Myosure Control Unit And Foot Pedal Cleaning; Maintenance And Service; Electrical Interference - Hologic MyoSure Manuel D'utilisation

ENGLISH
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 MyoSure Control Unit to overheat
and stop. During a procedure, a minimum distance of 5 feet
(1.5 meters) should be maintained between the MyoSure Control
Unit and the MyoSure 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 7.
FIGURE 7. ATTACH VACUUM TUBE TO COLLECTION CANISTER
6. The patient should be placed in dorsal lithotomy position, as the
MyoSure Tissue Removal System is performed as a hysteroscopic
procedure.
Operation
1. Push the power switch to the ON ( ) position.
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 8.
FIGURE 8. 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.
4. Introduce the tissue removal device through the straight 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 vacuum flow thereby
drawing tissue into the cutting window.
8. Cutting takes place when the tissue removal device cutting edge
rotates and translates across the tissue removal device's cutting
window.
CAUTION: If it appears that the blade has stopped rotating during
a procedure, check to ensure that all connections to the MyoSure
Tissue Removal Device and the MyoSure Control Unit (both
mechanical and electrical) are secure and that the drive cable has
not wrapped up into a loop.
NOTE: If system is turned off for any reason, wait at least
15 seconds before turning power back on.
CAUTION: Do not operate the tissue removal device in open air for
an extended period, as the lack of irrigation may cause the tissue
removal device to overheat and seize.
Cleaning

MyoSure Control Unit and Foot Pedal Cleaning

Follow this procedure after each operation to clean the MyoSure Control
Unit and the foot pedal:
1. Disconnect the tissue removal device from the MyoSure Control Unit
and dispose.
2. Disconnect the MyoSure Control Unit from the electrical source.
3. Wipe the MyoSure Control Unit with a clean damp cloth and mild
germicide or isopropyl alcohol.
CAUTION: Do not sterilize or immerse the MyoSure Control Unit in
disinfecant.
4. Wipe the foot pedal and the foot pedal connecting tube with a clean
damp cloth.
The foot pedal (REF 52124-001) has no electrical connections and is
watertight per IPX8.

Maintenance and Service

Maintenance

Electrical Interference

CAUTION: This equipment is designed and tested to minimize
interference with other electrical equipment. However, if
interference occurs with other equipment it may be corrected by
one or more of the following measures:
• Reorient or relocate this equipment, the other equipment, or both.
• Increase the separation between the pieces of equipment.
• Connect the pieces of equipment into different outlets or circuits.
• Consult a biomedical engineer.
6