator messages

Readout
SP present. Remove The system informs the 1) If the Stereotactic Positioner is installed,
face shield if present! operator that the Stereotactic remove the face shield if not yet done.
Positioner is present and 2) If the Stereotactic Positioner is not installed,
reminds the operator that the an error has occurred:
face shield must be removed a) Power OFF/ON from the X-ray Console.
for the Stereotaxy application. b) If the problem persists, note ALL messages
W13 Failed to switch An error occurred on the 1) Power OFF from the X-ray Console.
to angulation mode Rotation/angulation clutch/ 2) Unplug the Stereotactic Positioner.
brake control. 2) Reinstall the Stereotactic Positioner: check
that it is correctly installed and switched on.
3) Power ON from the X-ray Console.
4) If problem persists note ALL messages and
5) The system is still functional for Non
Stereotaxy exams.
W14 Failed to switch An error occurred on the 1) If an exam is currently in progress, continue
to rotation mode Rotation/angulation clutch/ it using the same rotation incidence.
brake control. 2) Move away from 0°, return to 0° - and try
again to switch to rotation mode.
3) If problem persist, power OFF from the X-ray
Console.
4) Unplug the Stereotactic Positioner.
5) Reinstall the Stereotactic Positioner: check
that it is correctly installed and switched on.
6) Power ON from the X-ray Console.
7) If problem persists note ALL messages and
W19 Stereotactic pos. Stereotactic Positioner motor No action required, but if this message occurs
motor slippage slippage during compression frequently, note ALL messages and contact
or needle holder movement. your Field Service representative.
W20 Rotation/ The Rotation/Angulation mode 1) No action required. Check the current
Angulation mode light may not be operating Rotation/Angulation mode on the Gantry
lamp failure correctly. display.
2) Contact your Field Service representative for
repair action.
W33 Angulation A danger of collision was The biopsy device must be removed before
motion now unlimited, detected, but the user has performing the angulation movement towards
ensure puncture tool decided to override the 0° in the range [-15° to +15°].
removed angulation interlock, and
intends to remove the biopsy
device. Angulation is now
possible in the full range [-
Parking to +Parking].

Operator messages

Readout
X08 Stereotactic The Gantry state cannot allow 1) Release and remove the Stereotactic
Positioner switch the acquisition: Positioner.
mode error - The Stereotactic Positioner 2) Power OFF from the X-ray Console.
cannot switch to puncture 3) Reinstall the Stereotactic Positioner; check
mode or cannot switch back to that it is correctly locked.
ready mode. 4) Power ON from the X-ray Console; check
- It is not possible to continue that the Stereotactic positioner is correctly
the current exam; exposure is installed and switched on (“READY” or needle
inhibited. holder parking coordinates are displayed on
the Stereotactic positioner LCD).

Operator messages

Specifications
Chapter 18 Specifications
1 Introduction
Specifications are given here only for functions and items specific to Senographe Essential Stereotaxy.
For specifications applicable to the Senographe Essential, refer to the Senographe Essential Acquisition
System Operator manual.
2 Senographe Stereotaxy functional specifications

2-1 Image format
• Scout view: 100 x 80 mm
• Stereotaxy views: 100 x 70 mm, with a total field of view of 140 x 70 mm
2-2 Accuracy of the Stereotactic Positioner

• ±1 mm in X, Y and Z axis
2-3 Biopsy VOLUME

• 50 mm in X axis
• 40 mm in Y axis
• 100 mm in Z axis
2-4 Compression paddle aperture

• 54 mm in X axis
• 43 mm in Y axis parking
2-5 Needle holder travel

• Motorized travel of the needle holder:
47 mm ± 0.5 mm along X–axis
37 mm ± 0.5 mm along Y–axis
60.5 mm ± 0.5 mm along Z–axis
• Manual travel of the needle holder:
50 mm ± 0.5 mm along X–axis
40 mm ± 0.5 mm along Y–axis
65 mm ± 0.5 mm along Z–axis
2-6 Type of materials in contact with skin

