Ethicon Gynecare Morcellex, Руководство пользователя

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Operation of the GYNECARE MORCELLEX™ Tissue Morcellator with the MDU
1. The blade’s rotational speed may be increased and decreased in increments of 42 rpm by pressing on the upward-pointing and downward-pointing yellow membrane
switches on the front of the MDU. The change in the number and/or intensity of the illuminated lights on the front panel of the MDU indicates that speed has been
increased or decreased.
2. 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 MDU
to overheat and stop. During a procedure, a minimum distance of 5 feet (1.5 meters) should be maintained between the MDU and the GYNECARE MORCELLEX™ Tissue
Morcellator to allow the drive cable to hang in a large arc with no bends, loops or kinks.
3. If it appears that the blade has stopped rotating during a procedure, check to ensure that all connections to the GYNECARE MORCELLEX™ Tissue Morcellator and MDU
(both mechanical and electrical) are secure and that the drive cable has not wrapped up into a loop.
4. If the Flexible Drive Cable wraps up and stalls the motor, press the red stop button, reverse the direction of blade rotation with the appropriate directional arrow
button, and intermittently run the motor in one second intervals until the drive cable unwraps and hangs freely with no loops.
5. The MDU contains an internal switch that automatically shuts the unit off if it overheats. In this event, switch the main power switch (on the back of the MDU unit) to
OFF and allow the unit to cool for several seconds before restarting.
Tissue Morcellation with the GYNECARE MORCELLEX™ Tissue Morcellator
1. When ready to morcellate tissue, slide the Detachable Handle into the Blade Housing Assembly until it seats firmly. Do not press the Activation Trigger during handle
assembly. See Figure 3.
2. Insert a 10mm claw forceps, tenaculum or similar instrument through the central lumen of the device and into the abdomen.
3. Grasp the tissue to be extracted and pull the specimen up to the distal end of the GYNECARE MORCELLEX™ Tissue Morcellator.
4. Set the desired amount of blade exposure by setting the Blade Position Selector to the “Fully Exposed” [Full] setting to morcellate via the coring technique or the
“Coreguard” [CoreGuard] setting to morcellate via the peeling technique. See Figure 4.
5. Partially depress the Blade Guard/Activation Trigger on the Detachable Handle to expose the blade. See Figure 4.
6. The Blade may be then activated via (a) the Activation Trigger on the Detachable Handle or (b) the Foot Pedal.
a. If the hand activation of blade rotation is desired confirm that the Detachable Handle Air Tube is connected to the back of the MDU. Then fully depress and hold the
Activation Trigger on the Detachable Handle to activate the MDU and start the rotation of the blade.
b. If foot pedal activation is desired confirm that Foot Pedal Air Tube is connected to the back of the MDU, depress the foot petal to activate the MDU and start the
rotation of the blade. When the foot pedal tube is connected to the MDU, further depression of the Blade Guard/Activation Trigger will have no effect once the
blade is exposed.
7. With the blade exposed and rotating, pull the tissue through the device. In order to prevent injury, the tissue to be morcellated should be completely exposed and freed
from surrounding tissue before attempting to extract it through the instrument. It is recommended that an assistant with a second pair of grasping forceps or other
fixation instrument help control tissue movement.
8. If desired, the location of the Coreguard can be changed to any of its twelve positions by pulling the Coreguard rotating knob towards the proximal end of the Blade
Housing Assembly and then rotating it to locate the Coreguard at the desired location. See Figure 5.
9. When morcellation of the tissue is complete, fully release the Blade Guard/Activation Trigger to stop and cover the blade. If using the foot pedal to activate the blade,
release the foot pedal to stop the rotation of the blade and then fully release the Blade/Guard/Activation Trigger to cover the blade.
10. To separate the Detachable Handle from the Blade Housing Assembly press the handle detachment buttons and remove the Detachable Handle from the Blade Housing
Assembly leaving the Blade Housing Assembly in place to serve as an operative port for any additional instruments required to complete the laparoscopic procedure.
See Figure 6.
Use of Reducer Cap with Blade Housing Assembly
1. Using sterile technique, remove the Reducer Cap from the package. To avoid damage do not flip the device into the sterile field.
2. Align the latches on the Reducer Cap with a latch slot on top of the Blade Housing Assembly.
3. Press the Reducer Cap into place by applying pressure. An audible “click” is heard when the cap is securely placed on the Blade Housing Assembly.
4. Insert instruments into the instrument port. The Reducer Cap can accept 5mm-12mm instruments through its self-adjusting seal without the need for manual
adjustment or the loss of pneumoperitoneum.
5. Remove the Reducer Cap from the Blade Housing Assembly by pulling or pushing up on the side of the Reducer Cap. See Figure 7.
NOTE: The Reducer Cap should be removed from the Blade Housing Assembly prior to attaching or detaching the Detachable Handle.
STORAGE
The GYNECARE MORCELLEX™ Tissue Morcellator should be stored at room temperature, away from moisture and direct heat. Do not use after expiration date.