Measurement Accuracy
Cerebral Accuracy
Accuracy (Bias ± Precision) not determined outside the following ranges:
Large Sensors:
45% to 95%: -0.14 ± 3.05% at 1 SD
Medium Sensors:
48% to 92%: 0.05 ± 5.06% at 1 SD
Small Sensors:
50% to 90%: -0.01 ± 5.38% at 1 SD
Non-Cerebral Accuracy
Accuracy (Bias ± Precision) not determined outside the following ranges:
Large Sensors:
45% to 95%: 0.24 ± 5.17% at 1 SD
Medium Sensors:
53% to 88%: -0.03 ± 5.52% at 1 SD
Small Sensors:
66% to 96%: 0.03 ± 5.69% at 1 SD
Intended Environment
The Oximeter is intended to be used in the following environments: operating, exam/procedure
rooms, surgical recovery, critical care, emergency room, and long-term care.
Likely Misuse
Warning:
The Oximeter may be misused if used in the following environments:
•
Transport vehicle
•
Areas with flammable anesthetic gases
•
In or near MRI equipment
•
Outside the recommended temperature range
•
Outdoors or high humidity environments
Note:
The Oximeter is intended to be stationary, but may be moved intra-hospital via
cart or roll stand. It may also be carried by its handle when in non-operational
mode (Off).
PN 21-22-3000 Rev 07
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FORE-SIGHT ELITE User Manual
