Medtronic Valleylab FT10

Asset Type

Electrosurgical Unit (ESU)

Manufacturer

Medtronic

Model

Valleylab FT10

Manual Reference

Valleylab FT10 Energy Platform Service Manual, FT Series Energy Platform, software version 2.0x, Part Number PT00047922.

Manufacturer Recommendation / AEM Status

The manufacturer-listed periodic safety check frequency is once a year, or as directed in Chapter 8, to verify that the system is functioning properly.

The manual also states to record the test results, keep the completed check sheet for future reference, and refer to troubleshooting if the system fails any checks.

Manufacturer-listed PM items include:

• Inspect the system and accessories.
• Inspect internal components when required.
• System self-test.
• Verify audio.
• Verify power output.
• Verify REM function.
• Verify cross coupling.
• Check leakage current and ground resistance.

Manual-listed low-frequency leakage limits include:

• Chassis / earth leakage: < 300 µA normal condition.
• Chassis / earth leakage: ≤ 1000 µA single fault condition.
• Total patient leakage source current: < 10 µA normal condition.
• Total patient leakage source current: ≤ 50 µA single fault condition.
• Total patient leakage sink current: ≤ 50 µA.

Manual-listed high-frequency leakage limits include:

• Monopolar high-frequency leakage: ≤ 100 mA.
• Patient return high-frequency leakage: ≤ 100 mA.
• Bipolar high-frequency leakage: ≤ 69 mA.
• LigaSure / Bipolar high-frequency leakage: ≤ 100 mA.

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

• External visual inspection.
• Accessory and receptacle inspection.
• Power-up self-test.
• Audio verification.
• RF output verification.
• REM function verification.
• Cross-coupling verification.
• High-frequency leakage testing.
• Low-frequency leakage testing.
• Ground continuity documentation.

Required Tools and Equipment

• Safety tester.
• Digital voltage meter.
• Leakage current measuring device.
• True RMS meter or oscilloscope.
• Current transformer, Volt per Amp = 0.10, 10 MHz bandwidth.
• Test cable leads.
• Banana cables / test leads, 18 inches or shorter where specified.
• Non-inductive resistive loads: 50 Ω, 100 Ω, 200 Ω 250 W 1%, 300 Ω, and 500 Ω.
• Monopolar foot pedal.
• Bipolar foot pedal.
• LigaSure foot pedal.
• Monopolar instrument or test leads.
• Bipolar instrument cord or test leads.
• LigaSure instrument or test leads.
• REM plug.
• Resistance decade box, 1 Ω resolution, 1% tolerance, 1/8 W or greater, or 50 Ω / 100 Ω non-inductive loads.
• Torx T30 screwdriver only when internal inspection is required.

Step-by-Step PM Procedure

1. Confirm Device Identification

Verify asset tag, serial number, model, and software version if available.

Expected outcome: Device identity matches the work order and the PM record.

2. Inspect Exterior and Rear Panel

With the unit powered off and unplugged, inspect the rear panel, power cord receptacle, fuse drawer, foot pedal receptacles, equipotential ground connection, and external system connectors.

Check for physical damage, loose or damaged connectors, obstructions, corrosion, incorrect fuses, damaged fuses, damaged power cord, or damaged plug.

Expected outcome: No damaged, loose, obstructed, or unsafe connections are found.

3. Inspect Front Panel and Accessory Receptacles

Inspect the touchscreen, buttons, REM receptacle, Monopolar 1 receptacle, Monopolar 2 receptacle, Bipolar receptacle, and LigaSure/Bipolar receptacle.

Insert appropriate accessories or test connectors to verify secure fit and detection where applicable.

Expected outcome: Receptacles are not damaged or obstructed, accessories fit securely, and the correct touchscreen quadrant becomes active when applicable.

4. Inspect Foot Pedals

Inspect monopolar, bipolar, and LigaSure foot pedals and connectors for damage, corrosion, or poor fit.

Reconnect and verify operation during functional testing.

Expected outcome: Foot pedals are physically intact and activate the expected function during testing.

5. Inspect Internal Components When Required

Only perform internal inspection when the unit has been opened for troubleshooting, repair, or spare part replacement.

Inspect for loose connectors, damaged wires, cracked or corroded PCBAs, loose debris, or improperly seated components.

Expected outcome: Internal components are secure, clean, and free of visible damage.

Remove from service if internal damage, corrosion, loose debris, damaged PCBAs, or unsafe conditions are found.

6. Perform Power-On Self-Test

Power on the unit and allow the internal self-test to complete.

Verify that the display illuminates, indicators illuminate, test tones sound, REM indicator illuminates, and no system error remains active.

Expected outcome: The unit completes self-test without error and reaches the normal operating screen.

Remove from service if the self-test fails, an error screen appears, or an alarm condition cannot be cleared.

7. Verify Audio

Use the audio control to increase and decrease the volume.

Expected outcome: Audio is present, adjustable, and distortion-free.

Why it matters: Activation and alarm tones are safety-critical on an ESU.

8. Verify RF Output

Enter the RF Output Test Screen and perform the manufacturer-listed RF output checks using the specified loads, current transformer, and meter setup.

