In order to ensure highest patient safety and to meet the growing demand in the field of home dialysis, SONOTEC enhanced its new BLD03 blood leak detector to work reliably in a wide range of medical applications. If the dialysate gets contaminated with blood during hemodialysis, 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 recognize 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 hemodialysis 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 hematocrit 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 with regard to the standard to enable even more precise measurements.
Maximum patient safety through proven hardware design and state-of-the-art software algorithms
SONOTEC developed the BLD03 sensor following the international standard for electromagnetic compatibility IEC 60601-1-2:2014 (4th edition), 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.
Meeting demands of medical device manufacturers with regard to safety and flexibility
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.