5
Boston S
cientific (Master Brand DFU
Template 8.2677in x 1
1.6929in
A4, 9223851
9A), EOP MANUAL, MB, REZUM, EN, 51
230807
-0
1A
Black (K) ΔE ≤5.0 / CMYK Images
I
O
Power
Button
Figure 6: Power Button
3. While the generator is powering up, it initially displays two
Start-up screens and a Test screen.
Warning:
In the event of power failure, the generator will
automatically shut off. Turn the power button OFF. Please
remove the Delivery Device from the patient
immediately
per
instructions in the IFU. Turn ON again to restart the generator
to begin a new therapy session.
Figure 7: Start-up Screens
Figure 8: Test Screen
4. It will automatically run the Start-up Diagnostics. During
this time the Test screen is displayed, and a bar and text
will indicate status of the tests on the screen.
5. After the Start-up Diagnostics are completed, the
generator will display the
Delivery Device Setup
screen.
Figure 9: Delivery Device Setup
After all connections are properly made, a message will be
displayed for 5 seconds letting the user know that items have been
connected and then the
Priming
screen will be displayed.
Figure 10: Connection Message
Priming the Delivery Device
Precaution:
When any of the following occur, turn the power OFF,
remove all accessories from the patient, and unplug the power
cord from the outlet.
• There is smoke or a strange odor leaking out of the generator.
• The generator has been dropped or impacted by an object.
• Liquid or foreign matter gets inside the generator.
• Damage to the generator is suspected.
Figure 11: Ready for Priming
When the operator starts priming the Delivery Device, a progress
bar will be initiated and displayed. The text will change, and a tone
will be generated to indicate that the operation is in progress.
Priming is initiated by deploying the needle and holding the Delivery
Device vapor activation button for the priming duration, which lasts
approximately 30 seconds. A message will be displayed indicating
when priming is complete.
If the vapor activation trigger is activated while the needle is being
deployed, priming, pretreatment, or treatment operation will not be
initiated until the vapor trigger is released and reengaged.
Figure 12: Priming Screen
Figure 13: Priming Complete
The
Setup Complete
screen will be displayed when the Delivery
Device has been successfully primed. There will also be an
audible tone that indicates success. Pre-Treatment Vapor
Cycle shall be performed prior to treatment.
Figure 14: Setup Complete Screen
If the device is not properly primed, an error message will be
displayed to the user. Upon resolution of the issue and closure
of the error message, the screen will display the
Priming
screen and the steps should be repeated.
Performing the Therapy
Warning:
If the generator measurement readings or messages
seem dubious or abnormal, check the condition of the patient
first and stop using the generator.
Precaution:
When any of the following occur, turn the power
OFF, remove all accessories from the patient, and unplug the
power cord from the outlet.
• There is smoke or a strange odor leaking out of the generator.
• The generator has been dropped or impacted by an object.
• Liquid or foreign matter gets inside the generator.
• Damage to the generator is suspected.
After setup is complete, perform a Pre-Treatment Vapor Cycle
immediately prior to procedure to initiate treatment stage.
