GB
| 8
GB
| 9
Calculated values of the indicators according to ISO80601-2-56-2012
Ear mode:
Group A1
Group A2
Group B
Group C
Bias
0.000
-0.097
-0.046
-0.060
Standard deviation
0.175
0.154
0.116
0.125
Limits of agreement
0.349
0.308
0.233
0.249
Clinical repeatability (for all groups)
0.057
Forehead mode:
Group A1
Group A2
Group B
Group C
Bias
-0.060
-0.083
-0.032
0.000
Standard deviation
0.170
0.144
0.139
0.120
Limits of agreement
0.340
0.288
0.278
0.239
Clinical repeatability (for all groups)
0.108
Forehead scan mode:
Group A1
Group A2
Group B
Group C
Bias
-0.015
-0.063
-0.068
-0.090
Standard deviation
0.173
0.167
0.135
0.125
Limits of agreement
0.345
0.334
0.269
0.250
Clinical repeatability (for all groups)
0.064
Safety classification of ME EQUIPMENT
Protection against electric shock
Internally powered ME equipment
Degree of protection
Type BF - applied part (the probe)
Protection against harmful ingress of water
or particulate matter
IP22
Mode of operation
Continuous operation
Note: Not intended to be sterilized. Not for use in an OXYGEN RICH ENVIRONMENT.
