katena K30-1440 Gebrauchsanweisung

Instructions for Use: Family of Vitrectomy Lenses and Products
Description: Family of Vitrectomy Lenses and Products includes these listed single use devices for use during
ophthalmic surgery. These are available either packaged together or separately.
Product Description
K30-1440 Plano Lens provides a view of the retina. 36° field of view with image magnification of 1.02X.
K30-1435 Magnifier Lens provides a view of the retina. 30° field of view with image magnification of 1.20X.
K30-1430 Bi-Concave Lens provides a view of the retina. 25° field of view with image magnification of 0.80X.
K30-1420 20 Degree Prism Lens for peripheral imaging of the retina. 36° field of view and image magnification
of 1.02X.
K30-1425 30 Degree Prism Lens for far peripheral imaging of the retina. 36° field of view with 1.02X image
magnification.
K30-1530 Suture Ring provides a stable platform to hold any of the vitreoretinal lenses.
K30-1535 Suture Ring with tabs provides a stable platform to hold any of the vitreoretinal lenses.
K30-1505 Forceps allow manipulation and placement of any of the vitreoretinal lenses.
K30-1450 Surgical Wide Field Lens produces an indirect wide field image of the retina. Image magnification of
0.42X and 155° field of view.
K30-1520 Surgical Wide Field Lens with Handle: the Surgical Wide Field Lens assembled with a handle.
Intended Use: The Family of Vitrectomy Lenses and Products allows visualization of the ocular fundus, vitreous and
retinal structures during vitrectomy surgery.
Usage Instructions:
1. Review all information in these Instructions for Use carefully before use.
2. The lenses and products are for use by qualified Ophthalmologists and Surgeons only.
3. Inspect packaging before use to ensure that sterile barrier is intact.
Caution: Do not use devices if not provided in original packaging, or if opened or damaged, as product
sterility could possibly be compromised.
4. Remove device from package and inspect for damage (such as scratches or sharp edges) before use.
Caution: Damaged devices should not be used, in order to avoid any harm to the ocular surface of the
patient.
5. Follow standard protocol for your facility when using these devices.
6. Dispose of properly after each use. These are single use, disposable devices and may not be re-used.
Warnings, Notes, and other Information to ensure Safety:
The Vitrectomy Lenses and Products are primarily used in hospitals or surgical centers. They are to be used only
by persons appropriately trained and qualified in the clinical and/or surgical use of such devices.
Caution: US Federal law restricts this device to sale by or on the order of a physician.
Caution: Procedures should be conducted with new devices only as reuse could transmit infection or
disease between patients.
Failure to comply with instructions or other information provided could result in injury to the patient.
Assessment by trained medical or otherwise qualified personnel is necessary and due care / caution is to be
exercised in cases of infection or the eye or ocular injury.
Specifications / Manufacturer's Information:
Devices are supplied sterile, via Ethylene Oxide.
Transport / storage / usage conditions: -20 to +60°C (-4 to +140°F)
Any alteration or misuse of the lenses voids the product warranty.
Katena Products, Inc reserves the right to update or alter the technical specifications at any time.
2797
Katena Products, Inc.
6 Campus Drive, Suite 310
Parsippany, NJ, 07054 USA
Phone: +1-973-989-1600
info@katena.com
IFU-004 Rev 6 2019-06
EN
Symbols Used in Labeling:
Caution, consult Instructions for Use
Sterilized using Ethylene Oxide
Do not use if package is damaged
Do not reuse
Do not resterilize
Manufacturer
For prescription use only
European Authorized Representative
"Use by" (expiration) date
Refer to Instructions for Use
European Representative:
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands