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Manual Reference
Dräger Isolette C2000 Instructions for Use, document MU26792, current English edition. Verify the exact serial number, software, installed oxygen/humidity/scale options, regional configuration, and locally controlled revision before service.
Manufacturer Recommendation / AEM Status
Dräger specifies inspection and safety checks once a year by service personnel. The annual work includes the functional checkout, high-temperature alarms, hand-port holding function, physical inspection, device-combination condition, required accessories, electrical safety, and acoustic/visual alarm indications. Safety checks do not replace the preventive replacement of wear parts.
The current maintenance table also assigns the air-intake filter every 3 months and whenever necessary; oxygen sensors annually when fitted; the heat-shield latch and optional oxygen solenoid valve every 2 years; the Isolette three-year service kit and sensor-module fan every 3 years; and the optional oxygen pressure reducer every 6 years. Condition- and option-dependent parts must follow the exact table and footnotes in the controlled IFU. Do not extend these intervals through an AEM program without the facility's documented risk assessment and approval.
What This PM Procedure Covers
- Identity, configuration, history, service intervals, and documentation
- Hood, access panels, hand ports, seals, mattress, deck, stand, casters, and accessories
- Controller, display, controls, startup, functional checkout, and alarms
- Air-mode and skin-mode temperature operation and annual temperature correlation
- Humidity, oxygen, weighing scale, and variable-height options when installed
- Air-intake filter and scheduled service-part status
- Electrical safety, final restoration, and CMMS documentation
Required Tools and Equipment
- Current Dräger Isolette C2000 Instructions for Use and applicable controlled technical service documentation
- Calibrated reference thermometer accurate to at least ±0.05°C; do not use a mercury-in-glass thermometer
- Electrical safety analyzer suitable for IEC/EN 60601-1, UL 60601-1, or IEC 62353 testing as locally applicable
- Correct replacement air-intake filter and due service parts
- Dräger-approved skin-temperature probe and covers for functional testing
- Calibrated oxygen analyzer and approved oxygen supply when the oxygen-control option is installed
- Known calibrated test weights when the weighing-scale option is installed
- Humidity verification equipment when required by the controlled service procedure
- Manufacturer-compatible cleaning/disinfection supplies and facility-required personal protective equipment
Step-by-Step PM Procedure
1. Remove From Patient Use
Action: Transfer the infant to an appropriate alternate thermal environment under clinical direction. Turn the Isolette off, disconnect mains and gas supplies, remove patient-use accessories, and clean/disinfect it according to the IFU and facility infection-control policy.
Expected outcome: No patient depends on the incubator during maintenance and the unit is safe to handle.
2. Verify Identity and Configuration
Action: Record asset tag, serial number, software version, mains rating, stand type, controller/sensor module, and installed humidity, oxygen, scale, variable-height, phototherapy, and other accessories. Confirm the correct manuals apply.
Expected outcome: The equipment matches the CMMS record and all applicable option-specific tests are identified.
3. Review History and Scheduled Service
Action: Review prior PM, repairs, alarm or temperature complaints, contamination, fluid entry, transport damage, recalls/field actions, and the dates of the three-month, annual, two-year, three-year, and six-year requirements. Resolve overdue or open work before release.
Expected outcome: Service history is complete and every due interval or safety action is addressed.
4. Inspect Documentation, Labels, and Device Combination
Action: Confirm the current IFU is available. Inspect safety labels, markings, serial label, configuration labels, accessories, cables, probes, and the entire device combination for completeness, compatibility, unauthorized probes, modifications, or missing parts.
Expected outcome: Documents and markings are legible and the configured system is complete and authorized.
5. Inspect the Hood and Patient Compartment
Action: Inspect the hood, front/rear access panels, hinges, latches, heat shield, tubing-access grommets, gaskets, hand-port doors, iris ports, cuffs/sleeves, mattress, mattress tray, x-ray tray, tilt mechanisms, and internal surfaces. Check for cracks, sharp edges, looseness, discoloration, deformation, contamination, or gaps.
Expected outcome: All patient-compartment components are clean, secure, intact, and seal correctly.
6. Verify Access and Holding Functions
Action: Open and close each access panel, hand port, iris port, and mattress/deck mechanism. Confirm positive latching, smooth movement, and the hand-port holding function using the controlled technical procedure. Do not apply an improvised force limit.
Expected outcome: Access components operate smoothly, remain secured as designed, and cannot open unexpectedly.
7. Inspect the Stand and Mobility System
Action: Inspect frame, cabinet, handles, shelf/rail accessories, fasteners, power-cord storage, casters, brakes, and variable-height mechanism when fitted. Move the empty incubator and verify directional control, stability, brake holding, and unobstructed height travel.
Expected outcome: The incubator moves, stops, supports its accessories, and changes height safely without looseness, instability, or interference.
8. Inspect Power and Controller Components
Action: Inspect the mains cord, plug, inlet, fuses/holder, strain reliefs, equipotential connection, controller, display, keys/knob, indicator lights, speaker openings, connectors, sensor module, fan openings, and cable routing. Check for wear, corrosion, fluid entry, blocked ventilation, or heat damage.
Expected outcome: Electrical and controller components are secure, clean, undamaged, and unobstructed.
9. Inspect and Replace the Air-Intake Filter
Action: Inspect the air-intake filter and compartment for dust, blockage, moisture, damage, or incorrect installation. Replace the filter at least every three months and sooner whenever condition requires, using the correct Dräger part. Secure the cover.
