User's Manual

1
INTRODUCTION
Thank you for purchasing this blood pressure monitor. Please read this manual thoroughly before use. Contact
your physician if you have any queries about your blood pressure.
This fully automatic instrument utilizes the non-invasive oscillometric method, which detects your blood
movement through you brachial artery, for measuring your blood pressure and pulse rate, and the result will
display on a digital panel. Without using a stethoscope, you can get the readings promptly and easily.
This device conforms to European Council Directive 93/42/EEC concerning medical devices. This is made
evident by the CE mark of conformity accompanies by the reference number of the designated authority.
This device complies with :
• EN ISO 81060 standard relating to non-invasive sphygmomanometers Part 1: Requirements and test methods
for non-automated measuremnt types and EN 1060 standard relating to non-invasive sphygmomanometers
Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems.
• EN 60601 standard relating to medical electrical equipment – Part 1-2: General requirements for basic safety
and essential performance and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests.
• EN 1060-4:2004 standard relating to non-invasive sphygmomanometers - Part 4: Test procedures to determine
the overall system accuracy of automated non-invasive sphygmomanometers.
• ISO 81060-2:2013 standard relating to non-Invasive sphygmomanometers - Part 2: Clinical validation of
automated measurement type.
• IEC 80601-2-30:2009+A1:2013 standard relating to medical electrical equipment - Part 2-30: Particular
requirements for the basic safety and essential performance of automated type non-invasive
sphygmomanometers.
Indication for Use
This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic
blood pressure of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped
around the upper arm. The patient is an intended operator.