Electromagnetic Safety - Hologic MyoSure Manuel D'instructions

ENGLISH
grasp the end of the MyoSure Tissue Removal Device drive cable with
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a hemostat or other clamping device;
hold the drive cable hub and tissue removal device to prevent twisting;
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open the tissue removal device's cutting window by manually twisting
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the hemostat counterclockwise; and
gently pull the MyoSure Tissue Removal Device into the hysteroscope
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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 60601-1-1.
• 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
MyoSure Hysteroscopic Tissue Removal System.
Precautions
U.S. 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. 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 control unit to overheat and stop. During a procedure, a
minimum distance of 5 feet (1.5 meters) should be maintained between
the control unit 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 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 tissue removal device's cutter blade has stopped
rotating during a procedure, check to ensure that all connections to
the tissue removal device and the control unit (both mechanical and
electrical) are secure and that the drive cable has not wrapped 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.
release Date:08/16/19
• 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.
• 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 sterilize or immerse the control unit in disinfectant.
• 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 Tissue Removal System needs special precautions
regarding electromagnetic safety and needs to be installed and put into
service according to the electromagnetic safety information provided in
the system's Operating Manual.
• This equipment is designed and tested to minimize interference
with other electrical equipment. However, if interference occurs with
other equipment it may be corrected by one or more of the following
measures:
Reorient or relocate this equipment, the other equipment, or both.
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Increase the separation between the pieces of equipment.
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Connect the pieces of equipment into different outlets or circuits.
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Consult a biomedical engineer.
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• All equipment performance is considered safety-related performance.
That is, the failure or degradation of the performance specified in
this manual may pose a safety risk to the patient or operator of this
equipment.
• Note: If the MyoSure Tissue Removal System is put into service in
accordance to the safety instruction in this manual, the product
should remain safe and provide the performance listed above. If
the product fails to provide this level of performance, the procedure
should be aborted and the biomedical staff alerted to the observed
problem. The problem needs to be corrected before continuing or
starting a new procedure.
• Portable and mobile RF communications equipment, including cellular
telephones and other wireless devices can affect medical electrical
equipment. To insure safe operation of the MyoSure Hysteroscopic Tissue
Removal System, do not operate communications equipment or cellular
telephones at a distance closer than specified in Table 4 of the Operating
Manual.
• The MyoSure Tissue Removal System is not designed to work with
or in the vicinity of electrical surgical equipment. If electrical surgical
equipment must be used in the same area as the MyoSure Hysteroscopic
Tissue Removal System, the MyoSure Tissue Removal System should
be observed for proper operation before performing a procedure. This
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