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.: (516) 594-1533

2023 by DDC Technologies, Inc.

Contacting DDC Technologies, Inc.

In the United States:

DDC Technologies, Inc.

311 Woods Avenue,
Oceanside, NY 11572
USA

Tel.: (516) 594-1533

(516) 770-0441 Customer Service
email: [email protected]

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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

Document Number 4000-002M Rev. 1-21

Document Number 4000-002M Rev. 2-21

Document Number 4000-002M Rev. 1-23

Prepared by: Joseph Buscarello Document No.: UM 4000-002M

Reviewed by: Dmitry Donskoy Current Revision: 1-21

Approved by: Dmitry Donskoy Effective Date: 9/10/19

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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

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 induce 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 various 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 of

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 your DDC Technologies Customer Service
Representative for further instructions.

Be sure to observe all precautions described in Chapter 2: Safety, in 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 hyperpigmentation 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 resolve
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 and reduce 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
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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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
4000-001A

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.

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Chapter 2: Safety

Overview 2-1

Optical 2-2

Safety Considerations 2-2

Electrical 2-3

Fire 2-4

Laser Safety Information 2-4

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
4000-001A

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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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
4000-001A 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 flashlamps change procedure described in this manual). To contact
a Service Representative, dial (516) 770-0441.

The electrical safety hazard of any laser cannot be ignored or taken

lightly. The POLYLASE MX 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 exists 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 CO2 fire 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/cm2 or fluence, also known as energy dosage, or 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 regarding 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.

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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 3-17

Peripheral Devices Contained with System 3-18

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
microprocessor 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 75 J 70 J
Pulse, 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) Optical fiber, 10 feet (3 m)
length length
Optical Fiber Core 1000 µm 1000 µm
Diameter
Handpiece Spot Size 10 mm, 12 mm or 16 mm dia. 10 mm, 12 mm or 16 mm dia.
(Optional: 14, 16 and 20 mm) (Or 2mm, 3mm, 4mm in
“Vein” mode)
Max. Energy Fluence 37.5 J/cm2 35 J/cm2
@ 16 mm spot size
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

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Components

The POLYLASE MX Laser consists of the following components: Optical Laser Head,
Power Supply Unit, System Control Electronics Module, Internal Cooling System, Beam
Delivery System with Handpiece.

Optical Laser Head

The optical laser head consists of an optical rail with two flashlamp pump chambers that
house the Alexandrite and Nd:YAG crystal and xenon flashlamps; laser resonator
mirrors; an energy meter sensors and other optical components.

Power Supply Unit

The power supply unit consists of a high voltage power supply with pulse-forming
network (PFN) electrical circuit, and power distribution system with power factor
corrector (PFC).

System Control Electronics

The system control electronics consists of the User Interface Controller (mini-PC) with
high resolution 10" touch screen control panel, System Input-Output PCB
(microprocessor-controlled I/O Board), system controls, interlocks and sensors.

Cooling System
This system uses a self-contained water-to-air chiller unit for laser pump chamber and
electronics cooling.

Optical Delivery System

The optical delivery system delivers laser energy from the device chassis to the treatment
area. The optical fiber cable, enclosed in reinforced protective jacket, is attached to the
fiber port at the rear panel of the laser.

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Laser Handpiece
The laser handpiece is equipped with the distance gauge, which provides fixed laser beam
spot size on the treatment area. The spot size and the fluence level can be changed from
the laser control panel. The motorized zoom lens position is electronically recognized by
the system and is reflected as the Laser Beam Spot Size (Spot Size) on the LCD display.
The system processor will calculate the energy fluence delivered to the patient skin in
accordance with selected laser beam spot size.

Component Description
Handpiece Handle The user holds the laser handpiece by the
body-handle during treatment. The
handpiece is also equipped with a trigger
button (pulse finger trigger), which can be
used instead of the footswitch. The use of the
finger trigger or the footswitch can be
selected by button (see Fig. 3-1).
Protective Window (Output The handpiece output window serves as the
Aperture) laser aperture. It protects the main focusing
lens from contamination during treatment.
The collimating lens inside the handpiece
changes the laser beam divergence out of the
fiber, and in combination with imaging zoom
lens provides fixed laser beam spot size at
the certain distance from the handpiece.
Fiber Cable Umbilical Jacket Contains optical fiber, electrical cables and
cooling air tubing. The reinforced umbilical
jacket protects optical fiber from mechanical
damage. It also prevents the fiber from being
bent to too small radius during treatment.
Warning! The umbilical jacket can
protect the optical fiber to a certain extent
only. Do not apply force to try to bend the
cable to the smaller radius, than the jacket
easily allows or by pulling on the fiber by
the handpiece. This can lead to the
permanent fiber cable damage, which is
not covered by Limited Warranty.
Distance Gauge Provides fixed distance to get correct beam
spot size on the treatment area. Second
gauge also serves as a guide and output
nozzle for the skin cooling air jet.
\

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Fiber Cable Distance Gauge
Umbilical

Trigger Button

Spot Size Display

Window

Protective Window
Holder
Cooling Air Supply
Nozzle

Zimmer Adaptor
Channel

Figure 3-2. Laser Handpiece Components

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Fiber Support Arm
The fiber support arm is intended to support the beam delivery system so that the conduit
is kept clear of the operation area, as well as providing support for the conduit while in
use. It is recommended to use the handpiece while the fiber conduit is attached to the
fiber support arm. The arm is capable of swinging to a convenient location or locking in
place by tightening the fiber support clamp on the rear of the machine (see “Fiber
Support Arm and Fiber Attachment” section of Chapter 4 for more details). By keeping
the handpiece attached to the arm, it will also prevent accidental dropping of the hand
piece.

