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Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7
Manufacturer’s Declaration and Guidance . . . . . . . . . . . . . . . . 11-7
11.8.1 Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7
11.8.2 Sensor and Cable Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-14
11.8.3 Safety Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-14
Essential Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-17
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Low Saturation Methodology (Low Saturation Study Only)
Motion Methodology (Motion Study Only)
. . . . . . . . . . . . . . . . . . . . . . . A-2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Accuracy Results (Low Saturation)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-23
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-37
Summary of Contents for Nellcor Series
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