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Ge Senographe 2000d Operator Manual
Ge Senographe 2000d Operator Manual
system
0459
Operator Manual
2269411–100
Revision 0
do not duplicate
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.
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REGULATORY REQUIREMENTS
This product complies with the regulatory requirements of the following:
- Council Directive 93/42/EEC concerning medical devices: the 0459 label affixed to the product
CAUTION United States Federal law restricts this device to use by or on the order of a
physician.
Note: Since the equipment allows the physician to store information on the patient with the function
IMAGE ANNOTATIONS, the European Directive regarding “the protection of the people with
regard of data management on their private life and to the free circulation of these data” requests
to the computerized file users (radiologists, physicians) not to store data related to their:
– race,
– philosophical opinions,
– religious opinions,
– political opinions,
– etc.
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This equipment generates, uses, and can radiate radio frequency energy. The equipment
may cause radio frequency interference to other medical and non-medical devices and radio
communications. To provide reasonable protection against such interference, this product
complies with emissions limits for a Group 1, Class A Medical Devices Directive as stated in
EN60601–1–2. However, there is no guarantee that interference will not occur in a particular
installation.
If this equipment is found to cause interference (which may be determined by turning the equipment on
and off), the user (or qualified service personnel) should attempt to correct the problem by one or more
of the following measure(s):
– reorient or relocate the affected device(s)
– increase the separation between the equipment and the affected device
– power the equipment from a source different from that of the affected device
– consult the point of purchase or service representative for further suggestions
The manufacturer is not responsible for any interference caused by using other than recommended
interconnect cables or by unauthorized changes or modifications to this equipment. Unauthorized
changes or modifications could void the users’ authority to operate the equipment.
To comply with the regulations on electromagnetic interference for a Class A FCC Device, all
interconnect cables to peripheral devices must be shielded and properly grounded. Use of cables not
properly shielded and grounded may result in the equipment causing radio frequency interference in
violation of the FCC regulations.
Do not use devices which intentionally transmit RF Signals (Cellular Phones, Transceivers, or Radio
Controlled Products) in the vicinity of this equipment as it may cause performance outside the published
specifications. Keep the power to these type 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.
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.
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TABLE OF CONTENTS
Regulatory requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1. FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1-1 The Aim of This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1-2 Associated Operator Manuals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1-3 Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2. CAD IN MAMMOGRAPHY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2-1 What CAD can do . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2-2 What CAD cannot do . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3. CAD PRINCIPLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
4. USING CAD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4-1 How do I know if CAD is available on this system? . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4-2 CAD On Demand/CAD Auto Push . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4-3 Which images can be CAD-analyzed? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4-4 Using CAD on demand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
4-5 Selecting images for CAD analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4-6 How do I know if an image has been CAD-analyzed? . . . . . . . . . . . . . . . . . . . . . . . . . 10
4-7 How do I Show/Hide CAD overlays? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4-8 How are CAD overlays Displayed? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4-8-1 Image successfully analyzed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4-8-2 CAD: Result not available . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
4-8-3 CAD: This image can not be processed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
4-9 Printing CAD results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4-10 Transferring the CAD overlay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4-11 Storing the CAD overlay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4-12 Access to historic CAD information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
5. CAD SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
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1. FOREWORD
1-1 The Aim of This Manual
This manual is provided for operators using the Senographe 2000 D equipped with the CAD (Computer
Aided Detection) option.
It describes the flow of images and explains how to use the CAD options on the Acquisition Workstation
(AWS) and the Review Workstation (RWS). It also provides guidelines on CAD use in different
situations and information on problem solving.
This manual does not contain information on CAD installation, configuration or algorithms performance.
Please refer to the appropriate manuals for information on these subjects.
The manual has been written to describe the use of the CAD 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.
This manual assumes that the reader is familiar with the Senographe 2000 D Acquisition Workstation
and Review Workstation.
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2. CAD IN MAMMOGRAPHY
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3. CAD PRINCIPLES
The CAD system includes three sub-systems: the CAD Processing Unit (DMPU), the Review
Workstation (RWS), and the Acquisition Workstation (AWS).
CAD processing functions are provided by the DMPU, a dedicated computer which runs the CAD
processing algorithms and generates the CAD results as an overlay. The RWS displays the overlay with
the associated image.
