4.6.3 Customized data preprocessing
The customized initial case files shall be processed for voltage conversion and frequency
conversion for resampling as the applicable format in the system. Then cases will be imported to
the device. After that, the verification of automated interpretation will be carried on.
5. Process and Result of Verification
5.1 Verification of measurement function
5.1.1 Verification and Process for CTS measurement database
The cases (CAL05000, CAL10000, CAL15000, CAL20000, CAL20002, CAL20100,
CAL20110, CAL20160, CAL20200, CAL20210, CAL20260, CAL20500, CAL30000,
ANE20000, ANE20001, ANE20002) imported to the device shall be used to verify the
automated measurement parameters.
Start
CTS preprocessing
Import preprocessing data to device
ECG automated measurement parameter
Calculate the difference of measurement and reference
Calculate mean differences
Eliminate the largest two deviations from the mean
Recalculate mean difference and standard deviation
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