Belmont Medical Technologies Rapid Infuser RI-2

Preventive Maintenance Procedure

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Asset Type

Rapid Infuser

Manufacturer

Belmont Medical Technologies

Model

Rapid Infuser RI-2

Manual Reference

Belmont Rapid Infuser RI-2 Operator's Manual, document 702-00190 Rev. 008. Verify the exact device configuration, serial number, installed software, current service notices, and locally controlled manual revision before maintenance.

Manufacturer Recommendation / AEM Status

Belmont states that routine maintenance—including cleaning and inspection—should be performed as needed, often before or after each use according to the clinical environment. Periodic preventive maintenance must be performed at least once every year by a qualified technician using the current preventive-maintenance checklist and calibrated test equipment.

The RI-2 does not require regular calibration. Its essential performance includes flow-rate accuracy, maximum heating accuracy, and air-detector functionality, so the complete operational checkout must not be replaced by a visual inspection alone. Do not perform hardware verification while the system is connected to a patient. Any AEM interval or procedure change requires the facility's documented risk assessment and approval.

What This PM Procedure Covers

Required Tools and Equipment

Step-by-Step PM Procedure

1. Remove From Clinical Use

Action: Confirm the RI-2 is not connected to a patient. Remove and dispose of any used disposable set under facility policy, decontaminate the device, protect stored information, and label it unavailable during maintenance.

Expected outcome: The unit is safe to handle and no patient depends on it during testing.

2. Verify Identity and Configuration

Action: Record asset tag, serial number, model, line voltage, CPU and HPCM software versions/checksums, installed accessories, and current configuration. Confirm the controlled manual and checklist apply to this unit.

Expected outcome: The device matches the CMMS record and the correct test requirements are identified.

3. Review Service History

Action: Review prior PM, repairs, alarms, overheating, flow or pressure complaints, battery issues, fluid intrusion, dropped-device events, recalls, and field/service notices. Resolve open corrective work before return to use.

Expected outcome: Relevant history and outstanding safety issues are known and documented.

4. Inspect the Exterior and Labels

Action: Inspect the enclosure, touchscreen/display, keypad, handle, feet, door, hinges, latch, ferrites, connectors, fan guards, labels, and accessories. Look for cracks, looseness, contamination, corrosion, impact, heat, blocked airflow, fluid entry, or unauthorized modification.

Expected outcome: All parts are secure, clean, legible, unobstructed, and free of damage that could affect safe operation.

5. Inspect Power Input and Pole Clamp

Action: Inspect the mains cord, plug, inlet, fuses/holder, power-input module, strain reliefs, equipotential connection when fitted, and IV-pole clamp. Remove dust from the power-input area and confirm the clamp securely supports the unit.

Expected outcome: Power components are clean and undamaged, and the RI-2 mounts securely without slipping or rotation.

6. Inspect the Pump Head and Roller

Action: Clean and inspect the pump head. Confirm each pump roller spins freely and shows no wear, damage, or contamination. Qualified service personnel should verify the pump-roller screw torque at 32 in-lb using the current Belmont procedure.

Expected outcome: Rollers move freely and the pump assembly is clean, intact, and correctly secured.

7. Inspect the Valve Mechanism

Action: Inspect the valve wand and mechanism for residue, binding, wear, damage, and correct alignment. Qualified service personnel should verify the 10-32 valve-wand set screw at 23 in-lb and follow the current manual's thread-locking instructions.

Expected outcome: The valve mechanism is clean, secure, aligned, and moves without binding.

8. Clean and Inspect the Sensors

Action: Carefully clean the infrared temperature sensors, air detector, fluid-out detector, and pressure-transducer area using the approved method. Inspect for scratches, residue, moisture, blockage, loose parts, or damage. Do not flood sensor openings.

Expected outcome: Sensor surfaces and optical paths are clean, dry, undamaged, and unobstructed.

9. Install and Prime the Test Circuit

Action: Install the approved disposable set and prepare the non-patient test fluid exactly as directed by the current checklist. Prime the reservoir and patient line, eliminate unintended air, and route the tubing correctly through the pump head, detectors, valve, and pressure sensor.

Expected outcome: The circuit primes without leaks, kinks, incorrect routing, or unexplained alarms.

10. Verify Startup and Basic Operation

Action: Connect AC power and start the RI-2. Confirm startup completes, the date is correct, controls respond, an audible beep occurs with key operation, fans run as required, and the green status LED behaves correctly. Confirm the fluid-out and air detectors show AIR when their sensing paths contain air.

