Technical Publications

0459

2155051-2-100
Revision 1

STEREOTIX 2 om Operator manual

do not duplicate

Copyrighte 2005 GE Medical Systems

ATTENTION
LES APPAREILS RAYONS X SONT DANGEREUX LA FOIS POUR LE PATIENT ET POUR LE MANIPULATEUR SI LES MESURES DE PROTECTION NE SONT PAS STRICTEMENT APPLIQUEES Bien que cet appareil soit construit selon les normes de scurit les plus svres, la source de rayonnement X reprsente un danger lorsque le manipulateur est non qualifi ou non averti. Une exposition excessive au rayonnement X entrane des dommages l'organisme. Par consquent, toutes les prcautions doivent tre prises pour viter que les personnes non autorises ou non qualifies utilisent cet appareil crant ainsi un danger pour les autres et pour elles-mmes. Avant chaque manipulation, les personnes qualifies et autorises se servir de cet appareil doivent se renseigner sur les mesures de protection tablies par la Commission Internationale de la Protection Radiologique, Annales 26 : Recommandations de la Commission Internationale sur la Protection Radiologique et les normes nationales en vigueur.

WARNING
X-RAY EQUIPMENT IS DANGEROUS TO BOTH PATIENT AND OPERATOR UNLESS MEASURES OF PROTECTION ARE STRICTLY OBSERVED Though this equipment is built to the highest standards of electrical and mechanical safety, the useful x-ray beam becomes a source of danger in the hands of the unauthorized or unqualified operator. Excessive exposure to x-radiation causes damage to human tissue. Therefore, adequate precautions must be taken to prevent unauthorized or unqualified persons from operating this equipment or exposing themselves or others to its radiation. Before operation, persons qualified and authorized to operate this equipment should be familiar with the Recommendations of the Internatio nal Commission on Radiological Protection, contained in Annals Number 26 of the ICRP, and with applicable national standards.

ATENCION
LOS APARATOS DE RAYOS X SON PELIGROSOS PARA EL PACIENTE Y EL OPERADOR CUANDO NO SE RESPETAN LAS NORMAS DE PROTECCION Aunque este aparato est construido segn las normas de seguridad ms estrictas, la radiacin X constituye un peligro al ser manipulado por personas no autorizadas o no calificadas. Una exposicin excesiva a la radiacin X puede causar daos al organismo. Por consiguiente, se deben tomar todas las precauciones necesarias para evitar que las personas no autorizadas o no calificadas usen este apara to, lo que sera un peligro para los dems y para s mismas. Antes de efectuar las manipulaciones, las personas autorizadas y calificadas en el uso de este aparato, deben informarse sobre las normas de proteccin fijadas por la Comisin Internacional de la Proteccin Radiolgica, Anales No 26: Recomendacines de la Comisin Internacional sobre la Proteccin Radiolgica y normas nacionales.

ACHTUNG
RNTGENAPPARATE SIND EINE GEFAHR FR PATIENTEN SOWIE BEDIENUNGSPERSONAL, WENN DIE GELTENDEN SICHERHEITSVORKEHRUNGEN NICHT GENAU BEACHTET WERDEN Dieser Apparat entspricht in seiner Bauweise strengsten elektrischen und mechanischen Sichereitsnormen, doch in den Hnden unbefugter oder unqualifizierter Personen wird er zu einer Gefahrenquelle. bermige Rntgenbestrahlung ist fr den menschlichen Organismus schdlich. Deswegen sind hinreichende Vorsichtsmanahmen erforderlich, um zu verhindern, daunbefugte oder unqualifizierte Personen solche Gerte bedienen oder sich selbst und andere Personen deren Bestrahlung aussetzen knnen. Vor Inbetriebnahme dieses Apparats sollte sich das qualifizierte und befugte Bedienungspersonal mit den geltenden Kriterien fr den gefahrlo sen Strahleneinsatz durch sorgfltiges Studium des Hefts Nr. 26 der Internationalen Kommission fr Strahlenschutz (ICRP) vertraut machen: Empfehlungen der Internationalen Kommission fr Strahlenschutz und anderer nationaler Normenbehrden.

ATTENZIONE
GLI APPARECCHI A RAGGI X SONO PERICOLOSI SIA PER IL PAZIENTE, SIA PER L'OPERATORE, A MENO CHE NON VENGANO STABILITI FATTORI DI SICUREZZA CONTRO LE ESPOSIZIONI E CHE DEVONO ESSERE OS SERVATI CON ESTREMA RIGOROSIT. Sebbene questo apparato sia costruito conformemente agli standard di sicurezza electtrici e meccanici pi elevati, il fascio radiogeno utile diventa una sorgente di pericolo quandunque usata da personale non autorizzato e per giuta incompetente. Una eccessiva esposi zione radiogena, dannegia sicuramente il tessuto umano. Perci, dovranno essere prese adeguate precauzioni per rendere impossibile a persone non autorizzate e non qualificate, l'uso di questi apparecchi, ed inoltre che esse stesse ed altre evitino queste radiazioni. Prima dell'uso, le persone qualificate e quindi autorizzate all'uso di questi apparecchi, dovranno conoscere a fondo i fattori di esposizione di sicurezza stabiliti, tramite uno studio attento della commissione internazionale per la protezione radiologica (ICRP), al numero 26 degli annali : raccomandazioni della commissione internazionale sulla protezione radiologica ed altre normative standard di livello nazionale.

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REGULATORY REQUIREMENTS

This product complies with the regulatory requirements of the following: D Council Directive 93/42/EEC concerning medical devices when it bears the following CE marking of conformity.
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For a system, the location of the CE marking label is described in the system manual. European registered place of business: GE Medical Systems Europe Quality Assurance Manager BP 34 F 78533 BUC CEDEX France Tel: +33 1 30 70 40 40 D D D D D D D Green QSD 1990 Standard issued by MDD (Medical Devices Directorate, Department of Health, UK). Medical Device Good Manufacturing Practice Manual issued by the FDA (Food and Drug Administration, Department of Health, USA). Underwriters Laboratories, Inc. (UL), an independent testing laboratory. Canadian Standards Association (CSA). International Electrotechnical organization, when applicable. Commission (IEC), international standards

General Electric Medical Systems is ISO 9001 certified. The original document was written in English.

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ELECTROMAGNETIC COMPATIBILITY (EMC)

This equipment complies with IEC6060112 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 radiated emissions as per CISPR11 Group 1, Class A standard limits. Detailed requirements and recommendations about power supply distribution and installation are listed in the PreInstallation Manual (pim) shipped with your system. 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): D D D D 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. 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. 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. Recommended separation distances are detailed in the PreInstallation Manual (pim) shipped with your system. Keep the power to this type 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. Further data and recommendations for meeting Electromagnetic Compatibility requirements for a typical installation are given in the PreInstallation Manual (pim) shipped with your system. Note that the magnetic field of an MRI device located nearby may cause a risk of interference. Magnetic field amplitude limits are specified in the PreInstallation Manual (pim) shipped with your system.

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RECYCLING:
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 endoflife machines and accessories (examples: dry and wet cell batteries, transformer oil, etc...). Please consult your local GEMS representative before discarding these products. 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.

