Hologic Myosure REACH 10-401FC Instrucciones De Uso página 4

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Please read all information carefully.
Description
The MyoSure Tissue Removal Device is a sterile,
disposable, hand-held tissue removal device used
to hysteroscopically remove intrauterine tissue. It is
connected via flexible drive cable to the Controller. A
foot pedal allows the user to control the tissue removal
device by turning the motor in the Controller on and off.
Refer to the following Table for the compatibility of the
MyoSure Tissue Removal Devices with the MyoSure
Controllers: The MyoSure Control Unit (10-500/10-550)
and the Fluent Fluid Management System (FLT-100):
Table 1
MyoSure Tissue
Compatible Controller(s)
Removal Device
Control Unit (10-500/10-550) or
LITE:
Fluent Fluid Management System
30-401LITE/30-403LITE
(FLT-100)
Control Unit (10-550) or
REACH:
Fluent Fluid Management System
10-401FC/10-403FC
(FLT-100)
XL for Fluent: Fluent Fluid Management System
50-601XL/50-603XL (FLT-100)
XL:
Control Unit (10-500/10-550)
50-501XL/50-503XL
Indications for Use
The MyoSure Tissue Removal System 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.
Patient Target Group
The MyoSure Tissue Removal System is intended for
use on women with submucosal fibroids, polyps and
retained products of conception. The MyoSure Tissue
Removal System is not appropriate for patients who are
or may be pregnant, or are exhibiting pelvic infection,
cervical malignancies or previously diagnosed with
uterine cancer.
Intended Clinical Benefits to Patient
To hysteroscopically resect and remove submucosal
fibroids, endometrial polyps, and retained products of
conception.
Intended User
The MyoSure Tissue Removal System is intended to
be used under control and guidance of an OB/GYN
physician or GYN physician or surgeon.
2
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:
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 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 uterine tissue
can be injured by improper use of the tissue removal
device. Use every available means to avoid such
injury.
• The use of other drive mechanism different than
the Control Unit (10-500/10-550) or Fluent Fluid
Management System (FLT-100) may result in a
failure of the device to operate or lead to patient or
physician injury. Refer to Table 1 for MyoSure Tissue
Removal Devices compatibility with the controllers.
• 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.
• For procedures performed using the Control Unit
(10-500/10-550) and a vacuum source, ensure
that the vacuum pressure is >200 mmHg before
commencing surgery.
• Do not use the MyoSure Tissue Removal Device to
resect tissue that is adjacent to an implant. When
resecting tissue in patients that have implants,
assure that:
•
MyoSure Tissue Removal System IFU
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.
the MyoSure Tissue Removal Device's cutting