Hologic PCB01647 RFID interface board for Selenia Dimensions / 3Dimensions Product Line User Manual 3Dimensions System User Guide
Hologic Inc RFID interface board for Selenia Dimensions / 3Dimensions Product Line 3Dimensions System User Guide
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Contents
- 1. User manual_3 Dimensions RFID_Updates EN part 1
- 2. User manual_3 Dimensions RFID_Updates EN part 2
User manual_3 Dimensions RFID_Updates EN part 2
3Dimensions System User Guide
Chapter 7: Accessories
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7.2.2 How to Use the Retractable Face Shield
Note
Before you make an exposure, make sure the Face Shield is completely extended or
completely retracted.
To extend the Face Shield, pull the Face Shield away from the C-arm until the device
latches in the outer position.
To retract the Face Shield:
1. Press a Latch Release (see item 2 in the figure Face Shield Operation on page 85—one
on each side).
2. Push the Face Shield toward the C-arm until the device stops.
Figure 56: Face Shield Installation
Figure 57: Face Shield Operation
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7.2.3 How to Install and Remove the Conventional Face Shield
Figure 58: How to Install the Conventional Face Shield
To install the Conventional Face Shield:
1. Carefully put the tab ends of the Face Shield (item 1 in the previous figure) into the
slots at the front of the tubehead mount.
2. Slide the Face Shield on the tubehead mount until the Face Shield locks.
To remove the Conventional Face Shield:
1. Pull the sides of the Face Shield in a horizontal direction (away from the tubehead).
2. Remove the Face Shield.
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7.3 Compression Paddles
Note
Some paddles are optional and may not be included with your system.
The system can identify each paddle and automatically adjust the collimator.
Available accessories depend on your system configuration.
Table 17: Available Accessories
Accessory 2D/BT 2D Screening
Routine Screening Paddles 18 x 24 cm * *
24 x 29 cm * *
Small Breast * *
18 x 24 cm SmartCurve™ * *
24 x 29 cm SmartCurve * *
Contact and Spot
Compression Paddles
10 cm Contact *
15 cm Contact *
7.5 cm Spot Contact * See Note
Frameless Spot Contact *
Magnification Paddles 7.5 cm Spot Mag *
10 cm Mag *
15 cm Mag *
Localization Paddles 10 cm Rectangular Open *
15 cm Rectangular Open *
10 cm Perforated *
15 cm Perforated *
10 cm Mag Perforated Loc *
10 cm Mag Localization *
Ultrasound Paddle 15 cm Large Ultrasound *
Patient Face Shield * *
Magnification Stand *
Localization Crosshair Device *
Magnification Crosshair Device *
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Note
On the 2D screening system, only use the 7.5 cm Spot Contact Paddle for compression
thickness calibration.
Note
The 24 x 29 cm frameless screening paddle, the 24 x 29 cm SmartCurve system paddle,
the magnification paddles, and the localization paddles are NOT compatible with the
paddle shift function.
7.3.1 Routine Screening Paddles
18 x 24 cm Frameless
Screening Paddle
24 x 29 cm Frameless
Screening Paddle
Small Breast
Frameless Paddle
SmartCurve System Paddles
Warning:
The SmartCurve™ system paddles do not meet the IEC 60601-2-45 standards
for minimum range of movement that require the paddle to compress to 10
mm. To ensure adequate compression of very small or very thin breasts, use
the standard flat screening paddle.
18 x 24 cm SmartCurve System
Frameless Screening Paddle
24 x 29 cm SmartCurve System
Frameless Screening Paddle
Note
The SmartCurve system paddles may not be suitable for patients with very small
breasts. If the breast cannot be properly immobilized or compressed due to the
curvature of the paddles, use the standard flat screening paddles.
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Note
The SmartCurve system paddles are not recommended for cleavage views, rolled
views, or mosaic views of very large breasts. Use the standard flat screening paddles for
these views.
Note
The SmartCurve system paddles accommodate most breast sizes. Due to the curvature
of the paddles, some patients who would use the smaller standard flat paddle may be
more easily positioned using the larger SmartCurve paddle.
Note
SmartCurve system paddles are not compatible with FAST Compression mode.
7.3.2 Contact and Spot Compression Paddles
10 cm Contact
Frameless Paddle
15 cm Contact
Frameless Paddle
7.5 cm Spot Contact
Frameless Paddle
Spot Contact
Frameless Paddle
7.3.3 Magnification Paddles
7.5 cm Spot Magnification
Paddle
10 cm Magnification
Paddle
15 cm Magnification
Paddle
Note
You cannot acquire Tomosynthesis images with the Magnification paddles.
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7.3.4 Localization Paddles
10 cm Rectangular Opening
Localization Paddle
15 cm Rectangular Opening
Localization Paddle
10 cm Magnification
Localization Paddle
10 cm Perforated
Localization Paddle
15 cm Perforated
Localization Paddle
10 cm Magnification
Localization Perforated
Paddle
7.3.5 Large Ultrasound Paddle
15 cm Large Ultrasound
Paddle
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7.3.6 How to Install and Remove a Compression Paddle
See the figure How to Install a Compression Paddle on page 91 to install a Compression
Paddle:
1. Hold the front of the paddle with one hand in front of the Compression Device.
2. Tilt the paddle (between 30 and 45 degrees), then put the rear of the paddle on the
groove in the rear of the Compression Device (item 1).
3. Slide the paddle along the groove until the slots on the top of the paddle are under
the locks on the Paddle Clamp (item 2).
4. Compress the Paddle Clamp (item 3) with your free hand.
5. Rotate the paddle up (item 4), then release the Paddle Clamp to lock the paddle.
Figure 59: How to Install a Compression Paddle
See the figure How to Remove the Compression Paddle on page 91 to remove the
Compression Paddle:
1. Hold the paddle with one hand while you use the free hand to compress the Paddle
Clamp to release the lock (item 1).
2. Lower the paddle (item 2) and remove the paddle from the Compression Device
(item 3), then release the Paddle Clamp.
Figure 60: How to Remove a Compression Paddle
7.3.7 Paddle Maintenance and Cleaning
Clean the paddles after each use. Refer to Maintenance and Cleaning on page 105 for
cleaning instructions.
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7.3.8 Paddle Shift
The system allows most paddles to move to the left or right of the center position. The
feature helps small-breast examinations with lateral views. When a lateral view is
selected, the system automatically moves the collimator for the selected paddle position.
Note
The 24 x 29 cm frameless screening paddle, the 24 x 29 cm SmartCurve system paddle,
and the magnification paddles are NOT compatible with the paddle shift function.
7.3.9 FAST Compression Mode
About FAST Compression Mode
The Fully Automatic Self-adjusting Tilt (FAST) Compression Mode is for use when the
composition of the breast tissue does not allow uniform compression across the complete
breast with a flat compression paddle. For these patients, not enough compression can
cause an image to appear to be out of focus at the anterior region from both involuntary
motion and not enough compression.
The FAST Compression mode used with this type of breast provides these features:
•Reduced motion artifacts, because the compression is more effective
•More uniform compression, from the chest wall to the nipple
•Maximum patient comfort, because over compression at the chest wall is prevented
When the FAST Compression mode is selected, the paddle automatically tilts when
compression is applied. The paddle starts at the flat position until some compression
force is applied. The paddle then tilts until its maximum angle is reached.
The FAST Compression mode does not require excessive compression, but you must use
enough compression to prevent the movement of the breast. You should use a consistent
amount of compression, especially for related left and right views.
The FAST Compression mode may not be best for breasts that are equal or symmetrical
in thickness from the chest wall to the anterior area of the breast.
Note
Only the 18 x 24 cm Frameless Screening Paddle and the 24 x 29 cm Frameless
Screening Paddle are compatible with FAST Compression Mode.
Note
The system beeps when FAST Compression Mode is engaged but is not compatible
with the current paddle.
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How to Use the FAST Compression Mode Slide
To engage FAST Compression Mode, push the slide (from either side) until the "F" is
visible and the slide clicks into position.
Figure 61: The FAST Compression Mode Slide
7.4 Magnification Stand
The Magnification Stand has a breast platform and an abdominal shield. When the
Magnification Stand is installed, the grid automatically retracts and the x-ray exposure
techniques are set to the Magnification default values. Only use the Magnification
paddles when the Magnification Stand is installed (refer to Magnification Paddles on page
89).
7.4.1 How to Install and Remove the Magnification Stand
Figure 62: Installation of the Magnification Stand
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To Install the Magnification Stand
1. Remove the Face Shield (refer to Patient Face Shields on page 84).
2. Remove the compression paddle (refer to How to Remove the Compression Paddle on
page 91).
