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Datascope Passport - Mindray

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Performance Specifications Appendix<br />

ESU Protection: 3 Lead and 5 Lead ECG shall meets standard<br />

IEC 601-2-25, clause 36.202.7 for<br />

functionality following ESU energy exposure.<br />

The 12 Lead ECG function provides no ESU<br />

protection.<br />

Electro Surgical Unit Noise Suppression: Peak noise is less than ±<br />

2mV from ECG baseline when used with<br />

AAMI compatible cables. Noise level is<br />

unspecified when the monitor is used with HP<br />

cables. The 12 Lead ECG function provides<br />

no ESU protection or noise suppression.<br />

ESU Withstand: 3 Lead and 5 Lead ECG shall withstand ESU<br />

stress from a High Frequency Surgical Units<br />

operating at 300 Watts in cut mode and 100<br />

Watts on coagulate mode. The 12 Lead ECG<br />

function provides no ESU protection.<br />

Input Bias Current: < 100 nA per lead, excluding driven lead<br />

(ANSI/AAMI EC13-1992, 3.2.5 or ANSI/<br />

AAMI EC 11-1991 3.2.10).<br />

Input Signal Range: ± 5.0 mV, minimum<br />

DC Offset: ± 300 mV minimum (ANSI/AAMI EC13-<br />

1992, 3.2.9.1 or ANSI/AAMI EC 11-1991,<br />

3.2.3).<br />

Input Impedance: > 2.5 MΩ single ended at 10Hz per ANSI/<br />

AAMI EC13-1992, 3.2.9.2 or ANSI/AAMI<br />

EC11-1991, 3.2.9.<br />

Noise: Less than 30 µV p-p, referred to input, through<br />

shielded 51KΩ resistors in parallel with 47nF<br />

capacitors (ANSI/AAMI EC13-1992, 3.2.9.3<br />

or ANSI/AAMI EC 11-1991, 3.2.12.1).<br />

Overall System Error: 5% or 40uV, whichever is greater (ANSI/<br />

AAMI EC-13-1992, 3.2.9.8 or ANSI/AAMI<br />

EC 11-1991, 3.2.7.1)<br />

Gain Stability: Per ANSI/AAMI EC13-1992, 3.2.9.5 (d) or<br />

ANSI/AAMI EC 11-1991, 3.2.4.4.<br />

6 - 4 0070-10-0649-01 <strong>Passport</strong> 2®/<strong>Passport</strong> 2 LT Operating Instructions

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