HoMedics HTD8216C Mode D'emploi page 9

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Calculated values of the indicators according to ISO80601-2-56-2012
Ear mode:
Bias
Standard deviation
Limits of agreement
Clinical repeatability (for all groups)
Forehead mode:
Bias
Standard deviation
Limits of agreement
Clinical repeatability (for all groups)
Forehead scan mode:
Bias
Standard deviation
Limits of agreement
Clinical repeatability (for all groups)
Safety classification of ME EQUIPMENT
Protection against electric shock
Degree of protection
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.
Group A1 Group A2
0.000 -0.097
0.175 0.154
0.349 0.308
0.057
Group A1 Group A2
-0.060 -0.083
0.170 0.144
0.340 0.288
0.108
Group A1 Group A2
-0.015 -0.063
0.173 0.167
0.345 0.334
0.064
Internally powered ME equipment
Type BF - applied part (the probe)
IP22
Continuous operation
GB | 9
Group B Group C
-0.046 -0.060
0.116 0.125
0.233 0.249
Group B Group C
-0.032 0.000
0.139 0.120
0.278 0.239
Group B Group C
-0.068 -0.090
0.135 0.125
0.269 0.250