Villa Sistemi · Model Apollo DRF/OPEN
Great versatility for radiographic applications The use of one single detector for both fluoroscopy and radiography offers an unparalleled range of applications that includes all the most common general radiographic procedures, gastro-intestinal studies, tomography and vascular studies. Maximum dose reduction In addition to the low dose required by the high sensitive dynamic digital detector, different solutions can be implemented on the system to further reduce the dose to the patient during the exam. Open tabletop structure The Open design, based on a single-side suspended tabletop, grants a direct and easy access to the patient from all sides of the table. This configuration is particular useful during interventional procedures, because two or more operators can be at direct contact with the patient. The mechanical structure of the tabletop grants a patient weight capacity up to 230 kg without limitations on the table movements. Wide range of fluoroscopy examinations Fluoroscopy exams also take benefit from the large active area of the detector that allows visibility of larger anatomic regions without patient repositioning.
Failure patterns typical of this equipment class - general BMET reference, not verified against this exact unit's own service history unless flagged. Severity is a category-level estimate.
Symptoms: Tube won't fire, heat-capacity alarm.
Root cause: Filament wear, cooling failure.
Symptoms: Image noise, artifacts, low SNR.
Root cause: Flat-panel / sensor aging.
Symptoms: Exposure fails, kV/mA out of range error.
Root cause: HV tank or generator board fault.
Symptoms: Frozen console, acquisition timeout.
Root cause: Workstation or RAID degradation.
The parts a BMET typically services on this class of equipment. Service class and relative cost are general engineering estimates for the category, not figures from this unit's documentation. Part numbers appear only when pulled from this unit's own service manual. Always confirm intervals and pricing against the manufacturer.
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Flat-panel detector | Major service part | $$$$ | Expert-level |
| Cooling pump & radiator | Periodic replacement | $$$ | Difficult |
| High-voltage generator | Major service part | $$$$ | Expert-level |
| Workstation RAID / GPU | Periodic replacement | $$$ | Difficult |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
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.
A structured starting point derived from the failure modes above. Follow the manufacturer's service documentation for the actual procedure.
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
No documents available for this device yet.
Synced live from the FDA openFDA API.
An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years.
Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.
The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop.
It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30x30 (12"x12") and 15x15 (6"x6). This could result in a deviation of the displayed values of Air Kerma Rate and Cumulated Air Kerma from the actual values greater then +/-35% and then in a failure to comply with the requirements of 21 CFR 1020.32(k)(6
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