Hamilton C1

Asset Type

Ventilator

Manufacturer

Hamilton

Model

C1

Manual Reference

HAMILTON-C1 Service Manual, Hamilton Medical AG, 624338/02, September 2014.

Manufacturer Recommendation / AEM Status

Manufacturer-Listed PM Frequency

The manufacturer-listed preventive maintenance and testing interval for the HAMILTON-C1 is once a year or once every 5000 operating hours, whichever comes first. Preventive maintenance and testing are also required after replacing any component.

Manufacturer-Listed PM Items

• Perform a visual inspection of the ventilator, safety markings, labels, cables, cleanliness, and physical condition.
• Replace the HEPA filter, PN 161236.
• Replace the HPO inlet filter kit, PN 160497.
• Perform all applicable calibrations and tests in Service Software.
• Perform all general tests and checks.
• Perform the pre-operational checks identified in the Operator’s Manual.
• Replace the oxygen cell, PN 396200, if depleted.
• Evaluate and replace the lithium-ion battery, PN 369108, when listed replacement criteria are met.
• Replace the blower module, MSP161170, when the blower timer reaches 100%.

Manufacturer-Listed Parts and Replacement Criteria

• HEPA filter: Replace during yearly / 5000-hour PM. Part number: 161236.
• HPO inlet filter kit: Replace during yearly / 5000-hour PM. Part number: 160497.
• Air intake dust filter / fan filter set: Check monthly or more often if required; clean or replace if needed. Part number: 161275.
• Oxygen cell: Replace if depleted. Part number: 396200.
• Lithium-ion battery: Replace when applicable capacity limit is reached, battery age exceeds 3 years, or battery cycles exceed 400. Part number: 369108.
• Battery Charger / Calibrator: Used for battery calibration; recommended once per year during PM. Part number: 369104, revision 07 or higher.
• Blower module: Replace when blower timer reaches 100%; typically after 8 years. Part number: MSP161170.

Battery Replacement Criteria

• PN 369108 Rev. 00-03: replace when capacity is less than 3600 mAh.
• PN 369108 Rev. 04: replace when capacity is less than 5360 mAh.
• Replace when battery age is greater than 3 years.
• Replace when battery cycle count exceeds 400.

The manual recommends performing a battery calibration cycle using Battery Charger / Calibrator PN 369104, revision 07 or higher, once per year during preventive maintenance.

Post-Repair Safety Inspection Requirements

The manual lists IEC 62353 electrical safety testing during preventive maintenance and after any repair, installation, power supply board replacement, control board replacement, driver board replacement, or removal of any ground contact from the ventilator.

AEM Status

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

What This PM Procedure Covers

• Scheduled yearly / 5000-hour preventive maintenance.
• Visual inspection and required filter replacement.
• Battery condition, age, cycle count, capacity, and annual calibration review.
• Blower service-life review.
• IEC 62353 electrical safety testing.
• Service Software calibrations and tests.
• General functional tests, option checks, pre-operational checks, and alarm verification.
• CMMS documentation supporting the return-to-service decision.

Required Tools and Equipment

The service manual states that maintenance and testing procedures are intended for personnel who have completed Hamilton Medical service training for the HAMILTON-C1.

• Personal protective equipment appropriate for potentially contaminated ventilator components.
• Cleaning and disinfection materials according to facility infection-control policy and the Operator’s Manual.
• HEPA filter, PN 161236.
• HPO inlet filter kit, PN 160497.
• Lithium-ion battery pack, PN 369108, if replacement criteria are met.
• Hamilton C1 oxygen cell, PN 396200, if depleted.
• Battery Charger / Calibrator, PN 369104, revision 07 or higher, for annual battery calibration.
• Complete adult breathing circuit, PN 260086, or equivalent applicable test setup.
• Test lung with ET tube, PN 151815, and adapter, PN 281420.
• Inspiratory filter, PN 279204.
• Bacterial filter between the ventilator and inspiratory limb when required for service testing.
• IEC 62353 electrical safety analyzer, such as RIGEL 288 or equivalent.
• Electrical safety test cable, PN 161618.
• CO2 option electrical safety test cable, PN 159171, when installed.
• SpO2 option electrical safety test cable, PN 159681, when installed.
• Standard service hand tools and ESD protection when accessing internal components.

Step-by-Step PM Procedure

1. Remove the Ventilator From Clinical Use

Action: Confirm that the ventilator is not connected to a patient. Remove the unit from clinical use before beginning maintenance or testing. Apply appropriate PPE if the unit or patient circuit components may be contaminated.

Expected outcome: The ventilator is available for safe maintenance without patient dependence or contamination exposure.

Why it matters: The service manual warns to disconnect the patient before beginning service or maintenance and identifies the unit and used components as potentially contaminated.

2. Confirm PM Interval and Review Service Status

Action: Review the device maintenance history, last PM date, operating hours, service timer hours, reported failures, and any recent repairs or component replacements. Access the Service Software information screens and document total operating hours, service timer hours, blower timer percentage, and hardware/software version information as applicable.

