Intra-cardiac echocardiography (ICE/DUC) catheters
Reprocessed Intra-cardiac echocardiography (ICE) catheters from Innovative Health provide highly reliable image quality aiding in the diagnosis and treatment of arrhythmias and structural heart disease. They are a safe and effective equivalent to costly options sold by the original equipment manufacturer.
ICE catheters improve efficacy and safety due to enhanced visualization and imaging of cardiac anatomical structures during complex EP ablation and structural heart procedures.
This well-established technology aids in intracardiac and intraluminal visualization of cardiac anatomy and physiology. Clinical efficacy and safety is improved by enhanced imaging and visualization of the anatomical structures during electrophysiology and structural heart procedures and in monitoring potential complications while reducing reliance on fluoroscopy.
An ultrasound transducer embedded in the tip acquires real-time ultrasound images. A location sensor, when embedded in the tip, provides location information to the ultrasound system.
Innovative Health’s validated cleaning process has been specifically designed and tested to provide consistent and repeatable results with high confidence and reliability.
The first step in the reprocessing process is the reduction of organic and inorganic contamination (e.g. hemoglobin, protein) and chemical residue (e.g. Total Organic Carbon (TOC)). This is achieved utilizing manual debris removal techniques, enzymatic cleaners, and Reverse Osmosis (RO) water.
The process has been validated in accordance with AAMI TIR-30: Compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices and FDA recommendations. This standard is considered to be the gold standard in cleaning medical devices.
Reprocessing helps hospitals achieve better financial results – reprocessed devices are often half the price of new ones – without compromising quality and safety. At the same time, the use of advanced third-party reprocessing provides significant environmental advantages.
The Ultrasound Transducer Test provides repeatable and quantifiable data required to determine the operational effectiveness of the reprocessed Intra-cardiac echocardiography (ICE/DUC) catheter transducer function.
The Ultrasound Transducer Test can detect the failure of any element from a number of root causes, such as dead or weak crystals within the ultrasound array, acoustic performance parameters of the ultrasound array, acoustic lens delamination, broken wires within the probe cable, broken wires within the flex circuit within the probe and also for defective electronics within the probe connector.
This is a widely used probe testing device that is the industry standard for testing the acoustic and electrical properties of ultrasound transducers. By independently exciting each crystal within the array of the probe, the Ultrasound Transducer Test measures the relative sensitivity of each element and analyzes the acoustic signature of the returning pulse for any variations in key performance characteristics.
Physical, mechanical and electrical testing is performed to provide objective evidence that the reprocessed device meets specifications and functions as intended.
The following tests are performed on 100% of the devices during reprocessing:
- Visual Inspection
- Curve Template / Functional (Steering Mechanism) Testing
- Ultrasound Transducer Testing
- HIPOT / Current Leakage Testing
Reprocessing Diagnostic Ultrasound Catheters involves the following steps*:
*Some tests are performed during validation activities only.
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Diagnostic Ultrasound/ICE Catheter