Disclaimer; Maintenance And Warranty; Use Of Generic Products And Reuse Of Single-Use Consumables; Head Calibration Value And Flap Thickness - MORIA One Use-Plus Benutzerhandbuch

1 DISCLAIMER

1.1 MAINTENANCE AND WARRANTY

The One Use-Plus system has been designed for optimal operation, provided that the recommendations
listed 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 sliding
characteristics. The dimensions and tolerances of the blade have been determined in consideration of the
dimensions and tolerances of the head of the keratome. MORIA's manufacturing and inspection procedures
guarantee there is no conflict in dimensions between head and blade, and that the blade 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 HEAD CALIBRATION VALUE AND FLAP THICKNESS

Flap thickness is a key factor for both LASIK and lamellar keratoplasty. Multiple parameters affect flap
thickness and standard deviation. Numerous scientific studies have demonstrated that flap thickness is
influenced by several patient-related factors such as keratometry (K) readings, corneal anatomy, preoperative
pachymetry and refraction, intraocular pressure (IOP), and also by surgery-related factors, such as corneal
hydration and the speed of the pass (when using manual microkeratomes).
Ultrasonic pachymetry measurements are not always accurate and reproducible, and results may also vary
with surgeons' techniques and calibration of the device. Thus, a MORIA One Use-Plus head labeled:
• "90" (SBK head) cuts, on average, a 100-micron flap with variations around this average.
• "130" cuts, on average, a 130-micron flap with variations around this average.
MORIA can only guarantee the dimensional characteristics of the head, not the surgical result.
For the EVOLUTION 3 and 3E consoles, please refer to the related instruction manuals (#65038, 65051,
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 #65040-F-02.2017