Not Recommended Cleaning Products; Cleaning Instructions; Routine Care Checklist; Authorized Repair Or Service - Boston Scientific Rezum Manuel D'utilisation

Not Recommended Cleaning Products

• Do not use abrasive cleaners or strong solvents such as acetone or
acetone-based cleaners.
• Do not mix disinfecting solutions (such as bleach and ammonia) as hazardous gases
may occur.
• Do not clean electrical contacts or connectors with bleach.

Cleaning Instructions

1. Before cleaning the generator, turn the generator off and disconnect the power cord.
2. To remove any foreign material and fluid (e.g. dust, paper, etc.), wipe thoroughly
with a soft cloth lightly dampened with water or 70% isopropyl alcohol. Super Sani-
Cloth wipes may be used per manufacturer instructions. To prevent scratching the
display, the use of a soft cloth is recommended.
3. When cleaning, do not immerse.
4. Wring any excess moisture from the cloth before and during cleaning.
5. Avoid pouring fluids on the generator, and do not allow fluids to penetrate the
exterior surfaces of the generator.
6. To dry the generator after cleaning, wipe with a dry, soft cloth.

Routine Care Checklist

Routine Care activities involve verifying operation and safety.
Maintenance should always be performed by the Customer at least once every 12 months.
The following checklist is recommended to be utilized when checking the generator:
Table 7: Routine Care Checklist
Visual Inspection
Warning: After the visual inspection, if the generator is damaged or a message
indicates to not use, take the generator out of service and call Boston Scientific
Technical Service.
• Carefully inspect the generator case for stress or physical damage.
• Inspect all external connections for loose connectors.
• Inspect the external power cord for damage or cracking.
• Inspect the display for marks, scratches, or other damage.
• Verify that the Safety label on the device is clearly legible and present.
Operating Test
Warning: If a Critical Error message is displayed, take the generator out of service
and call Customer Service.
• Set-up generator and turn on power to check the start-up diagnostics.

Authorized Repair or Service

Warning: 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.
Warning: 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. The generator has no
user-serviceable internal components. Try to resolve any maintenance issues with the
generator by using the Troubleshooting Table presented in Section 6, Troubleshooting.
If you are unable to resolve the problem, contact Technical Service.
The warranty will be void upon unauthorized disassembly or service of the
Rezūm Generator.

TECHNICAL SPECIFICATIONS

Overview

This section contains specifications for the Rezūm Generator and EMC information.

Generator Specifications

Caution: Exposing the Rezūm Generator to extreme environmental conditions outside
of normal parameters may compromise the ability of the Rezūm Generator to function
properly and/or cause the plastic to warp and/or crack.
Caution: If the Rezūm Generator is stored in an environment with a temperature below
the room temperature, the unit should be allowed to warm up to the needed operating
temperature before using.
Table 8: Generator Specification
Description Specification
Protection Against Electric Class I Equipment (generator)
Shock
Model Number G2200
100-240 VAC, 50-60HZ
Power Input 10 Amps Maximum
External Fuses Two, 10ah-250v, 5 x 20mm
Mode of Operation Continuous Operation
System Control Provides controlled flow of water vapor at ambient
temperatures below 25˚C
Case Dimensions 23L x 16W x 9H Inches
Weight 50 Pounds or less (generator only)
Power Cord Length 9 feet
Applied Parts Protection

Electromagnetic Compatibility Requirements

Warning: Use of accessories other than those specified in this document may result in
increased emission or decreased immunity of the Rezūm Generator.
Warning: The Rezūm Generator should not be used adjacent or stacked with other
equipment and, if necessary, observe its operation to verify its normal operation during
use. Refer to the Electromagnetic Immunity information in this section.
Caution: 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.
Caution: Use of portable and mobile RF communications equipment near the Rezūm
Generator may affect its operation.
Caution: 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.
Table 9: Electromagnetic Emissions
Guidance and Manufacturer's Declaration - Electromagnetic Emissions
The Rezūm Generator is intended for use in the electromagnetic environment
specified below. The customer or the user of the Rezūm Generator should assure
that it is used in such an environment.
Emissions Test Compliance
Radiated emissions Group 2
CISPR 11:2015
Conducted Class A
emissions
CISPR 11:2015
Harmonic current Class A
emissions
IEC 61000-3-2:2014
Voltage fluctuations Complies
and flicker
IEC 61000-3-3:2013
15
Type BF
Electromagnetic Environment - Guidance
The Rezūm Generator uses RF energy only
for its internal function. Therefore, its RF
emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.
The Rezūm Generator is suitable for use in
all establishments other than domestic and
those directly connected to the public low-
voltage power supply network that supplies
buildings used for domestic purpose.
Black (K) ∆E ≤5.0