User's Manual

8065751772 1.3
GENERAL INFORMATION
The Centurion
®
Vision System is indicated for emulsication, separation, irrigation, and
aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration
and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens
injection. The AutoSert
®
IOL Injector Handpiece is intended to deliver qualied AcrySof
®
intraocular lenses into the eye following cataract removal.
The AutoSert
®
IOL Injector Handpiece achieves the functionality of injection of intraocular
lenses. The AutoSert
®
IOL Injector Handpiece is indicated for use with AcrySof
®
lenses SN60WF,
SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof
®
lenses that are specically
indicated for use with this inserter, as indicated in the approved labeling of those lenses.
The Centurion
®
Vision System , including accessories approved by Alcon, constitutes a complete
surgical system and is intended exclusively for use by licensed ophthalmic surgeons and
their surgical teams. These surgical teams are experienced at conducting phacoemulsication
procedures in a properly maintained surgical environment (qualied personnel, availability of
backup equipment) and are familiar with the operation of the equipment used as outlined in
operator's manuals and directions for use (setup/checkout procedures to be completed before
the surgical procedure; processing of reusable devices; maintenance; etc.).
Patient selection for use with the Centurion
®
Vision System (such as age, ophthalmic
pathology, and other factors) is determined by the surgeon. The general patient age can range
from newborn to geriatric, although there have been studies that have identied the mean age
of patients that underwent cataract surgery was 72.32 yrs - men and 74.89 yrs - women.
1
Intended Use Environments
The Centurion
®
Vision System is intended for use in hospitals and ambulatory surgery centers.
Phaco Handpiece Note
Throughout the rest of this manual the CENTURION
®
OZil
®
handpiece and the INFINITI
®
OZil
®
handpiece will be referred to as phaco handpieces, unless one or the other must be
referred to exclusively.
Trademark Note
A button, mode, or step labeled OZil
®
, AutoSert
®
, or UltraChop refers to a display screen
control used with a phaco handpiece, INTREPID
®
AutoSert
®
IOL injector, or ALCON
®
UltraChopper
®
tip, respectively.
Abbreviation Descriptions
Many of the abbreviations used in this manual and on the Centurion
®
Vision System are
described in Table 1-x. Icons are identied in Figure 1-x.
Accessory Equipment
Accessory equipment connected to or used with this equipment must be certied according
to the respective IEC Standard (e.g., IEC 60950-1 for data processing equipment, and IEC
60601-1 for medical equipment). Furthermore, all congurations shall comply with clause 16
of IEC 60601-1:2005 (as amended). Anyone connecting additional equipment or otherwise
causing a different system conguration than provided by Alcon is responsible for continued
compliance to the requirements of clause 16 of IEC 60601-1:2005 (as amended). If in doubt,
consult the Technical Services department or your local Alcon representative.
Follow local governing ordinances and recycling plans regarding disposal or recycling of
device components and packaging.
1. “Age and sex prole of patients having cataract surgery between 1986 and 2003”
Philip O'Reilly, FRCSI (Ophth), U. Mahmound, FRCOphth, P. Hayes, FRCOphth, P. Tormey, FRCOphth, S. Beatty, MD.
Journal of Cataract Refractive Surgery 2005; 31:2162-2166