MAMMOMAT Inspiration Manual VB61+
MAMMOMAT Inspiration Manual VB61+
com/healthcare
MAMMOMAT Inspiration
Operator Manual
VB61 or higher
MAMMOMAT Inspiration
Operator Manual
VB61 or higher
Legend
Indicates a hint
Is used to provide information on how to avoid operating errors or information emphasizing
important details
Indicates a prerequisite
Is used for a condition that has to be fulfilled before starting a particular operation
Bold Is used to identify window titles, menu items, function names, buttons, and keys, for example,
the Save button
UI text Is used for on-screen output of the system including code-related elements or commands
Menu > Menu Item Is used for the navigation to a certain submenu entry
CAUTION
&$87,21
Used with the safety alert symbol, indicates a hazardous situation which, if not avoided, could
result in minor or moderate injury or material damage.
CAUTION consists of the following elements:
◾ Information about the nature of a hazardous situation
WARNING
:$51,1*
Indicates a hazardous situation which, if not avoided, could result in death or serious injury.
WARNING consists of the following elements:
◾ Information about the nature of a hazardous situation
4 Operator Manual
Print No. XPW7-330G.620.61.01.02
Table of contents
1 Introduction 9
1.1 Information about this Operator Manual 9
1.1.1 Operator Manual parts 9
1.1.2 Area of application 9
1.1.3 Required documents 9
1.1.4 Structure 9
1.1.5 Names and parameters 9
1.2 Use of the product 10
1.2.1 Intended use 10
1.2.2 Screening 10
1.2.3 Stereotactic biopsy 10
1.2.4 Patient group 11
1.2.5 Contraindications 12
1.2.6 Physical functionality 12
1.2.7 User profile 12
1.2.8 Conditions of use 12
1.2.9 Technical features 13
1.2.10 Frequently used operating functions 13
1.2.11 Operating functions regarding safety 13
2 Safety 15
2.1 General Information 15
2.1.1 Laws and regulations 15
2.1.2 Safety/protective measures 15
2.1.3 General safety information 22
2.2 Personal safety 24
2.2.1 Radiation safety 24
2.2.2 Mechanical safety 26
2.3 Equipment safety 29
2.3.1 Functional and safety checks 29
2.3.2 Cleaning, disinfection 32
2.3.3 Disposal 34
3 System overview 37
3.1 System description 37
3.1.1 Range of application 37
3.1.2 Automatic modes for optimized exposures 37
3.2 Overview of total system 37
3.3 X-ray stand - Design and functionality 38
3.3.1 X-ray tube unit and collimator 39
3.3.2 Display and control elements on the X-ray stand 40
3.3.3 Compression/Decompression 41
3.3.4 Foot switch 43
3.3.5 Object tables 44
3.4 Acquisition workstation - Design and function 48
3.4.1 TFT monitor 48
3.4.2 Control box 49
3.4.3 Radiation release 49
4 Operation 51
4.1 Unit 51
4.1.1 Preparations before start 51
4.1.2 Switching on/start-up 51
4.1.3 Calibration 52
4.1.4 Basic operation 60
4.1.5 Compression plate 62
4.1.6 Face shield 62
4.1.7 Angle and height adjustment 63
4.1.8 Compression/Decompression 65
4.1.9 Object lighting 68
4.1.10 Magnification table (Option) 69
4.1.11 Biopsy (Option) 71
4.1.12 Switching off 72
4.2 Workstation 73
4.2.1 Application program 73
4.2.2 High-resolution monitor (3MP monitor) 75
4.2.3 System messages 76
4.2.4 Status bar 77
4.2.5 Exiting the program 78
6 Examination 99
6.1 Examination task card 99
6.1.1 Layout of the Examination task card 99
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Table of contents
7 Configuration 131
7.1 Examination configuration 131
7.1.1 Configuration of the procedures 131
7.1.2 Configuration of WH AWS transfer 131
7.1.3 Starting configuration 131
7.1.4 Configuring procedures 132
7.1.5 Viewing the exposure programs 141
7.1.6 Changing projection name 142
7.2 Transfer and archive configuration 144
7.2.1 Image selection for auto transfer destinations 144
7.3 MoodLight configuration (option) 146
7.3.1 Calling up the configuration window 147
7.3.2 Configuring colors 147
9 Appendix 185
9.1 Calibration form 185
10 Glossary 187
Index 191
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Print No. XPW7-330G.620.61.01.02
Introduction 1
1 Introduction
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.
1.1.4 Structure
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.
All parameters and images shown in this Operator Manual are examples. Only
the parameters displayed on your system are relevant.
1.2.2 Screening
The 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.
X-ray stand MAMMOMAT Inspiration: Stand column with integrated generator, swivel arm,
compression unit, flat detector object table, 2 foot switches
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Print No. XPW7-330G.620.61.01.02
Introduction 1
STOP
CAUTION
Body region The system is suitable for a large variety of clinical visualizations such as:
◾ Visualization of vessels, soft tissues
◾ Visualization of implants
◾ Visualization of biopsy needles
◾ Visualization of preparations
1.2.5 Contraindications
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.
CAUTION
Untrained personnel.
Unnecessary radiation exposure or incorrect diagnosis!
◆ Qualified personnel shall thoroughly study user documentation before
use. Country specific regulations to be considered.
Federal law 21 CFR 801.109 Caution: Federal law restricts this device to sale by or on order of a physician.
Training 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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Print No. XPW7-330G.620.61.01.02
Introduction 1
CAUTION
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Print No. XPW7-330G.620.61.01.02
Safety 2
2 Safety
The organization responsible for the safety of the medical device according
to IEC 60601 ff. is the user or the operator/operating company of the device.
Country-specific regulations The legally established country-specific regulations must be followed in all
countries. Deviating from this Operator Manual, values may be set according to
country-specific regulations.
CE marking This product is provided with a CE marking in accordance with the provisions of
Directive 93/42/EEC of June 14th, 1993, concerning medical devices.
Data security Data related to individual persons is subject to data protection. Ensure
compliance with all applicable laws and regulations.
Legally required tests Legally required tests must be performed at the specified intervals. These tests
include, for example:
◾ Constancy test according to the X-ray ordinance (§16 RöV) in the Federal
Republic of Germany.
◾ Tests based on DHHS guidelines (Department of Health and Human Services)
where applicable.
150
(1)
ft)
m (5
.1,5
min
(2)
Explosion protection The system is not designed for operation in areas where there is an explosion
hazard.
Emergency STOP button If an emergency occurs in a movement of the system implying danger for the
patient, the operator or the system, press one of the red emergency STOP
buttons on the MAMMOMAT Inspiration at once.
(1)
ST OP
(2)
After engaging the emergency STOP button, the following should be observed:
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Safety 2
◾ All unit drives will be switched off and all movements as well as radiation will
be interrupted.
◾ Decompression must be performed manually using the emergency unlocking
device at the head end of the compression unit. ( Page 42 Emergency
release)
◾ The emergency STOP button may not be reset (by turning it clockwise) until
the cause of the danger has been clearly detected and rectified.
Should the expected switch-off function not work, immediately press one of the
emergency shutdown switches. ( Page 17 Emergency shutdown switch)
Note: the system can only be disconnected from the power supply using the
emergency shutdown switch fitted during installation or by authorized service
staff.
If an error message appears during the examination, decompress using the
foot switch/hand switch if there is still power available or press the
emergency unlocking button if there is no power available.
Emergency shutdown switch If the MAMMOMAT Inspiration system is connected to an emergency shutdown
switch in the room, observe the following:
◾ The emergency shutdown switch must be operated at once if there is a
hazard for the patient, the operators, or the equipment.
◾ The entire system is immediately disconnected from the power supply.
◾ The system may not be put into operation again until the cause of the danger
has been clearly detected and rectified. In all other cases, for example, if the
equipment malfunctions, Siemens' Customer Service must be notified.
Implants In exposures with implants, fluctuations in image brightness may occur during
image post-processing due to exposure errors. To obtain optimal image quality
in these cases, it may be necessary to adjust the brightness by windowing.
Using the exposure table provided is recommended to prevent exposure errors
in exposures with implants.
( Page 108 Settings in the generator control field)
WARNING
If breast implants are not taken into consideration, processing errors and
incorrect contrast settings will result in the examination.
Risk of injury during compression. Unnecessary radiation exposure if
repeat exposure is necessary!
◆ Ask the patient about existing implants prior to the examination. Provide
information about the risks of providing false information.
Archiving We urgently recommend that you archive the examination data as a routine at
regular intervals.
CAUTION
Make sure that no cables are disconnected during the current examination.
CAUTION
The syngo-specific data storage on the local hard disk does not fulfill the
requirements for long-term archival.
Loss of data due to unsuitable storage medium!
◆ Promptly archive data on external storage suitable for long time
archiving, e.g. PACS or CD-R/DVD-R for medical use. It is recommended
to use auto-transfer rules.
◆ Don’t delete data from database before the archive request is
successfully finished and committed.
Uninterruptable Power Supply (UPS) To ensure that no data (patient data, image data) get lost if there is an unstable
power supply and to protect the operating system (with all components), we
recommend that you install a UPS.
configures the system and is therefore responsible for ensuring that the
system configuration in its current version complies with the relevant
standards (e.g. system standard IEC/EN 60601-1-1 and/or other applicable
standards). In the case of queries please contact your local contact person.
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Safety 2
Use of accessories The use of accessories that do not comply with the relevant safety requirements
of this system can result in a reduced safety level of the combined system.
When choosing accessories, the following aspects must be considered in
particular:
◾ Use of accessories close to the patient.
◾ Proof that the accessories have been safety tested according to the applicable
IEC 60601-1 guideline and/or IEC 60601-1-1 harmonized national standard.
Software The system and user software used in this product is protected by copyright.
CAUTION
CAUTION
CAUTION
CAUTION
Checks, tests Before the system is used for examinations, the user must ensure that all safety-
relevant devices function correctly and that the system is ready for operation.
Important functional tests and checks must be made at certain time intervals.
