GE Senographe DS User manual

GE Healthcare
Senographe DS Acquisition System
Operator Manual
0459
5307907-3-S-1EN
Revision 1
Copyright©2009 by General Electric Company Inc.
All Rights Reserved.
FOR TRAINING PURPOSES ONLY!
NOTE: Once downloaded, this document is UNCONTROLLED, and therefore may not be the latest revision. Always confirm revision status against a validated source (ie CDL).

Page no. 2 Cover_ENG1.fm
GE Healthcare Senographe DS Acquisition System
Revision 1 Operator Manual 5307907-3-S-1EN
X-ray Warning
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 International
Commission on Radiological Protection, contained in Annals Number 60 of the ICRP, and with applicable national standards and should have
been trained in use of the equipment.
FOR TRAINING PURPOSES ONLY!
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GE Healthcare Senographe DS Acquisition System
Revision 1 Operator Manual 5307907-3-S-1EN
Regulatory Requirements
regulatory.fm Page no. 3
Regulatory Requirements
This product complies with the regulatory requirements of the following:
•Council Directive 93/42/EEC concerning medical devices: the label affixed to the product
testifies compliance to the Directive.
European registered place of business:
GE Medical Systems Société en Commandite Simple
Quality Assurance Manager
BP 34
F 78533 BUC CEDEX France
Tel: [phone]
•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 applica-
ble.
Compliance with these standards is evidenced by the presence of the appropriate labels on the exterior
of the Generator cabinet.
•USA/HHS: United States Federal law restricts this device to use by or on the order of a physician.
•General Electric Medical Systems is ISO 9001 and ISO 13485 certified.
•The original document was written in English.
Use within the patient environment
All components of the Senographe DS system (Generator Cabinet, Gantry, Control Station) are
designed to be suitable for use within the patient environment, and are compliant with the relevant
standards (UL 60601-1, IEC 60601-1).
Use in the presence of flammable gases
The Senographe DS system must not be used in the presence of flammable gases
Image annotations
•The equipment includes a function IMAGE ANNOTATIONS, which allows the physician to store infor-
mation on the patient.
•Note that the European Directive regarding "the protection of the people with regard of data manage-
ment 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.
045
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Page no. 4 regulatory.fm
GE Healthcare Senographe DS Acquisition System
Revision 1 Operator Manual 5307907-3-S-1EN
Regulatory Requirements
Electromagnetic Compatibility (EMC)
This equipment complies with IEC60601-1-2 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 radiated emis-
sions as per CISPR11 Group 1 Class A standard limits.
Detailed requirements and recommendations about power supply distribution and installation are
listed in the Pre-Installation section of the Service Documentation shipped with your system. How-
ever, 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.
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 interfer-
ence.
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 pub-
lished specifications. Recommended separation distances are detailed in the Pre-Installation section
of the Service Documentation shipped with your system. 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.
Further data and recommendations for meeting Electromagnetic Compatibility requirements for a
typical installation are given in the Pre-Installation section of the Service Documentation shipped with
your system. Note that the magnetic field of an MRI device located nearby may cause a risk of inter-
ference. Magnetic field amplitude limits are specified in the Pre-Installation section of the Service
Documentation shipped with your system.
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GE Healthcare Senographe DS Acquisition System
Revision 1 Operator Manual 5307907-3-S-1EN
Regulatory Requirements
regulatory.fm Page no. 5
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
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.
•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.
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 dis-
posed of as unsorted municipal waste and must be collected separately. Please contact
an authorized representative of the manufacturer for information concerning the decom-
missioning of your equipment.
This symbol indicates that the product contains hazardous materials in excess of the lim-
its established by the Chinese standard SJ/T11363-2006 (Requirements for Concentra-
tion Limits for Certain Hazardous Substances in Electronic Information Products).
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Page no. 6 regulatory.fm
GE Healthcare Senographe DS Acquisition System
Revision 1 Operator Manual 5307907-3-S-1EN
Regulatory Requirements
This page is blank.
