On this page
Asset Type
Manufacturer
Model
Manual Reference
Dräger Evita V300 Instructions for Use, software 2.n, document 9052995. Confirm the installed software, Infinity C300 display, GS500 gas-supply unit, PS500 power-supply unit, patient categories, flow-sensor configuration, CO2 option, trolley, and accessories before service.
Manufacturer Recommendation / AEM Status
- Inspection and safety checks: Every 12 months by service personnel.
- Ambient-air filter: Inspect and clean every four weeks, replacing if necessary; replace every 12 months.
- Expiratory-valve diaphragm: Replace every 12 months.
- Expiratory valve: Replace every two years.
- GS500 filters: Replace the blower-unit breathing-gas filter and filter mat every 12 months when installed.
- Battery capacity: Check the internal NiMH and PS500 VRLA batteries every three months.
- Battery replacement: Replace when necessary and every two years at the latest.
- Air gas-inlet filter: Replace every two years by qualified experts.
- O2 gas-inlet filter: Replace every six years by qualified experts.
Safety checks do not replace scheduled preventive replacement of wearing parts. Activities assigned by Dräger to service personnel or experts require the appropriate training, controlled documentation, and test equipment. Any changed task or interval belongs under the facility's approved AEM program, risk assessment, service history, and applicable regulatory requirements.
What This PM Procedure Covers
- Identity, software, configuration, service history, labels, fuses, and due maintenance
- Ventilation unit, display, trolley, power, gas, pneumatic, expiratory, flow-sensing, and accessory components
- Scheduled filter, diaphragm, expiratory-valve, and battery work
- Device check, breathing-circuit check, airway-pressure and flow measurement, safety devices, alarms, and battery operation
- IEC 62353 electrical safety and final return-to-service documentation
Required Tools and Equipment
- Current Evita V300 software-specific IFU, option instructions, and controlled service documentation
- Approved breathing circuit, humidification setup, appropriate expiratory or neonatal flow sensor, and compatible test lung
- Medical-grade Air and O2 supplies with correct hoses and fittings
- Calibrated ventilator analyzer capable of pressure, flow, volume, oxygen, and leak measurement
- Equipment specified by the controlled procedure for safety-valve and gas non-return-valve testing
- IEC 62353 electrical-safety analyzer
- Correct ambient-air filter, expiratory-valve diaphragm, expiratory valve, GS500 filters, gas-inlet filters, and batteries when due
- Warm soapy water for permitted interim filter cleaning, approved reprocessing supplies, PPE, and hand tools
Safety: Remove the ventilator from patient use and reprocess applicable components before service. Disconnect electrical and gas supplies before restricted internal work. Do not open the housing or perform expert-level service without the required authorization and documentation.
Step-by-Step PM Procedure
1. Remove the Ventilator From Clinical Use
Action: Confirm no patient is connected, provide alternate ventilation, place the unit in standby, shut it down safely, label it unavailable, and reprocess the device and reusable patient-gas-path components.
Expected outcome: Maintenance can proceed without interrupting therapy or exposing personnel to contamination.
2. Verify Identity, Configuration, and History
Action: Record asset tag, serial number, software revision, operating hours, mains rating, display, GS500, PS500, trolley, CO2, flow-sensor type, nurse call, and other options. Review alarms, repairs, field actions, battery tests, and replacement dates.
Expected outcome: The ventilator matches its CMMS record and all applicable tasks, parts, and intervals are identified.
3. Inspect Documentation, Labels, Fuses, and Completeness
Action: Confirm current instructions are available; labels are complete and legible; externally accessible fuses match specified values; and all components required for the configured system are present.
Expected outcome: Documentation, identification, protection, and configured equipment are complete and correct.
4. Perform the Physical Inspection
Action: Inspect the ventilation unit, display, system cable, housings, trolley, brakes, castors, rails, mounts, power cord, equipotential connection, gas hoses and fittings, ports, strain reliefs, GS500/PS500, expiratory assembly, water trap, emergency-air intake, exhaust, sensors, connectors, covers, and ventilation openings. Check for cracks, contamination, corrosion, fluid entry, deformation, loose hardware, exposed conductors, or blocked airflow.
Expected outcome: The complete system is stable, clean, intact, securely mounted, and free of visible electrical, gas, pneumatic, or mechanical hazards.
5. Service the Ambient-Air Filter
Action: Open the filter cover, remove the filter, and inspect it. At the four-week interval, clean it in warm soapy water and dry thoroughly or replace it if necessary. Install a new filter at 12 months. Insert it without creasing and secure the cover.
Expected outcome: A clean, dry, undamaged filter is installed correctly and is within its replacement interval.
6. Replace the Expiratory Diaphragm and Due Valve
Action: Remove the expiratory valve according to the IFU. Replace its diaphragm annually and confirm it is seated properly on the housing edge. Replace the complete expiratory valve every two years, then reinstall and verify secure engagement.
Expected outcome: The diaphragm and valve are current, clean, undamaged, correctly assembled, and securely installed.
7. Complete GS500 and Gas-Inlet Filter Service
Action: When GS500 is installed, replace its breathing-gas filter and filter mat annually under the service procedure. Verify qualified experts have replaced the Air gas-inlet filter at two years and the O2 gas-inlet filter at six years.
Expected outcome: All installed gas-path filters are correct, current, securely installed, and documented.
