Introduction

The process consists of implementing an extended and advanced version of the characterization procedure of implantable Cardiac Medical Devices defined by the CEI EN 45502-2-1 standard, extending the verification of the device functionality to multiple heart frequencies and allowing its characterization nearby both positive and negative sensitivity thresholds.

Technical features

The method proposed in the present invention enables carrying out an accurate and extensive performance assessment for an implantable cardiac medical device at variable heart rate. In particular, for each given heart rate value, it is possible to determine positive/negative sensibility and continuity thresholds, which represent the values of the amplitude of the hear rate signal in correspondence of which the device operating mode switchs from pacing to inhibition and viceversa. The identification of these values enables a characterization of device operation more accurate than that achievable by employing the procedures given by current standards, thus representing a useful tool for device manufacturers in order to assess that these devices work properly at different operating conditions.

Possible Applications

• Support tool for manufacturers of implantable medical devices in order to carry out more extensive functionality tests under different operating conditions.

Advantages

• More comprehensive characterization of ICMD compared to that achievable by following international standards;
• Analysis of the device inhibition nearby sensitivity thresholds (determining the positive and negative continuity thresholds).