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Manual Reference
HAMILTON-MR1 Operator’s Manual, PN 624495/04, software version 2.2.x, valid for devices with serial number 2000 or higher, dated April 20, 2020.
Manufacturer Recommendation / AEM Status
Manufacturer-Listed PM Frequency
Between Patients and According to Hospital Policy
Replace breathing-circuit components with sterilized or new single-patient-use parts. Run the tightness test, applicable calibration, and preoperational check.
Every 2 Days or According to Hospital Policy
Empty water from breathing tubes or water traps. Inspect breathing-circuit parts for damage and replace them as necessary.
Monthly or More Often When Required
Inspect the rear-panel fan filter for dust and lint. Clean or replace it as needed.
Every 6 Months
Recharge the batteries by connecting the ventilator to primary power for at least four hours. This interval also applies during storage.
Yearly or Every 5,000 Operating Hours
Replace the oxygen cell if depleted, replace the air-intake HEPA filter, and complete service-related preventive maintenance. Perform this service yearly or every 5,000 operating hours, whichever comes first, or as necessary.
Dynamic Lifetime Surveillance
Replace the blower when indicated by the applicable service procedure. The manual gives a typical blower lifetime reference of eight years, but actual replacement is based on dynamic lifetime surveillance and the service procedure.
The service-related preventive maintenance and blower evaluation must be performed by Hamilton Medical-authorized service personnel according to the applicable Service Manual.
Manufacturer-Listed Parts
Hamilton Medical oxygen cell: PN 396200
Hamilton battery charger/calibrator: PN 369104
Adult/pediatric demonstration lung with ET tube: PN 151815 or equivalent
Disposable adult/pediatric flow sensor referenced for calibration: PN 281637
Adult/pediatric reusable expiratory set: PN 161175
Neonatal reusable expiratory set: PN 161188
Reusable expiratory valve membrane and cover, pack of five: PN 161390
The reviewed operator-manual maintenance section does not provide part numbers for the HEPA filter, fan filter, air-intake filter, batteries, or yearly PM kit. Verify current parts through the applicable Hamilton service documentation or parts catalog.
Post-Repair Safety Inspection
The provided operator manual does not give a separate electrical-safety procedure specifically labeled as a post-repair safety inspection.
Necessary repairs must be completed before clinical use. All applicable tests must pass before the ventilator is returned to service. A ventilator that fails the preoperational check must be serviced, and procedures beyond those described in the operator manual must follow the Hamilton Service Manual.
After repair, complete the applicable Hamilton service-manual tests, full preoperational check, required calibrations, functional verification, and facility electrical-safety inspection before release.
AEM Note
The manufacturer-listed service interval is yearly or every 5,000 operating hours, whichever comes first. A different interval or modification of the listed activities must be managed through the facility’s approved AEM program, risk assessment, maintenance history, and applicable regulatory requirements.
What This PM Procedure Covers
This procedure covers manufacturer service-due review, physical and MRI-safety inspection, power-supply and battery checks, fan and air-intake filter maintenance, HEPA-filter replacement, oxygen-cell evaluation, startup testing, TeslaSpy status, tightness testing, flow-sensor calibration, oxygen-cell calibration when indicated, preoperational testing, controlled alarm checks, power-transfer verification, electrical-safety documentation, and the final return-to-service decision.
Required Tools and Equipment
HAMILTON-MR1 Operator’s Manual
Applicable HAMILTON-MR1 Service Manual for the yearly or 5,000-hour authorized-service portion
Compatible adult/pediatric breathing circuit, preferably equivalent to the circuit used clinically
Adult/pediatric flow sensor
Two-liter demonstration lung with adult ET tube, PN 151815 or equivalent
High-pressure medical oxygen source
Primary AC power through the approved Hamilton external power supply
Replacement HEPA, fan, and air-intake filters as needed
Hamilton Medical oxygen cell, PN 396200, when replacement is indicated
Electrical-safety analyzer when required by facility policy
Calibrated oxygen analyzer or ventilator analyzer when required by the applicable service procedure or facility policy
Soft lint-free cloth and approved cleaning agent
Mild soap and clean water for washable external filters
Basic hand tools needed to remove the rear filter cover
Use MR Safe or MR Conditional equipment and accessories when testing in or near the MRI environment. General bench PM should be performed outside the controlled MRI magnetic field unless the test specifically requires MRI-environment verification.
