Unetixs’ Vascular, a subsidiary of Opto Circuits and a leading manufacturer of peripheral vascular devices, has received CE (Conformité Européenne) mark for the product MultiLab Series II, 3-CP Vision which was Designed and Developed by India Research and Development Centre, Bengaluru. The CE Certificate confirms that 3-CP Vision met the necessary EU consumer safety, health and environmental requirements.
The Unetixs’ MultiLab Series II, 3-CP Vision is Dual-Channel peripheral vascular diagnostic system and vascular profiler enables vascular technologists to perform non-invasive diagnosis study about the Peripheral Arterial and Venous Diseases.
PAD (Peripheral Arterial Disease) is a disease in which plaque builds up in the arteries and restricts the flow of the blood. Early detection and treatment of PAD may slow or stop disease progress.
The system is intended to be used in podiatry practices, vascular Diagnostic centers, specialty practices (Cardiology and radiology), hospitals, general practices and internal medicines and wound care centres and etc. The device uses Doppler, photoplethysmography (PPG) and Calibrated-pulse-volume recording (C-PVR) techniques to identify the profile of blood flow. System can generate a full array of lower and upper arterial studies, including Ankle brachial index (ABI), Toe brachial index (TBI), full segmental exams, post-exercise exams, full waveforms including Doppler, PVR and PPG, and venous reflux dual-channel exam , Raynaud’s exam and Allen exam.
The system helps in conducting in-depth 'vessel specific' ABI studies for diagnosis or post-intervention follow-up, by obtaining individual pressures and waveforms from the dorsalis pedis and posterior tibial arteries, or to detect profile of blood flow using Unetixs TruDop continuous wave Doppler probes (available in 8 and 5MHz models).
In addition, the devices dual-channel PPG capability allows ABI and TBI pressures to be measured without holding a probe. Its two-channel calibrated-PVR capability also enables bilateral waveforms to be obtained simultaneously.
Medical professionals can perform the test, review the report, and send it to a vascular lab or specialist to review and interpret, and have it returned using Unetixs DICOM networking and reporting software.
CE certification will enable the company to market and sell this device in Europe, Asia, Latin America and other countries with such regulatory requirements.