New Flow-Bubble Sensor SONOFLOW CO.56 Pro V2.0 Meets Highest Medical Standards for Maximum Patient Safety

At the MD&M West show, the international market place for medical design and manufacturing (April 12-14, 2022, Anaheim, USA), SONOTEC launches the second generation of the SONOFLOW^® CO.56 Pro flow-bubble sensor. By improving the implemented multi-level safety concept and enhancing the measurement channel design, the second generation of the SONOFLOW^® CO.56 Pro sets a new standard on the market in the field of non-invasive ultrasonic sensors for medical applications.

The next generation flow-bubble sensor SONOFLOW CO.56 Pro V2.0 for medical applications accurately measures the flow rate of liquids, such as blood and reliably detects air bubbles in standard medical tubing. Particularly developed for the use in extracorporeal life support systems (ECLS), the aim of the re-design was to enhance the safety concept of the hybrid clamp-on sensor while further improving its reliability and accuracy. The advanced safety concept covers applications in surgery rooms, intensive care units as well as the mobile emergency care regardless of the patient’s state of consciousness.

“Thanks to its high stability and reliability, the compact SONOFLOW CO.56 Pro V2.0 has already been implemented in multiple medical devices being one of the key elements in therapies, where the heart or lungs of a patient are severely damaged and sufficient organ function cannot be achieved without any support. Particularly during the last two years of the pandemic we were able to contribute to the fight against the pandemic with our sensors being implemented in numerous medical support devices applied in case of acute lung failure caused by Covid-19 ”, explains Melanie Schmidt, Business Unit Director at SONOTEC GmbH.

Safe operation for medical applications

The multi-layer safety concept includes a number of safety aspects making the non-invasive clamp-on sensor the most reliable and safest flow-bubble sensor for medical applications. SONOFLOW CO.56 Pro V2.0 meets the high standards of the IEC 60601-1 3rd edition for medical devices ensuring highest patient safety and life support. The fail-safe architecture, implemented cyclical self-test routines and a highly secure software guarantee interruption-free operation of the hybrid sensor in ECMO machines, blood pumps, and organ transport systems.

In order to guarantee safe operation in applications with direct contact to the human heart or bloodstream, the compact SONOFLOW CO.56 Pro V2.0 achieves electrical resistance of up to 1000 V by means of strong isolation. In doing so, the sensor meets the most stringent cardiac floating (CF) classification of the international IEC 60601-1 medical standard. Hence, the sensor design protects the patient and the operator from electric shocks caused by leakage current.

The high level of electromagnetic stability and the use of lowest acoustic energy specified for diagnostic devices underline the sophisticated safety concept of SONOFLOW CO.56 Pro V2.0. Additionally, the ultrasonic flow-bubble sensor ensures system sterility and avoids any stress for blood cells as a result of its clamp-on design.

Improved measurement architecture for highest accuracy

For the new sensor generation SONOTEC slightly modified the geometry of the measurement channel. In doing so, operators benefit from a more precise bubble detection and a significant improvement of the accuracy after tubing re-insertions. SONOFLOW CO.56 Pro V2.0 offers a proven flow measurement accuracy of up to 2%. Depending on tubing diameter and process conditions, the hybrid sensor reliably detects life-threatening air bubbles.

Sensor design with greatest flexibility

The lightweight ultrasonic sensor can easily be clamped on the tubing or mounted onto medical devices. SONOTEC offers different sensor sizes for standard medical tubing sets. With its integrated electronics and on-board processing unit, the non-contact ultrasonic flow-bubble sensor has the smallest footprint in its market. The implemented serial RS-485 bus interface enables parallel operation of up to twelve sensors.

SONOTEC presents its new SONOFLOW CO.56 Pro V2.0 at the MD&M West from 12^th to 14^th April 2022 in Anaheim, USA. Visitors are invited to discuss their projects at booth 2074 of SONOTEC.