3. Move the Compression Device completely to the top.
4. Hold the stand on each side just below the black buttons, item 4. Do not press the
black buttons.
Note
The black buttons are used only when removing the Magnification Stand.
Note
There are two sets of mounting slots for the Magnification Stand—One set is for 1.8x,
and the other set is for 1.5x. See numbers 2 and 3 in the figure C-arm Accessories on page
83.
5. Align the thick black lines on the Magnification Stand with the thick black lines on
the C-arm. When these lines meet, the hooks of the Magnification Stand align to the
mounting slots on the C-arm. See item 1 in the previous figure.
6. Put the hooks of the Magnification Stand into the C-arm slots. Slide the
Magnification Stand down, until the thin black lines on the Magnification Stand and
the black line of the C-arm meet. See item 2 in the previous figure.
7. The locking pins slide into holes and lock the device. You hear an audible click.
Note
If the Magnification Stand is not installed correctly, there is an indicator with a red shaft
which protrudes. See item 3 in the previous figure. When the stand is installed correctly,
the indicator is retracted.
To Remove the Magnification Stand
1. Remove the Magnification paddle.
2. Hold the handles of the Magnification Stand and press the black buttons.
3. Lift and remove the device from the C-arm.
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7.5 Crosshair Devices
7.5.1 How to Install and Remove the Localization Crosshair Device
Figure 63: Installation of the Localization Crosshair Device
To Install the Localization Crosshair Device
1. Remove the face shield (refer to Patient Face Shields on page 84).
2. Move the Compression Device below the mounting slots, indicated by a crosshair
icon. See item 2 in the figure C-arm Accessories on page 83.
3. Hold the crosshair device by the handles and align the thick lines on the device with
the line on the C-arm. Compress the release levers.
4. Put the hooks into the C-arm slots.
5. Slide the hooks toward the bottom until the thin black lines on the crosshair meet the
black line on the C-arm.
6. Release the levers. The locking pins slide into holes and lock the device in position.
To Remove the Localization Crosshair Device
1. Compress the release levers.
2. Lift the frame toward the top and remove the hooks from the C-arm slots.
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7.5.2 How to Use the Localization Crosshair Device
1. The crosshair device rotates to the left or right of the tubehead. Rotate the device
away from the x-ray beam during the exposure acquired with the localization
paddle.
2. When you rotate the device back to the front for use, make sure the rotation
continues until the device clicks into position.
3. Turn on the light field lamp.
4. Rotate the two crosshair knobs until the shadow on the breast matches the crosshairs
on the image that identifies the suspect lesion.
7.5.3 How to Install and Remove the Magnification Crosshair Device
Figure 64: How to Install and Remove the Magnification Crosshair Device
To Install the Magnification Crosshair Device
1. Remove the face shield (refer to How to Install and Remove the Conventional Face Shield
on page 86).
2. Align the Magnification Crosshair Device with the tubehead.
3. Slide the crosshair device on the rails on each side of the tubehead that are used by
the Conventional Face Shield. Make sure the device locks into position.
4. Install the remaining magnification devices.
To Remove the Magnification Crosshair Device
1. Hold the sides of the device.
2. Pull the device toward you and remove from the tubehead.
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7.5.4 How to Align the Crosshair Device
Note
If the crosshair light rectangle appears skewed to the opening in the paddle, perform
this alignment procedure.
1. Install the rectangular localization paddle.
2. Loosen the adjustment lock screw on the bottom of the Crosshair Device.
3. Put a piece of white paper on the image receptor to make the shadows of the
crosshairs easier to see.
4. Move the localization paddle approximately 6 cm above the image receptor.
5. Turn on the light field.
6. Rotate the Crosshair Device until the rectangle of light aligns with the opening in the
localization paddle.
7. Tighten the adjustment screw.
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8: Clinical Procedures
Warning:
C-arm movement is motorized.
Warning:
Keep the hands of the patient away from all buttons and switches at all times.
Warning:
Place each footswitch in a position where, when used, they remain in reach of
the Emergency Off Switches.
Warning:
Position the footswitches to prevent accidental operation by a patient or
wheelchair.
8.1 Standard Workflow
8.1.1 Preparation
1. Select a patient from the worklist, or manually add a new patient.
2. Identify the required procedures.
3. Select the output device set if a different or additional device is needed.
4. Install the paddle.
5. Select the first view.
8.1.2 At the Gantry
1. Set C-arm height and rotation angle.
2. Make sure the light field illuminates the correct area.
3. Position the patient and compress the breast.
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8.1.3 At the Acquisition Workstation
1. Set the exposure technique.
2. Acquire the image.
3. Release the patient.
4. Preview the image. Look at the Exposure Index to make sure that the exposure is
within acceptable range.
5. You can use the Window/Level tool or other image review options during image
preview.
6. Accept, Reject, or Pend the image.
7. Perform the Acquisition cycle as required for the requested procedures.
8. If necessary, add an additional view or procedure.
9. Make sure that the patient is safely away from the system after you complete the
examination.
10. Close the procedure.
8.2 Screening Procedure Example
Figure 65: Example of a Screening Procedure Screen
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8.2.1 Position the Patient
1. Lift or lower the breast platform for the patient.
2. Move the tubehead to the projection angle.
3. Move the patient to the C-arm.
4. Position the patient as required.
5. Put the arm or hand of the patient on the Patient Handle or against the side of the
body.
6. Tell the patient to keep away from system controls.
7. Compress the breast.
•When possible, use the footswitch controls to provide hands-free compression
control and C-arm height adjustment.
•Use the light field lamp as necessary to see the x-ray field.
•Apply compression slowly. As necessary, stop and make the adjustments to
patient position.
•Use the handwheels for final compression.
8.2.2 Set the Exposure Techniques
Select the exposure techniques for the procedure. Refer to How to Set the Exposure
Parameters on page 70 for information.
8.2.3 Acquire the Exposure
1. Confirm that all exposure factors are set correctly.
2. If the system does not display Ready in 30 seconds, verify that the accessories are
correctly installed and the paddle is locked into position. When the generator status
displays Ready, the system is ready for exposure.
Warning:
This system can be dangerous to the patient and the user. Always follow the
safety precautions for x-ray exposures.
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3. Press and hold the x-ray button and/or the x-ray footswitch for the full exposure.
During the exposure:
•A System Message with the radiation symbol and a yellow background is
displayed (see the following figure)
•An audible tone continues to sound during the exposure
The behavior of the audible tone during a combo exposure has changed to avoid
early releases of the x-ray button and/or the x-ray footswitch by users. The
audible tone is now a continuous sequence of tones. The tone sounds during the
entire combo acquisition from the initiation of the exposure to the end of the
conventional view. There is no interruption of the audible tone between breast
tomosynthesis and conventional digital mammography exposures. Do not
release the exposure switch during the audible tone.
Figure 66: Exposure In Progress
4. When the tone stops and the System Message shows Standby (see the following
figure), you can release the x-ray button and/or the x-ray footswitch.
Figure 67: Exposure Complete
5. Release the compression device. If the automatic release feature is set, the
compression device automatically lifts after the exposure.
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8.3 Procedure for Needle Localization with Tomosynthesis
1. Install a Localization Paddle, and install the Crosshair Device at the Tubehead. Be
sure that the crosshair guides are out of the x-ray field.
2. Open a new procedure with a Tomo or TomoHD view for your approach.
3. Position the patient and apply compression.
4. Acquire a Tomo Scout. Make sure that the ROI is visible inside the Localization
Paddle opening. If not, reposition the patient and repeat.
5. Note the Compression Thickness, and note the thickness of the excess tissue through
the opening of the Localization Paddle.
6. Scroll through the reconstruction slices to identify where the lesion is best seen. Note
the slice number (each slice is 1 mm in thickness).
7. Place the Acquisition Workstation crosshair on the lesion.
8. To find the coordinates for the Gantry Crosshair Device, scroll through the
reconstructions until you can identify the alpha numeric coordinates.
9. Calculate the needle depth:
Value Example
Breast Compression Thickness 50 mm
(+) Thickness of the tissue through the opening of the paddle + 7 mm
(-) Slice number where the lesion is found - 30 mm
(+) Optional distance past the ROI for the wire + 5-15 mm
(=) Needle depth of the localization wire 32– 42 mm
10. Turn on the collimator light and align the Crosshair Device at the Tubehead to match
the Acquisition Workstation crosshair.
