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Asset Type
Manufacturer
Model
Manual Reference
Verathon BladderScan BVI 9400 Operations & Maintenance Manual, 0900-4412-xx-60; BVI 9400 Service Partner Manual, 0900-4472 Rev 12.
Manufacturer Recommendation / AEM Status
Verathon recommends certification of calibration once a year. The annual-certification sequence in the Service Partner Manual includes updating the system software through ScanPoint, calibrating the probe, and certifying the system. Verathon also recommends replacing the two lithium-ion batteries every two years.
Legacy-equipment notice: Verathon lists the BVI 9400 as discontinued in 2019. Its U.S. support notice states that support ended in December 2023 and that service/repair, ScanPoint calibration, and parts/accessories are unavailable after the support end date. Before starting, confirm that the facility still has an authorized and functional method to complete every required certification activity. Do not record a passed annual PM when calibration or certification cannot be completed.
Internal repair is Service Partner work, not routine operator maintenance. If the facility changes the manufacturer-listed interval or activities, handle that change under its approved AEM program, documented risk assessment, maintenance history, and applicable regulatory requirements.
What This PM Procedure Covers
- Identity, service history, support status, console, probe, batteries, charger/wireless hub, printer, labels, and accessories
- Cleaning, startup, controls, video, audio, self-test, printout, ScanPoint communication, and software
- Required annual probe calibration and certification using tissue-equivalent phantoms
- Three accuracy scans in each applicable male, female, and small-child mode
- Configuration-appropriate electrical safety, restoration, and documentation
Required Tools and Equipment
- Current BVI 9400 Operations & Maintenance and Service Partner manuals
- Personnel qualified and authorized for the certification activities being performed
- ScanPoint-enabled computer with the required QuickPrint/ScanPoint connection and current supported software
- BVI 9400 battery charger/wireless hub and both approved batteries
- Verathon calibration kit, part 0620-0340, including tank and target
- Clean room-temperature water and a clean soft cloth
- Certified adult tissue-equivalent bladder phantom with documented reference volume
- Certified pediatric phantom when small-child-mode certification is required
- Ultrasound gel, printer paper, and known-good compatible accessories as needed
- Manufacturer-compatible cleaning and disinfection materials
- Electrical safety analyzer appropriate to the verified charger/hub power-supply classification when required by facility policy
Step-by-Step PM Procedure
1. Verify Identity, Configuration, and Certification Capability
Action: Record asset tag, serial number, BVI 9400 console and probe identification, charger/wireless-hub and power-supply information, battery dates, printer configuration, and applicable adult/pediatric phantoms. Confirm access to the required ScanPoint functions, calibration kit, qualified personnel, and current documentation despite the product's discontinued status.
Expected outcome: The asset matches CMMS and every resource required for a complete annual certification is available. If any mandatory capability is unavailable, stop and route the asset through the facility's risk/disposition process.
2. Review History and Prepare Safely
Action: Review inaccurate-volume, calibration, probe, battery-runtime, charging, wireless, printer, audio, display, impact, liquid-ingress, repair, and prior-certification history. Remove the system from patient use and place it on a stable, dry work surface.
Expected outcome: Known concerns are identified and the system is safely prepared for testing.
3. Inspect the Console and Labels
Action: Inspect the enclosure, display, controls, handle, feet, printer door, paper path, battery compartment, connectors, labels, and openings for cracks, looseness, deformation, missing parts, contamination, impact evidence, or liquid ingress. Do not open the enclosure during routine PM.
Expected outcome: The console is complete, clean, legible, secure, and free of safety-affecting damage or ingress.
4. Inspect the Probe and Cable
Action: Inspect the probe dome, housing, LCD, scan button, cable, connector, pins, and strain reliefs. Look for cracks, cuts, separation, kinks, discoloration, contamination, fluid intrusion, bent contacts, or intermittent connection.
Expected outcome: The probe and cable are intact, clean, securely connected, and free of damage that could affect safety, imaging, or calibration.
5. Inspect Batteries, Charger/Hub, and Power Components
Action: Inspect both batteries, contacts, latches, charger/wireless hub, approved power supply, mains cord, low-voltage cable, plugs, pins, and strain reliefs. Check for swelling, leakage, corrosion, heat damage, exposed conductors, looseness, or unauthorized substitution. Compare battery age with Verathon's two-year replacement recommendation.
Expected outcome: Two compatible batteries and all charging/power components are secure, undamaged, and serviceable; overdue or defective batteries are replaced under facility policy.
6. Clean and Disinfect
Action: Power down and disconnect external power. Clean and disinfect the console, probe, cable, and reusable accessories using the current Verathon-approved product and method for each component. Prevent liquid entry, do not immerse the console or charger/hub, and dry all surfaces completely.
Expected outcome: All handled surfaces are visibly clean, dry, undamaged, and ready for functional testing without prohibited chemical or liquid exposure.
7. Verify Startup, Controls, Display, and Audio
Action: Install a charged approved battery and start the system. Verify normal initialization, date/time, battery indication, display quality, buttons, menu navigation, audible output, probe LCD, and absence of unresolved error messages.
Expected outcome: Startup completes normally; controls, indicators, displays, and audio respond correctly; no unresolved fault remains.
8. Verify Charger/Hub and ScanPoint Communication
Action: Confirm both battery bays charge correctly and that battery/charging indications are normal. Establish the required wireless/ScanPoint connection within the manual's operating setup and verify system recognition and data communication.
