Contraindications - Hologic MyoSure Gebrauchsanleitung

Please read all information carefully.
Description
The sterile, non-powered, hand-actuated MyoSure MANUAL Tissue Removal Device is a MyoSure Hysteroscope-compatible device that collects
uterine tissue. The device is intended to be used in the office setting.
RX ONLY (U.S.) Federal law restricts this device to sale by or on the order of a physician pursuant to 21 CFR 801.109(b)(1).
Indications for Use
The MyoSure MANUAL Tissue Removal Device is intended for intrauterine use by a trained gynecologist to hysteroscopically resect and remove
tissue, including focal lesions such as endometrial polyps and retained products of conception.

Contraindications

The MyoSure MANUAL Tissue Removal Device should not be used with pregnant patients or patients exhibiting pelvic infection, cervical malignan-
cies, or previously diagnosed uterine cancer .
Warnings
The brief operating instructions in this guide will make the system easier to use. As with any surgical instrument, there are important health and
safety considerations. These are as follows:
• Please consider pre-operative imaging prior to the procedure to assess the patient for evidence of placental invasion of the myometrium. In
the immediate postpartum phase, removal of retained products of conception (RPOC) in the setting of known or suspected placenta accreta,
placenta increta or placenta percreta poses a risk of significant and potentially life threatening bleeding.
• Before using the MyoSure MANUAL Tissue Removal Device for the first time, please review all available product information.
• Before using the MyoSure MANUAL Tissue Removal Device, you should be experienced in hysteroscopic surgery. Healthy uterine tissue can be
injured by improper use of the tissue removal device. Use every available means to avoid such injury.
• If visualization is lost at any point during a procedure, stop cutting immediately
WARNING: Exercise extreme caution when resecting tissue in patients who have implants that extend into the uterine cavity.
• Do not use the MyoSure MANUAL Tissue Removal Device to resect tissue that is adjacent to a tubal implant or intrauterine device.
• However when resecting tissue in patients that have implants, assure that:
- The MyoSure MANUAL Tissue Removal Device's cutting window is facing away from (i.e., 180°opposite) the implant;
- The visual field is clear.
- The MyoSure MANUAL Tissue Removal Device's cutting window is engaged with tissue and is moved away from the implant as tissue
resection proceeds.
• In the event that an implant becomes entangled with a MyoSure cutter, the following steps are recommended:
1. Cease cutting immediately.
2. Make sure the window is open. If not, push the Trigger forward to the full open position.
3. Dislodge by rotating the Adjustment Knob in either direction.
4. Gently pull the MyoSure MANUAL Tissue Removal Device into the hysteroscope to detach the MyoSure device from the implant
Precautions
Federal law restricts this device to sale by or on the order of a physician.
• The MyoSure MANUAL 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.
• The MyoSure MANUAL Tissue Removal Device is intended for single use only. Do not re-sterilize. Do not lubricate Tissue Removal Device.
Discard Tissue Removal Device after use.
English
MyoSure MANUAL Tissue Removal Device
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Instructions for Use
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