Complied Standards List; Fcc Statement; Emc Guidance - Vive DMD1001 User Manual

COMPLIED STANDARDS LIST

Complied Standards List
Risk management
management to medical devices
Labeling
used with medical device labels, labelling and information to
be supplied. General requirements
User manual
provide information
General
equipment - Part 1: General requirements for basic safety and
Requirements for
essential performance
Safety
Electromagnetic
Part 1-2: General requirements for basic safety and essential
compatibility
performance - Collateral standard:Electromagnetic
compatibility - Requirements and tests
Performance
2-30: Particular requirements for the basic safety and
requirements and
essential performance of automated non-invasive
Clinical Investigation sphygmomanometers
automated sphygmomanometers
Software life-cycle
- Software life cycle processes
processes

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.
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ISO/EN 14971:2012 Medical devices — Application of risk
ISO/EN 15223-1:2012 Medical devices. Symbols to be
EN 1041: 2008 Medical equipment manufacturers to
IEC 60601-1: 2005+A1：2012 Medical electrical
IEC/EN 60601-1-2:2007 Medical electrical equipment -
IEC 80601-2-30:2009 Medical electrical equipment- Part
ANSI/AAMI SP10:2002/A2: 2008 Manual, electronic, or
IEC/EN 62304:2006+AC: 2008 Medical device software

EMC Guidance

1. MEDICAL ELECTRICAL EQUIPMENT needs special precautions
regarding EMC and needs to be installed and put into service
according to the EMC information provided in the ACCOMPANYING
DOCUMENTS
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)
EMC GUIDANCE
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