Zila OH003 User Manual
Discus Dental, LLC
8550 Higuera Street
Culver City, CA 90232
USA
Tel: (310) 845-8200
Fax: (310) 876-9917
© 2010 Discus Dental, LLC. All rights reserved.
CaviWipes is a registered trademark of Metrey Research, LLC.
EC REP
EMERGO EUROPE
Molenstraat 15
2513 BH, The Hague
The Netherlands
0470
SL3 User’s Manual
This manual must be read thoroughly and understood prior to using
the laser system. CAUTION: Using the controls and adjustments or
performing laser procedures, other than as specified herein, may
20-2954 081710
result in hazardous radiation exposure.
Table of Contents Section 1: Introduction
Section 1: Introduction ...............................................1
Introduction ...................................................................................1
Indications for Use .......................................................................1
What’s in the box? ........................................................................1
Section 2: Specifications .............................................2
Laser System Specifications ......................................................2
Laser System Description ..........................................................2
LCD Screen ......................................................................................3
Unifiber
™
System ...........................................................................3
Section 3: Safety Indications ......................................4
Testing Standards ......................................................................... 4
Labels ................................................................................................4
Precautions ..................................................................................... 4
Warnings .......................................................................................... 5
Protective Eyewear.......................................................................7
Laser System Safety Features ...................................................7
Section 4: System Set Up .............................................8
Unpacking .......................................................................................8
What’s in the box? ........................................................................ 8
Installation ......................................................................................8
Cleaning and Sterilization .........................................................10
Transportation ...............................................................................10
Preparing the Unifiber Hand Piece Assembly .................... 11
Section 5: Operation ....................................................12
Procedure Guide ...........................................................................12
Laser Operation Procedure .......................................................13
Section 6: Labels & Symbols ......................................15
FCC Compliance Label ................................................................15
INTRODUCTION
The SL3™ is a Class IV soft-tissue diode laser that can be used for a wide variety
of soft-tissue procedures. This device uses a Gallium, Aluminum, Arsenic
(GaAlAS) diode for the active medium, producing laser energy at 810 nanometer
wavelength. Laser technology has been steadily evolving, allowing doctors to
provide less invasive treatment for many dental procedures, both preventative
and restorative. For a list of approved procedures please refer to page 12.
All of the safety features, warnings and precautions should be observed for the
™
SL3
. All of the Safety Warning Labels are described in detail on page 15 of this
guide. The SL3
friendly. It provides the practitioner with a versatile instrument for applications
ranging from excisions to vaporization of tissues. The diode laser energy is
delivered through optical fiber in the hand piece to the removable fiber tips. The
system may be utilized for a wide variety of surgical and cosmetic procedures.
Indications for Use
The SL3™ is intended to be used for oral soft tissue surgery, including: biopsies,
hemostatic assistance; treatment of apthous ulcers; frenectomy; gingival incision
and excision; gingivectomy; gingivoplasty; incising and draining of abscesses;
operculectomy; removal of fibromas; soft-tissue crown lengthening; sulcular
debridement (removal of diseased or inflamed soft tissue in the periodontal
pocket) and tissue retraction for impressions.
What’s in the box?
• Laser
• Unifiber
• Foot Pedal
• Disposable Tips (10)
• Power Adapter
• Safety Glasses (3)
• Introductory DVD
• Caution Sign
• Initiating Film
• User’s Manual
• Basic User’s Guide
™
is especially designed to be compact, portable, reliable and user
™
with Hand Piece
What’s in the box photo
Section 7: Warranty and Service ................................16
Service and Maintenance ..........................................................16
SL3 Unit Warranty .........................................................................16
Compliance ..................................................................................... 18
1
Section 2: Specifications
LASER SYSTEM SPECIFICATIONS
Size .....................................17.7 cm wide x 13 cm high x 14 cm deep (7” x 5.2” x 5.5”)
Weight ................................1.36 kg (3 lbs.)
Wavelength .....................808 +/- 10 nm
Operation modes ..........Continuous Wave & Pulsed at 10 Hz
Output power ..................3.0 w ± 20%
Pulse width ......................50 ms
Calibration ........................External power meter
Fiber optic port ..............Standard FT type connector, compatible with 400 μm
diameter single-core quartz fiber cable
Aiming beam ..................650 ± 10 nm red diode laser, 5 mW maximum
Input power ....................Laser Device: 9v
Power supply ...................100-240 VAC, 1.0 A max, 50-60 Hz, Class 1
Handling/storage ...........Between 0º – 50º C (32º – 122º F) conditions
Protection type ...............BF part
Footpedal protection ...IPX1
Laser System Description
The laser system is contained within a compact lightweight molded plastic
housing, consisting of a laser diode assembly with a self-contained cooling
system, a flat LCD screen connected to an interface PCB, and power controller PCB.
The base system has two physical buttons. The first button is a mechanical ON-OFF
button located on the rear left side of the unit. The second power button is a red
LASER STOP button located on the left side. The LASER STOP button de-activates
all lasing functions and puts the laser in stand-by mode. A warning message will
be displayed. Follow the screen instructions to de-activate the warning message.
The laser output power is regulated in 30 steps by “plus sign” and “minus sign”
buttons. The LCD front panel screen indicates the level of output power (in Watts)
delivered from the tip of the 400 μm fiber when in continuous wave (CW) mode.
An operator can choose CW or Pulsed operation mode by pressing the CW or
“Pulse” button on the LCD screen.
