Made in Switzerland

SWITZERLAND DESCRIPTION The viscoJECTTM injection system permits, thanks to the viscoJECTTM hydraulics system, the implantation of foldable one-piece intraocular lenses through incisions of about 1.5 to 2.8 mm, depending on the viscoJECTTM model and operating technique used. With the viscoJECTTM injection system, the majority of all foldable, one-piece acrylic lenses with an optical diameter of up to 6.5 millimeters can be injected, provided that the safe injection of the lens using the particular viscoJECTTM injection system was validated in advance by the lens manufacturer according to ISO 11979. The viscoJECTTM injection system consists of three parts: 1. The reusable viscoJECTTM titanium injector (Fig. 1a, 1b) 2. The silicone tip 3. The sterile, viscoJECTTM-BIO or viscoJECTTM single-use cartridge (Fig. 2) The cartridge may only be used once and not resterilized/treated. Reuse or resterilization may reduce the product's performance, which can result in serious impairments to the patient's health and safety. Store cartridge set at room temperature. APPLICATION Folding and injecting of one-piece foldable lenses into the capsular bag or sulcus after extra-capsular cataract extraction. Three-piece foldable intraocular lenses are not suited for implantation using the viscoJECTTM injection system. TREATMENT ACCORDING TO EN ISO 17664 General principles: Before every use, all instruments must be cleaned, disinfected and sterilized; this applies particularly to the first use after delivery since all instruments are delivered unsterilized (cleaning and disinfection after removal of protective shipping packaging; sterilization). An effective cleaning and disinfection is an absolute necessity for effective sterilization. As part of your responsibility for the sterility of instruments during use, please ensure that only appropriate deviceand product-specific procedures for cleaning/ disinfection are used, that the devices used (disinfector, sterilizer) are regularly maintained and inspected and that the validated parameters are adhered to with every cycle. Only qualified personnel should perform the treatment. In addition, please observe the applicable legal regulations in your country as well as the hygiene regulations of the doctor's practice or hospital. This is especially true for the different guidelines regarding an effective inactivation of prions. CLEANING AND DISINFECTION Principles according to EN ISO 15883: For the cleaning and disinfection of instruments, a mechanical process (disinfector) should be used, if possible. Due to its clearly reduced effectiveness, a manual procedure – even when using an ultrasound bath – should only be used if a mechanical process is not available. The use of a manual cleaning and disinfection procedure must be guaranteed by an additional productand procedure-specific validation and is the user's responsibility. In both cases, pretreatment must be performed. PRETREATMENT Immediately after use (within no more than 1 hour), rough impurities must be removed from the products. To do so, use running water or a disinfectant solution; the disinfectant should be free of aldehyde (otherwise, possible fixing of contaminants), have a tested effectiveness (e.g., German Hygiene and Microbiology Society [DGHM], or FDA approval or CE marking), be suitable for instrument disinfection and be compatible with the instruments (see chapter "Material Durability"). For manual removal of impurities, only use a soft brush or a clean soft cloth that is only used for this purpose; never use metal brushes or steel wool. Please note that the disinfectant used in pretreatment is only for protecting persons and must not replace the disinfection step to be carried out later, after cleaning has been done. Check all instruments for visible contamination. Repeat the pretreatment if contamination is found. MACHINE CLEANING/DESINFECTION In selecting the disinfector, make sure that • the disinfector basically has a tested effectiveness (e.g. DGHM, or FDA approval or CE marking), • a tested program for thermal disinfection (at least 10 minutes at 93 °C) is used (with chemical disinfection there is the danger of disinfectant residue on the instruments), if possible, • the program used is suitable for the instruments and has sufficient rinsing cycles, • for washing down, only sterile or low-germ (max. 10 germs/ml) and low-endotoxin (max. 0.25 endotoxin units /ml) water (e.g. Aqua purificata) is used (EN 285, Appendix B), • the air used for drying is filtered and • the disinfector is regularly maintained and inspected. In selecting the cleansing agent used, make sure that • it is basically suitable for cleaning the instruments (e.g. contains no abrasive materials), • if no thermal disinfection is used, a suitable disinfectant with a tested effectiveness (e.g. DGHM, or FDA approval or CE marking) is also used and that it is compatible with the cleansing agent used and • the chemicals used are compatible with the instruments (see chapter "Material Durability"). The concentrations indicated by the manufacturer of the cleansing agent and, if necessary, of the disinfectant, must absolutely be complied with. Sequence: 1. Place the instruments in the disinfector. While doing so, make sure that the instruments do not touch each other. 2. Start the program. 3. After the end of the program, remove the instruments from the disinfector. 4. Inspect and pack the instruments as quickly as possible after removal (see "inspection," "maintenance" and "packing" sections, if necessary after additional drying in a clean place). The cleansing and disinfection device or other measures must ensure sufficient drying. INSPECTION AND TESTING Check all instruments after cleaning or cleaning/disinfection for corrosion, damaged surfaces, chipping and contamination and sift out damaged instruments. Instruments that are still dirty must be re-cleaned and disinfected. ENGLISH