Priming The Delivery Device; Performing The Therapy - Boston Scientific Rezum Manuel D'utilisation

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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

Caution: 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.
• If you think the generator may have been damaged.
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 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.
Caution: 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.
• If you think the generator may have been damaged.
After setup is complete, perform a pre-treatment vapor cycle immediately prior to
procedure to initiate treatment stage.
9
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