7.

0 Maintenance
The Joule system is simple to use, yet at the same time is very complex piece of equipment. The following
maintenance procedures should be performed on a regular basis to keep the system operating at its optimum
performance. Please contact Sciton Service at 650-493-9155 to learn more about a maintenance contract that
will best suit your needs.

Maladjustment or damage to the beam delivery system can lead to considerable deviations of
the laser power incident on the patient from the laser power actually generated. It is therefore imperative that
the laser output actually emitted to tissue is checked by means of a calibrated laser power or laser energy
meter during regular inspections of the laser equipment.
No modification of this equipment is allowed. Do not modify this equipment without authorization of the
manufacturer. If this equipment is modified, appropriate inspection and testing must be conducted to ensure
continued safe use of the equipment.

7.1 Annual Maintenance

Preventative maintenance should be performed annually by a Sciton field service engineer (FSE) to
ensure proper laser and/or pulsed-light performance. During this visit, the FSE will perform the following
checks:
a. Full optical alignment
b. Complete power/energy check and calibration
c. Cooling system inspection and replacement of all filters and cartridges
d. High and low voltage testing
e. Optical inspection and cleaning
f. Full user mode operational check of the laser system
g. Mechanical integrity check
h. Inspection of all accessories, filters and handpieces

7.2 Routine Maintenance

7.2.1 Cleaning External Surfaces of the System
 
The external surfaces of the laser console should also be cleaned and disinfected by wiping down
on a regular basis using a soft dampened cloth with a non-caustic cleaning solution such as
water, isopropyl alcohol or a hospital grade disinfectant. The Articulated Arm, hand piece and
scanner can also be wiped clean with a soft damp cloth. Avoid excessively wet cloth to prevent
moisture from getting into the system.

Do not spray or pour cleaning solution directly on the control panel display screen, fiber
delivery port or the system console. Do not attempt to gain access to any internal components of
the console. Electrical shock and/or unintended laser exposure may result.

It may be necessary during the procedure to clean tissue debris from the scanner lens. To clean
the lens, gently wipe with a soft cotton swab or cloth that has been moistened with isopropyl
alcohol or sterile water. 
 

7.2.2 Cleaning & Disinfection Requirements of Handpieces & Scanners

Prior to Reuse
These instructions are provided for safely disinfecting Sciton handpieces and scanners prior to
reuse so that they will continue to meet their performance specifications. The sapphire and/or
stainless steel surfaces of a handpiece sometimes come into contact with a patient during
treatment. These surfaces require cleaning and disinfecting prior to reuse.

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 It is the responsibility of the medical practice to ensure that disinfection is performed using the
appropriate method and materials, and that personnel have been adequately trained in order to
achieve the desired result. Any deviation from these instructions should be properly evaluated for
effectiveness to avoid potential adverse consequences.

Never spray anything directly on the handpiece or scanner. Never soak a handpiece or
scanner and place it under running liquid.

Point of Use Preparation

Remove any fluid and/or contaminants with a disposable, non-shedding wipe or a soft, non-
scratching brush. The handpieces should be cleaned within 30 minutes of use to minimize the
potential for any substance to dry onto the sapphire and/or stainless steel surface, therefore
making it more difficult to clean.

Preparation of Cleaning Agents

Neutral pH enzymatic and cleaning agents with low foaming surfactants are recommended by
Sciton. All cleaning agents should be prepared with dilution and temperature recommended by
the manufacturer of cleaning agent. Dry powdered cleaning agents should be completely
dissolved prior to use to avoid staining, scratching or corrosion of instruments. Common hospital
grade disinfectants (such as MetriCide 28, Biocide or methanol) can also be used. If the
handpiece is currently connected to the articulated arm, ensure that the power to the system is
turned off prior to proceeding with the disinfection process.

Cleaning/Disinfection and Drying

Use a non-shedding wipe dampened with cleaning agent to remove all visible contamination.
Particular attention must be given to crevices, mated surfaces and other hard-to-clean areas.
Remove excess moisture from the handpiece with clean, absorbent and non-shedding wipe.
External scanner windows should be optically clean to prevent damage by the laser beam.

Inspection, Maintenance and Testing

Carefully inspect each device to ensure that all visible contamination has been removed. If
contamination is noted, repeat the cleaning/disinfection process. Visually inspect for
completeness of cleaning, damage and/or excessive wear. If damage or wear is noted that may
compromise the function of the handpiece, contact Sciton Service.

Packaging and Storage

If the handpiece is not being used, place the disinfected handpiece in the designated slot in the
Sciton carrying case prior to storage.
Do not leave handpieces out in the open where dust or particulate matter could contaminate the
optics located in each handpiece. Optics contamination will result in reduced efficiency and
premature failure of the system.

7.2.3 Cleaning & Sterilization Requirements Prior to Reuse of Devices

These instructions are provided for cleaning and sterilizing ALLURA cannulas and handpieces
prior to use and/or reuse so that they will continue to meet their performance specifications.

TM
Please note that the TempASSURE cannula (supplied with thermocouple) is a single
use device; do not reuse this device.

It is the responsibility of the medical practice to ensure that cleaning and sterilization is performed
using the appropriate method and materials, and that personnel have been adequately trained in
order to achieve the desired result. Any deviation from these instructions should be properly
evaluated for effectiveness to avoid potential adverse consequences.

Cleaning Procedure:

Prepare Cidex ®, Enzol®, or equivalent detergent, according to manufacturers’ instructions using

tap water. Fully immerse the devices in the detergent and allow to soak for a period noted in
manufacturers’ instructions. After the soak, scrub devices using a soft bristled brush paying
particular attention to hard-to-reach areas. A pipe cleaner and syringe may be used to brush and
flush the hard-to-reach areas of the devices.

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 Remove the devices from the detergent and rinse with tap water for a minimum of one minute to
remove any residual detergent. A syringe may be used to aid in rinsing.

Allow to clean in ultrasonic tank filled with reverse osmosis (RO) or deionized (DI) water for a
minimum of 10 minutes.

Remove devices from the ultrasonic tank and rinse with RO/DI water. A syringe may be used to
aid in the rinsing.

Visually inspect each device for visible soil, while paying close attention to hard to reach areas,
ensuring that all soil has been removed.

Dry devices using a clean, lint-free cloth. Pressurized air (<20 psi) may be used to assist in the
drying.

Sterilization Procedure:

Insert parts in steam sterilization pouch. Place pouch in sterilizer.

The following steam sterilization parameters, or those cleared at your medical practice for
autoclaving stainless steel and glass parts, should be used for sterilization.

Sterilizer Type: Gravity

Minimum Temperature: 132°C
Cycle Time: 15 minutes
Minimum Dry Time: 30 minutes

7.3 System Repair

Repair on the Joule system should be performed by a Sciton-Certified field service engineer. Contact
Sciton Service at 650-493-9155 if a repair is required.

Calibration of the Joule as described in the next section is to be performed only by Sciton-Certified field
service engineer. Calibration or other adjustment of this device by persons other than Sciton-Certified
field service engineer will result in the warranty of the unit being voided.

All equipment must be properly decontaminated before return to Sciton. Failure to perform
proper decontamination will result in delays and additional charges.

7.4 Disposal and Recycling

Contact your local recycling operator for separate collection or Sciton for appropriate disposal
information.

. Do not dispose laser console as unsorted municipal waste. End of life electronic equipment
must be collected separately to prevent harm to the environment or human health.

Used single use consumable items such as laser fibers should be disposed of according to your
institution’s protocol for disposal of medical waste.

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