Special Instructions - GEM FlowCOUPLER Instrucciones De Uso

SPECIAL INSTRUCTIONS

WARNINGS
• The Anastomotic Instrument, Vessel Measuring Gauge, COUPLER Forceps, and Sterilization Tray are
supplied non-sterile and must be sterilized prior to use
• The Anastomotic Instrument, Vessel Measuring Gauge, COUPLER Forceps, and Sterilization Tray should
be thoroughly inspected before use. Instruments that are damaged and/or in need of repair should not be
used.
LIMITATIONS ON REPROCESSING
No particular limitations
INSTRUCTIONS
Point of use: Rinse all instruments with water after use.
Preparation 1. Using a neutral (pH 7-10) detergent, wash each tool clean of all blood and debris after
for cleaning: every use. Scrub each tool with a soft brush. Pay particular attention to areas where
debris can accumulate.
CAUTION: Use of a cleaner with a pH greater than 10 will remove the anodized layer of
the Anastomotic Instrument and the Sterilization Tray.
2. Avoid use of any harsh material that can scratch or mar the surface of the instruments
3. Rinse the instruments thoroughly with running water. Apply a fine jet stream through the
hole in the Anastomotic Instrument knob end and press the release button while rinsing
to ensure that all surfaces of the instrument are cleaned.
Cleaning: Using an automated washing machine, clean at a temperature of 45º – 55º C, with a neutral
Automated (pH 7-10) cleaning solution for at least 10 minutes.
Cleaning: Place the instruments in an ultrasonic cleaner utilizing a neutral (pH 7-10) cleaning solution
Manual and clean ultrasonically for 15 minutes. Rinse the Anastomotic Instrument thoroughly again,
applying a fine jet stream of water through the hole in the Anastomotic Instrument knob
end.
Disinfection: (Optional) Using an automated washing machine, thermally disinfect the Instrument at a
temperature of 90º - 95º C, for a minimum of 5 minutes.
Drying: Following cleaning by either manual or automated cleaning methods ensure instruments are
fully dry. Do not exceed 100º C for 30 minutes.
Maintenance, • Ensure that all visible debris is removed to assure the continued quality of the
Inspection and instruments.
Testing: • Lubricate the cleaned Anastomotic Instrument (including knob) with a water-soluble
lubricant prior to sterilization. Failure to clean and lubricate the Anastomotic Instrument
as directed may result in instrument failure.
Packaging: Package the instruments using the appropriate method for the sterilization cycle chosen.
Sterilization: GRAVITY AUTOCLAVES
Temperature
250°F (121°C)
270°F (132°C)
PREVAC AUTOCLAVES
Temperature
270°F -273°F
(132°C - 134°C)
NOTE: It is recommended that each institution establish the efficacy of its sterilization
procedure.
Storage Recommended storage at controlled room temperature 20-25°C (68-77°F).
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Recommended Exposure Time (not Total Cycle Time)
15 minutes (wrapped or nonwrapped)
3 minutes (nonwrapped)/10 minutes (wrapped)
Recommended Exposure Time (not Total Cycle Time)
3-5 minutes (nonwrapped)
4-5 minutes (wrapped)