9
Boston S
cientific (Master Brand DFU
Template 8.2677in x 1
1.6929in
A4, 9223851
9A), EOP MANUAL, MB, REZUM, EN, 51
230807
-0
1A
Black (K) ∆E ≤5.0
Servicing
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PROPER CARE AND CLEANING
Overview
Proper care of the Rez
ū
m™ Generator is very simple, yet it is
an important factor in its reliability. This section describes the
proper care and cleaning required for the generator.
Warning:
No modification of this equipment is allowed. Do not
attempt to service or maintain the generator while in use with a
patient.
Precaution:
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.
• Damage to the generator is suspected.
Recommended Care
Warning:
Failure on the part of all responsible individuals,
hospitals, or institutions, employing the use of Rez
ū
m
Generator, to implement the recommended cleaning 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 Rez
ū
m Generator.
Warning:
Do not submerge the device in liquids or pour
cleaning liquids over, into or onto the generator.
Warning:
Before conducting proper care and cleaning, turn
the power OFF and unplug the power cord from the outlet to
prevent electric shock.
Precaution:
To prevent damage to generator, do not clean
any part of the device with phenolic compounds. Do not
use abrasive or flammable cleaning agents. Do not steam,
autoclave, or gas-sterilize the generator.
Precaution:
Using this generator with the ventilation ports
blocked could cause a breakdown. Clean this generator with
care.
Precaution:
Only approved equipment and accessories shall be
connected to the generator.
Precaution:
The Rez
ū
m Generator USB port is only intended for
use by authorized service personnel or to export treatment data.
To ensure the Rez
ū
m Generator is always functional when
required, Boston Scientific recommends performing the
following routine activities:
• Performing a Visual Inspection.
• Cleaning the Rez
ū
m Generator.
• Routine Care per checklist in this section.
It is important that the generator is stored at room temperature if
it is expected to be used.
The Rez
ū
m Generator requires no calibration.
Visual Inspection
Warning:
After the visual inspection, if the device is damaged
or a message indicating the generator is not to be used, take
the generator out of service and call Technical Assistance.
The generator should be carefully inspected prior to installation
and use.
• 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 product label on the device is clearly legible
and present.
Cleaning the Rez
ū
m Generator
It is recommended that the generator be inspected after each
use according to the Routine Care Checklist in this manual and
cleaned when appropriate. Listed below are recommendations
for cleaning the generator. The generator does not need to be
sterilized before or after use.
Warning:
Do not submerge the device in liquids or pour
cleaning liquids over, into or onto the generator.
Precaution:
After cleaning, allow complete drying before
plugging in to an outlet by wiping with a dry, soft cloth.
Precaution:
Do not soak the generator or accessories in any
medical liquid. Also, keep liquids out of the generator and
accessories.
Precaution:
When using disinfectant solutions, follow the
manufacturer’s directions.
Precaution:
Using this generator with the air vent blocked could
cause a breakdown. Clean this generator with care.
Precaution:
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.
Recommended Cleaning Products
The following cleaning products may be used to clean the
exterior surfaces of the generator:
• Water
• 70% Isopropyl Alcohol
• Super Sani-Cloth® Germicidal Disposable Wipes by PDI only
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 6: 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
Assistance.
• 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 product 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 Technical Assistance.
• 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 Rez
ū
m 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
Assistance.
The warranty will be void upon unauthorized disassembly or
service of the Rez
ū
m Generator.
TECHNICAL SPECIFICATIONS
Overview
This section contains specifications for the Rez
ū
m Generator
and EMC information.
Generator Specifications
Precaution:
Exposing the Rez
ū
m Generator to extreme
environmental conditions outside of normal parameters may
compromise the ability of the Rez
ū
m Generator to function
properly and/or cause the plastic to warp and/or crack.
Precaution:
If the Rez
ū
m 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 7: Generator Specification
Description
Specification
Protection Against
Electric Shock
Class I equipment (generator)
Model Number
G2200-003
Voltage and Frequency
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
2.5 m to 3.05 m
Applied Parts
Protection
Type BF
