Hologic MyoSure XL Instrucciones De Uso página 8

Connecting the Tissue Removal Device to the Fluent Fluid Management System
1. Remove the tissue removal device (REF 50-601XL/50-603XL) from the sterile package.
2. Sterile person hands the flexible drive cable and suction tube to the non-sterile person.
3. Non-sterile person inserts the flexible cable into the corresponding adapter on the Fluent
Fluid Management System as shown in Figure 3.
4. The tissue removal device flexible drive cable has a keyed feature that serves to align the
handpiece cable to the Fluent Fluid Management System connector. The metal tab on the
connector is pushed down, the flexible cable inserted and then the tab is released.
CAUTION:
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 motor 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.
5. Non-sterile person attaches the tissue removal device suction tube to the corresponding fitting on the Out-FloPak.
Operation
1. Set up the Fluent Fluid Management System for a MyoSure tissue removal procedure per the
instructions in the Fluent Fluid Management System Operating Manual.
2. The foot pedal activates tissue removal device operation. The foot pedal turns the motor ON
and OFF. Once the foot pedal is depressed, the tissue removal device accelerates and rotates
to the set speed and continues until the foot pedal is released.
3. Press the foot pedal and observe the tissue removal device action to verify that the motor
runs and that the cutting window is closed as shown in Figure 4.
WARNING:
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.
4. Introduce the tissue removal device through the straight 4 mm working channel of a
hysteroscope.
5. Under direct hysteroscopic visualization, position the tissue removal device's side facing
cutting window against target pathology.
CAUTION:
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 cutter assembly.
6. Press the foot pedal to activate the tissue removal device's cutting blade.
7. The tissue removal device's reciprocating action alternately opens and closes the device's cutting window to the outflow pump of the Fluent
Fluid Management System thereby drawing tissue into the cutting window.
8. Cutting takes place when the tissue removal device cutting edge rotates and translates through the tissue removal device's cutting window.
CAUTION:
If it appears that the 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 to the Fluent Fluid Management System are secure,
and that the drive cable has not wrapped into a loop.
NOTE:
If the Fluent Fluid Management System powers down unexpectedly, leave it off for 15 seconds, restart the system and follow
on-screen prompts.
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MyoSure XL Tissue Removal Device for Fluent
®
Figure 3. Insert drive cable and foot pedal into
the Fluent Fluid Management System.
Figure 4. Closed Tissue Removal Device
cutting window on left
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