Almaco Hybrid User manual

Alma
Manual

© 2021, Alma Lasers. All rights reserved.
No part of this manual may be reproduced or copied in any form by any means - graphic, electronic or
mechanical, including photocopying, typing, or information retrieval systems - without written permission of
Alma Lasers.
System specifications and the information contained in this document are subject to change without notice.
Alma Lasers, its logo and Alma Hybrid are either registered trademarks or trademarks of Alma Lasers Inc.
in the USA and/or other countries.
Alma Lasers Ltd.
18 Haharash Street, Caesarea
North Industrial Park
Israel 3079895
Tel: [phone]
Fax: [phone]
Email: [e-mail]
Catalog No.: OMHY18061902
Revision: 2, August 2021
Alma Lasers Inc.
485 Half Day Road Suite # 100
Buffalo Grove, IL 60089
Tel: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.almalasers.com/us

Table of Contents
Scope of This Manual
This Operator's Manual incorporates the following chapters:
Chapter 1
System Overview
Contains a general introduction to the system.
Chapter 2
Safety
Contains explanations and directions concerning safety measures for operating the system,
compliance, classifications and labels.
Chapter 3
System Description
Contains a detailed overview of the system and its various sub-systems.
Chapter 4
Installation
Lists electrical, space and environmental requirements for installation of the system.
Chapter 5
Operating Instructions
Explains how to operate the system as a platform, offering basic information and common
instructions for operation. Specific operating instructions for each of the applicators may be
found in the Applicators Operator's Manual
Chapter 6
Maintenance
Provides a detailed review of how to maintain the system.
Chapter 7
Troubleshooting
Lists the system error messages that might appear during operation, their probable causes and
what corrective actions to perform.
Chapter 8
Electromagnetic Compatibility
Conditions under which the system should be operated.
Following appendixes provides clinical information of applicators:
Appendix A
Clinical Guide –Clinical General
Appendix B
Clinical Guide - HyLight Applicator
Appendix C
Clinical Guide - Pixel Applicator
Appendix D
Clinical Guide - ProScan Applicator
Alma Hybrid - Instructions for Use i

Table of Contents
Table of Contents
Scope of This Manual ................................................................................................... i
Table of Contents .........................................................................................................ii
System Overview
1-1
1.1
Introduction.................................................................................................
1-1
1.2
Use of the Operator Manuals..................................................................
1-1
1.3
Physician Responsibility ..........................................................................
1-2
1.4
User Profiler / Intended User..................................................................
1-2
1.5
Maintenance................................................................................................
1-2
1.6
Modification of the System ......................................................................
1-2
1.7
Resale Inspection .......................................................................................
1-3
1.8
Abbreviations and Acronyms ..................................................................
1-3
Safety
2-1
2.1
Introduction.................................................................................................
2-1
2.2
System Safety Measures ..........................................................................
2-1
2.3
Electrical Safety .........................................................................................
2-1
2.4
The Treatment Room ................................................................................
2-3
2.5
General Precautions and Cautions ........................................................
2-4
2.6
Warnings Related to Laser Emission....................................................
2-5
2.7
System Safety Features............................................................................
2-7
2.8
System and Equipment Classifications and Compliance .................
2-7
2.9
Labeling and Signs ....................................................................................
2-8
System Description
3-1
3.1
Introduction.................................................................................................
3-1
3.2
System Specifications ...............................................................................
3-2
3.3
System Components and Controls .........................................................
3-2
3.4
Ordering Information................................................................................
3-6
Installation
4-1
4.1
Introduction.................................................................................................
4-1
4.2
Equipment List...........................................................................................
4-1
ii Alma Hybrid - Instructions for Use

Table of Contents
Alma Hybrid - Instructions for Use
iii
4.3 Facility Requirements...............................................................................4-1
4.4 Remote Interlock and Footswitch Connection.....................................4-3
4.5 Filling the Coolant Reservoir ..................................................................4-3
4.6 Moving the System ....................................................................................4-4
4.7 Environmental Conditions during Storage and Transportation .....4-4
Operating Instructions 5-1
5.1 Introduction.................................................................................................5-1
5.2 Turning ON the System............................................................................5-1
5.3 Operating the System ...............................................................................5-4
5.4 Changing Operation Parameters............................................................5-4
5.5 Error Detection ...........................................................................................5-4
5.6 System Shut-Down ....................................................................................5-5
Maintenance 6-1
6.1 Introduction.................................................................................................6-1
6.2 Periodic Service ..........................................................................................6-1
6.3 Routine Maintenance ................................................................................6-2
6.4 Service Information ...................................................................................6-5
Troubleshooting 7-1
7.1 Introduction.................................................................................................7-1
7.2 Troubleshooting Guides............................................................................7-1
Electromagnetic Compatibility 8-1
8.1 Cable Lengths and Replacements ..........................................................8-2
8.2 Manufacturer's declaration –Electromagnetic Emissions ...............8-2
8.3 Manufacturer's declaration –Electromagnetic Immunity................8-3