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SERVICE OFFICES IN EUROPE

For service issues, contact the Service office in your country or in France. AUSTRIA GE GesmbH Medical Systems Austria Prinz Eugen Strasse 8/8 A1140 WIEN BELGIUM GE Medical Systems Benelux Gulkenrodestraat 3 B2160 WOMMELGEM DENMARK GE Medical Systems Danmark Skovlytoften 4 DK2840 HOLTE FRANCE GE Medical Systems 283 rue de la Minire BP34 F78533 BUC CEDEX GERMANY GE Medical Systems Deutschland GmbH & Co. KG Praunheimer Landstrasse 50 D60488 FRANKFURT AM MAIN GREECE GE Medical Systems Hellas 41 Nikolaou Plastira Street GR171 21 NEA SMYRNI ITALY GE Medical Systems Italia Via Monte Albenza 9 I20052 MONZA NETHERLANDS GE Medical Systems Nederland B.V. Atoomweg 512 NL3542 AB UTRECHT POLAND GE Medical Systems Polska Krzywickiego 34 P02078 WARSZAWA

TEL: FAX: TLX:

0660 8651 toll free +43 1 505 38 74 136314

TEL: FAX: TLX:

+32 3 320 12 11 +32 3 320 12 59 72722

TEL: FAX:

+45 45 51 00 55 +45 42 42 59 89

TEL:

+33 1 30 70 40 40

TEL: FAX: TLX:

+49 69 9760 7380 +49 69 7682 237 412002 GEGF D

TEL: FAX:

+30 1 93 24 582 +30 1 93 58 414

TEL: FAX: TLX:

+39 39 20 881 +39 39 73 37 86 3333 28

TEL: FAX:

+31 304 79711 +31 304 11702

TEL: FAX:

+48 2 625 59 62 +48 2 615 59 66

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PORTUGAL GE Medical Systems Portuguesa S.A. Rua Sa da Bandeira, 585 Apartado 4094 P4002 PORTO CODEX RUSSIA GE VNIIEM Mantulinskaya UI. 5A 123100 MOSCOW

TEL: FAX: TLX:

+351 2 2007696/97 +351 2 2084494 22804

TEL: FAX: TLX:

+7 095 956 7037 +7 502 220 3259 613020 GEMED SU

SPAIN GE Medical Systems Espaa Avda. de Europa 22 Parque Empresarial la Moraleja E28100 ALCOBENDAS SWEDEN GE Medical Systems POBOX 1243 S16428 KISTA SWITZERLAND GE Medical Systems (Schweiz) AG Sternmattweg 1 CH6010 KRIENS TURKEY GE Medical Systems Turkiye A.S. Mevluk Pehliran Sodak Yilmaz Han, No 24 Kat 1 Gayretteppe ISTANBUL UNITED KINGDOM IGE Medical Systems Coolidge House 352 Buckingham Avenue SLOUGH Berkshire SL1 4ER

TEL: FAX:

+34 1 663 25 00 +34 1 663 25 01

TEL: FAX: TLX:

+46 87 50 57 00 +46 87 51 30 90 12228 CGRSWES

TEL: FAX:

+41 41 425577 +41 41 421859

TEL: FAX:

+90 212 75 5552 +90 212 211 2571

TEL: FAX:

+44 753 874000 +44 753 696067

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CONTENTS
CHAPTER TITLE
REGULATORY REQUIREMENTS SERVICE OFFICES IN EUROPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TABLE OF CONTENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . REVISION HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PAGE
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INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SECTION 1 - PRESENTATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SECTION 2 - DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1 2-2 2-3

1-1 1-3 1-3

Puncture Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7 Controller Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9 Deviation Readout Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11

OPERATING MODES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SECTION 1 - THEORY OF OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SECTION 2 - INSTALLING STEREORIX 2 ON SENOGRAPHE DMR . . . . . . . 2-1 STEREOTIX 2 installed on Senographe DMR . . . . . . . . . . . . . . . . . . . . . . . . 2-1-1 Removing Accessories from Senographe DMR . . . . . . . . . . . . . . . . . 2-1-2 Preparing Senographe DMR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1-3 Securing STEREOTIX 2 to Senographe DMR . . . . . . . . . . . . . . . . . 2-1-4 Starting Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Exposure with Phantom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2-1 Positioning the Phantom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2-2 Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2-3 Film . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Using the Controller Unit and the Puncture Device . . . . . . . . . . . . . . . . . . . . 2-3-1 Using the Controller Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3-2 Using the Puncture Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Selecting a Second Point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2-1 2-3 2-5 2-5 2-7 2-7 2-9 2-9 2-11 2-11 2-13 2-15 2-17 2-17 2-21 2-22

2-2

2-3 2-4

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CONTENTS (CONT'D)
CHAPTER TITLE PAGE

EXAM PREPARATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SECTION 1 - MAKING A PUNCTURE ON A PATIENT . . . . . . . . . . . . . . . . . . . . 1-1 Types of Breast Puncture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1-1 Cytologic Puncture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1-2 Histology Puncture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1-3 Preoperative Localization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3-1 3-3 3-3 3-3 3-3 3-4 3-4 3-7 3-7 3-7 3-11 3-12 3-12 3-12 3-12 3-13 3-13 3-14 3-14 3-15 3-15 3-16 3-18

1-2

SECTION 2 - MAKING A PUNCTURE USING STEREOTIX 2 . . . . . . . . . . . . . . 2-1 2-2 POSITIONING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1-1 Positioning STEREOTIX 2 on Senographe DMR . . . . . . . . . . . . . . 2-1-2 Positioning the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Operating Difficulties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2-1 X-ray Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2-2 Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2-3 Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Making Stereoscopic Exposures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3-1 Positioning the Breast . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3-2 Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3-3 Film Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Using the Controller Unit and the Puncture Device . . . . . . . . . . . . . . . . . . . . 2-4-1 Using the Controller Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4-2 Using the Puncture Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Selecting a Second Suspect Area (second lesion to be punctured) . . . . . . . . .

2-3

2-4 2-5

MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SECTION 1 - CLEANING AND DISINFECTION . . . . . . . . . . . . . . . . . . . . . . . . . . SECTION 2 - PREVENTIVE MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . SECTION 3 - MESSAGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-1 4-3 4-5 4-5

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CONTENTS (CONT'D)
CHAPTER TITLE PAGE

SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SECTION 1 - PHYSICAL SPECIFICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SECTION 2 - ELECTRICAL & TECHNICAL SPECIFICATION . . . . . . . . . . . . . . 2-1 2-2 2-3 Technical Specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Radiographic Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electrical Specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5-1 5-3 5-3 5-3 5-5 5-5 5-5 5-6

SECTION 3 - AMBIENT CONDITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SECTION 4 - MEANING OF SYMBOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

REGULATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-1

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This manual is provided for STEREOTIX 2 operators. It is designed to supply all the information required for the correct use of this equipment.

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REVISION HISTORY
REV 1 DATE June 2005 TYPE OF MODIFICATION New release based on document 2155051-100 rev. 1, with the following changes: - EURge 16438: Regulatory Requirements section updated for EMC installation recommandations IEC 601-1-2 Ed. 2. - WEEE Compliance: Chapter 5 Specifications, added Section 4 Meaning of Symbols, including symbol and text for waste of electrical and electronic equipment.

LIST OF EFFECTIVE PAGES PAGE Title page i thru xii 1-1 thru 1-12 2-1 thru 2-22 3-1 thru 3-18 4-1 thru 4-8 5-1 thru 5-6 6-1 thru 6-2 REVISION 1 1 1 1 1 1 1 1 PAGE REVISION PAGE REVISION

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CHAPTER 1 - INTRODUCTION
INTRODUCTION

1-1

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ILLUSTRATION 1-1 STEREOTIX 2

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INTRODUCTION

3 2
X 0.0 Y 0.0 Z 0.0

XI

I O

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L2

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The three-dimensional stereotaxy, STEREOTIX 2, is an optional unit for the Senographe DMR. This stereotaxy device computes the coordinates of a point reproduced on two stereotactic views taken at angles of +15_ and -15_ on the same film. The device allows the physician to locate in the three directions (X, Y and Z) of a radiographic image with suspected lesion previously detected on mammograms. STEREOTIX 2 permits cytologic and histologic puncture and/or preoperative localization of mammary lesions, irrespective of their position in the breast. SECTION 2 DESCRIPTION See Illustrations 1-1 and 1-2. The STEREOTIX 2 assembly consists of three units, interconnected by cable: D D D Note: Puncture Device (see Illustration 1-1, 1 ), Controller Unit (Illustration 1-1, 2 ), Deviation Readout Unit (Illustration 1-1, 3 ). The CE marking label is located on the back side of the Puncture Device.

1-3

INTRODUCTION

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ILLUSTRATION 1-2 ACCESSORIES

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INTRODUCTION

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1-4

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REV 1 To following accessories are supplied: D D Precision test phantom (Illustration 1-2, 1 ),

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Six needle-guides (sterilized and one-time use) with the following internal diameters (Illustration 1-2, 2 ).

TABLEAU 1-1 NEEDLE-GUIDES

Diameter (mm) Needle Needle-guide 0.8 0.9 0.9 1.0 1.1 1.2 1.2 1.4 1.6 1.8 2.0 2.25

1-5

INTRODUCTION

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ILLUSTRATION 1-3 PUNCTURE DEVICE

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INTRODUCTION

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REV 1 2-1 Puncture Device See Illustration 1-3

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The Puncture Device is a self-contained removable assembly attached to the film take-up arm of the Senographe DMR in place of the magnification plate.

