Precautions - Le Maitre TRIVEX Manuel D'utilisation

transformer and retest the system.
• In some cases, high voltage may persist after the power has been removed. Only personnel qualified to service electronic equipment should operate or
troubleshoot an "uncased" power supply.
• Dangerous voltages are present during leakage current testing. DO NOT TOUCH the TRIVEX System while power is applied.
• HIGH VOLTAGE (1500 VAC) is present during dielectric strength and Hi-Pot testing. Exercise extreme caution while operating the dielectric strength tester
or the Hi-Pot tester 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.
• To avoid fire hazard, use only fuses of the correct type, voltage rating, and current rating.
• The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the
resulting system. Consideration relating to the choice shall include:
• Use of the accessory in the patient vicinity.
• Evidence that the safety certification of the accessory has been performed in accordance to the appropriate IEC 60601 Standard.

PRECAUTIONS

• U.S. Federal law restricts this device to sale by or on the order of a physician.
• Prior to use, examine the device(s) for possible damage to assure proper functioning. If damaged, do not use.
• Verify that the resector handpiece and its cable are sterile.
• Verify that the Illuminator, Light Guide and adaptors are sterile.
• Check to ensure that the resector(s) required for the procedure are available.
• Verify that the Preoperative Setup has been successfully completed.
• Only LeMaitre Vascular Disposable TRIVEX Resector Kits can be used with the TRIVEX System. Resectors used with the TRIVEX System are for single use only.
Do not resterilize or lubricate the resectors. Dispose of the resectors after use.
• Use of reprocessed, single-use resectors may permanently damage, impede performance, or cause failure of your LeMaitre Vascular TRIVEX System. Use of
such products may render any warranties null and void.
• Make sure the wheels on the TRIVEX System roller base are locked to prevent the system from rolling during setup and use.
• As in conventional ambulatory phlebectomy procedures, bruising, hematoma, and hemosiderin deposits have been observed in clinical studies utilizing
the TRIVEX System.
• Disconnect power cord before cleaning the unit.
• Do not sterilize or immerse the TRIVEX System console in disinfectant.
• To prevent moisture from entering the handpiece cable during sterilization ensure that the protective cap is screwed on completely. Moisture can damage
the cable or handpiece connectors.
• Do not allow the rotating portion of any resector to touch any metallic object such as the illuminator. Damage to both instruments is likely. Damage to the
resector can range from a slight distortion or dulling of the resector edge to actual fracture of the tip in vivo. If such contact does occur, inspect the tip. If you
find cracks, fractures or dulling, or if you have any other reason to suspect a resector is damaged, replace it immediately.
• Excessive leverage on the resector does not improve cutting performance and, in extreme cases, may result in wear and degradation of the inner assembly.
• Do not cool the resector handpiece by immersing it in cold water.
• Do not operate the resector in the open air for an extended period.
• Use only the TRIVEX Light Source Adaptor (REF 7210375) with this system. Use of any other light source port adaptor may cause reduced light emission from
the fiber optic cable.
• The power switch must be turned off, and the power cord disconnected from the power source, before attempting to replace the lamp.
• Replace the lamp only with an appropriate LeMaitre Vascular lamp (REF 7210115) as specified for the TRIVEX System. Use of any other lamp will void the
warranty.
• Lamp may be very hot. Use protective eyewear and gloves when handling lamp.
• Do not leave the operating light cord without an Illuminator attached on the patient or surrounding materials. The light cord tip may reach a high
temperature due to the high intensity light.
• This unit complies with IEC 60601-1. However, the user must be aware that this does not necessarily ensure protection of the unit against interference from
other devices.
• Do not operate at line voltage other than those stipulated on the back of the unit.
• Ensure that the available mains voltage matches the data listed on the label attached to the back of the control unit. Incorrect voltage can cause errors or
malfunction, and may permanently harm the equipment.
• Handle the unit with care. If the unit is dropped or damaged in any way, it must be returned immediately for service.
• Electrical safety testing should be performed by a biomedical engineer or other qualified person.
• 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.
• This equipment is designed and tested to minimize interference with other electrical equipment. However, if interference occurs with other equipment it
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