Adverse Events; Reported Adverse Events; How Supplied; Handling And Storage - Boston Scientific Rezum Manuel D'utilisation

Do not place anything on this generator.
Do not soak the generator or accessories in any medical liquid. Also, keep liquids out of
the generator and accessories.
Equipment operating in close proximity may emit strong electromagnetic or radio
frequency interference (RFI), which could affect the performance of this device. Avoid
operating the Rezūm™ Generator near cauterizers, diathermy equipment, FM 2-way
radios, or cellular phones. Turn power off to radio, cellular and other like equipment
near the Rezūm Generator. Refer to the EMI tables.
Exposing the Rezūm Generator to extreme environmental conditions outside of its
specified parameters may compromise the ability of the Rezūm Generator to function
properly and/or cause the plastic to warp and/or crack.
Follow your facility's procedures and applicable regulations when disposing of anything
that has been used on patients.
The generator should be at room temperature prior to use.
If there is condensation on the generator, dry it thoroughly before turning the power on.
Input voltage range is 100 to 240V at 50 to 60 Hertz. Verify this voltage matches that of
the power outlet.
Observe the following cautions when connecting this generator with other equipment:
• Ensure that the connected equipment is in accordance with the IEC60601-1 or IEC
safety standards.
• Employ additional protective measures (e.g., additional protective earthing)
as necessary.
Only approved equipment and accessories shall be connected to the generator.
The Rezūm Generator USB port is only intended for use by authorized service personnel
or to export treatment data.
The generator conforms to the requirements of the EMC standards (IEC 60601-1-
2:2007 and IEC 60601-1-2:2014), so it can be used at the same time as other electrical
simulators. However, it may be affected by electrical scalpels and microwave treatment
devices and there may be an impact on measurement precision for patients using
cardiac pacemakers and the like. Check the operation of this generator during and after
use of such equipment and with such patients.
The Rezūm Generator is intended to be used indoors at a medical facility or physician
office environment only.
The Rezūm Generator power cord and delivery device cable may cause a trip hazard
while attached to the generator.
The Rezūm Generator needs special precautions regarding Electromagnetic
compatibility (EMC) and care should be taken in accordance to the EMC information
provided in this document.
To prevent damage to equipment, do not clean any part of the generator with phenolic
compounds. Do not use abrasive or flammable cleaning agents. Do not steam, autoclave,
or gas-sterilize the generator.
Use of portable and mobile RF communications equipment near the Rezūm Generator
may affect its operation.
Using this generator with the air vent blocked could cause a breakdown. Clean this
generator with care.
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.
When using disinfectant solutions, follow the manufacturer's directions.
Input voltage is pre-selected as labeled on the generator.
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.

ADVERSE EVENTS

The following adverse events have not been reported in the clinical trials: de novo erectile
dysfunction, pelvic abscess, rectal wall injury, and fistula. Delivering a form of thermal
therapy or misuse of the device has potential for producing these adverse effects.

Reported Adverse Events

The types of device related, or procedure related adverse events reported are typical
of thermal BPH ablation procedures. There were no clinically significant complications
resulting from the treatment.
A summary of the adverse events observed in clinical studies is presented in the Rezūm
Delivery Device Kit DFU.

HOW SUPPLIED

Do not use if package is opened or damaged. Do not use if labeling is incomplete or illegible.

Handling and Storage

This product has no specific storage or handling requirements.

User Interface Symbols

Symbol

Description

Priming the Delivery Device.
Perform a pre-treatment
vapor cycle.
Back to previous screen.
Complete
Confirmation message.
Continue
Critical error message.
Displayed for errors that are not of critical severity.
Informational error messages.
Export
Generator question that requires user response.
Home screen menu.
Navigation buttons for back, forward, up and down.
Options Menu
Volume Control

OPERATOR TRAINING REQUIREMENTS

WARNING: The generator is not intended to be deployed in settings or situations that
promote use by untrained personnel. Operation by untrained personnel can result
in injury or death. Persons authorized to operate the generator must have all the
following minimum training.
5
Black (K) ∆E ≤5.0