12.07.2015 Views

User manual in English - Humeca

User manual in English - Humeca

User manual in English - Humeca

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III. Service18- The Micrograft dermatome is guaranteed for two years,except for the blades. This guarantee implies free repair ofthe mach<strong>in</strong>e and accessories when used <strong>in</strong> a normal way. Ifproperly handled, replacement of the blades is onlynecessary after several years. They are coated with aceramic layer and can withstand thousands of cutt<strong>in</strong>gprocedures. Of course blunt blades can be replaced by newones.- The management system of <strong>Humeca</strong> for design, productionand sales has been certified accord<strong>in</strong>g to EN ISO13485:2003.- Accord<strong>in</strong>g to the European Medical Device Directory 93 / 42 /EEC the MEEK cutt<strong>in</strong>g mach<strong>in</strong>e come under the head ofclass I products.- The MEEK gauze is a Class I sterile product.- The CE-hallmark is <strong>in</strong>dicated on the bridge of the mach<strong>in</strong>eand on the package of the prefolded gauzes.- Do not use other than <strong>Humeca</strong> blades <strong>in</strong> the cutt<strong>in</strong>g mach<strong>in</strong>e.- Do not use MEEK gauzes and/or cork plates <strong>in</strong> case thepackage is damaged.- The manufacturer considers be<strong>in</strong>g only responsible for thesafety and performance of the MEEK cutt<strong>in</strong>g mach<strong>in</strong>e, if it isused <strong>in</strong> the way as described <strong>in</strong> this <strong>manual</strong>. Forreplacements only orig<strong>in</strong>al spare parts must be used.Replacements have to be carried out by the manufacturer orby one of his authorized local dealers.

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