DDC POLYLASE MX User manual

POLYLASE MX PULSED DUAL OUTPUT
LASER
Operator’s Manual
Caution: In the United States, federal law restricts this device to sale to or on the order of a physician or
any practitioner licensed by state law to use or order the use of this device.
Document Number 4000-002M
See Revision History page for revision of this manual.
Manufactured by

311 Woods Avenue, Oceanside, NY 11572
Tel.: [phone]
2020 by DDC Technologies, Inc.

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Contacting DDC Technologies, Inc.
In the United States:
DDC Technologies, Inc.
311 Woods Avenue,
Oceanside, NY 11572
USA
Tel.: [phone]
[phone] Customer Service
email: [e-mail]

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Revision History
Document Number 4000-002M Rev. 1-12
Document Number 4000-002M Rev. 1-17
Document Number 4000-002M Rev. 2-19
Document Number 4000-002M Rev. 1-20
Document Number 4000-002M Rev. 2-20
Prepared by:
Joseph Buscarello
Document No.:
UM 4000-002M
Reviewed by:
Dmitry Donskoy
Current Revision:
2-20
Approved by:
Dmitry Donskoy
Effective Date:
9/10/19

Chapter 1: Introduction
General Description 1-1
Operator Training 1-3
Indications for Use 1-3
Patient Exclusion Criteria 1-4
Warnings 1-4
Precautions 1-5
Complications/Adverse Effects 1-5
Operator Guidelines 1-6
Symbols Used in this Manual 1-7

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General Description
The POLYLASE MX Pulsed Dual Output Alexandrite and Nd:YAG Laser is designed to
deliver precise fluences of long pulses of laser energy at 755 nm and 1064 nm
wavelength to a predetermined target site to effect the elimination of unwanted hair.
The laser system (see Figure 1-1) is housed in a single protective cabinet. Delivery of
laser energy to the treatment site is through a fiber optic cable fitted with a handpiece,
designed to provide pre-determined laser beam spot sizes on the patient’s skin during
treatment. Once a foot switch is depressed, light is administered to the treatment area by
placing the distal end of the handpiece in contact with tissue.
The POLYLASE MX Pulsed Dual Output Laser is microprocessor-based to ensure
optimal flexibility and “user-friendly” control of the laser system. A touch-screen control
panel with color LCD display controls all laser system user functions. This display
provides visual feedback of system settings and operating parameters. Memory function
allows to store up to 5 five laser parameters’ settings, which provides the operator with
fast and repeatable laser setup.

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Figure 1-1. POLYLASE MX Dual Output Laser

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Operator Training
The POLYLASE MX Pulsed Dual Output Laser:
Caution: In the United States, federal law restricts this device to sale by or on the order of
a physician or any practitioner by state law to use or order the use of this device.
It is to be used by those trained in the safe handling and operation of this system. It is
recommended that, in addition to laser safety training of all operation room or clinic
personnel, the user/institution adopt a training and safety program as outlined in the latest
revision of the ANSI Standard Z-136.3, the American National Standard for the Safe Use
of Lasers in Health Care Facilities.
It is further suggested that practitioners desiring privileges for laser use should obtain
approval from the appropriate credential issuing body within their respective institutions.
Practitioners should consider the following training avenues:
1. An accredited training course within the practitioner’s specialty,
2. “Hands-on training under the preceptorship of a qualified used,
3. Attendance at specialty-specific courses presented during academy or college
meetings.
All practitioners handling lasers, including physicians, nurses and other allied
professionals, should also complete a training program which may include subjects such
as basic laser physics, laser safety, tissue interaction, laser operating procedures, laser set-
up procedures, potential hazards, and hands-on experience.
In-service training in the use of the POLYLASE MX Pulsed Dual Output Laser will be
provided near the time of the initial system installation. Clinical techniques described
here are presented only as a reference based on clinical experience with the device and
other laser devices reported in the published literature.
Indications for Use
The POLYLASE MX Pulsed Dual Output Alexandrite and Nd:YAG Laser indication for
use is based upon the selective absorption of natural chromophores, particularly melanin.
The Alexandrite Laser wavelength of 755 nanometers and Nd:YAG Laser wavelength of
1064 nanometers is well absorbed by this chromophore.
Indication for use:
The POLYLASE MX Pulsed Dual Output Laser is designed to effect hair removal of
patients with skin types I-VI through selective targeting of melanin in hair follicles.