8. Perform the Battery Test and Due Replacement
Action: Fully charge the internal NiMH and installed PS500 VRLA batteries. With central gas, mains power, and a test lung connected, start the manufacturer battery check from the System check page. Complete the charge-discharge-charge cycle, record the determined operating time, and compare it with the age-based IFU table. Replace batteries if the result is insufficient and every 24 months at the latest. Confirm charging and transfer to and from battery power.
Expected outcome: The three-month battery check completes, runtime is acceptable for battery age, and charging and power transfer operate normally.
9. Run the Device Check
Action: Configure the ventilator with the intended patient category, breathing circuit, humidification, sensors, gas supplies, and test lung. Run the complete device check, including alarm audio, breathing-system connection, humidifier, expiratory valve, safety valve, gas supplies, flow and O2 sensors, neonatal flow sensor when used, and GS500/CO2 functions when installed.
Expected outcome: Every applicable test step passes. Correct and repeat incomplete or failed steps before proceeding.
10. Run the Breathing-Circuit Check
Action: Run the breathing-circuit check for the selected circuit, humidification type, and patient category. Follow the displayed directions to seal and open the patient connection, then record leakage, compliance, inspiratory resistance, and expiratory resistance.
Expected outcome: Leakage is no more than 300 mL/min at 60 mbar (60 cmH2O), and compliance and resistance measurements complete successfully.
11. Verify Pressure, Flow, Oxygen, and Ventilation Performance
Action: Using a calibrated ventilator analyzer and the controlled service method, verify airway-pressure measurement, expiratory or neonatal flow measurement as configured, oxygen measurement, representative ventilation modes, set versus delivered rate/pressure/volume, PEEP, and applicable sensor calibration. Test configured nebulizer and CO2 functions when installed.
Expected outcome: Measurements, delivery, calibration, and installed functions meet the current software-specific Dräger criteria with no unresolved deviation.
12. Verify Safety Valves and Gas Non-Return Valves
Action: Using the manufacturer safety-check method, verify the emergency expiratory valve rises 1.9 to 4.4 mbar at 4.5 to 5.5 L/min; the emergency breathing valve pressure drop is no more than 4 mbar at 60 to 65 L/min; and the expiratory-valve non-return valve, Air/O2 inlet non-return valves, alarm generator, and LEDs function correctly.
Expected outcome: Every safety device passes the documented test point and prevents unsafe pressure, reverse flow, or loss of warning.
13. Verify Alarm and Power-Failure Functions
Action: Verify the primary and auxiliary acoustic alarms, visual alarm indication, priority behavior, silence/reset, gas-supply alarms, disconnection and pressure alarms, mains-failure alarm, battery alarms, and nurse call when connected.
Expected outcome: Audible, visual, power, gas, ventilation, and remote alarm functions operate reliably and recover correctly.
14. Perform IEC 62353 Electrical Safety Testing
Action: Test the complete installed combination according to IEC 62353, current Dräger documentation, equipment class, applied parts, options, and regional requirements. Include the display, ventilation unit, trolley, PS500, GS500, and powered accessories as applicable.
Expected outcome: Every required electrical-safety measurement passes its documented governing criterion.
15. Restore and Complete the Final Check
Action: Remove test equipment, reinstall covers and approved accessories, reconnect the intended clinical configuration, clean surfaces, and repeat device and breathing-circuit checks after work affecting the pneumatic path. Confirm settings, date/time, calibration status, charging, brakes, and absence of technical alarms. Record all parts, measurements, and corrective work.
Expected outcome: The Evita V300 is complete, clean, current on service, and either formally returned to use or clearly quarantined.
Electrical Safety Testing
The annual manufacturer safety check includes electrical safety according to IEC 62353. Use the current controlled Dräger procedure and document the complete installed configuration, analyzer method, equipment class, applied parts, and governing regional or facility limits.
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 =
Applied-part / PS500 / GS500 / accessory testing:
Method / limits / results / N/A =
The public IFU does not state one universal leakage-current limit for every configuration and regional method. Do not invent a manufacturer limit.
Pass / Fail Criteria
Pass
- Annual inspection and all scheduled filters, diaphragm, expiratory valve, batteries, labels, fuses, physical condition, configuration, and accessories are current and acceptable
- Device and breathing-circuit checks and all applicable sensor, gas, valve, alarm, battery, and installed-option checks pass
- Breathing-circuit leakage is no more than 300 mL/min at 60 mbar and compliance/resistance testing completes
- Emergency expiratory and breathing valves meet the stated test points; other safety and non-return valves function correctly
- IEC 62353 electrical safety and the final configured-system check pass with no unresolved technical alarm
Remove From Service
- A device-check step, circuit check, pressure/flow/oxygen measurement, valve, alarm, battery, gas, power, or electrical-safety check fails
- Circuit leakage exceeds 300 mL/min at 60 mbar or a safety-valve criterion is not met
- A due filter, diaphragm, valve, battery, inspection, or qualified service activity cannot be completed
- Physical damage, contamination, fluid entry, obstructed airflow, a damaged connection, or unstable mounting could affect safe ventilation
- The correct software-specific procedure, calibrated test equipment, required gas supply, or qualified technician is unavailable
Copy/Paste CMMS Work Order Procedure
Do not return the Evita V300 to service with a failed device or breathing-circuit check, excessive leakage, inaccurate pressure/flow/oxygen measurement, failed safety valve or alarm, unacceptable battery, overdue critical maintenance, failed electrical-safety result, or any unresolved condition that could interrupt or impair ventilation.