Hologic Myosure REACH 10-401FC Instrucciones De Uso página 8

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Figure 9. Insert drive cable and foot pedal
into the Fluent Fluid Management System.
The tissue removal device flexible drive cable has
4.
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.
Non-sterile person attaches the tissue removal
5.
device suction tube to the corresponding fitting on
the Out-FloPak.
6
Operation
Push the power switch to the ON ( ) position, to
1.
ensure controller power is on.
The foot pedal activates tissue removal device
2.
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.
Press the foot pedal and observe the tissue removal
3.
device action to verify that the motor runs and that
the cutting window is closed as shown in Figure 10.
Introduce the tissue removal device through the
4.
straight working channel of a hysteroscope.
Under direct hysteroscopic visualization, position the
5.
tissue removal device's side facing cutting window
against target pathology.
Press the foot pedal to activate the tissue removal
6.
device's cutting blade.
The tissue removal device's reciprocating action
7.
alternately opens and closes the device's cutting
window to the vacuum flow thereby drawing tissue
into the cutting window.
Cutting takes place when the tissue removal device
8.
cutting edge rotates and translates across the tissue
removal device's cutting window.
MyoSure Tissue Removal System IFU
Figure 10. Closed Tissue Removal Device
Cutting Window on Left
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.
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.
CAUTION:
If it appears that the blade
has stopped rotating during a procedure,
check to ensure that all connections to the
tissue removal device and the controller
(both mechanical and electrical) are secure
and that the drive cable has not wrapped
into a loop.