Philips Avalon FM30

Asset Type

Fetal Monitor

Manufacturer

Philips

Model

Avalon FM30

Manual Reference

Avalon Fetal Monitor FM20/FM30 Service Guide, Part Number M2703-9000A, printed 07/05.

Manufacturer Recommendation / AEM Status

Philips separates the manufacturer-listed activities into preventive maintenance, other regular tests, performance assurance tests, and safety tests.

Manufacturer-Listed Preventive Maintenance

The manual states that preventive maintenance is restricted to noninvasive blood pressure calibration and associated performance testing.

NIBP calibration and performance testing: Once every two years, or as specified by local laws, whichever comes first.

The FM30 must be equipped with the optional NIBP assembly for these tests to apply.

Manufacturer-Listed Other Regular Tests

Visual inspection: Before each use.

Recorder maintenance: Once a year, or when print quality becomes degraded.

Transducer and patient-module testing: Once a year, or when a measurement is suspected to be incorrect.

Manufacturer-Listed Performance Assurance

NIBP performance tests: Once every two years, or when the measurement is suspected to be incorrect.

SpO₂ performance test: Once every two years, or when the measurement is suspected to be incorrect.

Manufacturer-Listed Electrical Safety Testing

Perform enclosure and patient leakage-current tests:

• Once every two years.
• After repairs where the power supply is removed or replaced.
• After the monitor has been damaged by impact.

The FM30 is a Class II device. Protection against electric shock is provided by double or reinforced insulation. The protective-earth conductor is used for electromagnetic compatibility and is not the primary means of protection against electric shock.

A conventional protective-earth or ground-resistance test is therefore not the manufacturer-listed electrical safety test for this monitor.

Manufacturer-Listed Post-Repair Testing

• All repairs: Visual, power-on, and performance test blocks.
• Impact damage or power-supply removal or replacement: Visual, power-on, performance, and safety test blocks.
• Upgrades: Visual, power-on, and performance test blocks.
• System component changes or system reconfiguration: Perform the applicable system safety test.

If a facility performs this PM at a different interval or changes the listed activities, that should be handled under the facility’s approved AEM program, risk assessment, maintenance history, and applicable regulatory requirements.

What This PM Procedure Covers

• Exterior, cable, connector, and mounting inspection
• Power-on self-test
• Recorder inspection, cleaning, and self-test
• Ultrasound and Toco transducer functional checks
• Patient-module and Toco+ testing when included in the facility PM scope
• NIBP performance testing and calibration when equipped
• SpO₂ performance check when equipped
• Electrical leakage-current testing
• Final operational verification and documentation

Required Tools and Equipment

• Electrical safety analyzer capable of enclosure and patient leakage-current testing
• Reference manometer with accuracy of 0.2% of reading
• Hand pump and valve
• 250 mL expansion chamber, ±10%
• Appropriate NIBP tubing
• Lint-free cloth
• Soap-and-water solution
• Cotton swabs
• 70% isopropyl-alcohol-based solution
• Flat-bottomed pencil or similar object for ultrasound transducer testing
• Philips-approved fetal recorder paper
• Adult SpO₂ sensor when SpO₂ is installed
• Known-good transducer or patient module when needed for failure isolation

IUP Test Equipment When Included

• Manometer
• Expansion chamber
• Three lengths of silicone tubing
• T-adapter
• IUP adapter cable, part number 9898 031 43931
• IUP catheter, part number M1333A

Step-by-Step PM Procedure

1. Identify the Monitor and Installed Options

Action: Record the model, serial number, software revision, and installed options. Determine whether the monitor includes NIBP, SpO₂, LAN/RS232 interface, ultrasound transducers, Toco or Toco+ transducers, and an ECG/IUP patient module.

Expected outcome: The device and all applicable PM test sections are correctly identified.

2. Review Service History

Action: Review prior PM results, repairs, impact-damage reports, recurring recorder problems, transducer failures, and previous electrical safety values.

Expected outcome: Any testing required because of repair history or impact damage is added to the work scope.

3. Perform the Visual Inspection

Action: Inspect the following:

• Monitor housing for cracks or damage
• Display, touchscreen, keys, and recorder drawer
• AC power cord and strain relief
• Transducer cables for splits, cracks, twisting, or exposed conductors
• Transducer housings and belt buttons
• Toco+ and patient-module adapter sockets
• Sensor sockets and connector block
• NIBP and SpO₂ connectors when installed
• Mounting hardware, cart, wall mount, tray, and fasteners

Replace seriously damaged cables immediately. Do not use a transducer with a broken or damaged belt button.

