User's Manual
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FCC COMPLIANCE
FCC I D
Sensor ISM QBI-1011
Monitor I SM QBI-1012
Monitor Cell Modem RI 7CC864-DVAL
Base QBI -1013
ARRHYTHIMIA DETECTION ALGORITHM PERFORMANCE ANALYSIS
The CardioNet C5 System incorporates an arrhythmia analysis algorithm whose performance
is presented below:
The algorithm results were obtained from the respective databases in strict accordance with EC-
57 and with 0% downtime on both databases.
Performance Measure MIT Arrhythmia Database AHA Database
Average QRS Detection
Sensitivity %
99.96
99.74
Average QRS Detection
Positive Predictivity %
99.83
99.83
The CardioNet C5 system does perform analysis of ST Segment changes. The ST Segment
analysis is done on all leads without any signal scaling or gain adjustment. There are no
operator selectable detection criteria for ST segment shifts.
The ST algorithm has been tested for accuracy of the ST segment data. The significance of the
ST segment changes need to be determined by a physician.
HEART RATE MEASUREMENT REPORT
The performance of the analysis algorithm for heart rate detection on standard databases is
shown below. The average RMS errors for the AHA, MIT-arrhythmia, and NST databases are
1.23%, 1.08%, and 15.84% respectively for the C5 product (model CN1006).
Sustained heart rate (SHR) is inversely proportional to the RR interval averaged over 10
seconds or 12 consecutive beats, whichever is shorter. The Heart Rate Trend Graph shows
SHR and its minimum and maximum values during that interval.
FCC RULES PART 68
FCC Part 68 Registration
The Model CN1006 complies with FCC Rules, Part 68. On this equipment is a label that