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GE Healthcare Senographe DS Acquisition System
Revision 1 Operator Manual 5307907-3-S-1EN
Foreword
foreword.fm Page no. 7
Foreword
This manual is provided for Senographe DS operators. It is designed to supply all the information required
for the correct use of this equipment.
The manual has been written to describe the use of the Senographe DS 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 sections.
See your General Electric Medical Systems representative for the options available with the Senographe DS
system.
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Page no. 8 foreword.fm
GE Healthcare Senographe DS Acquisition System
Revision 1 Operator Manual 5307907-3-S-1EN
Intellectual Property Rights
Intellectual Property Rights
The Imaging Open Platform software used in the Senographe DS system is the property of the General
Electric Company (U.S.A.). Copyright © 1993-2004 General Electric Company (U.S.A.).
Portions of this software are the property of and copyrighted by Sun Microsystems Inc., Informix Soft-
ware Inc., OSF/Motif, J. Schilling, Free Software Foundation Inc., Merge Technologies Inc. and Cornell
University.
FOR TRAINING PURPOSES ONLY!
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GE Healthcare Senographe DS Acquisition System
Revision 1 Operator Manual 5307907-3-S-1EN
Table of Contents
SenoDS_OM_TOC.fm Page no. 9
Table of Contents
Regulatory Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Intellectual Property Rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Table of Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Chapter 1: Safety Recommendations
1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2. Potential adverse effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
3. Emergency Stop Motion and Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
4. Moveable components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
5. Operator protection against radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
6. Before starting an exam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
7. Acquisition and storage of Images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
8. Archiving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
9. AOP Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
10. Residual images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
11. Damaged Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
12. Damage to the Digital Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Chapter 2: Introduction
1. Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
2. System components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3. Accessories and options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4. Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
5. Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
6. Training program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
7. How to use the manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
8. Conventions for this manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Chapter 3: Senographe DS Gantry and Generator
1. Gantry Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
2. Generator Cabinet Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Chapter 4: X-ray Console
1. Console overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
2. Console functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
3. X-ray Console setup menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
4. View Name selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
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Page no. 10 SenoDS_OM_TOC.fm
GE Healthcare Senographe DS Acquisition System
Revision 1 Operator Manual 5307907-3-S-1EN
Table of Contents
Chapter 5: Control Station
1. Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
2. Startup and Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
3. Hardware controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
4. Windows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
5. On-screen tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Chapter 6: Startup and Shutdown
1. Startup procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
2. System Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
3. Emergency Stop Motion or Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
4. Gantry Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
5. Generator Cabinet push-buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Chapter 7: User Session and Account Management
1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
2. Opening an administrative session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
3. Configuration Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59
4. Reading access control log files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Chapter 8: Browser
1. Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
2. Browser restart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
3. System Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64
4. Log off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
5. Browser display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
6. Browser management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
7. Network transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
8. Tools menu utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
9. Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Chapter 9: Worklist
1. Worklist function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
2. Image acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
3. Bar Code scanner (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Chapter 10: Modality Performed Procedure Step (PPS)
1. Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
2. Theory of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .96
3. Special Configuration for CAD Workflows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
4. PPS Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .96
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Revision 1 Operator Manual 5307907-3-S-1EN
Table of Contents
SenoDS_OM_TOC.fm Page no. 11
5. PPS in the Viewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Chapter 11: Viewer
1. Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
2. View Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
3. Annotation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
4. Function Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
5. Scrapbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Chapter 12: Image Acquisition Procedure
1. Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
2. Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
3. .Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
4. AOP - Automatic Optimization of Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
5. Manual Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
6. Positioning the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
7. Compression . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
8. Thickness display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
9. Image acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
10. Check View Names . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
11. Quality Check (With or Without RRA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
12. Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Chapter 13: Printing
1. Printing conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
2. Printer management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .139
3. Print functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Chapter 14: Interchange Media
1. Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
2. Using the Interchange Media option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
Chapter 15: Maintenance
1. Cleaning and disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
2. Planned Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
3. Test for flexible paddle deflection in compression . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
Chapter 16: Error messages
1. Error messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
Chapter 17: Specifications
1. Technical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .199
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Table of Contents
2. Radiation and filter Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201
3. Ambient Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .203
4. Tube information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
5. Dimensions and Weights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205
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GE Healthcare Senographe DS Acquisition System
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Safety Recommendations
1-safety.fm Page no. 13 Chapter 1
Chapter 1 Safety Recommendations
1 Introduction
Routine mammography provides the best method of early detection of breast cancer, and every effort should
be made to encourage its acceptance by patients and all concerned organizations. Examinations performed
regularly without problems are an essential part of this process. All aspects of mammographic exams, and
especially safety, must be optimized to ensure effective diagnosis and allow the development of screening
programs.
