Product Manual
Table Of Contents
- Contents
- Introduction
- Maintenance
- Specifications
- Warranty
- Approved accessories
- EMC guidance and manufacturer’s declarations
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
IEC 60601-1-11 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 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