Regulatory information

Advice

MiraQ cardiac transit time flow measurement and high-frequency ultrasound system is a CE-marked class IIa medical device, and the probes used with the MiraQ system are CE-marked class III.

There is a field safety notice on Medistim ASA: VeriQ, MiraQ. Medistim is aware of incidences when flow measurement channels on Medistim devices have been operating with a significant zero-point offset value. The result is that flow measurements recorded with these channels will indicate that the flow is too high or too low. This might result in worse patient outcomes. Exploration of the issue has shown that this malfunction was caused by electrostatic discharge (ESD) damaging a component in the measurement chain on the Medistim systems, causing an offset from zero. Medistim tests the ESD resistance during compliance testing to ensure the system meets electromedical safety standard requirements. However, the incidences noted above have shown that severe ESD can surpass these requirements. Medistim has therefore further issued updated instructions for use which clarify the importance of routinely performing the probe and system functionality test before use to ensure that they function properly.