The CAD image workflow, illustrated below, includes three main steps:
1. Raw images are pushed to the CAD Processing Unit (DMPU) from the AWS or the RWS, or from an
image storage system if present. Each image must have been produced by a licensed workstation,
declared in the CAD configuration. Images may be pushed individually or in groups. Images from
the AWS must also be pushed to the RWS before results can be viewed.
2. The DMPU performs its analysis on each image and delivers the results of the analysis to the RWS
in the form of a CAD overlay.
CAD processing of an image is not instantaneous. The DMPU takes an average of 30 seconds
(maximum 120 seconds) to process a raw image and generate a CAD overlay, or 2 minutes for a
group of four images. Additional time may be required if there are multiple processing requests.
3. The CAD overlay is displayed with the associated images in the form of markers and labels.
CAD overlay
AWS
CAD overlay
RWS
AWS
computer
IDC
Raw and processed images
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4. USING CAD
Note that the host name is allocated at installation time; JFR_AWS
DMPU
your system may use a different name for the DMPU.
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Sort by: Name Sort by: Number Sort by: Name Sort by: Number
Network queues
Push images
1/2 examinations 1/2 examinations
Sort by: Number Sort by: Number
1/10 patients 1/2 examinations 1/10 patients Pull images 1/2 examinations
D When images are sent directly from the AWS to the DMPU, ensure that they are also transferred
to the RWS (manually or by auto-push). The CAD overlay and its associated image must both
be present in the RWS before the overlays can be viewed.
D The DMPU analyzes each image sent to it, generates a CAD overlay, and pushes it to the RWS,
where it is automatically associated with the corresponding image for display on demand.
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CAD overlays are arranged in series in the same way as images. When CAD overlays are present,
there is a series of overlays for each series of images.
D From the RWS Viewer:
With the image displayed in the viewer, try to display CAD overlays (see section 4-7). If a CAD
overlay is present it is displayed; the CAD label at the bottom of the screen indicates the status of
the image (see section 4-8).
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D Note that using the Erase all graphics button (in the Draw panel of the Viewer Control panel Tools
card) will hide the CAD overlay on selected images only.
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D Microcalcifications.
An area identified as a possible
cluster of microcalcifications is
indicated by a triangle:
D Masses.
An area identified as a possible
mass is indicated by an asterisk:
D CAD markers are linked to specific points on the image and cannot be moved. Changing the
image orientation, zooming, drawing objects, adding text, etc. does not change the display of the
markers relative to the image; they move with the image as it is rotated.
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5. CAD SPECIFICATIONS
Power Requirements ≤ 300 watts, 88/240 VAC, 50/60 Hz*
Power supply (UPS )selection 60 Hz/120 V installations (U.S.):
and electrical ratings Powervar ABCE350–11: VA Rating: 350VA Frequency: 60 Hz,
Watt Rating: 280W, Input Voltage: 120VAC, Output Voltage:
120VAC, Input Current: 3.2A, Output Current: 2.9A
50 Hz/230 V installations
Powervar ABCE350–22: VA Rating: 350VA Frequency: 50 Hz,
Watt Rating: 280W, Input Voltage: 230VAC, Output Voltage:
230VAC, Input Current: 1.9A, Output Current: 1.5A
Battery /Charger ratings Two Batteries – 12 V, 4.5 AH
Recharge time – 4 hours
Dimensions Main unit:
h 49 cm (19.3 in.), w 21 cm (8.3 in.), d 45 cm (17.7 in)
Power supply:
h 16.8 cm (6.6 in.), w 14 cm (5.5 in.), d 44.5 cm (17.5 in.).
