Cleaning And Sterilization; Resector Handpiece; Trivex System Control Unit And Footswitches; Fiber Optic Cable - Le Maitre TRIVEX Manuel D'utilisation

CLEANING AND STERILIZATION

RESECTOR HANDPIECE

Follow these steps after each procedure to sterilize the resector handpiece:
1. Dispose of the resector and tube set used during the procedure following standard protocols for disposal of biohazardous waste.
CAUTION: Resectors and tube sets used with the TRIVEX System are for single use only. Do not resterilize. Discard after use.
2. Disconnect the resector handpiece cable from the front panel. Screw the protective cap on to the connector end of the cable.
CAUTION: Do not disconnect the cable from the handpiece.
CAUTION: To prevent moisture from entering the handpiece cable during sterilization ensures that the protective cap is screwed on completely. Moisture
can damage the cable or handpiece connectors.
3. Set the suction to fully open by releasing the pinch valve on the suction tube.
Clean the unit thoroughly with soapy water by hand only. The unit may be immersed.
4.
CAUTION: Do not use ultrasonic cleaners or automated washers to clean the handpiece.
5. Clean the drain tube with a brush. Rinse the unit thoroughly with water. Do not use saline or solvents such as alcohol or acetone.
6. Thoroughly dry the unit using compressed air to evacuate water out of crevices.
7. Sterilize the handpiece using one of the following methods:
• Steam, pre-vacuum, wrapped at 270° F to 275° F (132° C to 135° C) for four minutes.
• Steam, gravity method, wrapped at 270° F to 275° F (132° C to 135° C) for ten minutes.
CAUTION: Do not cool the resector handpiece by immersing it in cold water.

TRIVEX SYSTEM CONTROL UNIT AND FOOTSWITCHES

The TRIVEX System control unit operates outside of the sterile field and does not require sterilization. Sterilization and/or disinfection procedures will
damage the product and void the warranty. Follow these steps after each procedure to clean the control unit:
1. Disconnect the TRIVEX System from the electrical source.
2. Wipe the console with a clean damp cloth and mild germicide or isopropyl alcohol.
CAUTION: Do not sterilize or immerse the TRIVEX System console in disinfectant.
Wipe the footswitches and footswitch cables with a clean damp cloth.

FIBER OPTIC CABLE

See the Fiber Optic Cable Instructions for Use (R2603) for proper cleaning and sterilization procedures.

TRIVEX SYSTEM ILLUMINATOR

See the TRIVEX System Illuminator Instructions for Use (R2596) for proper cleaning and sterilization procedures.

MAINTENANCE

ELECTRICAL INTERFERENCE

CAUTION: This equipment is designed and tested to minimize interference with other electrical equipment. However, if interference occurs with other equipment
it may be corrected by one or more of the following measures:
• Reorient or relocate this equipment, the other equipment, or both.
• Increase the separation between the pieces of equipment.
• Connect the pieces of equipment into different outlets or circuits.
• Consult a biomedical engineer.

ENVIRONMENTAL PROTECTION

CAUTION: This equipment contains electronic printed circuit assemblies. At the end of the useful life of the equipment it should be disposed of in accordance with
any applicable national or institutional related policy relating to obsolete electronic equipment.

PREVENTATIVE MAINTENANCE

Recommended Electrical Safety Checks
Three safety tests are conducted on each unit during factory acceptance testing:
• Dielectric Strength Test
• Ground Continuity Test
• Leakage Current Test
LeMaitre Vascular recommends that these tests be performed regularly to assure continued compliance with applicable safety requirements. These tests
should be conducted in accordance with specifications IEC 60601-1.
CAUTION: Electrical safety testing should be performed by a biomedical engineer or other qualified person.
WARNING: HIGH VOLTAGE is present during electrical safety testing. Exercise extreme caution to prevent personal injury from electrical shock, or damage to the
equipment. Ensure that only authorized personnel are in the test area during the tests.
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