Safety precautions and recommendations for the avoidance of potential hazards, and against misuse, are
given throughout this document. They must be made known to, and be practised by, all operators of the
Senographe DS equipment.
This chapter is intended to bring attention to and emphasize some of the more important of these precau-
tions and recommendations.
You are strongly recommended to keep this manual with the equipment at all times. Review it from time to
time and be sure that you are familiar with all aspects of use of the equipment, and especially those affecting
safety.
Stop all examinations and call your GEMS (General Electric Medical Systems) Service representative imme-
diately if you believe that the equipment is not operating correctly.
2 Potential adverse effects
•The following is a list of potential adverse effects that apply to mammography and are also applicable to
digital mammography using the Senographe DS system:
- Excessive breast compression.
- Excessive X-ray exposure.
- Electric shock.
- Infection.
- Skin irritation, abrasions, or puncture wounds.
3 Emergency Stop Motion and Shutdown
• Emergency stop motion switches are provided on both sides of the Senographe DS Gantry examina-
tion column, easily accessible to the operator.
Push either of these switches to immediately stop all positioner movement. Any compression which may
have been applied to the patient remains unchanged; the patient must be released by using the manual
compression knobs.
After use of one of these switches, the operator must turn power off and on (from the X-ray Console) to
restore normal use of the system.
• If an emergency arises which requires complete removal of power from all parts of the system,
the mains isolator switch which supplies power to the system from the hospital supply must be switched
off. Find out where this isolator is located and how to operate it.
Note that all image and patient information being processed at the time of cutting power will be lost, and
that power for the environmental control of the Digital Detector will be cut (this may entail a delay before
the system can be brought back into use).
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Chapter 1 Page no. 14 1-safety.fm
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Safety Recommendations
4 Moveable components
The equipment includes a number of moveable components.
Users must be instructed to monitor all movements, and to take all due care and precautions when mov-
ing any part of the equipment in the vicinity of themselves or other persons.
To ensure safe operation at all times, the Senographe DS compression system is fitted with a magnetic
braking mechanism, which prevents the compression paddle from falling in the event of power loss. If
power loss does occur while a patient is under compression, the compression force remains unchanged.
Disengage the patient by raising the paddle gently, using the manual compression knobs.
To minimize potential injury to the patient in decompression mode, the upward movement of the com-
pression paddle is stopped if a downward force greater than 3 daN is applied.
5 Operator protection against radiation
To avoid excessive exposure to radiation, operators must remain behind suitable radiation shields when-
ever X-ray exposures are made.
It is essential that the X-ray Console used to control X-ray exposures be permanently mounted behind a
radiation shield, in such a way that it can only be used by an operator in the protected area. If other con-
trols, such as the AWS controls in the Senographe DS Control Station, are to be used during exposures,
then they also must be installed in the protected area.
These requirements are met by the Senographe DS Control Station, which includes a radiation shield
(700 mm/25 inches wide; 0.3 mm lead equivalence shielding) and provides a suitable mounting position
for the X-ray Console in the protected area. Other radiation shields are available if required to meet the
requirements of local regulations or hospital working practices.
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GE Healthcare Senographe DS Acquisition System
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Safety Recommendations
1-safety.fm Page no. 15 Chapter 1
6 Before starting an exam
Check the system:
•Check that the compression paddle and the Bucky (grid) or magnification stand, are all well inserted
in their supports, and are being used as recommended. Be sure that the breast support is locked (not
only inserted).
•No modifications to system hardware or software may be made without prior approval from GEMS.