( Page 29 Functional and safety checks)
Information on the maintenance plan The tests and inspections required by national laws or regulations, such as DHHS
for checking the system regulations or RöV (constancy tests), are not part of the activities listed in the
Siemens maintenance plan.
If national laws or regulations specify more frequent checking and/or
maintenance, this must be observed.
Maintenance work should be performed by trained technical personnel only. To
keep the system in an optimum condition, we recommend that you conclude a
maintenance contract.
If you have any questions relating to maintenance/maintenance contract please
contact the appropriate Siemens Customer Service office.
CAUTION
Lack of maintenance.
Injury to persons or damage to equipment!
◆ Ensure the performance of maintenance activities according to the
defined intervals and content.
Checking the system Initial maintenance for a new system is performed after 24 months and includes
all maintenance activities.
System/components
System/Components
Visual inspections
Mammography unit
Mechanical safety
Electrical safety
Radiation releases
Quality test
Concluding steps
Options
MoodLight
Magnification table
Biopsy attachment
Tomosynthesis Option
2nd monitor
Installation, repair Modifications of or additions to the product must be made in accordance with
the legal regulations and generally accepted engineering standards.
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Safety 2
Error messages and status indicators The system displays warnings and error messages as well as information about
current system status on the screen. It gives information on how to proceed in
each situation.
The error messages displayed by the system are self-explanatory. If the
problems are still unresolved following a system restart, please call Siemens
Customer Service.
◾ Protocol control
The status of a projection view (modifications and exposure progress) is
displayed by symbols in the protocol control of the Examination task card.
( Page 99 Control area)
Temperature monitoring As soon as the MAMMOMAT Inspiration is turned on, internal temperature
monitoring for the X-ray tube unit and detector is active.
The info bar indicates if the temperature of the X-ray tube unit or detector is too
high. In this case, wait until the message disappears. Then continue with the
exposure.
CAUTION
Automatic deletion of archived patient data when database gets filled up.
Loss of patient data!
◆ Make sure that "archive" flag is set for transfer to authorized DICOM
archive nodes only.
CAUTION
Do not use auto transfer rule with "Sent" flag and auto deletion rule with
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Print No. XPW7-330G.620.61.01.02
Safety 2
Documentation
CAUTION
The syngo-specific data storage on the local hard disk does not fulfill the
requirements for long-term archival.
Loss of data due to unsuitable storage medium!
◆ Promptly archive data on external storage suitable for long time
archiving, e.g. PACS or CD-R/DVD-R for medical use. It is recommended
to use auto-transfer rules.
◆ Don’t delete data from database before the archive request is
successfully finished and committed.
CAUTION
CAUTION
CAUTION
If you flip an image, all graphic elements you have entered (comment
texts, drawing elements, shutters, pixel lenses) will be removed from the
image.
Loss of data due to incorrect handling!
◆ Always flip an image before you add the required graphic elements.
◆ After flipping insert a note of the changed image position in the image.
CAUTION
Sending data through the network with the attributes AC, SC signifies
secure data transfer. Flags AC/SC signal receipt and storage of data on hard
disk on the receiver side. However, the prescribed conditions with regard to
long-term archival are not fulfilled by this. Objects identified as
"committed" (confirmed) can be deleted by the user.
Risk of data loss in the prescribed archiving period due to erroneous/
incorrect interpretation of the AC/SC marks!
◆ Observe the regulatory requirements regarding the archiving procedure.
CAUTION
Systems that do not use storage commitment only report back to the
sending system when the data has been fully received (flags A and S). A
user or an auto-delete mechanism at the sending system might
subsequently delete the sent data. However, this response does not imply
that the data has already been stored at the receiving system.
Risk of data loss!
◆ Observe the regulatory requirements regarding long-term archiving.
Images that meet the criteria for automatic deletion will be deleted even if
they have the Prot (protected) status.
CAUTION
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Print No. XPW7-330G.620.61.01.02
Safety 2
CAUTION
Radiation-protection areas
m
5
1,
(1) (2)
45
(3)
(4)
(1) Patient
(2) Low-radiation area
(3) Radiation shield
(4) Radiation-protection area
Patient safety Before exposure is released, it is the operator's duty to check that the exposure
parameters set at the workstation are the ones intended and that they have not
changed, while attending to the patient. If this is not done, the patient can be
exposed to unnecessarily high radiation.
The (FD) flat detector object table including the detector function as a beam
stopper. The face shield prevents the patient's head from coming into the beam
path.
(1)
(2)
CAUTION
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Print No. XPW7-330G.620.61.01.02
Safety 2
CAUTION
CAUTION
CAUTION
Risk of stumbling The operating personnel must be aware of that certain components of the
workstation or cables pose a risk of stumbling.
Mobile installations If MAMMOMAT Inspiration is used in a bus, the proper transport safeguards have
to be in place prior to transport.
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Print No. XPW7-330G.620.61.01.02
Safety 2
(1)
Ensure that the collimator cover (1) is positioned during transport of the
MAMMOMAT Inspiration and afterwards removed.
CAUTION
Daily checks
CAUTION
Malfunction of the system control due to long operating time without self
test.
Injury to patient or operator!
◆ Restart the system at least once within 24 hours in order to run a full self
test every working day.
Basic system
1 Check the basic system for visible damages.
Displays and indicator lamps
2 Visually inspect all displays and indicator lamps on the stand.
CAUTION
CAUTION
Compression plates
3 The compression plates should only be used if they show no visible damages.
This is the only way to guarantee perfect functioning and minimize possible
risks for the patient.
Motorized movements
4 Make sure that the motorized movements run smoothly and normally.
Height adjustment and rotation
5 Check that height adjustment and rotation of the swivel-arm system are
blocked when the displayed compression force is ≥ 30 N (3 kg).
Movement of the swivel arm
6 Make sure that, during swivel arm movement with the single-touch functions,
neither the patient nor others are placed at risk or parts are found in the
swivel range.
Emergency release
7 Ensure that the emergency release works when pressed firmly.
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Safety 2
Radiation indicator lamp When the system is ready for exposure the radiation indicator on the keypad is
green. It may only light yellow when the exposure-release button is depressed.
Should the radiation indicator light up yellow without this button being
depressed, you must immediately switch the MAMMOMAT Inspiration off and
notify the Siemens Customer Service. Exception: During system startup the
radiation indicator will briefly light up yellow to check the LEDs.
Restart the system The system should be switched off after each working day ( Page 51 Starting
the system from the off state) and restarted on the next working day
( Page 72 Switching off).
Monthly checks
Emergency STOP button ◆ Check that the emergency STOP button is functioning correctly.
After pressing the emergency STOP switch, all motorized movements have to
be blocked.
In the case of malfunctions switch off the power supply to the system and
notify the Siemens Customer Service.
Annual maintenance To maintain the safety and reliability of the unit, maintenance must be
performed every 24 months. If you have not concluded a maintenance
contract, please advise the Siemens Customer Service department.
For further information, see ( Page 20 Information on the maintenance plan
for checking the system).
Cleaning All parts of the unit which come into contact with the patient must be cleaned
prior to examination. The plastic trays can be removed from the holder to
simplify cleaning.
CAUTION
CAUTION
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Print No. XPW7-330G.620.61.01.02
Safety 2
Never wipe the surface of the MoodLight Plexiglas cover (option) with a dry
cloth. Improper cleaning procedures can damage the surface of the
MoodLight Plexiglas.
Wipe off the system with a damp, lint-free, non-woven cloth or sponge.
Moisten the cloth only with water or a lukewarm, diluted, aqueous solution
using a household cleanser without abrasives.
For thorough cleaning, always a non-abrasive cleaning agent, such as
antistatic plastic cleaner and care product.
Disinfection As a general rule, no disinfectants sprays shall be used, since the spray mist may
penetrate into the equipment which means the safety of the equipment can no
longer be assured (damage to electronic components, formation of flammable
air solvent vapor mixtures).
Comply with the entries in the following table when disinfecting and sterilizing
mammography accessories:
Disinfection
Disinfection
Magnification table, faceshield, covers such as not permitted no known restrictions on disinfectants
the detector cover
permitted 30% H2O2 hydrogen peroxide (except AHP's -
accelerated hydrogen peroxide, such as Oxi-
vir1 and Optim 1)
disinfectants with alcohol
disinfectants with quaternary ammonium
compounds
Standard accessories manufactured by Siemens do not to be necessary to
sterilize, but accessories by suppliers e.g. bushings need to follow
manufacturer's guidance.
Please note that the operating elements (particularly grooves and narrow
gaps) must also be disinfected.
Please note that disinfectants based on substituted phenols and chlorine-
splitting compounds have a slightly corrosive effect and therefore are not
recommended generally.
2.3.3 Disposal
Laws and directives can contain special regulations regarding the disposal of this
product or its components (including packaging materials).
Observe the relevant laws and directives for the disposal of the materials
used. You can obtain further information about this from the Siemens
Customer Service.
Materials used
Radiation Protection Material
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Safety 2
Other Metal
Plastics
Electrolytic capacitors
Batteries
Mechanical dangers in disposal Please note that hazards may occur during disassembly and disposal of the unit.
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System overview 3
3 System overview
Optimized compression OPCOMP® The “optimized compression” (OPCOMP®) function determines the correct
compression force to be exerted on the breast based on individual features of
the breast. This provides optimal comfort for the patient as well as optimal
image quality.
AEC mode (Automatic Exposure The AEC automatic exposure control is available for standard exposures,
Control) magnification and spot examinations.
Principle of operation: A brief "AEC exposure" is taken before the actual
exposure. Using the pixel values (dynamic measurement over the entire breast
or in a limited area), the optimal parameters for the following exposure are
calculated and programmed into the system.
Automatic exposure system - OPDOSE With the automatic OPDOSE function, optimized exposure parameters for kV
and anode/filter combination are calculated based on the current compression
force and thickness. The larger the breast, the more high-energy radiation is
used. Dose and exposure time can be kept to a minimum in this way.
When using OPDOSE, it should be ensured that compression is carried out at
least up to the optimized OPCOMP compression to determine the optimized
exposure parameters.
