Direction For Use - Novartis Alcon Grieshaber Laureate WORLD PHACO SYSTEM Gebrauchsanweisung

LAUREATE® Anterior Vitrectomy Tip
1. Description and intended use
The LAUREATE® Anterior Vitrectomy Tip is intended for use with the ALCON® LAUREATE®
Anterior Vitrectomy Handpiece and only in combination with the ALCON® LAUREATE®
System. This combination serves for anterior vitrectomy in cataract surgery. The instru-
ments are ergonomically designed to provide maximum comfort.
The tip is provided sterile together with an aspiration tubing and an irrigating cannula.
All devices are intended for single-use.
2. Precautions and warnings
• The instrument may be used only by well trained physicians and personnel.
Caution: The vitrectomy tip Directions for Use are not intended to substitute for
the necessity of reading and understanding the LAUREATE® Operator's Manual.
The Operator's Manual, which is provided with the instrument, includes in-depth
material intended to familiarize the Operating Room Sta with the controls and
functions of the instrument.
• Federal (USA) law restricts this device to sale by or on the order of a physician.
• Do not use any instrument if the sterile package is damaged or the seal is broken
in any way.
• The instrument is a sterile single use device and shall not be reused. Alcon Grie-
shaber assumes no responsibility for complications that may arise as a result of the
reuse or improper use of the instrument.
450368B.indd 5
E N G L I S H
• Potential risk from reuse or reprocessing include: reduced vitreous cutting per-
formance, uid path obstruction, and foreign particle introduction into the eye.
• The instruments must be stored at a dry place at maximum temperature of 30°C
(86°F) and away from sunlight. Do not expose to organic solvents, ionizing radia-
tion or ultraviolet light.
• Do not use after the expiry date.
• If any instrument is received in defective condition, Alcon Grieshaber has to be
noti ed. Do not use damaged or defective instruments.
• Prior to use, the instrument must be thoroughly inspected for correct function and
damage.
• Good clinical practice dictates the testing for adequate irrigation and aspiration
ow prior to entering the eye. If stream of uid is weak or absent, good uidics
response will be jeopardized.
• Use appropriate ow parameters to avoid soft eye.
• Adhere to national regulations when disposing or recycling the product, its com-
ponents and its packaging.
3. Directions for use
Before use, perform the following steps to set up the probe:
Step One: Open pack containing vitrectomy tip, aspiration tubing and irrigating can-
nula and aseptically transfer contents to sterile eld.
5
22.01.2014 15:23:05