SERVI

CE
MANUAL
 CHAPTER 1
System Overview

Chapter Contents:
Section Title Page
1.1. Introduction........................................................................................ 1-2
1.2. Treatment Parameters ........................................................................ 1-2
1.3. Use of the Operator Manuals ............................................................. 1-2
1.4. Physician Responsibility .................................................................... 1-3
1.5. Maintenance....................................................................................... 1-3
1.6. Modification of the System ............................................................... 1-3
1.7. Resale Inspection ............................................................................... 1-4
1.8. Abbreviations and Acronyms ............................................................ 1-4

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System Overview

1.1. Introduction
The Harmony XL Pro system is a multi-application, multi-technology platform that
is intended for use in dermatological procedures using the following light based
technologies:
 Advanced Fluorescence Technology (AFT™)
 Ultraviolet B (UVB)
 Near Infrared (NIR)
 Light Emitting Diode (LED)
 Nd:YAG laser
 Er:YAG laser
 Q-Switched Nd:YAG laser
 Er:Glass laser
The Harmony XL Prosystem operates with various modules that may be connected
to the platform.
Please refer to Harmony XL Pro Modules operator's manual for a complete
discussion of each of the platform's available modules.

1.2. Treatment Parameters

Before treatment initiation, the operator selects the appropriate module and enters
the timer interval based on patient’s skin type or lesion depth/diameter and the
requested fluence; namely, the amount of energy expressed in J/cm2or mJ/p to
which the treated area is exposed. Each time the operator presses the footswitch, the
Harmony XL Pro emits a single pulse when using the non-laser modules. Laser
emission with the modules, however, is enabled only when the module’s trigger and
the footswitch are pressed simultaneously.

1.3. Use of the Operator Manuals

The Harmony XL Pro system is designed to meet international safety and
performance standards. Personnel operating the system must have a thorough
understanding of the proper operation of the Harmony XL Pro.
This manual and the Modules manual have been prepared to aid medical and
technical personnel to understand and operate the system. Do not operate the
system before reading this manual, the Modules Manual and gaining a clear under-
standing of system operation. If any part of these manuals is not clear, please
contact your Alma Lasers representative for clarification.

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 System Overview

Warning
Use of controls or adjustments, or performance of procedures other than those
specified herein may result in hazardous radiation exposure. Therefore, before
attempting to use or operate the system, personnel operating the Harmony XL Pro
system should read this manual and the Modules Manual, and become thoroughly
familiar with all its safety requirements and operating procedures.

The information provided in these manuals is not intended to replace the

professional training on the clinical use of the system. Please contact your Alma
Lasers representative for current information on available training. For clinical
information, refer to the Clinical Guide chapters in the Modules Manual, which
include set up guidelines for each application.
These manuals should always accompany the system and all operating personnel
must know their location. Additional copies of these manuals are available from
Alma Lasers or your local Alma Lasers representative.
For further information about Alma Lasers, visit the company website at:
www.alma-lasers.de

1.4. Physician Responsibility

The properly licensed practitioner will be responsible for the use and operation of
the device and for all operator qualifications. Alma Lasers makes no representations
regarding local laws or regulations that might apply to the use and operation of any
medical device. The physician is responsible for contacting his or her local
licensing agencies to determine any credential required by law for clinical use and
the operation of the device.

1.5. Maintenance
The Harmony XL Pro system is a precision, technical medical device that requires
periodic routine maintenance service, which must be performed by Alma Lasers
authorized technical personnel. Failure to obtain service voids all warranties
expressed and implied. Please contact Alma Lasers or your local representative for
details.

1.6. Modification of the System

Unauthorized modification of the hardware, software or specifications of the
Harmony XL Pro system voids all warranties, expressed and implied. Alma Lasers
takes no responsibility for the use or operation of such a modified device.

Warning
No modification of this equipment is allowed.

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System Overview

1.7. Resale Inspection

The Harmony XL Pro is a precision, technical medical device. If any Alma Lasers
device is resold by anyone other than an authorized sales representative, Alma
Lasers offers a resale inspection by an Alma Lasers technician to assure that the
device is working in accordance with manufacturer’s specifications. Using the
device after it has been resold and before it has been inspected is a misuse of the
device, which may result in injuries and voids all warranties, expressed and
implied.
Alma Lasers also offers service contracts and extended warranties for its devices.
For more information about the services or about the costs of inspections or service
calls, please contact Alma Lasers or your local representative.

1.8. Abbreviations and Acronyms

°C Degree(s) Centigrade/Celsius
A Ampere(s)
AC Alternating current
AFT Advanced fluorescence technology
CFR Code of Federal Regulations
cm Centimeter(s)
2
cm Centimeter(s) square
EDF Equally distributed fluence
Er:YAG Erbium-doped Yttrium Aluminum Garnet
Er:Glass Erbium Glass
FD Frequency-doubled
HR Hair removal
Hz Hertz (number of pulses per second)
IEC International Electrotechnical Commission
J Joule(s)
2
J/cm Joule(s) per square centimeter
J/P Joule(s) per pulse
Kg Kilogram(s)
KJ KiloJoule(s)
KTP Potassium Titanyl Phosphate
LCD Liquid crystal display
LED Light emitting diode
LP Long pulse

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 System Overview

m Meter(s)
2
mJ/cm MilliJoules per square centimeter
mJ/P MilliJoules per pulse
mm Millimeter(s)
msec Millisecond
Nd:YAG Neodymium-doped Yttrium Aluminum Garnet
nm Nanometers
nsec Nanoseconds
OD Optical density
PL Pigmented lesions
PRR Pulse repetition rate
QS Quality switched
Sec Second(s)
SHR Super hair removal
SR Skin rejuvenation
SSR Super skin rejuvenation
STBY Standby
SVL Superficial vascular lesions
TEC Thermo-electric cooling
UV Ultraviolet radiation (290-320nm)
V Volt(s)
VAC Volt(s) alternating current
VL Vascular lesions
VP Vascular/Pigmented (lesions)
W Watt(s)

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 CHAPTER 2
Safety

Chapter Contents:
Section Title Page
2.1. Introduction........................................................................................ 2-3
2.2. System Safety Measures .................................................................... 2-4
2.2.1. Electrical Safety ............................................................................. 2-4
2.2.2. Light and Laser Safety ................................................................... 2-4
2.3. The Treatment Room ......................................................................... 2-6
2.4. General Precautions and Cautions ..................................................... 2-7
2.4.1. Precautions ..................................................................................... 2-7
2.4.2. Cautions.......................................................................................... 2-7
2.5. Warnings Related to Laser and Intense Pulsed Light Emission ........ 2-8
2.5.1. Burn Hazards .................................................................................. 2-8
2.5.2. Direct and Reflected Eye Exposure Hazards.................................. 2-8
2.5.3. Explosion and Fire Hazards ........................................................... 2-9
2.5.4. High Voltage Hazards .................................................................... 2-9
2.5.5. Grounding the System .................................................................... 2-9
2.6. System Safety Features .................................................................... 2-10
2.6.1. Emergency Shut-Off Knob........................................................... 2-10
2.6.2. Main Circuit Breaker .................................................................... 2-10
2.6.3. Light Emission Indicators ............................................................ 2-10
2.6.4. Remote Interlock Connector ........................................................ 2-10
2.6.5. Double-Tiered Security for Laser Emission ................................. 2-11
2.6.6. Footswitch .................................................................................... 2-11
2.7. Equipment Classification and Compliance ...................................... 2-11
2.8. Device Labels .................................................................................. 2-14
2.8.1. System Labels .............................................................................. 2-14
2.8.2. List of icons .................................................................................. 2-18

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2.9. Module Labels ................................................................................. 2-19

2.9.1. Packaging Label ........................................................................... 2-22

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 Safety

2.1. Introduction
Warning
Hazardous voltages are energized when the emergency stop button is engaged.

This chapter describes general safety issues regarding the use of the HarmonyXL
Pro system, with special emphasis on optical and electrical safety.
For the specific treatment indications, please refer to the Harmony XL Pro Modules
operator’s manual.
With proper operation and maintenance, trained and qualified medical practitioners
can use the system safely. The supervising physician and all other personnel
operating or maintaining the HarmonyXL Pro must be familiar with the safety
information provided in this chapter.
The primary consideration should be for the safety of the patient, the physician and
other personnel. Patient safety is mainly assured by a well trained staff and a well
laid out treatment room. Patient education is also important, including information
about the nature of the treatment.

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Safety

2.2. System Safety Measures

The HarmonyXL Pro system was designed to maximize safety for both patient and
personnel. The following are some of the HarmonyXL Pro’s preventive safety
measures:

2.2.1. Electrical Safety

1. The system is protected by a semi-automatic circuit breaker.
2. Software protection, including:
 The software checks all safety related hardware after the system is switched
on.
 Emission timing is regulated by interrupts every 0.25 msec (250 μsec).
 A watchdog cycle continuously monitors operation of the system during
treatment.
 If an error occurs, the system displays a warning message to the operator
and disables further operation.
3. A self-test of the attached module is performed when the system is turned on.
The test includes module identification.
4. A self-test of the electrical circuitry takes place after the system is turned on.
The test circuits continuously monitor system operation during treatment.

2.2.2. Light and Laser Safety

1. Closed lightguide geometry is used to transmit light to the treatment site. Light
is emitted only through the front plane of the lightguide.
2. The system incorporates a safety remote interlock connector for connecting an
external interlock on the entrance door to the treatment room. The external
remote interlock is serially connected with the footswitch; therefore when
installed, disables the system and prevents operation when the entrance door is
opened.
3. An emergency shutoff knob expedites shutdown when necessary. When
pressed, it immediately shuts down system operation.
4. A password on the Service mode screen prevents unauthorized changes to the
system's basic operating parameters.
5. The system features two emission indicators: a yellow emission indicator lamp
located on the system console, and a buzzer.
 The yellow emission indicator lamp flashes when the system is ready to
trigger pulses, and becomes a continuous light when a light pulse is
triggered.

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 Safety

 The buzzer beeps once when the system switches to Ready mode.
6. Emission is enabled only when the operator switches to Ready mode and
presses the footswitch (minimum risk).
7. Laser emission (from the laser modules) is enabled only if both the footswitch
and the module's trigger are pressed at the same time. The trigger reduces the
risk of unintentional laser emission.
8. Water is circulated through the module as soon as the system is turned on in
order to cool the light source. Water flow is monitored and light emission is
disabled if the water flow stops.
9. The temperature of the water is monitored by a thermal sensor in order to
eliminate the risk of module overheating. Light emission is disabled if the
water temperature gets higher than 50ºC (122ºF).
10. The system is equipped with a pneumatic footswitch for ease of use. It is
pneumatic to eliminate the possibility of any short-circuiting in the
footswitch's wiring and to increase its durability to fluids.

Warning
Any laser or pulsed light-emitting device can cause injury if used improperly.
High voltages are present inside the HarmonyXL Pro system. Personnel who
work with lasers or pulsed light sources must always be aware of the possible
dangers and must take the proper safeguards as described in this manual.

Caution
Laser fume and/or plume may contain viable tissue particulates

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Safety

2.3. The Treatment Room

The treatment room must be clearly labeled with signs indicating that high intensity
light and/or laser energy are in use. The treatment room sign that is supplied with
the HarmonyXL Pro system is shown in Figure ‎2-1.

Figure ‎2-1: Treatment Room Warning Sign

The treatment room should not include any light reflecting objects such as a mirror.
Access to the HarmonyXL Pro treatment room should be allowed only to personnel
essential to the procedure and who are well trained in the required safety
procedures.
Assure that all of the treatment room personnel are familiar with the HarmonyXL
Pro controls and know how to shut down the system instantly.

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2.4. General Precautions and Cautions

The following precautions, cautions and warnings must be observed for the safe use
of the HarmonyXL Pro system.

2.4.1. Precautions
 Physicians and clinicians should read this manual thoroughly before attempting
to operate the HarmonyXL Pro system.
 Any module's lightguide must be kept clean at all times. Remember to clean the
cooling gel from the light guides after each patient.
 The system weighs 133 lbs. (60 kg.) and may cause injury if proper care is not
used when moving it. The system is well balanced and is designed to be moved,
but should always be moved carefully and slowly. Never pull or push the system
by any part other than the console handles.