ST OP
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System overview 3
(1)
(2)
(9)
(3)
(4)
(2)
(5)
(6)
(7)
(10)
(8)
(1) Swivel arm with X-ray tube unit and collimator (integrated)
(2) Swivel-arm operation keys (on both sides) to adjust the height and angle
of the swivel arm and to turn on the field light
(3) Compression emergency unlocking device
(4) Compression/decompression control knobs (on both sides)
(5) Compression unit
(6) Object Table
(7) Patient support handles (on both sides)
(8) Stand display, digital
(9) Emergency STOP button
(10) Foot switches (2 switches; figure shows one foot switch)
Filter disc The filter disc has three filters and one mirror.
The filter disc is positioned in the beam path with the mirror. When the exposure
button is pressed, the selected filter is inserted into the beam path.
Mo/W tube: Filter disc with three filters; 30 µm molybdenum, 25 µm rhodium
and 50 µm rhodium.
Object lighting The object lighting serves as a radiation-field indicator. It is turned on manually
using the swivel-arm operation keys or automatically by actuating the
compression foot switch.
( Page 40 Operation of swivel arm)
◾ Pressing (in an emergency): All system movements and X-ray radiation are
stopped.
◾ Turning clockwise (when situation has been rectified): Unit drives and X-ray
radiation are enabled again.
(3)
(6)
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System overview 3
The rotation of the swivel arm stops automatically at -90°, 0°, +90° for
manual movement.
CAUTION
CAUTION
3.3.3 Compression/Decompression
Control knobs Compression/decompression is driven by a motor. With the control knobs it is
possible to adjust compression/decompression manually.
◾ Turning knob downward: manually compress
◾ Turning knob upward: manually decompress
You can also control compression and decompression using the foot
switches. ( Page 43 Foot switch)
In the event of a power failure or if an error message is displayed (foot switch for
decompression does not work), release the patient as follows:
Emergency release
(1)
(1)
(3)
(2) (2)
1 Forcefully press the emergency release button (1) with one hand, and keep
the button pressed.
2 Place the other hand under the compression plate (2) and press it upward.
The patient's breast can be removed from the compression plate.
3 First remove the hand from the emergency release button, and then remove
the hand from the compression plate.
Make sure the compression plate does not fall on the detector.
If the emergency release button is blocked, proceed as follows:
(1) (1)
(3)
(2)
4 Forcefully press the emergency release button (1) with one hand, and press
against the compression holder (3) with the other.
The emergency release button is released.
5 Keep the emergency release button pressed.
6 At the same time, place your hand under the compression plate (2) and press
it upward.
The patient's breast can be removed from the compression plate.
7 First remove the hand from the emergency release button, and then remove
the hand from the compression plate.
Make sure the compression plate does not fall on the detector.
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System overview 3
Stand display The stand display is located at the base of the X-ray stand.
0 219 0
- mm N (5)
Fletcher Mae (4)
X-ray stand display
Make sure that the foot switch is positioned sot that the foot switch pedals
for compression (3, 4) point to the center in each case.
Magnification table
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System overview 3
Compression plates
(2)
(1)
Example: Compression plate 24x30H
You will find a complete list of the available compression plates in the
( Page 182 List of compatible components)
The plastic inserts in the compression plates can be re-ordered if there are
cracks or scratches on the plate.
The plastic trays can be removed from the holder to simplify cleaning.
To remove the exchangeable plastic trays, slightly lift the two latches (1) on
both sides and pull the plastic tray (2) out of the holder.
The size of the radiation field depends on the selected compression plate.
Spot Plus compression plate (Option) The Spot Plus compression plate is used for spot filming, where the spot of the
lesion is positioned in the center of the Spot compression plate. The collimator
format is 18 x 24 cm.
Shifting Paddle compression plate The Shifting Paddle compression plate can be used for 18 cm x 24 cm
(Option) exposures. The compression plate can be moved to the left or right by means of
a handle.
Functionality 1 Move the compression plate by actuating the handle until the plate is in the
right position.
The compression plate locks in position.
A green display (1) lights up in the small window.
The AEC segmentation follows the position of the plate.
The position of the collimator is controlled by the position of the tube head
(greater than +20°/less than -20° - corresponds to lateral compression plate
position).
The collimator automatically adjusts the radiation field size to the size of the
compression plate. For a CC view, the shifting paddle should be positioned in
the detector center. For MLO/ML/LM views, the paddle must be positioned at
the top (cranial).
2 Check that the illuminated field size matches the compression plate used.
CAUTION
2D biopsy compression plate (Option) The 2D biopsy compression plate is used for performing biopsies or for marking
the breast without biopsy unit. The coordinates (numbers and letters) are used
for guidance to signal in which hole the biopsy or marking is to take place. The
breast should remain compressed throughout the biopsy phase.
If the 2D biopsy compression plate is used in the examination, the X/Y
coordinates may not always be visible in the images. For smaller objects place a
skin marker (lead ball) (3) into the center of the compression plate.
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System overview 3
1 2 3 4 5 6 7 8 9 (1)
A A (2)
B B
C
(3)
C
D D
E E
Create procedures and the corresponding projection views for the 2D biopsy
images.
The 2D biopsy compression plate does not allow for measurements to
determine the depth of a lesion inside the breast. The depth of the lesion
must be determined from previous images.
(2)
(3) ST OP
(4)
(5)
(6)
(7)
(8)
When the main switch on the back of the RX360 monitor is used to turn off
the monitor, the image displayed on the RX360 monitor is shifted to the
second monitor. Even after the RX360 monitor is turned back on, the image
is not moved back. This RX360 monitor will still display a black screen. The
second monitor displays the contents of both monitors overlapping. Please
restart the system to correct this behavior.
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System overview 3
(1) STOP
(2) (5)
(3) (6)
(4)
(1) Emergency STOP
All system movements and X-ray radiation are stopped.
(2) Not used
(3) Raise compression plate (decompression)
Press the button. Decompression begins (to 130 mm).
(4) Start radiation (exposure button)
The button lights up yellow during irradiation (radiation display).
System readiness: Button flashes green
Exposure readiness: Button lights up solid green.
(5) System OFF
(6) System ON
When the system is ready for operation, the button lights up green.
CAUTION
With hand switch (option) The hand switch is plugged into the control box.
(1)
Releasing radiation
Please note that the operating staff always has to be located behind the
radiation shield when releasing radiation with the hand switch.
With foot switch (Option) The foot switch is plugged into the control box.
Foot pedal
Releasing radiation ◆ Keep the foot pedal pressed during radiation release.
Please note that the operating staff always has to be located behind the
radiation shield when releasing radiation with the foot switch.
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4 Operation
4.1 Unit
(1)
ST OP
ST OP
(2)
(3)
Starting the system from the off state If the MAMMOMAT Inspiration has been switched off at the main power switch,
you have to restart the entire system.
A login with user name and password is necessary if user administration has
set up access protection, see Option Security Package.
The on and off switching functions for the mammography system can be
configured by Siemens Customer Service:
To switch the system on, it is sufficient to press the system ON button on
the control box. This button switches on the MAMMOMAT Inspiration and
the AWS PC. The AWS PC does not have to be switched on separately.
Please note in the event the AWS is restarted and the message appears
indicating that the connection to the detector has been interrupted during
startup, confirm with OK.
4.1.3 Calibration
The detector settings can be changed by external influences (e.g. temperature
fluctuations, humidity, vibrations). For this reason, a regular calibration of the
detector is required.
Type of calibration Your MAMMOMAT Inspiration offers a large number of different types of
examinations. To ensure the optimal detector settings for each type in all cases,
the following different types of calibrations are performed:
Contact none
Note that the MAMMOMAT Inspiration requires approx. 5 minutes after start
up before the calibration can be started.
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Contact The Contact calibration method is used for standard mammography exposures.
Magnification After the calibration for magnification has been activated, it may take up to 10
minutes before the system is ready for calibration. The user receives the
message "Detector is busy. Please wait." After the message has disappeared from
the info bar, the magnification calibration can be performed.
Biopsy unit (option) Accuracy of the stereotactic biopsy unit, see Biopsy unit
Preparations
Removing the face shield The face shield must be removed prior to starting calibration.
◆ Bend the sides of the face shield slightly to the outside to withdraw it from
the holder.
Preparing the swivel arm Before you begin calibration, you have to set the swivel arm up for the
calibration.
1 Install the 40 mm Plexiglass plate on the swivel arm so that the entire image
area is covered.
2 Remove the compression plate.
Performing a calibration Calibration images are generated with constant exposure parameters in the
course of the calibration. You can evaluate the quality of each individual
exposure and determine which calibration images are to be used for the
detector calibration and which are rejected.
Starting the calibration 1 Select Patient > Detector calibration from the main menu of the
Examination task card.
The Service Patient is automatically registered.
The Calibration subtask card is displayed.
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When the calibration subtask is selected, the exposure parameters are
automatically correctly set and displayed in the generator control field for
each anode/filter combination. ( Page 102 Generator control field)
Calibration images When calibration is started, the Calibration subtask card for the type of
calibration selected changes. The projection view to be acquired is shown in the
Images subtask card.
Ending the calibration As soon as you have calibrated the detector using a sufficient number of suitable
exposures (recommendation: 15 images), then the calibration process is ended.
The following message window appears:
Calculation successful The following message window appears when the calculation is successful:
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A small rectangular structure can be seen on the calibration images in the
upper right corner of the detector. This has no effect on calibration and
image quality of the clinical exposures.
Calculation unsuccessful The following warning window appears when the calculation is unsuccessful:
This message means that several non-functioning pixels were found during the
calibration. This requires a system check by a Siemens service technician.
◆ Call a Siemens service technician or a technician trained by Siemens.
Until the analysis by the service technician, clinical operation may continue
if:
Check calibration results You can select and evaluate the calibration results. The results of all calibration
types can be found in the service menu.
The system generates a result in a log file for each individual calibration type:
◾ for calibration type CONTACT
◾ for calibration type MAGNIFICATION
◾ for calibration type TOMOSYNTHESIS
1 Select Options > Service > Local Service (without password).
2 Select Acquisition System > Detector > Detector Calibration.
The Log file of last calibration window is displayed.
