The Bausch + Lomb VITESSE® handpiece packs are intended for use with a Stellaris Elite® vision enhancement system to remove vitreous humor, lens tissue and other material from the posterior segment of the eye using ultrasound energy and aspiration during a typical or atypical surgery. VITESSE® handpiece packs are designed to be used with an appropriate Posterior or Combined Vitrectomy Pack, or Posterior or Combined Basic Pack, and appropriate accessories for posterior vitrectomy.

• Do not excessively flex the needle during use.
• If the handpiece fails to operate to commanded stroke length settings or loses efficiency during use, retune the handpiece.
• Exercise great care when operating near the retina or other sensitive structures within the eye.
• If needle port obstruction is suspected during use, use the reflux function (directed away from the retina or other eye structures) per the owner’s manual to attempt to clear material that may be blocking the port.
• Failure to follow priming, tuning, and retuning instructions may result in a reduction in the handpiece’s effectiveness.
• Exercise care when using the Single High reflux setting near the retina to minimize the risk of retinal damage.
• Bending of the needle can lead to needle damage and/or handpiece performance degradation.
• 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 product should only be used by a trained and registered physician.
• Only use this product with Bausch + Lomb products and Stellaris Elite^® vision enhancement systems. Use of this product with non-Bausch + Lomb products may affect system performance and create hazards.
• Do not use any item in this pack if received in an unsatisfactory manner.

• To avoid damage to handpiece internal components, do not submerge the front end of the handpiece body during priming and tuning.
• Do not allow needle to contact any hard surfaces during priming and tuning.

• If this product is reprocessed and/or reused, Bausch + Lomb cannot guarantee the functionality, material structure, or cleanliness or sterility of the product.
• Reuse could lead to illness, infection and/or injury to the patient of user and, in extreme incidents, death.
• This product is labeled as ‘single’ use which is defined as a device intended to be used once only for a single patient.