User`s guide

36 | Dome Sx Display User’s Guide, 020-0931-00 Rev. F
EU Declaration of Conformity for Medical Application
A Declaration of Conformity has been filed for this product. For additional
copies of the Declaration of Conformity document, contact NDS Surgical
Imaging.
Dome S3 and Dome S6c digital flat-panel displays meet the essential health
and safety requirements of, is in conformity with, and the CE marking has
been applied according to the relevant EU Directives listed below, using the
relevant section of the following EU standards and other normative
documents;
EU EMC Directive 2004/108/EC
EU Electromagnetic Compatibility Directive
EN 60601-1-2
Medical Electrical Equipment
Collateral standard electromagnetic
compatibility requirements
EN 55011 Limits and methods of measurements for
radio interference characteristics of
industrial, scientific, and medical
equipment
IEC 1000-3-2 Harmonic emissions
IEC 1000-3-3 Voltage fluctuations/flicker emissions
IEC 1000-4-2 Electrostatic discharge requirements for
industrial process measurement and
control equipment
IEC 1000-4-3 Radiated electromagnetic field
requirements for industrial process
measurement and control equipment
IEC 1000-4-4 Electrically fast transients for industrial
process measurement and control
equipment
IEC 1000-4-5 Surge requirements
IEC 1000-4-11 Voltage variations/dips/interrupts
IEC 1000-4-6 Conducted immunity
IEC 1000-4-8 Magnetic field immunity
Conformance to the Medical Device
Directive 93/42/EEC
EN 60601-1:2006
Medical Electrical Equipment
Part 1: General requirements for safety