Hose Attachment

Adjustment Knobs
Flexible Neck

Hose Hanger

Figure 3-3. Fiber Support Arm Components

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Air Filter Cleaning / Replacement
The Polylase-MX is equipped with two air filters that prevent dust and foreign matter
from building up inside the machine. These are located in the front of the machine,
behind the air vents on the bottom of the front panel, as shown in Figure 3-4. The
direction of the air flow is indicated by the yellow arrows.

Figure 3-4. Air Filter Location

There are two filters of different sizes: the vertical sitting filter is 5.6” x 12.9” and the
horizontal filter is 7.6” x 10”. There is a mesh screen on one side of the filter, and the
direction of air flow is marked as shown in Figure 3-5.

Figure 3-5. Air Filter Flow Direction

In order to access the air filters, remove the machine side panel. Then the vertical filter
can slide out of the bracket. Clean the horizontal filter in place with a vacuum and small
brush. To install cleaned or new filters, slide them into the brackets, making sure the
mesh screens on the filter face the inside of the machine.
To clean the filters, remove them from the machine and thoroughly wash with warm
water and allow to dry. Filters should be replaced when the foam begins to wear.

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 Controls and Indicators

The POLYLASE MX Laser is equipped with features designed specifically to provide

safe and reliable operation to laser users. All laser personnel should become familiar with
the location (see Figures) and operation of the safety features discussed below and on the
following pages.

Component Description
Main Power Switch This switch disconnects the system from
the power source when put in OFF
position (see Fig. 3-8).
Display Touch-screen Color LCD display prompts
the user to enter and initiate important
operating parameters.
Emergency Off Button A large red circular push-button switch
that disables the laser power supply.
(Note: The EMERGENCY OFF button
will remain depressed until it is rotated
clockwise and pulled up).
Key (power) Switch A key switch that activates the DC power
supply and laser controller. The key may
be removed only when in OFF position.

Figure 3-6. Front controls

-8-
Figure 3-7. Front and side of the POLYLASE MX Laser

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 External (door)
Main power switch interlock connector

Foot switch connector

Main power cable

Figure 3-8. Rear of the POLYLASE MX Laser

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Component Description
Optical Fiber Cable Laser light pulses are delivered via a fiber
optic cable.
Laser Handpiece The handpiece provides accurate laser
beam delivery to the treatment area.
Different spot sizes can be generated by
motorized zoom lens and provide fixed
laser beam diameter on the skin, helping
to maintain desired energy density
(Fluence) during treatment.
Rear Panel The power cord and footswitch cable are
attached at this panel, as well as
Alexandrite and Nd:YAG beam delivery
systems (see Fig. 3-8).
Footswitch Depressing the footswitch activates the
laser, permitting it to fire when the laser is
in READY mode.
Control Panel The control panel with touch-screen LCD
display shows the system status at all
times, allows the user to operate laser
controls, select treatment parameters and
displays various messages to the user.

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Main Control Panel

Figure 3-9. Control Panel – Parameter Setting (Edit) Screen

- 12 -
Control Description
Parameter Setting Buttons Serve to display current device settings:
Spot Size (mm); Pulse Duration (pulse width, ms);
Frequency (Hz)-pulse repetition frequency. Parameter
(except for the Spot Size) can be edited by either using
increase/decrease arrow buttons (incremental change) or by
sliding the gray bar left or right. The current value of each
laser setting is displayed in the center of the corresponding
horizontal window. The Spot Size can be selected by
pressing correspondent round Spot Size button.
Fluence Button Serves to set Fluence on the target. After user presets
desired fluence level, the system parameters are adjusted
based on the laser calibration table (stored in system
memory) and current Pulse Duration and Beam Size
settings. Fluence is a measure of energy density and is
shown as Joules/cm2. Fluence can be changed the same
way as other parameters (see above).
Memory Selection Buttons Serve to recall pre-set Operating Parameters stored for each
combination of Skin Type, Hair Type, Hair Color and
Body Area. The recalled pre-set treatment parameters can
be still adjusted with Parameter Setting Buttons, as
described above.
Save/Ready Button Serves to switch between EDIT and READY system modes
while saving new parameter settings for the current
treatment session.
Vein Button Serves to switch between HAIR and VEIN treatment
modes.
Switch to YAG Button Used to switch between Alexandrite and Nd:YAG
operation modes.
Memory Set Button Used to enter pre-set Operating Parameters Edit Screen,
where user can override factory memory settings for
preferred treatment parameters and customize it based on
his/her desire and experience.
Service Button Used to switch between EDIT and SERVICE screens

Sound ON/OFF Button Used to turn the pulse beep sound ON or OFF
Footswitch/Finger Trigger Used to switch between footswitch or finger trigger use
Selection Button
Shutdown Button Used to initiate system shutdown procedure

- 13 -
Required Labels

Government regulations require that certain labels appear on the POLYLASE MX Laser and be reproduced
in this manual.