2.4.2. Cautions
 Only Alma Lasers authorized personnel may service the HarmonyXL Pro
system. This includes making internal adjustments to the power supply, cooling
system, optics, modules, etc.
 Verify that the HarmonyXL Pro is wired for the appropriate electrical voltage of
your country (120VAC or 230VAC).
 Maintenance performed by the operator must only take place when the system is
shut down and disconnected from the electrical power source. Performing
maintenance procedures with the system powered-up can be hazardous to the
operator and/or destructive to the system.
 Always turn off the system when it is not in use.
 Never leave the system in Ready mode unattended.
 Never allow untrained personnel to operate the system.
 Never press the footswitch unless the moduleis safely oriented at a specific and
intended target.
 The module and lightguide or tip must always be visually inspected before treating
the patient. If any wear or damage is apparent, do not use the module or tip.
 Never leave the system turned on, open or unattended during system
maintenance.
 The device can be turned on only when the key is inserted in the keyswitch.
When not in operation, the key should be removed to prevent unauthorized use
of the device.

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2.5. Warnings Related to Laser and Intense Pulsed Light

Emission
2.5.1. Burn Hazards
The HarmonyXL Pro system emits a wide wavelength spectrum, which, in part, is
invisible to the human eye and can cause third degree burns.

2.5.2. Direct and Reflected Eye Exposure Hazards

It is essential that all people present in the treatment room during the treatment
(patient and medical personnel) protect their eyes by wearing Alma Lasers
recommended protective eyewear.
It is good practice to instruct the patient to close their eyes during treatment even
when wearing protective eye eyewear.
If the patient cannot wear the protective eyewear, fit the patient with opaque eye
protection that completely blocks light from the eyes.
If the treatment area is very close to the eyes (e.g. eyelids), protect the eyes with
corneal shields.

Warning
 Different protective eyewear is indicated for use with AFT, near IR, UV,
LED, Nd:YAG, Er:YAG or Er:Glass modules. Make sure you choose the
correct type.
 Do not treat eyebrows, eyelashes, or other areas within the bone area
surrounding the eye orbit with the Nd:YAG, Er:YAG or Er:Glass modules.
The light emitted by these modules can cause serious eye damage or
blindness. For maximum safety, the patient must wear metal eye goggles for
all facial treatments.

Please refer to Section A.10 of Appendix A in this manual (Eye Protection) for a
listing of safety eyewear specific to the system's various emitted wavelengths.

The Ocular Hazard Distance (OHD) is 300 m.

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 Safety

2.5.3. Explosion and Fire Hazards

The absorption of optical energy raises the temperature of the absorbing material.
Take precautions to reduce the risk of igniting combustible materials in and around
the treatment area.
The system is not suitable for use in the presence of flammable mixtures with air or
oxygen.
Do not operate in the presence of volatile solvents such as alcohol, gasoline or other
solvents.
Do not use any flammable substances such as alcohol or acetone in the preparation
of the skin for treatment. If necessary, use soap and water to clean before treatment.
If alcohol is used to clean and disinfect any part of the HarmonyXL Pro system,
allow it to dry thoroughly before operating the system.
Flammable materials must be kept at a safe distance from the system.

2.5.4. High Voltage Hazards

The system utilizes 120/230 VAC. To avoid personnel injury, do not operate the
system before ensuring that the exterior panels are properly closed. Do not attempt
to remove or disassemble the exterior panels.
The HarmonyXL Pro system produces very high voltages in various components.
Some components may retain a charge after the power supply has been turned off,
so no part of the exterior housing should be removed, except by Alma Lasers
authorized personnel.
Whenever system maintenance is performed, never leave the HarmonyXL Pro
system turned on, open or unattended.

2.5.5. Grounding the System

The system is grounded through the grounding conductor in the power cable and
internal grounding pin.

Warning
To avoid the risk of electric shock, this equipment must only be connected to a
supply mains with protective earth.

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Safety

2.6. System Safety Features

The HarmonyXL Pro system is equipped with a number of safety features. All
treatment room personnel should be familiar with the location and operation of
these safety features.

2.6.1. Emergency Shut-Off Knob

This red knob is used for emergency shutdown. When pressed, it immediately shuts
off power to the entire system.
To release the emergency shut-off knob, turn it clockwise. Otherwise, the system
will remain off (see Figure 4-1).

2.6.2. Main Circuit Breaker

A semi-automatic circuit breaker, located on the rear panel, protects the system
against excessive current consumption. The circuit breaker disconnects power to the
system in case of an electrical overload. To resume system operation, lift the circuit
breaker handle.

2.6.3. Light Emission Indicators

The system features two laser emission indicators: a yellowLED located on the
system console, and a buzzer.
The yellowLED has three modes:
 Off - when the system is turned on, and in Standby mode
 Blinking – during Ready mode
 Continuous – during laser emission (footswitch or footswitch and module
trigger are pressed)
The buzzer beeps once when the system switches to Ready mode.

2.6.4. Remote Interlock Connector

The system incorporates a safety remote interlock connector for connecting an
external interlock on the entrance door to the treatment room. The external remote
interlock is serially connected with the footswitch; therefore when installed, it
disables the system and prevents operation when the entrance door is opened.

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 Safety

2.6.5. Double-Tiered Security for Laser Emission

Nd:YAG, Q-Switched Nd:YAG, Er:YAG or Er:Glass lasing is enabled only when
the operator presses both the footswitch and moduletrigger; therefore accidental
lasing may only occur due to a double error condition (minimum risk).

2.6.6. Footswitch
The system is equipped with a pneumatic footswitch to eliminate the possibility of
short-circuiting in the footswitch wiring and to increase its durability to fluids.

2.7. Equipment Classification and Compliance

 Electrical shock protection: Class I, Type B or Type BF
 Protection against ingress of liquids: ordinary equipment
 Not suitable for use in presence of flammable anesthetic mixture with air or
nitrous oxide
The HarmonyXL Pro system complies with the following standards:
 ISO 13485: Medical devices - Quality Management Systems - Requirements for
Regulatory Purposes (2003).
 ISO 9001: Quality Management Systems – Requirements (2008).
 IEC 60601-1 Medical electrical equipment – Part 1: General Requirements for
Safety (Ed. 3.0, 2005).
 IEC 60601-2-57: Particular Requirements For the Basic Safety and Essential
Performance of Non-Laser Light Source Equipment Intended for Therapeutic,
Diagnostic, Monitoring and Cosmetic/Aesthetic Use (Ed. 1.0, 2011).
 IEC 60601-2-22: Particular requirements for basic safety and essential
performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
(Ed 3.0, 2007).
 IEC 60825-1: Safety of laser products – Part 1: Equipment classification and
requirements (Ed. 2.0, 2007)
 IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: Collateral Standard:
Electromagnetic compatibility - Requirements and tests (Ed. 3.0, 2007).
 IEC 61000-3-2 Electromagnetic Compatibility (EMC) – Part 3: Limits. Section
2; Limits for Harmonic Current Emissions for Equipment with Input Current
Less Than 16A [Ed. 3.0, 2005 + A1(08) + A2(09)].
 IEC 61000-3-3 Electromagnetic Compatibility (EMC) – Part 3: Limits. Section
3; Limitation of Voltage Changes, Voltage Fluctuations and Flicker In Public
Low Voltage Supply Systems, for Equipment with Rated Current Less Than
16A (ed. 2.0, 2008).

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Safety

 IEC 61000-4-2 Electromagnetic Compatibility (EMC). Part 4: Testing and

Measurement Techniques. Section 2: Electrostatic Discharge Immunity Test
(Ed. 2.0, 2008).
 IEC 61000-4-3 Electromagnetic Compatibility (EMC). Part 4: Testing and
Measurement Techniques. Section 3: Radiated, Radiofrequency, Electro-
magnetic Field Immunity Test (Ed. 3.2, 2010).
 IEC 61000-4-4 Electromagnetic Compatibility (EMC). Part 4: Testing and
Measurement Techniques. Section 4; Electrical Fast Transient/Burst Immunity
Test [Ed. 2.0, 2004 + A1(10)].
 IEC 61000-4-5 Electromagnetic Compatibility (EMC). Part 4: Testing and
Measurement Techniques. Section 5; Surge Immunity Tests (Ed. 2.0, 2005).
 IEC 61000-4-6 Electromagnetic Compatibility (EMC). Part 4: Testing and
Measurement Techniques. Section 6; Immunity to Conducted Disturbances
Induced By Radiofrequency Fields (Ed. 3.0, 2008).
 IEC 61000-4-8 Electromagnetic Compatibility (EMC). Part 4: Testing and
Measurement Techniques. Section 8: Power Frequency Magnetic Field
Immunity Test (Ed. 2.0, 2009).
 IEC 61000-4-11 Electromagnetic Compatibility (EMC). Part 4: Testing and
Measurement Techniques. Section 11: Voltage Dips, Short Interruptions and
Voltage Variation Immunity Tests (Ed. 2.0, 2004).
 CISPR 11 Special International Committee on Radio Interference: Industrial,
Scientific and Medical (ISM) Radiofrequency Equipment-Electromagnetic
Disturbance Characteristics. Limits and Methods of Measurement [2009 +
A1(10)].
 ISO 10993-1: Biological Evaluation of Medical Devices – Part 1: Evaluation
and Testing (Ed. 1.0, 2011).
 IEC 62304 Medical Device Software: Software Life Cycle Process (Ed. 1.0, 2006).
 IEEE 1012: IEEE Standard for Software Verification and Validation (2004).
 IEEE 830: Recommended Practice for Software Requirements Specifications (1998).
 IEEE 1016: IEEE Recommended Practice for Software Design Descriptions (1998).
 IEEE 829: IEEE Standard for Software Test Documentation (2008).
 ISO 14971: Medical Devices - Application of Risk Management to Medical
Devices (2012).
 IEC 62366 Medical Devices: Application of Usability Engineering to Medical
Devices (2007).
 ISO 15223-1: Medical Devices - Symbols to Be Used with Medical Device
Labels, Labeling and Information to Be Supplied (2012).
 EN 1041: Information Supplied By the Manufacturer with Medical Devices
(2008).

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 EN 980: Symbols for use in the labeling of medical devices (2008).

 ISO 17665-1: Sterilization of Health Care Products – Moist Heat – Part 1
Requirements for the Development, Validation and Routine Control of a
Sterilization Process for Medical Devices (2006).
In compliance with these standards, the system is equipped with:
 Laser emission indicators
 Energy and power display
 Emergency shut-off knob
 Remote interlock connector
 Proper labeling
In accordance with the regulations, a recommended routine inspection and
maintenance schedule is provided in the Maintenance chapter of this manual (see
Chapter 7).

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2.8. Device Labels

2.8.1. System Labels
The following Warning, Certification and Identification labels are adhered to the
HarmonyXL Pro system:
 Identification Label which is located on the service panel. This label contains
the following information:
Manufacturer's details
Name of the system
Serial number and date of manufacture
The system's electrical requirements
CE-MDD compliance symbol
Caution: Consult Operating Instructions
Degree and type of protection against electric shock
Label # 1 is adhered to systems shipped to 120VAC countries.
Label # 2 is adhered to systems shipped to 230VAC countries.

Figure ‎2-2: System Identification Labels

 Light emission warning label, including light source type and radiation
parameters, and indicating that the product is a Class IV device (see Figure
‎2-3&Figure ‎2-4), located on the rear panel of the system.

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Figure ‎2-3: Rear Warning Label

and:

Figure ‎2-4: Rear Warning Label

 Laser radiation warning label, located on the rear panel of the system.

Figure ‎2-5: Laser (left) and Intense pulse light (right) Radiation Warning Label

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Safety

 Laser aperture warning label, located on the rear panel of the system:

Figure ‎2-6: Laser Aperture Warning Label on Rear Panel

 Electrical Requirement and Hazard Label, located next to the power cable
connection port:

120V Or 230V
A AC
CRequirement and Hazard Labels
Figure ‎2-7: Electrical

 Grounded power cable warning label, located on the bottom of the rear panel,
next to the cooling system's venting port. Another card with the same message is
attached to the power cable's coiling stud.

