Prepare The Sterile Saline Bag; Unpack Contents Of Delivery Device Kit; Prepare The Syringe; Set Up The Rezūm Delivery Device - Boston Scientific REZUM Mode D'emploi

2. Place prep tray or cart near the Generator.
3. Open the display screen.
4. Plug the power cord from the Generator into an electrical outlet (Figure 3).
Figure 3. Power up the Rezūm™ Generator.
5. Turn on the Generator.
6. The Generator is in an inactive state until a valid Delivery Device is connected.

Prepare the Sterile Saline Bag

1. Obtain a brand new bag of saline fluid. 500 mL, 1000 mL, 2000 mL, 3000 mL, 4000 mL
and 5000 mL volume options are compatible with the Rezūm Generator.
2. Hang bag on an IV pole (Figure 4).
Figure 4. Hang the saline bag on IV pole.
Note: Bag spike is NOT needed; spike is pre-attached to Delivery Device Saline
Line Tubing.
Caution: Saline should be at room temperature. Do not use cold saline, as it may
reduce the effectiveness of the therapy.

Unpack Contents of Delivery Device Kit

Warning: Do not use the Delivery Device and its contents if the packaging's sterile
barrier is broken, the seal is damaged, or the device is damaged.
Caution: The exterior of the Sterile Water Vial is not sterile and should not be placed in
the sterile field.
1. Prior to opening, inspect the integrity of the outside and inside packaging to ensure
sterility. Do not use if the packaging is damaged.
2. Lay out sterile field and place lubricating gel in sterile field.
3. Remove the Sterile Water Vial from the corner of the box. Remove the cover from
the water vial and wipe with a sterile wipe. Place bottle outside of the sterile field.
4. Using sterile technique, remove the Tyvek® cover from the tray and remove and
discard retainer tray.

Prepare the Syringe

1. Using appropriate aseptic practices, remove Syringe and Spike adaptor.
2. Connect Spike adaptor to Syringe. Ensure connection ends remain sterile.
3. Remove protective cover from Spike and insert Spike into Sterile Water Vial.
4. Invert Sterile Water Vial and slowly pull back plunger shaft to fill Syringe (Figure 5).
Remove plunger shaft once Syringe is filled.
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Figure 5. Filling the syringe.
Caution: Ensure air bubbles are removed from the syringe. If bubbles are trapped in
the line, an insufficient treatment may result.
5. Keeping the Syringe connected to the Spike Adaptor and Sterile Water Vial, set
aside outside the sterile field.
Set Up the Rezūm Delivery Device
1. Remove the Delivery Device RF cable and plug into generator, ensuring white dot on
the top of the plug is aligned with red dot on the generator port (Figure 6).
Figure 6. Connecting cable into Generator.
2. Ensure needle has retracted on Delivery Device.
3. Remove Saline Flush Line and Water Line from tray.
4. Place the Saline Flush Line in the Saline Pump. Ensure Saline Flush Line is seated
such that the Saline Pump door can close smoothly. Align the color indicators on
the generator and saline flush line (Figure 7).
Figure 7. Loading Saline Flush Line into Saline Pump.
Caution: Use indicators on Generator to ensure Saline Flush Line is positioned in the
correct direction. If Saline Flush Line is placed in a backwards direction within the
Saline Pump, saline will not flow during procedure.
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Black (K) ∆E ≤5.0