Rear locating rods 7 , and side fasteners 6 secure this assembly to the Senographe (see Chapter 2, Para 2-1-3, Securing STEREOTIX 2 to Senographe DMR. The Instrument Unit comprises: D Plate 4 used to position the breast and which can receive an 18/24-cm

cassette. Two metal letters, R and L (right and left) and a metal locating inverted T are included in the magnification plate. The cassette moves from right to left and from left to right in the tunnel of the magnification plate. D Manual compression arm 1 equipped with aperture compression paddle 3 . To compress, use the knobs 5 located on either side of the compression arm. The window opens to 54 mm on the X-axis, and to 43 mm on the Y-axis. Note: When the compression paddle leaves the park position (High position) to compress the breast, the Up/Down and rotation movements of the Senographe DMR examination arm are inhibited. To tilt the tube arm support, use the locking lever located at the rear of the column. D A manually-adjusted needle-holder 2 can be moved in three directions

(X, Y and Z) via knobs 8 located on either side of the needle-holder. Needle-holder travel is: 50 mm 0.5 mm along X-axis 40 mm 0.5 mm along Y-axis 70 mm 0.5 mm along Z-axis The needle-holder receives the sterilized, disposable needle-guides. Note: There is a needle-holder for each needle size. The needle-guide contains a hole bored to a diameter suited to its needle (see Table 1-1).

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INTRODUCTION

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ILLUSTRATION 1-4 CONTROLLER UNIT

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INTRODUCTION

I O
19

X Y

X Y Z

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L1 -

L2

L3 +

12

11

10 14

13 20

XI

I O

X Y Z

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L1 -

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XB YAB

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REV 1 2-2 Controller Unit See Illustration 1-4. The Controller Unit consists of: D

STEREOTIX 2 om 2155051-2-100

Control and Display Console 1 used to compute the coordinates from a point marked on the film, and to select and/or adjust the needle length. See Illustration 1-4 2 3 4 ON switch. OFF switch. X coordinate readout. Y coordinate readout. Z coordinate readout. 5 6 7 8 9 10 11 12 RESET. ZERO SELECT. No. 1 needle length. No. 2 needle length. No. 3 needle length. Increment in needle length by 1 mm. Needle length readout. Decrement needle length by 1 mm.

Viewbox 18 which can receive 18 x 24 cm format film. The viewbox is equipped with two cross-hair cursors, X and Y, which can be moved via three knobs, XA, XB and YAB, located on the top of the unit on either side of the light plate. A line drawn on the light plate serves as a horizontal reference and is used to position the film. 13 14 15 Left cross-hair cursor movement knob, X axis (absissa). Right cross-hair cursor movement knob, X axis (absissa). Right and left cross-hair cursor movement knob, Y axis (ordinate). Right and left cross-hair cursor which move on X and Y axes.

16 and 17 Note:

On an exposure, the ordinate is identical for the same point appearing on the righthand view and on the lefthand view.

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INTRODUCTION

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REV 1
ILLUSTRATION 1-5 DEVIATION READOUT UNIT

STEREOTIX 2 om 2155051-2-100

INTRODUCTION

X 0.0

Y 0.0

Z 0.0

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REV 1 2-3 Deviation Readout Unit See Illustration 1-5

STEREOTIX 2 om 2155051-2-100

This unit is installed on the Senographe DMR column readout or on the STEREOTIX 2 Controller Unit. It displays the deviation between the X, Y and Z coordinates of the needle-holder before it is positioned, and the X, Y and Z coordinates of the suspect exposure (lesion to be punctured). While the operator is turning the needle-holder knobs or adjusting the needle length, the Deviation Readout Unit shows the variation in the deviation in real time.

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INTRODUCTION

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REV 1 Blank page
INTRODUCTION

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CHAPTER 2 - OPERATING MODES

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OPERATING MODES

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REV 1 Blank page

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OPERATING MODES

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CHAPTER 2 - OPERATING MODES

SECTION 1 THEORY OF OPERATION STEREOTIX 2 computes the coordinates of a suspect x-ray image from two stereotactic views of the same point taken at angles of +15_ and -15_ on the same film. The SID value is known.
OPERATING MODES

According to the length of the needle selected, the STEREOTIX also computes the difference between the X, Y and Z coordinates of the suspect exposure on the stereoscopic exposures and the X, Y and Z coordinates of the needle-holder before it is positioned. The deviation found between the respective coordinates of the image and the needle-holder along with the variations of this deviation are displayed on the Deviation Readout Unit. Note: To vary the deviation between the X, Y and Z coordinates of the image and of the needle-holder, adjust the needle-holder positioning knobs and change the needle length selection. Having selected the needle length (with or without adjustment), the operator moves the needle-holder via the knobs along the three axes to reduce the value displayed on the Deviation Readout Unit to zero. The needle-holder is now positioned over the lesion to be punctured in the breast. Place the needle-guide in the needle-holder and insert the puncture product.

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ILLUSTRATION 2-1 STEREOTIX 2 INSTALLED ON SENOGRAPHE DMR

STEREOTIX 2 om 2155051-2-100

- 15 - 27

+ 15

+ 27

OPERATING MODES

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REV 1 SECTION 2 INSTALLING STEREORIX 2 ON SENOGRAPHE DMR 2-1 STEREOTIX 2 installed on Senographe DMR See Illustration 2-1 Note:

STEREOTIX 2 om 2155051-2-100

The Senographe DMR Examination Arm carries Silk-screened user markings with the following color code:
OPERATING MODES

Blue:

Top holes and left middle hole, anchoring, SID: 510 mm Tube-arm support tilt: +/- 15_ Tube-arm support tilt: +/- 27_

Orange:

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REV 1
ILLUSTRATION 2-2 PREPARING SENOGRAPHE DMR TO RECEIVE STEREOTIX 2

STEREOTIX 2 om 2155051-2-100

OPERATING MODES

510

560 610

4
1 2 3

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REV 1 2-1-1 Removing Accessories from Senographe DMR See Illustration 2-2 1. Remove face shield 1 . 2. Remove compression paddle 2 by sliding it sideways. 3. Remove Bucky 4 as follows:

STEREOTIX 2 om 2155051-2-100

b. c. 2-1-2 Preparing Senographe DMR

Lift the lever. Hold Bucky grid by its sides and remove.

See Illustration 2-2 1. Move compression paddle to maximum High position.

WARNING

THE TURN-KNOBS 7

USED FOR THE MANUAL COMPRESSION

ADJUSTMENT IN STANDARD MAMMOGRAPHY (SEE SENOGRAPHE DMR OPERATOR MANUAL) MUST NOT BE OPERATED WHEN THE STEREOTIX 2 IS BEING USED. 2. Via two levers 6 , located one on either side of receptor-holder, reduce SID to 510 mm (SID 510 = Blue color code). Push lever 6 mechanism, then turn lever 6 SID. first to engage the

frontward to release mechanism and change

WARNING

SID 510 IS RESERVED FOR THE INSTALLATION OF STEREOTIX 2. AT SID 510 MM AND WITHOUT THE STEREOTIX 2, THE X-RAY EXPOSURE IS INHIBITED AND A MESSAGE APPEARS ON THE CONSOLE READOUT. 3. Place receptor-holder photocell in frontal position (blue color code).

WARNING

THE PHOTOCELL MUST BE PLACED IN THE FRONTAL POSITION (BLUE COLOR CODE) WHEN THE STEREOTIX 2 IS BEING USED. FAILURE IN DOING SO MAY RESULT IN INADEQUATE FILM QUALITY AND UNWANTED EXPOSURE.

2-7

OPERATING MODES

a.

Open flap located 3 on rear side of film-holder assembly 5 .

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REV 1
ILLUSTRATION 2-3 SECURING STEREOTIX 2 IN POSITION; CONTROLLER UNIT START-UP

STEREOTIX 2 om 2155051-2-100

2
OPERATING MODES

6
I O
X Y Z 0 0 L1 L2 L3 +

XA

XB YAB

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REV 1 2-1-3 Securing STEREOTIX 2 to Senographe DMR See Illustration 2-3 1. Move compression paddle of Instrument Unit to low position.

