WhaleTeq Test Solutionsfor
Medical Device Manufacturers

According to ISO80601-2-61:2011 standard – Every PULSE OXIMETER EQUIPMENT tester intended to generate simulated signals on the market at the time of writing is a FUNCTIONAL TESTER. An appropriate FUNCTIONAL TESTER allows the RESPONSIBLE ORGANIZATION to

Input impedance is an important factor that affects the accuracy of the ECG. Therefore, each ECG must test the input impedance. This article will explain the principle of input impedance and calculate the value of the input impedance of the ECG

Basically, the basic performance tests in all types of ECG machines should be based on the items that are used to test the basic safety and essential performance of electrocardiographs as specified in the three international ECG standards.

In the ECG performance standard IEC60601-2-47 has disclosed to evaluate HRV algorithm performance using artificial ECG signal. In subclause 201.12.1.101.2.3.3.2, there are two methods (analogue and digital). For fully compliance standard, it is better to

When using an electrocardiograph, the 50/60 Hz noise on the ECG is often increased due to the interference of the mains signal on the human body, which may cause the doctor to incorrectly interpret the heart disease represented by the ECG waveform.

The MECG 2.0 is designed around the high accuracy and test signals used in IEC 60601-2-25, with 14-bit simulation down to 2.5uV/LSB over a range of ±5mV and up to 8 channels at 1kHz, with an overall accuracy of ±5µV.

Insulation tests at high frequency (HF) need to be done with great care. The mechanism of breakdown is different to normal mains frequency dielectric strength tests - it is mostly thermal, rather than basic ripping apart of electrons from atoms.

ECG filters can have a substantial effect on the test results in IEC 60601-2-25, IEC 60601-2-27 and IEC 60601-2-47. In some clauses the standard indicates which filter(s) to use, but in most cases, the filter setting is not specified.

From a test engineer's point of view, it is easy to get confused with LEADS and LEAD ELECTRODES, because for a typical electrical engineer, "lead" and "electrode" are basically the same thing. But there is more confusion here than just terminology.