BMC Medical Co. Ltd. YH600AYH600B Manual De Usuario
YH‐600B Pro User Manual V1.0
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②
The finger sheath and cannula are CE marking approved, indicating compliance to the Medical
Device Directive.
③
Several accessories are available for using YH-600B Pro. To ensure a safe and effective therapy,
adopt only BMC accessories. All accessories do not contain latex.
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
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 Sleep 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.
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.
9.2 Main Device Structure
Display Screen
Shift Button
On-Off/OK Button
Flow/COM Port
SpO
2
Port
Figure 1-1 Main device structure