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COMPLIANCE
Compliance with the European Directive 93/42/EEC for Medical Products
This device conforms to the following requirements: European Directive 93/42/EEC for Medical Products
act; Medical Products Act; European Standards for Electrical Equipment EN 60601-1 (General Safety
Provisions), EN 60601-1-2 and EN 55011 (Electromagnetic Compatibility); European Standards
pertaining to Non Invasive Blood Pressure Instruments EN 1060-1(General Requirements), EN 1060-3
(Supplementary Requirements for Electromechanical Blood Pressure Measuring Systems).
This is evidenced by the CE mark of conformity accompanied by the reference number of a designated
authority.
This device was designed for use by adults only.
Compliance with the Australian EMC Frame Work
This device conforms to the following requirements: EMC Emission Standard for Industrial, Scientific and
Medical Equipment AS/NZS 2064-1997, EMC Generic Immunity standard AS/NZS 4252.1-1994. This is
evidenced by the C-Tick label.
Environment for use
The device is for use in offices, sports facilities, and hospitals (waiting rooms), etc.
NOTE
This device does not have the function of automatic cycling measurement.
Therefore, a part of this device does not conform to IEC60601-2-30.