, 3.5A / Footswitch: AA Cells, 1.5V
The SL3™ uses an internal battery that is recharged when it is plugged in. When
fully charged, the battery will last for 30 minutes in continuous use at maximum
power. The SL3
™
internal battery is not intended to be changed by the
operator. The laser energy is activated by a wireless foot pedal. Depressing the
foot-switch activates the lasing process, while releasing it stops the process. The
™
SL3
system is highly portable and self-contained with built-in safety features. It
is capable of producing the rated output power in a continuous wave mode for
more than half an hour without interruption, allowing completion of most surgical
procedures. In the pulsed mode, the system delivers pulsed (interrupted) radiation
at a repetition rate of 10 Hertz, and a pulse width of 50 ms.
™
The SL3
uses disposable, removable fiber-tips to accurately deliver the laser
energy. Please refer to page 11 for more information on the disposable tips.
LCD Screen
The SL3™ is equipped with a touch screen,
allowing the user to perform selections of
various settings. The screen graphics are
intuitive, allowing the user to select options
quickly and easily. An example of the main
touch screen display is shown in the pictures
below. For a complete list of all the features
on the “Main Display” screen, see page 12.
Unifiber System
Flexible fiberoptic cables are the most widely accepted delivery systems for diode
laser power. In the SL3
mounted into standard FC connectors. The fiber optic cable is coated in a steel
metal, offering superior protection and preventing damage to delicate fibers.
™
The SL3
uses a Unifiber™ system to deliver diode laser power. This consists of
an autoclaveable handpiece shell with internal optics. The hand piece is paired
with disposable, non-sterile fiber tips that can be easily removed and replaced in
between procedures. For information on setting up the Unifiber system, please
refer to page 11.
™
system, the 400 μm diameter single-core quartz fiber is
2 3
Section 3: Safety Indications
Testing Standards
The SL3™ Diode Laser has been tested to the standards applicable to medical
lasers including lEC60825, IEC60601-1, 60601- 2-22, and the Food and Drug
Administration’s Laser Performance Standard (21 CFR 1040.10 and 1040.11). Please
review all labels prior to using the laser.
Familiarity with the American National Standards Institute Z136.3 Document (and/
or Laser Institute Safety Manual) is strongly recommended.
Note: The laser must be installed and operated according to CAN/
CSA-Z386-92: Laser safety in health care facilities. The labels on the unit
are required under these standards for safety purposes and should not be
removed.
Labels
Caution Laser in Use
Each treatment area should have a “Laser in Use” warning sign posted at the
entrance to the treatment area. This signage serves to warn people not to enter
the treatment area without proper safety eyewear when the laser is in use.
The Nominal Ocular Hazard Distance with appropriate safety glasses is 1.5 meters
or 5 feet.
Class 4 Laser Product ............................... 808nm ± 10nm 3.0 Watts
Aiming Beam Laser ..................................650nm ± 10nm 5mW max
Pulse Duration ............................................ 50 ms
Beam Divergence ...................................... 617 mRad
Precautions
CAUTION: US Federal law restricts this device to sale by or on the order of a
physician.
DO NOT attempt to operate the laser system with any protective panels removed
or if the fiber delivery system is improperly connected. The system is equipped
with an interlock device for the protective housing/cover.
CAUTION: Do not attempt to remove the cover from the laser chassis for the
purpose of repairing the laser. Serious injury from an electrical shock or laser
radiation could occur. Removing the cover on the laser chassis will void the
warranty.
CAUTION: Not using the proper disposable tip may cause damage to the internal
components of the laser.
CAUTION: Changes or modifications not expressly approved by Discus Dental, LLC
could void the product warranty.
4 5
CAUTION: The remote interlock feature is disabled by default, so the laser is
functional. To use this feature, it must be enabled through the “Tools” screen, and
additional hardware is required.
CAUTION: Avoid prolonged exposure to the laser energy when working in and
around the cervical areas of the tooth. Due to the thin layer of enamel in this area,
the laser’s energy may be absorbed by the hemoglobin in the pulp in which case
pulpal hyperemia may occur. Extended exposure to laser energy could lead to
pain and possible pulpal necrosis.
CAUTION: Use a high-volume vacuum to remove the laser “plume.” Provide
high-filtration masks for all personnel in the treatment area. The laser plume may
contain viable tissue particulates.
CAUTION: The fiber optic cable is very fragile and can be damaged where it
attaches to the rear panel. Please be particularly careful when transporting or
placing the unit near protruding objects, so as not to damage the cable.
CAUTION: Do not touch the end of the fiber connector or place it on a dusty/
dirty surface prior to connecting to the rear panel. If contamination occurs, wipe
the connector end with lint free soft tissue dampened with 75-80% ethanol or
isopropyl alcohol. Make sure its dry and then attach the connector to the laser
port.
CAUTION: This device should be protected against unqualified use when
not in use.
DO limit access to the operation area to personnel who are trained in the
principles of laser safety. The laser system has a remote interlock option that
can be activated if necessary.
DO NOT attempt to defeat the system’s interlock or access the enclosures, as they
are designed for your protection.
DO NOT attempt repairs of this system. Service and maintenance should only be
performed by a qualified SL3
CAUTION: Avoid inadvertent laser firing. Turn the laser OFF when not in use for an
extended period of time.
™
Service Technician.
Warnings
WARNING: Laser Radiation – Avoid exposure to the eyes or skin from direct or
scattered radiation.
DO NOT place any part of the body in direct line with the laser beam.
WARNING: Use of controls or adjustments or performance of procedures other
than those specified herein may result in hazardous radiation exposure.
WARNING: Eyewear that protects your eyes from wavelengths other than 808nm
do not provide proper protection for use with this laser. Damage to the retina or
cornea may be irreparable if exposed to direct, reflected or scattered radiation.
Always wear protective eyewear when operating the laser.
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