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Patient Exclusion Criteria
There are no known absolute contraindications to laser treatment with the POLYLASE
MX Pulsed Dual Output Alexandrite and Nd:YAG Laser System. Patients who have had
prior problems with laser therapy, however, should be carefully screened prior to
treatment.
Persons known to form skin keloids may be more prone to scarring after any skin trauma,
including Alexandrite and/or Nd:YAG Laser treatment.
Relative patient exclusion criteria to Alexandrite and/or Nd:YAG Laser therapy include:
History of keloid scarring;
Active infections;
Herpes simplex within the treatment area;
Resent sun tanning;
Use of chemical or mechanical epilation 6 weeks prior to laser treatment;
Hypersensitivity to hydroquinone, if applicable.
Warnings
Patients should be cautioned in any of these situations apply.
The POLYLASE MX Pulsed Dual Output Laser is designed for treatment to
intact skin only;
Do not treat around the outer cantus of the eye;
Closing the eye is not sufficient protection from Alexandrite and Nd:YAG laser
light, therefore appropriate eye protection measures should be taken when treating
near the eye;
Should bleeding result at any time during the use of the POLYLASE MX Pulsed
Dual Output Laser contact cooling handpiece, discontinue use immediately and
quarantine the handpiece. Contact you DDC Technologies Customer Service
Representative for further instructions.
Be sure to observe all precautions described in Chapter 2: Safety, of this manual.

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Precautions
Clinical studies have shown that both treatment effectiveness and inflammatory response
to injury of the skin is exposure dose (FLUENCE) related; higher fluence level result in
greater effectiveness and also higher inflammatory response.
Begin treatment with a conservative exposure dose. If more tissue reaction is desired,
increase the energy level in 2-5 J/cm² increments until the desired tissue effect is
observed.
Treatment exposure dose should be based on test sites applicable to both the treatment
site and skin type of the patient to be treated.
Complications/Adverse Effects
In clinical studies involving the long pulse Alexandrite and Nd:YAG laser treatments, the
following minor complication were observed in some patients:
Hypopigmentation or hyperpigmentations may occur (Note: There complications
have been rated as both transient and minor and appear to resolve spontaneously
within several weeks or month after laser treatment.)
Pain during treatment sometimes occurs, but local anesthesia is generally not
required for these procedures.
Erythema and edema may occur immediately following treatment, but resolves
after several hours or days.
Blisters may occur during or sometimes after treatment, but since they are intra-
epidermal in nature, usually heal without scarring.

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Operator Guidelines
The following operator guidelines are provided as an outline of the general concepts for
properly using the POLYLASE MX Pulsed Dual Output Laser, and improve the care of
patients who choose this method of hair removal. For more information regarding
training on the use of the POLYLASE MX Pulsed Dual Output Laser, please refer to
page 1-2 of this Operator’s Manual.
Possible side effects or complications that may arise from use of the POLYLASE
MX Pulsed Dual Output Laser may include, but are not limited to:
hypopigmentation, hyperpigmentation, depigmentation, vesiculation (blister
formation), prolonged erythema and edema, scarring and poor clinical response.
These side effects are rare and can be minimized by following established
preoperative and postoperative instructions and using proper surgical technique.
Any hair that lies on the skin surface during treatment will absorb laser energy
and cause unnecessary discomfort or present other complications to the epidermis.
Therefore, all treatment areas should be shaved and cleared of all hair prior to
exposure to POLYLASE Alexandrite or Nd:YAG Laser pulses.
Performing tests at different energy fluences and properly evaluating the tissue’s
response prior to initiating treatment will help determine the proper energy
fluence for each site, reducing the risk of complications and side effects.
Vesicles (blisters) may sometimes occur at areas where the energy fluence used
was excessive. If a vesicle should form, it is important to recognize that it is
generally intra-epidermal and will usually heal without scarring. Vesicles should
be treated conservatively with gentle cleansing and application of a topical
antibiotic ointment until they have completely healed. If vesiculation or
nikolsky’s sign is encountered, the energy fluence should be reduced until these
reactions are no longer produced. If vesiculation occurs at even the lowest
fluence, then that person should be excluded from treatment.
Residue from hair shafts that have been destroyed by exposure to POLYLASE
MX Laser energy may accumulate on the surface of the handpiece protective
window during treatment. This debris may interfere with the effectiveness of the
treatment if it is not wiped off frequently using lint-free lens cloths or Q-tips.
It is recommended that the pulses be overlapped slightly to ensure that effective
energy is delivered to disable all hair follicles in the treatment site. The risk of
injury to the skin from overlapping pulses is very low. Overlapping using the
aiming beam as a guide is sufficient.
Since hair follicles typically grow at angles within the skin, it is possible to affect
follicles that are not directly in the beam’s apparent path at the skin surface. For
this reason, it is not advisable to use the POLYLASE MX Laser for shaping or
sculpting precise hair-bearing areas such as eyebrows.
Treatment of large areas may be somewhat time consuming and tedious. For that
reason, it is strongly recommended that POLYLASE MX Laser users take
frequent breaks or limit the length of each scheduled treatment session in order to
minimize eye strain of fatigue that could otherwise adversely affect the clinical
response.

