Drager Evita V500

Asset Type

Ventilator

Manufacturer

Drager

Model

Evita V500

Manual Reference

Instructions for Use, Infinity Acute Care System – Evita Infinity V500, Ventilation Unit, SW 2.n

Manufacturer Recommendation / AEM Status

The provided document is an Instructions for Use, not a full service manual. It does include manufacturer-listed maintenance and safety check information.

Manufacturer-Listed Inspection / Safety Check Frequency

Inspection and safety checks: every 12 months by service personnel.

The manual also notes that safety checks are not a substitute for preventive maintenance replacement of wear parts.

Manufacturer-Listed PM Items and Intervals

• Ambient air filter: clean every 4 weeks and replace if necessary. Replace every 12 months.
• Diaphragm of expiratory valve: replace every 12 months.
• Expiratory valve: replace every 2 years.
• GS500 breathing gas filter in blower unit: replace every 12 months by service personnel.
• GS500 filter mat: replace every 12 months by service personnel.
• Batteries: check capacity every 3 months by service personnel.
• Batteries: replace as needed by experts.
• Batteries: replace every 2 years by experts.
• Air filter in Air gas inlet: replace every 2 years by experts.
• O2 filter in O2 gas inlet: replace every 6 years by experts.

Manufacturer-Listed Safety Check Items

The 12-month safety check includes:

• Confirm instructions for use are available.
• Perform device check and breathing circuit check.
• Functional test of airway pressure measurement.
• Functional test of flow measurement.
• Functional test of batteries.
• Verify labels are complete and legible.
• Verify no visible damage.
• Verify externally accessible fuses match specified values.
• Verify equipment is complete according to the instructions for use.
• Check electrical safety according to IEC 62353.
• Check emergency expiratory valve function.
• Check non-return valve in expiratory valve.
• Check emergency breathing valve function.
• Check alarm generator.
• Check non-return valves in O2 and Air gas inlets.

Manufacturer-Listed Parts

Part numbers were not specified in the provided IFU.

Post-Repair Safety Inspection

The provided IFU lists 12-month inspection and safety check items. A separate post-repair safety inspection procedure was not specified in the provided document.

AEM Note

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

• Visual and documentation inspection.
• Manufacturer-listed 12-month inspection and safety checks.
• Device check and breathing circuit check.
• Battery check documentation.
• Electrical safety testing documentation.
• Filter, diaphragm, expiratory valve, and battery interval review.
• Copy/paste CMMS documentation.

Required Tools and Equipment

• Test lung appropriate for the patient circuit.
• Breathing circuit and accessories needed to perform system check.
• Electrical safety analyzer capable of IEC 62353 testing.
• Ventilator analyzer or facility-approved test equipment for airway pressure and flow verification.
• O2/Air gas supply.
• Replacement ambient air filter, if due.
• Replacement expiratory valve diaphragm, if due.
• Replacement expiratory valve, if due.
• Replacement GS500 breathing gas filter, if equipped and due.
• Replacement GS500 filter mat, if equipped and due.
• Replacement batteries, if due or failed capacity check.
• Replacement Air inlet filter, if due.
• Replacement O2 inlet filter, if due.

Part numbers were not specified in the provided IFU.

Step-by-Step PM Procedure

1. Remove From Patient Use

Action: Confirm the ventilator is not connected to a patient before maintenance.

Expected outcome: Device is safe to inspect, test, and service.

Why it matters: Maintenance work should not be performed while the device is connected to a patient.

2. Clean / Reprocess Status Check

Action: Verify the device and reusable components have been cleaned/reprocessed according to facility policy and the IFU before maintenance.

Expected outcome: Device is safe to handle and inspect.

3. Visual Inspection

Action: Inspect the housing, display/cockpit, touchscreen, power cord, gas hoses, O2 and Air inlet connections, expiratory valve, inspiratory port, water trap, flow sensor area, casters/trolley if attached, labels, and external fuses.

Expected outcome: No visible damage is found. Labels are complete and legible. Fuses accessible from outside match specified values. Equipment appears complete according to the IFU.

4. Review Manufacturer-Listed PM Intervals

Action: Check device records and replace or schedule replacement for any due interval items.

Expected outcome: Due maintenance items are completed or documented for follow-up.