• Compression paddle:
Lexan 141R, manufacturer Sabic.
• Breast Holder:
Compound of carbon fiber and epoxy resin.
Specifications.fm Page no. 207 Chapter 18

Specifications
3 Physical specification
3-1 Dimensions and weight
Component Dimensions in mm (inches) Weight
Depth Width Height kg (lbs)
Stereotactic Positioner 365 (14.4) 390 (15.4) 355 (14) 10.5 (23)
4 Trademark information
• GE and the GE Monogram are trademarks of the General Electric Company.
• Bard, Magnum and Vacora are trademarks and/or registered trademarks of C.R. Bard, Inc. or an
affiliate.
• EnCor is a registered trademark of SenoRx-Bard, Inc.
• ATEC and Suros are trademarks or registered trademarks of Suros Surgical Systems, Inc., a Hologic
Company.
• Mammotome is a registered trademark of Devicor, Inc.
• All other trademarks, service marks, logos, company names and product names are the property of
their respective owners.
Chapter 18 Page no. 208 Specifications.fm

Page no. 209 Last_Page.fm

To contact your local GE representative, please go to:
http://www.gehealthcare.com/helpcenter.html
China Service Agent Address:

通用电气医疗系统贸易发展（上海）有限公司
中国 ( 上海 ) 自由贸易试验区意威路 96 号 1 幢，邮编 200131
Turkey Importer Name:

GE Medical Systems Türkiye Ltd. Şti.
Esentepe Mah. Harman Sok. No:8
34394 Sisli-Istanbul Turkey
Manufacturer and Manufacturing Site:

GE MEDICAL SYSTEMS SCS
283, RUE DE LA MINIERE
78530 BUC
FRANCE

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Senographe Essential Stereotaxy

Operator manual Revision 3

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Page no. 2 Cover-Ess.fm

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radiation warning.fm Page no. 3

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Page no. 4 radiation warning.fm

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Chapter 1. Publication presentation

Chapter 2. Standards and regulations

Chapter 3. The Stereotaxy Application

Chapter 4. Stereotaxy components

Chapter 5. The Stereotactic Positioner

Chapter 6. Installation of the Stereotactic Positioner

TOC.fm Page no. 5

Operator manual Revision 3

2. Removing the Stereotactic Positioner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Chapter 7. Procedure Steering Guide

Chapter 8. Installation for Vertical Approach

Chapter 9. Installation for Lateral Approach

Chapter 10. Preparation for examinations

Chapter 11. Needle Setup

Page no. 6 TOC.fm

Operator manual Revision 3

Chapter 12. Stereotaxy Image Acquisition

Chapter 13. Stereotaxy Punctures

Chapter 14. Image Printing and Review

Chapter 15. System Hygiene

Chapter 16. Planned Maintenance

TOC.fm Page no. 7

Operator manual Revision 3

Chapter 17. Operator messages

Chapter 18. Specifications

Page no. 8 TOC.fm

Operator manual Revision 3

Chapter 1 Publication presentation

2 How to use the manual

2-2 Links between different chapters

Publication-Presentation.fm Page no. 9 Chapter 1

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2-3 List of chapters classified by type

Chapter 1 Page no. 10 Publication-Presentation.fm

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3 Conventions for this manual

Trackball Mouse buttons

Publication-Presentation.fm Page no. 11 Chapter 1

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3-3 Definitions of different types of Warnings

Chapter 1 Page no. 12 Publication-Presentation.fm

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Date Reference Revision Main modifications

Publication-Presentation.fm Page no. 13 Chapter 1

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2013-08 5262169-7-1EN 1 CFDA release:

Chapter 1 Page no. 14 Publication-Presentation.fm

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Standards and regulations

Chapter 2 Standards and regulations

regulatory.fm Page no. 15 Chapter 2

Operator manual Revision 3

Standards and regulations