GEMS cannot guarantee the integrity of the system if this recommendation is not followed.
•No application programs of any sort may be loaded onto the system computer without prior approval
from GEMS. GEMS cannot guarantee the integrity of the system if this recommendation is not fol-
lowed.
•Only accessories and components supplied by or specifically recommended by GEMS may be used
with the system. GEMS cannot guarantee the integrity of the system if this recommendation is not fol-
lowed.
•Only Senographe DS compression paddles may be used with the system. Use of other paddles may
adversely affect image quality by causing inaccurate measurements of breast thickness.
•All accessories should be checked regularly to ensure that they have no sharp edges or corners
which might cut, pinch, or otherwise hurt a patient.
•Check the integrity of the covers on the Compression Arm, Column and Control Station. If any of
these covers is damaged or detached, contact your GEMS Service representative to have it
replaced.
Check the patient:
Before beginning the mammogram, observe the following points:
•Before positioning the patient, make a visual assessment of the breast area, and note anything which
may affect or be adversely affected by the correct positioning of the breast for the mammogram, for
example, warts, scarring, or skin which is not intact. In patients with large breasts, perspiration under
the breast can cause the skin to soften, and become paper-thin.
To position the breast properly for a mammogram in the CC position, it is essential that the breast is
lifted away from the chest wall and gently pulled forward, in order to visualize the maximum amount
of breast tissue. Such pulling and lifting is necessary for correct positioning, but can cause damaged
skin to tear slightly, and may cause bleeding.
If any condition exists which may cause unusual discomfort or tearing of the skin, the patient should
be told of the importance of correct positioning, and should be warned in advance of the possibility
that minor tearing and /or slight bleeding might occur.
•Use suitable techniques for the positioning of patients with breast implants.
•It is normal that the front part of the breast support is warm to the touch, as it contains electronic com-
ponents which generate heat. However, the temperature is never high enough to be harmful.
To ensure that examinations are carried out under optimum conditions, any unusual rise in tempera-
ture causes a warning message to be displayed on the monitor screen, forbidding examinations. Any
further rise causes the detector system to be automatically shut down.
•GEMS can take no responsibility for injury to the patient caused by the use of heating or warming
devices external to the system.
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Chapter 1 Page no. 16 1-safety.fm
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Safety Recommendations
7 Acquisition and storage of Images
Images acquired during examinations are stored on an internal disk system for preliminary assessment,
before permanent archiving or printing to film. The system is designed to avoid all foreseeable problems
during the acquisition and storage operations. Precautions include continuous checks on all components
and the provision of a battery-backed UPS (Uninterruptable Power Supply), to allow correct processing
of images to be completed before shutdown in the event of a power failure.
Certain conditions may cause a loss in the ability of the system to acquire high quality images or a risk
that images might not be correctly saved (for example, if the UPS batteries are not sufficiently charged to
ensure correct shutdown). For these conditions a warning message is displayed on the Liquid Crystal
Display (LCD) monitor and/or the Gantry X-ray Console. A list of possible error messages, with explana-
tions and suggested actions, is given in Chapter 16 Error messages.
You should note the following recommendations:
•Always follow the correct system shutdown procedure as described in Chapter 6 Startup and Shut-
down.
•In spite of the presence of the UPS, it is not advisable to switch off power while an image is being
processed and stored.
•If defects or failures on the disk system are observed, call your GEMS Service representative. It may
be possible to recover information on the disk if the damage is not too severe.
8 Archiving
CAUTION
The digital technology used by the Senographe DS Control Station provides the ability to
transfer acquired images between workstations, and to store them on hard disk. However,
it is not intended or approved for use as an Archiving device.
9AOPMode
The Senographe DS provides an AOP (Automatic Optimization of Parameters) operating mode. This
mode is designed to optimize image quality for the examination of breasts with a compressed thickness
between 10 mm (0.4 inch) and 80 mm (3.15 inches).
However, there are some types of examination for which manual selection of parameters may be more
suitable. These are discussed in Chapter 12 Image Acquisition Procedure.