Calibration mode CONTACT 1 The results for the CONTACT calibration mode can be found under * Mode
CONTACT.
Only one evaluation is displayed at a time.
2 Scroll to the end of the CONTACT calibration type.
The end of the CONTACT calibration type is where the MAGNIFICATION
calibration type begins, entry * Mode MAG.
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Calibration mode MAGNIFICATION ◆ The results for the MAGNIFICATION calibration mode can be found under *
Mode MAG.
Calibration mode TOMOSYNTHESIS ◆ The results for the TOMOSYNTHESIS calibration mode can be found under *
Mode TOMO.
WARNING
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CAUTION
At the acquisition workstation 1 Register and load the patient into the Examination task card with the
required examination data.
( Page 105 Performing an examination)
2 Activate of the first projection view or, upon opening the examination, the
first projection view is activated.
( Page 111 Making an exposure)
At the acquisition workstation 1 Check the preset exposure parameters. Adapt the examination settings, if
necessary.
( Page 106 Selecting different examination settings)
2 Release an exposure. To do this, press and hold the exposure button on the
control box until the acoustic signal ends.
The radiation indicator may light only when the exposure button is
operated. Observe radiation protective measures.
At the X-ray stand or acquisition 1 Repeat steps “Adjust swivel arm to the desired projection angle.” ( Page 61 At
workstation the X-ray stand) to “Check image quality. Repeat image processing if
necessary.” ( Page 61 At the acquisition workstation) until you have acquired
all projections.
2 Finish the examination.
( Page 128 Finishing an examination)
For optimum exposure and lowest possible radiation exposure, select the
size of compression plate as small as possible.
◆ Press the release button on the compression-plate receiver and pull the
compression plate out.
Installing the face shield ◆ Push the face shield into the holder.
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Removing the face shield The face shield must be removed when using the magnification table.
◆ Bend the sides of the face shield slightly to the outside to withdraw it from
the holder.
The rotation and height adjustment are always locked when the
CAUTION
Note that the swivel arm always returns to the 0° position as soon as the
single-touch button is pressed at the end of an examination.
Adjusting the projection angle The swivel arm can be rotated isocentrically between +180° (clockwise) and
-180° (counterclockwise).
Moving to the projection angle The projection angle for each projection view is already preset in the
workstation configuration. ( Page 131 Examination configuration)
1 Briefly press the single-touch button.
The swivel arm automatically moves to the preset angle position for the next
projection view.
The angle position is displayed on the stand display.
2 Press any keypad to stop movement.
The rotation movement stops in the current angle position.
3 Press the single-touch button again to resume movement.
Trimming the projection angle If necessary, the projection angle can be trimmed by actuating the rotation
movement buttons again for desired adjustment.
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90°. To resume movement, release the button briefly and press it again.
Rotation automatically stops when the system end position of ± 180° is
reached.
Adjusting the height of the swivel The swivel arm can be adjusted to a height between 69 cm and 150 cm above
arm the floor relative to the 0° angle position.
Adjusting height with the foot switch The pedals for adjusting the height are marked with an X-ray tube icon.
1 Press and hold the corresponding pedal for raise or lower the swivel arm.
2 Release the pedal when you reach the desired height.
The movement stops at the current swivel-arm height.
For safety reasons the swivel arm automatically stops moving downward
4.1.8 Compression/Decompression
Compression and decompression are driven by a motor controlled with the foot
switch or the control knobs on the compression unit. The compression speed
will automatically decrease when the compression plate comes in contact with
the breast and the compression force is more than 10 N (1 kg).
CAUTION
CAUTION
Motor-driven decompression is not possible during a power failure. In this
case you have to activate the emergency compression release and push the
compression plate up by hand. ( Page 41 Compression/Decompression)
The maximum compression force applied by the motor is preset in the range
between 50 N and 200 N (approx. 5 kg - 20 kg) at the workstation.
Compression using foot switch The compression/decompression pedals are marked with a compression/
decompression icon.
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Optimized compression OPCOMP® The automatic “optimized compression” OPCOMP® mode is activated at the
workstation. Compression of the breast until the optimal compression force is
achieved is controlled with the foot switch or control knob.
Information about OPCOMP® ◾ It is important that you trust OPCOMP® when you learn to use it. If OPCOMP®
is used correctly, you achieve unchanging and correct compression
examination for examination.
◾ Some breasts may require 200 N (20 kg) for correct compression. If this is
more force than is permitted in the clinic, a maximum compression force for
the exposure technique concerned can be set at the workstation by service.
◾ The “optimized compression” is intended as a recommendation for the
operator. Additional force up to the preset value can be applied by pressing
the foot switch again. If the preset maximum compression force is less than
the “optimized compression” value, the preset maximum force applies.
◾ OPCOMP® optimized compression is always combined with the OPDOSE
procedure. OPCOMP® can only be switched off in the Advanced dialog box.
This setting remains for the entire examination.
◾ Patients with implants, or patients who recently had breast surgery, must not
be exposed to the “optimized compression”.
Use instead the foot switch in the normal way, or the control knobs for
manual compression, to adjust proper compression force on the breast.
◾ OPCOMP® optimized compression works with all compression plates. For the
24 cm x 30 cm Flex compression plates, the compression thickness and force
are displayed incorrectly.
Step-by-step procedure 1 Check the generator control field at the workstation to ensure that OPCOMP®
is switched on. ( Page 103 Advanced dialog box)
2 Set the object table to the correct height and the correct angle for each
patient.
3 Position the breast on the object table.
Compression using control knob The control knobs for compression/decompression are located on both sides of
the compression unit.
1 Turn the knob downward (compression) or upward (decompression).
2 Release the control knob when you reach the desired compression force.
The movement of the compression plate stops at the current height. As soon
as compression begins, the compression plate moves down more slowly.
The compression force and compressed thickness are indicated on the stand
display.
Automatic decompression When automatic decompression is active, the compression plate lifts up approx.
13 cm after each exposure.
Automatic decompression is already preset by the selection of the examination
procedure at the workstation. If necessary, it can be manually activated or
deactivated. ( Page 103 Advanced dialog box)
Decompression during a power If motor-driven decompression is not possible, you must actuate the emergency
failure unlocking device at the head of the compression unit.
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CAUTION
If the breast is positioned improperly, other body parts may also be in the
radiation field.
Unnecessary patient radiation exposure possible!
◆ Position the patient with the aid of the object lighting so that only the
breast being examined is located in the radiation field.
◆ Make sure that no area of the breast is in the X-ray shadow.
Manually switching on object lighting Object lighting can be switched on manually at any time using the swivel-arm
operation keys.
◆ Press the object lighting key.
Switching off object lighting Object lighting is automatically switched off after a certain time (determined at
the installation of the system, normally 20 seconds).
Object lighting also switches off when an exposure is started (if the exposure is
completed before the preset time has elapsed).
(1)
(2) (3)
Mounting the magnification table 1 Grasp the handles of the magnification table.
2 Press the bars on the handles of the magnification table and place the
magnification table on the object table.
The magnification table locks into place.
Removing the magnification table ◆ Press the bars on the handles of the magnification table and pull the
magnification table away from the object table at the same time.
When the magnification table is used for the first time on a work day, it may
take approx. two minutes for all required detector data to be loaded. The
waiting time will be shorter for all following examinations on the same
work day.
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If an exposure is possible, but the projection view does not match the system
status (e.g., magnification table and magnification compression plate installed,
but projection view for standard exposure), this projection view will be shown in
the Images subtask card.
As soon as the exposure is performed, the display of the exposure will be
followed by a projection view such as L-mCC (correct), with the corresponding
projection view (L-mCC).
When taking exposures with the magnification table, make sure to use the
In examinations using a magnification table and low compression pressure,
the spot paddle compression plate is easily visible on the exposure at the
edge of the chest wall side.
Specimen projection views cannot be acquired using the magnification
table. Perform a normal magnification projection view with a manual
exposure.
CAUTION
CAUTION
CAUTION
CAUTION
Examination interrupted.
Unnecessary radiation exposure if repeat exposure is necessary!
◆ Make sure that the switch off button on the control box is not pressed
during the examination.
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Shutting down workstation 1 Select the End Session dialog window at the workstation with Options > End
Session.
For details, see ( Page 78 Exiting the program).
2 Click Shutdown System.
The workstation is shut down.
4.2 Workstation
(1)
(2)
(3)
(4)
(5)
(6)
The workstation is only suitable for image acquisition and not as a reporting
station or long-term archive.
The AWS monitor does not show the images in original size. Use the
postprocessing tool to measure the dimensions. ( Page 119 Post-
processing examination images)
CAUTION
Task cards The arrangement of the task cards reflects routine operation in the hospital or
practice and their layout supports the examination procedure, for example:
◾ You can perform the examination in the Examination task card.
◾ You can view the results and process them in the Viewing task card.
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◆ Click on the tab on the right-hand side of the screen to activate a task card.
Calling up using the function keys You can also switch to each task card using the function keys.
1 Press the F5 key to switch to the Examination task card.
2 Press the F6 key to switch to the Viewing task card.
Setting the screen saver The screen saver is automatically enabled during system installation. Use the
Screen Saver configuration (Options > Configuration) to configure the inactivity
period (time-out) before activation.
This option is only available if access protection is set up, see Option
Security Package.
Even with the high-resolution monitor, the workstation is only suitable for
image acquisition and not as a reporting station or long-term archive.
Layout The display remains unchanged on both monitors except for the Examination
task card.
On the Examination task card on the left screen, the image section is on the
right and the control section is at the bottom.
After logging in, the Examination task card interface appears on your high-
resolution screen. It is subdivided into the following areas:
(1)
(2)
(3)
(4)
(5)
(1) Menu bar
(2) Examination task card
(3) Image and workspace of the task card
(4) Control area
(5) Information window
In the information window, you are guided step by step through the
examination.
