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Manual Reference
Dräger Babyleo TN500 Instructions for Use, software 1.0n, document 9054863, and applicable supplement 9056310. Later software and regional configurations may differ. Confirm the installed software, oxygen, humidity, scale, heated mattress, gas-supply, battery, and accessory configuration against the current controlled documentation before service.
Manufacturer Recommendation / AEM Status
- Inspection and safety check: Every 12 months by service personnel.
- Skin-temperature metrological check: Every 24 months by service personnel.
- Scale: Check measurement accuracy every 12 months when installed; verify according to applicable regulatory requirements and after events that invalidate verification.
- Internal compressed-gas hose: For the applicable software/configuration, visually check six years after commissioning; if replacement is not required, repeat every 24 months.
- Filter cloth in the sensor wall: Replace every six months and whenever soiled or worn.
- Oxycell O2 sensors: Adjust every two weeks when the oxygen option is active; replace every 24 months by service personnel.
- SoftBed mattress: Replace every two years or when damaged.
- Skin-temperature sensors and covers: Replace weekly, no later than a patient change; these are user-level clinical maintenance items.
- Heated mattress and hose grommets: Replace as required when damaged, brittle, or torn. The heated mattress has a minimum expected service life of three years when used properly, not an automatic three-year replacement interval.
Safety checks do not replace manufacturer-listed maintenance or preventive replacement of wear parts. 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, current Dräger documentation, and applicable regulatory requirements.
What This PM Procedure Covers
- Identity, configuration, software, service history, labels, and due maintenance
- Trolley, castors, brakes, lifting column, hood, access panels, hand ports, mattress tray, X-ray tray, seals, grommets, hoses, and cables
- Incubator/radiant-warmer transition, air and skin temperature, heated mattress, oxygen, humidity, alarms, and mains-failure response
- Optional scale measurement accuracy and verification status
- IEC 62353 electrical safety and final return-to-service documentation
Required Tools and Equipment
- Current Babyleo TN500 IFU, supplements, applicable technical documentation, and controlled service procedure
- Calibrated temperature reference with accuracy of ±0.05 °C or better for the published incubator-temperature check
- Manufacturer-specified skin-temperature simulation resistors: 1586 Ω, 1412 Ω, and 1312 Ω
- Calibrated oxygen analyzer and humidity reference appropriate to the installed options
- Calibrated force gauge capable of checking 20 N panel/hand-port closing force
- Calibrated weights and applicable scale procedure when a scale is installed
- IEC 62353 electrical-safety analyzer
- Approved filter cloth and other due replacement parts for the exact configuration
- Approved cleaning/reprocessing supplies, PPE, inspection light, and correct hand tools
Safety: Perform service only with no patient in the device. Provide another safe thermal environment, clean and disinfect the unit, isolate gas and electrical energy before internal work, allow heated parts to cool, and use qualified service personnel for restricted procedures.
Step-by-Step PM Procedure
1. Remove the IncuWarmer From Clinical Use
Action: Under clinical direction, transfer the patient, remove patient-use items, label the unit unavailable, allow heated components to cool, and complete current reprocessing instructions.
Expected outcome: No patient depends on the device and the system is safe and clean for maintenance.
2. Verify Identity, Configuration, and Due Work
Action: Record asset tag, serial number, software revision, mains rating, commissioning date, operating hours, and installed oxygen, humidity, scale, mattress, gas, battery, and accessory options. Review history, alarms, repairs, recalls/field actions, maintenance dates, and due parts.
Expected outcome: The asset matches the CMMS record and the correct manual revision, test path, and intervals are identified.
3. Inspect Documentation, Labels, and Completeness
Action: Confirm the applicable IFU is available; verify labels are complete and legible; and check that all components and accessories required for use are present.
Expected outcome: Documentation, identification, and configured equipment are complete and correct.
4. Inspect Trolley, Column, Hood, and Patient Barriers
Action: Inspect the trolley, housing, castors, steering function, locking brakes, lifting column, display, sensor unit, hood and hood arm, mattress tray, X-ray tray, access panels, hand ports, seals, grommets, strain reliefs, mounts, and fasteners. Move the lifting column through its complete range and confirm the hood is secured and moves safely.
Expected outcome: The system is stable and intact; steering and brakes work; the column and hood move smoothly; and no cracked, loose, deformed, or missing barrier is present.
5. Verify Panel and Hand-Port Closure
Action: Check side and front access panels and all hand ports for secure latching. Where performing the manufacturer safety check, verify the specified 20 N closing force in accordance with the applicable IEC 60601-2-19/-21 procedure.
Expected outcome: Every barrier closes, latches, and remains secure without an unsafe gap or excessive force.
6. Inspect Mattress, Air Path, Hoses, and Scheduled Parts
Action: Inspect the SoftBed or heated mattress, tray, fan impeller, sensor-wall filter cloth, gas inlets, internal/external hoses visible under the authorized procedure, cables, regulators, cylinder holder, seals, and hose grommets. Replace the filter cloth at six months and condition-based parts when due. For applicable configurations, perform the six-year internal compressed-gas-hose inspection and subsequent 24-month checks.
Expected outcome: The air and gas paths are clean and intact, the fan is undamaged, the mattress is serviceable, and all scheduled or damaged items are replaced and documented.
7. Run Startup, Controls, and Mode-Transition Checks
Action: Restore approved utilities, start the unit, and verify self-test, touchscreen, rotary knob, display, indicators, lights, date/time, menus, and configured interfaces. Confirm the device changes between incubator and radiant-warmer operation according to hood position.
