
14
EN
Calculated values of the indicators
according to ISO 80601-2-56
Forehead mode:
Group A1 Group A2
Group B
Group C
Bias
0.015
0.000
-0.042
-0.040
Standard Deviation
0.123
0.121
0.121
0.137
Limits of Agreement
0.245
0.243
0.243
0.274
Clinical Repeatability
(for All Group)
0.071
Note: the above value is calculated from clinical data of HTD8818A.
Safety classification of ME equipment
Protection against electric shock
Internally powered ME equipment
Applied part
Non Applied part
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
Summary of Contents for M340
Page 87: ......