User's Manual Part 5

8065751025 3.5
Constellation
®
Vision System
Constellation
®
Procedure Pak
The Constellation
®
Procedure Paks are available in three (3) procedural pak configurations:
Constellation
®
Vitrectomy Pak, Constellation
®
Phaco Pak, and Constellation
®
Combined
Procedure Pak. Each pak contains the sterile single-use supplies necessary to perform one
Posterior segment, Anterior segment, or Combined Procedure respectively. The Combined
Procedure covers both Anterior and Posterior segment procedures.
WARNINGS!
1. If any item in the pak is received in a defective condition, Alcon is to be notified immediately.
Do not use any of the contents if the sterile package is damaged in any way. In these cases,
please contact:
By Phone: By Mail:
In USA- [phone] Alcon, Inc.
Ask for Consumer Affairs Attention: Consumer Affairs Department
International [phone] 9965 Buffalo Speedway
Or contact local Alcon Representative Houston, TX 77054-1309, USA
Each pak is identified by a lot number which provides traceability and should be given to
Customer Service Department when discussing the pak.
2. Improper usage or assembly could result in a potentially hazardous condition for the patient.
Mismatch of consumable components and use of settings not specially adjusted for a
particular combination of consumable components may create a patient hazard.
3. Visually confirm that adequate infusion flow is occurring prior to attachment of the infusion
cannula to the eye.
4. Do not operate Vitrectomy probes in air. This could result in performance degradation and/or
potential hazard.
5. Replace Vitrectomy Probe if any of the following conditions are observed:
a. Excessive air bubbles are in the aspiration line.
b. Air bubbles are exiting the cutter port.
c. The cutter does not fully close or does not move when the probe is actuated.
d. The cutting port is not open when the probe is idle.
e. If a reduction of cutting capability or vacuum is observed during the surgical
procedure, stop immediately and replace the probe.
6. Minimize the light intensity and duration of exposure to the retina to reduce the risk of retinal
photic injury.
7. Use of incisions that are smaller than recommended during lens removal can lead to
mechanical and/or thermal damage to the eye tissue.