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AUTHORIZED COMPONENT
Adapter
Model: BLJ06L060100P-U
Input: AC 100-240V
50/60Hz 0.2A Max
Output: 6V 1A
FCC STATEMENT
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) this device may not cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause undesired operation.
Please use the authorized adapter.
Risk Management
EN ISO 14971:2019 / ISO 14971:2019 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 +A1:2013 Information supplied by the manufacturer of medical
devices
General Requirements
for Safety
EN 60601-1:2006+A1:2013+A12:2014 / 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: 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
IEC80601-2-30:2009 Medical electrical equipment - Part 2-30: Particular
requirements for the basic safety and essential performance of automated non-
invasive sphygmomanometers
Clinical Investigation
EN ISO 81060-2:2019/ISO 81060-2:2018, Non-invasive sphygmomanometers -
Part 2: Clinical validation of automated measurement type
Usability
EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013 Medical
electrical equipment - Part 1-6: General requirements for basic safety and
essential performance - Collateral standard: Usability IEC 62366-1:2015 Medical
devices - Part 1: Application of usability engineering to medical devices
Software life-cycle
processes
EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical device software
- Software life-cycle processes
Bio-compatibility
ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation
and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in
vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for
irritation and skin sensitization
COMPLIED STANDARDS LIST