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4000-001A
Symbols Used in this Manual
Danger
Indicates an imminent situation in which the possibility of exposure
to hazardous laser radiation may occur that could result in serious
injury to the operator, patient, or staff.
Danger
Indicates an imminent situation in which the possibility of exposure
to electrical shock or a fire hazard could result in serious injury to
the operator, patient, or staff.
Caution
Indicates a potentially hazardous situation that, if not avoided, could
result in damage to the equipment and serious injury to the operator,
patient, or staff.

Chapter 2: Safety
Overview 2-1
Optical 2-2
Safety Considerations 2-2
Electrical 2-3
Fire 2-4
Laser Safety Information 2-4

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4000-001A
Overview
All persons operating the POLYLASE MX Pulsed Dual Output Laser and all who are in
the vicinity of the laser must be aware of the potential hazards of the POLYLASE MX
Pulsed Dual Output Laser output. Be certain all personnel carefully review the safety
precautions pertaining to the POLYLASE MX Pulsed Dual Output Laser. Only
authorized individuals with appropriate laser training and knowledge should operate,
assist in the operation of, or provide maintenance/service to the laser system.
Warning
The electrical and laser radiation hazards present during servicing of
the POLYLASE MX Pulsed Dual Output Laser can be very
dangerous if proper safety precautions are not taken. Therefore, the
POLYLASE MX Pulsed Dual Output Laser may only be serviced by
qualified technicians who have received appropriate training on the
laser from DDC Technologies, Inc., and who are familiar with the
safety considerations discussed in this section.
The POLYLASE MX Pulsed Dual Output Laser has been designed
for the safest possible operation and maintenance. However, any laser
system can cause injury if it is not properly installed, operated,
moved and serviced. The potential hazards associated with the
POLYLASE MX Pulsed Dual Output Laser may include: ocular
damage resulting from exposure to direct or reflected laser radiation,
electrical shock from contact with electrical components inside the
system, and physical injury incurred while moving the laser.
Caution
Use of controls or adjustments or performance of procedures other
than those specified herein may result in hazardous radiation
exposure.
To avoid these hazards, the following precautions must be observed
when installing, operating, moving or servicing the system.

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4000-001A
Optical
The laser beam emitted by the POLYLASE MX Pulsed Dual Output Alexandrite and
Nd:YAG Laser is capable of causing loss of vision. The laser operates at 755 nm and
1064 nm, which fall within the near-infrared (IR) light spectrum. The cornea and lens of
the eye are partially transparent to near-IR light; therefore, any energy transmitted by the
POLYLASE MX Pulsed Alexandrite and Nd:YAG Laser that enters the eye will be
focused directly on the retina. Direct absorption of laser energy by the retina can result in
temporary clouded vision, retinal lesions, long-term scotoma (isolated voids in field of
vision), and long-term photophobia (sensitivity to light).
To avoid these vision hazards, everyone in the area where the POLYLASE MX Pulsed
Alexandrite and Nd:YAG Laser is operating or being serviced must wear appropriate eye
protection as described below. All windows in the room where the laser is being used
must be covered with opaque material, and measures should be taken to prevent
unauthorized access to the room. Laser warning signs must be posted at all entrances
wherever the POLYLASE MX Laser is in use. An ANSI approved laser safety sign is
provided with each laser system, and additional signs may be purchased directly from
Customer Support.
All personnel in the treatment room during operation or
service, including the person being treated, shall wear the
appropriate eye protection before starting the system and then
during use. Eye protection should not be removed until the
system is turned off. Note: merely closing your eyes offers
insufficient protection from Alexandrite and Nd:YAG laser
light.
Safety Considerations
Identify the laser room clearly, posting appropriate warning signs in prominent
locations.
Block all windows, portholes, etc. to prevent laser light from escaping the laser
room.
Restrict entry to the laser room when the laser is in use. Allow access to the laser
room only to those personnel both essential to the procedure and well-trained in
laser safety.
Make sure that all laser room personnel are familiar with the laser system controls
and know how to shut down the laser system instantly.
Appoint one person to be responsible for laser system controls during the
procedure.

