Welch Allyn CP 150 12-lead resting electrocardiograph v.1.00.XX - User Manual - Manual (Page 55)

Item Specification
CAN/CSA C22.2 No. 601.1.4
CAN/CSA C22.2 No. 601.2.25 IEC/EN 60601-1-6
IEC/EN 60601-2-25 ***
IEC/EN 60601-2-51* (3x4 report format)
Standard connectivity
1 USB client
4 USB hosts
Connectivity with electronic
medical records
Through the Welch Allyn CardioPerfect workstation software
Electrodes Rigorously tested for conductivity, adhesion, and hypoallergenic qualities, and exceed
all AAMI standards
Power cable Meets or exceeds Type SJT.
Environmental operating
conditions
Temperature +10° C to +40° C (+50° F to +104° F)
Relative humidity 15 - 95% noncondensing (30 - 70% for printing)
Atmospheric air-pressure limits 700 - 1060 hPa
Environmental storage
conditions
Temperature -20° C to +50° C (-4° F to +122° F)
Relative humidity 15 - 95% noncondensing
Atmospheric air-pressure limits 700 - 1060 hPa
Protection against electric shock Class I, internally powered Type CF
Mode of operation Continuous
* If you print at a high gain setting, the waveform or calibration marks might be clipped. This clipping does not
comply with clause 51.103.1 of the IEC/EN 60601-2-51 standard. Use a lower gain setting to observe the full
waveform.
** Per AAMI EC11:1991/®)2007 Diagnostic Electrocardiographic Devices, Section 3.1.2.1 Disclosure of cautionary
information/ performance characteristics paragraph c) Accuracy of input signal reproduction, the manufacturer
shall disclose the methods used to establish overall system error and frequency response. Welch Allyn has used
methods A & D, as prescribed in section 3.2.7.2 and 4.2.7.2 of this same standard, to verify overall system error
and frequency response. Because of the sampling characteristics and the asynchronism between sample rate and
signal rate, digital ECG systems such as the CP 150 may produce a noticeable modulating effect from one cycle to
the next, particularly in pediatric recordings. This phenomenon is not physiologic.
Directions for use Specifications 51