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Calculated values of the indicators according to ISO 80601-2-56
Indicators
Clinical bias, rcb
Standard deviation, σj
Limits of agreement, LA
Clinical repeatability, σr
Note: the above value is calculated from clinical data of HTD8818A.
Safety classification of ME EQUIPMENT
Protection against electric shock
Applied part
Protection against harmful ingress of water
or particulate matter
Mode of operation
Note: Not intended to be sterilized. Not for use in an OXYGEN RICH ENVIRONMENT.
Calculated value
-0.027
0.14
0.26
0.07
Internally powered ME equipment
Non-Applied part
IP22
Continuous operation
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