Weights Main unit: 15.3 kg (33.8 lbs) without peripherals
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AMERICAS
LATIN AMERICA
GE Medical Systems Tel: +1–305–497–1200
Latin America Headquarters
5101 NW 21st Avenue, Suite 350
FORT LAUDERDALE, FL 33309
USA
ASIA
NIPPON (Japan)
GEMSA Headquarters Tel: 81–426–48–2940
GE Medical Systems Asia Fax: 81–426–48–2905
67–4, Takakura, Hachioji
TOKYO, 192–0033, JAPAN
REST OF ASIA
GE Pacific Pte. Ltd (GEMS Asia) Tel: +65–291–8528
South East Asia Pacific Operations (SEAPO) Fax: +65–291–7006
298 Tiong Bahru Road
#15–01/06 Tiong Bahru Plaza
SINGAPORE 0316
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EUROPE
BELGIE/BELGIQUE (Belgium)
GE Medical Systems Benelux NV/SA (NL) Tel:+32 2 644 09 38
Manhattan Center (F) Tel:+32 2 644 08 42
Bolwerklaan 21 b 9 Avenue du Boulevard (LUX) Tel:0800 2973
B–1210 BRUSSEL/BRUXELLES Fax: +32 2 207 73 33
DANMARK (Denmark)
GE Medical Systems Danmark Tel: +45 45 51 00 55
Skovlytoften 4 Fax: +45 42 42 59 89
DK–2840 HOLTE
DEUTSCHLAND (Germany)
GE Medical Systems Deutschland GmbH & Tel: 49–6102–36–0
Co. KG Fax: +49 610–36–2588
Martin–Behaim–Strasse 10
D–63263 NEU ISENBURGS
ESPAÑA (Spain)
GE Medical Systems España Tel: +34 91 663 25 00
Avda. de Europa 22 Fax: +34 91 663 25 01
Parque Empresarial la Moraleja
E–28100 ALCOBENDAS
FRANCE (France)
GE Medical Systems Tel: +33 (0)1 30 70 40 40
283 rue de la Minière
BP34
F–78533 BUC CEDEX
HELLAS (Greece)
GE Medical Systems Hellas Tel: +30 1 93 24 582
41 Nikolaou Plastira Street Fax: +30 1 93 58 414
GR–171 21 NEA SMYRNI
ITALIA (Italy)
GE Medical Systems Italia Tel: +39 02 64 22 01
Viale Fulvio Testi 28–B Fax: +39 02 64 22 0401
20126 MILANO
NEDERLAND (Netherlands)
GE Medical Systems Nederland B.V. Tel: +31 73 6 457 457
Hambakenwetering 1 Fax: +31 73 6 441 233
NL–5231 DD S HERTOGENBOSCH
ÖSTERREICH (Austria)
GE GesmbH Medical Systems Austria Tel: 0660 8651 (gebührenfrei)
Prinz Eugen Strasse 8/8 Fax: +43 1 505 38 74
A–1140 WIEN Tlx: 136314
POLSKA (Poland)
GE Medical Systems Polska
Krzywickiego 34 Tel: +48 2 625 59 62
P–02–078 WARSZAWA Fax: +48 2 615 59 66
PORTUGAL (Portugal)
GE Medical Systems Portuguesa S.A.
Rua Sà da Bandeira, 585 Tel: +351 2 2007696/97
Apartado 4094 Fax: +351 2 2084494
P–4002 PORTO CODEX Tlx: 22804
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ROSSIYA (Russia)
GE Medical Systems Tel:+7 095 935 72 41
Kosmodamianskaya nab. 52, Bldg 1, 6th Floor Fax:+7 095 935 73 46 and 48
113054 MOSCOW Tel (satellite): +7 502 220 30 39
Fax (satellite): +7 502 220 32 59
Tlx:613020 GEMED SU
SVERIGE (Sweden)
GE Medical Systems Tel: +46 8 457 95 20
Box 6768 Fax: +46 8 457 95 47
St. Eriksgatan 117 Tlx: 12228 CGRSWES
S–113 85 STOCKHOLM
SCHWEIZ/SUISSE (Switzerland)
GE Medical Systems (Schweiz) AG Tel: 155 6958 (gebührenfrei)
Sternmattweg 1 Fax: +41 41 421859
CH–6010 KRIENS
TÜRKIYE (Turkey)
GE Medical Systems Turkiye A.S. Tel: +90 212 75 5552
Mevluk Pehliran Sodak Fax: +90 212 211 2571
Yilmaz Han, No 24 Kat 1
Gayretteppe
ISTANBUL
UNITED KINGDOM
IGE Medical Systems
Coolidge House Tel: +44 753 874000
352 Buckingham Avenue Fax: +44 753 696067
SLOUGH
Berkshire SL1 4ER
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REVISION HISTORY
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