4.7 Biological Hazard and Returns
The structure and the specifications of this device as well as the materials used for
manufacturing makes it easy to wipe and clean and therefore suitable to be used for various
applications in hospitals and other healthcare environments, where procedures for frequent
cleaning are specified.
However, normal use shall exclude biological contaminated environments, to prevent
spreading of infections. Therefore use of this device in such environments is at the exclusive
risk of Customer. In case this device is used where potential biological contamination cannot
be excluded.
Customer shall implement the decontamination process as defined in the latest edition of the
ANSI/AAMI ST35 standard on each single failed Product that is returned for servicing, repair,
reworking or failure investigation to Seller (or to the Authorized Service Provider). At least one
adhesive yellow label shall be attached on the top site of the package of returned Product and
accompanied by a declaration statement proving the Product has been successfully
decontaminated.
Returned Products that is not provided with such external decontamination label, and/or
whenever such declaration is missing, can be rejected by Seller (or by the Authorized Service
Provider) and shipped back at Customer expenses.
