Safety
100 KOSMOS User Guide
• IEC 62359:2017 Ultrasonics - Field characterization - Test methods for the
determination of thermal and mechanical indices related to medical
diagnostic ultrasonic fields
• NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for
Diagnostic Ultrasound Equipment Revision 3
Transducer surface temperature rise
TABLE 9-7 summarizes the expected maximum temperature rise for KOSMOS.
The values are based on a statistical sample test of production-equivalent
systems and were measured in accordance with IEC 60601-2-37. The values listed
in the table are determined with 90% confidence, that 90% of the systems will
result in a temperature rise less than or equal to that stated in the table.
ECG supplemental information
• Recommended ECG electrodes: Use a fluid-resistant, foam-backed electrode,
such as 3M™ Red Dot™ Clear Plastic Monitoring Electrode 2235.
• KOSMOS uses single ECG filter from 0.65 Hz - 47.5 Hz.
• KOSMOS, with a fully charged battery, provides about two hours of
continuous operation.
• The KOSMOS heart rate calculation is accurate to within ±10% or ±5/min,
whichever is greater for regular heart rates in the specified range per
60601-2-27 Heart Rate Accuracy Requirement.
• KOSMOS heart rate range (adult): 30/min to 200/min.
• KOSMOS heart rate range (pediatric): 30/min to 250/min.
• Noise suppression: Right leg drive max. voltage 2.12Vrms.
• Method of heart rate (HR) averaging: Data is analyzed for R-wave peaks in
approx 2.5 seconds sampling periods. If required, two sampling periods are
combined to capture a minimum of three R-wave peaks. The HR is updated
after every sampling period.
TABLE 9-7 Surface temperature rise
Test Temperature rise (
o
C)
Still air 16.02
Simulated use 9.85
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