• Ambient air filter: clean/replace if needed every 4 weeks; replace every 12 months.
• Expiratory valve diaphragm: replace every 12 months.
• Expiratory valve: replace every 2 years.
• GS500 breathing gas filter and filter mat: replace every 12 months, if equipped.
• Batteries: check every 3 months; replace every 2 years or sooner if needed.
• Air gas inlet filter: replace every 2 years.
• O2 gas inlet filter: replace every 6 years.

5. Ambient Air Filter Check / Replacement

Action: Inspect the ambient air filter for contamination. Clean or replace if needed. Replace at least every 12 months.

Expected outcome: Ambient air filter is clean, properly installed, and not creased.

6. Expiratory Valve Diaphragm / Expiratory Valve Review

Action: Review service history. Replace the expiratory valve diaphragm if due at 12 months. Replace the expiratory valve if due at 2 years. Confirm the expiratory valve is properly installed and engaged.

Expected outcome: Expiratory valve assembly is not damaged and due replacement items are completed or scheduled.

7. GS500 Gas Supply Unit PM, If Equipped

Action: If the ventilator has a GS500 gas supply unit, verify the GS500 breathing gas filter in the blower unit and the GS500 filter mat have been replaced every 12 months.

Expected outcome: GS500 filter maintenance is current.

8. Battery Maintenance / Capacity Check

Action: Perform or verify battery capacity check if due. Manufacturer-listed interval is every 3 months.

Expected outcome: Battery check passes, or failed/weak batteries are replaced or escalated to qualified personnel.

9. Device Check

Action: Run the ventilator device check from standby using the IFU procedure.

Expected outcome: Device check completes successfully.

Remove from service if: The device check fails and the failure cannot be corrected.

Important note: Safety-relevant device check failures involving the pressure sensor calibration valve, expiratory valve, or safety valve should not be ignored. Do not return the ventilator to service until corrected.

10. Breathing Circuit Check

Action: Perform breathing circuit check after the device check and whenever the breathing circuit, humidifier, or patient category has changed.

Expected outcome: Breathing circuit check passes. Leakage, compliance, inspiratory resistance, and expiratory resistance are documented as applicable.

Manual-listed leakage reference: Leakage flow up to 300 mL/min at 60 mbar / 60 cmH2O is acceptable.

11. Functional Testing

Action: Perform functional verification of airway pressure measurement, flow measurement, battery function, alarm generator, emergency expiratory valve, emergency breathing valve, non-return valves in the expiratory valve, and non-return valves in the O2/Air gas inlets.

Expected outcome: All safety and functional checks pass.

Manual-listed safety feature values:

• Emergency expiratory valve: pressure rise 1.9 to 4.4 mbar / cmH2O at flow 4.5 to 5.5 L/min.
• Emergency breathing valve: maximum pressure drop 4 mbar / cmH2O at suction flow 60 to 65 L/min.

Electrical Safety Testing

The manual lists electrical safety testing according to IEC 62353 as part of the safety check.

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

Touch/chassis leakage measured in microamps:
Facility limit used =
Result =
Pass / Fail =

IEC 62353 test performed:
Pass / Fail =

Do not invent a leakage current limit for this device unless facility policy, test standard setup, or service documentation provides one.

Pass / Fail Criteria

PM Pass Criteria

Pass this PM only if:

• Visual inspection passes.
• Labels are complete and legible.
• No visible damage is found.
• External fuses match specified values.
• Manufacturer-listed due interval items are completed or documented.
• Device check passes.
• Breathing circuit check passes.
• Battery check is current and acceptable.
• Electrical safety testing passes per IEC 62353 / facility criteria.
• Airway pressure and flow functional tests pass.
• Alarm generator and listed safety features pass.

Remove From Service Criteria

Remove from service if:

• Device check fails and cannot be corrected.
• Breathing circuit check fails and cannot be corrected.
• Safety valve, expiratory valve, or pressure sensor calibration valve check fails.
• Electrical safety testing fails.
• Battery capacity is unacceptable and required for facility use.
• Device has visible damage that could affect safe operation.
• Alarm generator does not function correctly.
• O2/Air gas inlet or non-return valve function is suspect.
• Any required safety check cannot be completed.

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