You can go all the way back to the first instruction step by step using the
Previous screen button. You can scroll forwards to the last instruction step
by step with the Next button.
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Action history The actions executed by the program are automatically logged together with
information about whether each step was successfully terminated or whether an
error occurred. You can query a list of the last entries in the history at any time.
◆ Click on the task bar with the left mouse button to list the last commands and
program actions.
You can determine the number of entries in the log in the History Size
dialog box that you call up by clicking the status bar with the right mouse
button.
Resource check Your system monitors the memory usage and the storage capacity of the main
database, the scheduler database and the exchange board (virtual memory).
By the storage capacity icon you can see how much space has already been
taken up in the local database. If the filled capacity rises above a configurable
limit (default 95 %), the icon changes color from green to red.
If you move the mouse pointer to this icon, the percentage of storage capacity
already taken up is displayed.
Archive the patient and examination data in time and delete them in the Patient
Browser to ensure that sufficient capacity is always available.
Virtual memory
CAUTION
The flashing storage capacity icon in the status bar indicates that the virtual
memory is already full.
The message Resource Monitor is displayed.
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End Session dialog box In the End Session dialog box, you have various ways of ending your session
and shutting down your system.
◆ Call up Options > End Session... in the main menu.
The End Session dialog box is displayed.
Locking the computer ◆ Click on Lock Computer to restrict access to your computer.
The computer can only be used after the password has been entered.
Logging off ◆ Click on Log Off <user name> to exit the program.
The computer ends the individual program parts one after the other and saves
the last settings.
Only available if access protection is set up, see Option Security Package.
Other users 1 Click Log In Different User... if you want to log in to the already started
system.
2 Enter the user name and the password.
Dialog boxes and patient data are hidden corresponding to your
authorization.
Shutdown ◆ Click on Shutdown System..., if you want to close the system or switch it off.
The system shuts down.
You can now switch the computer off with the on/off switch.
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Patient data management 5
For additional information regarding patient data, see the syngo VI10A
Online Help.
The user is aware that he is not allowed to use the Virtual Client for any
other applications.
If an image was repeated/rejected and the operator was changed during the
examination, the WH AWS Management of Repeated/Rejected Images
dialog will display the last operator name.
Rejected tomo images will be not displayed in the list but the are taken into
account for the statistical analysis.
3 Click Yes.
The rejected image is deleted from the list.
– or –
Click on No.
The rejected image is not deleted from the list.
Please note that the "Automatic Delete" function cannot be used with
rejected images.
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3 Click on OK.
The View Image dialog box closes.
3 Click Yes.
If the patient and examination data are no longer located in the local
database, you must check the name of the patient when restoring a
rejected image.
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If only one user exists, the bottom part of the dialog box can be ignored.
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You cannot resume a study if the study is open in the Viewer at the same
time.
First close the study in the Viewer.
3 Double click in the Images subtask card on the outstanding image to release
the operating console for the examination.
If the patient cannot be loaded in the scheduler with a double click in the
Examination task card, or if a resumption of the patient is not possible
(since the MPPS status is DONE), then the examination can be started via
Patient Registration > Examination. The corresponding procedure must
appear in the Examination task card.
If comments are stored in a new series and the patient is closed, this patient
cannot be opened again in the Examination task card. Reenter the
examination is not possible. Reenter the examination is only possible if a
study only consists of 2 series. Comments, remarks, etc. are only saved
upon resuming newly acquired images.
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2 First, define the special settings for the projection views (1) required.
3 Then click in the area of the available PVs (2) on the projection view you
want.
7 Double click in the Images subtask card on the outstanding image to release
the operating console for the examination.
8 Take the corresponding exposure.
Note that the KOS function cannot be used for examinations with the
biopsy unit and Tomosynthesis Option.
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The circle or also called pie-diagram shows the fill level of highest value of
partition D: or E: (1-st and 2-nd line of resource monitor window).
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3 From the autodelete point of view a flag is only set - and therefore will be
considered during the autodeletion checks - if it is set on the processed image
of an image pair. It means for example that if only a raw image has the
protect flag but all other autodelete conditions are fulfilled in a study, the
corresponding study will be deleted.
4 If the Patient Browser shows lower case flags (i.e. “a”, “p”, “r”), this indicates
that not all images of a patient have the corresponding flag.
Following cases are possible:
◾ A series has lower case flags if not all images in that series have the
corresponding flag (e.g. only 3 images out of 4 have the Archived flag).
◾ A study has lower case flags if not all its series have the corresponding
upper case flag (e.g. in case of 2 series only one has “A” or both have “a”).
◾ A patient has lower case flags if not all its studies have the corresponding
upper case flag (e.g. in case of 2 studies only one has “A” or both have “a”).
5 If all the studies of a patient are deleted, the patient will be deleted as well.
6 The default value of the autodelete configuration setting of printed images is
NO (see Figure 2), i.e. printed images are not deleted automatically per
default.
7 Rejected/discarded images are not deleted automatically.
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Abbreviations Definition
Abbreviations Definition
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Abbreviations Definition
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Examination 6
6 Examination
(2)
(3)
(4)
(5)
(6)
Menu bar Select the different functions which are relevant in the course of the
examination using the menu bar. These are displayed as menu items when you
click on the desired menu.
Control area The following data is displayed within the control area:
◾ Information about the current patient
◾ Examination settings
◾ Protocol control
– Projection views
– Status of projection views
Patient data
The patient folder with the last name and first name of the registered patient is
displayed in the upper part of the control area.
Procedures
You see the procedure selected for the current examination displayed in the
lower part of the control area.
Projection views The projection views and the order of their exposure are displayed as buttons in
the Images subtask card.
Projection view selected for exposure, wait- Repeated image finally acquired
ing for system to be ready for exposure
Projection view according to default, Projection view selected for exposure, sys-
Implant exposure scheduled tem is ready
Projection view according to default, Spot Projection view acquired, image transmis-
exposure scheduled sion runs
Projection view according to default, Prime Projection view acquired, image processing
Mode* exposure scheduled ongoing
Projection view according to default, Prime Projection view selected for exposure, sys-
and Tomo* exposure scheduled tem is ready.
NOTE: Some prerequisites have not been ful-
filled (e.g., magnification exposure without
magnification table), exposure is possible.
Projection view according to default, Tomo Projection view selected for exposure, sys-
Implant* exposure scheduled tem is not ready.
NOTE: Some prerequisites have not been ful-
filled (e.g., compression plate not installed),
exposure not possible.
* optional
If the red or yellow icons light up, your intervention or appropriate safety
measures are required.
Subtask cards for examination A stack with subtask cards with which you can control the examination is
settings located in the central part of the control area. Here you also select the
acquisition method, the operating program and the exposure technique with in
each case preset exposure parameters.
Image area The X-ray images of the current examination are displayed in the image area.
After every single acquisition the display in the image area is updated. According
to the set layout, the last image (layout 1:1) is displayed or the last images
(layout 2:1, 4:1, etc.) are displayed.
Generator control field The currently selected exposure parameters appear in the generator control field
(the first settings displayed are those configured for the selected exposure
procedure, the acquisition mode and the exposure technique).
( Page 102 Subtask cards for examination settings)
If you want to use parameters other than the preset parameters, set them in the
generator control field before beginning the exposure.
Settings
Advanced dialog box After clicking the Adv. button on the screen, the Advanced dialog box is
displayed. Detail parameters preset for the currently set exposure technique can
be changed in the Options fields here. The standby mode of the exposure
technique determines which options are available.
(2) (3) (4) (5) (6)
(1)
(c) Option AUTO - without grid and with PRIME algorithm if licensed
(3) Automatic decompression On/Off
On: if unit should automatically decompress following the exposure
(4) Optimized compression (OPCOMP) On/Off
(5) AEC-Segmentation On/Off (measurement range for automatic exposure
control)
On: for dynamic measurement of pixel values over the entire breast
Off: to limit to small, predetermined measurement area
(6) Dose level
(a) Low - dose level low
(a) (b) (c) (d) (e)
(b) Medium low - reduced dose level
(c) Normal - standard dose level
(d) Medium high - elevated dose level
(e) High - high dose level
CAUTION
Status bar System messages indicating the current state of the system or error messages
are displayed in the lower area of the Examination task card.
Info bar You will find help for your examination as well as information about the
exposure parameters used in the individual exposures on the info bar.
Information texts Information texts advise you of the current state of the exposure and give
instructions about the continuing procedure.
Exposure parameters used After irradiation is completed, the exposure parameters used are displayed for
your information. As soon as the completed image appears in the image area,
these data are hidden again.
Registration in the Examination task You can also select Patient Registration directly from the Examination task
card card in the Open Patient subtask card, e.g., if you want to examine the next
patient after an examination is complete.
You can change the Operator in the Open patient subtask card during an
examination.
You can find more information on the default procedure, and projection
sequences in ( Page 132 Configuring procedures).
Procedures You can select the procedure and sequence of the assigned projection views in
the Open patient subtask card.
You can set which procedures are available to you for examinations and
which procedure is the default in the configuration.
( Page 132 Configuring procedures)
1 Select the Procedure required for your examination from the selection list.
The projection sequence preset for the procedure is displayed in the PV
sequence selection list.
If the patient was requested from the RIS, the reason for the requested
procedure is shown as well.
2 If necessary select a different projection sequence in the PV sequence
selection list.
3 Select ON from the selection list Display Markers:
The projection view will then be saved with the image ("burned in").
The size of the burned-in markers will be scaled to the size of the image. The
markers should be placed relative to a corner.
The markings in the image are retained when repeating image processing.
After a Req. Reason(s) is specified in the RIS, it also displays in the Open
patient subtask card.
CAUTION
Automatic functions In the lower area of the Open patient subtask card select the automatic
functions to be performed during the examination, if necessary.
◆ Activate the desired functions using the check boxes.
◾ Auto Filming: Completed images are automatically copied to the Filming
task card.
◾ Auto Expose: The images collected in the Filming task card are
automatically forwarded to the printer as soon as a printer has been
configured.
Make sure that all images are sent to the printer if the Auto-expose function
is activated.
