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Required safety validation after integration of auxiliary equipment

The printer is equipped with interface(s) for connection to auxiliary equipment. If the printer will be connected to auxiliary equipment (by means of the provided interface), additional safety risk assessments are required and - as a result of which - a new CE Declaration of Conformity may be required for the complete machinery assembly. The system integrator is responsible for the safety of the machinery assembly, which shall comply to the essential health and safety requirements of the EU Machinery Directive (MD). In order to ensure such compliance a risk assessment must be carried out by the integrator, who may qualify as manufacturer of the assembly of machinery under the MD. Such risk assessment shall cover both the suitability of the constituent units for the safety of the assembly as a whole and the hazards resulting from the interfaces between the constituent units. By providing any interface to auxiliary equipment Canon Production Printing (CPP) does not act as system integrator or manufacturer of the assembly, comprising the printer with the connected auxiliary equipment.

The system integrator shall:

  1. draw up an instruction manual for the complete assembly of machinery according to the guidelines of the EU Machinery Directive (MD),

  2. carry out the appropriate conformity assessment procedure for the assembly of machinery according to the MD,

  3. affix a specific marking (for example a specific plate) to the assembly of machinery with the information required according to the MD, including the CE marking,

  4. draw up and sign a CE Declaration of Conformity for the assembly of machinery,

  5. compile a technical file for the assembly of machinery that must contain:

    • the results of the risk assessment

    • the design details of the interfaces (for example guards, linking conveyers, hoppers, feeders and electronic interface devices) between the assemblies

    • documentation about any modifications that have been made to the constituent units when incorporating the new modules into the assembly

    • the CE Declaration of Conformity for complete machines

    • the Declaration of Incorporation and the assembly instructions for partly completed machinery incorporated into the assembly of machinery