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Never operate the laser in the presence of flammable liquids (such as alcohol) or
flammable anesthetics (such as ether). Moisten combustible solids (such as gauze
and swabs) with water or saline for safety.
Safety Considerations continued
Ensure that the laser system and ancillary equipment are working properly before
beginning a procedure.
Never direct the laser beam at anything other than the intended treatment site,
especially not at reflective objects such as metal surgical instruments.
Be certain the laser footswitch is clean and working properly. Place the footswitch
where it will not be mistaken for another piece of equipment.
Appropriate eye protection must be provided for the patient.
Never look directly into the distal end of the handpiece.
All personnel in the operating room must wear laser safety eyewear approved for
the Alexandrite and Nd:YAG Laser wavelength, with an Optical Density of 7 or
greater at 755 nm and 1064 nm; this includes both practitioners and those being
treated. Patients may also wear opaque stainless steel eye shields.
Post warning signs on all doors and cover all windows with nonflammable
window covering in the operating area.
Always ensure that the handpiece is in proper contact with the area to be treated
prior to the delivery of each laser pulse.
Electrical
Although the POLYLASE MX Pulsed Dual Output Laser has many safety features in its
design, certain precautions must be observed:
No one should attempt to operate the POLYLASE MX Pulsed Dual Output Laser with
any panel removed. This may expose personnel to dangerous high voltages and
potentially dangerous optical radiation. Qualified DDC Technologies Service
Representatives should perform any service requiring access to the interior of the
instrument (except the flash lamps change procedure described in this manual). To
contact a Service Representative, dial [phone].
The electrical safety hazard of any laser cannot be ignored or taken
lightly. The POLYLASE laser system uses AC line voltage to
produce high DC voltages inside the cabinet which have the
potential to cause fatal electrical shock. It is possible for the high
voltage components to retain a charge even after the laser has
been turned off. Therefore, no part of the exterior housing (with
exclusion for the top cover panel during flash lamp change
procedure) should be removed except by trained and authorized
laser technicians.

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A safety self-surveillance system monitors appropriate electrical, temperature, contact
and other variables and notifies the user of abnormalities by generating an error or
warning message.
Fire
The potential for fire hazards exist because of the nature of laser treatment. The
absorption of emitted laser energy, no matter how brief, may raise the temperature of any
material. This phenomenon is the basis of many useful medical and surgical applications;
it is also the reason that these applications often require precautions against the risk of
igniting combustible materials in and around the treatment area. When the POLYLASE
MX Pulsed Dual Output Laser is used, the following precautions should be taken:
Do not use any flammable substances, such as alcohol or acetone, in the
preparation of the skin for treatment. Use soap and water if necessary.
Anesthetics administered either by inhalation or topically must be approved as
nonflammable.
Exercise particular care in the use of oxygen. The presence of oxygen can
accelerate the combustion of any flammable material.
Avoid using combustible materials, such as gauze and drapes, in the treatment
area. When they are required, these materials may be made fire-retardant by
keeping them moist with water or saline. Clothing should be kept well away from
the area of treatment.
Simple and effective means of extinguishing a small fire should be kept on hand
during each procedure. A CO2fire extinguisher is recommended.
Laser Safety Information
The FDA’s Center for Devices and Radiological Health and laser safety professionals
recognize the American National Standards Institute (ANSI) series of Safe Use of Laser
standards as an excellent means of establishing and maintaining an adequate laser safety
program. Moreover, Federal and State Occupational Safety and Health Administration
(OSHA) inspectors and the Joint Commission on Accreditation of Healthcare
Organizations (JCAHO) use these standards as guidelines for inspections and audits.
ANSI Standard Z136.3 for Safe Use of Lasers in Health Care Facilities contains specific
guidance for medical users of lasers. ANSI Standard Z136.1 is the primary source for
more detailed information on laser safety. Both standards should be used in conjunction
with this system.