11. Position and insert the needle.
12. Move the Crosshair Device guides out of the x-ray field.
13. Acquire another Tomo image to be sure that the needle is in the correct location. To
calculate if a correction is necessary, compare the slice number of the point of the
needle and the slice number of the lesion.
14. Insert the guide wire through the needle, and then remove the needle, if desired,
leaving the wire in position.
15. If desired, complete the following steps:
a. Acquire a Conventional or Tomo view to be sure of correct wire placement.
b. Take the orthogonal view to document wire or needle placement (either in Tomo
or conventional).
16. Only add one view icon at a time for orthogonal views to remove the possibility of
paddle shift due to possible minimal compression.
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Example: Calculating Needle Depth with Tomosynthesis
In this example, use the values from the table on the previous page and refer to the
following figure.
Calculate the needle depth from the tissue skin line (item 1) rather than from the
localization paddle (item 9). Insert the needle a minimum of 27 mm (breast compression
+ bulging tissue).
Figure 68: Calculating needle depth
Item Description Example
1 Thickness of the tissue through the opening of the localization paddle 7 mm
2 Thickness measured from the localization paddle to the lesion
3 Lesion slice number (the slice number where lesion is best seen (clearest)) 30 mm
4 Thickness measured from the detector to the lesion
5 Slice number 1
6 Needle
7 Lesion
8 Advancing the needle 5 - 15 mm more than the lesion (optional) 5 - 15 mm
9 Localization paddle
10 Thickness of the breast compression from the detector (0 mm) to the
localization paddle (50 mm in this example)
50 mm
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9: Maintenance and Cleaning
9.1 Cleaning
9.1.1 General Information About Cleaning
Before each examination, clean and use a disinfectant on any part of the system which
touches a patient. Give the attention to the paddles and the image receptor.
Caution:
Do not use any hot source (like a heating pad) on the image receptor.
Be careful with the compression paddles. Inspect the paddles. Replace the paddle when
you see damage.
9.1.2 For General Cleaning
Use a lint-free cloth or pad and apply a diluted dishwashing liquid.
Caution:
Use the least possible amount of cleaning fluids. The fluids must not flow or run.
If more than soap and water is required, Hologic recommends any one of the following:
•10% chlorine bleach and water with one part commercially available chlorine bleach
(normally 5.25% chlorine and 94.75% water) and nine parts water
•Commercially available isopropyl alcohol solution (70% isopropyl alcohol by
volume, not diluted)
•3% maximum concentration of hydrogen peroxide solution
After you apply any of the above solutions, use a pad and apply a diluted dishwashing
liquid to clean any parts which touch the patient.
Warning:
If a paddle touches possible infectious materials, contact your Infection
Control Representative to remove contamination from the paddle.
Caution:
To prevent damage to the electronic components, do not use disinfectant sprays on
the system.
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9.1.3 To Prevent Possible Injury or Equipment Damage
Do not use a corrosive solvent, abrasive detergent, or polish. Select a
cleaning/disinfecting agent that does not damage the plastics, aluminum, or carbon fiber.
Do not use strong detergents, abrasive cleaners, high alcohol concentration, or methanol
at any concentration.
Do not expose equipment parts to steam or high temperature sterilization.
Do not let liquids enter the internal parts of the equipment. Do not apply cleaning sprays
or liquids to the equipment. Always use a clean cloth and apply the spray or liquid to the
cloth. If liquid enters the system, disconnect the electrical supply and examine the system
before returning it to use.
Caution:
Wrong cleaning methods can damage the equipment, decrease imaging performance,
or increase the risk of electric shock.
Always follow instructions from the manufacturer of the product you use for cleaning.
The instructions include the directions and precautions for the application and contact
time, storage, wash requirements, protective clothing, shelf life, and disposal. Follow the
instructions and use the product in the most safe and effective method.
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9.1.4 Acquisition Workstation
How to Clean the Image Display Screen
Avoid touching the display screen of the Image Display monitor.
Use care when cleaning the outer surface of the LCD screen. Always use a clean, soft,
lint-free cloth to clean the display area. Microfiber cloths are recommended.
•Never use a spray or flow a liquid on the display.
•Never apply any pressure to the display area.
•Never use a detergent with fluorides, ammonia, alcohol, or abrasives.
•Never use any bleach.
•Never use any steel wool.
•Never use a sponge with abrasives.
There are many commercially available products to clean LCD displays. Any of the
products free of the ingredients described above and used according to the directions of
the manufacturer can be used.
How to Clean the Touchscreen Display
Use a window or glass cleaning product to clean the Touchscreen display. Apply the
cleaning product to a cloth, then clean the Touchscreen display. Do not apply the
cleaning product to the display without the cloth.
How to Clean the Keyboard
Wipe the surfaces with a CRT wipe. If necessary, clean the keyboard with a vacuum. If
liquids enter the keyboard, contact Technical Support for a replacement.
How to Clean the Fingerprint Scanner
Caution:
To protect the Fingerprint Scanner:
xDo not apply any liquid product directly on the Fingerprint Scanner window.
xDo not use products that contain alcohol.
xNever put the Fingerprint Scanner under liquid.
xNever apply any pressure to the Fingerprint Scanner window with abrasive
material.
xDo not push the Fingerprint Scanner window.
To clean the Fingerprint Scanner window, do one of the following:
•Apply the adhesive side of cellophane tape, then remove the tape.
•Apply a product with ammonia base to a cloth, and clean the Fingerprint Scanner
window.
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9.2 Maintenance
9.2.1 Preventive Maintenance Schedules
Table 18: User Preventive Maintenance
Recommended Frequency
Maintenance Task Description Each
Use Weekly Biweekly Monthly Bimonthly Semiannually
Clean & disinfect paddle x
Clean & disinfect breast platform x
Visually inspect all paddles for
damage
x
Detector Flat Field Calibration * x
Artifact Evaluation * x
Phantom Image * x
Signal to Noise / Contrast to Noise
Measurements *
x
Geometry Calibration
(Tomosynthesis Option) *
x
Compression Thickness Indicator * x
Visual Checklist * x
Compression * x
* Refer to Quality Control Manual
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Table 19: Service Engineer Preventive Maintenance
Maintenance Task Description Recommended Frequency
Semiannually Annually
Clean and Inspect the Gantry and Acquisition Workstation x
Inspect the radiation shield for chips, cracks, breaks, and for tight attachments. x
Check all primary power connections x
Check interlocks, safety and limit switches x
Inspect/Lubricate C-arm x
C-arm / Verify all C-arm buttons x
Verify C-arm and Rotational Calibration x
Replace Breast Platform Filter x
Verify Compression Force Calibration x
Verify Compression Thickness Calibration x
Inspect LED Collimator Lamp for dust and dirt x
Clean & lubricate collimator, and worm screws x
Perform Rotational Brake verification x
Verify X-ray Field / Light Field Calibration x
Verify kV Calibration and Tube Current Calibration x
Check HVL Evaluation x
Verify Target Dose Verification x
Verify AEC Exposure Compensation 2D x
Perform System Resolution Test * x
Perform Phantom Image Quality Evaluation * x
Perform Image Artifact Evaluation * x
Backup Acquisition Workstation files x
Evaluate UPS Performance Status/ Batteries Status x
Backup all Calibration Data x
* Refer to Quality Control Manual
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9.2.2 About Reclamation
Reclamation is an automatic function that makes disk space available for storing newly
acquired images. Configurable parameters let a given number of images collect before
reclamation starts and older images are removed from the system.
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10: System Administration Interface
10.1 Admin Screen
This section describes the functions available in the Admin screen. To access all the
functions in this screen, log in to the system as a user with administrator, manager, or
service permissions.
Refer to the table on the following page for descriptions of the Admin screen functions.
Note
Depending on the license settings for your system, you may see different buttons.
Figure 69: Admin Screen
Table 20: Admin Screen Functions
Group Button Function
Operators Manage Operators Add, delete or change Operator information.
My Settings Change the information for the current Operator.
Procedures Procedure Editor Add or Edit the procedures, or change the view order for each user.
Procedure Order Change the procedure list order.
View Editor Set the default view order for a procedure and edit individual
views.
Contrast Access the contrast enhanced digital mammography functionality.
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Table 20: Admin Screen Functions
Group Button Function
Quality Control Quality Control Select a Quality Control task to perform or mark completed.
QC Report Create a QC Report.
Test Patterns Select and send the test patterns to output devices.
Reject and Repeat
Report
Create a Reject and Repeat Report.
System System Tools The Interface for Service for the configuration of and identification
of problems in the Acquisition Workstation.
System Defaults Set the Gantry default values.
System Diagnostics Shows the status of all subsystems.
