Hologic MyoSure LITE Instrucciones De Uso página 5

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
includes operating the electrical surgical equipment in its active mode at
a power level suitable for the procedure.
• For more information regarding the electromagnetic safety of this
product, please see Tables 1–4 in the back of the Operating Manual.
Tissue Removal Device: 30-401LITE
The MyoSure LITE Tissue Removal Device is shown in Figure 1. It is
a hand-held unit which is connected to the control unit via a 6-foot
(1.8-meter) flexible drive cable and to a collection canister via a 10-foot
(3-meter) vacuum tube. Cutting action is activated by a foot pedal. The
tissue removal device is a single-use device designed to hysteroscopically
remove intrauterine tissue.
FIGURE 1. MYOSURE
The flexible drive cable is inserted into the drive cable connection on the
front panel of the MyoSure Control Unit.
The proximal end of the vacuum tubing is connected to a collection
canister. The vacuum pressure draws fluid and resected tissue through the
tissue removal device's cutting window.
Set-up
The tissue removal device is EtO sterilized. Verify that the tissue removal
device is sterile prior to use. Do not use if the package is opened or
damaged. Discard all opened, unused devices.
CAUTION: The tissue removal device is intended for single use only.
DO NOT RE-STERILIZE. DO NOT REUSE. Do not lubricate tissue removal
device. Discard tissue removal device after use. Dispose of the tissue
removal device and packaging according to your facility's policies
and procedures concerning biohazardous materials and sharps
waste.
WARNING-DANGER: Risk of explosion if used in the presence of
flammable anesthetics.
1. Review the System Configuration Diagram in Figure 2 for set-up
outline.
MyoSure
control unit
Foot Pedal
MyoSure LITE Tissue Removal Device
FIGURE 2. SYSTEM CONFIGURATION
LITE
TISSUE REMOVAL DEVICE
Vacuum Canister and
Vacuum Source
2. Place the control unit on top of a cart or other stable work surface.
Plug the control unit power cord into the rear panel connector and a
grounded AC power source.
3. Connect the foot pedal tube to the connector on the front of the control
unit panel.
Connecting Tissue Removal Device to the Control Unit
1. Remove the tissue removal device (REF 30-401LITE) from the sterile
package.
2. Sterile person hands the flexible drive cable and vacuum tubing to the
non-sterile person.
3. Non-sterile person inserts the flexible cable into the corresponding
connection on the control unit 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 control unit connector. The
metal tab on the connector is pushed down, the flexible cable inserted
and then the tab is released.
FIGURE 3. INSERT DRIVE CABLE AND FOOT PEDAL INTO CONTROL UNIT
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 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.
5. Non-sterile person attaches the tissue removal device vacuum tubing
to the corresponding connection on the tissue trap of the collecton
canister as shown in Figure 4.
3
ENGLISH