Operation - Hologic MyoSure Gebrauchsanleitung

Operation

After set up is complete, the physician may remove tissue with the MyoSure MANUAL Tissue Removal Device.
1. Actuate the MyoSure MANUAL trigger prior to introducing into the working channel of the hysteroscope.
2. Place outflow tubing into the under buttocks drape or other appropriate fluid collection mechanism.
3. Introduce the Tissue Removal Device through the 3mm working channel of the MyoSure hysteroscope.
4. Use the Adjustment Knob to orient the side-facing cutting window against the target pathology.
5. Actuate the Trigger to activate the cutting blade.
• Excised tissue is collected in the Tissue Trap.
Ending the Procedure
When the physician has determined sufficient tissue has been removed, perform the following steps.
1. Retract the MyoSure MANUAL Tissue Removal Device into the hysteroscope until the window is within the hysteroscope working channel.
2. Actuate the Trigger three times to ensure that all tissue is transferred into the Tissue Trap.
3. Remove the MyoSure MANUAL Tissue Removal Device from the MyoSure Hysteroscope.
4. To access excised tissue, do the following:
a. Orient the MyoSure MANUAL Tissue Removal Device with the distal tip of the device pointing upwards.
b. Rotate the Tissue Trap cover counterclockwise to remove.
c. Ensure Tissue Trap remains within the Tissue Trap cover.
d. Remove the Tissue Trap from the Tissue Trap cover.
e. If needed, tissue trap can be removed, emptied and reattached for additional tissue collection.
f. Transport and process tissue samples according to your facility's protocol.
Disposal
Dispose of the MyoSure MANUAL Tissue Removal Device according to your facility's policies and procedures for biohazardous materials and
sharps waste.
Storage
The tissue removal device should be stored at room temperature, away from moisture and direct heat.
Sterility
The tissue removal device is EO sterilized. DO NOT RE-STERILIZE. DO NOT REUSE. Do not use if package is opened or damaged. Discard all
opened, unused devices
Technical Specifications
Tissue Removal Device: 20-401ML/20-403ML
Sterile, single use device
Length: 21.75"/55.25 cm
Working Length: 12.6" / 32 cm
OD: 0.120" / 3.0 mm
Tissue Removal Device Accessories
MyoSure Hysteroscope with a 3 mm straight working channel
WARRANTY, SERVICE, AND REPAIR
Warranty
Except as otherwise expressly stated in the Agreement: i) Equipment manufactured by Hologic is warranted to the original Customer to perform
substantially in accordance with published product specifications for one (1) year starting from the date of shipment, or if Installation is required,
from the date of Installation ("Warranty Period"); ii) digital imaging mammography x-ray tubes are warranted for twenty-four (24) months, during
which the x-ray tubes are fully warranted for the first twelve (12) months and are warranted on a straight-line prorated basis during months 13-
24; iii) replacement parts and remanufactured items are warranted for the remainder of the Warranty Period or ninety (90) days from shipment,
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MyoSure MANUAL Tissue Removal Device
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