User's Manual

Complied Standards List
EN ISO 14971:2012 / ISO 14971:2007 Medical devices Application of risk management
to medical devices
EN 1041:2008 +A1:2013 Information supplied by the manufacturer of medical devices
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
EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General
require ments for basic safety and essential performance - Collateral standard:
Electromagnetic disturbances - Requirements and tests
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
Risk management
Labeling
User manual
General Requirements
for Safety
Electromagnetic
compatibility
Performance
Operating Frequency：2402 MHz – 2480 MHz
Type of Modulation: GFSK
Transmission power max. 4 dBm
Data transfer
requirements
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
IEC 80601-2-30:2009+A1:2013 Medical electrical equipment- Part 2-30: Particular
requirements for the basic safety and essential performance of automated non-invasive
sphygmomanometers
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COMPLIED STANDARDS LIST