Description

The PARAGON INTEGRATED OXYGENATOR by Chalice Medical Ltd is a highly specialized medical device designed for use in extracorporeal life support (ECLS) and cardiopulmonary bypass procedures. This single-use, sterile oxygenator features a hollow fibre membrane and an integrated heat exchanger, providing essential physiological gas exchange and blood temperature regulation across a diverse patient range, from neonates to large adults.

Key Features

• Membrane Types: Available in multiple models and sizes, the device offers different membrane types, including Polymethylpentene (PMP) and Polypropylene (PP), tailored for various clinical needs.
• Surface Coating: The Rheopak surface coating enhances biocompatibility by reducing platelet adhesion.
• Heat Exchanger: Utilizes non-porous polyester hollow fibres for effective blood temperature management.

Design and Safety

The oxygenator is equipped with multiple connection ports for comprehensive integration, including blood, gas, water, sampling, and venting. Safety is prioritized with double seals using silicone O-rings and UV adhesive, along with unique batch and serial numbers for traceability. The device is rigorously tested to meet pyrogen and bioburden limits and complies with BS EN ISO 7199 standards, ensuring high performance and safety.

Model Variants

The product line includes several model variants such as Adult Maxi, Adult Midi, Paediatric, Infant, and Neonatal, each with specific technical specifications:

• Blood Flow Range: Varies from 0.1 to 8 L/min depending on the model.
• Priming Volume: Ranges from 65 mL to 300 mL.
• Surface Area: Gas exchanger and heat exchanger surface areas are tailored to model requirements.

MicroNet Filter

Certain models feature an internal MicroNet filter, enhancing filtration with a polyester material that significantly improves air removal efficiency. The device operates within defined pressure and temperature limits, ensuring robust performance under clinical conditions.

Compatibility and Use

Compatible with continuous flow blood pumps, air/oxygen blenders, heater/coolers, and various tubing and reservoir systems, the oxygenator integrates seamlessly into existing medical setups. Indications for use include effective oxygenation, carbon dioxide removal, and precise blood temperature management.

Handling Instructions

Proper handling includes thorough inspection, priming, de-airing, and secure installation in a compatible holder. The device must be used by trained personnel, adhering to strict anticoagulation protocols and operational guidelines to prevent complications such as air embolism.

Storage and Quality

Storage conditions require a dry, frost-free environment with temperatures between +5°C and +40°C. Each unit undergoes extensive quality checks, is CE marked, and complies with relevant medical device regulations. Manufactured in the UK, the device assures high standards of biocompatibility and safety, making it a reliable choice for healthcare professionals worldwide.