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Manual Reference
Dräger Savina 300 Instructions for Use, Software 5.n, document 9054931, current English edition, plus current controlled technical service documentation. Verify software, installed ventilation options, CO₂ monitoring, low-pressure oxygen option, humidifier, trolley, batteries, and regional configuration before service.
Manufacturer Recommendation / AEM Status
Dräger specifies the first formal inspection after 2 years or 12,000 operating hours, whichever occurs first. Thereafter, inspection is due annually or every 6,000 operating hours, whichever occurs first. A safety check is required every 12 months. Safety checks do not replace preventive replacement of wear parts.
Scheduled user/service items include monthly dust-filter cleaning; annual microfilter, dust-filter set, reusable expiratory-valve diaphragm, and battery-capacity work; internal-battery replacement every two years; option- and component-specific replacement at two, six, and eight years. Do not extend these intervals through an AEM program without the facility's documented risk assessment and approval. Savina 300 is a life-support ventilator, and required technical inspection must be performed by appropriately qualified personnel.
What This PM Procedure Covers
- Identity, software, configuration, operating hours, history, and service intervals
- Enclosure, trolley, gas/power connections, filters, valves, circuit components, sensors, and accessories
- Device check and breathing-circuit check
- Ventilation, measurement, alarms, safety valves, and power-failure response
- Flow, oxygen, pressure, and optional CO₂ monitoring
- Internal/external battery capacity and power transfer
- IEC 62353 electrical safety with published Dräger limits
- Scheduled parts, restoration, and CMMS documentation
Required Tools and Equipment
- Current Savina 300 SW 5.n Instructions for Use and controlled technical service procedure
- Calibrated ventilator analyzer/test lung and configuration-appropriate breathing circuit
- Calibrated pressure-measurement source/instrument required by the controlled safety-valve procedure
- Calibrated oxygen analyzer and approved oxygen source for the installed HPO/LPO configuration
- CO₂ verification accessories or calibration gas when CapnoPlus/CO₂ is installed and the controlled procedure requires them
- IEC 62353 electrical safety analyzer
- Correct annual microfilter, dust-filter set, reusable expiratory-valve diaphragm, and other due Dräger parts
- Battery-capacity test equipment/procedure for installed internal and external batteries
- Manufacturer-compatible reprocessing supplies and facility-required personal protective equipment
Step-by-Step PM Procedure
1. Remove From Patient Use and Provide Backup Ventilation
Action: Transfer the patient to a suitable backup ventilator under clinical direction. Place the Savina 300 in a controlled service area, disconnect patient-use components, protect stored data/settings, and label the device unavailable.
Expected outcome: No patient depends on the ventilator during testing and an appropriate backup device remains available.
2. Verify Identity, Software, and Configuration
Action: Record asset tag, serial number, software version, device and turbine operating hours, installed ventilation options, CO₂, HPO/LPO oxygen configuration, humidifier, trolley/power strip, internal/external batteries, and accessories. Confirm the controlled documents apply.
Expected outcome: The device matches the CMMS record and all applicable test paths and service intervals are identified.
3. Review History and Due Intervals
Action: Review prior PM, repairs, ventilation or alarm complaints, failed checks, battery runtime, oxygen/flow/CO₂ issues, contamination, fluid entry, recalls/field actions, and open corrective work. Compare calendar dates and operating hours with every manufacturer interval.
Expected outcome: The earliest applicable calendar/hour trigger controls the work and no unresolved safety issue is overlooked.
4. Inspect Exterior, Controls, and Labels
Action: Inspect the enclosure, display/touchscreen, rotary knob, keys, alarm light, speaker openings, cooling openings, handles, rails, labels, external fuses, covers, screws, connectors, and communication ports. Look for cracks, looseness, contamination, corrosion, heat, blocked airflow, fluid entry, or unauthorized modification.
Expected outcome: The ventilator is complete, legible, clean, unobstructed, and free of visible damage.
