W & H Lisa, Инструкция по эксплуатации

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1. INTRODUCTION
1.1 SCOPE
The purpose of this user manual is to provide you with information about Lisa 517/522 sterilizers to
ensure:
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proper installation and set-up.
•
optimal use.
•
safe and reliable operation.
•
compliance with regular maintenance and servicing requirements.
NOTE: All drawings, images and texts contained in this manual are the property of the manufacturer.
All rights reserved. Even partial duplication of drawings, images or text is prohibited.
The information contained in this document is subject to change without notice.
1.2 FOREWORD
There are two types of users who may operate the sterilizer and who shall read this manual carefully:
Administrator
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 OPERATORS’ training and
the correct operation and maintenance of the equipment.
Operator
The person(s) who use(s) the sterilizer according to the ADMINISTRATOR’S instructions.
1.3 APPLICABLE EUROPEAN DIRECTIVES/NORMS
Lisa 517/522 sterilizers conform to the following European Directives:
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Medical Device Directive 93/42/CEE for devices class IIb, in accordance with rule 15 - Appendix IX
of the above directive.
•
Directive 97/23/CEE (Pressure Equipment Directive – PED) for every sterilization chamber
designed and manufactured in conformity to Annex I and to the procedure described in form
D1 annex III.
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Directive 2002/96/CEE (RAEE) for disposal of parts coming from electrical or electronic
parts.
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The sterilizer has been developed, produced and tested in accordance with the European
Norm relative to small water steam sterilizers EN13060, and with the applicable safety
norms (see Appendix 1).
In the enclosed documents, you will find the Declaration of Conformity and a Warranty Card spe-
cific to your sterilizer.
1.4 INTENDED USE
Lisa 517/522 sterilizers are fully automated bench top steam sterilizers that generate steam using electrical
heaters.
Lisa 517/522 sterilizers are used for medical purposes, e.g. in general medical practices, dental offices, fa-
cilities for personal hygiene and beauty care and veterinary practices. They are also used for materials and
equipment that is likely to be exposed to blood or body fluids, e.g. instruments used by beauty therapists,
tattooists, body piercers and hairdressers.
The types of loads that can be sterilized with Lisa sterilizers are described in Table 1 of the reference tech-
nical norm EN 13060. These loads include solid, porous, hollow loads type A and hollow loads type B, un-
wrapped, single wrapped and double wrapped.
Lisa sterilizers cannot be used to sterilize liquids or pharmaceutical products.