Figure ‎2-8: Grounded Cable Warning Label

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 The label indicating separate collection and disposal symbol, located near the
identification label: at the end of useful life the system Modules are to be
returned to the manufacturer for appropriate processing and disposal.

Figure ‎2-9: WEEE Label

 Do not drop warning label, located at the side of applied part:

Figure ‎2-10: Do Not Drop Label

Other cautionary and informative labels placed around the system:

 Emergency stop label located below the

emergency shut-off knob

 Interlock label located on the service

panel to identify the interlock connection port

 Footswitch label located on the service

panel to identify the footswitch connection port
FOOTSWITCH

 Fill label identifies the connection port for the

accessory used filling the cooling system's water  FILL
reservoir

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 Vent label identifies the connection port for the

air vent of the cooling system's water reservoir
VENT

 Drain label identifies the connection port used

for draining the cooling system's water reservoir
DRAIN

 Only deionized water may be introduced into Deionized Water

the Harmony's cooling system Only

Note

Since Harmony XL Pro system incorporates both Laser and

Intense Pulse Light technology, the Emergency Stop sign used
to identify the Emergency Shut Off Knob. It covers both

Emergency Laser Stop and Emergency Intense Pulse

Light Stop

2.8.2. List of icons

 Caution

 Warning

 Date of Manufacture

 Manufacturer

 Serial Number

 Temperature Limitation

 Humidity Limitation

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 Atmospheric Pressure Limitation

 Keep Dry

 The contents are fragile

 This side up

2.9. Module Labels

The following warnings and identification labels are attached to the system module
connectors:
 Module Identification Label – is located on the bottom of the module
connector. it includes the following information:
Manufacturer's details.
Name of the module.
Serial number and date of manufacture.
Degree and type of protection against electric shock.

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 Intense Pulsed Light Emission Danger – warns against possible exposure to

intense light radiation and specifies the type and classification of wavelengths
present.

Figure ‎2-11: LightEmission Warning Label

 Laser aperture / Optical radiation aperture warning label, located near the laser
applied part tip:

Figure ‎2-12: Optical radiation / Laser aperture on distal end

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Safety

2.9.1. Packaging Label

The following label is attached to the HarmonyXL Pro system's shipping crate:

Figure ‎2-13: Shipping Crate Label

The symbols on the label indicate the following:
This symbol indicates that the crate must be
protected from excessive humidity and must
accordingly be stored under cover. If particularly
large or bulky packages cannot be stored in
Keep Dry warehouse or sheds, they must be carefully
covered with tarpaulins.

Cargo marked with this symbol should be handled

carefully and should never be tipped over or
Fragile
slung.

The package must be always transported, handled

and stored in such way that the arrows always
point upwards. Rolling, Swinging, severe tipping
Top or tumbling or other such handling must be
avoided.
The symbol
The cargo need not, however,
provides be and
the storage stored “on top”.
transport
temperature range. In this case, the temperature
Temperature
limit is between high +50°C and low 0°C.
Limitations

The symbol provides the storage and transport

humidity range. In this case, the humidity limit is
Humidity
between 60% high and 10% low.
Limitations
The symbol provides the storage and transport air
pressure limit. In this case, indicating a low 90
Air Pressure
kPa and a high 110 kPa.
Limitations

HarmonyXL Pro System Service Manual 2-22

 CHAPTER 3
Installation

Chapter Contents:
Section Title Page
3.1. Introduction........................................................................................ 3-2
3.2. Equipment List................................................................................... 3-2
3.3. Facility Requirements ........................................................................ 3-3
3.3.1. Electrical Requirements ................................................................. 3-3
3.3.2. Space and Positioning .................................................................... 3-4
3.3.3. Environmental Requirements ......................................................... 3-5
3.4. Connecting the Module...................................................................... 3-6
3.5. Remote Interlock Connection ............................................................ 3-7
3.6. Connecting the Footswitch ................................................................ 3-7
3.7. Filling the Coolant Reservoir............................................................. 3-8
3.8. Storage and Transportation ................................................................ 3-8
3.9. Moving the System ............................................................................ 3-8

HarmonyXL Pro System Service Manual 3-1

Installation

3.1. Introduction
The HarmonyXL Pro system is designed for installation in an office or a clinic and
requires minimal site preparation. When the HarmonyXL Pro system is purchased,
complete on-site installation, including initial system testing and calibration, is
included.
System transportation and installation is carried out by Alma Lasers authorized
technical personnel, who will do the following:
 Unpack the system, assemble it, and position it in its pre-selected location
 Verify the integrity of the system and its components
 Connect system components (modules, footswitch, interlock connector)
 Plug the system into a designated electrical outlet
 Fill the cooling system reservoir with deionized water
 Test the system for proper calibration and functional operation of all
components and software
 Coordinate the performance of an on-site safety inspection, if required
Note

Any damage to the packaging or to the system found prior to

opening the package should be reported to your Alma Lasers
representative and to the insurance carrier.

3.2. Equipment List

The HarmonyXL Proplatform includes the following:
 HarmonyXL Pro system
 The selection of HarmonyXL Promodules that have been purchased with the
HarmonyXL Pro platform
 HarmonyXL Pro System operator's manual
 HarmonyXL Pro Modules operator's manual
 AFT/ near IR /UVmodulecradle
 Laser modulecradle
 Set of keys
 Footswitch
 Remote interlock connector

HarmonyXL Pro System Service Manual 3-2

 Installation

 Three pairs of safety eyewear for non-laser modules*

 Two pairs of Nd:YAG (1064nm & 1320nm) safety eyewear*
 Two pairs of Nd:YAG (532nm) safety eyewear*
 Two pairs of Er:YAG (2940nm) safety eyewear*
 Two pairs of Er:Glass (1540nm) safety eyewear*
 Water filling kit
 Laser radiation danger sign

3.3. Facility Requirements

Before unpacking the system, ensure that the site meets the requirements described
in the following sections.

Caution
In order to guarantee safe disconnection of the system in any hazardous situation
system shall be allocated in such a way that appliance coupler always accessible.

3.3.1. Electrical Requirements

The system is factory pre-wired for the local line voltage, as ordered by the
customer. Accordingly, the system will require a separate line supply of:
 120 VAC, 20A, 50/60 Hz, single phase, Or:
 230 VAC, 10A, 50/60 Hz, single phase
Input power lines should be free of transients, voltage and current spikes, sags and
surges. Consequently, the system power line should not be shared with other heavy
variable loads such as elevators, air conditioning systems, large motors, etc.
The system is grounded through the grounding conductor in the power cable that is
plugged into the wall power outlet. Good grounding is essential for safe operation.
Warning
Verify that the HarmonyXL Pro system is wired for the appropriate line voltage
of your country.

*
Depending on which of the Harmony modules have been purchased

HarmonyXL Pro System Service Manual 3-3

Installation

3.3.2. Space and Positioning

Space should be allocated with adequate ventilation and free airflow. The working
area for the system should be prepared according to the system dimensions
presented in Figure ‎3-1. In order to guarantee proper ventilation, always keep the
sides of the system at least 20" (0.5m) from the wall or from other obstructions to
air flow. After positioning the system, lock the breaks on the two front wheels by
pressing the pedals on top of each wheel. Information regarding the risks of
reciprocal interference posed by the presence of the device during specific
treatments can be found in Appendix C of this manual.
Note
The positioning of the system shall guarantee access to the system’s service panel
and disconnection devices: Mains switch, Circuit Breaker and Mains plug.

44 cm / 17’’

54 12
c 5
m c
/ m
21 /
’’ 49
’’

Figure ‎3-1: System Dimensions

HarmonyXL Pro System Service Manual 3-4

 Installation

3.3.3. Environmental Requirements

Air Quality:
The system should operate in a non-corrosive atmosphere. Corrosive materials can
damage electrical wiring, electronic components and surfaces of optical components.
Air-borne dust particles should be kept to a minimum. Dust particles absorb light
and heat up. Hot particles located on the optical lenses can damage them. Metallic
dust is destructive to electrical equipment.
Water Quality:
The system should be operated using deionized water only. Regular tap water
contains sediments that may damage the cooling system.
Temperature:
To ensure that the system performs optimally, maintain room temperature between
20°C and 25°C (68°F - 77°F), relative humidity of less than 80% and atmospheric
pressure: 90kPa to 110kPa.

Note
When the system is used intensively it emits heat. Therefore, it
is recommended to install air conditioning in the room in which
the system will be used.

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Installation

3.4. Connecting the Module

Connection of the module to the console is shown in Figure ‎3-2. It is designed to
enable easy replacement of the module when required. The module connection port
is located on the middle-right side of the front panel. For insertion and removal of
the connector, proceedas follows (refer toFigure ‎3-2):
1. Insert the moduleconnector into the connection port, as shown in view A, as far
as it will go in.
2. Turn the connector latch in a clockwise direction (B).
3. As you turn the latch, the connector will continue to go into the port until you
can turn it no more – at this point the module is properly connected to the
system (C).
4. To disconnect the module, reverse steps 1 through 3 above.

Caution
Never use tools to tighten the module connector – finger-tight pressure is
sufficient.

Module
Connection
Connector A
Port Latch

B C
Locked

Figure ‎3-2: Module Connection

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 Installation

3.5. Remote Interlock Connection

The HarmonyXL Prosystem is equipped with a remote interlock connector to
provide maximum safety. The connector is situated on the service panel (see Figure
‎3-3). An external switch may be wiredinto this connector to create a remote
interlock system. This switch should be mounted on the entrance door, so that if the
door opens the switch contacts also open and disable system operation.
To connect the remote interlock:
1. Turn the system off.
2. Remove the connector from the port on the system rear panel.
3. Open the connector cover.
4. Solder the two wires from the door switch to pins 1 & 2 (short-circuited on
delivery with a white wire).
5. Close the connector cover.
6. Reconnect to the port on the service panel.
7. Turn the system on.

3.6. Connecting the Footswitch

The footswitch supplied with the system is pneumatically operated for increased
safety.
To connect the footswitch, connect the footswitch's black tube to the connection
port on the system's service panel (see Figure ‎3-3).

Figure ‎3-3: Remote Interlock and Footswitch Connections

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Installation

3.7. Filling the Coolant Reservoir

The cooling system's reservoir must be filled with deionized water. It is imperative
that the level of the water in the reservoir be checked every three months and
deionized water added if necessary.
This operation is performed by Alma Lasers-authorized technical personnel.

3.8. Storage and Transportation

Transportation of the Harmony XL Pro system should be under normal
environmental conditions within the following range:
 Ambient temperature: 0º to 50ºC
 Relative air humidity: 10% to 60%
 Atmospheric pressure: 90kPa to 110kPa

Note
If the system is to be stored in a cold area where the temperature may fall below
0ºC (32ºF), the deionized water must be drained from the cooling system. Only
Alma Lasers authorized service personnel may perform this procedure.

3.8.1. Moving the System

To move the HarmonyXL Prosystem within the clinic, do the following:
1. Disconnect the module and store it in its dedicated carrying case.
2. Disconnect the power cable.
3. Disconnect the footswitch's air tube.
4. Disengage the wheel brakes.
5. Move the system to its new position by pushing/pulling with the console
handles.
6. Re-engage the wheel brakes.
7. Reconnect the footswitch and the power cable.
8. Connect the desired module and resume normal operation.

Caution
Never pull or push the system by any part other than the console handles.

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 Installation

To move the HarmonyXL Pro system to a different site:

The HarmonyXL Pro system is comprised of two modular sections that can be
separated from each other when transporting the system (refer to Figure ‎3-4):
1. Disconnect the module and store it in its dedicated carrying case.
2. Remove the detachable module cradle by sliding it up and out.
3. Disconnect the power cable and wrap it around the mounting studs (A).

A
B

Separation
Latch Knob

Power
Cable

Handle

Figure ‎3-4: System Disassembly

4. Disconnect the footswitch's air tube and remote interlock connector.
5. Make sure that the front wheel breaks are engaged!
6. Turn the separation latch knob(B) counter-clockwise –the top section of the
system will move forward. Keep turning the knob till you hear it "clicking"
and the top section has stopped moving; it can now be separated from the
bottom section.
7. Grab both console handles, and pull the top section up and off the bottom
section,as shown by the red arrow in view C.
8. ViewD shows both sections side-by-side.
9. After transport, re-assemble the HarmonyXL Pro system by reversing steps
‎3 through9 above.

