Flaem SfigmoLife Pro, Руководство пользователя

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Complied European Standards List
EMC Guidance
COMPLIED EUROPEAN
STANDARDS LIST
46
EMC GUIDANCE
47
1) This equipment needs to be installed and put into
service in accordance with the information provided in the
user manual;
2) Wireless communications equipment such as wireless
home network devices, mobile phones, cordless
telephones and their base stations, walkie-talkies can
affect this equipment and should be kept at least a
distance d=3,3m away from the equipment.
(Note: As indicated in Table 6 of IEC 60601-1-2:2007 for
ME EQUIPMENT, a typical cell phone with a maximum
output power of 2 W yields d=3, 3m at an IMMUNITY
LEVEL of 3V/m)
General
Requirements for
Safety
Electromagnetic
compatibility
Performance
requirements
Clinical investigation
Usability
Software life-cycle
processes
EN ISO 14971:2012 Medical devices - Application of risk
management to medical devices
EN 980:2008 Symbols for use in the labelling of medical
devices
EN 1041:2008 Information supplied by the manufacturer of
medical devices
EN 60601-1:2006 Medical electrical equipment - Part 1:
General requirements for basic safety and essential
performance
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
IEC 80601-2-30:2009 Medical electrical equipment - Part
2-30: Particular requirements for the basic safety and
essential performance of automated noninvasive
sphygmomanometers
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
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
EN 1060-4:2004 Non-invasive sphygmomanometers - Part
4: Test procedures to determine the overall system accuracy of
automated non-invasive sphygmomanometers
EN 60601-1-6:2010 Medical electrical equipment - Part
1-6: General requirements for basic safety and essential
performance - Collateral standard: Usability
EN 62366:2008 Medical devices - Application of usability
engineering to medical devices
EN 62304:2006/AC: 2008 Medical device software -
Software life cycle processes
Risk management
Labeling
User manual