Operational Instructions; Getting Started; Overview; Unpacking And Inspecting - Boston Scientific Rezum Manuel D'utilisation

• Training as required by state, province, or country regulations.
• Training on operation and use of the generator.
• Additional training as required by a physician or Medical Director.
• A thorough understanding of the procedures in this manual.

OPERATIONAL INSTRUCTIONS

GETTING STARTED

Overview

This section contains information on how to get started with your Rezūm™ Generator.

Unpacking and Inspecting

Caution: Please use caution in opening the shipping box and try not to use sharp utility
knives and such, as you risk cutting into yourself and/or product.
Every attempt is made to ensure your order is accurate and complete. However, to be
sure that your order is correct, verify the contents of the box against your packing slip.
The Rezūm Generator is designed for simplicity of operation and set-up and requires
minimal assembly. The following items are included in the Rezūm Generator box:
One (1) Rezūm Generator
One (1) Power cord
1. Carefully inspect each item as it is unpacked for any signs of damage that may have
occurred during shipment.
2. Check the components according to the packing list.
3. Check for any damage or defects. Do not attempt to set up the Rezūm Generator
if anything is damaged or defective. Contact Customer Service immediately if
anything is damaged or defective.

Generator Controls and Connections

Warning: The generator contains magnets in the LCD lid. Avoid close or prolonged
contact with electrical devices or devices that have strong magnetic fields.
Warning: The Rezūm Generator is equipped with a USB port that is sensitive to ESD
that may potentially result in injury or device failures.
Warning: Do not connect a grounding wire from a grounding stud to a gas pipe or
water pipe.
Caution: Using this generator with the air vent blocked could cause a breakdown.
Clean this generator with care.
Caution: Only approved equipment and accessories shall be connected to the generator.
Caution: The Rezūm Generator USB port is only intended for use by authorized service
personnel or to export treatment data.
The following figures and table explain the controls, connections, and their function.
A
B
C
D
Figure 1: Front and Top of Generator
Black (K) ∆E ≤5.0
Table 1: Front and Top of Generator Description Table
ID Item
A Display Screen
B Syringe Cradle
C Delivery Device
Port
D Roller Pump
E Power Indicator
F Power Switch
G USB Port
Table 2: Back and Side of Generator Description Table
ID Item
H Grounding Stud
I Air Vent
J Product Label
K Fuse Box
L Power Cord Plug
M Lid
N Handle
O Air Vent and
Speaker
P Rubber Feet (On
Bottom and Side)

Display Screen Map

E
The Rezūm Generator is equipped with a color touchscreen that can be viewed up to 8
feet away from the generator. The display allows interaction with the generator using
F
screen buttons icons and menus with the touch of a finger with or without latex gloves.
G
6
Description
Touch screen display to provide system feedback to the
user.
Holds water-filled syringe for vapor treatment.
The delivery device cable is the RF energy line and the
connections for the switches and thermocouples.
Delivers saline during procedure.
Displays system status.
Turns system on / off.
Allows data from system to be exported onto USB device.
H
I
J
Figure 2: Back of Generator
P
Figure 3: Side of Generator
Description
Grounding stud used for grounding product (required in
Europe).
Outgoing air vent.
Provides information about the generator.
Holds generator fuses.
Connection plug for electrical power cord.
Cover to protect display screen, syringe and pressure
sensor ports.
Use to transport the device by hand.
Incoming air vent (both sides) and speaker (left side only).
Allows product to be stored on base or bottom end.
L
K
M
N
O