(343 days)
The Bright Embrace Model SBL60 phototherapy light is intended for the treatment of neonatal hyperbilirubinemia. It is designed to provide phototherapy treatment from underneath and around the neonate. The Bright Embrace can be used in a clinical setting or in the home.
The Bright Embrace Model SBL60 is a single-patient, portable phototherapy light that was specifically designed to incorporate these features:
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- high intensity blue light over a large body surface area as recommended by the American Academy of Pediatrics (AAP);
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- the ability to hold the newborn during treatment;
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- single patient use to minimize cross-contamination in hospitals and to facilitate home care logistics:
The Bright Embrace Model SBL60 delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia, also called newborn jaundice. The Bright Embrace Model SBL60 is designed to provide phototherapy treatment from a wrap-around design that provides light from underneath, the sides and partially the front of the newborn to achieve a large body surface area of treatment.
The blue LEDs used in the Bright Embrace Model SBL60 emit light in the range of 430-510nm (peak wavelength 480nm). This range corresponds to the spectral absorption of light by bilirubin, and is thus considered to be the most effective for the desirable degradation of bilirubin under the exposed skin. Blue LEDs do not emit significant energy in the ultraviolet (UV) region of the spectrum, so there is no concern about UV exposure to the newborn. As with most phototherapy devices, protective eye shades or goggles must be used to protect the newborn's eyes from excessive light exposure.
The Bright Embrace Model SBL60 is a neonatal phototherapy light intended for the treatment of neonatal hyperbilirubinemia.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Irradiance | |
| Average irradiance ≥ 30 µW/cm²/nm (AAP recommended for "intense phototherapy") | 38 µW/cm²/nm (meets criteria) |
| Light distribution (Ebi min / Ebi max) ≥ 0.4 (IEC 60601-2-50 standard) | 0.46 (meets criteria) |
| Body Surface Area (BSA) Treatment | |
| > 20% BSA treated (desirable) | 28% BSA for normal-size newborn; 37% BSA for premie-size newborn (meets criteria) |
| Thermal Safety | |
| No location touching newborn exceeds 40°C (IEC 60601-2-50 standard) | Maximum temperature was 31.9°C (meets criteria) |
| Environmental Storage Limits | |
| Device functional after storage at -5°C (23°F) and 60°C (140°F) at 90% rH for 60 days | Device showed no visual defects, functioned normally, and irradiance readings were unchanged (meets criteria) |
| Leakage Testing | |
| Qualified for Applied Parts Type CF (e.g., Patient leakage current |
§ 880.5700 Neonatal phototherapy unit.
(a)
Identification. A neonatal phototherapy unit is a device used to treat or prevent hyperbilirubinemia (elevated serum bilirubin level). The device consists of one or more lamps that emit a specific spectral band of light, under which an infant is placed for therapy. This generic type of device may include supports for the patient and equipment and component parts.(b)
Classification. Class II (performance standards).