Expected outcome: Display, controls, audible indication, fans, status light, date, and detector indications operate normally.

11. Verify Valve and Line Functions

Action: Exercise the valve through its commanded positions and verify unobstructed movement. Run the prime and patient-line functions with the approved test setup and inspect the entire fluid path for leakage or abnormal restriction.

Expected outcome: Valve positioning, priming, and patient-line delivery complete correctly without leakage or binding.

12. Verify Flow Accuracy

Action: Using the controlled timing and collection method, perform every current checklist flow test. Rev. 008 acceptance volumes include 100 mL ±25 mL for the 10 mL/min test, 100 mL ±10 mL for the 100 mL/min test, 500 mL ±50 mL at 500 mL/min, 750 mL ±75 mL at 750 mL/min, and 1000 mL ±100 mL at 1000 mL/min. Verify the infuse arrows increment by 10 mL and continuously as specified.

Expected outcome: Every required flow measurement and volume indication meets the current controlled checklist.

13. Verify Temperature Sensing and Heating

Action: Perform the input/output sensor comparison and heating tests using the exact Rev. 008 setup. The input-to-output sensor comparison must be within 2°C, each displayed sensor must agree with the calibrated measured temperature within 1°C, output at 500 mL/min must be 37.5°C ±2°C, and the displayed output at 50 mL/min must be 39.0°C ±0.5°C.

Expected outcome: Temperature sensing and heating meet all specified tolerances with stable readings and no unexpected alarm.

14. Verify Overtemperature Protection

Action: Use the prescribed 43–45°C source-fluid setup and 500 mL/min test method. Confirm the overtemperature alarm, heater shutdown/protection response, displayed temperature, and calibrated measured temperature meet the exact acceptance values on the current controlled Rev. 008 procedure and record sheet.

Expected outcome: Overtemperature protection activates at the specified point and both recorded temperatures meet the controlled checklist.

15. Verify Fluid-Out and Air Detection

Action: Create each detector condition only as directed by the controlled procedure. Confirm the Fluid Out and Air Detected messages, audible/visual response, interruption of unsafe delivery, and required automatic re-prime/return-to-infusion behavior after the condition is corrected.

Expected outcome: Both detectors identify their test conditions and the RI-2 recovers exactly as specified.

16. Verify Pressure Measurement and Protection

Action: Apply the required calibrated pressure points from the current checklist. At minimum, confirm the display reads 300 mmHg ±25 mmHg and 200 mmHg ±25 mmHg at those applied pressures. Complete all additional points in the controlled revision and verify the low-pressure display behavior and High Pressure alarm response.

Expected outcome: Every required pressure point is within tolerance and pressure protection responds correctly.

17. Verify Battery Operation and Runtime

Action: Charge the battery for at least 8 hours before the runtime test. Verify transfer to battery, battery indication, and a battery voltage of at least 24 V. With heat off, operate at 50 mL/min on battery and time the run. Inspect for swelling, leakage, heat, or abnormal voltage decline.

Expected outcome: The battery is physically sound, measures at least 24 V, and operates the RI-2 for at least 30 minutes under the specified test.

18. Complete Electrical Safety, Restore, and Document

Action: Perform the electrical-safety sequence below. Remove the disposable test setup, clean and dry the unit, restore approved settings, reconnect AC power, repeat a final startup/readiness check, and document all instruments, readings, parts, corrective actions, and disposition.

Expected outcome: All tests pass, the device is clean and correctly configured, and the completed record is traceable.

Electrical Safety Testing

Use the current Belmont electrical-safety record and a calibrated analyzer. Perform the required tests in standby, powered on but not pumping, and infusing at 500 mL/min, including the specified normal/reverse polarity and ground/neutral conditions. For patient leakage in Rev. 008, limits include 10 µA with neutral closed and ground connected in normal or reverse polarity, 50 µA with ground open, and 50 µA with neutral open. Use the exact current table for every earth-leakage and patient-leakage condition; record actual readings rather than only Pass/Fail.

Stop testing and remove the RI-2 from service if any reading exceeds the applicable limit, if the analyzer setup cannot reproduce the required condition, or if the power cord, inlet, protective-earth path, or accessible conductive parts are damaged.

Pass / Fail Criteria

Pass

Remove From Service

Copy/Paste CMMS Work Order Procedure

The RI-2 is a high-risk rapid infusion and warming system. Only qualified personnel should perform this procedure, using the current controlled Belmont checklist and calibrated equipment. Never test it while connected to a patient.

Sources

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