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

Submucous myomas

Endometrial polyps

Retained products of conception

ContraindicationsTruClear™ disposable shavers are contraindicated for the following conditions:

Pregnancy

Pelvic infection

Cervical malignancy

Previously diagnosed endometrial cancer

General warnings

Contents are sterile unless package is opened or damaged. Visually inspect the package prior to use. Do not resterilize. For single use only. Discard any open, unused product. Do not use after the expiration date.

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.

Periodically irrigate the device to prevent accumulation of excised tissue in the surgical site.

Do not activate the device without clear visualization.

Keep the cutting window in the field of view while the device is active.

Operating the device inside the uterine cavity with no tissue contact may result in loss of uterine distension.

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

Ensure suction control is properly followed to maintain uterine distension when using the TruClear™ shavers and the TruClear™ handpiece.

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.

Failure to follow these Instructions for Use, or use of a damaged product, may result in residual risks to the patients, including: Infection, excessive bleeding, and carcinogen exposure.

Precautions

Hazards associated with reuse of this device include, but are not limited to, patient infection and/or device malfunction.

Prior to use, inspect the device to ensure it is not damaged. Do not use a damaged device.

Exercise care not to bend the distal end of the device or damage the cutting tip when inserting the device through the working channel of the hysteroscope.

Excessive leverage on the device does not improve cutting performance and, in extreme cases, may damage the device.

Discard the device if any component is cracked, worn, broken, or loose.

Direct contact of the turning cutting edge of the device with metal (e.g., sheath, hysteroscope, or other instruments) can cause damage to the device tip.

If any damage to the device should occur during use, stop using the device immediately.

Do not remove the end cap from the proximal end of the TruClear™ dense tissue shavers. The end cap is required for the device operation.

After use, this device may be a potential biohazard and should be handled in accordance with accepted medical practice and applicable local and national requirements.

In the event that a serious incident has occurred related to device use, immediately report the event to Covidien, the competent authorities, and any other regulators as required.

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

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