Bilisense Jaundice Treatment Pad

Product Description

The Bilisense Jaundice Treatment Pad is a maintenance-free solution for low-cost and mobile treatment of neonatal jaundice. The soft and flexible BilisenseTM therapeutic pad emits light in the recommended spectrum and of optimal intensity to treat neonatal hyperbilirubinemia^{Interview with representative}. This product is a prototype.

As of June 2019, this product is no longer featured on the manufacturer’s website and appears to be discontinued.

Market Suggested Retail Price

$700.00

Target Users (Target Impact Group)

Distributors / Implementing Organizations

None available, as the product is discontinued

Manufacturing/Building Method

None available, as this product is a prototype. Large-scale manufacturing has not been initiated, product seems discontinued.

Intellectural Property Type

Patent Protected

User Provision Model

None available.

Distributions to Date Status

None.

Design Specifications

Specifications are as follows^{Interview with representative}: Dimensions: 28cm x 14cm x 0.5cm (11” x 5½” x ¼”) Replaceable parts: None Power consumption: 1.5W (nominal), 2.5W (max) HS Code: 9018.90.84 Light intensity (APP recommended): ?30?W/cm2/nm Weight of pad: 70g (2½ oz.) Weight of power supply: 200g (7 oz.)

Technical Support

The product is meant to be used without required training or periodic maintenance^{Interview with representative}.

Replacement Components

The light source for the Bilisense Treatment Pad is meant to last the lifetime of the product, with no light bulbs needing to be replaced or outputs adjusted. A rechargeable battery pack is under development and estimated to be available in 2017 that will allow continued use for up to 12 hours without mains electricity, allowing mobility and making the blanket suitable for rural areas with no or unreliable mains supply^{Interview with representative}.

Lifecycle

Lifecycle of up to 5 years, shelf life of 10 years^{Interview with representative}.

Manufacturer Specified Performance Parameters

Portable, low-cost, safe, maintenance-free, minimal training, compatible in numerous healthcare environments^{Interview with representative}

Vetted Performance Status

Extensive testing and development over the course of multiple years by both the manufacturer and hospitals^{Interview with representative}.

Safety

Expert advisors advise the need of skilled supervision to follow the AAP guidelines that recommends evaluating response after 8 hours to see if Phototherapy device is effective, if not alternate treatment would be needed to avoid any health risks for neonates. Also they suggest that risk analysis for use / abuse conditions are needed.

Complementary Technical Systems

Can be used with disposable hygiene control sleeves and overhead phototherapy systems for additional coverage^{Interview with representative}.

Academic Research and References

None

Compliance with regulations

This product has a CE mark and conforms to the following EU Directives^{Interview with representative}: MDD 93/42/EEC (Medical Device Directive Class I device) EN 60601-1 (Medical Electrical Equipment) EN 60601-2-50 (Infant Phototherapy Equipment) EN 60601-1-2 (Collateral Standard) 2004/108/EC (Electromagnetic) 2006/95/EC (Low Voltage)

Other Information

Expert advisers agree that portability is a plus for this product. They also question if there is a use case for phototherapy in non-clinical settings/resource limited scenarios since there is a need of skilled supervision. AAP guidelines recommends evaluating response after 8 hours to see if Phototherapy device is effective, if not alternate treatment would be needed.