Tesla TSL-HC-A310B, User Manual, Page: 13 / 202

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blood samples with a laboratory CO-
oximeter. The accuracy of the sensors in
comparison to the CO-oximeter samples
measured over the SpO2 range of 70-100%.
Accuracy data is calculated using the root-
mean-square (Arms value) for all subjects.
Only about two--thirds of pulse oximeter
measurements can be expected to fall within
±Arms of the value measured by a CO-
oximeter. A pulse simulator shall be used to
assess pulse rate accuracy. The measured
pul-se rate is compared to the preset pulse
rate value in the simulator. Accuracy data is
calculated using the root-mean--square
(Arms value) for all subjects.
2.4 Expected Service Life
Is dependent on:
• The expected service life of the medical
electronic equipment;
• The expected service life of parts or acce-
ssories shipped with the medical electronic
equipment;
• Where the shelf life is less than the expect-
ed service life, the shelf life of parts or acce-
ssories shipped with the medical electronic
equipment;