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Installation

10. Connect the desired module and resume normal operation.

If further advice is needed, consult your Alma Lasers service representative.

HarmonyXL Pro System Service Manual 3-10

 CHAPTER 4
System Description
Contents
4.1. Introduction........................................................................................ 4-2
4.2. System Components and Controls ..................................................... 4-2
4.2.1. Main Console ................................................................................. 4-4
4.2.2. Power Supply Modules .................................................................. 4-5
4.2.3. The System Console ....................................................................... 4-5
4.2.4. The Service Panel ........................................................................... 4-5
4.2.5. Cooling System .............................................................................. 4-6
4.2.6. Switching Module .......................................................................... 4-7
4.2.7. Isolation Transformer ..................................................................... 4-7
4.2.8. Footswitch ...................................................................................... 4-7
4.3. Harmony XL Pro Modules – General Description............................. 4-8
4.3.1. Connecting the Module .................................................................. 4-8
4.3.2. AFT, Near IR, UV and LED Modules ........................................... 4-9
4.3.3. Laser Modules .............................................................................. 4-10
4.4. System Specifications ...................................................................... 4-11
4.4.1. Operation and Control Specifications .......................................... 4-14
4.4.2. Electrical Requirements ............................................................... 4-14
4.4.3. Physical ........................................................................................ 4-14
4.4.4. Classifications .............................................................................. 4-15
4.4.5. Main (Upper) Unit ...................................................................... 4-15
4.4.6. Lower Unit ................................................................................... 4-20

Harmony XL Pro System Service Manual 4-1

System Description

4.1. Introduction
This chapter provides a detailed description of the Harmony XL Pro system. The
description covers the system's main components, controls and functional sub-
systems, and technical specifications.
A complete discussion of the modules, their uses and technical specifications may
be found in the Modules Manual.

4.2. System Components and Controls

The Harmony XL Pro system consists of the following major components (see
Figure ‎4-1):
1. The main console unit that incorporates the touch-screen control panel, power
supply modules, cooling system, switching module, service panel and isolating
transformer.
2. Module (with umbilical cable and connector) that incorporates the optical
head, specialized tip and the (laser) module trigger. Several of the modules
include a tissue cooling system.
3. Footswitch.

Harmony XL Pro System Service Manual 4-2

 System Description

Touch-Screen
Control Panel

Module
Cradle
Module

System Controls Module

Emission Indicator Connector
and Port
Keyswitch

Emergency Shut-
Off Knob

Footswitch

Figure ‎4-1: Major System Components

Harmony XL Pro System Service Manual 4-3

System Description

Figure ‎4-2 presents a block diagram of the Harmony XL Pro system:

Air
Pump

Figure ‎4-2: Block Diagram

4.2.1. Main Console

The main console incorporates the following components:
 Control panel
 System controller
 Power supply modules
 Cooling system
 Switching module
 Isolation transformer

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 System Description

4.2.2. Power Supply Modules

There are three power supply modules in the system. Two of them are connected to
230 VAC from the isolating transformer:
 24VDC / 220W that supplies power to the fans and water pump.
 24VDC / 70W that supplies power to the micro-controller board.
The capacitor charger is a medical grade universal power supply and powered by
line voltage.

4.2.3. The System Console

The Harmony XL Pro’s console incorporates the following features:
 Emergency shut-off knob: this is a red, mushroom-like knob designed for
emergency shutdown of the system.
 Keyswitch: this turns on the Main User menu after the system is activated.
 Light emission indicators (See Section 2.6.3).
 Control Panel: the LCD display provides information on the status and settings
of the Harmony XL Pro system, with touch-screen technology for system
operation. The various module screens and their operation are described in detail
in the Modules Manual.

4.2.4. The Service Panel

The service panel (see Figure ‎4-3) is located on the system's rear side.
It incorporates all the required controls and connections for the system:
 Main switch (green) used to activate the controller and the LCD display
 Remote interlock connector
 Semi-automatic circuit breaker
 Footswitch connection port
 Connection fittings for water cooling system filling/draining
 Cooling system fan grill
 Latch knob for separating the system's top and bottom sections

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System Description

Remote
Interlock System
Separation Latch
Footswitch
Knob
Connection Port

Main Switch

Cooling System
Circuit Breaker Connection
Fittings
Fan Grills

Figure ‎4-3: Service Panel

Caution
To avoid overheating and system malfunction, do not block the airflow into the
system.

4.2.5. Cooling System

The Harmony XL Pro's cooling system incorporates a water pump, water reservoir,
a dual-fanned radiator, particle filter, deionizer, flow switch and thermal sensor.
The system circulates water from the fan-cooled radiator to the module.

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 System Description

4.2.6. Switching Module

The system ignites the lamp in the module and maintains it in a simmering mode.
When the system is switched to Ready mode, a command is delivered from the
micro-controller that partially discharges the capacitor bank into the lamp.

4.2.7. Isolation Transformer

The isolation transformer reduces the leakage current in the system to the ground
for safety. It is designed as a medical grade unit.

4.2.8. Footswitch
The footswitch is a pneumatically operated pedal. The footswitch is connected to
the system through the footswitch connector on the service panel.
If an AFT, near IR, UV or LED module is connected to the Harmony XL Pro
system, a pulsed light emission occurs only when the footswitch is pressed. When
any of the laser modules are connected, a pulsed emission is enabled only when
both the footswitch and module trigger are simultaneously pressed.
The footswitch is enabled only when the system is in Ready mode. Pressing the
footswitch in Standby or any other mode will not allow pulsed light emission.

Figure ‎4-4: Footswitch Pedal

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System Description

4.3. Harmony XL Pro Modules – General Description

The Harmony XL Pro system operates with various modules using diverse
technologies. Each handpiece comprises a complete module and incorporates the
entire optical bench that emits the light or laser beam.
Each module is connected to the system console by an umbilical cable that houses
the wiring and cooling water tubes. The Harmony XL Pro cannot be operated unless
a module is connected to the system.
The operating parameters of all Harmony XL Pro modules are pre-programmed.
The particular specifications and operating parameters for each module can be
found in the Modules Manual.
The modules are also preprogrammed to a given energy range based on their
intended use. The operator can adjust the energy fluence within the predetermined
range.

4.3.1. Connecting the Module

Refer to Chapter 3 – Installation – for detailed module connection instructions.

Caution
 These modules contain delicate optical components which may be severely
damaged if dropped. Except during treatment, these modules should be kept
in the cradle at all times.
 When moving the system, the module should be disconnected from the
system and stored in its carrying case.

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 System Description

4.3.2. AFT, Near IR, UV and LED Modules

Each of AFT, near IR and UV modules has a large color-coded section on the front
of the module's body (see Figure ‎4-6), identifying that particular module's treatment
module (e.g., green section identifies the VL/PL module (Vascular lesions &
Pigmented lesions).
The Yellow LED module has a unique construction, as shown in Figure ‎4-5.

Handle

Lightguide Umbilical Cable

Figure ‎4-5: Yellow LED Module

The operator holds the module by its handle in order to position the lightguide
against the patient’s skin.
The module's light source emits a pulse and is activated by pressing the footswitch.
The light passes through an aperture with a filter, into a lightguide that is located on
the module tip.

Figure ‎4-6: AFT/Near IR/UV Module Description

 Alma Lasers guaranties short wavelength boundaries during warranty period. After
warranty period short wavelength boundaries may deviate from specified values due
component deterioration and should be confirmed by Alma Lasers authorized
technical personnel. It is a user responsibility to request above procedure.
 The Optical output power deviation from the pre-set indicated values less than ±20%.

Harmony XL Pro System Service Manual 4-9

System Description

4.3.3. Laser Modules

The pistol-shaped laser modules (see Figure ‎4-7) incorporate a solid state Nd:YAG,
Q-Switched Nd:YAG, Er:YAG or Er:Glass crystal laser medium and a xenon
flashlamp as the heart of the optical bench. The laser beam is delivered when the
operator presses both the footswitch and the module trigger.
These modules house the mechanism that generates and delivers the laser pulse,
including:
 The Nd:YAG, Q-Switched Nd:YAG, Er:YAG or Er:Glass laser heads
 The laser cooling components
 The module trigger for laser beam emission
 The lightguide assembly that determines the spot size and delivers the laser
beam to the treatment site

Figure ‎4-7: Laser Module Description

 The Optical output power deviation from the pre-set indicated values less than
±20%.

Harmony XL Pro System Service Manual 4-10

 System Description
4.4. System Specifications
Pulse
Spot Size Wavelength Pulse Widths / Energy Density
Module Light Source 2 Mode Repetition Rate 2
(cm ) (nm) Timers (J/cm )
(Hz)
2
Cooled IPL Module 5 cm spot size

SHR Pro (5) HR 30, 40, 50 msec 1/2 5-20

Flash lamp 5 650-950
Cooled SHR Timer: 1,3,30 sec 3 3-7
2
Cooled IPL Module 3 cm spot size
SVL Cooled Flash lamp 3 515-950 10, 12, 15 msec 2/3 5-30
VL/PL Cooled Flash lamp 3 440-950 10, 12, 15 msec 2/3 5-30
SR Cooled Flash lamp 3 570-950 10, 12, 15 msec 2/3 5-30
Dye-SR 10, 12, 15 msec 1/2 Up to 14
Dye-SR Pro Flash lamp 3 550-650
Dye-SSR Timer: 1,3, 30 sec 3 1-4
Dye-VL 10, 12, 15 msec 1/2 Up to 15
Dye VL-Pro Flash lamp 3 450-600
Dye-SVL Timer: 1,3, 30 sec 3 1-4
SHR Pro (3) HR 30, 40, 50 msec 1/2 5-25
Flash lamp 3 650-950
Cooled SHR Timer: 1,3,30 sec 3 3-7
SSR Cooled Flash lamp 3 540-950 Timer: 1,3,30 sec 2 1-15
SST Cooled Flash lamp 3 780-950 Timer: 1,3,30 sec 5 0.5-3.5
2
Non cooled IPL Module 6.4 cm spot size
SVL Flash lamp 6.4 515-950 10, 12, 15 msec 2/3 5-25
VL/PL Flash lamp 6.4 440-950 10, 12, 15 msec 2/3 5-25
SR Flash lamp 6.4 570-950 10, 12, 15 msec 2/3 5-25
HR Flash lamp 6.4 650-950 30, 40, 50 msec 1/2 5-25
ST Flash lamp 6.4 780-950 Timer: 10,30,90 sec 2 1-7
Acne 30, 40, 50 msec 1/2 5-25
Acne Flash lamp 6.4 420-950
S-Acne 2 msec 10 0.3-1.2
High Power UV Flash lamp 6.4 270-380 30, 40, 50 msec 1/2 2-4.5

Harmony XL Pro System Service Manual 4-11

System Description Pulse
Spot Size Wavelength Pulse Widths / Energy Density
Module Light Source 2 Mode Repetition Rate 2
(cm ) (nm) Timers (J/cm )
(Hz)
NIR Module
NIR Face Lamp 6.4 1300 N/A 5-25 W
LED Module
Pulsed Up to 70 sec. Pulsed
Yellow LED LED array 560-620 1.5W
CW Up to 70 minutes CW

Waveleng Pulse Energy Density /

Module Technology Spot size(mm) Pulse Width
th (nm) Frequency (Hz) Fluence / Depth
Laser Nd:YAG cooled Module
2
2 10 msec 1 30-450 J/cm
2
Cooled Long Pulse 1064nm 6 15, 45, 60 msec 1 30-150 J/cm
Nd:YAG 1064
Nd:YAG 10 15 msec 1 20-50 J/cm
2

2
5x5 Pixel 10 msec 1 3–25 J/cm
2
Cooled Long Pulse 1320nm 6 30, 40, 50 msec 1 5-40 J/cm
Nd:YAG 1320
Nd:YAG 5x5 Pixel 30, 40, 50 msec 1 1-11 J/cm
2