STEREOTIX 2 om 2155051-2-100

2. Hold Instrument Unit, and engage pins 1 of rear section in holes marked on Senographe DMR receptor-holder arm 2 (top holes 3 and left middle hole 4 : Blue color code).
OPERATING MODES

3. Lock lateral fasteners 5 by folding them down on sides of receptor-holder arm.

2-1-4 Starting Up See Illustration 2-3 Press Note: I , 6 to switch on Controller Unit.

The Controller Unit autotests at switch-on. The automatic movement of the cross-hair cursors is part of this procedure.

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REV 1
ILLUSTRATION 2-4 INSTALLING THE PHANTOM; TUBE-ARM SUPPORT ANGLES

STEREOTIX 2 om 2155051-2-100

- 15 - 27

+ 15

+ 27

OPERATING MODES

1 1 2

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REV 1 2-2 Exposure with Phantom See Illustration 2-4

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The following accuracy test must be made before using STEREOTIX 2 on a patient. 2-2-1 Positioning the Phantom The phantom 3 is positioned under the compression paddle 2 so that the holes face the opening in the paddle. Compress the phantom by turning the knobs 1 located one on either side of the compression arm of the Instrument Unit. Note: When the compression paddle leaves the park (High) position, the Up/Down and tilting movements of the Senographe DMR are inhibited. To move the Tube-Arm Support, press the trigger lever located at its rear (see Senographe DMR om, Ill 1-3). This releases the Tube-Arm Support from the receptor-holder arm. The silk-screened indicators show the position of the tube-arm support when it is tilted to either side of the Examination Arm. The color code is: Blue: Orange: Four angle shifts are possible: +15_ thru -15_ to make stereoscopic views. +27_ thru -27_ to install the needle (exposure is inhibited). +/-15_ +/-27_
OPERATING MODES

CAUTION

When the tube-arm support is being tilted to +/-15_ (color code: Blue), exposure is permitted only with the STEREOTIX 2 installed. In all other cases, exposure is inhibited and a warning message appears on the Control Console of the Senographe DMR.

WARNING

WHEN THE X-RAY TUBE ARM IS BEING UNCOUPLED FROM THE RECEPTOR ARM SUPPORT, DO NOT ALLOW OBSTACLES BETWEEN THE TWO ARMS, AND KEEP YOUR HANDS ON THE LEVERS DURING THE WHOLE MOVEMENT.

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REV 1
ILLUSTRATION 2-5 EXPOSURE AND FILM

STEREOTIX 2 om 2155051-2-100

- 15

+ 15

OPERATING MODES

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REV 1 2-2-2 Exposure See Illustration 2-5

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WARNING

THE AOP (AUTOMATIC OPTIMIZATION PARAMETERS) MODE CANNOT BE USED WITH THE STEREOTIX 2 INSTALLED. 1. Place an 18/24 film cassette 3 in film-holder plate of Instrument Unit 4 .
OPERATING MODES

Note:

The same film cassette will be used to make the two exposures, left and right. 2. The tube and the film cassette must be positioned on the same side. You can start on either side. We start on the righthand side. D FIRST EXPOSURE of film-holder plate. 1. Insert film cassette into righthand side Y

2. Tilt tube 1 to +15_ on righthand side (color code: Blue) Y by pressing lever 2 of the Tube-Arm Support and by pushing the arm gently. When lock is engaged, release lever. 3. Select rad parameters. 4. Make an exposure. D SECOND EXPOSURE

1. Push film cassette to lefthand side of film-holder plate F. 2. Tilt tube to -15_ on lefthand side (color code: Blue) F by pressing lever of the tube-arm support and by pushing the arm gently. When lock is engaged, release lever. 3. Select rad parameters. 4. Make an exposure. 5. Remove film cassette and develop film.

WARNING

THE PHANTOM SHOULD NOT BE MOVED.

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REV 1 Blank page

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OPERATING MODES

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REV 1 2-2-3 Film The film comprises two exposures, left and right.
ILLUSTRATION 2-6

STEREOTIX 2 om 2155051-2-100

FILM

RL

Each exposure contains: D D D D Note: Inverted T reference mark. Letters L and R (left and right). Projection of phantom copper plugs. Projection of compression paddle aperture. The projection of the copper disks contained in the phantom should appear in the projection of the compression paddle aperture.

2-15

OPERATING MODES

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REV 1
ILLUSTRATION 2-7 USING THE CONTROLLER

STEREOTIX 2 om 2155051-2-100

X .

Y .

Z .

XI

I O

OPERATING MODES

X Y Z

0 0

L1 -

L2

L3 +

2
XA

XB YAB

X .

Y .

Z .

XI

I O

X Y Z

0.0 0.0 0.0

0 0

L1 -

L2

L3 +

5
XA XB YAB

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REV 1 2-3 Using the Controller Unit and the Puncture Device

STEREOTIX 2 om 2155051-2-100

2-3-1 Using the Controller Unit 1. Press RESET 1 twice. The X, Y and Z 6 readouts go off. 2. Slide film 4 along light plate 3 and under cross-hair cursors, and secure it with pressure rollers. 3. Position film with inverted Ts of film superposed on horizontal line of coordinates of light plate coordinates. 4. Position cross-hair cursors on inverted T of each exposure by turning XA, XB, and YAB knobs 2 (located on either side of light plate). Note: The Y-ordinate is identical for a same point on the lefthand and righthand exposures. 5. Press ZERO SELECT key 5 to validate location of inverted Ts. The X, Y and Z readouts 6 light, each displaying 0.0.

2-17

OPERATING MODES

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REV 1
ILLUSTRATION 2-8 USING THE CONTROLLER UNIT (continued)

STEREOTIX 2 om 2155051-2-100

XI

I O

OPERATING MODES

X YZ

0.2 13.7 32.9

0 0

L1 -

L2

L3 +

XA

XB YAB

*
3

- 8.5 - 17.5 -20.6

1
XI

I O

X YZ

0.2 13.7 32.9

0 0

L1 -

L2

L3 +

80

XA

XB YAB

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REV 1 See Illustration 2-8

STEREOTIX 2 om 2155051-2-100

6. Position cross-hair cursors XA, XB and YAB on each of the selected disk projections (one per exposure, lesion to be punctured, by turning the XA, XB, and YAB knobs

3 .

WARNING

Note:

The Y-ordinate is identical for a given point appearing on the lefthand and righthand exposures. The computer reads the deviation between the original coordinates (marked with an inverted T on film) and those of the lesion to be punctured. The deviation values are displayed on the X-Y-Z readout of the Controller Unit. 7. Press L1, L2 or L3 1 to select needle length. 8. Needle length can be adjusted in steps of 1 mm via the + key or - key 2 located on either side of the needle length readout. Hold one of the keys down for fast incrementation or decrementation. 9. Release the key to validate the length selected and to hold it in memory even when power is removed from the STEREOTIX 2.

Note:

Needle lengths are preprogrammed at installation: L1 = 70 mm: L2 = 80 mm; L3 = 90 mm. The user can modify this program via the + key or - key 2 . Releasing the key validates the length selected and holds it in memory even during STEREOTIX 2 switch-off. The needle length can be set to a depth of 60 mm thru 120 mm via its key (L1, L2 or L3, 1 ). The readout will not display less than 60 or more than 120.

2-19

OPERATING MODES

THE USER MUST ACCURATELY SELECT THE SAME POINT SEEN ON THE TWO EXPOSURES. THE XA, XB, AND YAB DEVIATIONS MAY LEAD TO DEVIATIONS OF ONE THRU SEVERAL MILLIMETERS WHEN THE NEEDLE IS BEING INSERTED IN THE PHANTOM OR IN THE LESION.

