Declaration Of Conformity - HMM Diagnostics Smart LAB pressure Bedienungsanleitung

Performance requirements
Clinical investigation
Usability
Software life-cycle processes

Declaration of Conformity

This product is compliant with the EC Directives: -93/42/EC Annex V
This product is compliant with the EC Directives: -1999/5/EC
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 a distance d=3,3m away from the equipment.
Note: As indicated in Table above 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
Safety Statement
Thisproducthasbeenverifiedtoconformtothesafetycertificationinaccordancewith
thespecificationofENStandards:EN60950-1:2006+A11:2009+A1:2010+A12:2011
WEEE note
The WEEE (Waste Electrical and Electronic Equipment) Directive, that came into effect as
European law on 13th February 2003, led to a major change in the disposal of electrical
equipment.
62
EN ISO 81060-1:2012(new) Non-invasive
sphygmomanometers - Part 1: Requirements and test methods for non-
automated measurement type (ISO 81060-1:2007)
EN 1060-3:1997+A2:2009 Non-invasive blood pressure Part 3: Supplemen-
tary requirements for electromechanical blood pressure measuring system
EN 1060-4: 2004 Automatic Blood Pressure Monitor overall system Inter-
ventional accuracy of the testing process
EN 60601-1-6: 2010 Medical electrical equipment -- Part 1-6: General re-
quirements for basic safety and essential performance - Collateral Stan-
dard: Usability
EN 62366: 2007 Medical devices - Application of usability engineering to
medical devices
EN 62304:2006/AC: 2008 Medical device software -
Software life cycle processes