Electromagnetic Safety - Hologic MyoSure XL Notice D'utilisation

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• If the leakage current of the configured system exceeds the limits of IEC 60601-1-1, install an appropriately rated UL 2601-1/IEC 60601-1

approved isolation transformer and retest the system.

• The use of accessory equipment in the patient vicinity not complying with the equivalent medical safety requirements of this equipment

may lead to a reduced level of safety of the resulting system. The use of accessory equipment outside the patient vicinity not complying with

medical or otherwise appropriate safety requirements may lead to a reduced level of safety of the resulting system.

• Use of an accessory, transducer, or cable other than those specified by Hologic may result in increased emissions or decreased immunity of

the Fluent Fluid Management System or the MyoSure XL Tissue Removal Device for Fluent.

Precautions

Federal law restricts this device to sale by or on the order of a physician.

• The tissue removal device should be stored at room temperature, away from moisture and direct heat.

• Do not use after expiration date.

• Do not use the device if the sterile package is open or appears compromised. Do not use the device if damage is observed.

• To assure optimal performance, replace the tissue removal device after 2 hours of cutting time.

• The tissue removal device is intended for single use only. Do not re-sterilize. Discard tissue removal device assembly after use.

• Do not lubricate tissue removal device.

• Use of a reprocessed, single-use tissue removal device may permanently damage, impede performance, or cause failure of the Fluent Fluid

Management System. Use of such products may render any warranties null and void.

• DO NOT attempt to sharply bend the flexible drive cable in a diameter of less than 8 inches (20 centimeters). A sharply bent or kinked drive

cable may cause the Fluent Fluid Management System to overheat and stop. During a procedure, a minimum distance of 5 feet (1.5 meters)

should be maintained between the Fluent Fluid Management System and the tissue removal device to allow the drive cable to hang in a large

arc with no bends, loops, or kinks.

• DO NOT rotate the tissue removal device >180° if the tissue removal device is not running. The cutting window may open up which will lead to

the inability to maintain distension. If this situation occurs, tap the foot pedal once or twice to run the tissue removal device; the cutting

window will then close automatically.

• If it appears that the tissue removal device's cutter blade has stopped rotating during a procedure, check to ensure that the tissue removal

device is properly connected to the Fluent Fluid Management System, all cables are secure, and that the drive cable has not

wrapped into a loop.

• Exercise care when inserting or removing the device from the MyoSure Hysteroscope. Insertion and removal of the device should be performed

under direct visualization at all times.

• To avoid perforation, keep the device tip under direct visualization and exercise care at all times when maneuvering it or cutting tissue close to

the uterine wall. Never use the device tip as a probe or dissecting tool.

• Excessive bending of the device distal tip can cause the tissue removal device's cutter to come out of the cutting window. If such damage

occurs, replace the device immediately.

• Do not allow the rotating portion of the tissue removal device to touch any metallic object such as a hysteroscope or sheath. Damage to both

instruments is likely. Damage to the tissue removal device can range from a slight distortion or dulling of the cutting 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

tissue removal device is damaged, replace it immediately.

• Do not operate the tissue removal device in the open air for an extended period, as the lack of irrigation may cause the tissue removal device

to overheat and seize.

• Excessive leverage on the tissue removal device does not improve cutting performance and, in extreme cases, may result in wear, degradation,

and seizing of the inner assembly.

• Do not cool the tissue removal device by immersing it in cold water.

• 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.