Passport® - Mindray

Performance Characteristics Appendix
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 characteristics
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 Accuracy
and Response to Irregular Rhythm: Ventricular bigeminy: 80 bpm; Slow alternating ventricular bigeminy:
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: