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Datascope Passport - Mindray

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Appendix Performance Specifications<br />

6.2.10.2 CO 2 Respiration Performance Requirements<br />

6.2.11 SpO 2<br />

MediCO 2 Microstream ® (Only in monitors with serial numbers<br />

below TS10000.)<br />

Respiration Rate Range: 0 - 150 RPM.<br />

Respiration Rate Accuracy: ± 1 RPM from 0 to 40 RPM<br />

MiniMediCO 2 Microstream ® (Only in monitors with serial number<br />

TS10000 and higher.)<br />

Respiration Rate Range: 0 - 150 RPM.<br />

SpO2 is a non-invasive measurement of the functional oxygen saturation.<br />

The SPO2 function is in accordance with the requirements of EN 865.<br />

6.2.11.1 Masimo ® SpO 2 Performance Requirements<br />

± 2 RPM from 41 to 70 RPM<br />

± 3 RPM from 71 to 100 RPM<br />

± 5 RPM from 101 to 150 RPM<br />

Respiration Rate Accuracy: ± 1 RPM from 0 to 70 RPM<br />

Sensor Compatibility:<br />

Masimo: LNOP ® Series.<br />

± 2 RPM from 71 to 120 RPM<br />

± 3 RPM from 121 to 150 RPM<br />

Connector Type: 14-lead “Mini D-Ribbon” Receptacle (Masimo<br />

PC-12).<br />

Measurement Technique:<br />

Masimo Sensors: Masimo proprietary algorithm (SET).<br />

SpO 2 Accuracy Saturation during No Motion Conditions 1 :<br />

Adults / Pediatrics: 70% to 100% ± 2 5 , 0 to 69% unspecified.<br />

Neonates: 70% to 100% ± 3, 0% to 69% unspecified.<br />

SpO 2 Accuracy Saturation during Motion Conditions 6 :<br />

Adults / Pediatrics 2 : 70% to 100% ± 3, 0 to 69% unspecified.<br />

<strong>Passport</strong> 2®/<strong>Passport</strong> 2 LT Operating Instructions 0070-10-0649-01 6 - 17

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