Preferences Set the system preferences.
About Describes the system. Refer to About Screen on page 113.
Exposure Report Create a radiation Exposure Report.
Biopsy Devices Lists available biopsy devices.
QAS Access the QAS Needle Test screen.
Lateral QAS Access the Lateral QAS Needle Test screen.
Connectivity Query Retrieve Query the configured devices.
Import Import the data from a DICOM source.
Manage Output
Groups
Add, delete, or edit output groups.
Incoming Log Shows log entries for images that do not import during manual
import or DICOM store.
Archive Send local studies to networked storage or export to removable
media devices.
You must have permission to access all features. The permission level controls the functions you can change.
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10.2 About Screen
The About screen provides information about the machine, such as system level, IP
address, and Gantry serial number. This type of data can be useful when you are
working with Hologic to resolve a system issue or configure the system. To access the
About screen, select About from the System group in the Admin screen.
Note
You can also access the About screen through the Taskbar. Select the Tube Icon” then
select About….
Figure 70: System Tab of the About (the Acquisition Workstation) Screen
There are five tabs on the About screen:
•System Tab (default) - lists system configuration information
•Licensing Tab - lists the Hologic-licensed options installed on this machine
•Institution Tab - lists the name and address of the organization assigned to this
machine
•Copyright Tab - lists the copyrights of Hologic and third-party software installed
on this machine
•UDI Tab - lists the unique device identifier(s) of this machine
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10.2.1 Licensing Tab
The Licensing tab of the About screen shows all the licenses installed on your system.
Note
Hologic configures some systems to meet specific requirements. Your system
configuration may not have all the options and accessories included in this manual.
Figure 71: Licensing Tab of the About Screen
10.3 Change the User Language Preference
Users can set the language on the user interface to automatically change to their
individual preference when logging in.
1. In the Operators group of the Admin screen, select My Settings.
Note
You can also access My Settings through the taskbar. Select the User Name area then
select My Settings in the pop-up menu.
2. The Users tab of the Edit Operator screen opens. From the Locale field, select a
language from the drop-down list.
3. Select Save, then select OK to the Update Successful message. The user interface
changes to the selected language.
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10.4 Set Auto-Hanging and Auto-Pairing
To set the system for Auto-Hanging and Auto-Pairing of images:
1. In the Operators group of the Admin screen, select My Settings.
Note
You can also access My Settings through the Taskbar. Select the User Name area then
select My Settings in the pop-up menu.
2. The Edit Operator screen opens. Select the Workflow tab.
•Select the Auto-Hanging check box to show a prior study in 4-up mode
automatically.
•Select the Auto-Pairing check box to show a prior view in multi-up mode next to
a newly captured image.
Figure 72: Enable Auto-Hanging and Auto-Pairing
3. Select Save, then select OK to the Update Successful message.
10.5 Set Multi Line Procedure Tabs
You can set the operator preferences to display more of the procedure name in the top of
the procedure tabs. To change the procedure tabs from a single line of text to multiple
lines of text:
1. In the Operators group of the Admin screen, select My Settings.
Note
You can also access My Settings through the Taskbar. Select the User Name area then
select My Settings in the pop-up menu.
2. The Edit Operator screen opens. Select the Workflow tab.
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3. Select the Use Multi Line Procedure Tabs check box.
Figure 73: Enable Multi Line Procedure Tabs
4. Select Save, then select OK in the Update Successful message.
10.6 Enable and Set the Height Memory
Users can enable and set the acquisition workstation height to automatically change to
their individual preference when logging in. To enable and set the height adjust memory:
1. In the Operators group of the Admin screen, select My Settings.
Figure 74: My Settings Button in the Admin Screen
Note
You can also access My Settings through the Taskbar. Select the User Name area then
select My Settings in the pop-up menu.
2. In the Edit Operator screen, select the Console tab.
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3. To enable the height adjust memory, select the radio button to the right of the "Auto-
Height adjustment on login" field. A check mark appears. (To disable the height
adjust memory, clear the radio button.)
Figure 75: Console Tab of the Edit Operator Screen
4. Use the Ÿ UP and ź DOWN buttons on the height adjust control panel to set the
desired height (see the following figure).
Figure 76: Height Adjust Control Panel
5. The Desired console height field displays the height as it is now positioned. The
Current console height field displays the most recently saved height. (See the
following figure.) To save your desired height setting, select Apply.
Figure 77: Desired Console Height and Current Console Height Fields
6. Select Save, then select OK to the Update Successful message.
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10.7 Set Auto-Accept and Auto-Pend Images
A manager user can configure the system to automatically accept or automatically pend
new images.
1. In the System group of the Admin screen, select Preferences. The System Preferences
screen opens.
2. Select the Image Auto Disposition tab.
3. Use the drop-down menus to select the auto disposition for each type of image.
•Select Manual to manually accept, reject, or pend each newly acquired image.
•Select Accept to automatically accept newly acquired images.
•Select Pend to automatically pend newly acquired images.
Figure 78: Set Image Auto Disposition
4. Select Save, then select OK to the Update Successful message.
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10.8 How to Set the Contrast Defaults
A manager user can configure the default timer periods and the default contrast
information.
Set the Default Timer Periods
1. From the Procedures group in the Admin screen, select the Contrast button.
Figure 79: I-View 2D Contrast Default Settings
2. Choose the plus (+) or minus (-) buttons to change the Minutes and Seconds for the
Waiting Period and Optimal Imaging Period.
3. Select Save.
Your selections appear as the default timer settings on the Contrast tab.
Set the Default Contrast Information
1. From the Procedures group in the Admin screen, select the Contrast button.
2. Select one or more Contrast agents, Entry routes, and Concentration. See the
previous figure.
3. Select Save.
Your selections appear as the default options in the Contrast Information dialog box.
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10.9 Enable and Set the Default Height
A manager can set the acquisition workstation to automatically return to a default height
when a user logs out. To enable and set the default height:
1. In the system group of the Admin screen, select Preferences.
Figure 80: Preferences Button in the Admin Screen
2. In the System Preferences screen, select the Console tab.
3. To enable the default height, select the radio button to the right of the "Auto-Height
adjustment on logout" field. A check mark appears. (To disable the default height
option, clear the radio button.)
Figure 81: Console Tab of the System Preferences Screen
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4. Use the Ÿ UP and ź DOWN buttons on the height adjust control panel to set the
desired height (see the following figure).
Figure 82: Height Adjust Control Panel
5. The Desired console height field displays the height as it is now positioned. The
Current console height field displays the most recently saved height. (See the
following figure.) To save your desired height setting, select Apply.
Figure 83: Desired Console Height and Current Console Height Fields
6. Select Save, then select OK to the Update Successful message.
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10.10 System Tools
The Radiologic Technologist Managers and users with Service permissions can access the
System Tools utility. The System Tools utility contains the configuration information
about the system. To access the utility, select System Tools from the System group in the
Admin screen.
Figure 84: System Tools Button
10.10.1 System Tools for the Radiologic Technologist Manager
Figure 85: System Tools Screen
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Table 21: Radiologic Technologist Manager—System Tools Functions
Section Screen Functions
Getting Started About: The introduction to the service tool.
FAQ: List of common questions.
Glossary: List of terms and descriptions.
Platform: List of directories, software version numbers, and system
software statistics.
Shortcuts: List of Windows shortcuts.
AWS Connectivity: List of Installed Devices.
Film & Image Information: Create an Image Report*. Create a QC
Report. (*You can also access this report from a remote computer.
Refer to Remote Access to Image Reports on page 124.)
Licensing: List of Installed Licenses.
User Interface: Change the options in the Software application.
Internationalization: Select the local language and culture.
Troubleshooting AWS: Allows for download of images.
Computer: System Management and Network Information.
Log: Change the event record options.
Backups: Control the backups for the system.
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10.10.2 Remote Access to Image Reports
Access image reports via a remote computer networked to the system. This function can
be useful for sites that do not permit USB downloads of reports directly from the system.
Follow these steps to access image reports from a remote computer. You must log in to
the System Tools as a Manager-level user for this procedure.
1. Get the IP Address for the system you want to access. You can get the IP Address
from your IT administrator or from the system. From the system, go to Select Patient
Screen > “Tube Icon” on Taskbar > About… > System Tab > IP Address. Write
down the IP Address.
2. Using an internet browser on your remote computer, navigate to http:// [IP
address]/Hologic.web/MainPage.aspx. Use the IP Address from step 1.
3. The Service Tools Logon screen opens. Type a Manager-level user name and password,
and then click Submit.
Figure 86: Remote Logon Screen for Service Tools
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4. The Service Tools Welcome screen opens. Go to AWS > Film & Image Information >
Create Image Report.
Figure 87: Service Tools Welcome Screen
5. Select the parameters for the report and click Generate.
Figure 88: Create Image Report Parameters
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6. The report shows on the screen. Scroll to the bottom of the report and select either
Click to Download (html) or Click to Download (csv) for the file download type.
Click Save when prompted.
Figure 89: Create Image Report
7. Select a folder on the computer, and then click Save.
8. Log out from Service Tools when finished.
10.11 Archive Tool
The archive feature in the Admin
screen lets you:
xSend local studies to an
archive.
xExport studies to removable
media.
Figure 90: Archive Button
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1. From the Connectivity group in the Admin screen, select the Archive button. The
Multi Patient On Demand Archive screen opens.
2. To search for a patient, enter at least two characters in the Search parameters area
and select the magnifying glass.
A list of patients that match the search criteria is displayed.
Figure 91: Multi Patient On Demand Archive Screen
Figure Legend
1. Search parameters
2. Patient List area
3. Patients To Be Archived
area
4. Add selection in the
Patient List area to the
Patients To Be Archived
area
5. Remove the selection from
the Patients To Be
Archived area
To Archive:
1. Select the patients and the procedures to archive.
•Select patients from the patient list, or do a search with the search parameters
(item 1) and select patients from the search results.
Note
The Select All button (on the right side of the screen) selects all the patients in the
Patient List area. The Clear button (on the right side of the screen) clears selections.
•Select the procedures for each patient.
•Select the Down Arrow (item 4) on the screen to move the selected patients to the
Patients To Be Archived area (item 3).
•Select the Up Arrow (item 5) on the screen to remove the selected patients from
the Patients To Be Archived area (item 3).
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2. Select a storage device.
•Select an option from the Store Device drop-down menu.
-OR-
•Select the Group List button, then select an option.
3. Select the Archive button. The list in the Patients To Be Archived area copies to the
selected archive devices.
Note
Use the Manage Queue utility in the taskbar to review the archive status.
To Export:
1. Select the patients and the procedures to export.
•Select patients from the patient list, or do a search with one of the search
parameters (item 1) and select patients from the search results.
Note
The Select All button (on the right side of the screen) selects all the patients in the
Patient List area. The Clear button (on the right side of the screen) clears selections.
•Select the procedures for each patient.
•Select the Down Arrow (item 4) on the screen to move the selected patients to the
Patients To Be Archived area (item 3).
•Select the Up Arrow (item 5) on the screen to remove the selected patients from
the Patients To Be Archived area (item 3).
2. Select the Export button.
3. In the Export dialog box, select the Target from the drop-down menu of media
devices.
Figure 92: Export Screen
4. Select other options, if necessary:
•Anonymize: to anonymize patient data.
•Advanced: to select a folder on your local system to keep the selections, and also
to select the Export types.
5. Select the Start button to copy the selected images to the selected device.
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Appen dix A Specifications
A.1 Product Measurements
A.1.1 Tubestand (Gantry with C-Arm)
Figure 93: Tubestand (Gantry with C-arm) Measurements
A. Height 223 cm (87.8 inches)
B. Width 66 cm (26 inches)
C. Width 173 cm (68 inches)
D. Depth 138 cm (54.25 inches)
Weight Maximum of 400 kg (882 pounds)
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A.1.2 Acquisition Workstations
Universal Acquisition Workstation
Figure 94: Universal Acquisition Workstation Measurements
A. Width (maximum) with optional
articulated display arm extended
136 cm (53.4 inches) - series I UAWS
128 cm (50.3 inches) - series II UAWS
Width (maximum) with standard
display arm
94.0 cm (36.9 inches) - series I UAWS
107 cm (42.0 inches) - series II UAWS
B. Depth (maximum) with keyboard tray
extended and optional articulated
display monitor arm
122 cm (48.4 inches) - series I UAWS, rotated to the side
115 cm (45.1 inches) - series II UAWS, rotated to the side
Depth (maximum) with keyboard tray
extended and standard display arm
83.6 cm (32.9 inches) - series I and II UAWS
C. Height (nominal) 219 cm (86.1 inches) after August 2017
204 cm (80.3 inches) before September 2017
Weight (maximum) 209 kg (460 pounds)
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Acquisition Workstation for Mobile Use
Figure 95: Mobile Universal Acquisition Workstation Measurements
A. Width (maximum) with mobile
display arm
100 cm (39.5 inches) - series I UAWS
107 cm (42.0 inches) - series II UAWS
B. Depth (maximum) with keyboard
tray extended
85 cm (33.5 inches)
C. Height (maximum) 180 cm (71 inches)
Weight (maximum) 179 kg (395 pounds)
A.2 Operation and Storage Environment
A.2.1 General Conditions for Operation
Temperature Range 20 °C (68 °F) to 30 °C (86 °F)
Relative Humidity Range 20% to 80% without condensing moisture
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A.2.2 Storage Environment
Gantry
Temperature Range –10 °C (14 °F) to 40 °C (104 °F)
Relative Humidity Range 10% to 90% without condensing moisture
(Put in a package for storage in a building.)
X-ray Detector
Temperature Range 10 °C (50 °F) to 30 °C (86°F) indefinitely
10 °C (50 °F) to 35°C (95 °F) for a maximum of 12 hours
Maximum rate of temperature change Less than 10 °C (50 °F) per hour
Relative Humidity Range 10% to 80% without condensing moisture
(Put in a package for storage in a building.)
Acquisition Workstation
Temperature Range –10 °C (14 °F) to 40 °C (104 °F)
Relative Humidity Range 10% to 90% without condensing moisture
(Put in a package for storage in a building.)
A.3 Radiation Shield
Radiation Shield Lead (Pb) equivalent 0.5 mm lead for x ray energy to 35 kV
A.4 Electrical Input
A.4.1 Tubestand
Mains Voltage 200/208/220/230/ 240 VAC ±10%
Mains Impedance Maximum line impedance not to exceed 0.20 ohms for
208/220/230/240 VAC, 0.16 ohms for 200 VAC
Mains Frequency 50/60 Hz ±5%
Average Current over 24 Hours < 5 A
Peak Line Current 4 A (65 A maximum for < 5 seconds)
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A.4.2 Acquisition Workstation
Mains Voltage 100/120/200/208/220/230/240 VAC ±10%
Mains Frequency 50/60 Hz ±5%
Power Consumption < 1000 watts
Duty Cycle (Standard Acquisition
Workstation)
10% ~ 6 minutes per hour or 2 minutes on, 18 minutes off
Overcurrent Protection 8A
A.5 Tubestand Technical Information
A.5.1 C-Arm
Rotation Range Conventional Mammography:
+195° +3°/–0.5° to 0° ±0.5° to –155° +0.5°/–3°
Tomosynthesis option:
+180° ±0.5° to 0° ±0.5° to –140° ±0.5°
Absolute Angular Position accurate to ±0.5°
Rotation Acceleration 18°/s2 +18/-9%
Rotation Deceleration 18°/s2 +18/-9%
Rotational Positioning Angular Velocity 18°/s ±25%
Note
The angular velocity is the average of the velocity of the tube arm rotating clockwise
between 0° and 90° or rotating counterclockwise between 90° and 0°. The angular
velocity does not include the time to accelerate from zero velocity and decelerate to zero
velocity.
Source-to-Image Distance (SID) 70.0 cm ±1.0 cm (27.6 inches ±0.4 inches)
(Focus position deviation is ±5 mm)
Patient Support (non-magnification)
Vertical Position Lower Limit 70.5 cm +5.1/-0 cm (27.75 inches +2.0/-0 inches)
Vertical Position Upper Limit 141 cm +0/-17.8 cm (55.5 inches +0/-7.0 inches)
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A.5.2 Compression
Manual Compression Force Maximum of 300 N (67.4 pounds)
Motorized Compression Functions in three operating modes:
Pre-compression, Full-Range, Dual Compression.
User selectable through software.
Pre-Compression Force 15 pounds to 30 pounds (67 to 134 N), motorized
Full Range Compression Force 20 pounds to 40 pounds (89 to 178 N), motorized
Dual Mode Compression Provides Pre-Compression force upon first activation of
compression switch; then, if switch is activated within 2
seconds, the force is increased incrementally for each
additional switch activation, up to the user selected full
compression force.
Compression Controls Up/Down controls on both sides of C-arm and on 2-position
footswitch (Motorized). Handwheel on both sides of
Compression Device (Manual).
