Operation and Maintenance Manual – Steam sterilizer mod. Matika
Rev. 05 of 01-12-2006 - C:\Documenti\Manuali di istruzione\Matika GB-R05.doc
Page 30 of 31
Via Don Luigi Sturzo n°6
42021 BARCO ( Reggio Emilia ) ITALY
Tel. 0039 ( 0 )522 / 875159
Fax 0039 ( 0 )522 / 875579
To
BARCO, …………
SUBJECT: TRACEABILITY OF THE AUTOCLAVES
IN COMPLIANCE WITH THE PROVISIONS ESTABLISHED BY DIRECTIVE 93/42/EEC
GOVERNING MEDICAL DEVICES IMPLEMENTED BY ITALY WITH LAW DECREE D.L. N° 46 OF
24.02.1997, REVERBERI S.R.L. IS OBLIGED TO BE ABLE TO TRACE ITS PRODUCTS THROUGH
TO THE END USER (PHYSICIANS, DENTAL STUDIOS, MEDICAL LABORATORIES).
THUS, THE PERSON IN CHARGE OF THE WAREHOUSE AND/OR THE DEALER SHALL
OBLIGATORILY KEEP THE TRANSPORT DOCUMENTS BEARING THE SERIAL NUMBERS OF
THE AUTOCLAVES IN THEIR FILES FOR AT LEAST 10 (TEN) YEARS. ALTERNATIVELY, THEY
SHALL KEEP A LIST OF THEIR END USER CUSTOMERS TO WHOM THE SERIAL NUMBERS OF
THE CONSIGNED AUTOCLAVES ARE ASSOCIATED.
IT MUST ALSO BE POSSIBLE TO TRACE THE AUTOCLAVES (THE SERIAL NUMBER OF THE
MACHINE MUST CORRESPOND TO THE END USER CUSTOMER) EVEN WHEN THEIR FINAL
DESTINATION CHANGES (AUTOCLAVES THAT CHANGE HANDS FROM ONE CUSTOMER TO
ANOTHER).
SHOULD REVERBERI S.R.L. BE PREVENTED FROM TRACING THE PRODUCT (TO HAVE IT
RETURNED TO THE COMPANY, FOR EXAMPLE) OWING TO FAILURE OF THE PERSON IN
CHARGE OF THE WAREHOUSE OR THE DEALER TO FULFILL THIS REQUIREMENT, IT SHALL
BE OBLIGED TO INFORM THE COMPETENT AUTHORITIES AND THE NOTIFIED BODY OF THIS
NON-PERFORMANCE AND RESERVES THE RIGHT TO CLAIM REIMBURSEMENT OF THE
DAMAGES DERIVING FROM FAILURE TO TRACE THE PRODUCT FROM THE PERSON IN
CHARGE OF THE WAREHOUSE AND/OR FROM THE DEALER IN QUESTION.
REVERBERI MANAGEMENT
WAREHOUSE OR DEALER’S REPRESENTATIVE
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SIGN FOR ACCEPTANCE AND RETURN TO REVERBERI