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Manual Reference
Dräger Babylog VN800 / VN600 Instructions for Use, software 2.n, document 9511645; Babylog VN800 / VN600 Instructions for Use, software 1.n, document 9055638; and current Dräger Evita V series / Babylog VN series Batteries Supplement, document 9510319. Confirm the installed software, display, GS500 gas-supply unit, PS500 power-supply unit, battery chemistry, flow sensor, CO2 option, trolley, and accessories before service.
Manufacturer Recommendation / AEM Status
- Inspection and safety check: Every 12 months by service personnel.
- Room-air filter: Clean every four weeks and replace if needed; 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 cloth every 12 months when installed.
- Air gas-inlet filter: Replace every two years by specialized service personnel.
- O2 gas-inlet filter: Replace every six years by specialized service personnel.
- Battery capacity: Perform the manufacturer battery test every three months and replace a battery sooner when indicated by the result.
- Battery replacement: Replace the internal NiMH battery and PS500 VRLA batteries every two years or according to battery-test results. Replace a PS500 LFP battery every four years or according to its battery-test result.
Battery chemistry must be positively identified before applying a replacement interval. Safety checks do not replace the scheduled preventive replacement of wearing parts. If a facility changes an activity or interval, the change should be handled under its approved AEM program, risk assessment, maintenance history, current Dräger documentation, and applicable regulatory requirements.
What This PM Procedure Covers
- Identity, software, configuration, service history, labels, and due maintenance
- Ventilation unit, display, trolley, power, gas, pneumatic, expiratory, flow-sensing, and accessory components
- Scheduled filters, diaphragm, expiratory valve, and battery work
- System test, breathing-circuit test, 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 Babylog VN600 IFU, battery supplement, installed-option instructions, and controlled service documentation
- Approved neonatal/pediatric breathing circuit, compatible humidification setup, neonatal flow sensor, and manufacturer-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 required by the controlled procedure for safety-valve and non-return-valve tests
- IEC 62353 electrical-safety analyzer
- Correct room-air filter, expiratory-valve diaphragm, expiratory valve, GS500 filters, gas-inlet filters, and batteries when due
- Warm soapy water for permitted interim room-air-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. Service-level procedures and replacements assigned to specialized personnel require appropriate Dräger training, documentation, and tools.
Step-by-Step PM Procedure
1. Remove the Ventilator From Clinical Use
Action: Confirm no patient is connected, provide an alternate ventilator, 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 Service History
Action: Record asset tag, serial number, software revision, operating hours, mains rating, display configuration, GS500, PS500, battery chemistry, trolley, CO2, flow-sensor type, nurse call, and other options. Review alarms, repairs, recalls/field actions, battery-test history, and replacement dates.
Expected outcome: The device matches its CMMS record and all applicable tests, 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 and accessories 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. Complete Scheduled Room-Air-Filter Service
Action: Open the room-air-filter cover, remove the filter, and inspect it. Clean it in warm soapy water every four weeks and dry it thoroughly, or replace it when needed. Install a new filter at the 12-month interval. 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 neonatal expiratory valve according to the IFU. Replace its diaphragm annually, seating the new diaphragm evenly without folds. Replace the complete expiratory valve every two years. Reassemble, lock it into the ventilation unit, and confirm secure engagement.
Expected outcome: The diaphragm and valve are current, clean, undamaged, correctly assembled, and securely locked.
7. Complete GS500 and Gas-Inlet Filter Service
Action: When the GS500 is installed, replace its breathing-gas filter and filter cloth annually under the service procedure. Verify the Air gas-inlet filter has been replaced at two years and the O2 gas-inlet filter at six years by specialized service personnel.
Expected outcome: All installed gas-path filters are correct, current, securely installed, and documented.
8. Perform the Battery Test and Due Replacement
Action: Identify the internal and PS500 battery chemistry. Perform the manufacturer charge-discharge-charge capacity test every three months and record the determined runtime. Replace batteries when the test recommends replacement. Replace NiMH and VRLA batteries by two years; replace PS500 LFP batteries by four years, unless testing requires earlier replacement. Confirm normal charging and transfer to/from battery power.
Expected outcome: Battery tests complete without interruption, runtime meets the current supplement criteria, replacement dates match the installed chemistry, and power transfer and charging operate normally.
9. Run the System Test
Action: Configure the ventilator with the intended patient category, breathing circuit, humidification, sensors, gas supplies, and test lung. Run the complete system test. Verify all applicable steps, including alarm audio, breathing-circuit connection, gas supplies, sensor calibrations, expiratory valve, safety valve, and installed GS500/CO2 functions.
Expected outcome: Every applicable system-test step passes. Correct and repeat any incomplete or failed step before proceeding.
10. Run the Breathing-Circuit Test
Action: Run the breathing-circuit test for the selected circuit, humidification type, and patient category. Record leakage, compliance, inspiratory resistance, and expiratory resistance. Follow the displayed instructions to seal and open the Y-piece.
Expected outcome: Leakage is no more than 300 mL/min at 60 mbar (or hPa or cmH2O), and compliance and resistance measurements complete successfully.
11. Verify Pressure, Flow, Oxygen, and Ventilation Performance
Action: With a calibrated ventilator analyzer and the controlled service method, verify airway-pressure measurement, neonatal flow measurement, 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: Use the software-specific safety-check procedure to verify the emergency expiratory valve, expiratory-valve non-return valve, emergency breathing valve, alarm generator, and Air/O2 gas-inlet non-return valves. For software 1.n, the public IFU lists an emergency-expiratory-valve pressure rise of 0.7 to 3.2 mbar at 4.5 to 5.5 L/min and an emergency-breathing-valve pressure drop no greater than 6.5 mbar at 60 to 65 L/min suction flow. Do not transfer these values to another revision without confirmation.
Expected outcome: All safety and non-return valves pass the criteria for the installed software revision and prevent unsafe pressure or reverse flow.
13. Verify Alarm and Power-Failure Functions
Action: Verify primary and secondary acoustic alarm signals, alarm bar/visual indication, priority behavior, alarm silence/reset, gas-supply alarms, disconnection/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 the System and Complete the Final Check
Action: Remove test equipment, reinstall covers and approved accessories, reconnect the intended clinical configuration, clean surfaces, and repeat the system and breathing-circuit tests after any work affecting the pneumatic path. Confirm correct settings, date/time, calibration status, charging, brakes, and absence of technical alarms. Record all parts, measurements, and corrective work.
Expected outcome: The Babylog VN600 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/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, scheduled filters, diaphragm, expiratory valve, batteries, labels, fuses, physical condition, configuration, and accessories are current and acceptable
- System test 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 circuit compliance/resistance testing completes
- Pressure, flow, oxygen, ventilation delivery, safety-valve, and non-return-valve checks meet the installed software-specific criteria
- IEC 62353 electrical safety and the final configured-system check pass with no unresolved technical alarm
Remove From Service
- A safety-relevant system-test step, circuit test, pressure/flow/oxygen measurement, valve, alarm, battery, gas, power, or electrical-safety check fails
- Circuit leakage exceeds 300 mL/min at 60 mbar
- 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 service procedure, calibrated test equipment, required gas supply, or qualified technician is unavailable
Copy/Paste CMMS Work Order Procedure
Do not return the Babylog VN600 to service with a failed system or breathing-circuit test, 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.