Disclaimer; Care And Maintenance; Use Of Generic Products And Reuse Of Single-Use Consumables; Head Calibration Value And Flap Thickness - MORIA M2 Manual De Instrucciones

1 DISCLAIMER

1.1 CARE AND MAINTENANCE

The M2-M2SU 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 unauthorized 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 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 LASIK surgery. 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 head labeled 130 cuts on average a
160-micron flap:
• 130 microns is a dimension on the head that can be measured and which corresponds to a
distance from the cutting edge of the blade to the front plate of the head
• 160 microns is the average flap thickness that will be cut by this head, with variations around this
average value.
In the example above, the "incremental value" for a 130 head is 30 microns on average.
Head calibration value
90/110/130
2
MORIA #65013-F-02.2017
Incremental value
+30
Average flap thickness
120/140/160