B-Right Screen Fetal Heart
Fetal EchoScan is a machine learning-based decision support system, indicated as an adjunct to fetal ultrasound examination in pregnant women anatomic ultrasound exams.
Intended use: An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.
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.
No or weak fetal heart-rate detection
HighSymptoms: No or intermittent fetal heart tones / rate, faint signal even with good gel and placement.
Root cause: Degraded or cracked ultrasound transducer, insufficient coupling gel, or a probe-cable fault.
Intermittent signal with cable movement
MediumSymptoms: Signal cuts out when the probe cable is flexed.
Root cause: Broken conductors in the probe cable.
Battery / power fault
MediumSymptoms: Will not power on, short battery life.
Root cause: Depleted battery or a contact fault.
Display / rate-readout fault
LowSymptoms: Rate not shown or implausible, display segments out.
Root cause: Display or processing fault.
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.
Ultrasound / Doppler probe
Class Periodic replacementRel. cost $$R&R Easy
Probe cable / connector
Class Periodic replacementRel. cost $$R&R Fairly easy
Battery
Class Frequent wear itemRel. cost $R&R Easy
Ultrasound coupling gel
Class Frequent wear itemRel. cost $R&R Easy
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Ultrasound / Doppler probe | Periodic replacement | $$ | Easy |
| Probe cable / connector | Periodic replacement | $$ | Fairly easy |
| Battery | Frequent wear item | $ | Easy |
| Ultrasound coupling gel | Frequent wear item | $ | Easy |
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: No or weak fetal tones
- Apply fresh coupling gel and confirm probe placement.
- Test the probe on a known-working unit.
- Flex the cable while listening for dropouts.
- Inspect the probe face for cracks.
- Replace the probe if a known-good unit still gives no signal.
Symptom: Signal cuts with cable movement
- Flex the cable along its length and at both ends.
- Inspect the connector.
- Clean and reseat the connector.
- Replace the probe if the fault tracks the cable.
- Confirm a stable signal.
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)
- Ultrasound imaging system application software
- FDA product classification
- Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
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.
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