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General
o the Mammotome revolve Dual Vacuum-Assisted Biopsy System is used in the presence of
flammable anesthetics. Avoid at all costs.
o As with any medical procedure, there is potential risk for infection.
o Minimally invasive instruments may vary in dimensions (e.g., diameter) from manufacturer to
manufacturer. When minimally invasive instruments and accessories from different manufacturers
are employed together in a procedure, verify compatibility prior to initiation of the procedure.
o Minimally invasive procedures should be performed only by persons having adequate training
and familiarity with minimally invasive techniques. Consult medical literature relative to
techniques, complications, and hazards prior to performance of any minimally invasive procedure.
System
o To avoid the risk of electrical shock, this equipment must only be connected to a supply mains
with protective earth.
o Changes or modifications not expressly approved by the party responsible for compliance could
void the user’s authority to operate the equipment.
o This medical device emits electromagnetic energy that may interfere with other nearby medical
devices, which may cause those devices to malfunction or seriously harm the patient.
o Do not use the Mammotome revolve Dual Vacuum-Assisted Biopsy System in an oxygen-rich
environment due to a small risk of fire. Avoid at all costs.
o Do not use this instrument in conjunction with Magnetic Resonance Imaging (MRI).
o This instrument should be used only by physicians trained in percutaneous needle techniques for
tissue collection.
o Do not attempt to sterilize the holsters, control module, cart, remote keypad, or remote footswitch
through autoclave, ethylene oxide, radiation, or plasma sterilization procedures. Do not spray with
fluids or submerge in fluids; this may damage the instrument. Improper cleaning may void the
warranties.
o Do not process the device through an automated washer-disinfect or ultrasound bath.
o Minimally invasive procedures should be performed only by persons having adequate training
and familiarity with minimally invasive techniques. Consult medical literature relative to
techniques, complications, and hazards prior to performance of any minimally invasive procedure.
o Do not immerse electrosurgical instruments in liquid unless the instruments are designed and
labeled to be immersed.
o The Mammotome revolve Dual Vacuum Assisted Biopsy System is not suit able for use in
environments that contain a mixture of flammable anesthetic and air or oxygen and nitrous oxide.
o Do not remove the vacuum tubing from the vacuum canister when the vacuum is being used by
the system.
o Products manufactured or distributed by companies not authorized by Devicor Medical Products,
Inc. may not be compatible with the Mammotome revolve Dual Vacuum-Assisted Biopsy System.
Use of such products may lead to unanticipated results and possible injury to the user or patient.
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