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To swaddle infants during neonatal phototherapy in the hospital or home setting. Single patient use only.

The Luma Wrap™ by Beevers Manufacturing & Supply, Inc./Salter Labs is a translucent, highly breathable, phototherapy-compatible, disposable infant swaddling blanket. It is made of spun bond polypropylene non-woven fabric that is more than 90% light-permeable. The Luma Wrap™ provides centered and comfortable boundaries to benefit many babies who exhaust themselves with their hyper-reactive, frantic movements while receiving phototherapy. The Luma Wrap™ is a stand-alone device and has no accessories. It is available in two designs: a square and a shape similar to baseball's home plate. A 2" strip of self-adhesive is an added optional convenience feature to assist the user in positioning the device by adhering two parts of the device together.

The Little Angels Swaddling Blanket developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used as an adjunct to neonatal phototherapy systems used for the treatment of neonatal hyperbilirubinemia in the clinical or home setting. It is intended to be used by or under the direction of a licensed physician.

The Little Angels Swaddling Blanket is intended to be used as an adjunct to neonatal phototherapy systems used for the treatment of neonatal hyperbilirubinemia in the clinical or home setting. The Little Angels Swaddling Blanket is similar in composition and function to other devices used as adjuncts to current neonatal phototherapy systems used to treat neonatal hyperbilirubinemia. The Little Angels Swaddling Blanket is comprised of a sheet of spun bond polypropylene material that is die-cut and heat welded in a pattern that allows an infant undergoing phototherapy for hyperbilirubinemia to be tightly swaddled in a fashion such that only a single layer of material is ever interposed between the infant and the phototherapy source. Spun bond polypropylene is a commonly used fabric in medical products and garments. Spun bond polypropylene is non-irritating to the skin. soft, and has a good drape that allows it to easily conform to body contours. Spun bond polypropylene is available in different fabric weights, depending on the tightness of the weave and fabric density. Light-weight spun bond polypropylene fabric is used in the Little Angels Swaddling Blanket to ensure maximum light transmittance from the phototherapy source to the patient's skin. {See section on "Bench Testing".) In use, an infant undergoing phototherapy for hyperbilirubinemia is first laid atop the Little Angels Swaddling Blanket, and the blanket is then folded around the infant in a prescribed fashion that ensures the infant is tightly swaddled and that only a single layer of fabric lies between the phototherapy source and the infant's skin. When an overhead phototherapy source is used, the swaddled infant is then placed under the light source in the usual fashion in order to receive the phototherapy treatment. The Little Angels Swaddling Blanket also has a pocket formed in its rear panel (under the infant). If a light emitting pad type phototherapy source is to be used, the light emitting pad is placed in this pocket and phototherapy is administered to the swaddled infant in the usual fashion. Also, double phototherapy can be administered to an infant swaddled using the Little Angels Swaddling Blanket by combining an overhead phototherapy source together with a light emitting pad type phototherapy source, each used as described above.