Expected outcome: The technician confirms whether the PM is due by yearly interval, 5000 operating hours, component replacement, or another service event.

3. Clean and Inspect the Ventilator

Action: Confirm the ventilator has been cleaned and disinfected according to applicable infection-control procedures. Inspect the ventilator and cables for damage, cracks, missing hardware, contamination, excessive wear, legible safety markings and labels, AC power cord condition, external cable condition, breathing circuit connections, oxygen connections, filter covers, option slot, display, controls, and alarm lamp condition.

Expected outcome: The ventilator is clean, intact, and free of visible conditions that would prevent continued testing or return to service.

Fail condition: Stop PM completion and remove the unit from service if physical damage, damaged cables, missing safety markings, contamination that cannot be corrected, or another unsafe external condition is identified.

4. Confirm Hospital Preventive Maintenance Items

Action: Review whether routine hospital-maintenance activities are being performed as listed in the manual:

• Between patients and according to hospital policy: Replace breathing circuit, mask, inspiratory filter, flow sensor, nebulizer jar, expiratory valve, and membrane with sterilized or new single-use parts as applicable; perform tightness test and flow sensor calibration.
• Every 2 days or according to hospital policy: Perform the ventilator pre-operational check.
• Every month or more often if required: Check the air intake dust filter and fan filter set for dust and lint; clean or replace as needed.
• Every 6 months while in storage: Recharge the battery by plugging the ventilator into AC power for at least 4 hours.

Expected outcome: Routine facility-level maintenance items have been reviewed and any overdue condition is addressed or documented.

5. Replace the HEPA Filter

Action: Replace the HEPA filter using the applicable procedure from the Operator’s Manual. Replacement HEPA filter: PN 161236.

Expected outcome: A new HEPA filter is installed and properly seated.

Why it matters: HEPA filter replacement is a manufacturer-listed yearly / 5000-hour engineer PM activity.

6. Replace the HPO Inlet Filter

Action: Replace the high-pressure oxygen inlet filter according to the service manual procedure. HPO inlet filter kit: PN 160497.

Expected outcome: A new HPO inlet filter is installed correctly without damage to the oxygen inlet assembly.

Why it matters: HPO inlet filter replacement is a manufacturer-listed yearly / 5000-hour engineer PM activity.

7. Evaluate the Oxygen Cell

Action: Inspect the oxygen cell status and performance during the required calibration and testing sequence. Replace the oxygen cell if depleted. Oxygen cell: PN 396200.

Expected outcome: The installed oxygen cell successfully completes applicable calibration and oxygen-related tests, or it is replaced and retested.

Fail condition: Do not return the ventilator to service if the oxygen cell is depleted and calibration or oxygen monitoring performance cannot be restored.

8. Evaluate and Calibrate the Lithium-Ion Battery

Action: Using Service Software technical-state information, document the battery part number and revision, battery age, battery cycle count, and full-charge capacity. Replace the battery if any manufacturer-listed replacement criterion is met. Perform the manufacturer-recommended annual battery calibration cycle using Battery Charger / Calibrator PN 369104, revision 07 or higher.

• PN 369108 Rev. 00-03: replace when capacity is less than 3600 mAh.
• PN 369108 Rev. 04: replace when capacity is less than 5360 mAh.
• Replace when battery age is greater than 3 years.
• Replace when battery cycle count exceeds 400.

Expected outcome: The battery remains below all replacement thresholds, successfully completes annual calibration, and provides an acceptable charge indication; or the battery is replaced and verified.

9. Evaluate Blower Service Life

Action: Access the blower timer in Service Software and document the blower timer percentage.

Expected outcome: The blower timer is below 100%, with no blower-service alarm present.

Fail condition: If the blower timer reaches 100% or the unit displays Blower service required, replace blower module MSP161170 and complete required follow-up testing before return to service.

10. Perform Electrical Safety Testing

Action: Perform IEC 62353 electrical safety testing using a suitable analyzer such as the RIGEL 288 or equivalent. Test the ventilator in standby mode according to its installed configuration:

• Class II, Type B: No CO2 or SpO2 option board installed.
• Class II, Type BF: Capnography and/or pulse oximetry option board installed.

Expected outcome: Measured leakage values do not exceed the manufacturer-listed limits for the installed device configuration.

Important note: The HAMILTON-C1 is identified in the provided manual as a Class II device. Protective-earth ground resistance is not listed as a routine PM acceptance measurement for this device in the provided electrical safety specifications. Do not add a ground-resistance pass limit unless required by facility procedure for this specific configuration.

11. Perform Service Software Calibrations and Tests

Action: Allow the ventilator to warm up for at least 20 minutes in ventilation software before performing Service Software procedures. Use an adult breathing circuit when required and place a bacterial filter between the ventilator and inspiratory limb during applicable testing.

Enter Service Software and complete all applicable calibrations and tests identified by the service manual and test report, including applicable calibrations, component tests, system tests, sensor and option checks when installed, service log review, technical-state review, service timer documentation, and service timer reset after successful service.

