MORIA Epi-K 65043 Manuel Utilisateur page 6

5 IMPORTANT INFORMATION
5.1 DESCRIPTION
The Epi-K epikeratome is used to create a corneal epithelial sheet during an Epi-LASIK procedure, prior to
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photoablation of the stroma with an excimer laser.
The Epi-K epikeratome is an automated, mechanical, linear epikeratome designed to create epithelial
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flaps. It has three components:
• a handpiece (#19342), containing two independent motors: one for advancement, and one for
oscillation.
• a metallic suction ring (#19389/-1, 19389/0, 19389/1, 19399/-1).
• a single use plastic head (#19390) encasing a pre-inserted separator.
The Epi-K epikeratome operates with the EVOLUTION 3E control unit (#19380).
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Please refer to user guide:
• #65051 (EVOLUTION 3E serial number below 5000)
• #65060 (EVOLUTION 3E serial number 5000 and above).
5.2 INDICATIONS
The Epi-K epikeratome is indicated for the cleavage of the epithelium from the Bowman's membrane in
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patients suitable for surface ablation with intact Bowman's membrane, and keratometries between 39 D and
48 D.
5.3 CONTRAINDICATIONS
• Patients who have had any previous surgery that could have damaged Bowman's membrane,
including but not limited to RK, PRK, LASEK, PTK, LASIK or Epi-LASIK.
• Patients with any pathologies such as pterygium, keratoconus, corneal ulcers, corneal scars etc.
that could have damaged Bowman's membrane.
• Patients who have had a foreign body in cornea.
5.4 WARNINGS
• Design of this medical device does not allow its reuse. Reusing this medical device affects
its clinical performance and exposes the patient to adverse events.
• Do not mix Epi-K
• Do not use disposable materials and/or components or a brand other than MORIA with the Epi-K
epikeratome.
• The heads must only be screwed on by hand. Dismantling should be done only with the provided
wrench (#19345C) or by hand. Never use any tools or other spanners. Incorrect assembly may
cause incomplete or uneven cuts due to lack of separator oscillation.
• Never pull on the cable from the handpiece and never hold the motor by its cable.
5.5 POTENTIAL ADVERSE EVENTS
As with any surgical procedure, there is risk involved. Epi-LASIK surgery requiring the use of an epikeratome
that cuts an epithelial flap, potential side effects of laser refractive surgery may include but are not limited to:
visual anomalies, dry eye and flap related complications (incomplete flap, buttonhole, epithelial defect, flap
dislocation, flap striae, wrinkles, etc.).
Inappropriate use, deterioration of epikeratome and/or non-respect to contraindications (§ 5.3) and warnings
(§ 5.4) expose patient at higher risk to adverse events.
Note: Additional surgery may be necessary to correct some of these potential adverse events.
heads with One Use-Plus heads.
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#65043-H-02.2017 MORIA
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