OMNERA 400T
Arcoma AB · Model 0180
Stationary x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment. The device is not intended for mammography.
Intended use: An assembly of devices that comprise general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.
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
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.
Detector calibration drift
MediumSymptoms: Image noise, artifacts, low SNR.
Root cause: Flat-panel / sensor aging.
Cooling system fault
HighSymptoms: Tube temp alarm, duty-cycle limited.
Root cause: Pump/radiator or coolant loss.
Generator / high-voltage fault
HighSymptoms: Exposure fails, kV/mA out of range error.
Root cause: HV tank or generator board fault.
Recon / system software hang
LowSymptoms: Frozen console, acquisition timeout.
Root cause: Workstation or RAID degradation.
Serviceable Parts & Consumables
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.
Workstation RAID / GPU
Class Periodic replacementRel. cost $$$R&R Difficult
X-ray tube insert
Major R&R; track mAs history.
Class Major service partRel. cost $$$$R&R Expert-level
Flat-panel detector
Class Major service partRel. cost $$$$R&R Expert-level
Cooling pump & radiator
Class Periodic replacementRel. cost $$$R&R Difficult
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Workstation RAID / GPU | Periodic replacement | $$$ | Difficult |
| X-ray tube insert Major R&R; track mAs history. | Major service part | $$$$ | Expert-level |
| Flat-panel detector | Major service part | $$$$ | Expert-level |
| Cooling pump & radiator | Periodic replacement | $$$ | Difficult |
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 structured starting point derived from the failure modes above. Follow the manufacturer's service documentation for the actual procedure.
Symptom: X-ray tube overheating / filament failure
- Confirm the presentation - typically tube won't fire, heat-capacity alarm - and note the exact alarm or message and the conditions when it occurs.
- Check the most likely cause first: filament wear, cooling failure.
- Isolate the affected subsystem using the manufacturer's functional check or self-test, where one is provided.
- If the fault is confirmed and not a field adjustment, service or replace the x-ray tube insert per the manufacturer's service documentation.
- Return the device to service only after the manufacturer's functional and applicable electrical-safety checks pass.
- Record the findings, any parts used, and the verification results in the maintenance history.
Symptom: Detector calibration drift
- Confirm the presentation - typically image noise, artifacts, low SNR - and note the exact alarm or message and the conditions when it occurs.
- Check the most likely cause first: flat-panel / sensor aging.
- Isolate the affected subsystem using the manufacturer's functional check or self-test, where one is provided.
- If the fault is confirmed and not a field adjustment, service or replace the flat-panel detector per the manufacturer's service documentation.
- Return the device to service only after the manufacturer's functional and applicable electrical-safety checks pass.
- Record the findings, any parts used, and the verification results in the maintenance history.
Technical Specs
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- No
- Single use
- No
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- Stationary basic diagnostic x-ray system, digital
- FDA product classification
- Solid State X-Ray Imager (Flat Panel/Digital Imager); System, X-Ray, Stationary
- Manufacturer support
- +46(0)740706970 · service@arcoma.se
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
There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of the Overhead Tube Crane (OTC).
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