Note:
GE recommends that Standard (STD) and Dose (DOSE) mode be used for routine mammography.
The Senographe DS Contrast (CNT) mode delivers more dose than Standard and Dose modes.
GE recommends that Contrast mode be used only after consultation with an interpreting physician
or radiologist.
Note:
To fulfill the requirements of certain countries, if desired, access to Contrast Mode can be restricted
as described in the Service Documentation.
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GE Healthcare Senographe DS Acquisition System
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Safety Recommendations
1-safety.fm Page no. 17 Chapter 1
10 Residual images
Repeated exposures made with a high contrast object in the digital detector area may lead to the cre-
ation of a ghost image, caused by an excessive difference of residual charges between cells of the
detector. The time taken for this ghost image to disappear depends upon the magnitude of the residual
charges.
This effect can occur during checks to measure the X-ray field which use a dosimeter ionization chamber
in the beam. To avoid it, use one of the following solutions:
•Reduce the contrast of the object by including it in a field protected by an X-ray attenuator of ade-
quate thickness.
•Use the internal dose measurement facility.
•Protect the digital detector by means of a 3 mm steel plate for the duration of the measurements.
11 Damaged Equipment
CAUTION
If equipment is damaged or fails, have it repaired immediately by authorized GE Service
personnel, even if the damage or failure does not affect the functions you normally use.
The damage or failure can result in a potentially serious patient safety hazard under other
circumstances.
12 Damage to the Digital Detector
CAUTION
The digital detector contains thallium doped cesium iodide, a substance which requires
special precautions for handling and recycling. If the protective casing of the digital detec-
tor sustains damage, please consult your local GEMS representative.
CAUTION
If the digital detector casing is punctured, the detector must be removed by authorized GE
Service personnel wearing protective gloves and dust masks.
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Chapter 1 Page no. 18 1-safety.fm
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Safety Recommendations
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GE Healthcare Senographe DS Acquisition System
Revision 1 Operator Manual 5307907-3-S-1EN
Introduction
2-intro.fm Page no. 19 Chapter 2
Chapter 2 Introduction
1 Overview
Senographe DS is a Digital Mammography System from GE Medical Systems. It has been designed to per-
form Screening examinations as well as Diagnostic Views (including Spot compression, Magnified and/or
Coned views). It is a modular system that eliminates the need for film cassettes, and takes advantage of dig-
ital technology, including on-screen image display, Networking, Filming, and Archiving.
2 System components
Gantry
Generator Cabinet
X-ray Console mounted
on top of console
Image Receptor
AWS Cabinet
Access to workstation computer and
optional CD-R Interchange Media
unit from side of cabinet
Radiation screen
AWS monitor
Control Station
Mouse or optional trackball
AWS keyboard pulls
out from top of cabinet
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Chapter 2 Page no. 20 2-intro.fm
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Introduction
3 Accessories and options
3-1 Senographe DS accessories
Accessories delivered with the Senographe DS or available as options are listed in Chapter 3
Senographe DS Gantry and Generator.
3-2 System options
System options available include:
•Review workstation
•Mass archiving system
When this option is installed and connected to the Senographe DS, acquired images can be sent to
the mass archiving device for permanent storage, either automatically or on request. A list of all
patients ever imaged on the Senographe DS system can be kept on the mass archiving device, mak-
ing future retrievals fast and easy.
•Laser Camera
To provide "hard copies" of images, the Senographe DS system can be connected to a high resolu-
tion DICOM MG compatible laser camera for film printing.
WARNING
Only images produced by ge-recommended laser cameras can be used for final interpreta-
tion of examinations. for compatible printers see the latest product data sheet for this sys-
tem, which may be obtained from your local ge sales representative.
•Networking
The Senographe DS is DICOM compliant, allowing it to be connected in a network with other compli-
ant devices for the exchange of images. Networking allows transmission of images acquired with the
Senographe DS system to other DICOM-compatible review stations, using the "Network Push" func-
tion of the Browser. In some cases, detailed evaluations will be needed for the implementation of
customized connections.
See your General Electric Medical Systems Representative for more information on accessories and
options.
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