Step-by-Step PM Procedure
1. Remove the Ventilator From Clinical Use
Confirm the ventilator is not connected to a patient. Disconnect or isolate patient-use accessories according to facility infection-control procedures. Keep an alternative ventilator available when the unit is removed from a clinical area.
Expected outcome: Maintenance can be performed without affecting patient ventilation.
2. Review Device Identification and Service Status
Record the model, serial number, software version, total operating hours, time-to-service indication, installed options, and battery-capacity information. Access available information through System > Info.
Determine whether the yearly or 5,000-operating-hour manufacturer interval has been reached.
Expected outcome: Device configuration, operating hours, and manufacturer service status are documented.
3. Review Service History and Reported Problems
Review the CMMS history, previous PM findings, repairs, recurring alarms, battery complaints, TeslaSpy events, filter replacements, oxygen-cell replacements, and open recalls or safety notices.
Do not clear unresolved technical faults solely to complete the PM.
Expected outcome: Recurring or unresolved conditions are identified before testing.
4. Inspect the Ventilator Exterior
Inspect the enclosure, display, touchscreen, Press-and-Turn knob, control keys, alarm lamp, TeslaSpy indicators, loudspeaker opening, inspiratory and expiratory ports, flow-sensor ports, nebulizer port, oxygen inlet, USB cover, power receptacle, equipotential grounding post, cooling-air intake and outlet, labels, and serial-number markings.
Check for cracks, loose parts, contamination, corrosion, liquid intrusion, impact damage, blocked vents, or missing covers.
Expected outcome: No physical condition is present that could affect safe ventilation, electrical safety, or MRI use.
Visible damage requires removal from clinical use and technical service.
5. Inspect the External Power Supply and Cord
Inspect the power transformer, AC cord, ventilator cable, locking ring, strain reliefs, connector contacts, and insulation.
Confirm that no conductors are exposed, insulation is intact, contacts are secure, the ventilator connector locks correctly, the power supply is securely mounted, and an approved protective-earth connection is used.
The HAMILTON-MR1 is a Class I device and must be connected to a supply with protective earth.
Expected outcome: The external power system is secure and undamaged.
6. Inspect the Trolley and MRI-Safety Components
When mounted on the HAMILTON-MR1 trolley, inspect the ventilator attachment, power-supply attachment, oxygen-cylinder holder and straps, wheels, casters, auto-lock brake, brake-release lever, handle, tether and wall-anchor attachment when used, breathing-circuit supports, and MRI-safety labels.
In the United States, the manual identifies use of the HAMILTON-MR1 tether as required when securing the trolley in the MRI environment.
Expected outcome: The trolley, brake, mounts, and restraint components operate correctly and securely hold the equipment.
Do not return the system for MRI use if the auto-lock brake, tether, mounting hardware, or gas-cylinder restraint is defective.
7. Verify TeslaSpy Startup Status
Power the ventilator in a safe test area. Confirm that the TeslaSpy green indicator is illuminated and blinking, the red TeslaSpy indicator is not illuminated, the red-X internal-fault indicator is not illuminated, and no nonsilenceable TeslaSpy alarm remains active.
The green indicator represents an acceptable surrounding magnetic field. A red or red-X condition requires removal from service and Hamilton-qualified evaluation.
Expected outcome: TeslaSpy initializes without a fault and indicates a safe magnetic-field condition.
8. Service the Fan and Air-Intake Filters
Remove and inspect the rear-panel fan filter and air-intake dust filter for dust, lint, moisture, damage, deterioration, or restricted airflow.
Clean reusable filters in a mild soap solution, rinse thoroughly, allow them to dry completely, and reinstall them. Replace damaged, deteriorated, or excessively contaminated filters.
The manufacturer-listed fan-filter inspection interval is monthly or more often when required.
Expected outcome: External filters are clean, dry, intact, and correctly installed.
9. Replace the Air-Intake HEPA Filter
Remove the filter cover and retaining clip. Replace the air-intake HEPA filter at the manufacturer-listed yearly or 5,000-hour interval.
