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Indications, Safety, and WarningsIndications for useThe TruClear™ hysteroscopic tissue removal system and the TruClear™ tissue shavers are intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as:

Submucous myomas

Endometrial polyps

Retained products conception

ContraindicationsThe TruClear™ hysteroscopic tissue removal system should not be used with pregnant patients or patients exhibiting pelvic infection, cervical malignancies, or previously diagnosed endometrial cancer.Warnings

It is the surgeon's responsibility to be familiar with the appropriate surgical techniques prior to use of this device.

Read these instructions completely prior to use.

Healthy uterine tissue can be injured by improper use of this device. Use every available means to avoid such injury.

Do not advance the hysteroscope forward in the uterine cavity when the tissue shaver is activated.

If visualization is lost during any point in the procedure, stop cutting immediately.

Irrigate the tissue shaver periodically to provide adequate cooling of the tissue shaver and to prevent accumulation of excised materials in the surgical site. Ensure that minimum suction of 150 mmg is flowing while the tissue shaver is active.

Danger: Risk of explosion if used in the presence of flammable anesthetics.

Do not use this device in oxygen rich environments (>25%).

Do not hang the fluid bags directly over the control unit.

High voltage (1500 VAC) is present during dielectric strength testing. Exercise extreme caution while operating the dielectric strength tester to prevent personal injury from electrical shock, or damage to the equipment. Ensure that only authorized personnel are in the test area during testing.

To prevent electric shock, do not remove the control unit cover.

To avoid the risk of electric shock this equipment must be connected only to a supply mains with protective earth.

If this unit is configured as part of a system, the entire system should be tested for compliance with IEC 60601-1.

If the leakage current of the configured system exceeds the limits of IEC 60601-1, install an appropriately rated IEC 60601-1 approved isolation transformer and retest the system.

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 with IEC 60601-1.

Do not use the handpiece continuously for more than 10 minutes at speeds greater than 1,500 rpm as the handpiece temperature may reach unsafe levels (i.e., > 41 C) after this point. After 10 minutes of continuous use, the handpiece must have a 30 minute cool-down period.

Consider preoperative imaging prior to the procedure to assess the patient for evidence and level of placental invasion of the myometrium. Removal of retained products of conception in the setting of known or suspected placenta acreta, placenta increta, or placenta percreta poses a risk of significant and potentially life threatening bleeding with the highest risk occurring in the immediate postpartum phase.

Stacking other electrical equipment or placing other electrical equipment near the system may affect EMC performance. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

The use of accessories, transducers, and cables, other than those specified, with the exception of transducers and cables sold by Medtronic as replacement parts for internal components, may result in increased emissions or decreased immunity of the TruClear™ hysteroscopic tissue removal system. It is anticipated that the equipotential cabling will be fabricated as required during the testing with lengths adjusted as necessary to assure good grounding.

Precautions

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

Prior to each use, inspect the device to ensure it is functioning properly and not damaged. Do not use a damaged device.

Only TruClear™ disposable tissue shavers can be used with the TruClear™ hysteroscopic tissue removal system. Do not lubricate tissue shavers.

Use of reprocessed, single-use tissue shavers may permanently damage, impede the performance, or cause failure of the TruClear™ hysteroscopic tissue removal system.

Do not allow the rotating portion of any tissue shaver to touch any metallic object such as a hysteroscope or sheath.
Damage to both instruments is likely. Damage to the tissue shaver 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 there are cracks, fractures, or dulling, or if there is any other reason to suspect a tissue shaver is damaged, replace it immediately.

Do not operate the handpiece in the open air for an extended period, as the lack of irrigation may cause the handpiece or a tissue shaver inserted into the handpiece to overheat and seize.

Excessive leverage on the tissue shaver does not improve cutting performance and, in extreme cases, may result in wear and degradation of the inner assembly.

As with any surgical instrument, do not place excessive force on the instrument. Excessive force can result in instrument failure.

Do not sterilize or immerse the TruClear™ control unit in disinfectant.

Do not cool the handpiece by immersing it in cold water.

Electrical safety testing should be performed by a biomedical engineer or other qualified person.

For more information, refer to the Instructions for Use (IFU).

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Customer Care Team