Medical, Diagnostic & Hospital Supplies

The performance and functional characteristics of YH-600B Pro include all the user-friendly features of the predicate device. YH-600B Pro is powered by one 1.5 V AA battery. Testing was performed to demonstrate that the performance of YH-600B Pro in its intended environment is as safe and effective as that of the legally marketed predicate devices. The safety and effectiveness of YH-600B Pro have been verified through performance-related testing that consisted of Electrical Safety, Electromagnetic Compatibility, Mechanical and Environment Testing. The recorded data, such as SpO2, pulse rate, airflow waveform, snore and CPAP pressure, can be replayed on a computer via the PolyLogic Analysis Software which is provided with YH-600B Pro. The device can be used as a standalone unit for recording data. It can also interact with a commercially available IEC60950-1 compliant computer, which can be used to review data. The device does not have any audible alarms, and, therefore, should not be used for continuous monitoring. Patient is an intended operator, who can safely use all functions and can perform all maintenances mentioned in the User Manual. All parts of the device are applied parts.