YH-600B Pro User Manual V3.0
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9. System Features
9.1 General Introduction
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 SpO
2
, 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.
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