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REV 1
ILLUSTRATION 2-9 USING THE PUNCTURE DEVICE

STEREOTIX 2 om 2155051-2-100

- 27

OPERATING MODES

- 8.5 - 17.5 - 20.6

0.0

0.0

0.0

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REV 1 2-3-2 Using the Puncture Device See Illustration 2-9

STEREOTIX 2 om 2155051-2-100

The Deviation Readout Unit shows the deviation between the needle-holder 3 and the point selected in the phantom 2 (lesion to be punctured). 1. Turn the X, Y, and Z 1 of the needle-holder until the deviation shown by the
OPERATING MODES

readout is reduced to zero at X, Y, and Z. The needle-holder is now opposite the point selected in the phantom (point to be punctured). 2. Move the tube-arm support 4 to the righthand or lefthand side at + or - 27_ (color code: Orange) by pressing the trigger lever of the tube-arm support and by pushing the arm gently. When the lock is engaged in the notch, release the lever. The space above the needle-holder is thereby free and facilitates the installation of the needle and needle-holder.

CAUTION

At +27_ and - 27_ tilt, exposure is inhibited and a warning message appears on the Senographe DMR Control Console readout.
3. Insert needle-guide of suitable diameter in needle-holder 3 . 4. Slide needle into needle-guide. Check by eye that the needle adjusts easily and correctly in the the three axes, X, Y, and Z.

WARNING

WHEN THE X-RAY TUBE ARM IS BEING UNCOUPLED FROM THE RECEPTOR ARM SUPPORT, DO NOT ALLOW OBSTACLES BETWEEN THE TWO ARMS, AND KEEP YOUR ON THE LEVERS DURING THE WHOLE MOVEMENT.

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REV 1 2-4 Selecting a Second Point

STEREOTIX 2 om 2155051-2-100

To check that STEREOTIX 2 is operating correctly, the operator can select a second point in the phantom, using the same reference exposure as above: 1. Mark the first point, and leave the film in position on the light plate of the Controller Unit. It is not necessary to reposition the reference marks on the inverted T marks of the film.
OPERATING MODES

2. Hit RESET once to cancel needle and previous point coordinates. 3. Position cross-hair cursors XA, XB, and YAB on each copper disk selected (one per exposure), seen on lefthand and righthand exposures by turning knobs XA, XB, and YAB located on either side of light plate.

WARNING

THE OPERATOR MUST ACCURATELY SELECT THE SAME POINT SEEN ON THE TWO EXPOSURES. THE XA, XB, AND YAB DEVIATIONS MAY LEAD TO DEVIATIONS OF SEVERAL MILLIMETERS WHEN THE NEEDLE IS BEING INSERTED IN THE PHANTOM OR IN THE LESION.

Note:

The Y-ordinate is identical for a given point appearing on the lefthand and righthand exposures. The computer reads the deviation between the original coordinates (marked with X on film) and those of the lesion to be punctured. The deviation values are displayed on the X-Y-Z readout of the Controller Unit. 4. Press L1, L2 or L3 to select needle length. The needle length appears on the corresponding readout. 5. Apply Para 2-3-2: Using the Puncture Device.

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CHAPTER 3 - EXAM PREPARATION

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EXAM PREPARATION

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EXAM PREPARATION

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CHAPTER 3 - EXAM PREPARATION

SECTION 1 MAKING A PUNCTURE ON A PATIENT 1-1 Types of Breast Puncture

1-1-1 Cytologic Puncture Cytologic puncture means taking a sample of the cells from a suspect area in the breast, whether this zone is palpable or non-palpable in the exposure. The diameter of the needle used for the puncture is usually 0.8 mm thru 1.2 mm. The sample is called the 'material'. A anatomopathology examination is made on the material to determine the type of cells, and to confirm or invalidate its pathological character. Two techniques can be used to obtain a sufficient quantity of cells:
EXAM PREPARATION

a. b. 1-1-2 Histology Puncture

Aspiration by a syringe with its needle inserted in the suspect area. Needle left inserted in the suspect area for a few minutes allowing the cells to move up the needle by capillary action.

Histology puncture takes a small fragment of tissue from the suspect area in the breast, whether this area is palpable or not in the clinical examination. This sample is called a 'core sample'. A anatomopathology examination is made on the material to determine the type of cells, and to confirm of invalidate its pathological character. The diameter of the needle used for the puncture is usually 0.8 mm thru 2.0 mm. The needle is always equipped with a localization wire and has a cutting edge at its distal part or along the length of the needle to cut through the tissue. The core sample is held in the needle by aspiration (syringe).

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REV 1 1-1-3 Preoperative Localization

STEREOTIX 2 om 2155051-2-100

Preoperative localization entails inserting an x-ray-opaque metal wire which emerges from the skin. The wire allows the surgeon to accurately locate the lesion in the breast, as well as to reduce the size of the tissue sample to be removed and so preserve the esthetic form of the breast. Localization can be preceded by a cytologic or histologic puncture using a needle of 0.9 thru 1.4 mm in diameter. The needle is equipped with a metal wire whose distal point is in the shape of a hook. (The wire may be shipped in the needle or packaged separately.) When the needle is removed from the breast, the wire catches in the lesion and remains in place.

1-2

Preparation The following model list should be adapted to the requirements and techniques of each user. The decision to apply local anaesthetic before the puncture is made by the radiologist.

EXAM PREPARATION

The following items are arranged on a tray (the Senographe DMR accessory tray may be used): D D D D D D D D Note: Sterilized gloves (if required by the radiologist). Sterilized compresses. Disinfectant. Local anaesthetic (if required). Sparadrap or equivalent. Local anaesthetic needle (if required). Local anaesthetic syringe (if required). Puncture needle as required (cytology, histology, preoperative localization). The operator must decide the needle length, measured from the point to the bottom of the guard. D D Syringe, with socket matching the needle (concerns cytologic or histology puncture when the syringe is not supplied with a needle). Vacuum pumping device of size suited to syringe (concerns cytologic or histology puncture when the gun is not supplied with a needle).

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REV 1 D Two needle-guides to suit the needle diameter.

STEREOTIX 2 om 2155051-2-100

WARNING

THE INTERNAL DIAMETER OF THE NEEDLE-GUIDE MUST ALWAYS BE GREATER THAN THE INTERNAL DIAMETER OF THE NEEDLE, EG: NEEDLE = 0.8 MM INSERTED IN NEEDLE-GUIDE = 0.9 MM D D Short, flexible adaptor to connect syringe to puncture needle if the syringe cannot be positioned vertically on the needle. Sample spreading equipment or storage bottle for tissue sample.

3-5

EXAM PREPARATION

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REV 1
ILLUSTRATION 3-1 POSITION OF STEREOTIX 2 ON SENOGRAPHE DMR; OBLIQUE VIEW

STEREOTIX 2 om 2155051-2-100

EXAM PREPARATION

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REV 1 SECTION 2 MAKING A PUNCTURE USING STEREOTIX 2 2-1 POSITIONING

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2-1-1 Positioning STEREOTIX 2 on Senographe DMR See illustrations 3-1, 3-2 and 3-3. Depending on the position of the suspect x-ray image on the standard mammography exposures, the operator decides the tilt of the Senographe DMR examination arm. For example, if the lesion is distinct and accessible at an oblique angle of 60_, the operator tilts the examination arm to 60_ so that the patient can be positioned identically for the stereotactic localization exposures. Sometimes, as in preoperative localization, patient positioning depends on the incision to be made by the surgeon. Operator and surgeon need to agree on a suitable positioning for installing the localization wires.
EXAM PREPARATION

1. Disassemble Senographe DMR accessories. 2. Reduce SID. 3. Place photocell in frontal position (see Chap 2, Para 2-1: STEREOTIX 2 installed on Senographe DMR). 4. Place STEREOTIX 2 on Positioning Arm of Senographe DMR, and close fasteners. 5. Tilt column to selected angular shift using tilt control knobs located above and below of left- and righthand levers of Senographe DMR. Note: The STEREOTIX 2 compression paddles must be in park (High) position. Otherwise, the Up/Down movement and Positioning Arm tilt of the Senographe DMR are inhibited). THE ARM OF THE SENOGRAPHE DMR MUST NOT BE ANGLED MORE THAN +90 OR 90 (i.e. arm horizontal on either side) WHEN STEREOTIX 2 IS USED.

