Warning; Safety; Danger; Device Description - Boston Scientific Rezum Manuel D'utilisation

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Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

WARNING

Users of the Rezūm™ Delivery Device Kit and Generator should read this manual
thoroughly before attempting surgical procedure. Pay attention to all warnings,
contraindications, precautions, and adverse events in this manual and other related
material. Failure to thoroughly understand and follow all instructions may result in harm
to the patient or the user of the laser system.

SAFETY

This section contains information about the Rezūm Generator including safety. Please
make sure you read this entire operator's manual prior to using the Rezūm Generator.
Note: Field service is not available, all repairs are done at the original equipment
manufacturer.
This section contains important safety information. Boston Scientific requires that you
read and understand all warnings, cautions, and the operator's manual prior to using the
Rezūm Generator.

DANGER

Do not take or use the device in locations where combustible anesthetics or flammable
gases are used or in high-pressure oxygen rooms or inside oxygen tents.
After use, dispose of product and packaging in accordance with hospital, administrative
and/or local government policy.

DEVICE DESCRIPTION

The Rezūm Generator is designed to heat the RF coil within the hand-held Delivery
Device rapidly. The device uses radio frequency (RF) energy to heat water into vapor
outside the body.
The vapor is injected into the tissue and rapidly disperses through the interstitial
spaces between the tissue cells. The vapor begins to cool and condenses immediately
on contact with tissue. The stored heat energy is released, gently denaturing the cell
membranes and causing instantaneous cell death.
The denatured tissue is absorbed by the body over time. The vapor condensation
process also causes a rapid collapse of blood vessels in the ablation treatment zone,
resulting in a bloodless procedure.
The generator rapidly heats and converts sterile water into nearly pure vapor at slightly
above 100°C. The generator delivers this thermal energy in the form of vapor through
precise vapor emitter openings at the tip of the Vapor Emitter Needle. The rate and
time over which the thermal energy in the form of vapor is delivered is monitored and
regulated by the generator.

INTENDED USE/INDICATIONS FOR USE

The Rezūm Generator is intended to be used with the Rezūm Delivery Device Kit, Model
D2201 only. Refer to the Directions for Use for the Rezūm Delivery Device Kit for the
Indications for Use/Intended Use.

CONTRAINDICATIONS

Refer to the Directions for Use for the Rezūm Delivery Device Kit for the Contraindications.

WARNINGS

A protective ground connection by way of the grounding conductor in the power cord
is essential for safe operation. To avoid electrical shock, plug the power cord into a
properly wired receptacle, use only the power cord supplied with the generator, and
make sure the power cord is in good condition.
After visual inspection, if the generator is damaged or a message is indicated to not
use the generator, please contact Boston Scientific Technical Service and take the
generator out of service.
Before conducting routine care, turn the power off and unplug the power cord from the
outlet to prevent electric shock.
Do not modify this equipment.
Carefully read and understand all instructions, indications, warnings, and cautions in
this operator's manual prior to using the Rezūm Generator. Failure to do so could result
in compromised patient safety, patient complications and/or insufficient treatment.
Do not connect a grounding wire from a grounding stud to a gas pipe or water pipe.
Do not connect to an electrical outlet controlled by a wall switch because the device
may be accidentally turned off.
Do not plug power cord into an outlet (or unplug it) with wet hands.
Do not submerge the device in liquids or pour cleaning liquids over, into or onto
the generator.
Black (K) ∆E ≤5.0
Do not use the generator if it is damaged, is not functioning properly, or fails to meet
an electrical safety check. Notify the appropriate personnel to ensure the generator is
removed from service and properly repaired.
Failure on the part of all responsible individuals, hospitals, or institutions, employing the
use of Rezūm Generator, to implement the recommended maintenance schedule may
cause equipment failure and possible health hazards. The manufacturer does not, in
any manner, assume the responsibility for performing the recommended maintenance
schedule. The sole responsibility rests with the individuals, hospitals, or institutions
utilizing the Rezūm Generator.
If a critical error message is displayed, take the generator out of service and call Boston
Scientific Technical Services. Do not attempt to service or maintain the generator while
in use with a patient.
If the generator measurement readings or messages seem dubious or abnormal, check
the condition of the patient first and stop using the generator.
In the event of power failure, the generator will automatically shut off. Turn the power
button off. Please remove the Delivery Device from the patient immediately per
instructions in the Rezūm Delivery Device DFU. Turn on again to restart the generator to
begin a new therapy session.
No modification of this equipment is allowed. Do not attempt to service or maintain the
generator while in use with a patient.
RF Interference - Known RF sources, such as cell phones, radio or TV stations, and
two-way radios, may cause unexpected or adverse operation of this generator. Consult
qualified personnel regarding system configuration.
Shock Hazard - Do not open, disassemble, or alter the Rezūm Generator. Failure to
observe this warning can result in personal injury or death. Refer maintenance issues
to authorized service personnel.
The generator contains magnets in the LCD lid. Avoid close or prolonged contact with
electrical devices or devices that have strong magnetic fields.
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.
The generator needs special precautions regarding Electromagnetic Compatibility
(EMC) and needs to be installed and put into service according to the EMC information
provided in this operator's manual.
The generator should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, test the generator to verify normal operation.
Refer to the Electromagnetic Immunity information.
The Rezūm Generator is equipped with a USB port that is sensitive to ESD that may
potentially result in injury or device failures.
The Rezūm Generator is reusable but is restricted to a single patient at a time for a
therapy session.
To avoid the risk of electric shock, this equipment must only be connected to a supply
mains with protective earth.
Use a grounded AC outlet for the power supply and ground this generator.
Use of accessories other than those specified in this document may result in increased
emission or decreased immunity of the Rezūm Generator.
Use only approved and specified parts, accessories, optional parts, consumables,
and components.
Use only specified power cord.
Use with the specified AC voltage and frequency.
When transporting the generator, it is important to position it with the display facing
away from the body.

PRECAUTIONS

None.

CAUTIONS

After cleaning, allow complete drying before plugging into an outlet.
Before conducting maintenance work, turn the power OFF and unplug the power cord
from the outlet to prevent electric shock.
Before moving this generator, turn the power OFF, remove all accessories from the
patient, and unplug the power cord from the outlet.
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.).
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