Laser Nd:YAG non cooled Module

1064 1,2,3,4,5,6 20 nsec 1, 2, 4
Q-Switched
Q-Switched 1064nm Nd:YAG 1064 5x5 Pixel 20 nsec 1, 2, 4 600-1200 mJ/p
Nd:YAG
532 2, 3, 4 KTP 20 nsec 1, 2, 4
1064 1,2,3,4,5,6 20 nsec 1, 2, 4
1064 5x5 Pixel 20 nsec 1, 2, 4
High Power Q-Switched Q-Switched
532 2,3,4 mm KTP 20 nsec 1, 2, 4 600-1200 mJ/p
1064nm Nd:YAG Nd:YAG
1064 5X5 Roller
20 nsec N/A
1064 7x1 Roller

Harmony XL Pro System Service Manual 4-12

 Waveleng Pulse SystemEnergy
Description
Density /
Module Technology Spot size(mm) Pulse Width
th (nm) Frequency (Hz) Fluence / Depth
Laser Nd:YAG not cooled modules (Cont.)
2
2 10 msec 1 30-450 J/cm
2
6 15, 45, 60 msec 1 30-150 J/cm
Long Pulse 1064nm Nd:YAG Nd:YAG 1064 2
10 15 msec 1 20-50 J/cm
2
5x5 Pixel 10 msec 1 3 – 25 J/cm
2
6 30, 40, 50 msec 1 5-40 J/cm
Long Pulse 1320nm Nd:YAG Nd:YAG 1320
5x5 Pixel 30, 40, 50 msec 1 1-11 J/cm2
1 0.1-3.0 msec 10, 30 100-200 mJ/p
2
Fungus 1064nm Nd:YAG Nd:YAG 1064 2 10 msec 1 30-450 J/cm
2
6 15, 45, 60 msec 1 30-150 J/cm
Q-Switched 20 nsec
1064 1,2,3,4,5,6 1, 2, 4 600-1200 mJ/p
Nd:YAG
Q-Switched Pixel 1064nm FD Q-Switched 20 nsec
1064/532 2, 3, 4 mm KTP 1, 2, 4 600-1200 mJ/p
Nd:YAG Nd:YAG
Q-Switched
1064 5x5 Pixel 20 nsec 1, 2, 4 600-1200 mJ/p
Nd:YAG
Laser Er:YAG not cooled modules
1 Short: 200-1200 mJ/p
Stack: 4
4 Medium: 600-1800 mJ/p
Short - 1 msec Non-stack: 2
Er
iPixel Scanner 2940nm 7x7 Pixel Long: 800-2500 mJ/p
Er:YAG 2940 Medium - 1.5 msec
Nd:YAG
Long - 2 msec Short: 200-600 mJ/p
7x1 Scanner N/A Medium: 300-800 mJ/p
Long: 400-1000 mJ/p
Laser Er:Glass cooled modules
4 mm
Er:Glass 1540nm Er:Glass 1540 30, 40, 50 msec 1, 2, 3 300 – 1000 mJ/P
7 x 7 Pixel

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 System Description

4.4.1. Operation and Control Specifications

System Control
 Fully computerized, microprocessor based

Graphic User Interface

 High-resolution, color LCD display
 Touch-screen technology

Laser Emission Indicators

 Visual, illuminating yellow indicator:
OFF when no lasing occurs
Blinking during Ready mode
Illuminating continuously during laser emission
 Audible indicator
Activated during laser emission, when pressing the operation buttons (user-
controlled) and upon detection of an error condition

4.4.2. Electrical Requirements

 120 VAC, 20A, 50/60 Hz.
 230 VAC, 10A, 50/60 Hz.

Note
Isolation from supply mains is provided by mains plug or circuit breaker.

4.4.3. Physical
System Dimensions (W x D x H)
 44 x 54 x 125 cm
 17 x 21 x 49 inches

Weights
 Total: 60 kg. / 133 lbs.
 Upper unit: 15 kg. / 33 lbs.
 Lower unit: 45 kg. / 100 lbs.

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 System Description

4.4.4. Classifications
CDRH Laser Classification according to 21CFR 1040.10
 Class IV

Laser Classification according to EN 60825-1

 Class 4

Non-laser light source equipment Classification according to IEC 60601-2-57

 Risk Group 3

Mode of Protection against Electric Shock

 Class I Equipment

Degree of Protection against Electric Shock

 Type B or BF Applied Part

4.4.5. Main (Upper) Unit

The upper unit includes the following components: Control Panel, Interface
Controller Board, Service Panel, Switching Module, Dump Card, Power Supplies,
PIC Controller, Impact generator, impact 48VDC power supply and iPixel Scanner
control card.
The Control Panel,
The HarmonyXL system is controlled by state of the art microprocessor and the
control of system parameters is done by the 8'' color LCD touch screen in the front
panel.
Interface Controller Board,
This is the microcontroller unit that controls the system, it controls the following
parts:
 Digital I/O:
o Buzzer
o Yellow Lamp
o Key Switch
o Interlock
o FootSwitch
o Cap Charger inhibit
o Discharge
o Simmer Status

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 System Description

o Leakage Status
o IGBT Trigger
o Scanner board
o Flow Switch
o Thermal Switch
o Level Switch
o RS232 interface with LCD touch screen
 All analog I/O:
o Charge voltage control
o Charge voltage monitor
o Tip ID.

Figure ‎4-8: Interface Controller

4.4.5.1. Service Panel Upper Unit

This panel includes:
1. Remote Interlock Connection, this interlock designed to interrupt emission
whenever the room door is opened.
2. The Footswitch Connection.
3. Units Lock knob.

Caution
If the system is in READY mode, pulse light emission occur when the
footswitch is pressed

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 System Description

Figure ‎4-9: Service Panel - Upper Unit

4.4.5.2. Switching Module

The switching module has two functions
1. The unit ignites the lamp in the Handpiece and keeps it in a simmer mode.
2. In READY mode it gets a command from the micro controller unit and
partial discharges the capacitor bank to the lamp.

Figure ‎4-10: Switching module

4.4.5.3. Dump Card

The Dump card is responsible to measure capacitors voltage and to dump capacitors
on a command from the Interface controller.

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 System Description

Figure ‎4-11: Dump Card

4.4.5.4. Power Supplies

1. 24VDC 70 Watts PS to LCD, Interface controller and Impact generator see
Figure ‎4-12
2. 24VDC 220 Watts to fans, water pump and TEC see Figure ‎4-12.
3. 48VDC 120 Watts to Impact Generator, located under the LCD Screen see
Error! Reference source not found.

Figure ‎4-12: Power Supplies

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 System Description

4.4.5.6. PIC Controller (Controller Mini)

Self unit that tests several parameters in the system and send feedback to the
interface Controller, if there's any fault, Interface Controller will display an error on
system's LCD and will stop system operation.

Figure ‎4-8: PIC Controller (Controller Mini)

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 System Description

4.4.5.7. iPixel Scanner Controller Board

Scanner Controller Board allows using iPixel Scanner Handpiece on HarmonyXL
system, iPixel Scanner controller board is installed at factory on every new
HarmonyXL systems as of HXL01125. If required it can be installed on previous
systems per kit order or per handpiece iPixel Scanner order.

Figure ‎4-9: iPixel Scanner controller board

4.4.6. Lower Unit

The Lower unit includes the following components:
1. Service Panel Lower Unit
2. Isolation Transformer
3. Capacitor Bank and Charger
4. Dump Module
5. Water System

4.4.6.1. Service Panel Lower Unit

The service panel includes:
1. Main switch
2. Power Cord
3. Circuit Breaker
4. Water Filling
5. Water Drain and Vent fittings

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 System Description

Figure ‎4-10: Service Panel - Lower unit

4.4.6.2. Capacitor & Charger

The capacitors bank contains 4 electrolytic capacitors each of 26000uF 250V.

Figure ‎4-11: Capacitor Charger and Capacitors Bank

4.4.6.3. Dump Module

The Dump module includes resistor and contactor. When the machine is switched
OFF, the contactor connects the capacitors to the dump resistor and discharges the
capacitors. In normal operation, when the user reduces the energy the dump card
connects the capacitors to the dump resistor and discharges the capacitors.

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 System Description

Figure ‎4-12: Dump Module

Harmony XLPro System Service Manual 4-22

 System Description

4.4.6.4. Water System

The water system includes: Water pump, water tank, heat exchanger (radiator),
fans, particles filter, deionizer filter, flow switch, level switch and thermal switch.
The unit circulates cold water from the water tank to the handpiece and back to the
water tank via the heat exchanger. The heat exchanger is cooled with two fans that
their speed is controlled by the fan control board base on the water temperature.
In order to maintain good cooling and long lasting handpiece, once a year the
deionizer filter, particles filter and deionized water should be replaced. Heat
exchanger (Radiator) and all air filters should be cleaned from dust.

Figure ‎4-13: Water System Components

Harmony XL Pro System Service Manual 4-23

 CHAPTER 5
Controls and Indicators

Chapter Contents:
Section Title Page
5.1. Introduction........................................................................................ 5-2
5.2. Main Circuit Breaker ......................................................................... 5-2
5.3. Main Power Switch............................................................................ 5-2
5.4. Keyswitch .......................................................................................... 5-3
5.5. Emergency Shut-off Knob ................................................................. 5-3
5.6. Light Emission Indicator ................................................................... 5-3
5.7. Audio Indicator .................................................................................. 5-4
5.8. Touch-Screen Control Panel .............................................................. 5-4
5.9. Service Panel ..................................................................................... 5-5
5.10. Footswitch.......................................................................................... 5-6
5.11. Laser Module Trigger ........................................................................ 5-7

HarmonyXL Pro System Service Manual 5-1

Controls and Indicators

5.1. Introduction
This chapter details the system controls and indicators of the HarmonyXL Pro
system:
 Main Circuit Breaker  Audio Indicator
 Main Power Switch  Touch-Screen Control Panel
 Keyswitch  Service Panel
 Emergency Shut-Off Knob  Footswitch
 Light Emission Indicator  Laser Module Trigger

5.2. Main Circuit Breaker

The semi-automatic circuit breaker is located on the system's service panel (see
Figure ‎5-1) and protects the HarmonyXL Pro against excessive current
consumption. The circuit breaker disconnects power to the system in case of an
electrical overload. To resume operation after the circuit breaker trips off, lift the
circuit breaker handle and restart the system.

5.3. Main Power Switch

The main power switch is located on the system's rear panel(see Figure ‎5-1). This
green is switch used to activate the touch-screen LCD display. A correct operation
sequence starts with switching on the main power switch prior to turning on the
keyswitch.

Main Switch Circuit Breaker

Figure ‎5-1: Main Circuit Breaker and Main Switch

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 Controls and Indicators

5.4. Keyswitch
The keyswitch is located on the system's front panel (seeFigure ‎5-2). It is used to
turn on the main operating menu after the system is activated. To switch the system
into operational mode, the keyswitch is turned a quarter of a turn, clockwise.

Warning
To avoid misuse of the system, do not leave the key in the keyswitch while the
system is unattended.

5.5. Emergency Shut-off Knob

In case of emergency, press the red emergency shut-off knob (seeFigure ‎5-2) to
stop all system operations. To resume operation, release the knob by turning it a
quarter of a turn clockwise.

5.6. Light Emission Indicator

The yellowemission lamp, located on the front panel (seeFigure ‎5-2), indicates the
following:
 Off - when the system is turned on, and in Standby mode
 Blinking – during Ready mode
 Continuous – during light emission (footswitch or footswitch and
moduletrigger are pressed)

Emission Indicator

Keyswitch

Emergency
Shut-Off Knob

Figure ‎5-2: System Controls

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Controls and Indicators

5.7. Audio Indicator

A single audio signal sounds when the system is set to Standby mode or when the
footswitch is pressed in Ready mode.

5.8. Touch-Screen Control Panel

The control panel (see Figure ‎5-3) is fixed to the end of the folding hinge that
allows for adjusting the position of the panel to the comfort level of the system's
operator.
The touch-screen panel is designed to provide simple and comprehensive control of
the system by means of interactive touch & the high resolution color monitor.
The operator may access the system's features and functions by selecting the
desired modes and operating parameters, and executing them by simply touching
the appropriate soft-keys on the touch-screen panel.
Refer to Chapter 6 for detailed explanations regarding the soft-keys. Proprietary
information for each of the individual module operating screens may be found in
the Modules Manual. Figure ‎5-3 presents a view of the control panel.

