User Manual

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Blood Pressure Monitor
General
requirements
for safety
• EN 60601-1:2006+A1:2013/ IEC
60601-1:2005+A1:2012 Medical electrical
equipment - Part 1: General requirements for basic
safety and essential performance
• EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical
electrical equipment - Part 1-11: General
requirements for basic safety and essential
performance - Collateral standard: Requirements for
medical electrical equipment and medical electrical
systems used in the home healthcare environment
Electomagnetic
compatibility
• EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical
electrical equipment - Part 1-2: General
requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
disturbances - Requirements and tests
Performance
requirements
• EN ISO 81060-1:2012 Non-invasive
sphygmomanometers - Part 1: Requirements and
test methods for non-automated measurement
type
• EN 1060-3:1997+A2:2009 Non-invasive
sphygmomanometers - Part 3: Supplementary
requirements for electro-mechanical blood pressure
measuring systems
• IEC 80601-2-30:2018 Medical electrical equipment-
Part 2-30: Particular requirements for the basic
safety and essential performance of automated
non-invasive sphygmomanometers
Clinical
investigation
• EN 1060-4:2004 Non-invasive sphygmomanometers
- Part 4: Test procedures to determine the overall
system accuracy of automated non-invasive
sphygmomanometers
• ISO 81060-2:2013 Non-invasive
sphygmomanometers - Part 2: Clinical validation of
automated measurement type