Ultrasound Transducer Cover
Vitrolife Sweden AB · Model 14220
Ultrasound Transducer Cover.
Intended use: A sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, oesophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device.
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.
Element drop-out / dead elements
HighSymptoms: Black vertical band in the image, halved sensitivity, artefact that stays with the probe on any port.
Root cause: Cracked or delaminated piezo elements, or broken cable conductors into the array.
Lens / membrane damage or delamination
HighSymptoms: Near-field haze, bubbles under the lens, visible crack or a bite mark (TEE).
Root cause: Impact, aggressive disinfectant, or age; the acoustic lens has lifted from the array.
Connector / strain-relief fault
MediumSymptoms: Image comes and goes when the cable or connector is flexed.
Root cause: Broken conductors at the connector or at the probe strain relief.
Electrical-safety / insulation failure
HighSymptoms: Fails the leakage / insulation test; unsafe for patient contact (critical for intracavitary and TEE probes).
Root cause: Fluid ingress or a lens breach compromising patient isolation.
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.
Transducer (exchange / repair)
Element or cable damage is usually an OEM/third-party repair, not a field fix.
Class Periodic replacementRel. cost $$$$R&R Fairly easy
Connector pins / housing
Class Major service partRel. cost $$R&R Moderate
Acoustic lens / membrane
Class Periodic replacementRel. cost $$$R&R Difficult
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Transducer (exchange / repair) Element or cable damage is usually an OEM/third-party repair, not a field fix. | Periodic replacement | $$$$ | Fairly easy |
| Connector pins / housing | Major service part | $$ | Moderate |
| Acoustic lens / membrane | 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 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: Dead band or drop-out in the image
- Confirm the artefact follows the probe onto a second port / system.
- Run the system's transducer element-test if available.
- Inspect the lens for cracks and the cable for kinks.
- Quarantine the probe and arrange an element/cable repair or exchange.
- Do not use an intracavitary/TEE probe that fails the element or leakage test.
Symptom: Image drops out when the cable is moved
- Flex the cable along its length and at both ends while scanning.
- Inspect the connector for bent pins and the strain relief for splits.
- Try the probe on another system to rule the system out.
- Send for a connector / cable repair.
- Re-test electrical safety before returning to service.
Technical Specs
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- Yes
- Single use
- Yes
- Prescription use
- Rx only
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- Body-orifice ultrasound imaging transducer cover, basic
- FDA product classification
- Transducer, Ultrasonic, Diagnostic
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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