Emc Guidance - inventum BDP421 Instruction Manual

Usability
Software life-cycle processes
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EMC guidance

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 at a distance d=3.3 m 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=3.3 m at an immunity level of 3 V/m)
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
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