Directions For Use - Rayner Rayone Bedienungsanleitung

Preloaded Hydrophilic Acrylic IOL Injection System

Directions for Use

The RayOne preloaded injector should only be used for the placement of Rayner
IOLs into the eye.
To ensure optimum injection performance of the IOLs, the blister pack should be
allowed to equilibrate to a temperature of 21°C or above before use. The use of a
sodium hyaluronate based OVD is recommended. Insert the IOL into the eye within
3 minutes of closing the cartridge.
Use of RayOne
Completely peel back the foil lid of the first blister pack.
Fig 1
Carefully peel back the foil lid half way down the second blister pack.
Fig 2
Carefully drain the saline from the blister tray and peel off remaining
Fig 3
foil lid. Do not remove the injector from the blister tray. Do not wait more
than 3 minutes before adding OVD - Dehydration risk.
Insert the viscoelastic cannula into the opening marked with an arrow on
Fig 4
the cartridge and apply sufficient OVD to completely fill the cartridge.
Keep the injector in the tray and close the cartridge firmly together by
Fig 5
pushing the moving half of the cartridge (Labelled 2) against the fixed half until you
hear it click closed. Check both clips have "clicked" shut and secured the cartridge.
Gently lift out the injector from the tray.
Fig 6
Press the plunger in a slow and controlled manner. If excessive resistance
Fig 7
is felt this could indicate a blockage; stop and discard the injector and lens. In the
case of IOL rotation during ejection from the nozzle, gently rotate the injector in
the opposite direction to counteract any movement. Stop depressing the plunger
when the IOL exits the nozzle. Discard the injector after use.
Following implantation, irrigate/aspirate to eliminate any OVD residues from the
eye, especially behind the IOL.
IOL Placement
Ensure that the IOL is implanted in the capsular bag with the
correct anterior/posterior placement. Correct anterior/posterior
placement is achieved when the haptics sweep away from the optic
in a counter-clockwise direction (anterior view Figure 10). The IOL
can be dialed clockwise as is usual for posterior chamber IOLs. The
anterior continuous curvilinear capsulorhexis should be positioned
just covering the 360° anterior edge of the IOL optic by 0.5 to 1.0
mm. Correct rotational orientation for toric IOLs is achieved when
the IOL's axis marks (the lowest IOL power meridian) aligns with the
cornea's highest power meridian. The IOL axis marks are therefore
oriented in parallel to (or on) the steeper corneal meridian.
Note: The toric axis marks are on the anterior IOL surface.
Calculation of IOL Power
The surgeon should preoperatively determine the power of the IOL
to be implanted. Lens power calculation methods are described in
the following references:
1. Retzlaff J., Sanders D. & Kraff M. Lens Implant Power
Calculation, A Manual for Ophthalmologists & Biometrists -
Third Edition, 1990
2. Holladay J. A Three-part System For Refining Intraocular Lens
Power Calculations. J. Cataract Refract. Surg. V14:17-24, 1988
3. Holladay J. Standardizing Constants For Ultrasonic Biometry, Keratometry
& IOL Power Calculations. J. Cataract Refract. Surg. V23:1356-1370, 1997
4. Hoffer K. The Hoffer Q Formula: A Comparison of Theoretic and Regression
Formulas. J. Cataract Refract. Surg. V19:700-712, 1993; ERRATA, 20:677,
1994; ERRATA, 33:2, 2007
EN
Figure 10
IOL Haptic
Orientation