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Safeloader® Instructions for Use
2-Component Autoloading System
These instructions for use are applicable for the Safeloader®
in combination with the following Medicel AG injectors:
MODEL
ACCUJECT™ 1.8 -1P
ACCUJECT™ 2.0 -1P
ACCUJECT™ 2.2 -1P
Description of the Safeloader®
The Safeloader® 2-Component Autoloading System is composed of an
ACCUJECT™ injector with integrated cartridge (manufacturer: Medicel AG)
and an autoloading container with a preloaded acrylic intraocular lens (IOL)
(see Fig. 1).
Using the Safeloader®
• Before implantation, check the lens package for the correct lens model
and dioptric power.
• Check also the expiration dates of the lens and the injector. The lens and
the injector should not be used after the indicated expiration dates.
• Before use, check the integrity of the sterile barrier system of the lens and
the injector. The IOL and the injector are sterile only if the sterile pouch
is undamaged.
• The blister packaging of the autoloading container and the injector should
be opened just before use by pulling the Tyvek® foil off. The autoloading
container and the injector must be removed from their packaging under
sterile conditions.
Attention: The outer blister packaging is not sterile.
• Do not use the product if the sterile barrier system is damaged or if liquid
is leaking from the container.
• Before use, the IOL should be warmed to temperatures between 18 °C
(operating room) and 36 °C (internal temperature of the eye) to avoid
damage to the IOL during implantation.
Attention: The IOL must not dehydrate! Hydrophilic acrylic IOLs should
be moistened in isotonic saline solution only.
Implantation
• The capsulorhexis diameter should be approximately 0.5 mm smaller
than the IOL optical diameter.
• Before implantation fill the anterior chamber and capsular bag ade-
quately with viscoelastic material in order to ensure a smooth and safe
IOL implantation.
• During implantation, ensure the correct anterior / posterior orientation
of the IOL: C-loop haptics are pointing from the optics in a counterclock-
wise direction (anterior view, see Fig. 2a). The IOL may be rotated clock-
wise to the appropriate axis, as is the usual case with posterior chamber
lenses. IOLs with cut-out haptic design are correctly oriented when one
marking appears on the top right and the other marking on the bottom
left (see Fig. 2b).
• Follow the instructions for use of the ACCUJECT™ injector and check its
suitability for use with reference to the IOL power. If in doubt consult
the manufacturer.
• The sterile OR team member removes the Safeloader from the proffered
packaging container (Fig. 3).
• Grasp the sealing foil on the autoloading container where the tab sticks
out and pull it off (Fig. 4).
• Open the ACCUJECT™ injector's cartridge completely (Fig. 5).
• Hold the ACCUJECT™ injector's handpiece in one hand and insert the car-
tridge wings into the two outer slots of the autoloading container (Fig. 6).
• Press the ACCUJECT™ injector down and hold it in this position while
rotating the injector clockwise to the stop (Fig. 7).
• Pull the ACCUJECT™ injector out of the autoloading container. One wing
of the cartridge exits the autoloading container from the middle slot
(Fig. 8a and 8b).
36396_BUCH_IFU_Safeloader.indb 4
en
LP no. (Medicel AG)
LP604540
LP604510
LP604530
• Check that the IOL has been correctly loaded. The IOL should be in the
center of the loading chamber between the silicone plunger and the
beginning of the cartridge tunnel (Fig. 9a and 9b). The position of the
cartridge wings in relation to each other must not be changed.
• Close the ACCUJECT™ injector's cartridge while at the same time apply-
ing slight pressure to the lens optic with the forceps. This ensures that
the lens folds in the correct direction. The lens is securely loaded and
ready for injection as soon as the "click-lock" mechanism has engaged
(Fig. 10a and 10b). The lens should be injected immediately after insertion
into the cartridge tunnel.*
• Press the injector plunger with the silicon plunger forward and push the
IOL into the conical tip of the cartridge.
Important: Pull the plunger back a few millimeters and then push for-
ward again. This step ensures that the IOL is always grasped correctly.*
• Insert the tip of the cartridge through the incision and push it over the
iris to the near edge of the pupil.*
• Press the plunger with the silicon plunger forward slowly in order to
push the lens forward.*
• Inject the lens slowly into the capsule bag and withdraw the injector
from the eye.*
Notes
The autoloading container is only compatible with the ACCUJECT™ injector
(1.8, 2.0, 2.2) with a yellow plunger made by Medicel AG.
There is a risk that an excessive amount of viscoelastic material in the region
of the loading chamber will cause the IOL to fold in the wrong direction
when the cartridge is closed. The IOL might then exit the nozzle wrong sided.
If difficulties should develop during the implantation, the implantation
must be stopped and a new product must be used.
Reprocessing
Reprocessing of the implant is strictly prohibited, since material changes,
for example, may cause serious complications and can be fatal.
Disclaimer
The manufacturer is not liable for the implantation method or the operative
technique used by the physican performing the procedure or for the selec-
tion of the IOL in relation to the patient or his condition.
* According to the ACCUJECT™ Instructions for Use GAAJ1P_rev06/31.07.2017.
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08.10.2018 17:20
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