Performance Validation of a Non-contact Breathing Frequency Monitor (Model BM07)

The purpose of this study is to compare the accuracy of the BiancaMed BM07 breathing frequency indicator device with the respiration rate measured by a SomnoScreen RC Easy device on 20+ human volunteers. This is being carried out in support of a 510(k) submission.

• The BM07 is a non-contact device, using radio frequency (RF) range measurement to detect the chest wall motion, and thus the respiration rate. The BM07 is a CE Class IIa cleared device.

• The SomnoScreen RC Easy is both a CE and FDA (K060708) cleared device, used as an overnight, portable sleep recorder. One of its inputs is a pair of chest respiration effort bands that can be used to record the breathing rate of the subject.

• The human volunteers are selected to be a range of age, body mass index (BMI) and gender so as to cover a broad cross section of the population. BMI, gender and age are features that might affect the performance of the RF reflected signal:

• High BMI or low BMI could affect the skin RF reflectivity.

• High BMI may mask chest wall movement during breathing.

• The thinner skin often associated with increasing age may affect RF reflectivity.

• Female breast tissue may affect RF reflectivity or mask chest wall movement.

The target performance is an agreement between the BM07 and the Somnoscreen of +/- 5 breaths per minute. This target has been selected based upon a literature review, in particular:

• Lim et al: Respiratory Rate Measurement in Adults - How Reliable is it?
• Droitcour PhD Thesis: Non-Contact Measurement of Heart and Respiration Rates with a Single-Chip Microwave Doppler Radar.