Selenia® Dimensions®
Hologic, Inc. · Model ASY-10775-3D-UPS
Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Intended use: A stationary assembly of devices designed to generate x-ray images of the breast using digital techniques for image capture and display. It is designed specifically to compress the breast during imaging and is intended to visually evaluate the anatomy and function of blood and lymphatic vessels within the breast. Often referred to as a digital mammography system (DMS) it is typically used for breast cancer screening or during biopsy procedures (e.g., placement of biopsy markers, stereotactic biopsy). It is designed to capture two-dimensional (2-D) x-ray images, however may include software intended to process multiple images to create a three-dimensional (3-D) image/model (tomosynthesis).
Key tips
- ·Never bypass a radiation interlock to "just get the image" - this is one of the few true zero-tolerance rules in BMET work.
- ·Trend image-quality phantom results over time - drift shows up before an outright failure does.
- ·Portable/mobile units take real physical abuse from transport - check wheel locks and cable strain reliefs more often than fixed units.
Typical Failure Modes
Compiled for this model from its own documentation and established engineering knowledge for this equipment class - not from a verified service record. Confirm against the manufacturer's service manual.
Will not power on or unexpected shutdown
HighSymptoms: The medical imaging is dead, reboots, or shuts down mid-use.
Root cause: Mains lead / fuse, an aged battery, or a power-supply board fault.
Battery will not hold charge
MediumSymptoms: Short run time on battery; low-battery alarm soon after a full charge.
Root cause: Aged rechargeable battery pack or a charger fault.
Display / control-panel fault
MediumSymptoms: Blank, dim or distorted display; unresponsive keys or touchscreen.
Root cause: Display, backlight, or control-board fault.
Fails self-test or calibration
MediumSymptoms: Power-on self-test or the scheduled performance check fails or is out of tolerance.
Root cause: Sensor drift or an internal board fault; recalibration or repair needed.
Serviceable Parts & Consumables
Serviceable items for this model, compiled from its documentation and engineering knowledge for this equipment class. Service class and relative cost are estimates, not manufacturer figures; no part numbers are given. Confirm intervals and pricing against the manufacturer.
Rechargeable battery pack
Class Periodic replacementRel. cost $$R&R Fairly easy
Power supply / mains board
Class Major service partRel. cost $$$R&R Difficult
Display / control-panel assembly
Class Major service partRel. cost $$$R&R Moderate
Cooling fan
Class Major service partRel. cost $R&R Moderate
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Rechargeable battery pack | Periodic replacement | $$ | Fairly easy |
| Power supply / mains board | Major service part | $$$ | Difficult |
| Display / control-panel assembly | Major service part | $$$ | Moderate |
| Cooling fan | Major service part | $ | Moderate |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
PM Checklist
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
- ·Daily QC per modality: image-quality phantom test
- ·Tube and detector inspection
- ·Annual state-required radiation safety survey
- ·Vendor-scheduled preventive maintenance
Troubleshooting Approach
A starting sequence for this model, compiled from its documentation and engineering knowledge for this equipment class. Follow the manufacturer's service documentation for the actual procedure.
Symptom: Will not power on
- Confirm the outlet, mains lead and fuse.
- Try on battery, then on mains only, to isolate the supply.
- Look for a power indicator or POST code.
- Replace the fuse / battery / power supply as isolated.
- Run the self-test after any repair.
Symptom: Fails self-test or calibration
- Note the exact failure message / code.
- Power-cycle and repeat the self-test.
- Verify against a reference / simulator where one applies.
- Recalibrate per the service manual.
- Refer the affected board for service if it will not hold calibration.
Technical Specs
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- No
- Single use
- No
- Prescription use
- Rx only
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- Stationary mammographic x-ray system, digital
- FDA product classification
- Digital breast tomosynthesis
- Manufacturer support
- +1(800)442-9892 · CustomerSupport@hologic.com
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Radiology / Imaging department
- Emergency Department (portable units)
- Operating Room (C-arms)
- Cath lab
- Bedside ICU (portable X-ray)
Documents & Manuals
No documents available for this device yet.
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
- RECALL
Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is impacted and may appear blurry and result in misdiagnosis with the possibility being a false negative diagnosis
- RECALL
C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual
- RECALL
The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing or dropping during field repairs and cleaning of the systems.
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