Envitec MySign s - Page 8

Pulse oximeter MySign
®
S
Essential Performance
Essential Performance is performance, the absence or degradation of which, would result in an
unacceptable risk, and includes the following functionalities:
• Accuracy of blood oxygen saturation (SpO2) measurement
• Accuracy of pulse rate measurement
• Alarm indication
• Alarm adjustment within safe limits and silence/pause
• Indication of measured results (saturation, pulse) and associated alarm limits on displays
8 066-07-1002197_GA_MySignS_FDA / 06.14