1 Safety Information............................................................................................................ 1
Intended use ..............................................................................................................................................1
Clinical Benefits and Performance Characteristics ....................................................................................1
Conventions in This Manual ......................................................................................................................2
Warnings and Safety Instructions ..............................................................................................................2
Cleaning, Disinfecting, Sterilizing ..............................................................................................................6
Precautions Before Use .......................................................................................................................... 10
2 Regulatory Information ............................................................................................... 11
Marking and Labeling Symbols ............................................................................................................... 11
Regulatory Information .......................................................................................................................... 12
Compliance with European and International Standards ...................................................................... 12
Classification in Accordance with EN/IEC 60601-1 ................................................................................. 13
Conformity with EN/IEC 60601-1-2 ........................................................................................................ 14
WiFi ........................................................................................................................................................ 14
Guidance and Manufacturer’s Declaration ............................................................................................ 15
Accessories ............................................................................................................................................. 17
Other Equipment .................................................................................................................................... 17
3 Technical Specification ................................................................................................. 18
Model ..................................................................................................................................................... 18
AS 200E Technical Specifications ............................................................................................................ 18
AS 200E Environmental Requirements ................................................................................................... 19
4 Contact Information ..................................................................................................... 20
Manufacturer ......................................................................................................................................... 20
Authorized Representatives ................................................................................................................... 20