GRIESHABER® DSP Combined
Indications for Use: The CONSTELLATION® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery.
GRIESHABER® DSP instruments are a line of single-use vitreoretinal micro-instruments which are used in ophthalmic surgery, for cases either in the anterior or the posterior segment. The GRIESHABER® Advanced Backflush Handles DSP are a family of instruments for fluid and gas handling in vitreoretinal surgery.
Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.
Warnings and Precautions: CONSTELLATION® Vision System
- The disposables used in conjunction with ALCON® instrument products constitute a complete surgical system. Use of disposables and handpieces other than those manufactured by Alcon may affect system performance and create potential hazards.
- Attach only consumables supplied by Alcon to console and cassette luer fittings. Do not connect consumables to the patient's intravenous connections.
- Mismatch of consumable components and use of settings not specifically adjusted for a particular combination of consumable components may create a patient hazard.
- Vitreous traction has been known to create retinal tears and retinal detachments.
- The closed loop system of the CONSTELLATION® Vision System that adjusts IOP cannot replace the standard of care in judging IOP intraoperatively. If the surgeon believes that the IOP is not responding to the system settings and is dangerously high or low, this may represent a system failure. Note: To ensure proper IOP Compensation calibration, place infusion tubing and infusion cannula on a sterile draped tray at mid-cassette level during the priming cycle.
- Leaking sclerotomy may lead to post operative hypotony.
Warnings and Precautions: GRIESHABER® DSP Instruments
- Potential risk from reuse or reprocessing GRIESHABER® DSP instruments include: foreign particle introduction to the eye; reduced cutting or grasping performance; path leaks or obstruction resulting in reduced fluidics performance.
- Verify correct tip attachment, function and tip actuation before placing it into the eye for surgery.
- For light fiber instruments: Minimize light intensity and duration of exposure to the retina to reduce risk of retinal photic injury. The light fiber instruments are designed for use with an ALCON® illumination source.
- Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye. If stream of fluid is weak or absent, good fluidics response will be jeopardized.
- Use appropriate pressure supply to ensure a stable IOP.
- If unwanted tissue gets engaged to the aspiration port, it should be released by interrupting aspiration before moving the instrument.
Attention: Reference the device specific Directions for Use for a complete listing of indications, warnings, and precautions.