Description

The BILICOCOON™ Phototherapy System by NeoMedLight is a specialized medical device designed for the effective treatment of neonatal jaundice in infants. This innovative system offers two configurations: the BiliCocoon™ Nest System for preterm babies and the BiliCocoon™ Bag System for term babies, providing comprehensive 360° light exposure. These configurations are adaptable for use in various settings, including incubators and during kangaroo care, enhancing versatility.

Key Features

• Advanced Phototherapy: Utilizes fiber optic technology to deliver blue light within the 430–490 nm wavelength range, precisely targeting the bilirubin absorption spectrum. This ensures effective treatment through homogeneous and intensive light emission.
• Light Components: Comprises a Light Box and a light-emitting Pad, both engineered for optimal performance. The system includes single-use disposable covers for hygiene and convenience.
• Durability and Longevity: Equipped with LEDs designed for a system lifetime of at least 8000 hours, ensuring long-term reliability.

Technical Specifications

• Light Box Dimensions: 215 x 198 x 160 mm, weighing 1.4 kg.
• Pad Specifications: Features a light-emitting surface of 40 x 30 cm, with a flexible optical fiber cable.
• Power Supply: Compatible with both European and North American electrical standards, enhancing usability across regions.

Safety and Usability

• Sound Level: Operates quietly at 37 dB(A), minimizing disruption in clinical environments.
• Environmental Protection: Rated IP21 for the Light Box and IPX3 for the Pad, offering protection against water and solid object ingress.
• User-Friendly Controls: Session settings are easily adjustable on the Light Box, even with medical gloves, and are retained after power interruptions.

Infant Care Integration

• Positioning: Infants are positioned on disposable covers with mandatory eye protection, ensuring safety during treatment. The system is suitable for use in hospitals, during transport, and potentially at home under medical supervision.
• Safety Indicators: Includes features such as overheating alerts and LED failure indicators, with automatic session termination to enhance safety.

Maintenance and Cleaning

• Cleaning Protocols: Light Box and Pad should be cleaned with approved agents. The system should not be immersed or autoclaved, and disposable covers are intended for single use only.
• Maintenance Needs: Annual preventive maintenance is recommended, with specific tasks like calibration and filter replacement to be performed by authorized personnel.

Regulatory Compliance

• Medical Device Classification: Classified as a Class II electro-medical device with CE Marking and ISO 13485 certification, ensuring adherence to international standards.
• Use Precautions: Not suitable for infants with certain medical conditions or those weighing less than 2500 g without professional consultation.

The BILICOCOON™ Phototherapy System stands out as a comprehensive solution for healthcare providers, offering effective jaundice management while supporting essential infant care practices such as breastfeeding and skin-to-skin contact.