Description

The BILICOCOON™ Phototherapy System is a specialized medical device designed to effectively treat neonatal jaundice in infants under 3 months old, weighing less than 10 kg. This advanced system is suitable for use in both clinical and home settings, providing flexibility by allowing treatment in incubators, cradles, or even in the arms of a caregiver. Its operation requires a medical prescription and should be conducted by trained clinicians or properly supervised laypersons.

System Components

The system comprises a Light Box and a Pad, each engineered to deliver precise phototherapy. The Light Box serves as a blue light electronic generator, featuring a digital display, ergonomic handle, and essential indicators for operation, overheating, and LED performance. The Pad, available in Nest or Bag configurations, is crafted from woven textile and optical fibers, enclosed in polyurethane to transmit blue light safely and effectively to the infant. A single-use, non-woven Disposable Cover ensures hygiene and safety, designed strictly for one-time use.

Technical Specifications

Light Emission

• Wavelength: 430–490 nm
• Mean Spectral Irradiance: 35 μW·cm⁻²·nm⁻¹
• LED Configuration: 6 LEDs, each with a maximum of 15 W

These specifications are meticulously aligned with the bilirubin absorption spectrum, enhancing treatment efficacy.

Light Box Features

• Dimensions: 215 x 198 x 160 mm
• Weight: 1.4 kg
• Power Supply: 100–240 VAC
• Sound Level: 37 dB(A) at 1 meter

The Light Box includes a session timer adjustable from 10 minutes to nearly 100 hours, with clear display and control features. It also boasts environmental protection ratings of IP21 for the Light Box and IPX3 for the Pad, ensuring durability against water exposure.

Operating Conditions

The system is intended for indoor use, with specific conditions for temperature, humidity, and pressure. The Pad can be placed within an incubator, while the Light Box remains outside, maintaining optimal operating conditions.

Safety and Maintenance

The BILICOCOON™ system includes crucial safety features such as indicators for overheating and LED failure. Maintenance involves regular cleaning with appropriate agents and annual checks by authorized personnel. The Disposable Cover must not be reused or cleaned, and only specific disinfectants are recommended for the Light Box and Pad.

Compliance and Certification

The device is CE marked and complies with European medical device directives, ensuring adherence to high safety and performance standards. With a system lifetime expectation of over 8000 hours, the BILICOCOON™ Phototherapy System offers a reliable solution for managing neonatal jaundice, providing comprehensive coverage and comfort through its innovative design.