Hologic MyoSure LITE Instrucciones De Uso página 3

PLEASE READ ALL INFORMATION CAREFULLY.
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Description
The MyoSure Tissue Removal System consists of the following procedural
components:
• Control Unit
• Tissue Removal Device (Single Use)
• Foot Pedal
The sterile, disposable, hand-held tissue removal device is used to
hysteroscopically remove intrauterine tissue. It is connected via a flexible
drive shaft to a motorized control unit. A foot pedal allows the user to
control the tissue removal device by turning the motor in the control unit on
and off.
Indications for Use
The MyoSure Hysteroscopic Tissue Removal System and MyoSure Tissue
Removal Devices are 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 Tissue Removal System 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:
• Before using the MyoSure Tissue Removal System for the first time,
please review all available product information.
• Before using the MyoSure Tissue Removal System, you should be
experienced in hysteroscopic surgery with powered instruments. Healthy
MyoSure Hysteroscopic Tissue Removal System
®
MyoSure LITE Tissue Removal Device
Instructions for Use
uterine tissue can be injured by improper use of the tissue removal
device. Use every available means to avoid such injury.
• Use only the MyoSure Control Unit to connect to the MyoSure LITE Tissue
Removal Device. Use of any other drive mechanism may result in failure
of the device to operate 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.
• Ensure that vacuum pressure >200 mm Hg is available before
commencing surgery.
• 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 LITE Tissue Removal Device to resect tissue that
is adjacent to an implant. When resecting tissue in patients that have
implants, assure that:
the MyoSure LITE Tissue Removal Device's cutting window is facing
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away from (i.e., 180° opposite) the implant;
the visual field is clear; and
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the MyoSure LITE Tissue Removal Device's cutting window is engaged
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in tissue and is moved away from the implant as tissue resection
proceeds.
• 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.
• In the event an implant becomes entangled with a MyoSure cutter, the
following steps are recommended:
cease cutting immediately;
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kink the MyoSure LITE Tissue Removal Device's outflow tube to
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prevent a loss of uterine distension;
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