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E Introduction Cautions Domain Surgical’s FMwand® Ferromagnetic Surgical System is a unique ferromagnetic surgical instrument designed to simultaneously and safely cut and coagulate soft tissue using pure thermal energy. The FMwand provides precise control of thermal effects and consistent hemostasis in a wide variety of tissue types. Since it does not use the patient as part of the electrical current path, the FMwand System does not require a grounding electrode pad. • Federal (US) law restricts this device to sale by or on the order of a physician. Indications for Use The FMwand Ferromagnetic Surgical System is indicated for cutting and coagulation of soft tissue. Contraindications • This device is not intended for incising bone. • This device is not intended for vessel sealing that requires pressure to coapt the vessel, with applied energy over time. • This device is not intended for contraceptive tubal ligation. • This manual and the equipment described within are for use only by qualified medical personnel trained in the surgical procedures to be performed. • Prior to initial use of the FMwand System, ensure that all package inserts, including warnings, precautions and instructions are read and understood. Precautions • The FMwand System and components should only be used by qualified medical personnel trained in the surgical procedures to be performed. • Take care when handling the handpiece to prevent possible damage to the tip. • Do not use abrasive materials or metal instruments to clean the wire loop tip. This can damage the tip and cause the device to fail to function as intended. Gauze moistened with water or saline is recommended for removing heavy coagulum. Important Information • Use the lowest power level and the shortest activation time necessary to achieve the desired surgical effect. • Prior to use of the FMwand System, ensure that all package inserts, including warnings, precautions, and instructions are read and understood. • Prior to use, carefully inspect the FMwand Handpiece for any defects. DO NOT USE if the packaging, cable insulation or the connector appear damaged. 4 FMwand® Ferromagnetic Surgical System