Expected outcome: No cracks, loose parts, damaged cables, damaged sockets, or insecure mounting components are present.

4. Perform the Power-On Self-Test

Action: Connect the monitor to AC power and turn it on.

Verify that:

• The green power LED illuminates briefly during startup.
• The Philips boot screen appears.
• The test sound is issued.
• The normal monitoring display appears.
• The touchscreen becomes functional.
• No unresolved equipment-malfunction INOP is present.

Expected outcome: The monitor completes its startup self-test and reaches the monitoring screen without an unresolved fault.

5. Check the Display, Touchscreen, Controls, and Alarm Audio

Action: Confirm the display is readable and has normal brightness. Verify touchscreen response across the active screen area. Confirm that keys and controls respond correctly and that audible alarm and system sounds are available.

Confirm the speaker is not muted or set to zero solely for testing. Calibrate the touchscreen only when the touch position is inaccurate.

Expected outcome: Display, touch input, controls, and audible output operate normally.

6. Inspect and Clean the Fetal Recorder

Action: Open the paper drawer and inspect the recorder.

• Clean the platen with a lint-free cloth using a soap-and-water solution.
• Clean the thermal printhead with a cotton swab moistened with a 70% isopropyl-alcohol-based solution.
• Confirm the paper-sensor area is free of dust.
• Load Philips-approved paper with the correct scale and orientation.
• Confirm the drawer closes fully.

Expected outcome: The platen, printhead, and sensor are clean, and the paper is correctly installed.

7. Run the Fetal Recorder Self-Test

Action: In Service Mode, select:

Main Setup → Fetal Recorder → Selftest

Inspect the printed test pattern.

Manufacturer-listed criteria:

• No more than 20 missing dots over the entire printhead
• No more than two adjacent dots inoperative
• No missing dots in mode annotations such as FHR1
• Printed lines are straight
• The Toco baseline line prints on the 20-unit gridline when the recorder offset is correct

Expected outcome: The recorder feeds paper consistently and meets the printhead and alignment criteria.

If the resting Toco trace does not print at 20 units, perform recorder calibration and adjust the offset.

8. Test the Ultrasound Transducers

Action: For each ultrasound transducer:

• Connect the transducer to the monitor.
• Turn on the recorder.
• Select fetal heart sound for that channel.
• Raise the speaker volume to an audible level.
• Hold a flat-bottomed pencil approximately 2–3 cm above each of the seven crystals and move it up and down.
• Move the transducer back and forth over a solid surface or the hand.

Expected outcome: A sound is produced from each of the seven crystal positions and when the transducer is moved over a solid surface.

If the test fails, repeat it using another transducer to distinguish a transducer failure from a monitor or connector-block problem.

9. Test the Toco Transducers

Action:

• Connect the Toco transducer.
• Apply gentle pressure to the Toco sensor.
• Confirm that the displayed and printed values increase.
• Place the transducer face up on a flat surface.
• Press the Toco Baseline key to set the displayed value to 20.
• Turn the transducer over so the sensor rests on the surface.

Expected outcome:

• Resting baseline is approximately 20.
• Face-down value on a flat surface is approximately 35–45.
• Displayed and printed values respond to applied pressure.

10. Test Toco+ or Patient-Module Functions When Included

DECG Mode

Action: Connect the DECG adapter cable M1362B. Confirm that the monitor initially displays the DECG LEADS OFF INOP. Connect a fetal scalp electrode and establish continuity between the spiral and reference electrode using an approved test method.

Expected outcome: The DECG LEADS OFF INOP disappears.

MECG Mode

Action: Connect the MECG adapter cable M1363A and attach it to electrodes or a patient simulator.

Expected outcome: MECG values appear on the maternal display or recorder trace.

IUP Mode

Action: Apply 80 mmHg ±5 mmHg using the specified manometer, expansion chamber, tubing, T-adapter, IUP cable, and catheter setup. Slowly release the applied pressure.

Expected outcome: The monitor and printed trace correspond to the applied pressure and decrease as pressure is released.

11. Perform the NIBP Accuracy Test

Applicable only when NIBP is installed.

Action: Connect the reference manometer, hand pump, tubing, and 250 mL expansion chamber.

