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6. Specifications
EN
Notes:
• These specifications are subject to change without notice.
• In the clinical validation study, the 5th phase was used on 85 subjects for determination of diastolic blood
pressure.
• This device has not been validated for use on pregnant patients.
• This device fulfils the provisions of EC directive 93/42/EEC (Medical Device Directive).
• This device is designed according to the European Standard EN1060, Non-invasive
sphygmomanometers Part 1: General Requirements and Part 3: Supplementary
requirements for electromechanical blood pressure measuring systems.
• This OMRON device is produced under the strict quality system of OMRON HEALTHCARE
Co. Ltd., Japan. The core component for OMRON devices, which is the Pressure Sensor, is
produced in Japan.