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o Attempts to disassemble or service any Mammotome product other than in the manner described
in the product’s accompanying labeling, or by anyone other than a qualified technician, may
cause injury because of electrical shock.
o All appropriate surgical rom safety precautions should be observed and implemented before and
during the tissue sampling procedure.
o Inspect the power cords on the holster, remote footswitch, and remote keypad for fraying or
damage prior to each use. Do not use the component if it shows signs of damage or wear.
o Do not touch exposed parts of connectors on the control module, holster, or touchscreen while
simultaneously contacting the patient, as safety hazards may exist.
o Ensure that all cords are clear of the cart wheels prior to transporting the system.
o Do not attempt to open or access internal components of the Mammotome revolve Dual Vacuum-
Assisted Biopsy System, as safety hazards may exist.
o No modification of this equipment is allowed.
o Do not modify this equipment without the manufacturer’s authorization. If this equipment is
modified, appropriate inspection and testing must be conducted to ensure the continued safe use
of equipment.
o The pressure differential created in the canister during the procedure can cause blood discharge.
o This medical device emits electromagnetic energy that may interfere with other nearby medical
devices, which may cause those devices to malfunction or serious injury to patient.
Control Module
o To ensure adequate ventilation, position the control module at least 6" (15.24 cm) from
all walls. Do not block the exhaust fan at the rear of the control module. Do not position
the device where it is difficult to operate the mains disconnect device. The power switch
is used for mains disconnect.
o Do not use if the Control Module is damaged. Electric shock is possible.
o To avoid the risk of electrical shock, this equipment must only be connected to a supply mains
with protective earth."
Holster
o When system power is on, keep the holster cavity clear of all foreign objects.
o During use, ensure the electric cable is not pinched or bound. The cable should be free of kinks
or stress for proper operation.
Probe
o Do not reuse, reprocess, or resterilize the probe. The device is packaged and sterilized for single
use only. Reuse, reprocessing, or resterilization may compromise the structural integrity of the
device and/or lead to device failure, which may result in patient injury, illness, or death. In
addition, reprocessing or resterilization of single use devices may create a risk of contamination
and/or cause patient infection or cross-infection, including, but not limited to, the transmission of
infectious disease(s) from one patient to another. Contamination of the device may lead to injury,
illness, or death of the patient.
o Ensure that the connection tubes are not placed over the docked handpiece.
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