Direct Image AFX (Air Fluid Exchange) SSV® (ACS®) Lens

Safety Information

DIRECT CONTACT CHALAM SSV (ACS) LENSES:

Do not use a microfiber cloth, as over time these tend to collect dirt and dust which can damage the anti reflective coating on the lens.

Never use a device that shows any sign(s) of damage.

Failure to follow the point-of-use processing steps could adversely affect further decontamination steps.

Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the member state in which the user and/or patient is established.

A thorough, manual cleaning process is recommended. Corrosive cleaning agents (i.e. acids, alkalines, etc) are not recommended. Detergent cleaning agents with neutral ph are recommended.

Do not use detergents that contain any type of emollients.

Wiping the lens with a microfiber cloth will cause lens damage. Be sure to use only a soft, lint-free
cotton cloth.

Ensure the device is completely submerged in the disintectant solution for the entirity of the recommended or desired soak time. Do not allow the device to become unsubmerged from the disinfectant solution.

Colored rings may discolor when exposed to Sodium Hypochlorite or Glutaraldehyde. To avoid further degradation please follow only the disinfection procedures indicated for these products in instruction. This color change is purely cosmetic and will not affect the function of the lens.

Do not brush lens portion to avoid scratching. Use a soft, cotton cloth.

To avoid surface damage to contact lenses, NEVER clean the contact elements with alcohol, peroxide or acetone.

Do not use the lens when the contacting surface(s) show(s) any signs of damage.

Do not attempt to use the lens unless an adequate type and amount of coupling fluid is present between the cornea and the contacting lens surface.

Care should be taken to avoid excessive pressure on the cornea as it may affect aqueous dynamics.
Do not attempt to use the lens if, for any reason, the retinal image is unclear or unfocused.
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the member state in which the user and/or patient is established.

For use by trained personnel only.

Manufacturer details

Volk Optical INC.
7893 Enterprise Dr, Mentor
OH 44060 Mentor,
United States

+1 440-942-6161
volk@volk.com

Responsible person

Rudolf Riester GmbH
Bruckstrasse, 31
72417 Jungingen
Germany

+49747792700
pfister@riester.de