Compression Release Manual Motorized Release controlled by push-buttons on both
sides of the C-arm.
Automatic Compression Release User selectable automatic release mode raises Compression
Device upon exposure termination.
Down Motion Variable Speed 4.2 cm/s ±15% (1.66 inches/s ±15%)
Compression Force Display Two LCDs on the Compression Device show the compression
force through the range of 18 N to 300 N in 1 N increments (4
pounds to 67 pounds in 1 pound increments).
Compression Force Display Accuracy ±20 N (±4.5 pounds)
Compression Thickness Display Two LCDs on the Compression Device measure compression
thickness in 0.1 cm increments. The display is visible from
both sides of the patient.
Compression Thickness Accuracy ±0.5 cm (±0.2 inches) for thicknesses between 0.5 cm and 15
cm (5.9 inches)
Breast Tomosynthesis Compression
Thickness
Standard resolution tomosynthesis
Maximum: 24 cm (restricted by compression device geometry)
High resolution tomosynthesis
Maximum: 15 cm (restricted by DICOM limitations)
Compression Paddles Compression Paddles are transparent. The paddles are
composed of polycarbonate resin or the equivalent. With
compression applied, paddle deflection from a plane parallel to
the patient support surface shall be less than or equal to 1.0
cm.
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A.5.3 X-ray Tube
Focal Spot Large (0.3 mm) Nominal
Small (0.1 mm) Nominal
Tube Voltage 20 kV to 49 kV
Anode Material Tungsten
X-Ray Window Beryllium 0.63 mm
Tube leakage test conditions 49 kVp, 2.0 mA
A.5.4 X-ray Beam Filtration and Output
Filtration Five-position filter wheel:
Position 1: Rhodium, 0.050 mm ±10%
Position 2: Aluminum, 0.70 mm (nominal) (Tomosynthesis
option)
Position 3: Silver, 0.050 mm ±10%
Position 4: Copper, 0.3mm
Position 5: Lead (provided for servicing)
kV/mA Range
Table 22: Maximum mA Setting as a Function of kV
kV LFS mA SFS mA
20 100 30
21 110 30
22 110 30
23 120 30
24 130 30
25 130 40
26 140 40
27 150 40
28 160 40
29 160 40
30 170 50
31 180 50
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Table 22: Maximum mA Setting as a Function of kV
kV LFS mA SFS mA
32 190 50
33 200 50
34 200 50
35 200 50
36 190 50
37 180 50
38 180 50
39 180 50
40 170
41 170
42 160
43 160
44 150
45 150
46 150
47 140
48 140
49 140
mAs Steps (Table 1, default) 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 22, 25, 30, 32.5, 35, 37.5,
40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60, 62.5, 65, 67.5, 70, 75,
80, 85, 90, 95, 100, 120, 140, 160, 180, 200, 220, 240, 260,
280, 300, 320, 340, 360, 380, 400, 420, 440, 460, 480, 500
Attenuation of Carbon Fiber
Image Receptor < 0.3 mm Al
Magnification Platform < 0.3 mm Al
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A.5.5 X-ray Collimation
Collimation Fields 7.0 cm x 8.5 cm
10 cm x 10 cm
15 cm x 15 cm
18 cm x 24 cm
18 cm x 29 cm (Tomosynthesis option)
24 cm x 29 cm
A.5.6 Light Field Indication
Light Field to X Ray Congruency Within 2% of SID
A.5.7 X-ray Generator
Type Constant Potential High Frequency Inverter
Rating 7.0 kW, maximum (isowatt), 200 mA at 35 kV
Electrical Power Capacity 9.0 kW maximum
kV Range 20 kV to 49 kV in 1 kV increments
kV accuracy ±2%, over range 20-49 kVp
mAs Range 3.0 mAs to 500 mAs in Manual Mode mAs (8 mAs minimum
in AEC Mode)
mAs Accuracy ±(10% + 0.2 mAs)
mA Range 10 mA to 200 mA, Large Focal Spot
10 mA to 50 mA, Small Focal Spot
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A.6 Imaging System Technical Information
A.6.1 Image Receptor
Fluid Ingress No fluid from accidental spillage on the Image Receptor may
seep inside.
Deflection Does not exceed 1.0 mm at maximum compression.
Active Imaging Area Not less than 23.3 cm by 28.5 cm (9.2 inches x 11.2 inches)
DQE Conventional Mammography Not less than 50% at 0.2 lp/mm
Not less than 15% at the Nyquist limit
DQE (Tomosynthesis option) Not less than 30% at 0.2 lp/mm
Not less than 15% at the Nyquist limit
Dynamic Range and Linearity Detector Subsystem response is linear with linearity of 0.999
over a dynamic range of 400:1 in x-ray exposure.
Uniformity Detector Subsystem can correct pixel-to-pixel gain variations.
For conventional mammography procedures, the uniformity of
flat field image response of the detector shall be no greater than
2% after gain calibration is applied over an exposure range of
0.5 mR to 200 mR.
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Appen dix B System Messages and Alert Messages
B.1 Error Recovery and Troubleshooting
Most faults and alert messages are cleared without result to your workflow. Follow the
instructions on the screen or fix the condition then clear the status from the Taskbar.
Some conditions require a system restart or indicate that more action is necessary (for
example, to call Hologic Technical Support). This appendix describes the message
categories and your actions to return the system to normal operation. If errors repeat,
contact Hologic Technical Support.
B.2 Types of Messages
B.2.1 Fault Levels
Each Message has a particular set of the following characteristics:
•Aborts an exposure in progress (yes/no)
•Prevents an exposure from starting (yes/no)
•Displays a message to the user on the Acquisition Workstation (yes/no)
•May be reset by the user (yes/no)
•May be reset automatically by the system (yes/no)
Displayed Messages
All displayed messages will be shown in the user’s selected language.
Any message which aborts an exposure or prevents an exposure from starting will
always display a message directing the user’s actions required to proceed.
Additional Message Information
Technical information about the message is available in the log file.
Some messages always show as a critical fault (a system restart is necessary). These
messages result from a condition which prevents an exposure, and which cannot be reset
by the user or the system.
Appendix B
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Appendix B: System Messages and Alert Messages
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B.2.2 System Messages
When the following system messages show, do the step shown in the User Action
column to clear the message and allow the next exposure.
Table 23: System Messages
Icon Message User Action
Paddle is moving No action needed.
Sending notice No action needed.
Invalid use of Magnification
Stand
You selected a tomographic view with the Magnification
Stand installed. Select a non-tomographic view.
(Tomosynthesis option)
Face shield is not secured Fully extend or fully retract the Face Shield. (Tomosynthesis
option)
Invalid use of compression
paddle
Remove the Magnification Stand or install the Magnification
Paddle.
Paddle position does not
match selected view
Shift the Paddle to the correct location for the selected view.
Compression is less than 4.5
cm during calibration
Move the Compression Paddle higher than 4.5 cm to
complete the calibration procedure.
FAST compression is engaged Disengage FAST compression and install a paddle
designated for this mode.
License is missing A license is necessary to use this feature or function. (This
message is for your information only. There are no user
actions.)
Invalid detector calibration Install the Magnification Stand for Small Focal Spot
calibration. Remove the Magnification Stand to do Large
Focal Spot calibration.
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Table 23: System Messages
Icon Message User Action
Invalid geometry calibration Repeat the geometry calibration before you try to take an
exposure. (Tomosynthesis option)
Configuration file is missing Applies to Service Personnel.
Waiting for Detector No action needed.
System in Test Mode Applies to Service Personnel.
Tube needs to be manually
positioned (move to 0 degrees)
Rotate the C-arm to 0 degrees.
Tube needs to be manually
positioned (move to -15
degrees)
Rotate the C-arm to -15 degrees.
Tube needs to be manually
positioned (move to 15
degrees)
Rotate the C-arm to +15 degrees.
The Emergency Stop switch
has been engaged.
Turn the Emergency Off switch one-quarter turn to reset the
switch.
Compression too low for tomo
reconstructions.
Move the Compression Paddle higher than 0.5 cm to take
tomography exposures.
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Appendix B: System Messages and Alert Messages
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B.3 UPS Messages
Note
The User Guide for the UPS is supplied with the system. Refer to the UPS User Guide for
complete instructions.
The LCD in the UPS shows the power status.
Figure 96: UPS LCD Display
Figure Legend
1. UPS Mode
2. UPS Load
3. UPS Efficiency
4. UPS Battery level
If the UPS battery expires, the Mode icon changes as shown. Contact
your service representative to replace the battery.
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Appendix C: Use of Mobile System
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Appen dix C Use of Mobile System
This appendix describes the system installed in a mobile environment.
C.1 Conditions for Safety and Other Precautions
An acceptable, stable, clean VAC power source is required to make sure that the system
meets all its performance specifications. Where available, shore power correctly supplied
to the system provides the best performance. If a mobile power generator is used, you
must keep the specifications for input power during all load conditions.
Warning:
The radiation shield is not approved for mobile use and is not provided. The
coach manufacturer must provide adequate shielding.
Caution:
When shore power is unavailable, mobile power sources that provide equivalent
performance may be employed. (Refer to Specifications for Mobile Use on page 144.)
Proper system function and performance can only be ensured if continuous true
sinusoidal VAC power is supplied per the system power input specifications and
loading characteristics. Intermittently, the power source must provide 65 Amps at 208
VAC for a minimum of 5 seconds, and 4 Amps maximum continuous otherwise. This
load must be supported once every 30 seconds. In the event of shore or mobile power
service interruption, the UPS must be capable of providing the operational power
described above for a minimum of 4 minutes. Acquisition Workstation and Gantry
power must be fed on separate dedicated circuits. The use of an uninterruptible
power supply with active line conditioner is recommended on each power circuit.
Accordingly, all ancillary mobile coach power should be distributed by other circuits.
The electrical installation must be verified to meet system power input specifications
and IEC 60601-1 safety requirements after initial installation and upon each
relocation of the mobile coach.
Caution:
The temperature and humidity inside the vehicle must be maintained at all times. Do
not allow environmental conditions to exceed stated specifications when the unit is
not in use.
Caution:
Voltages cannot change by more than ±10% when the x-ray unit or other equipment
(for example, heating or air conditioning) is operated.
Appendix C
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Appendix C: Use of Mobile System
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Caution
To avoid image artifacts from occurring:
xCare should be exercised not to locate or park the mobile coach near sources of
high power (such as power transmission lines and outdoor transformers).
xMake sure that any mobile power generator, uninterruptible power system
(UPS), or voltage stabilizer is at least 3 meters (10 feet) from the closest point of
the image detector travel.
C.2 Specifications for Mobile Use
The following system specifications are for mobile use only. For all other specifications,
refer to the section Specifications on page 129.
C.2.1 Shock and Vibration Limits
Vibration Limit Maximum of 0.30 G (2 Hz to 200 Hz), measured at the point
where the system mounts to the coach.
Shock Limit Maximum of 1.0 G (1/2 sine pulse), measured at the point
where the system mounts to the coach. An “air ride” coach
suspension is recommended.
C.2.2 Coach Environment
Operation Environment
Temperature Range 20 °C (68 °F) to 30 °C (86 °F)
Relative Humidity Range 20% to 80% without condensing moisture
Non-operating/Transit Environment
Temperature Range 10 °C (50 °F) to 35 °C (95 °F) for a maximum of 12 hours
10 °C (50 °F) to 30 °C (86 °F) indefinitely
Maximum Rate of Temperature Change <10 °C/hr.
Relative Humidity Range 10% to 80% without condensing moisture
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C.3 Electrical Input
C.3.1 Gantry
Mains Voltage 200/209/220/230/ 240 VAC ±10%
Mains Impedance Maximum line impedance not to exceed
0.20 ohms for 208/220/230/240 VAC,
0.16 ohms for 200 VAC
Mains Frequency 50/60 Hz ±5%
Average Current over 24 Hours < 5 A
Peak Line Current 4 A (65 A maximum for 3 seconds)
C.3.2 Acquisition Workstation
Mains Voltage 100/120/200/ 208/220/230/ 240 VAC ±10%
Mains Frequency 50/60 Hz ±5%
Power Consumption < 1000 watts
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C.4 Prepare the System for Travel
Before travel, perform these steps:
1. Rotate the C-arm to 0 degrees (CC position).
2. Lower the C-arm to its lowest position.
3. Turn off the system through the user interface.
4. Place the mouse in the keyboard tray.
5. Lock the keyboard tray (see the following figures):
a. Close the tray.
b. Find the knob under the tray.
c. Turn the knob 90° until the knob fits into the lock. Position A in the following
figure shows the locked position.
Figure 97: Keyboard Tray Lock Knob
Figure 98: Keyboard Tray Lock Knob
Figure 99: Tray Lock Release from Locked (A) to Unlocked (D)
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6. If using the mobile Universal Acquisition Workstation, lock the swivel display using
the knobs provided (see the following figure).
Figure 100: Swivel Lock Knobs for Image Display
Monitor on Mobile Universal Acquisition Workstation
7. Lower the work surface to the minimum height.
8. Remove all system accessories.
9. Put all accessories in a safe storage area.
C.5 Prepare the System for Use
1. Unlock the keyboard tray:
a. Find the knob under the tray.
b. Pull the knob down.
c. Turn the knob 90°. This position keeps the latch open. Position D (in the
following figure) shows the unlocked position.
Figure 101: Tray Lock Release from Locked (A) to Unlocked (D)
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Appendix C: Use of Mobile System
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2. Pull the tray out, if needed.
3. If using the mobile Universal Acquisition Workstation, unlock the swivel display (see
the following figure).
Figure 102: Swivel Lock Knobs for Image Display Monitor
on Mobile Universal Acquisition Workstation
C.6 Test the System after Travel
C.6.1 Mobile System Controls and Functional Tests
Perform the Controls and Functional Tests. Refer to Perform the Functional Tests on page
32.
•Compression Up/Down
•Compression Release
•C-arm Rotation
•C-arm Up/Down
•Collimator Override
•Light Field Lamp
•Shifting Paddle System
•Emergency Off Switches
C.7 Quality Control Tests
Refer to your quality control manual for quality system checks.
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Appendix D: Dose Information
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Appen dix D Dose Information
D.1 EUREF Dose Tables
Notes
This information is only applicable for the European Union.
The following values are for the default dose tables.
The following tables show typical dose values when operating the system in 2D and in
BT imaging modes. The tables follow the procedures given in the European guidelines for
quality assurance in breast cancer screening and diagnosis, Fourth edition: section 2a.2.5.1
Dosimetry, and Appendix 5: Procedure for determination of average glandular dose.
Table 24: 2D Dose (EUREF)
Phantom cm kV Anode Filter EUREF dose (mGy)
2.0 cm PMMA 2.1 25 W 0.05 mm Rh 0.55
3.0 cm PMMA 3.2 26 W 0.05 mm Rh 0.75
4.0 cm PMMA 4.5 28 W 0.05 mm Rh 1.05
4.5 cm PMMA 5.3 29 W 0.05 mm Rh 1.42
5.0 cm PMMA 6 31 W 0.05 mm Rh 2
6.0 cm PMMA 7.5 31 W 0.05 mm Ag 2.7
7.0 cm PMMA 9 34 W 0.05 mm Ag 3.1
Table 25: BT Dose (EUREF)
Phantom cm kV Anode Filter EUREF dose (mGy)
2.0 cm PMMA 2.1 26 W 0.7 mm Al 1
3.0 cm PMMA 3.2 28 W 0.7 mm Al 1.15
4.0 cm PMMA 4.5 30 W 0.7 mm Al 1.5
4.5 cm PMMA 5.3 31 W 0.7 mm Al 2.00
5.0 cm PMMA 6 33 W 0.7 mm Al 2.5
6.0 cm PMMA 7.5 36 W 0.7 mm Al 3.9
7.0 cm PMMA 9 42 W 0.7 mm Al 5.15
Appendix D
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Appendix D: Dose Information
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Table 26: CEDM Dose (EUREF)
Phantom cm kV Anode Filter EUREF dose (mGy)
2.0 cm PMMA 2.1 26/45 W 0.05/0.3 mm Rh/Cu 0.83
3.0 cm PMMA 3.2 26/45 W 0.05/0.3 mm Rh/Cu 1.1
4.0 cm PMMA 4.5 28/45 W 0.05/0.3 mm Rh/Cu 1.6
4.5 cm PMMA 5.3 29/49 W 0.05/0.3 mm Rh/Cu 2.1
5.0 cm PMMA 6 31/49 W 0.05/0.3 mm Rh/Cu 3.0
6.0 cm PMMA 7.5 32/49 W 0.05/0.3 mm Ag/Cu 4.1
7.0 cm PMMA 9 33/49 W 0.05/0.3 mm Ag/Cu 4.7
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Glossary of Terms
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11: Glossary of Terms
ACR
American College of Radiology
AEC
Automatic Exposure Control
Annotations
Markings on an image to indicate an area of
interest.
