W&H LINA MB17, Instructions For Use Manual

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Qualifications of the users Qualifications of the users Qualifications of the users Qualifications of the users
There are two types of users who may operate the sterilizer:
The Advanced user The Advanced user The Advanced user The Advanced user is the head of the clinic/practice, who is legally responsible for the efficiency of the hygiene protocol in place as
well as the sterilization process. He/she is also responsible for the USERS’ training and the correct operation and maintenance of the
equipment.
The Users
The Users The Users
The Users are the persons who use the sterilizer according to the ADVANCED USER’s instructions. They must be trained in operating
the sterilizer and in its safe use. Training must be regular and evidence of the understanding shall be recorded.
Conformity to European Standards and Directives Conformity to European Standards and Directives Conformity to European Standards and Directives Conformity to European Standards and Directives
Medical Device Directive 93/42/CEE for devices class IIb, in accordance with the Rule 15 – Appendix IX of the above
Directive.
Directive 97/23/CEE (PED – Pressure Equipment Directive) for every sterilization chamber designed and manufactured in
conformity to the Appendix 1 and to the procedure described in the form D1 Annex III.
Directive 2002/96/CEE (RAEE) for disposal of parts coming from electrical or electronic products.
European standard EN13060 (small water steam sterilizers).
See the Declaration of Conformity and the Warranty Card in the enclosed documents.
Introduction
Introduction Introduction
Introduction
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