Directions For Use Symbols used on packaging Symbol P h g Meaning Authorized Representative in the European Community Catalogue Number Batch Code Not made with natural rubber latex Symbol M d Y i Meaning Allegro™ I/A Handpiece™ Manufacturer Non Sterile Caution Consult instructions for use Patents Pending 67-0070-01 Rev A Graphic Illustration may differ in design MST Allegro™ Instructions CAUTION: This instrument is packaged in a non-sterile condition. To ensure patient safety, handpiece the instrument carefully and protect it from damage. Do not use this instrument if it appears damaged in any manner. Do not attempt to alter or repair the instrument. Prior to initial and each subsequent use, wash, flush, rinse, dry, & sterilize the instrument. INTENDED USE The MST Allegro™ handpiece provides the user with a means to aspirate material, and supply irrigation fluid during cataract surgery. DIRECTIONS FOR USE The MST Allegro™ handpiece must be sterilized in a steam autoclave prior to each use. The handpiece and tip should not be assembled during autoclaving. Connection to the Phaco System 1. Follow the manufacturer’s instructions for priming the system. 2. Connect the female Luer to the aspiration port and the male Luer to the irrigation port of the I/A handpiece. 3. Insert the Allegro™ Single Use Silicone I/A tip onto the handpiece making sure that it is correctly engaged, as shown in the figures below. CAUTION: Only touch the white base. Twist the tip onto the handpiece using the white base finger tight. The recommended cleaning process for the Allegro™ system is as follows: 1. DURING THE PROCEDURE Immediately after use, soak the Allegro handpiece in distilled water. 2. POST PROCEDURE CLEANING This procedure describes the cleaning of the Allegro™ handpiece without the Allegro™ Single Use Silicone I/A tip attached to the handpiece. Part I: a. Fill a 10cc syringe with distilled water. b. Connect syringe to the handpiece irrigation port and expel the water. c. Disconnect the syringe and repeat steps a and b two more times. d. Repeat this same process for the handpiece aspiration port. Part II: a. Sonicate the handpiece in fresh DI water for 3 minutes. Part III: a. Flush both lumens of the handpiece with 10cc of air 3 times each. b. Dry the handpiece with clean lint-free cloth NOTE: To avoid damage due to incidental contact, the Allegro™ handpiece should be kept apart from other instruments during cleaning and sterilization. NOTE: When the Allegro™ handpiece will not be immediately sterilized, it is important to make sure that the instrument is clean and dry. Using a syringe free of water, force 10cc of air through the irrigation line to ensure the line is clear. Repeat this step twice to clear and dry the irrigation path. This same procedure should be followed for the aspiration path. STERILIZATION CAUTION: Do not sterilize prior to performing cleaning procedure described above. 1. Sterilize to your facility’s standard practice or to industry standards. 2. The following techniques, times and temperatures are recommended by MicroSurgical Technology: Gravity Displacement Pouched Unwrapped 132°C (270°F) 132°C (270°F ) 15 min 15 min 15 min dry time CAUTION: Never touch the silicone as that will twist /damage the tip and will result in leakage or lack of aspiration. PreVacuum Cycle Pouched Unwrapped 132°C (270°F) 132°C (270°F) 4 4 min 20 min dry min time MAINTENANCE The MST Allegro™ handpiece requires regular cleaning after each use. The MST Allegro™ handpiece must be sterilized before each use. The Allegro™ handpiece should be inspected for signs of damage or buildup of cortical material in the fluid pathways at least once per day of use. Patents Pending 4. Initiate irrigation fluid flow (following the manufacturer’s instructions) and verify fluid flow out of the irrigation ports. CLEANING The MST Allegro™ handpiece must be sterilized in a steam autoclave prior to each use. The handpiece and tip should not be assembled during autoclaving. CAUTION: Improper or inadequate cleaning may result in particulate matter adhering to the instrument and exfoliation into the surgical field. In addition, the function and life expectancy may become compromised. M MicroSurgical Technology Inc. 8415 154th Ave NE Redmond, WA USA 98052 Phone 425.861.4002 email: [email protected] GmbH P MDSS Schiffgraben 41 30175 Hannover, Germany C0473 67-0070-01 Rev A
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