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2) Specification of Network connection
Communication protocol: the protocol between the Sensor device and the Mobile
app is a BLE central (Mobile) – peripheral (Sensor device) communications and they
communication with security requirements defined in the BLE Protocol Stack.
C. Responsibility Organization
Connection of the PEMS to an IT-Network that includes other equipment could
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result in previously unidentified risks to patients, operators or third parties;
The responsible organization should identify, analyze, evaluate and control
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these risks;
Subsequent changes to the IT-Network could introduce new risks and require
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additional analysis; and
Changes to the IT-Network include:
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• changes in the IT-Network configuration;
• connection of additional items to the IT-Network;
• disconnecting items from the IT-Network;
• update of equipment connected to the IT-Network; and
• upgrade of equipment connected to the IT-Network
5.7. Heart Rate Algorithm
The ECG signals converted to the digital values after the analog front-end blocks. The digital
signals are filtered to reduce the noise such as electrical motion, AC power noise (50/60 Hz),
and motion artifacts. After enhancing the quality of the ECG signals, the R peaks in the QRS
complex are detected and the interval (henceforth referred to as RRI) between every R peak is
calculated in the Sensor device. The data are transmitted to the smart phone via BLE. In the host
mobile application of the smart phone, the HR and HRV algorithms are estimated on data
received from the Sensor devices.
HR
The "RRI Estimation" block calculates differences between each pair of QRS indexes. Ectopic
beats results in a sharp transient of R-R interval. The "Ectopic Beat Removal" block detects these
abnormal beats and the values are replaced by the average value of adjacent R-R intervals.
Samsung Confidential
1
60
RRI
avg
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