Document pass/fail for Monopolar 1 COAG output, Monopolar 2 COAG output, Monopolar 2 CUT output, Monopolar 2 VALLEYLAB mode output, Bipolar output, and LigaSure/Bipolar output.

Expected outcome: All measured RF output readings are within the manufacturer-listed ranges.

Remove from service if any RF output measurement is outside the manufacturer-listed range.

9. Verify REM Function

Test the REM circuit using the REM plug and resistance decade box or specified non-inductive loads.

Document 100 Ω reading within 93 Ω to 107 Ω, 50 Ω reading within 43 Ω to 57 Ω, 0 Ω reading within 0 Ω to 4 Ω, REM indicator green where expected, REM indicator red where expected, and open REM reading less than 2000 Ω.

Expected outcome: REM readings and indicators match the manufacturer-listed values.

Remove from service if REM readings are outside limits or REM alarm behavior is incorrect.

10. Verify Cross Coupling

Perform the manufacturer-listed cross-coupling checks using the RF Output Test Screen, 200 Ω load, current transformer, and specified modes.

Document pass/fail for Monopolar 1 current expected 0 to 150 mA, Monopolar 2 current expected 0 to 150 mA, Bipolar current expected 0 to 50 mA, and LigaSure/Bipolar current expected 0 to 50 mA.

Expected outcome: Cross-coupling current remains within manufacturer-listed limits.

Remove from service if any cross-coupling measurement exceeds the listed limit.

11. Check High-Frequency Leakage

Perform high-frequency leakage tests using the manufacturer-listed setup.

Document monopolar leakage, patient return leakage, bipolar leakage, and LigaSure/Bipolar leakage.

Expected outcome: Monopolar HF leakage ≤ 100 mA, patient return HF leakage ≤ 100 mA, bipolar HF leakage ≤ 69 mA, and LigaSure/Bipolar HF leakage ≤ 100 mA.

Remove from service if any high-frequency leakage value exceeds the manufacturer-listed limit.

12. Check Low-Frequency Leakage

Perform IEC 60601-1 low-frequency leakage testing before returning the unit to clinical use.

Document chassis / earth leakage normal condition, chassis / earth leakage single fault condition, total patient leakage source current, and total patient leakage sink current.

Expected outcome: Chassis / earth leakage normal condition < 300 µA, chassis / earth leakage single fault condition ≤ 1000 µA, total patient leakage source normal condition < 10 µA, total patient leakage source single fault condition ≤ 50 µA, and total patient leakage sink current ≤ 50 µA.

Remove from service if any low-frequency leakage value exceeds the manufacturer-listed limit.

13. Ground Continuity Testing

Measure ground continuity between the equipotential ground lug on the rear of the unit and the supplied Covidien power cord ground, or directly to the middle ground pin of the inlet receptacle.

Expected outcome: Ground continuity passes facility/IEC criteria.

Ground resistance measured in ohms, expected ≤ 0.5 Ω or facility/NFPA 99 criteria if different.

Electrical Safety Testing

Ground Resistance

Ground resistance measured in ohms, expected ≤ 0.5 Ω or facility/NFPA 99 criteria if different.

Result =

Pass / Fail =

Low-Frequency Leakage

Touch/chassis leakage measured in microamps:

Facility limit used = < 300 µA normal condition / ≤ 1000 µA single fault condition

Result =

Pass / Fail =

Total patient leakage source current measured in microamps:

Facility limit used = < 10 µA normal condition / ≤ 50 µA single fault condition

Result =

Pass / Fail =

Total patient leakage sink current measured in microamps:

Facility limit used = ≤ 50 µA

Result =

Pass / Fail =

High-Frequency Leakage

Monopolar high-frequency leakage measured in milliamps:

Facility limit used = ≤ 100 mA

Result =

Pass / Fail =

Patient return high-frequency leakage measured in milliamps:

Facility limit used = ≤ 100 mA

Result =

Pass / Fail =

Bipolar high-frequency leakage measured in milliamps:

Facility limit used = ≤ 69 mA

Result =

Pass / Fail =

LigaSure/Bipolar high-frequency leakage measured in milliamps:

Facility limit used = ≤ 100 mA

Result =

Pass / Fail =

Pass / Fail Criteria

PM passes if:

• Unit passes visual inspection.
• Power cord, receptacles, foot pedals, and accessory ports are not damaged.
• Unit completes self-test without error.
• Audio is functional and distortion-free.
• RF output checks pass manufacturer-listed ranges.
• REM function passes manufacturer-listed checks.
• Cross-coupling checks pass manufacturer-listed limits.
• High-frequency leakage passes manufacturer-listed limits.
• Low-frequency leakage passes manufacturer-listed limits.
• Ground continuity passes facility/IEC criteria.
• No active errors or unsafe conditions remain.

Remove from service if:

• Self-test fails.
• Any receptacle, power cord, foot pedal, or connector is damaged.
• REM function fails.
• RF output is outside manufacturer-listed range.
• Cross-coupling exceeds limits.
• High-frequency leakage exceeds limits.
• Low-frequency leakage exceeds limits.
• Ground continuity fails.
• Internal damage, corrosion, loose debris, or damaged PCBAs are found.
• Unit displays an unresolved system error.

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