Expected outcome: A clean, dry, correct filter is installed and airflow is unobstructed.
10. Verify Scheduled Replacement Parts
Action: Check condition and replacement records for mattress, grommets, gaskets, cuffs/iris sleeves, skin probe/covers, and fitted oxygen sensors. Confirm the heat-shield latch and optional oxygen solenoid status at two years, the three-year service kit and sensor-module fan at three years, and the optional oxygen pressure reducer at six years. Only qualified service personnel should perform controlled internal replacement.
Expected outcome: All condition-based and time-based parts are current, traceable, and correctly installed.
11. Perform Startup and Incubator Functional Checkout
Action: Reassemble the unit, connect approved mains power, and perform the complete Incubator Functional Checkout Procedure in the current IFU. Verify startup/self-test, display, controls, heater and fan operation, temperature indications, modes, panel/port functions, and all configuration-specific checks.
Expected outcome: The functional checkout completes without error and every tested control and indication operates as specified.
12. Verify Acoustic and Visual Alarms
Action: Test the acoustic and visual alarm signals and the alarm-silence/control functions through the prescribed checkout. Verify the high-temperature alarm tests and all applicable sensor, probe, airflow/fan, power-fail, and system alarm conditions without bypassing an interlock.
Expected outcome: Each required alarm is detected, displayed, sounded, prioritized, and reset as specified.
13. Verify Annual Temperature Correlation
Action: Install the calibrated non-mercury reference thermometer in the prescribed location and allow the empty incubator to stabilize at a set temperature of 35°C. Compare the incubator temperature indication with the reference using the exact IFU setup.
Expected outcome: The incubator indication and reference temperature correlate within ±0.8°C.
14. Verify Skin-Temperature Operation
Action: Inspect and connect an approved skin-temperature probe and cover. Verify recognition, displayed value, skin-control selection, probe-related alarms, and response using the current functional checkout or controlled service method. Do not warm a probe by an uncontrolled method.
Expected outcome: The probe is recognized, temperature indication is plausible and stable, and skin-mode safety functions pass.
15. Verify Installed Options
Action: Test humidity control, servo oxygen control, weighing scale, and variable-height operation only when fitted. Use calibrated measurement equipment and the exact option-specific procedure. Verify oxygen-sensor annual service and gas-system leak/condition requirements; verify scale zero and known-weight accuracy.
Expected outcome: Each installed option meets its controlled acceptance criteria or is documented N/A.
16. Perform Electrical Safety Testing
Action: Complete the inspection and measurements described below with the incubator fully assembled and the intended power cord/accessories connected. Record the adopted standard, analyzer identity, applicable limits, and actual readings.
Expected outcome: Every applicable electrical-safety result meets the current manufacturer and facility criteria.
17. Restore and Document
Action: Remove test equipment, clean and dry the incubator, reinstall approved accessories, return controls to the facility-approved configuration, secure the hood and ports, and repeat a final startup/readiness check. Record all readings, filters/parts, due dates, corrective work, and disposition.
Expected outcome: The Isolette is clean, complete, correctly configured, current on scheduled service, and either returned to use with traceable records or clearly removed from service.
Electrical Safety Testing
Dräger's annual safety checks require electrical safety verification according to IEC/EN 60601-1, UL 60601-1, or IEC 62353, as applicable to the regional device and the facility's adopted program. Begin with a detailed power-cord, plug, inlet, fuse, strain-relief, equipotential-connection, enclosure, connector, and accessible-metal inspection. Perform protective-earth resistance and leakage/touch-current tests applicable to the exact construction and installed accessories.
Use the limits in the current Dräger technical documentation and adopted standard; do not substitute a generic numeric limit. Record actual readings and the conditions under which they were obtained. Remove the incubator from service for a damaged power path, unreliable ground connection, excessive leakage, or any test that cannot be completed correctly.
Pass / Fail Criteria
Pass
- Identity, documentation, labels, device combination, power components, enclosure, hood, seals, ports, mattress, stand, casters, and accessories pass inspection
- Hand ports, access panels, brakes, deck/tilt, and variable-height mechanisms operate and hold correctly
- The air-intake filter and all condition-/time-based service parts are current
- The complete incubator functional checkout passes
- All required acoustic, visual, high-temperature, sensor, probe, airflow/fan, and power alarms pass
- Temperature correlation at a 35°C set point is within ±0.8°C
- Skin temperature and installed humidity, oxygen, and scale options pass or are documented N/A
- Electrical safety, restoration, and documentation are complete and acceptable
Remove From Service
- Damage, contamination, a sharp edge, failed seal/latch, unstable stand, ineffective brake, or unauthorized modification could affect infant safety
- Functional checkout, temperature correlation, high-temperature protection, fan/airflow, or any required alarm fails
- A skin probe or installed humidity, oxygen, scale, or height option is inaccurate or unreliable
- A required filter, wear part, two-/three-/six-year service item, recall, or field action is overdue
- Electrical safety fails or the applicable test cannot be completed
- Required technical documentation, calibrated equipment, or qualified service support is unavailable
Copy/Paste CMMS Work Order Procedure
The Isolette C2000 supports thermoregulation of vulnerable neonatal patients. Only qualified personnel should perform maintenance, using the current controlled Dräger documents and calibrated equipment. Never test the incubator while occupied.