Welch Allyn Holter System - User Manual - Manual (Page 55)

Directions for Use 51
Table 17. Bluetooth Protocol
Conformance to Regulatory Standards
International Electrotechnical Commission
• CAN/CSA C22.2 No. 601.1-M90
• IEC 60601-2-47, 2001
• USA: UL60601-1
• IEC 601-1-2, conforms to EN 55011
• EN 61000-4-2:1999
• EN 61000-4-3, 1995
• EN 61000-4-5, 1995
American Advancement of Medical Instrumentation
• ANSI/AAMI EC38-2007
Table 15. Device Classification
AECG Device Type Type I
EMC Class IIb
IEC Type Type BF
Table 16. Software Technical Specifications
Specification Value
Rate 30 to 250 BPM
QRS Detection amplitude
 0.5 mV
Analysis Channels any combination of up to three channels
Report Durations up to 48 hours
Pacemaker Detection ANSI/AAMI EC38-1998
A/D bit Resolution 0.5 µV
Sampling Rate 200 sps, 500 sps, 1000 sps
Mains Filter 50, 60 Hz, off (default=60Hz)
Muscle Filter 35, 60 Hz, off (default=off)
Baseline Filter 0.5 Hz, off (default=off)
FREQUENCY RANGE 2402-2480 MHZ
PEAK OUTPUT POWER -11dBm (EIRP)
EMISSION DESIGNATOR 864K F1D
RATED POWER 0 dBm
MODULATION GMSK