BT
Breast Tomosynthesis. An imaging procedure that
provides information about the breast in three
dimensions
CEDM
Contrast Enhanced Digital Mammography
Collimator
A device at the x-ray tube to control the x-ray
beam exposure area.
Conventional Mammography
Single projection x-ray images of views for
screening and diagnostic purposes
C-View
A licensed Hologic feature where a digital
mammography (DM) image is generated from
data acquired during a breast tomosynthesis (BT)
scan
DICOM
Digital Imaging and Communications in Medicine
DM
Digital Mammography (2D)
EMC
Electromagnetic Compatibility
FAST Paddle
Fully Automatic Self-adjusting Tilt Paddle
FDA
Food and Drug Administration (in the United
States)
Grid
An element within the Digital Image Receptor that
reduces scatter radiation during the exposure
Image Receptor
Assembly of the x-ray detector, x-ray scatter
reduction grid, and carbon fiber cover
Intelligent 2D
A licensed Hologic feature where a high-
resolution digital mammography (DM) image is
generated from data acquired during a high
resolution breast tomosynthesis (BT) scan
I-View
A licensed feature for 2D Contrast Enhanced
Digital Mammography
MPPS
Modality Performed Procedure Step
MQSA
Mammography Quality Standards Act
Notice
Annotations and comments per image
communicated between Diagnostic Review
Workstations, Technologist Workstations, and
Acquisition Workstations
PACS
Picture Archiving and Communications System. A
computer and network system that transmits and
archives digital medical images.
Pend
The action taken on an image to mark the image if
the Technologist is not positive about the image
quality (pended images must be Accepted or
Rejected before the procedure is closed)
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Glossary of Terms
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Projection Image
One of a group of breast tomosynthesis images
taken at different projection angles and used to
produce the final reconstructed image
Reclamation
Automatic removal of patient images and related
information to allow storage of new patient image
acquisitions
RF
Radio Frequency
ROI
Region of Interest
SID
Source to Image Distance
Tomosynthesis
An imaging procedure that combines a number of
breast images taken at different angles. The
tomosynthesis images can be reconstructed to
show focal planes (slices) within the breast.
UDI
A United States Food and Drug Administration
program for Unique Device Identification (UDI).
For more information about UDI, go to
http://www.fda.gov/MedicalDevices/DeviceRegulationa
ndGuidance/UniqueDeviceIdentification/UDIBasics/de
fault.htm.
UPS
Uninterruptible Power Supply
USB
Universal Serial Bus
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Index
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Index
2
2D contrast - 79
2D contrast settings - 82, 119
A
about (acquisition workstation) screen - 113
accept images - 71, 73, 118
accept rejected images - 73
accessories - 83
compression paddles - 87
crosshair devices - 95
face shields - 84
install on C-arm - 83
magnification stand - 93
acquire images - 71, 101
acquisition modes - 70
Acquisition Workstation
about (acquisition workstation) screen - 113
maintenance - 107
add
new patient - 50
procedure - 59
view - 60
admin screen - 111
about (acquisition workstation) screen - 113
admin button - 55
functions - 111
remote access to image reports - 124
alerts - 139
archive - 64
auto-hanging, auto-pairing - 115
Automatic Exposure Control
buttons - 25
Sensor position - 25
auto-rotation - 39, 41
C
calibrations, perform - 45
C-arm
auto-rotation - 39, 41
controls and indicators - 24, 26
displays - 25
rotation and movement - 34
slots for accessories - 83
cine tab - 77
circuit breaker
Gantry - 23
clinical procedures - 99
close
patient - 62
procedure - 62
collimator
override - 42
programmed to paddle - 87
columns tab - 55
comments tab - 77
compression
controls and displays - 25
FAST compression mode - 92
paddles - 87
release - 101
specifications - 134
compression force, range - 25
computer power button - 23
contact paddles - 89
contrast procedures - 79
contrast settings - 82, 119
controls
C-arm - 26, 27
collimator override - 42
compression - 27
compression brake - 33
footswitches, AWS - 27
Gantry Tubestand - 24
handwheels - 25
indicators - 23
light field lamp - 42
system - 23
conventional face shield, install - 86
custom output - 64
cybersecurity statement - 8
D
data loss - 13
delete patient - 53
display
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clean - 107
compression force - 25
preview image - 69
thickness - 25
types of images selection - 77
window level - 75
dose information - 149
EUREF dose tables - 149
E
edit
patient information - 51
user information - 46
view - 61
Emergency Off Switch - 17, 23, 24
functional test - 32
export - 65, 126
exposure
parameters - 70
sequence - 101
techniques, set - 70
F
face shield - 84
FAST compression mode - 92
faults - 139
filter tab - 54
other functions - 54
filter, information options - 53
fingerprint scanner - AWS - 31
footswitches, AWS - 27
function, select to perform - 45
functional tests - 32
Emergency Off Switch - 17, 44
G
generator tab, set techniques - 70
H
Hologic technical support - 105
I
images
accept - 71, 73, 118
acquisition mode - 70
output options - 78
preview - 69
reject - 71
remote access to image reports - 124
review - 74
review tools - 62, 75
store - 71, 118
Implant Displaced views - 60
Implant Present button - 57
indicators - 23
install
compression paddles - 91
conventional face shield - 86
localization crosshair device - 95
magnification crosshair device - 96
Magnification Stand - 93
retractable face shield - 84
Intelligent 2D - 5
international symbols - 9
I-View - 79
I-View settings - 82, 119
L
label locations - 21
laser film printer, isolation requirements - 13
licenses - 114
light field lamp
use - 101
localization crosshair device
align - 97
install and remove - 95
use - 96
localization paddles - 90
Log In - 31
fingerprint scanner - 31
Log Out - 55
M
magnification crosshair device, install and remove
- 96
magnification paddles - 89
Magnification Stand - 93
install and remove - 93
maintenance
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Index
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general - 105
manage
alarms - 46
notices - 46
output groups - 63
messages and alerts - 139
MLO rotation - 41
mobile system
QC tests - 148
safety - 143
specifications - 144
test after travel - 148
My Settings icon - 46
N
needle localization - 103
Notices tab - 77
O
On/Off button - 23
on-demand outputs - 64
open patient procedure - 50
output devices
custom output - 64
manage output groups - 46
output groups - 78
taskbar icons - 46
output groups, manage - 78
output groups, select - 63
outputs, on-demand - 64
P
paddle shift - 43, 58
paddle shift buttons - 25
paddles
compression - 89
install - 91
remove - 91
shift - 25, 43, 58
shift to new position - 58
SmartCurve paddle - 87, 88
patient
add - 50
close - 62
delete - 53
edit information - 51
face shield - 84
filter - 53
open - 50
position - 101
pended image, accept or reject - 73
permissions, by user group - 122
power button - 23
prerequisites for system use - 6
preview image screen - 69
print - 66
procedure screen - 56
procedures
add - 59
close - 62
Q
quality control requirements - 7
quality control tasks, perform - 45
query worklist - 55
R
radiation safety - 13
reject images - 71
remote access to image reports - 124
remove
compression paddles - 91
conventional face shield - 86
localization crosshair device - 95
magnification crosshair device - 96
Magnification Stand - 93
retractable face shield - 84
view - 60
requirements
quality control - 7
skills needed - 6
training - 7
retractable face shield
install - 84
use - 85
review
images - 74
rejected image - 73
ROI tab - 77
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Index
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S
safety
data loss - 13
equipment damage - 13
general information - 13
radiation - 13
screening
acquire the image - 101
screens
add new patient - 50
add view - 60
admin - 111
filter patient information - 53
preview image - 69
query - 55
Select Function to Perform - 45
select
exposure parameters - 70
output groups - 63
send images to outputs - 78
Shifting Paddle system - 43, 58
SmartCurve paddle - 87, 88
specifications - 129
electrical - 132
spot compression paddles - 89
statement, cybersecurity - 8
system
administration - 111
capabilities - 2
description - 11
messages - 140
power controls - 23
ready - 101
status icons - 46
T
tabs
filter, column - 54
taskbar - 46
technical support - 8
tools, image review - 75
training requirements - 7
tubehead, display - 25
tubestand, controls and indicators - 24
turn off system - 44
turn on system - 29
Log In - 31
startup - 29
U
uninterrupted power supply - 142
user interface - 45
user profiles - 6
users menu - 46
V
view
add - 60
edit - 61
W
warnings, cautions and notes - 13
defined - 10
window level - 75
workflow, standard - 99
worklist, query - 55
X
x-ray
acquire image - 101
collimated fields - 42
indicators - 101