Figure ‎5-3: Touch-Screen Control Panel

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 Controls and Indicators

5.9. Service Panel

The service panel is located on the HarmonyXL Pro's rear side and incorporates the
system controls and connections exhibited in Figure ‎5-4.

Remote
Interlock System
Separation Latch
Footswitch
Knob
Connection Port

Main Switch

Cooling System
Circuit Breaker Connection
Fittings
Fan Grills

Figure ‎5-4: Service Panel

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Controls and Indicators

5.10. Footswitch
Pulsed light emission with the non-lasermodules occurs only when the footswitch is
activated.
Laser pulse emission occurs when the footswitch is activated at the same timeas the
moduletrigger. This requirement for simultaneous activation of both triggers
minimizes the risk of unintentional laser beam emission.
The footswitch (see Figure ‎5-5) is enabled only when the system is in Ready mode.
Activation of the footswitch in Standby mode does not result in light emission.
The footswitch is a pneumatic pedal that connects to the system through the
footswitch connection port on the service panel (see Figure ‎5-4).

Figure ‎5-5: Footswitch

Warning
If the system is in Ready mode, laser beam emission occurs when the footswitch
and the moduletrigger are simultaneously activated.

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 Controls and Indicators

5.11. Laser Module Trigger

The module trigger is the push button located on the pistol-shaped handle (see
Figure ‎5-6) of the laser modules. Laser radiation emission is enabled only when
both the module trigger and the footswitch are activated.

Figure ‎5-6: Laser Module Trigger

Warning
If the system is in Ready mode, laser beam emission occurs when the footswitch
and the module trigger are simultaneously activated.

HarmonyXL Pro System Service Manual 5-7

 CHAPTER 6
Maintenance and Software
Installation

Chapter Contents:
Section Title Page
6.1. Introduction........................................................................................... 2
6.2. Periodic Service .................................................................................... 2
6.3. Service Information .............................................................................. 3
6.4. Routine Maintenance ............................................................................ 4
6.4.1. Cleaning and Disinfecting the System .............................................. 4
6.4.2. Cleaning and Disinfecting the Non-LaserModules ........................... 4
6.4.2.1. Cooled Modules ........................................................................ 4
6.4.2.2. Non-Cooled Modules ................................................................ 5
6.4.2.2.1. The Module parts: ................................................................ 5
6.4.2.2.2. Cleaning and Disinfection Instructions .............................. 6
6.4.3. Cleaning and Disinfecting the Laser Modules .................................. 7
6.4.3.1. Laser ModuleStandard Tip Parts Identification ........................ 7
6.4.3.2. Laser ModuleStandard Tip Cleaning & Disinfection Instructions ....
................................................................................................... 8
6.4.4. Cleaning and Sterilizing the iPixelEr:YAG Laser Module's Tip
Sections ......................................................................................................... 8
6.4.4.1. Cleaning the iPixelEr:YAG/ YAG 1064 QSW iPixel Laser
Module's Wheeled Tip Section ..................................................................... 9
6.4.4.2. Sterilizing the iPixelEr:YAG/ YAG 1064 QSW iPixelLaser
Module's Tip Sections ................................................................................. 10
6.5. Filling/Draining the Cooling System's Water Reservoir .................... 11
6.5.1. Water Filling Procedure .................................................................. 12
6.5.2. Water Draining Procedure ............................................................... 12

HarmonyXL ProSystem Operator's Manual 6-1

Maintenance

6.1. Introduction
This chapter contains maintenance instructions for the HarmonyXL Pro system.
Routine maintenance may be performed by clinic staff unless otherwise specified.
Any maintenance procedure not mentioned in this chapter must be performed only
by Alma Lasers authorized technical personnel.
The system is designed to operate reliably without any need for operator
maintenance. However, the outer surfaces of the system should be kept clean for
hygienic reasons and the lightguides & tips should be cleaned between sessions to
enable effective treatment.

Warning
Maintenance by the operator should be performed only when the system is shut
down and disconnected from the mains power source. Performing maintenance
procedures with the system turned on may be hazardous to the operator and/or
destructive to the system.

6.2. Periodic Service

The system should be periodically inspected and maintained to keep it in peak
operating condition.
The following routine service operations should be performed by Alma Lasers
authorized technical personnel every 12 months:
 General system check
 Interior inspection, including cleaning accumulated layers of dust
 Verification of the light/laser output power rates with a power meter
 Cooling system:
Check the water level in the cooling system; refill if necessary
Replace the deionizer filter
Replace particles filter
Clean the radiator
Check the water quick-connector O-rings on the modules
If periodic service is not performed according to schedule (every 12 months) by an
Alma Lasers-authorized service provider, any warranty agreement of the system
and its associated modules and/or accessories will be invalidated.

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 Maintenance

Warning
 The HarmonyXL Pro system generates hazardous voltages within the main
console.
 The interior of the system may be serviced only by Alma Lasers authorized
technical personnel.

6.3. Service Information

In communications with Alma Lasers authorized representatives regarding the
system, always include the part number and serial number indicated
on the identification label located on the system's service panel.

Warning
 Unauthorized servicing or modification of this system not described in this
manual may expose the operator or patient to potential high voltage and laser
radiation hazards.
 Improper use or adjustment of this system may invalidate the service
warranty agreement.

Questions or problems should be referred to your Alma Lasers representative, or to

the Alma Lasers Service Center at:
Alma Lasers GmbH
Nordostpark 100-102
90411 Nuernberg, Germany
Tel. + 49 911 / 89 11 29-0
Fax + 49 911 / 89 11 29-99
Email: http://www.almadeutschland.de/kontakt/ansprechpartner
Website: www.alma-lasers.de

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Maintenance

6.4. Routine Maintenance

The following routine maintenance procedures should be performed by the clinic
staff on a regular basis determined by the clinic protocol.

Warning
 The HarmonyXL Pro system generates high voltages and pulsed light/laser
radiation when powered up.
 Always turn the system off and unplug the power cable before performing
maintenance procedures.
 The interior of the system or its components may be serviced only by Alma
Lasers authorized technical personnel.

6.4.1. Cleaning and Disinfecting the System

The outer surface of the system may be wiped clean with a soft cotton cloth
swabbed in a mild soap and water solution.
Use vacuum cleaner to clean dust from the air filters externally every 3 months.

6.4.2. Cleaning and Disinfecting the Non-LaserModules

6.4.2.1. Cooled Modules
Preventive inspection of the non-lasermodules should be performed after each
treatment. The inspection consists of checking the output surface of the lightguide.
If the module'stip is dirty, it should be cleaned with a damp cotton cloth.
The outer surface of the modulebody and the umbilical cable may be wiped clean
with a soft cotton cloth swabbed in 70% alcohol.

Caution
 Never immerse any part of the modulein water, nor hold it under running
water.
 The window of the lightguide should be cleaned at the end of each session to
remove gel and dirt to avoid interference in light distribution, which may
reduce effectiveness of subsequent treatments.

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 Maintenance

6.4.2.2. Non-Cooled Modules

Note

Cleaning and disinfection should be performed after each

treatment.

6.4.2.2.1. The Module parts:

1. Applicator 1
2. Light-guide (LG)
4
3. Light-guide sleeve (LGS)
4. Umbilical Cord
5. Connector

Figure ‎0-1 : The Module's Parts (1)

3

Figure ‎0-2: The Modules Parts (2)

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 Maintenance

6.4.2.2.2. Cleaning and Disinfection Instructions

1. Turn the system "off ".

2. Clean external surface of LG with soft cloth or cotton ball. Wipe and
cleanany traces of ultrasonic gel from the LGS external surface using a dry
cloth.
3. Grasp the LGS as shown in Fig. 1 and pull away from LG.
4. The naked LG (glass) should be observed for stains or ultrasonic gel debris
5. (Fig. 2).
6. Clean the external LG borders with warm water using small soft cloth or
cotton ball (no water should be allowed inside the LG assembly).
7. The LG guide external glass should be disinfected externally using 70%
alcohol antiseptic solution.
8. Immerse LGS in hot water and clean inside-out using dry soft cloth (Fig.
3).
9. Both LG and the LGS areas should be dried before reassembly.
10. Insert the LGS fully over the LG (Fig. 4).

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 Maintenance

6.4.3. Cleaning and Disinfecting the Laser Modules

The cleaning and disinfection instructions should be applied to the all of the laser
modules and their tips.
It is imperative that the laser module tips and their lenses remain clean and free of
dirt. The laser tips and the lenses must be cleaned with a cotton swab and warm
water after each treatment. During long treatments, the operator should visually
inspect the tip attachment and clean it as necessary. For disinfection use 70%
alcohol.
The outer surface of the modulebody and the umbilical cable may be wiped clean
with a soft cotton cloth swabbed in 70% alcohol.

Caution
 Never immerse any part of the modulein water, nor hold it under running
water.
 The window of the lightguide should be cleaned at the end of each session to
remove gel and dirt to avoid interference in light distribution, which may
reduce effectiveness of subsequent treatments.

6.4.3.1. Laser ModuleStandard Tip Parts Identification

The laser module tip consists of the following parts (see Figure ‎0-3):
 Tip body
 Guiding tip
 Removable lens
The guiding tip may be pulled out of its base in the body of the tip, and the
removable lens can be pushed out of the tip body with your finger.
Guiding Tip Snap the tip out and in

Removable Lens

Figure ‎0-3: Disassembling the Laser Module Tip

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Maintenance

6.4.3.2. Laser ModuleStandard Tip Cleaning & Disinfection Instructions

1. Turn the system off.
2. Unscrew the tip from the laser module.
3. Pull the guiding tip out of the tip body and push the removable lens out of the
tip body.
4. Wipe and clean any traces of gel or dirt from the three components using a dry
cloth.
5. Clean the external surfaces of the tip body and all the surfaces of the guiding
tip with warm water using a small soft cloth or cotton ball.
6. Both sides of the lens should be cleaned using a gentle optical lens cleaning
solution, such as Fisherbrand® Optical Lens Cleaner or equivalent.
7. All components of the tip should be completely dry before reassembly!

Note

Some laser module tips may not have a removable lens.

6.4.4. Cleaning and Sterilizing the iPixelEr:YAG Laser Module's Tip

Sections
It is imperative that the wheeled tip sections of the Er:YAG laser module's iPixel tip
remain clean and free of debris. After each treatment these parts should be detached
from the handpiece cleaned and disinfected as follows.

Warning
 Do not treat a patient with an unsterilized tip; this can lead to cross-
contamination!
 Ensure that the tip is absolutely dry before inserting it back into the module and
before treating a patient.
 Read the disinfectant manufacturer's instructions carefully before use.
 Use appropriate personal protective equipment during cleaning/sterilization.

HarmonyXL ProSystem Operator's Manual

 Maintenance

6.4.4.1. Cleaning the iPixelEr:YAG/ YAG 1064 QSW iPixel Laser Module's
Wheeled Tip Section
1. Prepare Enzol enzymatic detergent (or equivalent natural pH enzymatic)
solution according to the manufacturer's recommendations (1 oz. per gal./8 ml.
per liter), using lukewarm tap water. If at any time during the cleaning
procedure the detergent becomes grossly soiled, prepare fresh detergent.
2. Detach the Right Wheeled Arm and the Wheel (see Figure ‎0-4) from the
main body of the tip and immerse fully in the solution; soak them for at least
10 minutes.

