Philips Avalon FM20

Asset Type

Fetal Monitor

Manufacturer

Philips

Model

Avalon FM20

Manual Reference

Philips Avalon Fetal Monitor FM20/FM30 Service Guide, part number M2703-9000A, together with the current Avalon FM20 Instructions for Use and option-specific service documentation. Confirm the product number, hardware revision, software revision, installed options, and current Philips documentation before service.

Manufacturer Recommendation / AEM Status

• Visual inspection: Before each use.
• Recorder maintenance: Once a year, or whenever print quality is degraded.
• Transducer and patient-module testing: Once a year, or whenever a measurement is suspected to be incorrect.
• NIBP calibration and performance testing: Every two years, or sooner when required by local law or suspected measurement error; applies only when NIBP is installed.
• SpO2 performance testing: Every two years, or whenever the measurement is suspected to be incorrect; applies only when SpO2 is installed.
• Enclosure and patient leakage-current testing: Every two years, after impact damage, and after power-supply removal or replacement.
• Battery: Inspect, exercise, and evaluate according to the current IFU, battery age, runtime, service history, and facility policy.

Philips separates preventive maintenance, other regular tests, performance assurance, and safety tests. A facility interval that differs from the manufacturer schedule must be supported by an approved AEM program, risk assessment, service history, applicable regulations, and current Philips instructions.

What This PM Procedure Covers

• Identity, configuration, history, labels, housing, mounting, power, battery, and accessories
• Startup, display, touchscreen, hard keys, alarm audio, indicators, date/time, and communications
• Fetal recorder cleaning, paper path, self-test, printhead, alignment, and paper feed
• Ultrasound, Toco/Toco+, DECG, MECG, and IUP checks as configured
• NIBP and SpO2 performance testing when installed
• Electrical leakage-current testing and final functional verification

Required Tools and Equipment

• Current Philips FM20/FM30 service guide, FM20 IFU, option-specific instructions, and facility PM form
• Calibrated electrical-safety analyzer capable of enclosure and patient leakage-current testing
• Reference manometer accurate to 0.2% of reading, hand pump, valve, 250 mL expansion chamber ±10%, and compatible NIBP tubing
• Approved fetal-monitor simulator or test fixtures for configured DECG, MECG, IUP, SpO2, and NIBP functions
• Known-good Philips-compatible ultrasound, Toco/Toco+, patient-module, cableless, and maternal-parameter accessories as configured
• Philips-approved fetal recorder paper, lint-free cloth, cotton swabs, mild soap solution, and 70% isopropyl-alcohol-based solution
• Flat-bottomed pencil or equivalent non-damaging object for the manufacturer-described ultrasound-crystal response check

Step-by-Step PM Procedure

1. Remove the Monitor From Patient Use

Action: Confirm the monitor is not supporting active care, remove patient-connected and single-use items, control protected health information, and clean the unit according to current Philips and facility instructions.

Expected outcome: The monitor is safely controlled for service, clean, dry, and disconnected from the patient.

2. Verify Identity and Configuration

Action: Record the asset tag, serial number, product number, hardware/software revision, battery, recorder, network/interface, ultrasound channel count, Toco/Toco+, patient module, NIBP, SpO2, cableless system, mount, and accessories.

Expected outcome: The physical device matches the CMMS record, model is Avalon FM20, and every applicable test path is identified.

3. Review Service History

Action: Review prior PM results, impact or liquid events, repairs, power-supply work, battery age/runtime, recorder complaints, measurement concerns, recalls, updates, and open corrective work.

Expected outcome: Required annual, two-year, post-repair, and condition-driven testing is included.

4. Perform the Visual Inspection

Action: Inspect the housing, display, touchscreen, keys, alarm openings, labels, recorder drawer, paper path, feet, mounting hardware, power cord/supply, battery compartment, connectors, transducer sockets, cables, housings, belt buttons, strain reliefs, NIBP hose/cuff, SpO2 accessories, patient modules, and cableless equipment. Check for cracks, loose parts, fluid entry, corrosion, contamination, bent pins, exposed conductors, or insecure mounting.

