17
EN
date of purchase. Warranty for the cuff is 1 year from the date of purchase. The
warranty does not apply to batteries and damage caused by improper handling,
accidents, not following the operating instructions or self-maintained alterations
made to the device. The warranty is only valid upon presentation of the warranty
card with purchase date and stamp of trade organization.
COMPLIED STANDARDS LIST
Risk management
EN ISO 14971:2012 / ISO 14971:2007 Medical devices
-Application of risk management to medical devices
Labeling
EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical
devices. Symbols to be used with medical device labels,
labelling and information to be supplied. Part 1 : General
requirements
User manual
EN 1041:2008 Information supplied by the manufacturer of
medical devices
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
Electromagnetic 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: Electro-
magnetic 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 sphygmomanom-
eters - Part 3: Supplementary requirements for electro-
mechanical blood pressure measuring systems
IEC 80601-2-30:2009+A1:2013 Medical electrical equip-
ment- 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 accu-
racy of automated non-invasive sphygmomanometers
ISO 81060-2:2013 Non-invasive sphygmomanometers -
Part 2:Clinical validation of automated measurement type