MAMMOMAT Inspiration Operator Manual VB30 or higher Dec 2014

MAMMOMAT Inspiration Operator Manual VB30 or higher

www.siemens.com/healthcare

This device bears a CE mark in accordance with the provisions of Council Directive 93/42/EEC of June 14, 1993 concerning medical devices and the Council Directive 2011/65/EU of June 08, 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment.

Global Business Unit Siemens AG Medical Solutions X-Ray Products Henkestr. 127 DE-91052 Erlangen Phone: +49 9131 84-0 www.siemens.com/healthcare

The CE marking applies only to medical devices which have been put on the market according to the above mentioned EC Directive. Unauthorized changes to this product invalidate this declaration. Please observe the Safety register. This must be studied thoroughly before starting up the system. Original language: English

Global Siemens Headquarters Siemens AG Wittelsbacherplatz 2 80333 Muenchen Germany

Global Siemens Healthcare Headquarters Siemens AG Healthcare Henkestraße 127 91052 Erlangen Germany Phone: +49 9131 84-0 www.siemens.com/healthcare

Legal Manufacturer Siemens AG Wittelsbacherplatz 2 DE-80333 Muenchen Germany

www.siemens.com/healthcare

Order No. XPW7-330.620.01.02.02 | Printed in Germany 12-2014 | All rights reserved | © 2014, Siemens AG

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We make every effort to continuously improve our product documentation. Therefore, we would like to offer you the opportunity of giving us your direct feedback concerning your requests, suggestions and criticism with respect to this operator manual.

o For feedback by fax, please use the following fax number: +49 9131/84-2378 o If you prefer to send your feedback by e-mail, please use this address: [email protected] In this case, we request that you include the complete print number in the footer of this page in the subject line.

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Optional information Name Hospital City/country E-mail Telephone/fax Number of fax pages

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Register 1

Introduction

Register 2

Safety

Register 3

System overview

Register 4

Operation

Register 5

Patient data

Register 6

Examination

Register 7

Configuration

Register 8

User management and access protection

Register 9

Technical Description

Register 10

Appendix

Register 11

Index

Overall Table of Contents

Register 1: Introduction General Information ... 3

Register 2: Safety General information ... 3 Personal safety ... 17 Equipment safety... 25

Register 3: System overview System description ... 3

Register 4: Operation Unit ... 3 Workstation... 33

Register 5: Patient data Patient data management... 3

Register 6: Examination Examination task card ... 3

Register 7: Configuration Configuring the examination ... 3 Transfer and archive configuration... 37 Configuring MoodLight (Option) ... 41

Register 8: User management and access protection Safety settings ... 3

Register 9: Technical Description Identification labels and technical specification ... 3

Register 10: Appendix

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MAMMOMAT Inspiration Overall Table of Contents

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Operator manual XPW7-330.620.01.02.02

Register 1

Introduction

Chapter: General Information Operator Manual layout ... 3 syngo Operator Manual - syngo VE33A ... 4

Information about this Operator Manual ... 5 Area of application ... 5 Required documents ... 5 Structure ... 6 Warnings ... 6 Text layout ... 7 Names and parameters ... 8

Use of the product ... 8 Intended use ... 8 Patient group ... 10 Contraindications ... 10 Physical functionality ... 10 User profile ... 11 Training ... 11 Conditions of use ... 12 Maintenance, cleaning and disinfection ... 12 Service ... 12 Technical features ... 12 Frequently used operating functions ... 12 Operating functions regarding safety ... 12

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Introduction Table of Contents

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Operator Manual XPW7-330.620.01.02.02

Register

Introduction

General Information

To operate the mammography system accurately and safely, the operating personnel have to have the necessary expertise as well as knowledge of the entire Operator Manual. It has to be read carefully prior to starting up the mammography system.