Expected outcome: No defect could affect measurement, alarm, power, isolation, transport, or mechanical safety. Replace seriously damaged cables and do not use a transducer with a damaged belt button.

5. Verify AC Power and Battery Operation

Action: Verify approved AC supply operation, power and charging indicators, battery recognition, controlled transfer to battery, representative runtime/capacity assessment, low-battery indication, reconnection to AC, and normal shutdown. Evaluate age, swelling, heat, leakage, physical condition, and service history.

Expected outcome: AC and battery operation are stable, charging and transfer are correct, and the battery meets current Philips and facility acceptance criteria.

6. Perform Startup and User-Interface Checks

Action: Power on the FM20. Confirm the startup indicator, Philips boot screen, test sound, normal monitoring screen, touchscreen, hard keys, display quality, speaker, alarm light, date/time, patient type, and expected configuration. Confirm no unresolved INOP or equipment-malfunction message remains.

Expected outcome: Startup completes and all controls, display, audio, indicators, configuration, and installed interfaces operate normally.

7. Inspect and Clean the Recorder

Action: Open the drawer. Clean the platen with a lint-free cloth and mild soap solution, the thermal printhead with a cotton swab moistened with 70% isopropyl-alcohol-based solution, and the paper-sensor area without damaging components. Load the correct Philips-approved paper in the correct orientation and close the drawer.

Expected outcome: Printhead, platen, sensor, paper path, drawer, and paper are clean, intact, and correctly assembled.

8. Run the Recorder Self-Test

Action: In authorized Service Mode select Main Setup > Fetal Recorder > Selftest and inspect the complete pattern.

Expected outcome: Paper feeds consistently; printed lines are straight; the Toco baseline aligns with the 20-unit gridline; no more than 20 dots are missing across the printhead; no more than two adjacent dots are inoperative; and no dot is missing from a mode annotation such as FHR1. Calibrate recorder offset only when required by the current service guide.

9. Test Every Ultrasound Transducer

Action: Connect each transducer, enable fetal heart sound and the recorder, and pass a flat-bottomed pencil approximately 2–3 cm above each of the seven crystal positions. Move the transducer over a solid surface or hand. Repeat with a known-good transducer if isolation is needed.

Expected outcome: Each crystal position produces a response, movement produces a response, the monitor recognizes the transducer, and the channel and recorder trace behave correctly.

10. Test Every Toco or Toco+ Transducer

Action: Connect the transducer, apply gentle pressure, and verify that displayed and printed values increase. Place it face up, set the Toco baseline to 20, then place the sensing face on a flat surface.

Expected outcome: Resting baseline is approximately 20, the face-down value is approximately 35–45, and display and trace respond smoothly to pressure without drift or interruption.

11. Test Patient-Module Functions as Configured

Action: Use approved simulators, adapters, and test fixtures to verify DECG lead-off and signal response, MECG acquisition, maternal pulse, and IUP response. For the service-guide IUP check, apply 80 mmHg ±5 mmHg and release it slowly.

Expected outcome: The correct mode is recognized; lead-off indications clear when continuity is established; maternal and fetal signals are credible; and IUP display and trace correspond to applied pressure.

12. Perform NIBP Accuracy, Leakage, Linearity, and Valve Tests

Applicable only when NIBP is installed. Connect the calibrated reference manometer, hand pump, valve, tubing, and 250 mL chamber. In Service Mode close the valves, pressurize to 280 mmHg, stabilize for 10 seconds, and compare readings. Hold for 60 seconds for leakage; then compare again at 150 mmHg. Repressurize to 280 mmHg, open the valves, and record remaining pressure after five seconds.

Expected outcome: Monitor/reference difference is ≤3 mmHg at 280 and 150 mmHg; pressure loss is <6 mmHg in 60 seconds; and remaining pressure after opening the valves is <10 mmHg. Calibrate only by the authorized procedure if accuracy fails.

13. Perform the SpO2 Performance Test

Applicable only when SpO2 is installed. Use a calibrated compatible simulator and test cable or the exact current Philips service method. Verify representative saturation, pulse, waveform, sensor disconnect, and alarm conditions.