Do not wash or reuse the HEPA filter unless current Hamilton service documentation specifically permits it.
Reinstall the retaining clip, external filters, and rear cover securely.
Expected outcome: A serviceable HEPA filter is correctly installed without gaps or damage.
10. Evaluate the Oxygen Cell
Inspect oxygen-cell status and review related alarms or calibration history. Replace the cell when depleted using a genuine Hamilton Medical oxygen cell, PN 396200.
After replacement, confirm the cell is connected correctly, keep an oxygen cell installed even when external monitoring is used, enable oxygen monitoring, allow approximately 30 minutes for stabilization when practical, and complete oxygen-cell calibration.
The manufacturer does not list unconditional annual replacement. Replace the oxygen cell if depleted during the yearly or 5,000-hour review or as necessary.
Expected outcome: Oxygen monitoring is available, stable, and calibrates successfully.
11. Inspect and Charge Both Internal Batteries
Confirm that both batteries are recognized. Both batteries are required for ventilator operation.
Inspect for battery-related alarms, missing or crossed-out battery symbols, failure to charge, swelling, leakage, heat, odor, visible damage, abnormal capacity indication, or incompatible battery revisions when identifiable.
Connect the ventilator to primary power for at least four hours as required by the manufacturer-listed six-month battery-maintenance interval.
A battery replacement interval is not specified in the provided operator manual. Replace batteries based on failed testing, degraded capacity, alarms, damage, or applicable service-manual criteria.
Expected outcome: Both batteries are recognized, charge normally, and show no evidence of failure.
12. Inspect the Patient Breathing-System Connections
Inspect the inspiratory port, expiratory-valve connection, expiratory valve cover and membrane, flow-sensor tubing connectors, flow sensor, test breathing circuit, filters, adapters, and test lung.
Confirm that the expiratory valve membrane is correctly seated with its metal plate facing the ventilator. Use components appropriate for the selected patient group.
Expected outcome: The test breathing system is complete, correctly assembled, and free from visible damage or obstruction.
13. Verify Startup Self-Test
Turn on the ventilator and observe startup. Verify that the red and yellow alarm-lamp indications illuminate in sequence, the audible buzzer sounds briefly, startup completes without a technical fault, the Patient Setup or Standby screen appears, the display remains stable, and the touchscreen, Press-and-Turn knob, and controls respond.
Expected outcome: Startup self-test completes and the visual and audible alarm indicators function.
14. Perform the Tightness Test
Place the ventilator in Standby and select System > Tests & calib > Tightness. Follow the displayed instructions.
The ventilator pressurizes the circuit to 45 cmH₂O. The test passes when pressure can be maintained and a green check mark is displayed.
Expected outcome: The tightness test displays a green check mark.
A failed test requires inspection of the circuit, expiratory valve, flow sensor, and connections. Do not return the ventilator to service until the test passes.
15. Calibrate the Flow Sensor
Select System > Tests & calib > Flow Sensor. Follow all displayed instructions, including reversing the sensor or installing the required adapter when prompted.
For disposable adult/pediatric flow sensor PN 281637, use the additional calibration adapter identified by the manual.
For nCPAP or nCPAP-PC operation, perform the applicable breathing-circuit calibration instead of flow-sensor calibration.
Expected outcome: The installed flow sensor or neonatal circuit calibrates successfully and displays a green check mark.
16. Calibrate the Oxygen Cell
When replacement, an alarm, PM findings, or facility policy indicate calibration, confirm oxygen monitoring is enabled, connect the approved oxygen supply, select System > Tests & calib > O₂ cell, follow the displayed procedure, and confirm a green check mark.
Hamilton recommends calibration using 100% oxygen to improve measurement stability at higher oxygen concentrations.
Expected outcome: Oxygen-cell calibration passes without an alarm.
17. Complete the Preoperational Check
Use a compatible test circuit and two-liter demonstration lung. Complete startup observation, the tightness test, flow-sensor or circuit calibration, oxygen-cell calibration when necessary, controlled alarm generation, alarm reset, and verification of controls and displayed values.
Hamilton states that a ventilator failing any preoperational test must be removed from clinical use until repairs are completed and all tests pass.