Located on front lower panel of the laser system

DANGER (4000-001D)

VISIBLE and/or INVISIBLE LASER

RADIATION AVOID EYE OR SKIN
EXPOSURE TO DIRECT OR
SCATTERED RADIATION
75J max. 1-100 msec
@ 1064 nm and 755 nm

CLASS IV LASER PRODUCT

Located on the laser rear panel and output end of the handpiece
LASER APERTURE (4000-001A)
4000-001A

Located on front and rear panels of the laser system

(4000-003D)

4000-001A

DANGER Located on the laser head cover

LASER RADIATION WHEN OPEN (4000-002D)
AVOID EYE OR SKIN EXPOSURE TO
DIRECT OR SCATTERED RADIATION

4000-002D

- 14 -
 Located on rear panel of the laser system.
(4000-001S)

Figure 3-10. Labels, front of the POLYLASE MX Laser

- 15 -
Figure 3-11. Labels, rear of the POLYLASE MX Laser

- 16 -
Laser Aperture Label
(4000-001A)

Figure 3-12. Handpiece Label

Figure 3-13. Laser Head Cover Label

- 17 -
Peripheral Devices

Peripheral devices contained with the POLYLASE MX Laser are as follows:

• Footswitch

• 2 Pairs of Safety Glasses

• Laser Key

• Operator’s Manual

• Laser Safety Door Sign (optional)

System Accessories
Laser Safety Eyewear Order P/N GCYN-35
These glasses are designed to protect the person operating the POLYLASE™ MX Dual
Alexandrite/Nd:YAG Laser, as well as the patient and others who may be in the room.
They are designed to provide OD>6.0 at 755 nm and 1064 nm. Their shape is designed to
protect the wearer at various angles. Two pairs are included with each system.

Laser Key Order P/N CKL12BFW01

The laser is powered up by turning the supplied key in the switch located on the upper-
front console. One key is included with each system.

Operator’s Manual Order P/N 4000-002M

Replacement or additional copies of this manual are available. Everyone who works with
the POLYLASE MX Laser should read and familiarize themselves with the contents of
this manual. One is included with each system.

Laser Safety Door Sign Order P/N 4000-010D

This sign should be posted outside of the room where the POLYLASE MX Laser is
located. It serves as an informative warning to those who wish to enter the room that
there are potential hazards related to the device and what level of precaution they should
consider before entering. One sign is supplied with each system upon request.

- 18 -
Chapter 4: Installation

Customer’s Responsibilities 4-1

Manufacturer’s Responsibilities 4-1

Facilities Requirements 4-2

Electrical Requirements 4-2

Ambient Temperature 4-2

Air Quality 4-2

Space Requirements 4-3

Footswitch Connection 4-3

Beam Delivery System Connection 4-4

Customer’s Responsibilities

Before installation of the laser system, the intended site must be prepared as described in
this section. The selected site must have sufficient space to accommodate the laser
system, must possess the proper electrical power configuration and receptacles, and must
meet the environmental specifications outlined in this section. DDC Technologies, Inc.
cannot guarantee the operating parameters of any system installed on a site that does not
meet the specifications described in this section.
Note: Generally, laser installation is performed at customer’s facilities by qualified laser
engineer or technician. However, certain experienced customers and authorized specially
trained distributors can successfully perform device installation on their own. Please,
refer to POLYLASE MX: Brief Installation Guide attached to this Manual for step-by
–step installation instructions.

Manufacturer’s Responsibilities

Installation of the laser system is performed by a qualified laser engineer. (NOTE: Initial
installation and test can be a lengthy process; the room where the laser will be housed
should be blocked off for about one day to allow adequate time for this procedure.) Upon
arrival, the DDC Technologies Service Technician will complete the following:

• Uncrate the POLYLASE MX Laser System, and position it in the location you
have pre-selected.
• Couple the laser to the existing 215-250V AC receptacle and check the ground
connection.
• Fill the cooling system with fresh distilled water and test the laser for proper
alignment, power detector calibration, and functional operation of all components.
• Coordinate the performance of on-site safety checks by biomedical engineering
personnel.

Following installation, a qualified service representative will instruct designated

personnel on the basic operation and care of the laser system, which supplements the
information in this manual. This instruction is not a substitute for the in-depth clinical
training required for a practitioner to become proficient in the use of this laser.

-1-
Facilities Requirements

Electrical Requirements

The room where the laser will be installed should be equipped with a 215-250VAC,
single phase, 20 A electrical service. It is recommended that the electrical supply to the
equipment be independently fused and switched by a 20 A circuit breaker, mounted at a
convenient height in the operating area. This will enable the POLYLASE MX Laser to be
electronically isolated for maintenance purposes.

Due to many electrical codes and preferences of most facilities, it is the responsibility of
the user to provide the male plug for attachment to the line cord for use in your
receptacle. Before plugging the system, make sure that the key switch and Main switch
are in OFF position and the main electrical cable is tightly connected to the wall
receptacle.

Ambient Temperature

Proper ambient temperature must not exceed 25 °C and must not fall below 15 °C. It is
likely that the laser will continue to function normally if the temperature is not within
these limits. However, high temperature warning message and system shut-off due to
overheating condition may take place.
The laser will generate approximately 3500 watts of heat into the room when operating at
full power. Therefore, the air conditioner you select for the laser room must be able to
accommodate this additional heat.
If the coolant water is colder than 15 °C the laser controller will not allow starting the
laser and will respond with the Error Message: “System is too cold” with actual coolant
water temperature being displayed on the screen. The water in this case has to be
naturally warmed up to above 15 °C without the pump running the cold water through the
system, before the laser controller will allow the system to start.

Air Quality
Ensure that the atmosphere is non-corrosive, with no salts or acids in suspension in the
air. Acids, corrosives, and volatile materials are likely to attack electrical wiring and the
surfaces of optical components.

Keep airborne dust particles to a minimum. Dust particles can cause permanent damage
to optical surfaces and excessive dust can clog the cooling system heat exchanger and air
intake filters. Never place the laser in an environment proximal to areas undergoing
construction or remodeling.

-2-
Space Requirements
Sufficient floor space is also required for the laser system. The suggested minimum room
size is 10 x 10 feet (3 x 3 meters). Allow 24 inches (61 cm) of clearance on all sides of
the machine so that the air vents will not be obstructed.
The POLYLASE MX Laser is moved easily from room to room. Make sure that adequate
space and appropriate electrical hookups are available in each room where its use is
anticipated. If the system is moved, care must be taken to ensure that the optical fiber
cables and laser handpieces are not damaged.