Acquisition The corresponding acquisition mode and IPPG for the selected procedure are
shown in the Acquisition subtask card.
Examples:
CAUTION
Settings You can change individual exposure parameters for the current examination, if
necessary.
CAUTION
If possible, use the automatic modes AEC or OPDOSE to ensure that the
exposure parameters are optimized.
◆ If necessary, change the settings for exposure mode, kV, mAs, and anode/filter
combination. ( Page 102 Generator control field)
Manual mode: The maximum mAs value that can be set depends on the set kV
value. If the mAs value is further increased for a specific kV value, then the kV
value is reduced to reach the mAs value.
kV 23 24 25 26 27 28 29 30 31 32 33 34 35
Maximum 560 560 500 500 500 500 450 450 400 400 400 400 360
mAs
Exposure parameters for implant For acquisition mode “Implant” manual exposure parameters are provided by the
exposures system. Note that these figures are just suggested guideline values for the
exposure.
◆ It may be necessary to adjust the exposures depending on the nature of the
breast or implant concerned.
20 WRh 25 50
30 WRh 26 70
40 WRh 26 90
50 WRh 27 110
60 WRh 28 120
70 WRh 29 130
80 WRh 30 140
90 WRh 30 160
First, take an exposure with the recommended parameters. Depending on
the image impression, the parameters for further exposures may need to be
adjusted.
CAUTION
If you switch on AEC segmenting in the Advanced dialog box, you can
check the position of the AEC region in the image after the exposure. To do
this, select Tools > AEC region.
Modifying the projection view 1 With the right mouse button, click on the Images subtask card of the
projection view you want to modify.
2 Select Modify in the displayed popup menu.
The Modified Views window is opened.
Adding a projection view 1 With the right mouse button, click on an arbitrary projection view in the
Images subtask card.
2 Select Add in the displayed popup menu.
The Modified Views window is opened.
3 Select the desired projection view and confirm by clicking OK.
The new projection view is added at the end of the projection sequence on the
Images subtask card.
Inserting a projection view 1 With the right mouse button, click on the Images subtask card of the
projection view in front of which you want to insert an additional projection
view.
2 Select Insert in the displayed popup menu.
The Modified Views window is opened.
3 Select the desired projection view and confirm by clicking OK.
On the Images subtask card, the new projection view is inserted in sequence in
front of the originally selected projection view.
Deleting a projection view 1 With the right mouse button, click on the Images subtask card of the
projection view you want to delete.
2 Select Delete in the displayed popup menu.
The projection view is removed from the Images subtask card.
CAUTION
Starting the projection series The projection views to be performed are displayed as buttons in sequence on
the Images subtask card.
1 In the Images subtask card, double-click on the first projection view to release
the exposure.
Possible setting: automatic activation of the first exposure when the patient
record is opened, Options > Auto Enable First PV. ( Page 132 Configuring
procedures)
Wait until the system is ready (green light stops blinking) before making the
exposure.
4 Press and hold the exposure button on the control box as long as the signal is
audible.
The button will light up yellow during the exposure.
Radiation is released and the first examination image is taken.
After the exposure is complete, the finished image is displayed in the image
area.
CAUTION
CAUTION
If a non-recoverable error occurs during the exposure, the maximum ADG
value could be estimated at < 3 mGy for AEC Mode (90 mm breast
thickness).
If, after an exposure, the image appears black, reprocess the raw data, set
the correct IPPGs, or click on the Reenter examination screen button.
Some parts of images may be black for acquisitions of large breasts where
the edge of the breast can no longer be recognized.
Process the raw data again, select the MagSpot IP parameter set and click
Reenter examination.
Start with different view You can also begin a projection series with a projection view other than the one
displayed first.
Continuing the projection series The exposure of the other projection views is automatically released.
The next projection view to be performed is selected for exposure in the Images
subtask card.
1 Position the swivel arm of the MAMMOMAT Inspiration corresponding to the
intended projection view.
2 Position the breast to be examined on the object table according to the
intended projection view.
3 Press the exposure button on the control box.
Radiation is released and the next examination image is taken.
After the exposure is complete, the finished image is displayed in the image
area.
You can monitor the progress of the current examination on the Images subtask
card. After the last exposure, all screen buttons show the images you have taken
as thumbnails.
Cancelling the exposure Exposure of a projection view can be cancelled as long as no radiation has been
released.
1 Right-click on the projection view selected for exposure in the Images subtask
card.
A pop-up menu is displayed.
2 Select the Disable exposure item.
3 Click Yes in the dialog box displayed.
The continuation of the projection series is canceled.
All remaining projection views remain in the Images subtask card. They can
now be processed or you can restart.
CAUTION
If the incorrect breast side or a different view is exposed than intended, the
image is saved under an incorrect projection view.
Faulty diagnosis or incorrect treatment possible!
◆ Check that the image is assigned to the correct projection view and
correct it, if necessary.
3 Select the correct projection view in the New projection view selection list
and click on OK.
A dialog box is displayed.
4 Click on Yes to make the change.
The image is reconstructed and displayed in the changed view.
CAUTION
CAUTION
6 Click on OK.
A dialog box appears prompting you to confirm the change.
Rejected images are deleted. You can view them in the WH AWS
Management of Repeated/Rejected Images dialog box.
3 Click on Close.
The Image attributes dialog box is closed.
You can find detailed information about the individual tools for image
processing and evaluation in the syngo VI10A Online Help.
◆ To view a large-format image, select View > a 1:1 in the main menu.
The current layout is now marked with a checkmark.
You can set the following layout sizes: a 1:1, b 2:1, c 4:1, d 9:1, e 16:1
6.3.3 Scrolling
You will usually have taken more images of a patient than can be displayed in
the image area of the Examination task card. All the images that cannot be
displayed due to lack of space are placed in the background.
The Examination task card provides you with several alternative ways of
scrolling through the taken images:
◾ By using the Scroll menu
◾ By using the scroll bar to the right of the image area.
◆ In the main menu select Image > Magnify by 2.0 or click the button.
The image is displayed in twice its size.
Zooming of point
Zooming with the mouse The left mouse key is used to select or deselect images and objects. However,
you can also switch over the function of the left mouse button to perform
zooming and panning.
1 Select Image > Zoom/Pan.
2 Position the mouse pointer in the outer area of the image.
The cursor changes shape.
3 Drag the mouse cursor up/down with the left mouse button pressed.
The image is zoomed in/out.
As soon as you release the mouse button, the new zoom factor is applied to
all the selected images or the selected scope of action.
4 Deselect Image > Zoom/Pan again.
The left mouse button is available for selecting images again.
Panning images After zooming, portions of the images may be outside the visible image
segment. Therefore always pan the image so that the region of diagnostic
interest is in the center of the image segment again before storing.
1 Select Image > Zoom/Pan.
The function of the left mouse button is now switched from selection to
Zoom & Pan On.
2 Now place the mouse cursor in the inner area of the image.
3 To pan the content of the image, press and hold the left mouse button while
dragging the mouse upward, downward, to the left or to the right.
You can see the result of your mouse movements in the image on which the
mouse cursor is located immediately.
◆ Firstly, select the image in which you want to display in an enlarged image
section.
6.3.8 Angle
With the Angle function, you can determine the angle enclosed between two
lines drawn in a clockwise direction. If the angle is larger than 180°, the program
subtracts 180° from the angle.
1 Select Tools > Angle or click the button.
The cursor changes its shape.
2 Set the mouse pointer on a starting point for the first side.
3 With the left mouse button pressed, draw a line to the end point of the first
side.
4 Draw the second side in the same way.
The measured angle is displayed while you are drawing it.
6.3.9 ROIs
You can designate questionable areas in images as Regions of Interest (ROIs)
and evaluate them. For this purpose, draw a frame around the relevant area.
1 Select Tools > Circle or Tools > Rectangle or click the button.
The cursor changes its shape.
2 Click on the image and draw the ROI (a rectangle or circle) with the mouse
button kept pressed.
3 Release the mouse button as soon as the ROI has the desired size.
The gray-scale values inside the ROI are evaluated statistically and the result is
indicated on the edge line.
Freehand ROIs
Inserting an annotation
Saving annotations ◆ Select Patient > Save from the main menu.
The images are saved with the annotation text.
Take care that the saves notes are not located in the region of tissue of
diagnostic relevance.
In the Reenter examination mode, comment texts for the newly acquired
images are saved.
Adding a comment
The image comment is displayed on the lower image margin and saved
automatically.
You can insert text input fields in all available images, even if the Comment
button is dimmed.
Change window values ◆ Use the center mouse key to individually set the window values.
Deleting graphics and annotations You can delete graphic objects that you have drawn from the image using the
post-processing tools.
1 Disable the currently activated tool, if required.
2 Click on the graphic (line, ROI, annotation) which you want to delete.
Grab handles are displayed for the selected graphic object.
3 Press Del on the keyboard or select delete in the context menu (right mouse
button).
4 Select Save.
The images are saved without the deleted graphics or annotations.
In the Reenter examination mode, images and comments are only deleted
for the newly acquired images.
Restoring the starting image ◆ Select the Image > Invert command once again.
The selected images are displayed in inverted display.
Using the Auto-Filming and Auto-Expose functions, the filming/printing
processes can be run automatically. ( Page 106 Selecting different
examination settings)
task card even if 100 % is specified in the configuration. This is because the
printed images are displayed using the same magnification as the earlier
analog images. The SOD/SID (source-object distance/source-image distance)
results in a magnification factor of approx. 104%.
CAUTION
◆ Click on the Film Preview button on the Post processing subtask card.
The Film Sheet window is opened.
1 Click on the Open MPPS Dialog check box (if RIS is connected) if you want to
edit the billing documentation later on.
2 Click on the Open Scheduler check box if you want to examine the next
preregistered patient.
If required, the Auto Transfer function can be deselected for a current
examination in the Close Patient subtask card.
3 Deselect the Skip Auto-Transfer Rules check box.
The images will not automatically be sent to the configured nodes.
4 Select Examination > End of examination in the main menu or click the
button.
