MORIA ONE 17204 Instrucciones Para El Uso página 4

#65092
Leading Innovations
in Ophthalmology
EN
Indication
The ONE single-use artificial chamber #17204 features to be used in combination with the single-use trephine (#17201Dxxx or #17202Dxxx)
®
for the preparation of the donor graft during corneal transplant procedures.
Device components
The Moria single-use artificial chamber (#17204) is composed of 3 pieces (Fig.1 and Fig.2):
• Artificial chamber base on which 2 ports with silicone tubing with a one-way stopcock on each. Either port may be used to inject or
aspirate viscoelastic, corneal storage medium, balanced salt solution, or air beneath the donor cornea
• Chamber cover for single-use trephine
• White screw to seal the chamber cover on the artificial chamber.
The most recent version of this document is available on Moria website (http://www.moria-surgical.com) via the restricted access
heading "Documentation/Library". Registration required.
Warning
• These instructions explain only how to use this medical device and do not describe the steps necessary to perform a corneal graft.
The surgical procedure remains the responsability of the surgeon experienced in performing corneal grafts.
• Check the integrity of the pouch.
• Check also the expiration date on the packaging.
• The ONE artificial chamber for single-use trephine is sterile and ready for use. Do not use it if the pouch in which it is packaged is
®
damaged.
• Design of this medical device does not allow its reuse. Reusing this medical device affects its clinical performances and exposes
the patient to adverse events.
• Only the chamber #17204 is compatible with the trephines #17201Dxxx and #17202Dxxx. Do not use the chamber #19182.
Directions
1/ Preparing the artifi cial chamber:
• Remove all the sterile parts of the artificial chamber from the pouches. Place the base of the chamber on the table and make sure it
is stable.
2/ Connecting the pressure system to the artifi cial chamber:
• Attach one tubing of the artificial chamber to the pressure system chosen (infusion set with syringe #19183 or Tubing set with bottle
#19181) filled with storage medium (Optisol GS
3/ Filling the artifi cial chamber:
• Open the two one-way stopcocks and fill the chamber.
• Then, close the two stopcocks.
4/ Positioning the graft on the artifi cial chamber:
RECOMMENDATION: Use grafts with a rim having a minimum diameter of 16 mm and a well-centered cornea.
• If desired, apply cohesive viscoelastic to the endothelium and to the top of the well of the artificial chamber.
• Open the irrigation system in order to obtain a continuous flow under the graft.
• Position the donor graft on the top of the well, endothelium downwards. Slightly lift the graft with forceps to remove the possible air
bubbles.
• Precisely center the graft on the well.
• Place the cover carefully in position (inserting the pin into the slot). Check that the graft is well centered.
• Seal the chamber by placing the white locking ring over the cover and turning clockwise to tighten.
5/ Establishing pressure:
• Set up the pressure into the system (at least 40 mmHg) with the syringe or by elevating the IV bottle to a height of at least 55cm/21.65
inches (from the BSS level in the drip chamber to the cornea).
• Close the stopcocks to maintain pressure. Check the pressure with a tonometer.
6/ Positioning the single-use trephine on the artifi cial chamber:
• Prepare the single-use trephine (please refer to the instructions for use #65085 for the trephine #17201Dxxx or #65086 for the trephine
#17202Dxxx).
• Press the single-use trephine on the chamber cover. (Fig.3)
• Trephining:
o Hold the trephine between the thumb and index finger on the grip area
o Slowly turn the collar clockwise to cause the blade to descend, until the desired depth.
Warning: The outcomes obtained depend on different parameters such as pressure, pachymetry, keratometry...
• To ensure optimal result the trephine should be turned on the cover to finalize the cut. (Fig.4)
7/ Removal of the graft and disposal of the devices:
• Remove the single-use trephine from the cover.
• Open the irrigation to maintain the graft on the well of the artificial chamber and prevent its collapse during the dismantling
• Unscrew the white screw and lift carefully the cover to grasp the graft.
• At the end of the surgical procedure, discard all the pieces of the artificial chamber and the trephine into an appropriate container
for disposal (according to the regulations in force).
Instructions for use for the ONE
chamber #17204 with single-use trephine
or similar) or physiologic solution (BSS or similar).
TM
single-use artifi cial
®
#65092-E-05.2023
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MORIA