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Stellaris Elite Important Safety Information

Stellaris Elite Important Safety Information

Indications:

The Bausch + Lomb Stellaris Elite vision enhancement system is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. The Stellaris Elite vision enhancement system configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty.

Contraindications:

  • All Models: Use of accessories not designated by Bausch + Lomb for use with this equipment may result in serious permanent patient injury, adverse surgical outcome, or damage to the equipment.
  • Systems with Laser Module: Photocoagulation is not indicated for patients without pigmentation (albino eyes). In addition, Laser Indirect Ophthalmoscope (LIO) is not indicated for cases involving laser photocoagulation within the arcades.

Warnings:

  • All Systems:
    • Implantable defibrillators present a risk of injury if triggered by a fibrillatory event during intraocular surgery, due to involuntary motion by the patient. Patients being considered for intraocular procedures must be questioned to determine if they have such a device, and, if so, the defibrillator manufacturer must be consulted to determine the appropriate action.
    • Electromagnetic interaction between the phacoemulsification (phaco) handpiece and an implanted cardiac pacemaker is unlikely, but cannot be ruled out. Patients should be questioned to determine if they have such an implant, and, if so, the manufacturer of the implant should be consulted to determine the proper course of action.
  • Systems with Laser Module:
    • All support personnel who are present during laser treatment must wear appropriate laser protective eyewear.
    • The laser protective eyewear provided is not optimized for the aiming beam. DO NOT look directly into the aiming beam even with laser protective eyewear.
    • Never look directly into the fiber optic cable which delivers the aiming or treatment laser beam, with or without laser safety eyewear.
    • The use of unapproved delivery devices may cause inaccurate laser delivery which could result in serious permanent patient injury. Use only approved delivery devices.
  • When using the Vitesse handpiece for vitrectomy in the posterior segment of the eye:
    • Use only the Entry Site Alignment (ESA) devices provided with the Vitesse handpiece pack (yellow trocar caps). Do not use any ESA with metal components to avoid particulate in the eye.

This is not all you need to know. Systems with Laser Module: Misuse of the laser system may lead to dangerous situations and severe injuries. All Systems: See the appropriate Operator Manual for detailed directions, proper use, and full risk and safety information. See Vitesse handpiece pack Instructions for Use for detailed information on the use of the Vitesse handpiece.

CAUTION: Federal (U.S.) Law restricts this device to sale, by or on the order of a physician.