Operator Manual layout

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To improve readability, your complete Operator Manual has been broken down into several individual Operator Manuals with thematically distinct content: o Operator Manual - MAMMOMAT Inspiration system o Quality control manual o syngo Operator Manual - syngo VE33A o Options

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Introduction General Information

syngo Operator Manual - syngo VE33A

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o This Operator Manual includes descriptions covering standard as well as optional hardware. Consult the respective Siemens sales organization to determine the type of software available for your system. The description of an option is not legally binding for providing it. o The volume of smaller Operator Manuals that you receive depends on your system configuration and may vary. All parts of the complete Operator Manual contain safety information requiring strict adherence. The Operator Manual for hardware and software are intended for authorized users. They assume a basic knowledge of working with PCs and software. o The graphics, figures, and medical images used in this Operator Manual are examples only. The actual appearance and design of these may be slightly different. For the sake of linguistic simplicity, male and female patients are referred to as "the patient". o The Operator Manual is intended as a guide when working with the syngo applications of the mammography system. It focuses on completing typical actions quickly and easily. A complete description for operating the syngo VE33A software is included in the extensive Online Help. To select Online Help, press the F1 key on your keyboard or click the Help button in the active dialog window. o The syngo VE33A software on your system differs in some aspects from the basic syngo version as described in the syngo Operator Manual syngo VE33A. The following parts from the syngo Operator Manual - syngo VE33A are not relevant to our mammography system: – Part D Evaluation - D.2 syngo 3D – Part E Documentation - E.2 Camtasia

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Operator Manual XPW7-330.620.01.02.02

Introduction General Information

Information about this Operator Manual Area of application

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This Operator Manual is valid for the following products: o MAMMOMAT Inspiration

Required documents

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Reference is made in this Operator Manual to the following documents: o MAMMOMAT Inspiration Quality control manual o syngo VE33A Operator Manual o Supplied documentation for the monitor

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Introduction General Information

Structure

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Register

This Operator Manual includes various registers. The first header line shows the title of the register.

Chapter

Every register can contain one or more chapters. The chapter title is in the second header line.

Page numbers

The footer contains the page numbers and the number of pages in the register. Only the registers have consecutive page numbers.

Warnings Warning

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Warning is used to indicate the presence of a hazard which can cause personal injury or death to patients, operating personnel or others.

Warning First the source of danger is mentioned. Then possible consequences are pointed out. u Finally, information on how to avoid the danger is provided. Caution

Caution is used to indicate that minor injuries or damage to the system may occur if the system is not used properly.

Caution First the source of danger is mentioned. Then possible consequences are pointed out. u Finally, information on how to avoid the danger is provided.

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Operator Manual XPW7-330.620.01.02.02

Introduction General Information

Text layout

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A set of conventions has been observed in this operator manual that is intended to help you perceive the importance of a piece of text at a glance. The following notations are used: Instructions

guides you in the proper use of your system. u A diamond precedes text of this type.

Lists Explanatory text

Reference

o A square precedes text of this type. subdivides an instructional text or a list into further subitems. – A dash precedes text of this type. refers you to further explanations on another page of your Operator Manual or in a separate document. → An arrow indicates texts of this type.

Note

is used in two different ways: o emphasizes a safety-relevant piece of information without there being direct danger o contains a summary of the most important information on a subject This text is highlighted in gray.

Information

text that provides additional useful explanations about a subject.

This text is indicated by the icon for information and is printed in italics.

Menus and buttons

Designations of software menus, buttons and dialog boxes are printed in bold.

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Introduction General Information

Names and parameters

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All names and data on patients and equipment that are used as examples in this Operator Manual are entirely fictional. Any resemblance to names of real persons and institutions is entirely coincidental. All parameters and images shown in this Operator Manual are examples. Only the parameters displayed on your system are relevant.

The MAMMOMAT Inspiration may be shown with expanded equipment or with optional accessories in some figures.

Use of the product

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Intended use

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The MAMMOMAT Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Screening

MAMMOMAT Inspiration is ideally suited for screening purposes: it offers a high degree of patient comfort and care and features a low-dose concept. Smart features such as one-click image access and positioning with the push of a button greatly simplify handling and enable the clinical user to arrive at a precise diagnosis with ease. Due to its high patient throughput and its future-proof design, MAMMOMAT Inspiration meets the strategic demands of cutting-edge clinical facilities, thereby offering excellent investment protection.

Stereotactic biopsy

A simple workflow was one of the main design objectives for the MAMMOMAT Inspiration. The smart, ergonomic design and intuitive operation allow for fast, smooth, and user-friendly stereotactic biopsy exams. For even more efficiency, biopsy images have the same high image quality as regular mammography images.

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Operator Manual XPW7-330.620.01.02.02

Introduction General Information

The MAMMOMAT Inspiration comprises the following system components:

MAMMOMAT Inspiration

(1) X-ray stand MAMMOMAT Inspiration Stand column with integrated generator, swivel arm, compression unit, flat detector object table, 2 foot switches

(2) Acquisition workstation MAMMOMAT Inspiration Control console table with radiation shield (optional), PC, flat screen, keyboard, mouse, keypad

Caution Display of Acquisition Workstation used for diagnostic purposes. Incorrect diagnosis! u The display of Acquisition Workstation shall not be used for diagnostic purposes. Use viewing workstation certified as diagnostic workstation.

SIEMENS

MAMMOMAT Inspiration XPW7-330.620.01.02.02

(3) MAMMOMAT Inspiration biopsy unit (optional) Needle holder/needle positioning device, safety switch, compression plate, hand box

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Introduction General Information

Body region

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The system is suitable for a large variety of clinical visualizations such as o Visualization of vessels, soft tissues o Visualization of implants o Visualization of biopsy needles o Visualization of preparations

Patient group

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The MAMMOMAT Inspiration can be used for examining all types of patients except pregnant women. When this system is used, the relevant applicable country-specific requirements must be complied with. Qualified medical personnel decide whether a radiographic examination is suitable or not based on the patient's health and physical condition.

Contraindications

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Patients have to be informed about the hazards and safety measures during an examination. Prior to the examination, it must be confirmed by a physician that an examination is permissible, and checked whether increased precautions are necessary.

Physical functionality

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MAMMOMAT Inspiration universal X-ray system for screening and diagnosis with digital detector and X-ray tube unit for examinations of breast tissue.

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Operator Manual XPW7-330.620.01.02.02

Introduction General Information

User profile

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The system can be used properly only by suitably qualified medical personnel in compliance with the relevant applicable country-specific regulations. This requires operating personnel to be familiar with the Operator Manual. This manual must be studied thoroughly prior to starting up the system. Special attention must be paid to the following sections: o General Safety Information o Personal Safety o Equipment Safety o Maintenance

Caution Untrained personnel. Unnecessary radiation exposure or incorrect diagnosis! u Qualified personell shall thoroughly study user documentation before use. Country specific regulations to be considered.

Training

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Instruction in the use of the system can take place either through application training provided by a Siemens qualified application trainer or through self-training based on this Operator Manual.

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Introduction General Information

Conditions of use

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The system is suitable for use in medical facilities such as hospitals or doctor's offices. It can also be used in mobile units. MAMMOMAT Inspiration may only be run in an environment approved or authorized by the manufacturer. The system may not be operated in public networks without firewalls or isolation. Comply with the climate range specified in the Technical Description register.

Caution Operation in unsuitable environment. Malfunction of system! u The system may only be run in an environment approved or authorized by the manufacturer. The system may not be operated in public networks without firewalls or isolation. The climatic conditions specified in the Technical Description register must be complied with.

Maintenance, cleaning and disinfection

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refer to the Functional and safety checks section

Service

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Service must be performed only by qualified technical personnel.

Technical features

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refer to the Technical description register

Frequently used operating functions

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refer to the Examination register

Operating functions regarding safety

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refer to the Safety register

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Operator Manual XPW7-330.620.01.02.02

Register 2

Safety

Chapter: General information Laws and regulations ... 3 Country-specific regulations ... 3 CE marking ... 3 Data security ... 3 Legally required tests ... 4

Safety/Protective Measures ... 4 Installation site ... 4 Explosion protection ... 5 Emergency STOP button ... 5 Emergency shutdown switch ... 6 Implants ... 6 Data security ... 7 Archiving ... 7 Uninterruptable Power Supply (UPS) ... 8 General safety requirements ... 8 Software ... 9 Checks, tests ... 9 Information on the maintenance plan for checking the MAMMOMAT Inspiration system ... 10 Checking the system ... 11 Installation, repair ... 12 Installation ... 12 Error messages and status indicators ... 13

General safety information ... 14 Patient data ... 14 Documentation ... 15

Chapter: Personal safety Radiation Safety ... 17 Safety of the personnel ... 17 Patient Safety ... 19

Mechanical Safety ... 20 Risk of collision and crushing ... 20 Risk of stumbling ... 22 Mobile installations of MAMMOMAT Inspiration ... 23

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