FAQ
Problem Description
Symptom
Possible Cause/
Possible Solution
Error
Message
21 shows
• Relax for a moment and
then measure again.
•
The treatment of the measurement
failed.
Error
message
• EExx,shows on
the display.
• A calibration error
occurred
• Retake the measurement.
If the problem persists,
contact the retailer or our
customer service
department for further
assistance. Refer to the
warranty for contact
information and return
instructions.
Complied European Standards List
Risk management
ISO/EN 14971:2012 Medical devices — Application of risk management to medical devices
Labelling
EN 980 Symbols for use in the labelling of medical devices
User manual
EN 1041: 2008 Medical equipment manufacturers to provide information
General Requirements
for Safety
EN 60601-1: 2006 Medical electrical equipment - Part 1: General requirements for basic safety
and essential performance
IEC/EN 60601-1-11: 2010 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
IEC/EN 60601-1-2:2007 Medical electrical equipment -Part 1-2: General requirements for basic
safety and essential performance - Collateral standard: Electromagnetic compatibility-
Requirements and tests
Performance
requirements
EN 1060-1:1995+A2:2009 Non-invasive blood pressure
Part 1: General requirements
EN 1060-3:1997+A2:2009 Non-invasive blood pressure
Part 3: Supplementary requirements for electromechanical blood pressure measuring system
Clinical investigation
EN 1060-4: 2004 Automatic Blood Pressure Monitor overall system Interventional accuracy of the
testing process
Usability
IEC/EN 60601-1-6: 2010 Medical electrical equipment --
Part 1-6: General requirements for basic safety and essential performance - Collateral Standard:
Usability
IEC/EN 62366: 2007 Medical devices - Application of usability engineering to medical devices
Software life-cycle
processes
IEC/EN 62304:2006+AC: 2008 Medical device software
-
Software life cycle processes
