Precautions - Hologic MyoSure Manuel D'utilisation

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 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.
• Use only the MyoSure Control Unit to connect to the MyoSure 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 the 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 Tissue Removal Device to resect tissue that
is adjacent to an implant. When resecting tissue in patients that have
implants, assure that:
the MyoSure Tissue Removal Device's cutting window is facing away
•
(i.e., 180° opposite) the implant;
the visual field is clear;
•
the MyoSure Tissue Removal 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 MyoSure Tissue Removal Device's outflow tube to prevent a
•
loss of uterine distension;
disconnect the MyoSure Tissue Removal Device's drive cable from
•
the control box;
grasp the end of the MyoSure Tissue Removal 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's cutting window by manually
•
twisting the hemostat counterclockwise;
gently pull the MyoSure Tissue Removal Device into the
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hysteroscope to detach the MyoSure device 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, and any equipment used
with the MyoSure Tissue Removal System should be Type BF.
• If the leakage current of the configured system exceeds the limits of
IEC 60601-1, 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.
• The use of an accessory, transducer, or cable, other than
those specified by Hologic may result in increased emissions
or decreased immunity of the MyoSure Hysteroscopic Tissue
Removal System.

Precautions

U.S. Federal law restricts this device to sale by or on the
order of a physician.
• The MyoSure 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. Do not lubricate tissue removal device. Discard
tissue removal device assembly after use.
• Use of a reprocessed, single-use tissue removal device may
permanently damage, impede performance, or cause failure
of the MyoSure Hysteroscopic Tissue Removal 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 MyoSure Control Unit to
overheat and stop. During a procedure, a minimum distance
of 5 feet (1.5 meters) should be maintained between the
MyoSure Control Unit and the MyoSure 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 inability to maintain distension. If such
situation occurs, just 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 MyoSure Tissue Removal Device's cutter
blade has stopped rotating during a procedure, check to
ensure that all connections to the MyoSure Tissue Removal
Device and the MyoSure Control Unit (both mechanical and
electrical) are secure and that the drive cable has not wrapped
up into a loop.
• Exercise care when inserting or removing the device. 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 uterine wall. Never use the device
tip as a probe or dissecting tool.
• Exercise care when inserting or removing the device.
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.
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