Expected outcome: The complete preoperational check passes.
18. Verify Alarm Functions
At minimum, verify the alarm lamp and audible alarm by generating a controlled alarm such as loss of external power.
Facility policy or the applicable service procedure may also include controlled tests for high pressure, low minute volume, low oxygen, patient-side disconnection, loss of external power, exhalation obstructed, and apnea.
Do not obstruct the expiratory valve or create alarm conditions while connected to a patient.
Expected outcome: Applicable visual and audible alarms activate, display the correct message, and reset after the condition is corrected.
19. Verify Power Transfer
With the ventilator operating on a test lung, confirm AC is the active power source. Disconnect external power, verify the Loss of external power alarm activates, and confirm ventilation continues on battery power.
Reconnect external power and confirm the alarm resets and AC again becomes the active source.
Do not use this brief switchover test as a substitute for a formal battery-capacity test when one is required.
Expected outcome: Transfer between external power and battery power occurs without interruption of ventilation.
20. Perform Functional Ventilation Verification
Using a test lung and appropriate test equipment when required by facility policy or the Hamilton Service Manual, verify stable breath delivery, pressure generation, flow and volume monitoring, PEEP, respiratory rate, FiO₂ delivery, alarm response, and the absence of abnormal blower noise, excessive vibration, heat, or odor.
The provided operator manual does not list yearly numerical ventilation-performance tolerances for a complete service PM. Use the current Hamilton Service Manual for authorized performance-testing limits.
Expected outcome: Ventilator operation is stable and all measured values meet the applicable manufacturer or facility acceptance limits.
21. Final Inspection and Documentation
Confirm that all covers and filters are installed, no test adapters remain attached, power and gas connections are secure, both batteries are recognized, no alarms or technical faults remain, TeslaSpy shows a normal green indication, the preoperational check passes, and the device is clean and ready for storage or clinical setup.
Document the PM, test results, replaced parts, operating hours, and final status.
Expected outcome: The ventilator is formally returned to service or clearly removed from service.
Electrical Safety Testing
The operator manual identifies the HAMILTON-MR1 as Class I equipment requiring protective earth. It does not provide manufacturer-specific ground-resistance or leakage-current PM limits.
Perform electrical-safety testing according to facility policy, the applicable edition of NFPA 99 or adopted standard, and the Hamilton Service Manual.
Ground resistance measured in ohms, expected ≤ 0.5 Ω or facility/NFPA 99 criteria if different:
Result =
Touch/chassis leakage measured in microamps:
Facility limit used =
Result =
Pass / Fail =
Also inspect the external power transformer, power cord, locking connector, protective-earth conductor, and equipotential grounding post.
Electrical-safety testing does not replace the preoperational or service-manual performance tests.
Pass / Fail Criteria
Pass
The HAMILTON-MR1 passes PM when manufacturer-listed maintenance is current; yearly or 5,000-hour authorized-service requirements are satisfied; filters are clean and correctly installed; the HEPA filter has been replaced at the applicable interval; both batteries are recognized and charge normally; oxygen monitoring functions and calibrates when applicable; startup self-test passes; TeslaSpy indicates normal operation; the tightness test passes; flow-sensor or circuit calibration passes; the preoperational check passes; required alarm and power-transfer tests pass; electrical-safety results meet documented facility criteria; and no damage, unresolved alarm, or technical fault remains.
Remove From Service
Remove the ventilator from service when any preoperational test or calibration fails; a technical fault remains active; TeslaSpy displays a red or red-X condition; visual or audible alarms are unreliable; either required battery is missing, defective, or not recognized; ventilation stops or restarts during power transfer; the ventilator cannot deliver stable ventilation; oxygen measurement cannot be calibrated or verified; the HEPA filter is missing or cannot be installed correctly; power components have exposed contacts or damaged insulation; the trolley, brake, tether, or equipment mounting is unsafe for MRI use; electrical-safety criteria are not met; or visible damage, liquid intrusion, overheating, smoke, or abnormal odor is present.
Copy/Paste CMMS Work Order Procedure
Filter Change Only
Use the manufacturer service manual, facility policy, and approved AEM program to determine the final PM interval and return-to-service requirements.