Figure ‎0-4: YAG 1064 QSW iPixelTip Disassembly

Figure ‎0-5: iPixelEr Tip Disassembly

3. With the Right Wheeled Arm and Wheelcompletely immersed, scrub
thoroughly using a soft-bristled brush, a minimum of three times, until all
visible soil has been removed. Ensure that the components are rotated through
360 degrees, throughout each of the three scrubbing passes.
4. Rinse: flush the Right Wheeled Arm and Wheel thoroughly, using a syringe
filled with the prepared detergent (Enzol).
5. Fully immerse the Right Wheeled Arm and Wheelin tap water and allow
them to soak for a minimum of 1 minute. After soaking, flush thoroughly using
a syringe and a fresh batch of tap water to rinse in between the plates of the

HarmonyXL ProSystem Operator's Manual

Maintenance

wheels, for a minimum of one minute. Ensure that the wheels are exposed 360
degrees throughout the rinsing pass.
6. Repeat the previous rinsing step two more times (total of 3 times), using fresh
tap water each time for each soak and flush. Each rinse should be at least 2
minutes long with the entire rinse time totaling a minimum of 6 minutes.
Ensure that the wheels are exposed 360 degrees throughout the rinsing pass.
7. Visually inspect the wheels paying close attention to hard-to-reach areas. If
visible soil remains repeat the applicable cleaning steps above.
8. Prepare Endozime® AW Triple Plus with APA, according to the
manufacturer’s recommendations in the supplied digital ultrasound cleaner.
9. Fully immerse the Right Wheeled Arm and Wheel in the ultrasound cleaner
and allow them to sonicate for a minimum of 10 minutes.
10. Fully immerse the Right Wheeled Arm and Wheelin tap water and allow
them to soak for a minimum of 1 minute. After soaking flush the components
thoroughly using a syringe and a fresh batch of tap water to rinse in between
the plates of the wheel, for a minimum of one minute. Ensure that the
wheelsare exposed 360 degrees throughout the rinsing pass.
11. Repeat the previous rinsing step two more times (total of 3 times), using fresh
tap water each time for each soak and flush. Each rinse should be at least 2
minutes long with the entire rinse time totaling a minimum of 6 minutes
Ensure that the wheelsare exposed 360 degrees throughout the rinsing pass.
12. Repeat the above sonication and rinsing steps two more times (total of 3
cycles), using a fresh batch of detergent each time.
13. Shake the Right Wheeled Arm and Wheeldry, and dry them using a clean
lint-free cloth. Pressurized air can be used to dry the tip if applicable (< 20 PSI
/ < 1.4 Bar).
14. The Left Wheeled Arm section and the Focusing Lens are designed to be
cleaned only internally. Clean the body of the Left Wheeled Arm section and
the frame of the Focusing Lens with a clean lint-free cloth dipped in 70%
isopropyl alcohol.

6.4.4.2. Sterilizing the iPixelEr:YAG/ YAG 1064 QSW iPixelLaser Module's Tip
Sections
1. Wrap the Right Wheeled Arm and Wheelin two layers of 1-ply
polypropylene wrap (KC600).
2. Sterilize the wrappedRight Wheeled Arm and Wheel according to the
sterilizer settings in the table below.
Sterilizer Type: Prevacuum
Pre-Conditioning Pulses: 3
Minimum Temperature: 132C / 270F
Full-Cycle Time: 4 minutes

HarmonyXL ProSystem Operator's Manual

 Maintenance

Minimum Dry Time: 30 minutes

6.5. Filling/Draining the Cooling System's

Water Reservoir
The HarmonyXL Pro cooling system's water reservoir must be filled/refilled with
deionized water in the following instances:
 Upon installation of a new system.
 Every 3 months add water to compensate for water loss during
disconnection of modules.
 If the water level is found to be low during a periodic maintenance check.
Filling/refilling the water reservoir is done with the water filling kit that is supplied
with the system, which includes (see Figure ‎0-6):
 A water filling tube, with a funnel connected to one side and a quick-
connector attached to the other side
 An elbowed white CPC fitting
 One 5 liter (1.3 gal.) container of deionized water

Figure ‎0-6: Water Filling Kit

Caution
Never fill the water reservoir with regular tap water. Use only deionized water

HarmonyXL ProSystem Operator's Manual

Maintenance

Water Filling Procedure

Refer to Figure ‎0-7:
1. Disconnect the mains power supply cable.
2. Connect the elbow fitting to the right port (labeled Vent) on the lower right
side of the service panel.
3. Connect the clear tube with the funnel to the port labeled Fill in the middle-
right of the service panel.
4. Use the supplied 5 liter (1.3 gal.) container of deionized water, and pour it
slowly into the funnel. Stop filling as soon as the water starts to spill from the
Vent port.
5. Disconnect the Fill/Drain Kit components.
6. Reconnect the mains power supply cable.
7. Connect any moduleto the system.
8. Turn the system on and let it run for five minutes. You may experience a
failure to start due to a low water error. Repeat turning the system on until it
runs smoothly.
9. Turn the system off.
10. Repeat steps # ‎4 and # ‎8 several times, until no more water can be added (spills
out of the elbow fitting right away).
11. Turn the system on; it is ready for normal operation.

6.5.1. Water Draining Procedure

1. Draining is required when the system needs to be moved or shipped away,
particularly in cold weather (to avoid freezing hazards).
2. Place a shallow container able to contain about 2 liters (0.5 gal.) of water and
locate it under the Drain port.
3. Connect the clear tube with the funnel to the port labeledVent on the service
panel.
4. Connect the elbow fitting to the port labeledDrain on the service panel, facing
down into the container.
5. Once the fitting is connected, water will start draining from the port to the
container. Allow it to drain until dry.

HarmonyXL ProSystem Operator's Manual

 Maintenance

Filling Port

Drain Port

Vent Port

Figure ‎0-7: Cooling System Fill, Drain and Vent Ports

HarmonyXL ProSystem Operator's Manual

 CHAPTER 7
Troubleshooting

Chapter Contents:
Section Title Page

7.1. Introduction........................................................................................ 7-2

7.2. Troubleshooting Guides..................................................................... 7-2
7.3. Software Installation Instructions ............................................ 7-6
7.3.1. Required Equipment ................................................................. 7-6
7.3.2. Software installation on the Rabbit 4000 ............................ 7-6
7.3.3. LCD Software Installation 1. Turn on the system 7-8
7.3.4. Pulse Player Installation ........................................................ 7-11
7.3.5. Screen Operating System Installation (Android) ............ 7-11

HarmonyXL ProSystem Operator's Manual 8-1

Troubleshootingand Software Installation

7.1. Introduction
The HarmonyXL Pro laser system is equipped with self-testing software routines
that continuously monitor the system operation. If a system malfunction is detected,
an error message will appear on the LCD touch-screen.
An error will disable the system operation and the operator should turn the system
off using the keyswitch and the main switch.
The following troubleshooting tables do not attempt to list all possible system
failures. Any fault not listed should be referred to Alma Lasers Service personnel.

Warning
Do not attempt to open or disassemble the system covers.

7.2. Troubleshooting Guides

Table ‎8-1 provides a list of alarms and error messages that may appear on the
touch-screen, their possible causes and corrective actions to be performed. If the
corrective actions listed in the table do not solve the problem, contact your Alma
Lasers Service representative.
Table ‎8-2 lists some probable system malfunctions for which no messages are
displayed. If the corrective actions listed in the tables do not solve the problem,
contact your Alma Lasers service representative.
The following troubleshooting guides do not attempt to list all possible system
failures. Any fault not listed should be referred to your Alma Lasers
servicerepresentative.
Please advise the Alma Lasers Service Department of all error messages that occur,
with the exceptions of Pulse Limit Reached and Interlock Not Connected.

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 Troubleshootingand Software Installation

Table ‎7-1: Error Message Troubleshooting Guide

Error Message/Alarm Probable Cause Corrective Action

Charge Time Limit Error System malfunction Call Alma Lasers Service
1. Close the door, restart the
system via the keyswitch and
Treatment room door (with resume normal operation
installed remote interlock
Interlock Not Connected Error 2. Make sure the remote
connection switch) has been
opened interlock is properly
connected to the service
panel
1. Turn system off, wait 1
minute and restart; resume
FlowSw Error Cooling system malfunction normal operation
2. If problem persists, call Alma
Lasers Service
1. Turn system off, wait 1
minute and restart; resume
FlowSw OFF Error Cooling system malfunction normal operation
2. If problem persists, call Alma
Lasers Service
Handpiece Error VB1=0 VB2=0 System software malfunction Call Alma Lasers Service
1. Replace module and resume
normal operation; return
defective module to Alma
HandpieceRES Error Modulesoftware malfunction Lasers for diagnostics.
2. If problem persists, call Alma
Lasers Service
1. Modulemalfunction 1. Replace module and resume
normal operation; return
Handpiece not Calibrated for defective module to Alma
this System Lasers for diagnostics.
2. System malfunction 2. Call Alma Lasers Service
1. Module connection 1. Reconnect the module to the
system and resume normal
ibuttonINC Failure Error operation
2. System malfunction 2. Call Alma Lasers Service
1. Module connection 1. Reconnect the module to the
system and resume normal
ibuttonFailure Error operation
2. System malfunction 2. Call Alma Lasers Service

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Troubleshootingand Software Installation

Table ‎7-2: Error Message Troubleshooting Guide (continued)

Error Message/Alarm Probable Cause Corrective Action

Discharge Time Limit Error System malfunction Call Alma Lasers Service
Modulehas reached the end of
Pulse Limit Reached Replace the module
its rated lifetime
Leakage Error Electrical malfunction Call Alma Lasers Service
1. Modulemalfunction 1. Replace module and resume
normal operation; return
defective module to Alma
JouleLimit Error Lasers for diagnostics. If
problem persists, call Alma
Lasers Service.
2. System malfunction 2. Call Alma Lasers Service
1. Module light source 1. Replace module and resume
malfunction normal operation; return
Simmer St Error defective module to Alma
Lasers for diagnostics
2. Electrical malfunction 2. Call Alma Lasers Service
Vcaps Out of Range Error System malfunction Call Alma Lasers Service
VcapsSelf Test Failure Error System malfunction Call Alma Lasers Service
Vcaps2/3 Out of Range Error System malfunction Call Alma Lasers Service
Turn system off, wait 1 minute
Electrical system discharge
Vcaps> 10 and restart; resume normal
malfunction
operation
1. Turn system off, wait 1
minute and restart; resume
Data Buffer Overload System malfunction normal operation
2. If problem persists, call Alma
Lasers Service
1. Turn system off, wait 1
minute and restart; resume
Date Time Error System malfunction normal operation
2. If problem persists, call Alma
Lasers Service

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 Troubleshootingand Software Installation

Table ‎7-3: System Malfunctions Troubleshooting Guide

Symptom Probable Cause Corrective Action

 Check power cable

Power disconnected
 Plug cable into wall
System does not start Call Alma Lasers customer
Internal fuse blown
support
Red emergency shutoff knob is Release emergency shutoff
engaged knob by turning it clockwise
Make sure the power cable in
Monitor does not respond when The monitor is not receiving
the rear of the monitor is
the system is on power
connected

 Check the LAN cable

connection between the
The screen loos communication screen and the Rabbit 4000
System not responding message
with the controller  reinstall the pulseplayer and
the latest software
(Rabbit+Screen)

 Make sure the system is

connected to a single power
outlet
 Make sure there is no other
power consumer on the
same power line of the
system
System freezes or restarting communication or electric
itself problem  Check the LAN cable
connection between the
screen and the Rabbit 4000
 Reinstall the full Android
operating system with the
latest software
 Connect the system to an
online UPS 10 KVA

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Troubleshootingand Software Installation

7.3. Software Installation Instructions

7.3.1. Required Equipment

1. PC computer
2. Disk On Key
3. Programing cable for Rabbit 4000
4. RFU 10.72 (Rabbit Field Utility)

7.3.2. Software installation on the Rabbit 4000

1. Run the RFU.exe file (Rabbit Field Utility) on your computer from its location;
the main screen appears and choose Processor Type Rabbit 4000
(see Figure ‎7-1)

Figure ‎7-1: Main Screen

2. Connect the cable connector marked PROG on the other end of the cable to the
Rabbit processor. Make sure that the cable's red lead is facing out
(see Figure ‎7-2)

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 Troubleshootingand Software Installation

Figure ‎7-2: connecting the programming cable to the Rabbit Processor

3. Check the box of the of the port that end's with USB (see Figure ‎7-3)
4. From the opening screen menu bar, select Setup and Communications.
5. Make sure to leave the Baud Rate at 57600 (see Figure ‎7-3)