Footswitch Connection

Check to see that the footswitch cable is firmly connected to the footswitch receptacle
input on the back of the laser unit.

Foot switch connector

Figure 4-1. Footswitch connection.

-3-
 Beam Delivery System Connection

Fiber Support Arm Installation

Before attaching the beam delivery system, it is important to install the fiber support arm
(fiber support pole) to the back of the machine. This arm provides support for the fiber
conduit and handpiece both while in use and in standby.
The black adjustment knobs on the arm (see Figure 3-3) can be loosened in order to
position the arm segments in the desired positions. Then, firmly lock the knobs in place
to keep the arm rigid. For installation, position the arm as shown in Figure 4-2. Screw the
attachment knob all the way into the fiber support holder. The pole should rest in the
groove of the clamp already installed on the rear of the machine. Once the pole is
installed, attach the second piece, Fiber Support Clamp 2 (see Fig. 4-2) with 4 M3
screws. Tightening the M3 screws all the way will lock the pole in place while loosening
the screws will allow the pole to freely swing back and forth.

Fiber Support Clamp 1

Fiber Support Clamp 2

Fiber Support Arm

Attachment Knob

Fiber Support Arm

Holder

Figure 4-2. Fiber Support Arm Installation

-4-
Beam Delivery System Attachment
After the fiber support arm is installed, the beam delivery systems can be securely
installed. Remove the fiber from the box and place the handpiece into the handpiece
holder (white grommet) on the laser front handle. Feed the fiber conduit into the hose
hanger, then push it into the hose attachment (see Fig. 4-4). Before attachment of the
fiber to the fiber port pull the green fiber cable attachment out of the grey rubber cuff of
the conduit. Finally, remove the black vinyl cover from the end of the fiber. Insert the
fiber end (Blast Shield Holder / FC Connector) into the fiber port receptacle on the laser
rear panel. Screw the fiber cable attachment into the laser port all the way to the end.
Gently push the rubber cuff back onto fiber cable attachment (see Fig. 4-3). Connect all
electrical cables to appropriate sockets. Connect air cooling system tubing (if equipped)
to the cooling air supply connector.
Error! Objects cannot be created from editing field codes.Never touch the glass
surface of the fiber Blast Shield Window at the fiber end during this procedure!
Only use metal parts for holding the assembly. Make sure the Blast Shield Window
is clean from fingerprints and dust before inserting fiber end to the fiber port.
Error! Objects cannot be created from editing field codes. It is important not to
over tighten the fiber cable attachment. Screw the part until it reaches the bottom of
the threads but do not apply excessive force. Figures 4-3 and 4-4 show the fiber
securely attached to the arm and the fiber port at the rear panel of the laser.

For more information about this procedure, refer to SOP1: "Beam Delivery System
Installation" in the Service Manual.

Figure 4-3. Fiber Cables Attached to the Fiber Port.

-5-
Figure 4-4. Fibers Installed on Fiber Support Arm

-6-
Chapter 5: System Operation

Control System 5-1

Before Beginning 5-2

Operating Instructions 5-3

Start-Up 5-5

Edit Mode (Setting Parameters) 5-7

Ready Mode 5-10

Switch Laser Function 5-11

Session Complete 5-11

Handpiece Cleaning 5-12

Cleaning the Laser Console 5-13

Other System Features 5-14

Handpiece Vein Mode 5-14

Handpiece Manual Mode 5-15

System Sounds 5-15

Error Messages and Troubleshooting 5-16

System/Interlock Errors 5-16

System Faults 5-17

Laser Controller Errors 5-19

Flashlamp Service 5-20

Coolant Water Replacement 5-20

Calibration Procedure 5-20

 In the United States, federal law restricts this device to sale by or
on the order of a physician or any practitioner licensed by state law
to use or order the use of this device. No such restrictions apply to
international sales. Those who use the system should be properly
trained and authorized by the practitioner or institution.
Although the determination of appropriate training criteria is the
responsibility of the practitioner or institution, it is recommended
that minimal training include education on laser physics, laser
safety, laser interaction with tissue, guidelines for use in specific
applications, and hands-on training with appropriate models.

Control System

The POLYLASE MX Laser is a microprocessor-controlled system designed to be “user-

friendly” while providing highly reliable laser output. The touch screen color LCD
display shows important operating data, instructions for use and messages to the user.

Figure 5-1. Main control panel

-1-
Before Beginning

Before you turn on the laser, ensure that the location of the POLYLASE MX Laser does
not interfere with other objects (including the door) in the room. There should be at least
two feet (61 cm) of free air space around all sides of the system.

Treat the optical fiber/handpiece assembly with care: if the handpiece hits the
console, floor or other treatment room equipment, damage can result. Such damage
is not covered in the standard warranty or service contract.

Do not have the main cable stretched so tightly that it puts unnecessary strain on the cable
and its terminations. Be sure that the main cable is out of pedestrian traffic around the
system.

Ensure that protective eyewear appropriate for the Alexandrite / Nd:YAG Laser system
(>OD 7 at 755 nm and 1064 nm) is readily available to be put on before the system is
energized.
Additional goggles or glasses are available. Please contact Customer Service for more
information.

