Description

The Koala Intrauterine Pressure Catheter (IUPC) by Clinical Innovations is a specialized medical device designed for precise intrauterine pressure monitoring during labor. This single-use, disposable catheter provides healthcare professionals with accurate, real-time data on uterine contractions, enhancing the management and assessment of labor.

Key Features

• External Transducer Design: The catheter itself is free from electronics, with the pressure transducer located externally. This allows for 'true zero' calibration while in utero, ensuring precise measurements.

• 360° Circumferential Sensing: Equipped with a circumferential sensor at the tip, the catheter offers comprehensive pressure measurement.

• Clear Lumen: The clear lumen design enables visual confirmation of proper placement through amniotic fluid flashback.

• Soft, Flexible Tip: The small, malleable urethane tip facilitates safer and easier insertion, while the flexible catheter body maintains position during monitoring.

• Amnioport Functionality: Allows for amnioinfusion or amniotic fluid sampling, adding versatility to its use.

Compatibility and Setup

• Streamlined Setup: Easily connects to a reusable cable and monitor, with straightforward zeroing and setup procedures.

• Monitor Compatibility: Compatible with standard fetal monitors from brands like Philips, GE Medical, and others, using specific reusable cables.

Safety and Sterilization

• Gamma Sterilized: Each catheter is gamma-sterilized for enhanced patient safety and biocompatibility.

• Prescription Use: Intended for clinical use under physician supervision, suitable for cases where external monitoring is insufficient.

Clinical Performance

Clinical studies have demonstrated the Koala IUPC's safety and effectiveness, with high ratings for ease of use, accuracy, and setup. It provides stable pressure readings with minimal drift, aligning with standard intrauterine pressure monitoring protocols.

Contraindications

The catheter is not intended for use with intact fetal membranes or for home monitoring of pre-term labor. Other contraindications include uterine cavity bleeding, infection, and placenta previa, among others.

General Use Instructions

Healthcare providers are advised to insert the catheter 10–14 cm into the intra-amniotic space, confirm placement, and secure it as instructed. Proper connection to the reusable cable and monitor is essential, along with adherence to all warnings and precautions provided.

Maintenance

The reusable cable should be cleaned with water or alcohol, ensuring the transducer gel remains undisturbed.

Regulatory Information

The Koala IUPC is classified as a Class II medical device under 21 CFR 884.2720, aligning with regulatory standards for external uterine contraction monitors and accessories.