Myosure Tissue Removal Device; Connecting A Myosure Tissue Removal Device To The Control Unit; Myosure Control Unit - Hologic MyoSure Manuel D'utilisation

MyoSure Tissue Removal Device

The MyoSure Tissue Removal Device is shown in Figure 3. It is a hand-
held unit which is connected to the MyoSure 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
MyoSure Tissue Removal Device is a single-use device designed to
hysteroscopically remove intrauterine tissue.
FIGURE 3. MYOSURE TISSUE REMOVAL DEVICE
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.
MyoSure Foot Pedal (REF 52124-001)
The tissue removal system foot pedal (Figure 4) controls tissue removal
device operation. The foot pedal plugs into the connector on the
front of the MyoSure Control Unit panel. It has a single pedal and is
pneumatically operated.
FIGURE 4. FOOT PEDAL
Set-up
Setting up the Hologic MyoSure Hysteroscopic Tissue Removal System
WARNING: Before using the MyoSure Tissue Removal System for
the first time, you should review all available product information.
You should be experienced in hysteroscopic surgery with powered
instruments. Healthly uterine tissue can be injured by improper use
of the tissue removal device. Use every available means to avoid
such injury.
The MyoSure Tissue Removal Device is EtO sterilized. Verify that the
tissue removal device is sterile prior to use. Do not use if package is
opened or damaged. Discard all opened, unused devices. Do not use
after expiration date.
CAUTION: The MyoSure Tissue Removal Device is intended for
single use only. DO NOT RE-STERILIZE. DO NOT REUSE. Do not
lubricate MyoSure Tissue Removal Device. Discard MyoSure Tissue
Removal Device after use. Dispose of the MyoSure 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 5 for set-up
outline.

MyoSure Control Unit

Foot Pedal
FIGURE 5. SYSTEM CONFIGURATION
2. Place the MyoSure Control Unit on top of a cart or other stable work
surface. Plug the MyoSure 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
MyoSure Control Unit panel.
Connecting a MyoSure Tissue Removal Device to the Control
Unit
1. Remove the tissue removal device 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 MyoSure Control Unit as shown in Figure 6.
4. The tissue removal device flexible drive cable has a keyed feature
that serves to align the handpiece cable to the MyoSure Control
Unit connector. The metal tab on the connector is pushed down, the
flexible cable inserted and then the tab is released.
FIGURE 6. INSERT DRIVE CABLE AND FOOT PEDAL INTO
MYOSURE CONTROL UNIT
5
ENGLISH
Vacuum Canister and
Vacuum Source
MyoSure Tissue Removal Device