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Troubleshootingand Software Installation

Figure ‎7-3: Communication Options

6. Check the Use USB to Serial Converter box. And Uncheck the Enable Processor
Detection box. (see Figure ‎7-3)
7. Connect the power cable to the Harmony XL system and turn the system on.
8. From the Main screen of the RFU program, press on the small gray box on
the right side of the Firmware Image line to choose and load the file
(see Figure ‎7-1)

7.3.3. LCD Software Installation

1. Turn on the system

2. If the screen not connected to a system, connect the power cord to the screen and
Press on the "Back" button (located on the back of the screen) (see Figure ‎7-4)

Figure ‎7-4: Back Button and Power Cordconnection

3. Enter password 22492249 (see Figure ‎7-5)
4. Press on "Exit" (see Figure ‎7-5 )

Figure ‎7-5: Screen Password Figure ‎7-6: Option Screen

5. Press on "settings" (see Figure Figure ‎7-7)

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 Troubleshootingand Software Installation

6. Press on Apps (see Figure ‎7-7)

Figure ‎7-7: Setting Button Figure ‎7-8: Setting Screen

7. Press on "Harmony XL" (if exist) (see Figure ‎7-9)
8. Press on "uninstall"
9. Press "ok"
10. Press on the "Back" button (located on the back of the screen) (see Figure ‎7-9)

Figure ‎7-9: App Selection Screen Figure ‎7-10: Back Button

11. Press on the "Apps Button" (see Figure ‎7-11)
12. Press on the "Explorer" (see Figure ‎7-11)

Figure ‎7-11: App Soft Key Figure ‎7-12: Explorer App

13. Press on the "Nand Flash" or "Internal Memory"
14. Open folder "0" (see Figure ‎7-13)
15. Press on the ***.apk file for few seconds (see Figure ‎7-13 )

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Troubleshootingand Software Installation

Figure ‎7-13: Folder Selection Figure ‎7-14: APK selection

16. Press on "Delete"
17. Press on "Delete" again
18. Press on the "Back" button (located on the back of the screen)
19. Insert the DOK with the ***.apk file in to USB-1 witch located on the back of
the screen.
NOTE: (make sure the file is inside folder "0" without any other files)
20. Open the "PulsePlayer" app (see Figure ‎7-15)
21. Enter password 22492249
22. Press on "Delete Before Copy"
23. disconnect the DOK from USB-1
24. Press on "Install"
25. Press on "open"
26. If the installation was successful, the "Welcome" screen will appear
(see Figure ‎7-15)

Figure ‎7-15: PulsePlayer App Figure ‎7-16: Welcome Screen

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 Troubleshootingand Software Installation

7.3.4. Pulse Player Installation

* See Technical Bulletin #101
7.3.5. Screen Operating System Installation (Android)
* See Technical Bulletin #103

HarmonyXL ProSystem Operator's Manual7-11

 CHAPTER 8

Spare Parts
Catalog
 Spare Parts Catalog

Table of Contents
Section Page
3 .........................................................................................................................Introduction 8.1
3 ................................................................................................................. Spare Parts List 2.8

Harmony XL Pro System Operator's Manual

 Spare Parts Catalog

8.1 Introduction
The following spare parts catalog lists all of the Harmony XL modules and parts that should be stored
by the Alma Lasers depot or distributorship for the use of the field service engineers.
The Item # column of the table indicates the item number as shown in the illustration on the pages
following the table.
The Figure # column notes in which illustration (following the table) the particular item can be
found.
The Description column of the table provides the item name and/or its brief description.
The Part # column of the table shows the item part number, by which it should be ordered from
Alma Lasers.

8.2 Spare Parts List

Item # Figure # Part Description Part #

Harmony XL Pro Lower System 230V

1 Fuse 2AG S 3.15A EGDL12060112
2 Figure 1 Thermal Switch EGIP04050501
3 Thermistor Probe NTC EGGG01070701
4 Figure 2 Fan 120x120x38 24VDC EGHP26030701
5 Figure 3 Switch Rocker EGDD22040202
6 Figure 4 Filter 1/4" NPT 178 Micron PGGG18120801
7 Contactor 110V EGHR26070402
8 Figure 5 Fan Control PCFC01070701
9 Figure 6 Contactor 220V EGID24100101
10 Figure 7 Emergency Stop Switch EGIP21110601
11 Figure 8 Main RFI Filter EGHP24010601
12 Figure 9 CONTACTOR LP4-K09004BW3 EGIP24090701
13 Figure 10 Level Switch EGIP27060401
14 Figure 11 CONTACTOR LP1K09008BD 24V DC EGGG02020604
15 Figure 12 Filter Water DI Cartridge PGHR15110101
16 Figure 13 Harmony Pro Water Tank AAIP02020650
17 Figure 14 RESISTOR 200W 220 OHM EGHP22030601
18 Circuit Braker 20A (visual similar as the 10A) EGGG08030603
19 Figure 15 Circuit Braker 10A EGHR26070401
20 Figure 16 Flow switch (service) EGGG18030903
21 Figure 17 Water Pump CPD 8800 (Service) EGSH18011003
Heat Exchanger 731 1/4"" NPTF Fittin-
22 Figure 18
Thermatron PGHR11110101

Harmony XL Pro System Operator's Manual

 Spare Parts Catalog

23 Figure 19 Cap. Charger CCPF-1500-0.6-Dual EGGG03111011

24 Figure 20 Castor with stopper PGIP05050402
25 Figure 21 Castor without stopper PGIP05050403

Harmony XL Pro Upper System

26 Figure 22 Lamp Filament 24-30V (together with item 28) EGIP14040301
27 Figure 24 FAN 80*80*25mm 24VDC EGDL12060105
28 Figure 23 Signal Indicator Yellow Rafix 16 EGSP29090501
29 Figure 25 Switch , Foot Switch EGID21100101
30 Figure 26 Footswitch pedal EGGG28100110
Figure 27 Vacuum Pump WAHP23010730
Figure 28
33 Figure 29 Dump Card CL21060101-A AEIP18030301
34 Figure 30 KEY SWITCH Lovely EGIP14010306
35 CONTACTOR LP4-K09004BW3 EGIP24090701
36 Figure 31 Power Supply 70W 24V EGSP21020504
37 Figure 32 Solid State Relay EGIP15110501
38 Figure 33 Power Supply TXL-220-24S EGHP16010601
39 Figure 34 Interface module for Harmony XL Pro ELGG05111311
40 Figure 35 Switching Module ( Harmony XLI Pro) AAHL03011201
40 Figure 35 Switching Module ( Harmony XL Pro) AASM26051300
41 Figure 36 screen iDisplay 15.6" EGGG22041411
42 Panel Set AAHP07090801
43 Key Set EGIP16110601
44 Figure 37 Controller Mini For HXL AESP16111004
44 Figure 38 Lasers Tip Scanner Assy For HXL AETS29061001

Harmony XL Pro System Operator's Manual

 Spare Parts Catalog

Harmony XL Pro System Operator's Manual

 Spare Parts Catalog

Figure 1: Thermal Switch,turns the system off when water temperature exceeds 50 degrees

Figure 2: Fan 120x120x38 24VDC, fan for pushing cool air through the system

Figure 3: Switch Rocker,Indicates that the system is connected to the electricity power grid

Harmony XL Pro System Operator's Manual

 Spare Parts Catalog

Figure 4: Filter 1/4" NPT 178 Micron,filters large particlesin the water system

Figure 5: Fan Control, control system fans

Harmony XL Pro System Operator's Manual

 Spare Parts Catalog

Figure 6: Contactor 220V

Figure 7: Emergency Stop Switch, performs immediate disabling system

Harmony XL Pro System Operator's Manual

 Spare Parts Catalog

Figure 8: Main RFI Filter, filters Radio Frequency Interference, cannot be opened

Figure 9: CONTACTOR LP4-K09004BW3

Harmony XL Pro System Operator's Manual

 Spare Parts Catalog

Figure 10: Level Switch, water level indicator

Figure 11: CONTACTOR LP1K09008BD 24V DC

Harmony XL Pro System Operator's Manual

 Spare Parts Catalog

Figure 12: Filter Water DI Cartridge,mineral ions filter for water system, cannot be opened

Figure 13: Harmony Pro Water Tank,contains all the water of the cooling system, cannot be opened

Harmony XL Pro System Operator's Manual

 Spare Parts Catalog

Figure 14: RESISTOR 200W 220 OHM, Load for discharge capacitors, cannot be opened

Figure 15: Circuit Braker 10A

Harmony XL Pro System Operator's Manual

 Spare Parts Catalog

Figure 16: Flow switch (service), water flow indicator

Figure 17: Water Pump CPD 8800 (Service),activate cooling water circulation, cannot be opened

Harmony XL Pro System Operator's Manual

 Spare Parts Catalog

Figure 18: Heat Exchanger 731 1/4"" NPTF Fittin-Thermatron,Heat exchange connected to the
water cooling system, cannot be opened

Figure 19: Cap. Charger CCPF-1500-0.6-Dual, charge the capacitors bank, cannot be opened

Harmony XL Pro System Operator's Manual

 Spare Parts Catalog

Figure 20: Castor with stopper, front system wheel

Figure 21: Castor without stopper,back system wheel

Harmony XL Pro System Operator's Manual

 Spare Parts Catalog

Figure 22: Lamp Filament 24-30V, indication lamp

Figure 23: Signal Indicator Yellow Rafix 16,cover for indication lamp

Harmony XL Pro System Operator's Manual

 Spare Parts Catalog

Figure 24: FAN 80*80*25mm 24VDC, Heat exchanger fan for pushing cool air through the system

Figure 25: Switch, Foot Switch, pneumatic trigger

Harmony XL Pro System Operator's Manual

 Spare Parts Catalog

Figure 26: Footswitch pedal, pneumatic trigger operate by foot press

Figure 27: Vacuum Pump

Harmony XL Pro System Operator's Manual

 Spare Parts Catalog

Figure 28:

Figure 29: Dump Card CL21060101-A, measure capacitors voltage and to dump capacitors

Harmony XL Pro System Operator's Manual

 Spare Parts Catalog

Figure 30: KEY SWITCH Lovely, manual system Lock

Figure 31: Power Supply 70W 24V, Supplies power to the Interface controller and LCD, cannot be
opened

Harmony XL Pro System Operator's Manual

 Spare Parts Catalog

Figure 32: Solid State Relay, electronic switching device controls current for TEC, cannot be opened

Figure 33: Power Supply TXL-220-24S, Supplies power to fans, water pump and TEC, cannot be
opened

Harmony XL Pro System Operator's Manual

 Spare Parts Catalog

Figure 34: Interface module for Harmony XL Pro,Controlled system data via software

Figure 35: Switching Module, This unit ignites the lamp in the Handpiece and partial discharges the
capacitor bank to the lamp, cannot be opened

Harmony XL Pro System Operator's Manual

 Spare Parts Catalog

Figure 36: system screen iDisplay 15.6", cannot be opened

Figure 37: Controller Mini For HXL, Self-unit that tests several parameters in the system and send
feedback to the interface Controller

Harmony XL Pro System Operator's Manual

 Spare Parts Catalog

Figure 38: Lasers Tip Scanner AssyFor HXL, Scanner controller Board allows using iPixel Scanner

Harmony XL Pro System Operator's Manual

 Spare Parts Catalog

Harmony XL Pro System Operator's Manual

Harmony XL Pro System Service Manual

APPENDIX A

Electrical
Schematic
Service Manual – Electrical Schematics Harmony XL Pro System

Table of Contents
Section Page
A.1. Upper Part Wiring Diagram......................................................................................... A-3
A.2. Lower Part Wiring Diagram ........................................................................................ A-4

A-2 SMSPNXLI10071001, Rev. A

Harmony XL Pro System Service Manual – Electrical Schematics

A.1. Upper Part Wiring Diagram

SMSPNXLI10071001, Rev. A A-3

Service Manual – Electrical Schematics Harmony XL Pro System

A.2. Lower Part Wiring Diagram

A-4 SMSPNXLI10071001, Rev. A

Harmony XL Pro System Service Manual – Electrical Schematics

Notes:

SMSPNXLI10071001, Rev. A A-5