EVERYONE in the treatment area should have on protective

eyewear at this point, and as long as the system is turned on.
4000-001A

-2-
Operating Instructions

Main power switch

Foot switch connector

Water Drain Outlet

External (door) interlock

connector
Main power cable

Figure 5-2 (a). Rear panel controls and connectors (bottom)

-3-
 Air Cooler Switch
Air Compressor Switch

Fiber Cable Connector

Air Hose Connector

Handpiece Cable
Connector

Figure 5-2 (b). Rear panel controls and connectors (top)

-4-
Start-Up
Ensure that the main power line is plugged into the wall receptacle.
Turn on the Main Power Switch located at rear of the unit by switching it to the ON
position. (See Figure 5-2)

Figure 5-3 (a). Front control panel (key on)

Figure 5-3 (b). Laser Output Selection Screen

-5-
To activate the POLYLASE MX Laser:
Insert the laser key and rotate clockwise (see Figure 5-3 (a)).
After the system is turned on and the software self-test procedure is complete, the Laser
Output Selection screen will be displayed.
Press corresponding button on the touch screen to select Alexandrite or Nd:YAG laser
output (see Fig. 5-3 (b)).

At this moment the cooling system pump will start and laser lamp(s) will ignite. After the
system has completed a start up cycle, laser will stay in Edit mode (see Fig. 5-4). In this
mode laser operating parameters can be modified by the operator and the laser energy
cannot be emitted.
After the system is turned on, Parameter Settings used during previous session are used
as default operating parameters, until different parameters are selected by the user.

Note: If the coolant water temperature is measured < 40⁰ C after Alexandrite laser start
button was pressed, the automated laser warm up procedure will start. Since the power of
the flash lamps is used to warm up the coolant water in Polylase, the sound of the flash
lamp discharge pulses can be heard during the warmup procedure. This is normal.
The following message is displayed on the screen during the warmup procedure: see Fig.
5-3 (c). The warmup procedure automatically stops when the coolant water temperature
reaches 40⁰ C.
There is no laser warm up procedure if Nd:YAG laser is selected.

Figure 5-3 (c). Laser Warmup Message

-6-
Edit Mode (Setting Parameters)

Figure 5-4. Edit Mode Screen

All parameters that can be modified by the operator are entered while in the Edit mode.
To switch between Ready and Edit mode Save/Ready button on the touch-screen panel
must be depressed. Pressing Save/Ready button will save all parameter changes that have
been made in Edit mode.
Parameter Setting Buttons serve to change and display current device settings:
Fluence (J/cm2); Spot Size (mm); Pulse Duration (pulse width, ms); Frequency (Hz)-
pulse repetition frequency. Parameter (except for the Spot Size) can be edited by either
using increase/decrease arrow buttons (incremental change) or by sliding the gray bar left
or right. The current value of each laser setting is displayed in the center of the
corresponding horizontal window. The Spot Size can be selected by pressing
correspondent round Spot Size button.
Fluence Setting arrow buttons and slide serve to set Fluence on the target. After user
presets desired fluence level, the system parameters are adjusted based on the laser
calibration table (stored in system memory) and current Pulse Duration and Beam Size
settings. Fluence is a measure of energy density and is shown as Joules/cm2.
The operator also can select Parameter Settings with patient skin and hair evaluated
features selections, using corresponding buttons to recall pre-set Operating Parameters
stored for each combination of Skin Type, Hair Type, Hair Color and Body Area. The
user can select among 4 different skin types (6 for Nd:YAG), 2 hair types (coarse and
fine), 3 different hair color tones and various body areas ( button can be used to switch
between 5 women's and 6 men's body areas). The currently selected setting is highlighted
with red circle and/or pointed with a triangle.

-7-
Memory Set Button switches to Pre-set Operating Parameters Edit Screen, where user
can override factory memory settings for preferred treatment parameters and customize it
based on his/her desire and experience.

Figure 5-5. Memory Set Screen

After pre-set parameters adjustments are finished, press Save/Edit button to return to
Edit screen.

The laser beam Spot Size can only be changed from the touch-screen control panel. This
function works only in Edit mode. Three spot sizes (14 mm, 16 mm and 20 mm for the
Alexandrite and 10, 12 and 16 mm for the Nd:YAG) are available in the POLYLASE
MX handpieces. The currently selected spot size is displayed on the highlighted Spot
Size Button on the laser control display. It is also displayed on the handpiece LED spot
size indicator.
Note: handpiece LED spot size indicator always displays actual handpiece state, i.e., it
will display previously used spot size until Save/Ready button is pressed and the zoom
lens moves to new position.
The treatment area (laser beam spot size on the skin) will be also illuminated by the red
aiming beam in Ready mode. The spot size of the aiming beam is changing
proportionally to the actual laser beam spot size.
The system will keep pre-selected Fluence value constant, no matter what spot size has
been chosen by the user. However, if the pre-set Fluence level cannot be supported with
selected spot size, the system will automatically reduce the Fluence to the maximum
possible level and reflect the change on the LCD display. The Pulse Duration will be
automatically adjusted to the higher value by the system software if selected Fluence is
too high and cannot be achieved with currently selected Pulse Duration.

-8-
Note: Pulse Duration settings range is always limited by selected Fluence, i.e., some
pulse widths may not be available at certain combinations of the Fluence and Beam Size
settings. This is normal.

When the Save/Ready button is pressed after parameters selection and editing is finished,
a new set of operating parameters is saved for the current treatment session and the
system switches to Ready mode.

LONG PULSE MODE

All pulses with Durations above 10 ms (Nd:YAG) and 7 ms (Alexandrite) are

“stretched”, i.e., consist of a train of shorter pulses spaced in time. The sum of the pulse
widths in each train is equal to 10 or 7 ms respectively. This mode of operation is called
Long Pulse Mode and is designed to provide a certain degree of pain relief for patients
with too sensitive skin. It is not recommended to use this mode for treatment of areas
with very fine (thin) hair.

