Breas iSleep 20+ system
Breas Medical AB · Model US
Ventilator Non-continuous (Respirator)
Intended use: A portable, mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous respiration, primarily to treat adult patients affected by obstructive sleep apnoea (OSA); it may also be intended to treat snoring. It is a small desktop unit with controls, and may include a built-in humidifier; the airway pressure may be automatically adjusted to help provide optimal CPAP through use of a sensor (auto CPAP). The device is intended for use in the home but may also be used in healthcare facilities.
Key tips
- ·Never disable a low-pressure/circuit-disconnect alarm while troubleshooting - silence it, don't disable it.
- ·Verify the O2 supply source and pressure before assuming an internal fault.
- ·Circuit type must match the patient population (adult/pediatric/neonatal) - a mismatched circuit invalidates delivered volumes.
Typical Failure Modes
Failure patterns typical of this equipment class - general BMET reference, not verified against this exact unit's own service history unless flagged. Severity is a category-level estimate.
Exhalation valve leak / failure
HighSymptoms: Low exhaled tidal volume, high leak alarm, inability to maintain PEEP.
Root cause: Diaphragm/valve degraded by secretions and cleaning cycles.
Power supply / battery failure
HighSymptoms: Unexpected shutdown, persistent low-battery alarm.
Root cause: Aged internal battery or failed PSU.
Patient circuit leak
LowSymptoms: Leak alarm, low circuit pressure, volume loss.
Root cause: Disconnected or punctured patient circuit / humidifier.
O2 blender / mixer fault
MediumSymptoms: FiO2 out of range, oxygen alarm.
Root cause: Failed solenoid or proportional valve in blender.
Serviceable Parts & Consumables
The parts a BMET typically services on this class of equipment. Service class and relative cost are general engineering estimates for the category, not figures from this unit's documentation. Part numbers appear only when pulled from this unit's own service manual. Always confirm intervals and pricing against the manufacturer.
Exhalation valve assembly
Most-replaced wearable part; stock spares.
Class Frequent wear itemRel. cost $$R&R Fairly easy
Flow / differential pressure sensor
Class Periodic replacementRel. cost $$$R&R Moderate
Bacterial / HEPA filter
Consumable, replace per PM schedule.
Class ConsumableRel. cost $R&R Easy
Compressor / turbine module
Class Periodic replacementRel. cost $$$R&R Difficult
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Exhalation valve assembly Most-replaced wearable part; stock spares. | Frequent wear item | $$ | Fairly easy |
| Flow / differential pressure sensor | Periodic replacement | $$$ | Moderate |
| Bacterial / HEPA filter Consumable, replace per PM schedule. | Consumable | $ | Easy |
| Compressor / turbine module | Periodic replacement | $$$ | Difficult |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
PM Checklist
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
- ·Daily pre-use check: self-test, circuit integrity, alarm function
- ·Scheduled circuit and inspiratory filter replacement per manufacturer interval
- ·Flow and pressure sensor calibration verification
- ·Battery load test and runtime check
- ·Annual full PM and electrical safety test
Troubleshooting Approach
A structured starting point derived from the failure modes above. Follow the manufacturer's service documentation for the actual procedure.
Symptom: Exhalation valve leak / failure
- Confirm the presentation - typically low exhaled tidal volume, high leak alarm, inability to maintain PEEP - and note the exact alarm or message and the conditions when it occurs.
- Check the most likely cause first: diaphragm/valve degraded by secretions and cleaning cycles.
- Isolate the affected subsystem using the manufacturer's functional check or self-test, where one is provided.
- If the fault is confirmed and not a field adjustment, service or replace the exhalation valve assembly per the manufacturer's service documentation.
- Return the device to service only after the manufacturer's functional and applicable electrical-safety checks pass.
- Record the findings, any parts used, and the verification results in the maintenance history.
Symptom: Flow / pressure sensor drift
- Confirm the presentation - typically inaccurate delivered volume, false volume/pressure alarms - and note the exact alarm or message and the conditions when it occurs.
- Check the most likely cause first: sensor contamination or aging of differential-pressure transducer.
- Isolate the affected subsystem using the manufacturer's functional check or self-test, where one is provided.
- If the fault is confirmed and not a field adjustment, service or replace the flow / differential pressure sensor per the manufacturer's service documentation.
- Return the device to service only after the manufacturer's functional and applicable electrical-safety checks pass.
- Record the findings, any parts used, and the verification results in the maintenance history.
Technical Specs
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- No
- Single use
- No
- Prescription use
- Rx only
- FDA distribution status
- Not in Commercial Distribution
- Device type (GMDN)
- Home CPAP unit
- FDA product classification
- Ventilator, Non-Continuous (Respirator)
- Manufacturer support
- +4631868860 · techsupport@breas.com
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- ICU / CCU
- Emergency Department
- Operating Room (anesthesia-adjacent)
- NICU
- Respiratory Therapy department
- Patient transport
Documents & Manuals
No documents available for this device yet.
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