WARNING

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REV 1
ILLUSTRATION 3-2 POSITION OF STEREOTIX 2 ON SENOGRAPHE DMR; CRANIOCAUDAL VIEW

STEREOTIX 2 om 2155051-2-100

EXAM PREPARATION

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REV 1
ILLUSTRATION 3-3 POSITION OF STEREOTIX 2 ON SENOGRAPHE DMR; LATERAL VIEW

STEREOTIX 2 om 2155051-2-100

3-9

EXAM PREPARATION

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REV 1
ILLUSTRATION 3-4 POSITIONING THE PATIENT

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EXAM PREPARATION

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REV 1 2-1-2 Positioning the Patient See Illustration 3-4

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Mammary puncture with STEREOTIX 2 is always carried out with the patient in the seated position. Use the examination seat of the Senographe DMR. Adjusting the Chair: 1. Set chair height and depth of back of chair so that patient is sitting comfortably with her back straight and firmly against the chair back. 2. Set height of footstand so that patient feet are resting without effort. 3. Set height of arm rests to support patient elbows if required by exam position selected. Note: The patient should be seated in a comfortable position in order to remain motionless for the duration of the exam. This condition is essential for the accuracy of the puncture.
EXAM PREPARATION

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REV 1 2-2 Operating Difficulties

STEREOTIX 2 om 2155051-2-100

It is essential to proceed in a methodical manner for the preparation and running of mammary puncture examinations with the STEREOTIX 2. Observe the following recommendations to ensure the accuracy of the system is maintained. 2-2-1 X-ray Image The suspect image must be of sufficient radiographic quality to be correctly displayed on the localization exposures. This does not concern the size of the image, but its visibility, so that lesions of a size smaller than 0.5 mm can be punctured. The physician must be able to accurately determine the same point to be punctured on each of the two localization exposures, left and right. A deviation of a few millimeters in the X, Y and Z axes may lead to errors in accuracy when inserting the needle into the breast. 2-2-2 Patient
EXAM PREPARATION

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. The patient should be comfortably seated, and well supported by the chair, in order to remain motionless throughout the examination. While the films are being processed, an operator should remain with the patient to ensure that she does not move. The breast should be firmly compressed without, however, causing discomfort to the patient. 2-2-3 Equipment The equipment should be prepared before the start of the examination and placed beside the physician. The accessory tray of the Senographe DMR can be used. The operator must know exactly the length of the needle being used in order to program this length on the STEREOTIX 2. The length is measured from the point to the bottom of the guard. When installing the localization hook, it is recommended to place the point of the needle 5 mm to 10 mm below (0) zero of the Z-coordinate (Z = depth) so that the hook opens below the lesion and surrounds it. This should then to be approved by the physician.

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REV 1 2-3 Making Stereoscopic Exposures

STEREOTIX 2 om 2155051-2-100

2-3-1 Positioning the Breast The breast is positioned under the compression paddle so that the area to be examined is opposite the aperture in the paddle (manual and x-ray localization is required). Compress breast by turning compression knobs (compression must be firm). Note: To ensure that the area to be examined is opposite the aperture of the compression paddle, it is recommended to use an exposure with a 0_ angular shift, an 18 x 24 cm format cassette placed at the center of the cassette-holder of the STEREOTIX 2.

WARNING
Note:

THE AOP (AUTOMATIC OPTIMIZATION PARAMETERS) MODE CANNOT BE USED WITH STEREOTIX 2.
EXAM PREPARATION

When the compression paddle leaves the park (High) position, the Up/Down and rotation movements of the Senographe DMR are inhibited. To move the tube-arm support, press the trigger lever located at its rear. The silk-screened indicators show the position of the tube-arm support when it is tilted to either side of the Positioning Arm. The color code is: Blue: +/-15_ Orange: +/-27_ Four angle shifts are possible: +15_ thru -15_ to make stereoscopic exposures. +27_ thru -27_ to install the needle (exposure is inhibited).

CAUTION

When the tube-arm support is tilted to +/-15_ (color code: Blue), exposure is permitted only with the STEREOTIX 2 installed. In all other cases, exposure is inhibited and a warning message appears on the Control Console of the SENOGRAPHE DMR.

WARNING

WHEN THE X-RAY TUBE ARM IS BEING UNCOUPLED FROM THE RECEPTOR ARM SUPPORT, DO NOT ALLOW OBSTACLES BETWEEN THE TWO ARMS, AND KEEP YOUR HANDS ON THE LEVERS DURING THE WHOLE MOVEMENT.

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REV 1 2-3-2 Exposure

STEREOTIX 2 om 2155051-2-100

WARNING

THE AOP (AUTOMATIC OPTIMIZATION PARAMETERS) MODE CANNOT BE USED WITH STEREOTIX 2. Place an 18/24 film cassette in the film-holder plate of the Instrument Unit.

Note:

The same film cassette will be used to make the two exposures, left and right. The tube and the film cassette must be positioned on the same side. You can start on either side. Here, we start on the righthand side. D First Exposure:

1. Insert film cassette in righthand side, for example, of film-holder plate. 2. Tilt tube to +15_ on righthand side (color code: Blue) by pressing lever of the tube-arm support and by pushing the arm gently. When lock is engaged, release lever. 3. Select rad parameters. 4. Make the exposure. D Second Exposure:

EXAM PREPARATION

1. Push film cassette to lefthand side of film-holder plate. 2. Tilt tube to -15_ on lefthand side (color code: Blue) by pressing lever of the tube-arm support and by pushing the arm gently. When lock is engaged, release lever. 3. Select rad parameters. 4. Make an exposure. 5. Remove film cassette and develop film.

WARNING

WHILE THE FILM IS BEING DEVELOPED, THE PATIENT MUST REMAIN STATIONARY AND BE ACCOMPANIED BY ONE OF THE OPERATORS.

2-3-3 Film Description The film contains two exposures, left and right. Each view carries an inverted T reference mark, the letters L or R (left or right), the projection of the radiographic image with suspected lesion, and the projection of the compression paddle aperture.

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REV 1 2-4 Using the Controller Unit and the Puncture Device

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2-4-1 Using the Controller Unit 1. Press key 1 to switch on controller. 2. Press RESET twice to cancel the parameters of the previous exam and to avoid an operating error. The X, Y and Z readouts go off. 3. Slide film along light plate and under cross-hair cursors, and secure it with pressure rollers. 4. Position film with inverted Ts of film superposed on horizontal line of light plate coordinates. 5. Position cross-hair cursors on inverted T of each exposure by turning XA, XB, and YAB knobs (located on either side of light plate). Note: The Y ordinate is identical for a same point on the lefthand and righthand exposures. 6. Press ZERO SELECT key to validate location of inverted Ts. The X, Y and Z readouts light, displaying 0, 0, 0. 7. Position XA, XB and YAB cross-hair cursors on each of the selected disk projections (one per exposure, lesion to be punctured, by turning the XA, XB, and YAB knobs.
EXAM PREPARATION

WARNING

THE USER MUST ACCURATELY SELECT THE SAME POINT SEEN ON THE TWO EXPOSURES. THE XA, XB, AND YAB DEVIATIONS MAY LEAD TO DEVIATIONS OF ONE THRU SEVERAL MILLIMETERS WHEN THE NEEDLE IS BEING INSERTED IN THE LESION.

Note:

The Y-ordinate is identical for a given point appearing on the lefthand and righthand exposures. The computer reads the deviation between the original coordinates (marked with an X on film) and those of the lesion to be punctured. The deviation values are displayed on the X-Y-Z readout of the Controller Unit. 8. Press L1, L2 or L3 to select needle length. The needle length appears on the corresponding readout. 9. Release L1, L2 or L3 to confirm and store the length selected even after power is removed from STEREOTIX 2.

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STEREOTIX 2 om 2155051-2-100 10. Needle length can be adjusted in steps of 1 mm via the + key or - key located on either side of the needle length readout. Holding one of the keys down provides fast incrementation or decrementation.

Note:

Needle lengths are preprogrammed at installation: L1 = 70 mm: L2 = 80 mm; L3 = 90 mm. The user can modify this program via the + key or - key located on either side of the needle length readout. Releasing the key validates the length selected and holds it in memory even during STEREOTIX 2 switch-off. The needle length can be set to a depth of 60 mm thru 120 mm via the L1, L2 or L3 key. The readout will not display less than 60 or more than 120.