Example: To select and then adjust the Fluence setting for the patient with Skin Type 3
and coarse dark hair for underarm hair removal, do the following:

1. Press SKIN TYPE button and then select the Skin Type III option from the
horizontal row (see Fig. 5-4)
2. Press HAIR TYPE button and select Coarse from two options that will appear on
the screen.
3. Press HAIR COLOR button and select III (the dark one) from three options in the
horizontal row.
4. Press BODY AREA button and select Underarms from the options in the
horizontal row or use the body figure on the left and pick the underarm area using
the touch screen.
5. If there is a desire to adjust the recommended settings recalled from the system
memory, use > button if you want to increase the Fluence and < button if the
Fluence must be decreased or use a slide bar to quickly change its value.
6. When the desired Fluence value is displayed, adjust the other parameters (if
necessary) and then press Save/Ready button to switch the laser to Ready mode.

-9-
Ready Mode

Figure 5-6. Ready Mode Screen

When in Ready mode, please ensure that everyone in the treatment room is wearing
proper eye protection. For more information regarding eye safety, please see
Chapter 2, Laser Safety Information.

Press Save/Ready button to switch the laser from Edit to Ready mode. The screen will
change to Ready mode. The red sign on the LCD display will read: “LASER IS
READY”. In Ready mode the laser is armed and ready to fire. The intra-cavity shutter is
open and the laser power can be released by depressing a footswitch or a trigger button
on the handpiece. The use of the footswitch or the handpiece trigger button can be
selected by the button (see Fig. 5-4, 5-6). Unless the footswitch or the handpiece
trigger button is depressed, it is not possible to fire the laser in this mode.
It is not possible to change parameters while in Ready mode.

To enter Standby/Edit mode from Ready mode, press Standby button.

When you are ready to begin laser treatment, press the footswitch. At this moment laser
energy will be delivered to the treatment area.
The Frequency display in the Treatment Parameters display area will show laser Pulse
Repetition Frequency (PRF) in Hz. In the Single Shot mode only one laser pulse will be
delivered when the footswitch is depressed. In order to fire the laser again, the footswitch
must be released and then depressed one more time. In this mode the frequency display in
the Parameter Settings area will read “0”.

- 10 -
The laser PRF will be automatically reduced by the system software to the maximum
possible value, if selected combination of Fluence, Beam Size and Frequency results in
the average power that cannot be supported by the laser power supply. This is normal.

Pulse Counter displays number of laser pulses fired since last counter reset. In order to
reset the pulse counter, press and hold Reset button for ~2 sec.

SWITCH LASER FUNCTION

In order to quickly switch between Alexandrite and Nd:YAG laser mode, press and hold
Switch to YAG (or Switch to Alex if current selection is Nd:YAG) button on the Edit
screen for ~3 sec. The laser controller display will switch to the Start Screen (see Fig. 5-3
(b)), where Nd:YAG or Alexandrite laser can be selected for the next treatment session.

Session Complete

When the session is complete:

If another patient is scheduled within 30 minutes, place the system into the Edit mode
and clean the handpiece. The handpiece MUST be cleaned prior to the next patient
treatment. See the handpiece cleaning procedure below.
If the system is not used again within 30 minutes, it is recommended to turn off the
system by pressing the Shutdown button in the upper right corner of the screen (see
Fig. 5-7).

Figure 5-7 Shutdown Screen

Press “OK” to initiate system shutdown procedure and follow instructions on the screen.
Press “Restart” to quickly restart the laser software and return to Laser Output Selection
Screen.

- 11 -
Handpiece Cleaning

The handpiece is a non-critical product per APIC Guidelines and requires cleaning of the
output protective window by an alcohol swab in-between patients. This window is
located inside the snap-in holder at the handpiece output aperture (between two distance
gauges) and should be cleaned during extended use to reduce dirt accumulation. Products
such as standard alcohol prep pads or Q-tips soaked with acetone or methanol may be
used to clean the laser handpiece protective window between patients. Always finish the
cleaning process with a fresh wipe or Q-tip to ensure that all areas are cleared of all
debris. For better cleaning or for protective window replacement pull the holder out of
the handpiece. Unscrew the holding nut and remove the protective window from the
holder.
Note: After extended use the optical surface of protective window can be damaged,
despite regular cleaning. This is normal. If extensive damages can be seen on the window
surface, replace it with a new one. Please, contact DDC Technologies Customer service
department and ask for Part #W-755/1064-0501 to order.

Figure 5-8. Handpiece protective window is located inside the snap-in holder
between distance gauges.

- 12 -
Cleaning the Laser Console

Clean the external surfaces of the laser console periodically with a clean cloth wetted
with a spray cleaner (do not use acetone to clean any Laser Console parts!). Dry with
clean, dry cloth.

DO NOT spray or pour any type of cleaning agent directly onto

the system, as it could lead to injury, such as electrical shock, or
result in damage to the equipment.

To avoid electrical hazards, do not allow fluid of any kind to leak

into the laser console.

- 13 -
Other System Features

HANDPIECE VEIN MODE

Figure 5-9. Vein Mode Screen.

The POLYLASE MX software allows both Nd:YAG and Alexandrite handpieces to

operate in Vein Mode, i.e., with the optional insert objective. The optional VEIN
OBJECTIVE allows to operate the handpiece with 3 small spot sizes (2, 3 and 4 mm),
which allow to generate high fluences during spider and varicose vein treatment
(specifically, with Nd:YAG laser). This objective must be installed in the handpiece
output aperture instead of the Protective Window Holder prior to entering Vein Mode.
When this optional objective is installed, the user has to switch the laser into Vein Mode.
The handpiece mode selection button (Vein or Hair) is located on the footer toolbar on
the Edit screen (see Fig. 5-4 and 5-9). The laser is always in Hair mode by default after
system start-up, therefore, normally this button has the name Vein displayed on it. In
order to switch to Vein Mode, press and hold Vein button for at least 3 sec. The button
will change its name to Hair and the laser software will switch to Vein Mode (see Fig. 5-
9). The spot size selection options will change to 2, 3 and 4 mm and all displayed
Fluence values will be re-calculated reflecting the small spot size selected. In order to
switch the laser back to Hair mode, press and hold the Hair button for at least 3 sec.