5. Inspect Trolley, Power, and Gas Connections
Action: Inspect trolley mounting, casters/brakes, cylinder holders, mains cord/plug, inlet, strain reliefs, equipotential connection, power strips, external DC/battery connections, oxygen hose/inlet, and LPO components when fitted. Verify compatible accessories are secure.
Expected outcome: The system is stable and mobile, brakes hold, and all power/gas connections are undamaged and correctly secured.
6. Service the Air Filters
Action: Clean the dust-filter set every four weeks. At annual PM, replace the microfilter and dust-filter set with correct parts regardless of appearance. Inspect filter compartments and air inlets for dust, moisture, blockage, or damage, and reinstall covers securely.
Expected outcome: New annual filters are installed, airflow is unobstructed, and filter service is dated/documented.
7. Inspect the Expiratory Valve and Replace the Diaphragm
Action: Remove and reprocess the reusable expiratory valve as directed. Inspect the housing, water trap, non-return components, seating surfaces, and connectors. Replace the reusable expiratory-valve diaphragm every 12 months and reassemble correctly.
Expected outcome: The valve is clean, dry, intact, correctly assembled, and fitted with a current diaphragm.
8. Inspect Sensors and Patient-System Components
Action: Inspect the Spirolog flow sensor and wiring connection, oxygen sensors/status, pressure ports, optional CO₂ sensor/cuvette, breathing hoses, Y-piece, test lung, bacterial filters, humidifier, and accessories. Check for moisture, residue, damage, obstruction, leakage, or overdue separate maintenance.
Expected outcome: All measurement and patient-system components are compatible, clean, dry, intact, and correctly connected.
9. Power Up and Verify Basic Operation
Action: Connect approved AC power and oxygen as configured, start the ventilator, and verify boot completion, display, touchscreen, rotary control, indicators, date/time, alarm speaker, auxiliary acoustic alarm, cooling/turbine sound, and absence of unresolved technical alarms.
Expected outcome: Startup completes normally and all user-interface and alarm-output functions are available.
10. Perform the Device Check
Action: Prepare the Savina 300 in standby, connect the test lung, open the Device check page, start the check, and follow every on-screen instruction. Verify all safety-relevant test steps, including alarm signals, auxiliary acoustic alarm, and expiratory-valve checks. Do not start ventilation if any required step fails.
Expected outcome: Every test step and the overall device-check result show a successful green status with current date/time.
11. Perform the Breathing-Circuit Check
Action: Immediately after a successful device check, perform the breathing-circuit check with the complete circuit, humidifier/filter arrangement, and accessories intended for testing. Record compliance, resistance, leakage, and circuit result presented by the device.
Expected outcome: The circuit check completes successfully with no unresolved leak, obstruction, or configuration error.
12. Verify Ventilation and Measurement Performance
Action: Using the calibrated ventilator analyzer and controlled service procedure, verify representative volume- and pressure-controlled ventilation, delivered volume/flow, airway pressure, PEEP, respiratory rate/timing, oxygen concentration, and monitoring values across the required test points. Test installed options and modes that require scheduled verification.
Expected outcome: Delivered and monitored values meet every tolerance in the current Dräger technical procedure.
13. Verify Sensor Calibration and Monitoring
Action: Confirm pressure-sensor automatic calibration, flow-sensor recognition/calibration, oxygen-sensor calibration, and optional CO₂ zero/reference check. Savina 300 automatically calibrates the flow sensor after startup, ventilation start, every 24 hours in operation, sensor replacement, and other specified events. Replace oxygen sensors if FiO₂ measurement fails or calibration is no longer possible.
Expected outcome: All installed measurements calibrate successfully and remain stable without sensor alarms.
14. Verify Alarms and Safety Equipment
Action: Test required ventilation, disconnection/leak, pressure, volume, oxygen, apnea, sensor, battery, and power-supply alarms under controlled conditions. Verify the pneumatic safety valve at 100–110 mbar, emergency expiratory valve at 5–10 mbar, expiratory non-return valve, emergency breathing valve, and power-supply-failure alarm using the current procedure.
