3
5.
Allow the system to initialize. When the system is ready to calibrate, the READY LED
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Breast Biopsy Probe. Reference the
applicable Probe Instructions for Use for further information on Probe setup. After the Probe
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Figure 15
. Reference the ‘Troubleshooting’ section to address any alerts that occur during
initialization and Probe calibration.
Figure 15 – System Display
6.
Complete the biopsy procedure per the ‘Directions for Use’ section of the
E
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Breast
Biopsy Driver Instructions for Use.
7. The
E
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Breast Biopsy System status is indicated on the display panel as shown
in
Figure 15
.
a. To change the sample mode from normal tissue to dense tissue, press the DENSE tissue
button as illustrated in
Figure 15
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sampling is selected. Press the DENSE tissue button again to return to normal tissue
sampling.
After Use
8.
Remove disposables and discard per your facility’s procedures. Clean and disinfect the
system hardware per the instructions located under the ‘Cleaning and Maintenance’ section.
Note:
The system may be left on if additional procedures are to be performed; it is not
recommended to leave the main power on overnight. It is not recommended to unplug the Drivers
after each use. The Driver and Foot Pedal may be left connected to the E
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LTRA
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Breast
Biopsy System if all procedures are to be performed with the same Driver.
9.
To turn off the system, press and hold the Power Switch on the front of the console as
illustrated in
Figure 12
until the system shuts down.
Cleaning and Maintenance
To clean the E
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Breast Biopsy System, turn off the power and disconnect the Power
Cord from the AC outlet. Leave all other cables connected. Clean all exposed surfaces of the
E
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LTRA
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Breast Biopsy System, cables, and Foot Pedal with a soft, lint-free cloth dampened
with a cleaning solution such as those recommended below. Follow the procedures approved by
your facility or use a validated infection control procedure. Always follow the instructions provided
by the manufacturer of the cleaner or disinfectant used.
Recommended Cleaning Solutions:
• Isopropyl
Alcohol
• Dispatch
®
Hospital Disinfectant
• Sani-cloth Disinfectant Wipes
• CaviWipes Disinfectant Wipes
• Cidex
Disinfectant
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E
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Breast Biopsy System or cables. Spraying the system may cause it to malfunction
and will void the warranty.
Do not submerge any component of the E
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LQÀXLGVPD\FDXVHWKHV\VWHPWRPDOIXQFWLRQDQGZLOOYRLGWKHZDUUDQW\6WHULOL]DWLRQDQGH[SRVXUH
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cleaned it may cause the system to malfunction and will void the warranty. Do not autoclave any
components of the E
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Disposal of Equipment
After following the cleaning recommendations above, there are no biohazard risks involved with the
disposal of the E
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Breast Biopsy System or any of the reusable accessories at the end
of the E
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Breast Biopsy System’s useable life per Waste of Electrical and Electronic
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Instructions for Use for the disposable device.
Do not dispose of the E
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Breast Biopsy System by placing into trash receptacles.
Routine Maintenance
No calibrations or adjustments are necessary for the E
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Breast Biopsy System outside
of normal use. In addition, the following routine maintenance activities may be completed:
• Electrical safety testing should be performed at intervals no greater than 12 months, using a
standard medical safety analyzer.
• Regularly inspect all cables and connectors for possible wear or damage.
Odor Control Filter Replacement
Turn the Power Switch to off. Remove the old Odor Control Filter by rotating it counter-clockwise
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ORFDWLRQRIWKH2GRU&RQWURO)LOWHULVLGHQWL¿HGLQ
Figure 16
.
Figure 16 – Odor Control Filter
Fuse Replacement
The Fuse Holder is accessible after the Power Cord is removed. Unplug the E
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Breast
Biopsy System from the wall outlet and remove the Power Cord from the power inlet connector
on the rear panel of the console. Using a small slotted screwdriver, press the release tab located
near the center of the Fuse Holder. Pull the Fuse Holder assembly outward to remove it. Install
the Fuse Holder as illustrated in
Figure 17
. Remove and replace any blown fuses in the Fuse
Holder assembly and snap it back into place. The Fuse Holder orientation determines the voltage.
Figure 17
illustrates the 115V orientation. Rotate the fuse 180 degrees for 230V orientation.
Replace the Fuse Holder assembly and reconnect the Power Cord to the power inlet connector.
Recommended Fuse for Replacement:
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Rated: 250V, 8 Amp, Slo-Blo
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)RUH[DPSOH/LWWH;3
Figure 17 – Fuse Holder
Troubleshooting
The E
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Breast Biopsy System will display any alert conditions that occur on the front
display panel illustrated in
Figure 15
.
Depending on the cause of the alert, different actions may be required to clear the alert. Certain alert
conditions, when corrected, allow the system to recover automatically and return to a ready state.
Other alerts require pressing a button on the display panel to clear. If a Driver is connected and is
the cause of the alert, follow the troubleshooting instructions in the
E
N
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OR
®
Breast Biopsy Driver
Instructions for Use to clear the alert.
Some conditions may require the user to clear the alert condition by turning off main power using the Power
Switch on the display panel (illustrated in
Figure 12
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restart the E
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Breast Biopsy System with the Power Switch on the display panel (illustrated in
Figure 12
If any alert condition persists after correcting known problems and clearing the alert condition using the
display panel, contact Bard for service.
