Guidance And Manufacturer's Declaration - Omron M7 Intelli IT Instruction Manual

11. Guidance and Manufacturer's Declaration

•This blood pressure monitor 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.
•Hereby, OMRON HEALTHCARE Co., Ltd., declares that the radio
equipment type M7 Intelli IT (ALRU) is in compliance with Directive
2014/53/EU.
•The full text of the EU declaration of conformity is available at the
following internet address: www.omron-healthcare.com
•This OMRON product is produced under the strict quality system of
OMRON HEALTHCARE Co., Ltd., Japan. The Core component for
OMRON blood pressure monitors, which is the Pressure Sensor, is
produced in Japan.
•Notify the authorized representative of the manufacturer of any
serious incidents involving this product.
Applied Standards
EN ISO 15223-1:2016
EN 1041:2008+A1:2013
EN 1060-1:1995+A2:2009
EN 1060-3:1997+A2:2009
EN 60601-1:2006+A1:2013
EN 60601-1-2:2015
EN 60601-1-6:2010+A1:2015
EN 60601-1-11:2015
EN 80601-2-30:2010+A1:2015
EN 62304:2006+A1:2015
EN 62366-1:2015
EN ISO 10993-1:2009/AC:2010
EN55
EN ISO 10993-5:2009
EN ISO 10993-10:2013
EN ISO 13485:2016
EN ISO 14971:2012
EN ISO 81060-2:2014
EN 300 328 V2.2.2
EN 301 489-1 V2.2.3
EN 301 489-17 V3.2.4
EN 62479:2010
EN IEC 62368-1:2020+A11:2020
EN IEC 63000:2018