The neoblue radiometer instead was designed specifically for measurement of the led. This site is not affiliated with or endorsed by the FDA. Per the natus calibration report, the unit was found to be with in. Patient Sequence No: 1, Text Type: N, H10ĥ900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108 This would not be related to "under treatment " it would be related to the infant's pathology. Even when the light is functioning according to the prescribed phototherapy intensity, there may still be the need for adjunct therapy, regardless of the intensity. While it is common that treatment is prescribed as "intensive" phototherapy (based on aap guidelines), studies have shown clinical benefits can be derived from irradiance levels well below 10uw/cm2/nm. Phototherapy does not, in and of itself, expose a patient or user to significant hazard. A clinical evaluation for "low-intensity" was conducted simultaneously with the investigation performed by the capa. Natus reported mdrs related to this issue because the neoblue 3 product risk analysis report indicated some potential risk of injury if the phototherapy intensity was not within specification. If this meter is not available, it is important to measure the intensity with a radiometer specifically designed to measure the narrow wavelength spectrum of blue LEDs. This conversion chart has since been removed from the service manual. Natus Medical Incorporated recommends using a properly calibrated neoBLUE Radiometer for measuring the intensity of the neoBLUE light. The investigation concluded that the root cause was in the conversion chart in the neoblue 3 service manual, and that the neoblue led phototherapy system units and olympic bili-meter radiometers were operating within specifications. This discrepancy led users to the incorrect conclusion that the neoblue 3 units were generating low intensity. A root cause investigation, which took place in the natus capa process, confirmed that the target values listed for the bili-meter radiometer intensity readings in the neoblue 3 conversion chart were too high. As a convenience for neoblue 3 users and/or customers which already had the bili-meter, a conversion chart was provided in the neoblue 3 service manual. Due to technological differences, the bili-meter radiometer readings will differ from neoblue radiometer readings when measuring light output intensity from a neoblue led phototherapy system. Prior to an ongoing natus capa, the service instructions for the neoblue 3 referenced the use of the olympic bili-meter radiometer as an alternate to the preferred neoblue radiometer. The neoblue radiometer instead was designed specifically for measurement of the led light output spectrum generated by the neoblue products. The olympic bili-meter was not intended to measure the narrow-spectrum light output generated by the newer led technology products like the neoblue 3. The olympic bili-meter radiometer is a legacy product designed to measure the broad-spectrum light output generated by older technology phototherapy products such as the olympic bili-bassinet.
Per the natus calibration report, the unit was found to be with in specifications and was shipped back to the customer. The meter was requested back for further evaluation.
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