If a component is replaced, update the technical state, restart the ventilator, and repeat the required series of tests.

Expected outcome: All applicable Service Software tests and calibrations complete successfully and are documented on the HAMILTON-C1 test report.

Fail condition: Any failed calibration, failed component test, failed system test, unresolved technical fault, or required part replacement not followed by successful retesting prevents return to service.

12. Perform General Tests and Applicable Option Checks

Action: Complete applicable general tests identified in the service-manual test report:

• AC-battery test.
• Power-loss / battery-loss test.
• Fan check, when required after reassembly.
• Expiratory proportional valve exhaust tubing check, when required after reassembly.
• Nebulizer tube / connection tightness check.
• USB port check.
• CO2 sensor accuracy check, if installed and applicable.
• SpO2 sensor check, if installed and applicable.
• RS232 communication interface functional test, if installed and applicable.
• Nurse call functional check, if installed and applicable.

Expected outcome: All applicable general and option-related checks pass.

13. Perform Pre-Operational Checks and Alarm Tests

Action: Perform the pre-operational checks according to the Operator’s Manual, including battery charge indicator verification, tightness test, flow sensor calibration, and O2 cell calibration.

Perform the listed alarm tests:

• High pressure alarm.
• Low minute volume alarm.
• Low oxygen / oxygen supply failed alarm.
• Disconnection on patient side alarm.
• Loss of external power alarm.
• Exhalation obstructed alarm.
• Apnea alarm.

Expected outcome: Pre-operational checks and all listed alarm tests complete successfully.

14. Complete Documentation and Return-to-Service Decision

Action: Document the PM interval basis, visual inspection results, filters replaced, battery data and calibration or replacement result, blower timer percentage, oxygen cell status, electrical safety measurements, Service Software test completion, general test and option-check results, pre-operational and alarm-test results, any parts replaced, repeat testing completed, and final service status.

Reset the service timer only after successful completion of the required maintenance and testing sequence.

Expected outcome: The PM record supports the final return-to-service or removed-from-service decision.

Electrical Safety Testing

Manufacturer-Listed Device Classification

• C1 without CO2/SpO2 option board: Class II, Type B.
• C1 with capnography and/or pulse oximetry option board installed: Class II, Type BF.

Manufacturer-Listed IEC 62353 Limits

• Equipment leakage current, direct method, Type B: Expected ≤ 0.1 mA / 100 µA.
• Equipment leakage current, direct method, Type BF: Expected ≤ 0.1 mA / 100 µA.
• Patient leakage current, direct method, Type BF only: Expected ≤ 5 mA AC / 5000 µA AC.
• Patient leakage current, direct method, Type B: Not listed in the provided manual table.

The manual states that all measured values must be documented and treated as reference values for future maintenance evaluations.

Electrical Safety Documentation Fields

Installed configuration:
Type B / Type BF =

Option board installed:
None / CO2 / SpO2 / CO2 and SpO2 =

Ground resistance:
Not listed as a routine manufacturer PM acceptance measurement for this Class II device configuration in the provided manual.

Touch/chassis leakage measured in microamps:
Facility limit used = ≤ 100 µA for equipment leakage current, direct method, or facility-approved criterion if different
Result =
Pass / Fail =

Patient leakage current, direct method, Type BF only:
Facility limit used = ≤ 5000 µA AC, or facility-approved criterion if different
Result =
Pass / Fail / Not Applicable =

Electrical safety analyzer used:
Manufacturer / Model =

Test cables used, as applicable:
PN 161618 / PN 159171 / PN 159681 / Other documented equivalent =

Reference values recorded for future PM comparison:
Yes / No =

Pass / Fail Criteria

PM Pass Criteria

The ventilator may be returned to service only when:

• Visual inspection is acceptable and safety labels remain legible.
• Required HEPA and HPO inlet filter replacements are complete.
• The oxygen cell is functional and required calibration passes.
• The battery remains within manufacturer-listed replacement criteria or has been replaced and successfully verified.
• The blower timer is below 100%, or the blower has been replaced and required follow-up testing passes.
• Electrical safety testing passes for the installed Type B or Type BF configuration.
• All applicable Service Software calibrations and tests pass.
• All applicable general and option checks pass.
• Pre-operational checks and required alarm tests pass.
• Required documentation is completed.

Remove From Service Criteria

Remove the ventilator from service if any of the following remain unresolved:

• Damaged ventilator, damaged power cord or cables, contamination, or missing or illegible safety markings.
• Failed electrical safety test.
• Failed Service Software calibration, component test, or system test.
• Failed pre-operational check or alarm test.
• Depleted oxygen cell that cannot successfully complete required calibration or testing.
• Battery exceeding manufacturer-listed replacement criteria without replacement and successful verification.
• Blower timer at 100% or Blower service required condition without replacement and successful follow-up testing.
• Unresolved technical fault or failure requiring repair.

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