Performance Characteristics Appendix
19 - 6 0070- 0-0704-02 Passport V Operating Instructions
19.8 Performance Characteristics
19.8.1 ECG Specifications
Regulations
Complies with the following regulations:
• ANSI/AAMI EC11 / EC13:2001/2002*
• ANSI/AAMI EC57:1998 (R2003)
• IEC 60601-2-27:2005 / EN60601-2-27:2006
• IEC 60601-2-25:1993 + A1:1999 / EN60601-2-25:1995 + A1:1999
* Accuracy of input signal reproduction: Methods A & D were used, as prescribed in section 3.2.7.2 and 4.2.7.2 of
this standard, to establish overall system error and frequency response. Because of the sampling characteris-
tics and the asynchronism between sample rate and signal rate, the Passport V may produce a noticeable
modulating effect from one cycle to the next, particularly in pediatric recordings. * Heart Rate Meter Accu-
racy and Response to Irregular Rhythm: Ventricular bigeminy: 80 bpm; Slow alternating ventricular bigem-
iny: 60 bpm; Rapid alternating ventricular bigeminy: 120 bpm; Bidirectional systoles: 90 bpm. * Response
time to HR change: From 80 to 120 bpm: less than 11 s; From 80 to 40 bpm: less than 11 s * Time to alarm for
tachycardia: <11s (measured in accordance with EC 13 and IEC 60601-2-27)
ECG Function and Specifications
Measured Parameters:
•HR
•ST value
•PVCs
• Arrhythmia events
ST Unit
•mm
• The unit conversion of ST value: 10mm/mV
Lead Type (Optional 3- and 5-lead sets)
• 3-lead: displays I, II or III
• 5-lead: displays I, II, III, aVR, aVL, aVF, and V
Intelligent Detection of Lead Sets
• Automatic detection of 3- or 5-lead ECG lead when ECG leads are connected to the
patient.
Waveform Sweep Velocity
• 6.25mm/s, 12.5mm/s, 25.0mm/s, 50mm/s; its accuracy complies with 50.102.7 of
IEC60601-2-27:2005.
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