MasimoSET® LNOPv™ Ad SpO2 Pulse Oximeter Adhesive Sensor Adult
MASIMO CORPORATION · Model 1277
MasimoSET® LNOPv™ Ad SpO2 Pulse Oximeter Adhesive Sensor Adult
Intended use: A photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. The is a single-use device.
Key tips
- ·A no-signal/flatline alarm gets checked on the patient first, not the monitor - rule out a real clinical event before troubleshooting.
- ·Recalibrate NIBP against a reference manometer, not just a self-test pass.
- ·Reused patient cables (SpO2, ECG leads) are a common source of intermittent-fault complaints - swap the cable before the module.
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.
- ·Routine cable and lead-wire inspection for fraying/wear
- ·Battery conditioning cycle
- ·NIBP calibration check against a reference manometer
- ·ECG / SpO2 accuracy verification against a patient simulator
- ·Annual electrical safety test
Technical Specs
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- No
- Single use
- Yes
- Prescription use
- Rx only
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- Pulse oximeter probe, single-use
- FDA product classification
- Oximeter
- Manufacturer support
- +1(949)297-7498 · TechService-US@masimo.com
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- ICU / CCU
- Emergency Department
- OR / PACU
- General med-surg floors
- Step-down units
- Telemetry units
Documents & Manuals
No documents available for this device yet.
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
- RECALL
TC-I tip clip sensor may produce readings outside the accuracy specification.
- RECALL
Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator pressing the power button.
- RECALL
Masimo Corporation is initiating a voluntary recall on the Pronto-7 rainbow 4D Resuable Sensor because when performing an SpHb measurement, the sensor may incorrectly read actual finger temperature. As a result, Pronto-7 Check Pulse CO-Oximeter may provide an incorrect SpHb measurement.
- RECALL
Internal testing revealed that some of the sensors might not meet the accuracy specifications of : 2% for SpO2 and of: 3% for SpCO, due to the tolerance of one of the emitter LED's used in the calculation ofSpO2 and SpCO. The SpO2 reading may have a negative bias of up to 1 % and the SpCO reading may have a negative bias of up to 4%.
- RECALL
Speaker component failure resulting in ceasation of an audible alarm even though the condition continues that caused the alarm.
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