mk-motion in medical technology
Medical devices rarely fail completely due to EMC interference. They exhibit subtle deviations – noise on a curve, an alarm LED that doesn't light up, a display that freezes briefly. The test engineer must reliably detect precisely these deviations over hours. mk-motion does this automatically. Our motion detection software assists with the documentation and detection of anomalies.
What the interface does not provide
Electrical measurements and device states can often be logged and subsequently verified via Ethernet, USB, or another interface. However, the device's display—the screen, the waveform, the alarm LED—is the end of the signal chain. Here, EMC-related interference can become apparent that doesn't show up at the interface: a display controller that produces artifacts under electromagnetic interference, even though the data is correct; an alarm LED that doesn't light up, even though the alarm condition has been internally detected; an ECG waveform that shows noise, even though the digital signal is clean. In clinical practice, the physician relies on precisely this display—and it is typically defined as Essential Performance according to IEC 60601-1-2.
Where mk-motion comes in
Monitor the display quality of curves and images. ECG, plethysmogram, ultrasound, endoscopic imaging – frame-to-frame difference and reference image difference detect artifacts, noise, and freezing on the display throughout the entire test duration. These are errors that directly impair clinical decision-making and are not necessarily visible at the digital interface.
Monitor visual alarm indicators. Is the LED actually lit? Correct color? Correct flashing frequency? Brightness and hue monitoring in the pipeline, along with a period module for flashing frequencies, are helpful. A comparison with the state acquired via the interface allows for the automatic detection of discrepancies between the electrical signal and the visual display.
Check display integrity. Changes in brightness and contrast, severe flickering, black screen, spontaneous restart – these are error patterns that a user in clinical practice would immediately recognize as device malfunctions. mk-motion captures them frame-accurately and assigns them to the test point – the engineer decides on the evaluation.
Detect unintentional actuator movement. Infusion pumps, surgical tables, robotic systems – motion detection captures physical movement without a control command and marks it in the log. Uncontrolled movement can constitute a violation of basic safety according to IEC 60601-1.
Throughout the entire immunity test
Radiated RF immunity testing according to IEC 61000-4-3 – 80 MHz to 2700 MHz, with device-specific dwell times, in several operating states – takes place over several hours. IEC 61000-4-39 adds a proximity test and new frequencies, simulating near-field exposure from mobile phones, RFID readers, Bluetooth, and WLAN in close proximity to the device. Throughout all these tests, the visual integrity of the display must be continuously monitored.
Seamless recording, targeted clips. Continuous recording throughout the entire test duration. Triggered recording with pre-buffering generates short clips whenever an anomaly is detected. The result is an event list with test parameters – not hours of footage.
By integrating mk-motion with your existing test software, anomalies are correlated with the exact test conditions. Frequency, level, and modulation from the test software, along with values extracted from the image data and derived analyses, are logged and stored with the video data. This is reproducible for development purposes and traceable in the Risk Management File according to ISO 14971.
Switch operating states without reconfiguration. Mains operation, battery operation, various measurement modes – the test software signals the operating state, mk-motion activates the corresponding ROI and pipeline configuration and evaluation logic.
Quantitative logging for regulatory documentation. All pipeline signals are logged frame-wise and exportable as CSV. This provides time-resolved documentation of visual integrity, complementing the essential performance data captured via interfaces. Combined with video recording, this results in complete, auditable documentation: what was displayed on the screen and when, and what corresponding evaluation results did the pipeline provide.
Please consult our team of experts regarding your specific applications...