Medicel ACCUJECT DUAL ADT1500 Gebrauchsanweisung Seite 2

EN
ACCUJECT DUAL
1. Scope of application
These instructions for use apply to the following medical devices:
Reference number
ADT1500
ADT1600
ADT1800
ADT2000
ADT2100
ADT2200
ADT2400
ADT2600
ADT3000
2. Intended field of application
The suitability of the intraocular lens (IOL) in combination with the medical device (IOL injector)
must be tested and approved in advance by the intraocular lens manufacturer.
2.1 Intended use
Folding and injecting of an intraocular lens (IOL) during eye surgery.
2.2 Clinical benefit
IOL injector allows IOL implantation through small incisions.
3. Notes on safety
Warning
Using a damaged or non-sterile medical device can lead to infection / endophthalmitis in the patient.
Do not use the medical device if there are signs of damage to the medical device itself or to the sterile packaging.
Warning
The medical device must not be used after the expiry date. Use after the expiration date may result in
infection / endophthalmitis of the patient.
Warning
Touching the endothelium with the silicone cushion or IOL can damage the corneal endothelium.
Warning
Appropriate surgical technique is the responsibility of the individual surgeon. The surgeon has to assess the suitability of the respec-
tive procedure on the basis of his / her training and experience.
Warning
The medical device is intended for single use only. Reuse or inappropriate reprocessing may lead to serious adverse
effects on the health and safety of the patient.
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- Reuse may result in infection / endophthalmitis, TASS or allergic reaction due to cleaning residues.
- The performance of the medical device may be compromised. Heat or the cleaning process will destroy
performance properties (e.g. mechanical properties and gliding properties) of the medical device.
Warning
The medical device may be handled by healthcare professionals and applied to the patient by the surgeon. Use by unqualified
personnel could result in patient injury.
A patient-related, careful preoperative assessment, with well-founded clinical judgment and risk-benefit assessment, is the
ONLY
responsibility of the surgeon. U.S. federal law restricts the sale of this medical device to physicians or on the order of physicians.
Caution
In order to avoid capsule rupture, the IOL must be injected slowly and carefully into the eye.
Medicel AG
Dornierstrasse 11
TM
Top-Loaded
9423 Altenrhein T +41 71 727 10 50
Switzerland F +41 71 727 10 55
Product name
Accuject Dual 1.5-TL Injector
Accuject Dual 1.6-TL Injector
Accuject Dual 1.8-TL Injector
Accuject Dual 2.0-TL Injector
Accuject Dual 2.1-TL Injector
Accuject Dual 2.2-TL Injector
Accuject Dual 2.4-TL Injector
Accuject Dual 2.6-TL Injector
Accuject Dual 3.0-TL Injector
info@medicel.com
www.medicel.com 2