12. After the test completes, disassemble the test equipment and slide the end of the
device tubing over the Flexiport
®
hose fitting barb.
13. Open the battery door and remove one of the batteries to power off the device.
Note Press the Power button to ensure that all power has been
removed from the device. The device can now be powered
on to begin using the device in normal mode.
Complied standards list
Item Standard
Risk management ISO/EN 14971 Medical devices — Application of risk
management to medical devices
Labeling ISO/EN 15223-1 Medical devices. Symbols to be used with
medical device labels, labeling and information to be
supplied. General requirements
User manual EN 1041 Medical equipment manufacturers to provide
information
General Requirements for Safety IEC 60601-1+A1 Medical electrical equipment - Part 1:
General requirements for basic safety and essential
performance
Electromagnetic compatibility IEC/EN 60601-1-2 Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests
Performance requirements and clinical investigation IEC 80601-2-30 Medical electrical equipment- Part 2-30:
Particular requirements for the basic safety and essential
performance of automated non-invasive
sphygmomanometers ISO81060-2 Non-invasive
sphygmomanometers — Part 2: Clinical validation of
automated measurement type
Software life-cycle processes IEC/EN 62304+AC: Medical device software - Software life
cycle processes
Usability IEC 62366 Medical devices - Application of usability
engineering to medical devices (IEC 62366) IEC 60601-1-6
Medical electrical equipment - Part 1 -6: General
requirements for basic safety and essential performance -
collateral standard : Usability
Directions for use Specifications 21
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