Expected outcome: Both batteries charge, the hub functions, and the BVI 9400 communicates reliably with ScanPoint.
9. Update Software and Run the Self-Test
Action: Through ScanPoint, identify the installed software and complete the manual-directed update when a supported update is available. Run the BVI 9400 self-test and record the results.
Expected outcome: The installed software is confirmed/current for the available support environment and the self-test completes without an unresolved failure.
10. Verify the Printer and Self-Test Record
Action: Print the self-test record. Inspect paper feeding, cutter/tear edge, print density, alignment, content, date/time, and legibility.
Expected outcome: The printer feeds correctly and produces an accurate, complete, and legible self-test record.
11. Perform the Required Annual Probe Calibration
Action: Prepare calibration kit 0620-0340 on a flat, nonreflective surface within 3 m (10 ft) of the charger/wireless hub. Fill to the marked level with clean room-temperature water that is as free of bubbles as practical; water may be allowed to sit for 24 hours to degas. Install the target and lid correctly, seat the probe with its tip submerged, and complete the ScanPoint calibration exactly as directed.
Expected outcome: ScanPoint reports successful probe calibration. A failed or unavailable calibration is not a passing annual certification.
12. Establish Phantom Reference Values and Limits
Action: Record each certified tissue-equivalent phantom's identification, certification status, reference volume, and due date. Calculate the service-manual acceptance range for each phantom as reference volume ±(10% of reference volume + 10 mL). Use an adult phantom for male and female modes; use a certified pediatric phantom for small-child mode.
Expected outcome: Valid phantom reference values and calculated lower/upper service limits are documented before accuracy testing.
13. Certify Male-Mode Scan Accuracy
Action: Apply gel and acquire three male-mode scans of the certified adult phantom. For each scan, confirm all eight directional arrows on the probe LCD flash, center the bladder image, inspect the ultrasound images for clarity, and record the measured volume.
Expected outcome: All three readings fall within the calculated service range of certified volume ±(10% + 10 mL), with centered, clear images and normal directional guidance.
14. Certify Female-Mode Scan Accuracy
Action: Acquire three female-mode scans of the same certified adult phantom. Confirm all eight directional arrows, centered bladder images, clear ultrasound images, and record each volume.
Expected outcome: All three readings fall within the calculated service range of certified volume ±(10% + 10 mL), with centered, clear images and normal directional guidance.
15. Certify Small-Child Mode When Applicable
Action: When a certified pediatric phantom is available, acquire three small-child-mode scans and evaluate them exactly as above. If no certified pediatric phantom is available, do not substitute the adult phantom; document small-child certification as N/A in accordance with the service procedure.
Expected outcome: When tested, all three readings are within the pediatric phantom's calculated service range and imaging/guidance pass; otherwise the test is explicitly documented N/A.
16. Verify Voice Annotation, Review, and Record Handling
Action: Record and play back a test voice annotation; verify it is audible and clear. Review the test exams, images, modes, and displayed results, then delete the test exams so no PM records remain as clinical studies.
Expected outcome: Voice annotation and exam review function normally, images/results are complete, and all nonclinical test exams are removed.
17. Perform Electrical Safety, Restore, and Document
Action: Perform the configuration-appropriate electrical safety inspection/tests described below. Remove gel, clean and dry the equipment, restore approved batteries and accessories, repeat startup/charging checks, and document calibration, phantom readings, calculated limits, electrical results, corrective work, and final disposition.
Expected outcome: The complete system is clean, correctly assembled, fully certified, and either returned to service with traceable records or clearly removed from service.
Electrical Safety Testing
The console and probe operate from a battery during patient use, while the charger/wireless hub and its power supply are mains connected. Inspect and test the exact approved charger/hub/power-supply configuration according to its labels and the facility's adopted electrical-safety standard. Record the analyzer, standard, equipment classification, applicable touch/enclosure leakage, limits, readings, and result. Perform protective-earth resistance only when the verified configuration has an accessible protective-earth path; document N/A for a verified Class II/double-insulated supply. The reviewed manuals do not state one routine numeric leakage limit, so this procedure does not invent one. Maintain required charger/hub separation from the patient vicinity.
Pass / Fail Criteria
Pass
- Identity, support/certification capability, history, console, probe, cable, labels, batteries, charger/hub, power supply, printer, and accessories pass inspection
- Cleaning, startup, controls, video, audio, self-test, printer, charging, ScanPoint communication, and software checks pass
- Probe calibration completes successfully through ScanPoint
- All three readings in male and female modes, and in small-child mode when applicable, fall within certified phantom volume ±(10% + 10 mL)
- Images are centered and clear, all eight directional arrows respond, voice annotation is clear, and test exams are deleted
- Configuration-appropriate electrical safety, restoration, and documentation are complete
Remove From Service / Do Not Certify
- Required ScanPoint access, calibration kit, qualified personnel, certified adult phantom, or another mandatory certification resource is unavailable
- Probe calibration, self-test, printer, display, controls, audio, charging, hub, communication, or software verification fails
- Any required scan result is outside the service-manual limit or images/directional guidance are unacceptable
- Damage, swelling/leakage, liquid ingress, severe impact, exposed conductors, incompatible parts, or an unresolved error is present
- Electrical safety fails or required repair/parts/support cannot be obtained for this discontinued system
Copy/Paste CMMS Work Order Procedure
Use the current Verathon documentation, facility policy, and approved AEM program to determine the final interval and return-to-service requirements. This discontinued model must not be recorded as certified when required calibration or support capability is unavailable.