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MyoSure
®
XL Tissue Removal Device for Fluent
Storage
The tissue removal device should be stored at room temperature, away from moisture and direct heat. Do not use after expiration date.
Sterility
The tissue removal device is EtO sterilized. DO NOT RE-STERILIZE. DO NOT REUSE. Do not use if package is opened or damaged. Discard all
opened, unused devices
Disposal
Disconnect the tissue removal device from the Fluent Fluid Management System. Dispose of the tissue removal device and packaging according
to your facility’s policies and procedures concerning biohazardous materials and sharps waste.
CAUTION:
The tissue removal device contains electronic printed circuit assemblies. At the end of the useful life of the equipment
it should be disposed of in accordance with any applicable national or institutional related policy relating to obsolete
electronic equipment.
Troubleshooting
If the device does not operate, check the following:
1. The Fluent Fluid Management System is plugged into a wall outlet.
2. The wall outlet has power.
3. The power cord is attached to the rear of the Fluent Fluid Management System.
4. The foot pedal is connected to the front of the Fluent Fluid Management System.
5. The suction tubing is connected.
If excess bending force is applied to the MyoSure XL Tissue Removal Device for Fluent, the system may temporarily stop to prevent further
damage.
NOTE:
If the Fluent Fluid Management System powers down unexpectedly, leave it off for 15 seconds, restart the system and follow
on-screen prompts.
Technical Specifications
Tissue Removal Device: 50-601XL/50-603XL
Sterile, single use device
Working Length: 12.6” / 32.0 cm
OD: 4 mm
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,
whichever is longer; iv) consumable Supplies are warranted to conform to published specifications for a period ending on the expiration date
shown on their respective packages; v) licensed Software is warranted to operate in accordance with published specifications; vi) Services are
warranted to be supplied in a workman-like manner; vii) non-Hologic Manufactured Equipment is warranted through its manufacturer and such
manufacturer’s warranties shall extend to Hologic’s customers, to the extent permitted by the manufacturer of such non-Hologic Manufactured
Equipment. Hologic does not warrant that use of Products will be uninterrupted or error-free, or that Products will operate with non-Hologic
authorized third-party products.
These warranties do not apply to any item that is: (a) repaired, moved, or altered other than by Hologic authorized service personnel; (b)
subjected to physical (including thermal or electrical) abuse, stress, or misuse; (c) stored, maintained, or operated in any manner inconsistent
with applicable Hologic specifications or instructions, including Customer’s refusal to allow Hologic recommended Software upgrades; or (d)
designated as supplied subject to a non-Hologic warranty or on a pre-release or “as-is” basis.
