Audible Tones; Volume Control; Detachable Parts And Accessories; Detachable Parts - Supplied With The Rezūm Generator - Boston Scientific Rezum Manuel D'utilisation

A: Title Bar
B: Information
Screen
Figure 4: Display Screen Map
Table 3: Display Screen Map
Item Description
A. Title Bar Brief title of the screen displayed.
B. Information Main area for screen information and error messages will be
Screen shown to the user. Replace saline button is also available on the
saline bag.
C. Lower Toolbar The bottom of all screens, except the start-up screens, will
include the same lower bar. This will have three features on it:
volume adjustment, product logo, and the Options menu button
(if applicable).

Audible Tones

The generator emits different audible tones to indicate to the user different events.
These tones vary with the type of message and its content. The description of each tone
is explained in Table 4.
Table 4: Tone Description
Tone Name Tone Description
1. Start-up A musical tone is played during generator power on sequence.
2. Treatment A single quick tone played when there is a warning after
Warning treating - running low on treatments, running low on treatment
time, and other alerts that may require user intervention.
3. Partial Tone emitted when the delivery device vapor activation button
Treatment has been deactivated prior to the completion of a treatment.
Tone
4. Treatment Played when the system is ready to perform a treatment.
Ready
5. Treatment and Beep tone is repeated once per second while performing
Priming Priming and Treatment operations.
6. Success Tone emitted when a full treatment has been administered,
after successful priming, and as feedback while adjusting the
volume.
7. Error Two quick tones in succession are played whenever the
Message generator displays an error message on the generator screen.
8. Critical Error A single high-pitched tone is played when the generator
Message encounters a critical error. In addition, three quick tones in
succession are played whenever the generator displays a
critical error message on the generator screen.
9. Delivery A high-pitched tone followed by a low-pitched tone played
Device when the delivery device is disabled.
Disable Tone

Volume Control

The generator has an on-screen volume control as depicted in Figure 5.
Figure 5: Volume Control
• Touch the minus symbol to decrease or silence the volume and touch the plus
symbol to increase the volume. A tone will be emitted upon each button press.
• The Critical Error and Delivery Device Disabled alarm tones cannot be silenced by
the volume control.
• The volume resets to the default when the generator is turned off and on again.
• Set the volume loud enough to be heard adequately in the actual use environment.

Detachable Parts and Accessories

Warning: Use only approved and specified parts, accessories, optional parts,
consumables, and components.
Caution: The Rezūm™ Generator power cord and delivery device cable may cause a
trip hazard while attached to the generator.
C: Lower Toolbar
The Rezūm Generator has the following detachable parts and accessories:
Detachable Parts - Supplied with the Rezūm Generator
Table 5: Detachable Parts
Model Number
1519-001
1519-002
1519-003
1519-004
1519-005
1519-006

Accessories - Supplied Separately

Table 6: Accessories
Model Number
D2201
USING THE REZŪM GENERATOR

Overview

This section provides step by step instructions and sequence of operation for the
Rezūm Generator.

Step by Step Instructions

This section contains step by step instruction on how to connect the power cord, turn
on and off the generator, prime the delivery device, perform treatment, and use the
option menu.
Warning: When transporting the generator, it is important to position it with the display
facing away from the body.
Caution: Follow your facility's procedures and applicable regulations when disposing
of anything that has been used on patients.
Caution: Do not install this generator in the following locations:
• Locations where gases and flames are used.
• Locations where the air includes dust, salt, or sulfur.
• Locations exposed to prolonged direct sunlight.
• Locations that vibrate or are subject to sharp impacts.
• Locations near heating equipment.
• Locations where chemicals are stored.
This generator cannot be used in any room in which noise-generating apparatuses are
used (such as an MRI room, CT room, X-ray room, etc.)
Caution: Do not place anything on this generator.
7
Description, Function
Power Cord
3.05 meter hospital grade power cord North
American, 15 amp
Power Cord
3.05 meter hospital grade power cord
Continental Europe, 10 amp
Power Cord
2.50 meter hospital grade power cord Swiss,
10 amp
Power Cord
3.00 meter hospital grade power cord United
Kingdom/Ireland, 10 amp
Power Cord
2.50 meter hospital grade power cord Italian,
10amp
Power Cord
3.00m hospital grade power cord Australian,
10amp
Description, Function
Delivery Device Kit
Delivers the vapor into the tissue
Type
Reusable
Reusable
Reusable
Reusable
Reusable
Reusable
Type
Disposable,
single use
Black (K) ∆E ≤5.0