Calculated values of the indicators according to ISO 80601-2-56
Safety classi�ication of ME EQUIPMENT
Dimension and Weighting
Compliance
Item Compliant with
Weight (without batteries) 90g
Size
Equipment classi�ication Safety Standards: EN 60601-1: 2006+A1:2013, EN 60601-1-2: 2015
Type of protection Internally powered equipment (on battery power)
Degree of protection Non Applied part
Front panel and case labeling EN ISO15223-1:2016
Temperature EN ISO80601-2-56:2017
Home healthcare environment EN 60601-1-11:2015
Indicators Calculated value
Clinical bias,△cb -0.027
Standard deviation,σj 0.14
Limits of agreement, LA 0.26
Clinical repeatability, σr
Note: the above value is calculated from clinical data of HTD8818A.
Note: Not intended to be sterilized. Not for use in an OXYGEN RICH ENVIRONMENT
0.07
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
L:138mm X W:95mm X H:40mm
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