Symbols Used On Labeling; Introduction, Indications For Use, And Contraindications; Introduction; Indications For Use - Hologic MyoSure Manuel D'utilisation

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Symbols Used On Labeling

Atmospheric Pressure Limitation
Authorized Representative in the European Community
Batch code
Lot number
Catalogue number
Part number or reorder number
Consult instructions for use
Contents
Earth ground
Equipotential terminal
Equipment classification
Type BF equipment
European Community Waste Electrical and Electronic
Equipment (WEEE) Directive 2002/96/EC
Follow instructions for use

Foot pedal

Foot pedal control
Fuse
Humidity Limitation
Manufacturer
Non-sterile
OFF
Main electrical power off.
ON
Main electrical power on.
Patient contact parts do not contain phthalate
Radio-frequency (RF) energy
(non-ionizing radiation)
Serial number
Sterilized using irradiation
Temperature Limitation
U.S. federal law restricts this device to sale by or on the
order of a physician
Use by
Watertight Equipment per IEC 60529
Per People's Republic of China Standard SJ/T 11364: The
product does not contain any hazardous substances and
is a green environmentally friendly product which can be
recycled anytime
Symbols Used On Labeling
Symbols used only on Tissue Removal Device
Do not re-use
Do not use if package is damaged
Do not resterilize
Sterilized using ethylene oxide
Introduction, Indications for Use,
Contraindications

Introduction

Read these instructions completely prior to using the
MyoSure Hysteroscopic Tissue Removal System.
The MyoSure Hysteroscopic Tissue Removal System is designed to meet
the requirements of intrauterine tissue removal. The system consists of
the following procedural components:
• Control Unit
• Tissue Removal Device (Single Use)
• Foot Pedal
A sterile, disposable, hand-held tissue removal device is used for tissue
removal. 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 off and on.
The MyoSure Hysteroscopic Tissue Removal System features many
performance and ease-of-use advantages, including:
• A simple user interface with only a power switch and
• A display that shows the time spent cutting and removing tissue.
The MyoSure Hysteroscopic Tissue Removal System is designed to be
used in operating room, ambulatory surgical center, and physician's
office environments. The gynecologist should be trained in diagnostic
and therapeutic hysteroscopy, resection, and removal of gynecological
tissue.

Indications for Use

The Myosure Hysteroscopic Tissue Removal System and Myosure
DEHP
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 Hysteroscopic 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, while the recommended maintenance procedures will
ensure optimal performance over years of reliable use. Of course, as
with any surgical instrument, there are important health and safety
considerations. These are listed below and highlighted within the text.

Warnings

• 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
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