The comments are saved automatically when closing the patient.
The graphics, annotations and window values have to be saved manually.
The examination of the current patient is now finished.
The patient and examination data are deleted from the Examination task
card.
Sending and completing a report 1 Check the performance report and add any missing entries.
If all data in the performance report is entered correctly, you may close the
report. Depending on operational requirements, you can pass the report on to
the HIS/RIS system.
2 Click the Save button to save your changes to the report.
The report has not yet been completed.
– or –
Click the Completed button to complete the report.
A message referring to this process is sent to the HIS/RIS system, if connected.
You cannot make any further changes to the performance report.
7 Configuration
Saving settings and closing the dialog You make your changes to the configuration of the system in the individual tab
box cards. You must confirm your changes before exiting a tab card.
1 Click on Apply, if you want to make further settings.
Your settings will be saved; the dialog box remains open.
2 Click on OK, once you have made all your settings.
Your settings will be saved; the dialog box is closed.
The saved settings will be available when you call up the next examination.
Changes to the procedure definitions become effective only on selection of
the next examination. Procedures that are used in a current examination
remain unaffected until the examination is ended.
List of available procedures The examination procedures currently stored in the system are listed in the left-
hand area of the Procedures tab card. The check marks in front of the entries
identify those procedures that are available for an examination (selectable via
the selection list Procedure in the Open patient subtask card).
Creating procedure You can copy an already existing procedure and redesign it according to your
requirements, or you can create a procedure that has to be configured
completely from scratch.
1 Select a procedure from the list that comes close to your requirements.
2 Click on Copy.
A procedure named "Copy from..." is created in the list.
– or –
Click on New.
A procedure named *New appears in the list.
You edit the settings of the added examination procedure like those of an
already existing procedure.
Defining defaults With the Set default button you determine which examination procedure is
preselected as default if no procedure is selected through the registration.
1 Select a procedure from the list.
2 Click Set default.
The selected procedure is identified in the list with the addition "(Default)".
Deleting procedures You can delete for more clarity user-defined procedures you no longer require.
1 Select a procedure to be deleted from the list.
2 Click on Delete.
The procedure is no longer available for future examinations.
2 Drag the procedure to the desired position with the arrow buttons.
Procedure details You define the name, examination purpose and availability of the edited
procedures in the Procedure details area. In addition you can preset automatic
functions.
3 In the selection list, define whether the procedure should be available only
under your login or generally (only selectable if the system is configured with
user management).
Default for layout The reconstructed images can be displayed in different layouts during the
examination. 1:1 representation is recommendable (one image in the image
area).
◆ Select the display that should be default in the Default Display Layout
selection list.
Please note that for Tomosynthesis Option always 1:1 layout will be used.
Details of the projection views In the course of an examination procedure different projection views are
acquired in a defined sequence. You can determine the composition and
sequence of the projection views in the PVS Dialog.
◆ Click on Modify PVS in the Procedure Handling Configuration dialog.
The PVS Dialog dialog box opens.
Modifying projection views 1 Click on the Modify PVs tab into the foreground.
4 Double click in the area of the available PVs (lower box area) on the projection
view you want.
The selected projection view is transferred to the current set of projection
views (lower box area).
The projection views are transferred to the current set of projection views in
the order of their selection. You can still change the order later.
5 Double click in the area of the current PVs on the projection view to be
removed.
The selected projection view is removed from the current set of projection
views.
Modifying the sequence of projection You can change the order of the projection views to adapt it to your
views requirements.
1 Click on Modify PVS.
The PVS Dialog dialog box opens.
2 Click the Modify PV sequences tab into the foreground.
The currently projection view orders that can be selected in this procedure are
listed in the Projection view sequences area.
4 In the Selected PV sequences area move a projection view (PV) with the
mouse to the required position in the projection view order.
– or –
Select a projection view.
5 Drag the projection view to the desired position with the mouse.
The selected projection view is moved by one step.
Saving projection views ◆ Click on Apply, if you want to make further settings.
Your settings will be saved; the PVS Dialog dialog box remains open.
– or –
Click on OK to accept the changes.
Your settings will be saved; the PVS Dialog dialog box closes.
Creating further projection view You can create further projection view orders and then revise their order.
orders
1 Click New, to make the projection views in a further projection view order
ready for the examination.
The new projection order is included in the list.
2 If necessary, you can change the distribution of the projection views inside
the new projection view set details.
Defining the default projection views You can determine a projection order that should be used as default for the
order procedure.
1 Select the required projection order from the Projection view sequences list.
2 Click on Set default, to determine the selected order as default for the
examination.
The selected order is preset with the appropriate procedure for the
examination.
In order to make changes in the EXPOSURE Programs, you have to select
Local Service > Acquisition System in the menu (using a service
password).
(1) The window area (top left) lists the preset Acquisition Modes with the
original name.
(2) The window area (top right) contains a list of parameter for exposure
technique that works with OPDOSE with the original parameters.
(3) The window area (bottom left) contains the thickness independent
parameters.
(1) The window area (top left) lists the preset side designations of the PVs with
the original name and the modified name.
(2) The window area (top right) contains a list of angles for the single-touch
function with the original angles and the changed angles.
(3) The window area (bottom left) contains the item designation and available
projection views (PVs) with the original names and the changed names in
each case.
By placing a checkmark, you select which PV is to be displayed in the
Modifying projection views dialog window.
Changing side designation ◆ You change the designation for the side designations in the Modified name
input field.
The modified designation is marked in the original name column with an
asterisk.
Changing position designation 1 Mark the name you want to change in the list of the position designations.
The name to be changed appears on the right in the Modified name input
field.
2 You change the name in the Modified name input field.
The modified name is marked in the original name column with an asterisk.
Changing preset angles ◆ In the Preset angle input field, set the preset angle of the swivel arm for the
projection views.
These changes are active only locally. When sending to DICOM nodes or into
an archive the original names are used, since these are filed in the standard.
Other names are not allowed.
If you want to reset only individual names to the original names, select
these in the list and enter the original name in the Modified name input
field. To save the original names, proceed in the following as for entering a
modified name.
Opening the configuration dialog 1 Select Options > Configuration... in the menu bar.
Destination address
◆ Select the destination address for which you want to specify the image
material to be sent in the Transfer destinations selection list.
The DICOM nodes configured in the Local Service are available for selection.
Image type
◆ Select the image type that should be sent to the selected destination address.
Single Images for processing only individual raw data (suitable for image
processing/CAD server); correspond to 2D images.
Single Images for presentation only single processed images (suitable for
reporting station, for example); correspond to 2D images.
Examination purpose
◆ If necessary you restrict the image material to the examination purpose that is
relevant for the selected destination address.
◾ Screening: Only image material acquired within the scope of a procedure
with a Screening examination purpose is sent.
◾ Diagnostic/Specimen/Stereo: Only the image material acquired within the
scope of procedures for diagnostics, preparations and the Stereo Mode (if
available) will be transmitted.
◾ Calibration/Biopsy Calibration/Phantom: Only the image material
acquired within the scope of procedures for Calibration/Biopsy Calibration
(if available) and Phantoms will be transmitted.
rules, e.g. Examination reason: "No images exported to...".
All transfer rules can be overridden and all images can be sent to all
configured nodes using the following method:
◾ Select Patient List.
◾ Select Patient/Studies/Series.
◾ Open Transfer > Skip Transfer Configuration for Next Export.
◾ Select Transfer > Send.
Configuring the data transfer The AWS only supports the following rule for automatic transfer:
◾ Work status: Completed
◾ Processing status: Don't care
◾ Objects: Images
Rules for automatic transfer and automatic deletion with the "sent” status
must not be used.
2 Select the file with the required MoodLight settings in the Existing files area.
3 Click on OK.
The MoodLight settings are read from the file.
The Load file dialog box is closed.
Activating the MoodLight settings ◆ Click on transmit in the Light Shield V1.06 window.
The illuminated glass wall is lit using the changed color settings.
Defining a single color You can define a single color using the Microsoft palette.
Number of colors
◆ Set the number of different colors to "1" in the Light Shield V1.06 window.
Select color
1 Use the right mouse button to click on the color bar Color No. 1 in the Light
Shield V1.06 window.
The Color dialog window is displayed with the Microsoft color palette.
2 Click on the required color in the Basic colors section or select Custom
colors.
You can define further colors in the right section of the window using the
crosshairs in the color matrix (hue and saturation) and the slider
(brightness). Use the Add colors screen button to make the new color
available in the Custom colors area.
3 Click on OK.
The Color dialog box is closed.
The color bar Color No. 1 is displayed in the selected color.
Activating the MoodLight settings ◆ Click on transmit in the Light Shield V1.06 window.
The illuminated glass wall is lit using the changed color settings.
Saving the MoodLight settings If you also want to make the single color available for future use, then you have
to save it in the system.
1 Click on save in the Light Shield V1.06 window.
The Save file dialog box is displayed.
2 Enter a suitable file name for your color setting and click on OK.
The MoodLight setting can now be loaded from the system at any time under
the entered file name. ( Page 147 Predefined colors and color changing
programs)
Creating a color changing program You create a color changing program by specifying the required colors first and
then specifying the duration of the color and the transfer to the next color.
Number of colors
Select color 1 Use the right mouse button to click on the color bar Color No. 1 in the Light
Shield V1.06 window.
2 Select the required color from the Microsoft® color palette and confirm with
OK. ( Page 148 Defining a single color)
3 Define the other colors in the same way until all color bars appear in the
required colors.
Enter the holding time During the holding time the illuminated panel is only lit in the respective color.
1 Click on the hold-time field under the color bar Color No. 1 with the right
mouse button.
The Please enter time dialog box is displayed.
Entering the dimming time During the dimming time, the illuminated panel is lit in a continuous color
transition, in which the intensity of the previous color reduces while the
intensity of the next color increases.
1 Click on the dim-time field under the color bar Color No. 1 with the right
mouse button.
The Please enter time dialog box is displayed.
Activating the MoodLight settings 1 Click on transmit in the Light Shield V1.06 window.
The Transfer of data dialog box is displayed.