Expected outcome: SpO2 and pulse values meet the current option-specific manufacturer tolerances and required alarm and sensor responses operate correctly.

14. Verify Alarms, Communications, and Cableless Options

Action: Test representative fetal/maternal parameter alarms, INOPs, speaker output, alarm light, silence/reset, configured central monitoring or data interface, and cableless transducer recognition, charging, assignment, communication, and signal transfer when installed.

Expected outcome: Alarm priority and annunciation are correct, required data reaches the approved destination, and installed wired/cableless accessories remain recognized and reliable.

15. Perform Electrical Safety Testing

Action: Perform the manufacturer-listed enclosure/functional-earth and applicable patient leakage-current tests at the required two-year or post-event interval. Use the current service-guide setup, analyzer instructions, and documented voltage/configuration.

Expected outcome: Sum of functional-earth and enclosure leakage is ≤100 µA, and patient leakage with mains on the applicable ECG applied part is ≤50 µA at the manufacturer-specified 264 V test condition. Do not substitute a conventional protective-earth resistance requirement for the Class II monitor's listed tests.

16. Restore and Return to Service

Action: Remove test equipment, reinstall approved accessories, restore institutional settings and paper configuration, confirm date/time, perform a final startup and complete configured-system check, and document measurements, equipment, parts, corrective work, and disposition.

Expected outcome: The FM20 is clean, complete, correctly configured, fully functional, and either returned to service with traceable results or clearly removed from service.

Electrical Safety Testing

The Avalon FM20 is a Class II, double-insulated device. Its protective-earth conductor supports electromagnetic compatibility and is not the primary means of protection from electric shock. Use the manufacturer-described accessible metal points, applied parts, polarity, normal condition, and single-fault condition.

Electrical-safety analyzer / serial / calibration due:
Result =

Functional-earth plus enclosure leakage:
Manufacturer limit = 100 µA maximum
Highest result in microamps =
Pass / Fail =

Patient leakage with mains on ECG applied part, when applicable:
Manufacturer limit = 50 µA maximum at specified 264 V test condition
Highest result in microamps =
Pass / Fail / N/A =

Additional facility-required testing:
Method / limits / results =

Pass / Fail Criteria

Pass

• Identity, configuration, service history, housing, labels, mount, power system, battery, connectors, cables, transducers, modules, and accessories are acceptable
• Startup, display, controls, date/time, audio, indicators, alarms, INOP handling, data, and installed cableless functions pass
• Recorder is clean and meets paper-feed, printhead-dot, straight-line, annotation, and Toco alignment criteria
• Each ultrasound and Toco/Toco+ transducer and each configured patient-module function passes
• NIBP accuracy, leakage, linearity, valve, and calibration requirements pass when installed
• SpO2 performance and alarm response pass current option-specific criteria when installed
• Required leakage-current tests pass and no unresolved safety or measurement fault remains

Remove From Service

• Startup, display, control, alarm, power, battery, recorder, measurement, communication, or electrical-safety testing fails
• Housing, cable, connector, transducer, belt button, module, mount, power supply, battery, or accessory damage could affect safe use
• Recorder exceeds missing-dot criteria, transducer response is absent or intermittent, or NIBP/SpO2 performance is outside current tolerance
• A required annual, two-year, post-impact, or post-repair test cannot be completed with current documentation and calibrated equipment
• Any unresolved condition could produce missed, delayed, inaccurate, or unannunciated fetal or maternal information

Do not service the Avalon FM20 while it is connected to a patient. Do not return it to service with failed alarms, unreliable fetal or maternal measurements, recorder failure, damaged accessories, inadequate battery operation, electrical-safety failure, or any unresolved condition that could affect clinical decisions.

Sources

• Philips Avalon FM20 Product and Support Page
• Philips Avalon FM20/FM30 Instructions for Use
• Philips Avalon Fetal Monitor FM20/FM30 Service Guide, part number M2703-9000A
• Philips Avalon FM20/FM30 Configuration Setting Appendix
• Philips Avalon CL Transducer System Service Guide