Novartis Alcon Grieshaber DSP Manual Del Usuario página 7

-- 450366.PDF, Backflush Handle DSP, J.2 -- State: RELEASED -- Printed on: 05-12-15 -
Advanced Backflush Handle DSP
1. Description and intended use
The GRIESHABER* Advanced Backflush Handles DSP are a family of Instruments for
fluid and gas handling in vitreoretinal surgery. They are used for extracting fluids,
internal drainage of sub retinal fluid, retinal fold manipulation (PVR, giant breaks,
retinotomies, translocation), simultaneous or sequential exchanges (fluid-air, air-gas,
fluid-gas, fluid-PFC, PFC-gas, etc.).
For a high comfort in the OR, they have been ergonomically designed and are sold
sterile (terminally sterilized by ethylene oxide) for single-use.
The Advanced Backflush Handles DSP are available with blunt or soft tip. They are
available in the following gauge sizes. Each gauge size is represented by color:
20 Gauge (0.9mm), yellow
23 Gauge (0.6mm), orange
25 Gauge (0.5mm), teal
27 Gauge (0.4mm), purple
2. Precautions and warnings
• Be cautious using soft tip instruments in combination with valved entry systems
(valved cannula). Soft tip may kink and be damaged during insertion of soft tip. To
prevent this, retract the instrument slightly as soon as the soft tip has passed the
valve of the cannula. This maneuver allows the soft tip to straighten up behind the
valve and then smoothly pass through the cannula. See picture 2.
E N G L I S H
• Familiarity and training associated with ophthalmic surgery is required before
attempting use of this device.
• 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
Grieshaber assumes no responsibility for complications which may arise as a result
of the reuse or improper usage of the instrument.
• Potential risk from reuse or reprocessing include: fluid path leaks or obstruction
resulting in reduced fluidics performance, and foreign particle or bacteria
introduction into the eye.
• The Instruments must be stored in a dark, dry place at maximum temperature of
30 °C (86°F).
• Do not use after the expiry date.
• If any instrument is received in defective condition, Alcon Grieshaber has to be
notified.
Do not use damaged or defective Instruments.
• Good clinical practice dictates the testing for adequate irrigation and aspiration
flow prior to entering the eye. If stream of fluid is weak or absent, good fluidics
response will be jeopardized.
• Use appropriate pressure supply to ensure a stable IOP.
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