2-4-2 Using the Puncture Device The deviation readout shows the deviation between the needle-holder and the point selected in the breast (lesion to be punctured).
EXAM PREPARATION

1. Turn the X, Y, and Z of the needle-holder until the deviation shown by the readout is reduced to zero at X, Y, and Z. The needle-holder is now opposite the point selected in the breast (lesion to be punctured). 2. Move the tube-arm support to the righthand or lefthand side at + or - 27_ (color code: Orange) by pressing the lever of the Tube-arm Support and by pushing the arm gently. When the lock is engaged, release the lever. The space above the needle-holder is thereby free and facilitates the installation of the needle-holder and the needle.

CAUTION

At +27_ and -27_ tilt, exposure is inhibited and a warning message appears on the Senographe DMR Control Console readout.

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REV 1 3. The radiologist disinfects the skin of the patient. 4. Insert needle-guide of suitable diameter in needle-holder. Note:

STEREOTIX 2 om 2155051-2-100

The tray containing the equipment required for the puncture must be ready and beside the radiologist. The tray provided on the accessory support of the Senographe DRM can be used. 5. Slide needle into needle-guide. 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.

WARNING

WHATEVER THE TYPE OF PUNCTURE PERFORMED, TEST EXPOSURES MUST BE MADE WITH THE NEEDLE IN PLACE IN THE BREAST. 6. Insert film cassette and make exposures as described in Para 2-3-2, Exposure.
EXAM PREPARATION

7. The radiologist inspects the exposure; the tip of the needle should be at the center of the suspected lesion. 8. The examination progresses according to the type puncture being made and the technique of the radiologist. 9. Following removal of the needle, and especially in the event of presurgical localization, the radiologist applies a dry sterilized compress over the skin.

WARNING

WHEN SURGICAL LOCALIZATION IS COMPLETE AND AFTER REMOVAL OF THE NEEDLE, THE SURGEON ENSURES THAT: 1. THE COMPRESSION PAD IS RELEASED SLOWLY, AND 2. THAT THE LOCALIZATION WIRE EMERGING FROM THE SKIN IS MOVED CAREFULLY SO AS NOT TO MOVE THE WIRE HOOK FROM THE CENTER OF THE LESION. A biopsy gun hoder is delivered with the system in order to allow use of such gun to perform a breast biopsy.

Note:

WARNING

WHEN A BIOPSY GUN IS USED, IT IS MANDATORY TO TAKE INTO ACCOUNT THE STRIKE MARGIN (DEPENDENT ON THE TYPE OF NEEDLE AND TYPE OF GUN USED) TO AVOID HITTING THE TRAY.

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REV 1 2-5 Selecting a Second Suspect Area (second lesion to be punctured)

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If two radiographic images with suspected lesions appear on the same exposure, and if the projection of these two images is within the aperture of the compression paddle, a puncture can be made of each suspect area without moving the patient: 1. Use same reference exposure as above, if desired. 2. Mark the first point, and leave the film in position on the light plate of the Controller Unit. 3. Hit RESET ONCE to cancel needle and previous lesion coordinates. 4. Position cross-hair cursors XA, XB, and YAB at center of each of suspect areas selected for second selection (one per exposure), by turning knobs XA, XB, and YAB located on either side of light plate.

WARNING
EXAM PREPARATION

THE OPERATOR MUST ACCURATELY SELECT THE SAME POINT SEEN ON THE TWO EXPOSURES. THE XA, XB, AND YAB DEVIATIONS MAY LEAD TO DEVIATIONS OF SEVERAL MILLIMETERS WHEN THE NEEDLE IS BEING INSERTED IN THE LESION.

Note:

The Y-ordinate is identical for a given point appearing on the lefthand and righthand exposures. The computer reads the deviation between the original coordinates (marked with an X on the film) and those of the lesion to be punctured. The deviation values are displayed on the X-Y-Z readout of the Controller Unit. 5. Press L1, L2 or L3 to select needle length. The needle length appears on the corresponding readout. 6. Apply Para 2-4-2, Using the Puncture Device.

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CHAPTER 4 - MAINTENANCE

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MAINTENANCE

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MAINTENANCE

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CHAPTER 4 - MAINTENANCE
SECTION 1 CLEANING AND DISINFECTION Adequate cleaning and disinfection is necessary to prevent disease transmission between patients. Be sure to thoroughly clean and disinfect equipment surfaces that contact the patient and all equipment surfaces likely to become soiled from patient contact. Mammography equipment surfaces (Table 4-1) that normally contact the patient's intact skin need only low or intermediate level disinfection. However, when dealing with patients having exposed wounds, lesions or other conditions where breached skin may contact the equipment surface, a high-level disinfection may be warranted.
TABLE 4-1 CLEANING

Description Bucky plates Compression paddles Magnification plate tummy shield face shield other plastic or painted surfaces

Operation Use mild soap or a disinfectant Use mild soap or a disinfectant Use mild soap or a disinfectant Use mild soap or a disinfectant Use mild soap or a disinfectant
MAINTENANCE

Use mild soap

CAUTION
D

Improper cleaning methods or the use of certain cleaning and disinfecting agents can damage the equipment, cause poor imaging performance or increase the risk of electric shock. To avoid possible injury or equipment damage: Do not use harsh detergents, abrasive cleaners, strong concentrations of alcohol or any products containing methyl alcohol. If skin prep products contain high alcohol concentrations, allow sufficient drying time before applying compres sion. Do not expose equipment parts to steam or high temperature sterilization. Never allow liquids to enter the internal parts of the equipment. If you become aware of liquid entry, disconnect the electrical supply and have the equipment checked by qualified service personnel before returning it to use.

D D

Equipment Cleaning Instructions Equipment parts may be washed with mild soap in lukewarm water. Removable parts that do not contain electrical components such as the compression paddles may be removed from the equipment and immersed. Equipment surfaces that enclose electrical components may be wiped with soft dampened cloth, taking care not to allow liquids to enter the equipment. Surfaces should be scrubbed as needed using a soft sponge, gauze or cloth to remove all visible residue.

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STEREOTIX 2 om 2155051-2-100 Scrubbing with a soft bristle brush (such as a toothbrush) may be necessary to reach corners or to remove material that has dried onto the surface. Rinse all surfaces with clean water to remove visible soap residue, taking care to prevent liquid entry to internal equipment parts. Dry surfaces with a soft cloth to remove any visible residue. Low or Intermediate Level Disinfection Before each use, equipment surfaces that contact the patient (Bucky, compression paddle, cassette holder or magnification device) should be subjected to low or intermediate level disinfection with a suitable disinfecting or sanitizing agent. Use an EPA registered disinfectant and be sure to follow the label instructions and precautions for use, storage and disposal. High Level Disinfection In the event of equipment contacting breached skin or being used with infected or immune compromised patients, equipment surfaces that contact the patient should be subjected to high level disinfection. Use only FDA cleared and EPA registered high-level disinfecting agents and be sure to follow the label instructions and precautions for use, storage and disposal. Cidex liquid chemical germicide is recommended for this purpose. Recommended Cleaning Agents The following products have been used on GE equipment without causing equipment damage. This list is not exclusive nor intended to certify these product in any way. GE does not warrant any of these products, please contact the manufacturer of the cleaning agent directly with any questions you may have. T-Spray disinfectant detergent, mfg. by Pharmaceutical Innovations, Inc., Newark, NJ, USA EPA Reg. No. 1839-83-65071, EPA Est. No. 65071-NJ-01 Do Not Use any of the following chemicals at or above the concentrations given: D D D D D D Methanol - all concentrations, Ethanol - 50% or greater, Sodium hypochlorite (bleach) - 5% or greater, abrasive cleansers, organic solvents, Other chemicals that may react with Lexan (tm), epoxy resins or paint.

MAINTENANCE

If you are unsure, contact the manufacturer of the cleaning agent directly.

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REV 1 SECTION 2

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PREVENTIVE MAINTENANCE
STEREOTIX 2 operational reliability ensures accurate measurement over a long period. However, it is recommended to check overall calibration regularly using the Plexiglas phantom supplied with the system. Checking frequency depends on the frequency of use, but should be at least monthly. A GEMS-E Service Engineer will carry out the annual planned maintenance during one of the two annual site calls scheduled for the SENOGRAPHE DMR. SECTION 3

MESSAGES
Three types of messages may be displayed for the user on the gantry or on the Control Console: D D D Note: I xx: E yy: S zz: Information message: fault message which does not inhibit the exposure. Error message: fault inhibits the exposure. Stop message: exposure is stopped due to incorrect use of equipment.