WARNING! POLYLASE MX does not have automatic recognition of the optional

VEIN OBJECTIVE. Please, remember to switch the laser into Vein Mode every
time you use the OBJECTIVE. Failure to do so will lead to incorrect Fluences
displayed and may result in patients’ skin burns and/or other injuries.

- 14 -
HANDPIECE MANUAL MODE

In some situations, the POLYLASE MX laser handpiece detection system can be turned
off. This is useful when handpiece-related errors happen in the system and the operator
needs to complete the treatment session. In order to start the laser in handpiece Manual
Mode, on the laser controller Start Screen press and hold (Handpiece Mode)
button for 3 sec. The button status will change from “Auto” to “Manual” and now the
laser can be started with all handpiece-related errors ignored by the system.
WARNING! When laser is started in Manual Mode, handpiece spot size cannot be
changed as usual or automatically recognized by the laser controller! It is only
possible to work with one currently installed handpiece spot size. If the decision was
made to start the laser in Manual Mode, the operator is responsible for the correct
selection of the handpiece spot size (on the laser controller screen) that will match
the actual handpiece output beam spot size. Failure to do so may result in severe
skin burns due to incorrect Fluence settings or other injuries to the patient!
Do not use the laser in handpiece Manual Mode without need and arrange for laser
handpiece service as soon as possible, to eliminate handpiece malfunction that
results in handpiece errors.

SYSTEM SOUNDS

The POLYLASE MX is equipped with the system sounds function. This includes Pulse
Sound and Error Sound options. The laser is factory-configured with Pulse Sound option
turned OFF by default, but it could be turned ON from the laser Settings and Constants
screen in the Service Mode. Error Sound is turned ON by default.
In order to turn system sounds on or off, select (Service) button from the Edit
mode, then turn the desired sound option (either both or only one) ON or OFF by the
corresponding slider button in the Settings and Constants screen of the Service Mode.
The Sound ON/OFF Button can also be used to turn the pulse beep sound ON or
OFF directly from the Edit screen.

- 15 -
ERROR MESSAGES AND TROUBLESHOOTING

The POLYLASE MX Laser has a number of internal interlock circuits and sensors that
control the status of the laser. If the system detects an interlock error or inappropriate
value of the monitoring parameter, the Error Message will appear in the Message area on
the LCD display. The possible errors are divided into three categories:
SYSTEM/INTERLOCK ERRORS, SYSTEM FAULTS and LASER CONTROLLER
ERRORS

System/Interlock Errors
When the error of this category takes place, the following error messages are possible:

Error Message Possible Cause Recommended Operator Action

External Interlock Open The external (door) Check the external interlock circuit.
interlock is open
Lamp change is due. Please, The # of pulses for the Perform Flashlamp Service (see p. 20
replace the flashlamps. currently installed flash below)
lamps exceeded
recommended number
Laser Autocalibration is due: Laser output fluence is Confirm the warning with OK button and
Low Fluence Reading. Please, measured below set value continue to work normally. Perform Laser
perform the Autocalibration during operation Output Autocalibration Procedure at
Procedure. convenient time (see p. 20 below)
Laser Autocalibration is due: The # of pulses on the Confirm the warning with OK button and
Lamp Counter Over Limit. flash lamps exceeded continue to work normally. Perform Laser
Please, perform the recommended amount Output Autocalibration Procedure at
Autocalibration Procedure. since last autocalibration convenient time.
Laser Autocalibration is due: Laser Output Perform Laser Output Autocalibration
Lamp Counter Reset. Please, Autocalibration Procedure Procedure as soon as possible.
perform the Autocalibration was not performed since
Procedure. last lamp counter reset
Laser not calibrated Laser autocalibration Perform Laser Output Autocalibration
procedure was not Procedure (see p. 20 below)
performed when it was
required
System Is Too Cold Water Temperature in the Laser Controller will not allow the system
XX °C laser cooling system is start until the water temperature is within
less than 15 °C normal range. Warm up the room and wait
until water temperature will increase above
15 °C, then start the laser as usual.
System Overheat, XX.X°C > Water temperature in the Release the footswitch and wait ~1 to 3 min
50°C. cooling system is too high until the error message disappears. If it
Please, Wait. takes longer time to cool down the system,
make sure that ambient room temperature is
below 25°C.
Remove the side panels and check if the
system heat exchanger under main fan is
clean from dust. Clean with vacuum
cleaner, if necessary.

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System Faults
When the error of this category takes place, the system controller automatically turns off
the high voltage power supply, clears the LCD screen and displays corresponding error
message. This procedure takes place after each SYSTEM FAULT and does not depend
on the current system settings or operation mode. The laser operation can be resumed
only after completing system TURN OFF procedure and then turning it back on.

Note: Turning the system OFF using red Emergency Button is also considered by
controller as SYSTEM FAULT. To resume operation, the Emergency Button must be
released by slightly rotating it clockwise and the system must be turned back ON using
the Key Switch.