2 Click on Test.
The illuminated glass wall is briefly lit using the changed color settings.
3 Click on Read.
The changed color settings can be verified.
4 Click on Send.
The illuminated glass wall is lit using the changed color settings.
Saving the MoodLight settings If you also want to make the color changing program available for future use,
then you have to save it in the system.
1 Click on save in the Light Shield V1.06 window.
2 Save your color changing program using a suitable name in the Save file
dialog box. ( Page 148 Defining a single color)
8 Technical description
All labels displayed in the operator manuals are examples only and may
differ from the labels attached to the system and components.
(7) (1)
(6)
(5)
(2)
(3)
(4)
or
(5) Transport label: When transporting the device standing up, the tube arm must be
lowered to the end stop.
(11) Label EAC countries for Russian federation, Kirgiztan, Kazakhstan, Armenia
Detector labels
(1) - (3)
(1) Identification label
Collimator labels
(1)
(1)
(1) Identification label
(1)
(2)
(1) Label for emergency clutch - handle
(1)
Identification label
(3)
(1)
(4)
ST OP
(2)
(1) Monitor
(2) Workstation
(3) Indication of radiation protection
(4) Control box
Monitor label
Workstation label
(1)
(1)
ST OP
P 40 Mo W
Room temperature: 20 °C
Average rotor power: 124 W
Mains voltage 208 / 220 / 230 / 240 / 277 VAC, For USA/Canada only:
1P/N/PE
208 / 230 / 240 / 277 VAC, 1P/N/PE
208 / 220 / 230 / 240 / 277 / 400 VAC,
208 / 230 / 240 / 277 VAC, 2P/N/PE,
2P/N/PE,
50/60Hz
50/60 Hz
Disconnection from the power supply The system can only be disconnected from the power supply by trained person-
nel or using corresponding means fitted during installation.
Generator
kV accuracy ± 1 kV
PC hardware / software
100,000 images (20 MB per image) or 1300 tomosynthesis scans (1.5 GB per
scan for 50 mm breast thickness)
Operating system Windows 10 operating system with syngo-based applications and proactive
virus protection (whitelisting)
Displays
3 MP 21“ TFT color display (Option) Screen size 21“ (53 cm)
Radiation shield
Detector
Image Receptor Overall Dimensions 35.92 cm (W) x 34.65 cm (D) x 4.5 cm (H)
Pixel size 85 µm
Focus-to-detector distance 65 cm
Dose Five dose modes can be selected by the user on the workstation.
X-ray tube
Tube current (Mo/W) Molybden focal spot track maximum Wolfram focal spot track maximum
current; current;
Large focal spot: 150 mA at ≤ 24 kV Large focal spot: 190 mA at ≤ 26 kV
Small focal spot: 28 mA at 25 kV Small focal spot: 34 mA at 25 kV
Current range: 20 to 150 mA Current range: 20 to 190 mA
Max. power Mo W
large focus spot 3.7 kW 5 kW
small focus spot 0.7 kW 0.85 kW
Heat storage capacity of tube assem- 1800 000 J (2 430 000 HU)
bly
The dose value is a theoretically calculated value based on exposure and source
table data.
Source-table data ◾ Dose absorbed by the glandular for 50/50 % (glandular tissue/fatty tissue)
◾ Typical HVL values (half value layer, thickness of aluminum that reduces the
dose to 50 % at 28 kV)
W/Rh 50 μm 0.55 mm Al (typical value)
Users should be aware of that the dose value displayed is an estimated
value and the accuracy of all parameters in the calculation affects the
accuracy of displayed value.
Magnification table < 0.3 mmAl (typical 0.10 mmAl without object table)
(Al equivalent)
Biopsy table < 0.3 mmAl (typical 0.10 mmAl without object table)
(Al equivalent)
Network connection information Contact manufacturer for more detailed information (Medical IT-Network Secur-
ity Statement)
Image format See the “DICOM Conformance Statement”. The “DICOM Conformance State-
ment” is available on request from Siemens Healthcare or via the Siemens inter-
net homepage.
Classifications
Protection against electrical shock Class I, Applied Part Type B (Object table and accessories), in accordance with
IEC 60601-1
Attention: To avoid the risk of electrical shock, a protective conductor must be
implemented when connecting this device to line power.
Mechanical stability of stand (system The device does not tilt over if, when used under normal conditions, it is tilted
not secured to the floor by bolting) horizontally up to an angle of 5° or if a force of 220 N is exerted at a distance of
1.50 m above the floor.
The device should only be transported horizontally or vertically, if the tube arm
has been placed in the lowest position.
Degree of protection against ingress of Ordinary equipment (enclosed equipment without protection against ingress of
water water, protection class IPX0 (IEC60529).
* The leakage radiation of the tube housing assembly and attached collimator
complies with the requirements of 21 CFR, part 1020.30(k).
Further information about maintenance, disposal and environmental
protection and information on installation may be found in the Siemens
Customer Service technical documentation.
Operation
Height ≤ 3000 m
110
65
max. 235
180˚ 180˚
193
69 - 150
65 34
92 78
Electrical connections
not listed. This cabling is part of the system and was considered in all EMC
measurements. Without this cabling the equipment or system would not
function.
CAUTION
- Control Box
In case of electrostatic discharge of high voltages (> 8 kV) at Control Box, the
Mammo Unit might switch off suddenly. Please restart the Mammo Unit for
recovery.
- Biopsy Handbox
In case of electrostatic discharge of high voltages (> 8 kV) at Biopsy Handbox, it
might freeze. Please disconnect and reconnect the coiled cable for recovery.
RF emissions Group 1 The system uses RF energy exclusively for its internal func-
tion. Therefore, its RF emissions are very low and are not
according to CISPR 11
likely to cause any interference in nearby electronic equip-
ment.
RF emissions Class A The system is intended for use in all facilities other than
domestic establishments and for those directly connected
according to CISPR 11
to a public low-voltage power supply network which also
Harmonic emissions Class A supplies buildings used for domestic purposes.
Immunity tests IEC 60601 test level Compliance level Electromagnetic environment – Guidelines
Discharge of static ± 8 kV contact dis- ± 8 kV contact dis- Floors should be wood, concrete or ceramic
electricity (ESD) charge charge tile. If the floor is covered with synthetic mate-
rials, the relative humidity must be at least 30
IEC 61000-4-2 ± 15 kV air discharge ± 15 kV air discharge
%.
Electrical fast transi- ± 2 kV for power ± 2 kV for power The mains power quality should correspond to
ent/bursts cables cables that of a typical commercial or hospital envi-
ronment.
according to IEC ± 1 kV for input and ± 1 kV for input and
61000-4-4 output cables output cables
Surges ± 1 kV normal mode ± 1 kV normal mode The mains power quality should correspond to
voltage voltage that of a typical commercial or hospital envi-
according to IEC
ronment.
61000-4-5 ± 2 kV common mode ± 2 kV common mode
voltage voltage
Voltage dips, short < 5 % UT (> 95 % dip Not applicable The mains power quality should correspond to
interruptions and fluc- of the UT) for 0.5 that of a typical commercial or hospital envi-
tuations of the supply periods at 0°, 45°, ronment. If the user of the system requires
voltage 90°, 135°, 180°, 225°, continued operation during power mains inter-
270°, 315° ruptions, it is recommended that the system
according to IEC
be powered from an uninterruptible power
61000-4-11 < 5% UT (95% dip of
supply.
the UT) for 1 period
The stand has a nominal input current of more
70% UT (30% dip of
than 16 A per phase and is therfore excluded.
the UT) for 25 periods
Remark: UT is the a.c. line voltage prior to application of the test levels.
Immunity tests IEC 60601 test level Compliance level Electromagnetic environment – Guidelines
Immunity tests IEC 60601 test level Compliance level Electromagnetic environment – Guidelines
Immunity tests IEC 60601 test level Compliance level Electromagnetic environment – Guidelines
Remark 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Remark 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
be able to assess the electromagnetic environment with regard to the stationary transmitters, an electromagnetic site
study should be considered. If the measured field strength at the location where the system is used exceeds the applica-
ble RF compliance level specified above, the system should be observed to verify normal operation. Should unusual per-
formance features be observed, additional measures (such as change in orientation or change of site of the system) may
be necessary.
b Above the frequency range of 150 kHz to 80 MHz the field strength should be less than 3 V/m.
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters
(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output
power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Remark 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Remark 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
ensuring that the current system configuration complies with the relevant
standards (e.g. system standard IEC/EN 60601-ff and/or other applicable
standards).
In case of doubt, please consult your local contact person.
Please note that the dimensions for the compression plates in the following
table are given with a tolerance of ± 5 %.
Object tables*
Compression plates*
9 Appendix
Record the calibrations on a copy of the appendix page and file it along with
the Operator manual.
Location: __________________________
Year
Month
Day
Time
Tempera-
ture
Performed
by
Comment:
Checked:
Date:
10 Glossary
AT Axillary Tail
CC Cranio Caudal
CV Cleavage View
id Implant displaced
L* Latero*/-Lateral
LM Latero Medial
m* Magnification
M* Medio*/-Medial
ML Medio Lateral
O* .-oblique
r* .-rolled
rl rolled laterally
rm rolled medially
s* Spot
tan Tangential
X* Exaggerated
Status
symbols 100 V
Status bar 77, 104 Virtual machine
connection to the AWS 81
Status indicators 21
Virtual memory 77
Stereotactic biopsy 10
Storage
W
technical specifications 173
WH AWS transfer
Stumbling
configuration 131
risk 28
Workflow
Subtask cards
examination 61
examination settings 102
Workstation 73
Switching off 72
label 161
Switching on 51
Swivel arm X
adjusting height 65
X-ray stand
operation 40
design and functionality 38
Swivel-arm movements labels 153
information 63
X-ray tube 39
sXCC 94 technical specifications 170
sXCCL 94 X-ray tube assembly
Symbols heating and cooling curves 165
status 100 X* 94
System XCC 94
labels 154
XCCid 94
overview 37
restart 31 XCCL 94
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