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biodex 950-440 - Product Certifications and Classifications

biodex 950-440
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Balance System SD (with v4.X software) 7
Product Certifications and Classifications
The Balance System SD has received the following certifications, and falls within the
following classifications:
! ETL Listed Electrical Equipment, Laboratory Use; Part 1, General Requirements for Safety
conforms to UL 60601-1, CAN/CSA C22.2 No: 601-1-M90, IEC 60601-1, IEC 60601-1-4 and
IEC 60601-1-2 and CE Marked.
! FDA Class II Equipment.
! EC Certificate: EC # 4132458.
NOTE: Circuit diagrams for this product are provided in the Schematics section at the
back of this manual.
! Type B Applied Part.
! Electromagnetic Compatibility: This equipment complies with the Medical Equipment ICC
60601-2 EMC Standard.
Authorized European Community Representative:
Emergo Europe
Prinsessegracht 20
2514 AP, The Hague
The Netherlands

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