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The POLYLASE MX Laser is a long pulse dual output Alexandrite and Nd:YAG laser
operating at 755 nanometers (nm) and 1064 nm in the near-infrared (IR) light spectrum.
The laser light is emitted from the end of an optical fiber with a cooled handpiece. When
the laser is directed to the tissue being treated there is little chance of health care worker
exposure. However, as with any device, precautions must be taken to ensure there are no
unintended injuries.
The ANSI Z136.1 standard uses the concept of Nominal Hazard zone (NHZ). The NHZ
is an indication of the distances a laser may be capable of exceeding the Maximum
Permissible Exposure (MPE) and therefore cause eye injury. Persons within the NHZ
may, under ideal conditions for laser reflections, be exposed to levels of laser radiation
above the MPE.
The POLYLASE MX Pulsed Alexandrite and Nd:YAG Laser produces a maximum
possible output of 70 J/cm2or fluence, also known as energy dosage, or called radiant
exposure. The MPE for long pulse Alexandrite and Nd:YAG Laser is given in ANSI
Z136.1 as 2.3 x 10-5 J/cm2 . Using the equations in Appendix B of ANSI Z136.1, the NHZ
for this laser has a radius of approximately 11 meters, or 36 feet. This means that there is
a potential for exposure above the ANSI MPE within 36 feet of the laser during
operation, maintenance or service. Since this distance is larger than most installations in
which the laser is to be used, it would be safe to assume that the entire operating room or
theater is within the NHZ.
The ANSI standards contain guidance on protective procedures and administration of a
laser safety program as well as sample Standard operating Procedures. Please, follow the
recommendations of these standards. In particular, the use of safety eyewear, specific for
the Alexandrite Laser wavelength of 755 nm and Nd:YAG Laser wavelength of 1064 nm
with an adequate optical density rating (OD 7) must be used for all personnel with the
potential for laser exposure. Consult with your laser safety eyewear supplier for
recommendations, or contact DDC Technologies Customer Service.
The laser system should also be placed in relation to doors or entry ways in such a
manner as to contain stray laser emissions. ANSI Z136.1 and Z136.3 contain diagrams
and suggestions on how to properly set-up a laser laboratory. Please refer to the latest
editions of these documents.

Chapter 3: System Description
Overview 3-1
Wavelength 3-2
POLYLASE MX System Specifications 3-2
Components 3-3
Optical Laser Head 3-3
Power Supply Unit 3-3
System Control Electronics Module 3-3
Cooling System 3-3
Optical Delivery System 3-3
Laser Handpiece 3-4
Fiber Support Arm 3-6
Air Filters 3-7
Controls and Indicators 3-8
Main Control Panel 3-12
Required Labels 3-14
Location of Chassis Labels 3-15
Location of Handpiece Labels 3-16
Peripheral Devices Contained with System 3-17

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Overview
The POLYLASE MX Laser provides the hair removal market with a solid-state laser for
use in hair removal applications requiring the precise delivery of laser treatment energy
to a predetermined target site.
The design for the POLYLASE MX Laser incorporates a number of features that provide
high reliability, versatility, compact size and superior performance. The system is micro-
processor based to ensure maximum safety, flexibility in function and ease of use. The
touch-screen control panel (see Figure 3-1) displays:
Sequential use instructions
Key operating data
System status information
This information is shown on a color LCD display, which is mounted on the front panel
of the laser chassis.
Figure 3-1. POLYLASE MX Laser Control Panel

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Wavelength
The POLYLASE MX Dual Output Alexandrite and Nd:YAG Laser emits laser radiation
at 755 nanometers and 1064 nanometers (nm) wavelength. The beam is aligned and
delivered to the treatment area via an optical fiber with attached handpiece device.
POLYLASE MX System Specifications
Item
Description
Laser Type
Long Pulse Alexandrite Laser
Long Pulse Nd:YAG Laser
Laser Wavelength
755 nm
1064 nm
Max. Energy Per
Pulse, J
75 J
70 J
Laser Pulse Width
0.5-100 ms (user selectable)
0.5-100 ms (user selectable)
Max. Average Power
120 W
120W
Pulse Repetition Rate
Single Shot –5 Hz
Single Shot –10 Hz
Beam Delivery
Optical fiber, 10 feet (3 m)
length
Optical fiber, 10 feet (3 m)
length
Optical Fiber Core
Diameter
1000 m
1000 m
Handpiece Spot Size
10 mm, 12 mm or 16 mm dia.
(Optional: 14, 16 and 20 mm)
10 mm, 12 mm or 16 mm dia.
(Or 2mm, 3mm, 4mm in
“Vein” mode)
Max. Energy Fluence
@ 16 mm spot size
37.5 J/cm2
35 J/cm2
Handpiece Cooling
Compressed chilled air jet
Compressed chilled air jet
Dimensions (HxWxL)
33.5”x 18.5”x 43.5” (850x470x1105 mm)
Weight
70 kg (155 lbs.)
Power Requirements
215…240V single phase ~50/60Hz, 20A
Noise Level
<70 dB