Example:

I 76 FAULT

A message displayed on the Control Console has 40 characters. The first three characters are identification characters. The next 28 characters comprise the message. The seven remaining characters are also identification characters. Example: I 76 DETECTOR FAILURE 158/011

When calling the Field Service of GE CGR, it is essential to note each message in its entirety (2 for the Readout messages, and 3 for the Control Console messages). Listed below by type are all the messages which can appear on the Column Readout and on the Control Console, with the corresponding corrective action. For a description of the messages for the SENOGRAPHE DMR and STEREOTIX 2, see the SENOGRAPHE DMR om, Chapter 4, Section 3.

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MAINTENANCE

A 15-character message is displayed on the Readout located on top of the Column. The first three characters are identification characters. The remaining 12 characters constitute the message.

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TABLEAU 4-2 ERROR MESSAGES DISPLAYED ON READOUT AND ON CONTROL CONSOLE

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Message No. I 50

Message on Column Readout LOCK JAMMED

Message on Control Console None

Explanation/meaning of message LOCK PROBLEM: In spite of command, lock release does not operate.

Corrective Action 1. Try again to release lock. 2. If fault continues, note ALL messages and contact GEMS-E Field Service - Wait for lock to cool.

I 51

HOT LOCK

None

Lock temperature too high (used for too long period and/or too frequently). Tube housing arm in unsta ble position because lock is badly latched.

I 52

ARM UNLOCKED

TUBE HOUSING ARM UNLOCKED

1. Pivot arm to latch correctly. 2. If fault continues, note ALL messages and contact GEMS-E Field Service. 1. Check that image receptor is correctly locked in a given SID position. 2. If fault continues, note ALL messages and contact GEMS-E Field Service. 1. Switch OFF, and switch ON. 2. If fault continues, note ALL messages and contact GEMS-E Field Service. 1.Connect controller of Stereo tix 2 to Senographe. 2.Connect positioner to controller. 3.Switch controller on. 4.Move Stereotix 2 paddle up to end of travel. 5.If fault continues, note ALL messages and contact GEMS-E Field Service.

I 53

UNLOCKED SID

UNLOCKED IMAGE RE CEPTOR

Image receptor is incorrectly locked.

I 74

LOCK FAILURE

ARM LOCK FAILURE

Arm lock is not functioning correctly .

MAINTENANCE

I 80

STEREOTIX

None

Movements requested (ele vator or rotation) cannot be made by interlock with Ster eotix 2 option.

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Message No. E 51 Message on Column Readout COLLIM FAIL Message on Control Console LATERAL COLLIMATOR FAILURE Explanation/meaning of message Lateral collimator is faulty, so a good format cannot be en sured. Exposure is inhibited. E 53 COLLIM FAIL REAR COLLIMATOR FAILURE Rear collimator is faulty, so a good format cannot be en sured. Exposure is inhibited. S 50 None INCORRECT X-RAY IN CIDENCE Position of Tube-arm Support does not permit exposure: - Position not locked - Outside 15 range (Stereotix 2 not installed) - Outside 27 range (Stereotix 2 installed) Image receptor is at SID 510 mm and Stereotix 2 not installed. Stereotix 2 is installed and the image receptor is not at SID 510 mm.

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Corrective Action 1. Switch OFF. 2. Switch ON. 3. If fault continues, note ALL messages and inform GEMS-E Field Service. 1. Switch OFF. 2. Switch ON. 3. If fault continues, note ALL messages and inform GEMS-E Field Service. - Correct the position of the tube carrying arm.

S 51

None

INCORRECT SID

- Change the focal distance.

S 52

None

DET. CELL DISTANCE NOT OK

- Change SID to 510 mm. MAINTENANCE

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MAINTENANCE

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CHAPTER 5 - SPECIFICATIONS

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SPECIFICATIONS

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ILLUSTRATION 5-1 INSTRUMENT UNIT & CONTROLLER UNIT: SPACE REQUIREMENTS

Z Y X

300

435

425

370

SPECIFICATIONS

320

210 130

480

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REV 1 SECTION 1

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PHYSICAL SPECIFICATION
See Illustration 5-1
TABLEAU 5-1 SPACE REQUIREMENTS & WEIGHT

Description Length mm (ft) Controller Unit without Readout Controller Unit with Readout Instrument Unit 480 480 435 (1.57) (1.57) (1.43)

Dimensions Width mm (ft) 320 370 425 (1.05) (1.22) (1.39) Height mm (ft) 130 210 300 (0.43) (0.69) (0.98)

Weight daN (lb) 8.2 8.2 8.5 (18.1) (18.1) (18.7)

Illustration

1-4 1-4 1-5 1-3

SECTION 2 2-1

ELECTRICAL & TECHNICAL SPECIFICATION

Technical Specification NEEDLE-HOLDER TRAVEL: D D D 50 mm 0.5 mm, on X axis, 40 mm 0.5 mm, on Y axis, 70 mm 0.5 mm, on Z axis.

ACCURACY: D Needle: 1 mm, in X, Y and Z axes.

SPECIFICATIONS

COMPRESSION PADDLE APERTURE: D D 54 mm in X axis, 43 mm in Y axis.

TYPE OF MATERIALS IN CONTACT WITH SKIN: D D Compression paddle: - Lexan polycarbonate, Film cassette holder: - Impax.

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30 50 40 30 25

4 R=1

15 5 13,5

54 23

5 10

Edge (gravure)
20

43
57

SPECIFICATIONS

Five holes 0.9 thru 1.3 mm dia.

A
5 (PM) 0.1

Five copper plugs/hole + 0. 1 mm

SECTION A-A

5-4

35

15

25

100

30

ILLUSTRATION 5-2 PRECISION TEST PHANTOM

4 R=3

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REV 1 2-2 Radiographic Specifications D Film cassette to DIN standard: - 18 x 24 mm. D Film: - 18 x 24 mm. D A and B exposure formats: - 85 x 75 mm. D Measurement surface: - 54 x 43 mm. D Resolution: - 1 mm. D Precision test phantom (see Illustration 5-2) - 50 x 100 x 57 mm (n x L x W). Five holes drilled for accuracy test: - 0.9 0.13 mm, - Depths: 5, 10, 20, 30 and 40 mm. 2-3 Electrical Specification Power supply: 27 VAC, supplied by SENOGRAPHE DMR gantry. SECTION 3

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TABLEAU 5-2 AMBIENT LIMIT CONDITIONS

RELATIVE HUMIDITY without condensation In operation Min. 80% 15 C (59 F)

TEMPERATURE Storage and transportation Min. -30 C (-22 F) Max. 60 C (140 F)

ALTITUDE In operation Storage and transporta tion 3000 m (9842')

Max. 40 C (104 F)

3000 m (9842')

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SPECIFICATIONS

AMBIENT CONDITIONS

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REV 1 SECTION 4 MEANING OF SYMBOLS

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Protective earth (ground)

Earth (ground)

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.

SPECIFICATIONS

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STEREOTIX 2 om 2155051-2-100

CHAPTER 6 - REGULATIONS
The STEREOTIX 2 complies to the following regulations: D D D UL 187 X-ray equipment CSA 22.2, No. 114 IEC 601-1 Radiation Emitting Equipment Medical Electrical Equipment Part 1: General requirements for safety Medical Electrical Equipment Part 2: Particular requirements for the safety of high voltage generators of diagnostic x-ray generators. Code of Federal regulation Performance standards for ionizing radiation emitting products.

IEC 601-2-7

21 CFR, Part 1020.30, sub. J

D D D

EMC (Electromagnetic compatibility): Emission: Electromagnetic disturbances. Electrostatic discharge (conducting parts:3kV, non-conducting parts:8kV). Radiated electromagnetic fields (3 V/m, from 26MHz to1GHz). Elecrical fast transient/burst (2kV on power supply cables, 500 V interconnection cables). Shock waves: (2kV common mode, 1kV differential mode). Immunity

1. CISPR11 class A: 1. IEC 801-2 2. IEC 801-3 3. IEC 801-4 4. IEC 801-5 D

CE Marking according to council directive 93/42/EEC.

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REGULATIONS

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REGULATIONS

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