Hologic MyoSure XL Instructions For Use Manual

Form ENG-0034-T01, Rev. 005

TITLE

DOCUMENT NUMBER

REV

TEXT, MYOSURE XL MODIFIED FOR

FLUENT, TEXT, EN OUS,

AW-15026-002

010

SIZE A

SHEET 1 OF 1

REV AUTHORED BY

DATE

S VAILLANCOURT

03/21/19

REV DRAFTED BY

DATE

S VAILLANCOURT

03/21/19

PROPRIETARY: This document contains
proprietary data of Hologic, Inc. No
disclosure, reproduction or use of any
part thereof may be made except by
written permission from Hologic.

REV. RELEASE DATE:

15 MAY 2019

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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).

ONLY

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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MyoSure® XL Tissue Removal Device for Fluent

• If the leakage current of the configured system exceeds the limits of IEC 60601-1-1, install an appropriately rated UL 2601-1/IEC 60601-1
approved isolation transformer and retest the system.

• The use of accessory equipment in the patient vicinity not complying with the equivalent medical safety requirements of this equipment
may lead to a reduced level of safety of the resulting system. The use of accessory equipment outside the patient vicinity not complying with
medical or otherwise appropriate safety requirements may lead to a reduced level of safety of the resulting system.

• Use of an accessory, transducer, or cable other than those specified by Hologic may result in increased emissions or decreased immunity of
the Fluent Fluid Management System or the MyoSure XL Tissue Removal Device for Fluent.

Precautions

Federal law restricts this device to sale by or on the order of a physician.

• The 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.

• To assure optimal performance, replace the tissue removal device after 2 hours of cutting time.

• The tissue removal device is intended for single use only. Do not re-sterilize. Discard tissue removal device assembly after use.

• Do not lubricate tissue removal device.

• Use of a reprocessed, single-use tissue removal device may permanently damage, impede performance, or cause failure of the Fluent Fluid
Management System. Use of such products may render any warranties null and void.

• DO NOT attempt to sharply bend the flexible drive cable in a diameter of less than 8 inches (20 centimeters). A sharply bent or kinked drive

cable may cause the Fluent Fluid Management System to overheat and stop. During a procedure, a minimum distance of 5 feet (1.5 meters)
should be maintained between the Fluent Fluid Management System and the tissue removal device to allow the drive cable to hang in a large
arc with no bends, loops, or kinks.

• DO NOT rotate the tissue removal device >180° if the tissue removal device is not running. The cutting window may open up which will lead to
the inability to maintain distension. If this situation occurs, tap the foot pedal once or twice to run the tissue removal device; the cutting
window will then close automatically.

• If it appears that the tissue removal device’s cutter blade has stopped rotating during a procedure, check to ensure that the tissue removal

device is properly connected to the Fluent Fluid Management System, all cables are secure, and that the drive cable has not
wrapped into a loop.

• Exercise care when inserting or removing the device from the MyoSure Hysteroscope. Insertion and removal of the device should be performed
under direct visualization at all times.

• To avoid perforation, keep the device tip under direct visualization and exercise care at all times when maneuvering it or cutting tissue close to

the uterine wall. Never use the device tip as a probe or dissecting tool.

• Excessive bending of the device distal tip can cause the tissue removal device’s cutter to come out of the cutting window. If such damage
occurs, replace the device immediately.

• Do not allow the rotating portion of the tissue removal device to touch any metallic object such as a hysteroscope or sheath. Damage to both

instruments is likely. Damage to the tissue removal device can range from a slight distortion or dulling of the cutting edge to actual fracture
of the tip in vivo. If such contact does occur, inspect the tip. If you find cracks, fractures, or dulling, or if you have any other reason to suspect a
tissue removal device is damaged, replace it immediately.

• Do not operate the tissue removal device in the open air for an extended period, as the lack of irrigation may cause the tissue removal device
to overheat and seize.

• Excessive leverage on the tissue removal device does not improve cutting performance and, in extreme cases, may result in wear, degradation,

and seizing of the inner assembly.

• Do not cool the tissue removal device by immersing it in cold water.

• Electrical safety testing should be performed by a biomedical engineer or other qualified person.

• This equipment contains electronic printed circuit assemblies. At the end of the useful life of the equipment it should be disposed of in
accordance with any applicable national or institutional related policy relating to obsolete electronic equipment.

Electromagnetic Safety

The MyoSure XL Tissue Removal Device for Fluent is only to be used with the Fluent Fluid Management System. The Fluent Fluid Management
System needs special precautions regarding electromagnetic safety.

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