Expected outcome: Startup completes without unresolved messages, controls respond, indications are clear, and hood-dependent mode transition works correctly.
8. Verify Incubator Temperature Performance
Action: Using the applicable controlled setup, set 36.0 °C and measure stabilized incubator temperature with a reference thermometer accurate to ±0.05 °C. The published supplemented criterion is 36.0 °C ±0.8 °C.
Expected outcome: Air-temperature regulation is stable and remains within ±0.8 °C of the 36.0 °C set value.
9. Verify Skin-Temperature Measurement and Control
Action: Inspect sensor connectors and channels. For the annual safety check, apply 1412 Ω in place of a sensor and verify 36.0 °C ±0.2 °C under the supplemented procedure. When the 24-month metrological check is due, also test 1586 Ω = 33.2 °C and 1312 Ω = 37.8 °C; each displayed value must be within ±0.2 °C. Verify sensor-fault and temperature-alarm responses using the current procedure.
Expected outcome: Both applicable channels display the simulated temperatures within tolerance and protective alarms/control responses function correctly.
10. Verify Heating, Oxygen, and Humidity Options
Action: Verify radiant-warmer operation, heated-mattress control when installed, and applicable overtemperature/protective responses. When oxygen control is installed and active, verify the controlled test point of 50 Vol% within ±3 Vol%. When humidity is installed, verify the controlled test point of 70% within ±10% using the current service setup.
Expected outcome: Heating systems regulate without damage or an unresolved alarm; oxygen and humidity performance meet the applicable published criteria.
11. Verify Audible, Visual, and Mains-Failure Alarms
Action: Test the acoustic alarm generator, optical alarm display, secondary alarm path where applicable, and mains-supply-failure alarm using the manufacturer procedure. Restore power and confirm normal recovery.
Expected outcome: Alarm audio and visual indications are unmistakable and the device recovers normally after power restoration.
12. Check the Optional Scale
Action: Confirm the scale belongs to the device, the cable and seals are intact, and regulatory markings remain valid. Verify zero, weighing, stability, units, and annual measurement accuracy with calibrated weights under the current scale procedure. Arrange official verification when due or invalidated by adjustment, repair, altered basic settings, damaged seals/marks, or exceeded service-error limits.
Expected outcome: The scale passes its annual accuracy check and its verification status is valid for the facility and jurisdiction.
13. Perform IEC 62353 Electrical Safety Testing
Action: Test the complete installed configuration according to IEC 62353, the current Dräger procedure, equipment class, applied-part classification, and regional requirements. Include the powered trolley, heated mattress, scale, and electrical accessories as applicable.
Expected outcome: Every required electrical-safety measurement passes its governing criterion with traceable results.
14. Reassemble and Complete the Final Check
Action: Remove test equipment, reinstall covers and approved accessories, restore authorized settings, clean surfaces, and repeat a final startup, mode, brake, panel, temperature, alarm, and option check. Record parts, measurements, corrective work, and disposition.
Expected outcome: The Babyleo is complete, clean, current on service, and either formally returned to use or clearly quarantined.
Electrical Safety Testing
Dräger includes electrical safety according to IEC 62353 in the safety check. The public IFU does not supply one universal set of numeric limits for every regional method and configuration. Use the current controlled service procedure, installed options, analyzer method, equipment class, applied parts, and regional/facility requirements.
Analyzer / serial / calibration due:
Result =
Equipment class / applied parts / configuration / method:
Result =
Protective-earth resistance, where applicable:
Test points =
Governing limit =
Highest result =
Pass / Fail / N/A =
Equipment or touch leakage:
Facility / IEC 62353 limit used =
Highest result =
Pass / Fail =
Applied-part / heated-mattress / scale / accessory tests:
Method / limits / results / N/A =
Pass / Fail Criteria
Pass
- Annual inspection, due maintenance, labels, configuration, structure, barriers, hood, column, castors, brakes, hoses, cables, mattress, air path, and accessories are acceptable
- Panels and hand ports close securely and the applicable 20 N check passes
- Incubator temperature at 36.0 °C is within ±0.8 °C using a ±0.05 °C reference
- Skin-temperature measurement passes the applicable 1412 Ω annual check and all due 24-month simulation points within ±0.2 °C
- Heating, oxygen at 50 Vol% ±3 Vol%, humidity at 70% ±10%, alarms, mains-failure response, and mode transition pass when applicable
- Optional scale passes annual accuracy and has valid regulatory verification
- IEC 62353 electrical safety and final functional check pass
Remove From Service
- An access panel, hand port, hood, castor, brake, lifting column, mattress, fan, hose, gas connection, cable, seal, or structural part is unsafe
- Temperature, heating, oxygen, humidity, alarm, mains-failure, scale, mode-transition, or electrical-safety testing fails
- A prescribed inspection, maintenance item, regulatory verification, current service procedure, calibrated test instrument, or qualified technician is unavailable
- Any unresolved condition could expose an infant or user to fall, thermal, oxygen, electrical, mechanical, or infection risk
Copy/Paste CMMS Work Order Procedure
Do not return the Babyleo TN500 IncuWarmer to service with a failed barrier, temperature-control, heating, oxygen, humidity, alarm, scale, mobility, or electrical-safety check; an overdue safety inspection or critical maintenance item; or any unresolved condition that could place an infant or user at risk.