In Service Mode:

• Open the NIBP setup menu.
• Set Close Valves to On.
• Raise the pressure to 280 mmHg.
• Allow 10 seconds for stabilization.
• Compare the monitor reading with the reference manometer.
• Record the displayed value.

Expected outcome: The difference between the monitor and reference manometer is ≤3 mmHg.

If the difference exceeds 3 mmHg, perform the manufacturer-listed NIBP calibration procedure.

12. Perform the NIBP Leakage Test

Action: With the system at approximately 280 mmHg, record the initial pressure, wait 60 seconds, record the final pressure, and calculate the pressure loss.

Expected outcome: Pressure loss is less than 6 mmHg in 60 seconds.

Result calculation: Initial pressure − Final pressure

13. Perform the NIBP Linearity Test

Action: Reduce the pressure to 150 mmHg. Wait 10 seconds and compare the monitor value with the reference manometer.

Expected outcome: The difference is ≤3 mmHg.

14. Perform the NIBP Valve Test

Action: Raise the pressure to 280 mmHg. Set Close Valves to Off. Wait five seconds and record the remaining displayed pressure.

Expected outcome: The remaining pressure is less than 10 mmHg.

15. Perform the SpO₂ Performance Test

Applicable only when SpO₂ is installed.

Action: Connect an adult SpO₂ sensor and obtain a reading on a healthy test subject according to facility policy.

Expected outcome: Displayed SpO₂ is 95%–100%.

This is the manufacturer-listed functional check in the provided service guide. It is not a substitute for a simulator-based accuracy test when one is required by facility policy.

Electrical Safety Testing

The manufacturer-listed periodic safety tests for the Avalon FM30 are leakage-current tests.

16. Enclosure and Functional-Earth Leakage Test

Action: Measure the highest leakage current in normal and reversed polarity and under normal and single-fault conditions using the manufacturer-described accessible metal points.

Manufacturer-listed limit: Sum of functional-earth and enclosure leakage current ≤100 µA.

Result =

17. Patient Leakage-Current Test

Applicable to ECG measurement inputs.

Action: Perform the patient leakage-current test with mains applied to the applied part under a single-fault condition at the specified test voltage.

Manufacturer-listed limit: Patient leakage current ≤50 µA at 264 V.

Result =

Touch/chassis leakage measured in microamps:

Facility limit used =

Result =

Pass / Fail =

Ground resistance is not included as a manufacturer-listed PM measurement because the FM30 is a Class II, double-insulated device. Document any additional facility-required electrical safety testing separately.

18. Complete the Final Functional Verification

Action: Confirm the following:

• No unresolved INOP messages are present.
• The display and touchscreen operate normally.
• Alarm sound is audible.
• The recorder starts, feeds paper, and prints normally.
• Installed transducers are recognized.
• Applicable measurements respond correctly.
• The paper scale and recorder speed match facility configuration.
• Cables and accessories are reconnected.
• The monitor is clean and complete.

Expected outcome: The monitor is ready for clinical use with no unresolved safety, measurement, recorder, or accessory defect.

Pass / Fail Criteria

Pass

• Visual inspection is acceptable.
• Power-on self-test completes.
• No unresolved equipment-malfunction INOP is present.
• Display, touchscreen, controls, and alarm audio operate.
• Recorder meets print-quality and alignment criteria.
• Ultrasound and Toco transducers pass functional checks.
• Patient-module functions pass when tested.
• NIBP accuracy, leakage, linearity, and valve tests meet the listed limits.
• SpO₂ displays 95%–100% during the manufacturer-listed functional check.
• Leakage-current tests meet manufacturer-listed limits.
• Mounting hardware and accessories are secure.

Remove From Service

Remove the monitor or affected accessory from service when:

• Housing, cable, connector, transducer, or mounting damage presents a safety risk.
• A transducer has a broken or damaged belt button.
• The monitor fails startup or displays an unresolved equipment-malfunction INOP.
• Alarm audio is unavailable.
• NIBP performance exceeds the manufacturer-listed limits.
• Electrical leakage exceeds the applicable limit.
• Recorder print quality exceeds the allowed missing-dot criteria.
• A measurement cannot be verified.
• Required post-repair testing cannot be completed.
• Any condition could result in an erroneous measurement or unsafe clinical operation.

Use the manufacturer service manual, facility policy, and approved AEM program to determine the final PM interval and return-to-service requirements.