Expected outcome: Every required alarm and safety device activates, indicates, sounds, and resets correctly within its specified criterion.
15. Verify Internal and External Batteries
Action: Check internal-battery capacity every 12 months and replace it if necessary; replace the internal battery every two years. Check external-battery capacity annually when fitted and replace as condition requires. Dräger identifies the external-battery capacity test as the user's responsibility. Verify AC-to-battery transfer, indications, alarms, charging, and expected runtime under the controlled load.
Expected outcome: Batteries are undamaged, charging and transfer are reliable, and documented capacity meets the applicable service criterion.
16. Verify Long-Term Scheduled Components
Action: Check records and condition for the LPO gas-inlet filter every two years when fitted; O₂ inlet filter, real-time clock, and Spirolog flow-sensor wiring harness every six years; and turbine every eight years. Have the assigned qualified personnel replace each due item under controlled instructions.
Expected outcome: Every applicable two-, six-, and eight-year item is current and traceable or the ventilator remains out of service.
17. Perform Electrical Safety Testing
Action: Test the complete system—including breathing-gas humidifier and trolley power strip individually and together when present—according to the electrical-safety section below. Record analyzer identity, conditions, limits, and actual readings.
Expected outcome: All IEC 62353 measurements meet the published Dräger limits.
18. Restore and Document
Action: Remove test equipment, reprocess applicable components, restore approved configuration and alarm settings, connect charged power sources, and repeat final startup, device, circuit, and readiness checks as required. Document hours, parts, readings, calibrations, corrective work, and disposition.
Expected outcome: The Savina 300 is clean, complete, current on service, and either returned to clinical use with traceable records or clearly removed from service.
Electrical Safety Testing
Dräger requires annual electrical safety testing in accordance with IEC 62353. Inspect the mains cord, plug, inlet, fuses, strain reliefs, equipotential/protective-earth connections, enclosure, connectors, accessible conductive parts, humidifier, trolley power strip, and connected electrical accessories. Test accessories individually and together as the clinical system.
The Savina 300 safety-check limits are: protective-ground conductor contact resistance ≤0.2 Ω, equivalent device leakage current ≤1 mA, and equivalent patient leakage current ≤5 mA. Record actual readings. Remove the system from service for a damaged electrical path, unreliable protective earth, excessive leakage, or any incomplete required measurement.
Pass / Fail Criteria
Pass
- Identity, software, hours, history, enclosure, labels, trolley, power/gas connections, sensors, circuit components, and accessories pass inspection
- Annual microfilter, dust-filter set, expiratory-valve diaphragm, and battery-capacity actions are complete
- Device check and breathing-circuit check complete successfully
- Ventilation delivery, monitoring, sensor calibration, alarms, and installed options meet the controlled criteria
- Pneumatic safety valve is 100–110 mbar and emergency expiratory valve is 5–10 mbar; remaining safety valves and power-failure alarm pass
- Internal/external battery capacity, transfer, indication, and charging pass; the internal battery is within its two-year replacement interval
- All due two-, six-, and eight-year components are current
- Protective-ground resistance is ≤0.2 Ω, device leakage is ≤1 mA, and patient leakage is ≤5 mA
- Final restoration and documentation are complete
Remove From Service
- Physical, electrical, gas, filter, valve, sensor, battery, trolley, or accessory damage could affect safe ventilation
- Device check, breathing-circuit check, ventilation accuracy, calibration, alarm, or safety-device verification fails
- Any safety-valve pressure or electrical-safety measurement exceeds its applicable limit
- Battery transfer/capacity is unreliable or a scheduled replacement component is overdue
- A required inspection, test, recall/field action, controlled technical procedure, or qualified service resource is unavailable
Copy/Paste CMMS Work Order Procedure
Savina 300 is a life-support ventilator. Never perform maintenance while it is supporting a patient, never bypass a failed device/circuit check, and do not return it to use with an unresolved alarm, overdue service item, or unavailable backup ventilation.