Description

The BILICOCOON MAINTENANCE KIT is an essential accessory designed specifically for the upkeep of the BiliCocoon™ Phototherapy System. This system plays a crucial role in treating neonatal jaundice, providing effective care for infants under three months old and weighing less than 10 kg. Ensuring the phototherapy system remains in optimal condition, this kit supports both clinical and home use environments.

Kit Components

• Fuse: SCHURTER 0001.1013, 8A/250V/FAST, 5x20mm
• Dust Filter: SANYO DENKI 109-1001F20
• Instructions: Detailed guidance for replacement and maintenance procedures

Maintenance Operations

The kit facilitates key maintenance operations, including:

• Fuse Replacement: To be conducted if a fuse is blown.
• Dust Filter Replacement: Recommended annually as part of preventive maintenance.
• Calibration and System Verification: Intended for authorized technical staff.
• Cleaning Guidelines: Provides instructions for maintaining system components.

Usage Guidelines

Maintenance tasks should only be performed by authorized technical personnel, ensuring the system is unplugged during operations. It is crucial to use only the specified parts for replacements, and the dust filter should neither be cleaned nor reused. Post-replacement, verifying the system's irradiance is essential before resuming use.

Safety and Handling

The kit does not include the phototherapy Pad or any disposable parts. Users are advised not to attempt LED replacements, which should be managed by the supplier. Both the system and the kit should be stored indoors, away from heat, moisture, and dust, with air inlets kept clear.

Environmental Conditions

• Operating Conditions: Temperature between 10–35°C, with 15–90% relative humidity.
• Storage Conditions: Temperature range from -25 to 50°C, with 10–90% relative humidity.

Proper handling is necessary, and disposal should align with local regulations for electrical and electronic equipment.

Compliance and Warnings

The BILICOCOON MAINTENANCE KIT complies with Directive 93/42/EEC for medical devices and has been CE marked since 2016. Disposal practices should adhere to Directive 2012/19/EU regarding electronic waste. Improper use, insufficient maintenance, or unauthorized repairs may pose risks or alter the system's performance. Therefore, maintenance should strictly be conducted by authorized personnel. For disposal concerns, consulting local authorities or the manufacturer is recommended.