Hologic MyoSure XL Instrucciones De Uso página 3

MyoSure XL Tissue Removal Device for Fluent
®
Instructions for Use
Please read all information carefully.
Description
The MyoSure XL Tissue Removal Device for Fluent is a sterile, hand-held tissue removal device used to remove intrauterine tissue. It is connected
via a flexible drive shaft to the Fluent Fluid Management System. A foot pedal allows the user to control the tissue removal device by turning the
motor in the Fluent Fluid Management System on and off.
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 XL Tissue Removal Device for Fluent is intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove
tissue such as: Submucous myomas, Endometrial Polyps, and Retained products of conception.
Contraindications
The MyoSure XL Tissue Removal Device for Fluent should not be used with pregnant patients or patients exhibiting pelvic infection, cervical
malignancies, or previously diagnosed uterine cancer.
Warnings and Precautions
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:
• Warning: 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 acreta, placenta increta or placenta percreta poses a risk of significant and potentially life threatening bleeding.
• Before using the MyoSure XL Tissue Removal Device for Fluent for the first time, please review all available product information.
• Before using the MyoSure XL Tissue Removal Device for Fluent, you should be experienced in hysteroscopic surgery with powered
instruments. Healthy uterine tissue can be injured by improper use of the tissue removal device. Use every available means to avoid such
injury.
• The MyoSure XL Tissue Removal Device for Fluent is only compatible with the Fluent Fluid Management System. Use of any other motorized
power source or fluid management system may fail to operate the device or lead to patient or physician injury.
• If visualization is lost at any point during a procedure, stop cutting immediately.
• Periodic irrigation of the tissue removal device tip is recommended to provide adequate cooling and to prevent accumulation of excised
materials in the surgical site.
DANGER: Risk of explosion if used in the presence of flammable anesthetics.
WARNING: Exercise extreme caution when resecting tissue in patients who have implants that extend into the uterine cavity.
• Do not use the MyoSure XL Tissue Removal Device for Fluent to resect tissue that is adjacent to an implant. When resecting tissue in patients
that have implants, assure that:
• the device's cutting window is facing away from (i.e., 180° opposite) the implant;
• the visual field is clear; and
• the device's cutting window is engaged in tissue and is moved away from the implant as tissue resection proceeds.
• In the event an implant becomes entangled with a MyoSure cutter, the following steps are recommended:
• cease cutting immediately;
• kink the device's outflow tube to prevent a loss of uterine distension;
• disconnect the device's drive cable from the Fluent Fluid Management System;
• grasp the end of the device drive cable with a hemostat or other clamping device;
• hold the drive cable hub and tissue removal device to prevent twisting;
• open the tissue removal device cutting window by manually twisting the hemostat; and
• gently pull the device into the hysteroscope to detach the MyoSure XL Tissue Removal Device for Fluent from the implant.
• If this unit is configured as part of a system, the entire system should be tested for compliance with IEC 60601-1-1.
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