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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.
Transport/Storage Storage temperature: -4°F to 131°F (-20°C to 55°C)
condition: Relative humidity: 93%,
Atmospheric pressure: 70 Kpa - 106 Kpa
Dimension and Weight
Weight: .26 lbs (116g) (without batteries)
Size: 5.9” L x 3.7” W x 1.7” H (150mm x 95mm x 44mm)
Compliance
Item: Compliant with
Equipment classification:
Safety standards: EN 60601-1: 2006+A1:2013,
EN 60601-1-1-2: 2015
Type of protection: Internally powered equipment (on battery power)
Degree of protection: Non applied part
Front panel and
case labeling: EN ISO 15223-1:2016
Temperature: EN ISO 80601-2-56:2017
Home healthcare
environment: EN ISO 60601-1-11:2015
Calculated values of the indicators according to ISO 80601-2-56
Indicators: Calculated value
Clinical bias,
▲
cb: -0.027
Standard deviation, j: 0.14
Limits of agreement, LA:0.26
Clinical repeatability, r: 0.07
NOTE: The above value is calculated from clinical data of the 433 (Model HTD8818A).
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