If any system fault occurs, the following error messages are possible:

Error Message Possible Cause Recommended Operator

Action
Charger Not Ready. Please, call Capacitor charger cannot charge Restart the laser. If the problem
for service. to required voltage or charging is persists, turn the system OFF and
too slow. call Customer Service for
assistance.
Charger Overheat Error. Capacitor charger IGBT Make sure that ambient room
Please, call for service! temperature is too high. temperature is below 25°C. Do
not turn the laser off. Please,
allow time for the system to cool
down and restart the laser. If the
problem persists, call Customer
Service for assistance.
Emergency Button depressed. Laser was turned off using the Release (rotate CW and pull up)
Please release the button and Emergency Button. the Emergency Button and restart
restart the laser. the laser.

Lamp not ignited. Please, The simmer circuit is not on. Restart the laser. If the problem
restart the laser Flash lamp cannot be ignited. persists, turn the system OFF and
call Customer Service for flash
lamp replacement.
Low water flow. There is insufficient water flow in Check the water level in the
Please, call for service! the cooling system. cooling tank. Add distilled water,
if necessary. Restart the laser. If
the problem persists, turn the
system OFF and call Customer
Service for assistance.
Main Switch Error: Please, call One of the communication relays Please, restart the laser. If the
for service! was not operating properly. problem persists, call Customer
Service for assistance.
OverFluence Error. Please, The measured Output Fluence Restart the laser. If the problem
restart the laser. was more than 20% higher than persists, call Customer Service
pre-set by the operator. for assistance.
Overcharge error. Please, call The measured charge on the Critical system fault. Please, call
for service! capacitor bank was more than Customer Service for assistance.
10% higher than ordered by
controller.

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PFC Fault. PFC circuit output voltage is Critical system fault. Please, call
Please, call for service! incorrect. Customer Service for assistance.
Shutter Error! Improper operation of the laser Restart the laser. If the problem
resonator shutter. persists, turn the system OFF and
call Customer Service for
assistance.
System Overheat: T=xx.x. Water temperature in the cooling Please, allow time for the system
Please, call for service. system was above critical level. to cool down and restart the laser.
Make sure that the cooling
system fan has turned on. If not,
please, call Customer Service for
assistance.

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Laser Controller Errors
When the error of this category takes place, the following error messages are possible:

Error Message Possible Cause Recommended Operator

Action
Error: I/O Board There is no response from the The software will
Communication Error! I/O Board through COM port automatically reset the error
Please, call for service! within required timeout when communication between
period. controllers is re-established. If
the problem persists, call
Customer Service for
assistance.
Handpiece Error: There was no response from Check the handpiece
Handpiece not connected the handpiece to User communication cable
Interface Controller within the connection to the laser. The
required timeout period. May software will automatically
also indicate handpiece zoom reset the error when
lens movement malfunction. communication between
controller and handpiece is re-
established. If the problem
persists, call Customer Service
for assistance.
Handpiece Error: Please There was no response from Check the handpiece
check the Handpiece the handpiece to User communication cable
Interface Controller within the connection to the laser. Restart
required timeout period during the laser. If the problem
laser operation. persists, call Customer Service
for assistance.
Wrong Spot Size Error There was handpiece zoom Restart the laser. Check if the
lens movement malfunction or handpiece zoom lens actually
spot size settings discrepancy moves to the desired spot size.
between handpiece and Main If the problem persists, call
Controller settings. Customer Service for
assistance.

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Flashlamp Service
The POLYLASE MX Laser will eventually need to have a certain internal component
known as a “flashlamp” replaced. The system will start giving a warning message “Lamp
change is due. Please, replace the flashlamps” at the startup when the flashlamps
replacement is due. The replacement of the flashlamp is covered under the standard
warranty and extended service contracts, however it does necessitate a visit of a field
service technician. The advanced laser head design of the POLYLASE MX Laser allows
easy and fast flashlamp replacement. The whole procedure takes approximately 15
minutes and can be performed by the user after the corresponding training course.
For more information regarding the flashlamp replacement refer to SOP 2 and 47: "Flash
Lamps Replacement Procedure" in the Service Manual. For corresponding technical
training availability call DDC Technologies Customer Service at +1 (516) 770-0441.

Coolant Water Replacement

The coolant water in the laser cooling system has to be replaced at least every 6 months.
It is recommended to replace coolant water every 2 months during summer time or in the
regions with warm climate. Always drain coolant water when the laser is put into storage
or if you do not plan to use the laser for more than 1 month.
Use steam distilled or air condensed (obtained from dehumidifier) fresh distilled water
only. Use of any other coolant can damage the system and will void the manufacturer’s
warranty.
To replace coolant water:
1. Drain the old water using Water Drain Valve at the laser rear panel (see Fig.
5-2 (a)). Use the Water Drain Plug supplied with the laser to release the shut-
off drain valve.
2. Remove laser left side panel. Locate white water tank in the middle of the
compartment. Pull the strap that holds the water tank lid to the side. Remove
the lid and refill the water tank from top with fresh distilled water. Fill the
tank to ~ 4/5 volume. Start the laser and let it run for ~ 1 min, then turn it off
and add water if necessary.
3. Replace the water tank lid and strap and reinstall the side panel.
4. Alternatively, the water tank can be re-filled through the drain valve without
removing the side panel. Use supplied refill hose with attached funnel to do it.
When refill through the drain valve make sure to stop when water level in the
refill hose reached the level mark on the laser rear panel.

Calibration Procedure
The FDA and other regulatory agencies require that manufacturers of US FDA CDRH
Class III and IV and European EN 60825 Class III and IV medical lasers supply their
customers with power calibration procedures. Calibration of the POLYLASE MX laser
output should be checked routinely. DDC Technologies recommends that under normal
usage, calibration is checked semi-annually (every 6 months) to ensure that the laser
output from the handpiece corresponds to the output selected by the user. If necessary,

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the autocalibration procedure must be performed in accordance with SOP3. Complete
Calibration Procedure (SOP3) should be performed by qualified trained technician after
any service or repair work.

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