Disclaimer; Care And Maintenance; Use Of Generic Products And Reuse Of Single-Use Consumables; Creation Of An Epithelial Flap - MORIA Epi-K Benutzerhandbuch

1 DISCLAIMER

1.1 CARE AND MAINTENANCE

The Epi-K system has been designed for optimal operation, provided that the recommendations listed
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in this user manual are followed carefully. If, for any reasons, the system does not perform properly, have
it checked immediately by MORIA. In order to maintain the original performance of your microkeratome,
MORIA strongly recommends annual maintenance and servicing of all its reusable products.
As only MORIA and its agents are fully expert in MORIA products, servicing and maintenance must be carried
out by MORIA or its approved agents.
MORIA shall not be held liable for any malfunction or damage to the apparatus, poor results, or surgical
complications due to maintenance being having been carried out by an unqualified operator or third party.
Any such unauthorised intervention shall render the guarantee and any maintenance contract null and void.

1.2 USE OF GENERIC PRODUCTS AND REUSE OF SINGLE-USE CONSUMABLES

The materials used in the microkeratome blade, blade holder, and head have been selected for their
biocompatibility and sliding characteristics. The dimensions and tolerances of the separator have been
determined in consideration of the dimensions and tolerances of the head of the epikeratome. MORIA's
manufacturing and inspection procedures guarantee there is no conflict in dimensions between head and
separator, and that the separator will slide smoothly in the head.
Single-use devices should not be re-used. Doing so will negatively affect their clinical performance
and increase the potential for adverse events.
The reuse of single-use products, or the use of consumables other than those supplied by MORIA,
may entail serious surgical consequences for the patient and damage the microkeratome.
MORIA shall not be held liable in the event of a malfunction or damage to the microkeratome, poor results or
surgical complications due to the reuse of a single-use product or the use of consumables other than those
supplied by MORIA.
MORIA handpieces must only be connected to MORIA devices (console unit, heads, suction rings,
etc.).
All warranties become null and void if the microkeratome degrades or malfunctions due to such practices.

1.3 CREATION OF AN EPITHELIAL FLAP

Creation of an epithelial flap depends on a number of factors relating to the product (separator integrity, and
advance rate) as well as patient characteristics and surgical technique. MORIA strongly recommend that
surgeons attend an Epi-K™ training session to gain familiarity with the device and the technique. MORIA can
only guarantee the dimensional characteristics of the system, not the surgical result.
For the EVOLUTION 3E console with serial number below 5000, please refer to instruction manual #65051.
For the EVOLUTION 3E console with serial number 5000 and above, please refer to instruction manual
#65060/INTL.
The most recent version of this user guide and additional information on your keratome are available on the
MORIA website: http://www.moria-surgical.com.
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MORIA #65044-B-02.2017