SONOTEC takes steps to improve blood leak detector – Med-Tech Innovation
If the dialysate gets contaminated with blood during haemodialysis, it can lead to unintended blood loss and be life threatening for the patient. For this reason, blood leak detectors are implemented in all dialysis machines, which permanently monitor the dialysate for smallest amounts of blood.
SONOTEC developed the non-invasive, optical sensor to recognise smallest traces of blood in clear fluids in transparent and flexible tubing. If the BLD03 identifies blood in the dialysate, an alarm is triggered. The new and improved BLD03 blood leak detector meets highest safety standards for components integrated into medical devices such as haemodialysis machines. The non-contact blood leak sensor reliably detects 0.35 ml/min of blood at a dialysis flow rate of 800 ml/min and a haematocrit level of 32%. With the new sensor, the measurement technology specialist not only meets the requirements of the medical safety standard IEC 60601-2-16:2018 but has also imposed stricter rules on itself regarding the standard to enable even more precise measurements.
SONOTEC developed the BLD03 sensor following the international standard for electromagnetic compatibility IEC 60601-1-2:2014 (4thedition), AMD1:2020 for continuous operation in medical devices. The embedded software meets the international standard IEC 62304:2006, AMD1:2015. Implemented advanced algorithms ensure reliability and accuracy of the BLD03 and prevent the sensor from any malfunction caused for example by changes in the intensity of ambient light. Additionally, the blood leak detector evaluates the plausibility of the measurement data. The proven hardware design and innovative software algorithms ensure maximum patient safety. This is particularly essential in the field of home dialysis. At home, the patient carries out his treatment independently and without on-site medical staff.
The BLD03 consists of a sensor head and an external electronics board. The sensor head with measurement channel is mounted on the dialysis machine. The electronics board with integrated firmware is built into the medical device. SONOTEC offers the BLD03 in two configurations differentiating in the firmware design: A configuration meets the Class C software standard without adjustable settings and logical signal output. The other more flexible configuration meets the Class A software standard. It offers for example adjustable blood sensitivity settings. In addition to the logical signal output, this configuration includes a serial interface for input and output in ASCII code.
The maintenance-free BLD03 sensor has been designed for integration in different medical devices in various environments such as hospitals, emergency rooms, intensive care units, and home care applications. Properly mounted and implemented, the blood leak detector offers a very long operating life of several years.