Alma Hybrid - Instructions for Use
1-1
System Overview
1.1 Introduction
The Alma Hybrid Laser System is a new laser system and a unique medical device. Alma Hybrid
Laser System offers monochromatic and sequential radiation delivery of two wavelengths and is
intended for a wide spectrum of medical and aesthetical applications. The Alma Hybrid Laser
System incorporates two laser wavelengths: CO2 (10,600nm) and 1570nm lasers for the emission
of non-fractional or fractional output. The system offers an advanced computerized, multi-
technology platform, utilizing: a 10600nm laser and 1570nm fiber laser wavelengths. The system
has a user-friendly interface which provides the practitioner with the ability to predefine their
desired treatment parameters settings.
1.2 Use of the Operator Manuals
The system is designed to meet international safety and performance standards. Personnel operating the
system must have a thorough understanding of how to properly operate the system.
This manual has been prepared to aid medical and technical personnel to understand and operate the
system. If any part of this manual is not clear, please contact your Alma Lasers representative for
clarification.
The information provided in this manual is not intended to replace professional training on the clinical
use of the system. Please contact your Alma Lasers representative for current information on available
training.
This manual should always accompany the system and all operating personnel must know its location.
Additional copies of this manual are available from Alma Lasers or your local Alma Lasers
representative.
For further information about Alma Lasers, visit the company website at: http://www.almalasers.com
Warning
Use of controls or adjustments or performing procedures other than those specified herein may
result in hazardous radiation exposure.
DO NOT operate the system before reading this manual and gaining a clear understanding and
become thoroughly familiar with all its safety requirements and operating procedures.

1-2
Alma Hybrid - Instructions for Use
System Overview
1.3 Physician Responsibility
Regulatory statutes in most countries restrict prescription of medical systems for sale by or on the
order of a physician, or a properly licensed practitioner. The physician will be responsible for the
use and operation of the system and for all operator qualifications. Alma Lasers makes no
representations regarding state or local laws or regulations that might apply to the use and operation
of any medical system. The physician is responsible for contacting his or her local licensing
agenciesto determine any credential required by law for clinical use andthe operation of thesystem.
1.4 User Profiler / Intended User
The system is intended to be used by professional practitioners (specialized physician /authorized
technical personnel) in the medical field. The system is intended for use in professional healthcare
facility environment (such as Physician offices, clinics, hospitals etc.) and intended for indoor-
environment use only. The system was designed for safe operation for patients and practitioners.
1.5 Maintenance
The system requires periodic routine maintenance service, which must be performed by Alma
Lasers authorized technical personnel only. 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
Warning
No modification of this equipment is allowed.
Unauthorized modification of the hardware, software or specifications of the system and its
accessories voids all warranties, expressed and implied. Alma Lasers takes no responsibility for
the use or operation of such a modified system.
Use of this equipment adjacent to or stacked with other equipment should be avoided because it
couldresult in improper operation. If such use is necessary, this equipment and the other equipment
should be observed to verify that they are operating

Alma Hybrid - Instructions for Use
1-3
System Overview
1.7 Resale Inspection
If any Alma Lasers system 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 system is working
in accordance with manufacturer’s specifications. Using the system after it has been resold and
before it has been inspected is a misuse of the system, which may result in injuries and voids all
warranties, expressed and implied.
Alma Lasers also offers service contracts and extended warranties for its systems. 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
"
Inches
LCD
Liquid Crystal Display
°C
Degree(s) Celsius
LED
Light Emitting Diode
°F
Degree(s) Fahrenheit
MHz
Mega Hertz
mJ
MilliJoule
Hz
Hertz
mJ/Pixel
MilliJoule per Pixel
kHz
kilo Hertz
W
Watts
kg
Kilogram(s)
mW
MilliWatts
kJ
KiloJoule
cm
Centimeter(s)
SW
System Software
nm
Nanometers
GHz
Giga Hertz
Sec
Second(s)
A
Ampere(s)
mm
Millimeter(s)
VAC
Volt(s) Alternating Current
ms / msec
Milliseconds
AC
Alternating Current
CW
Continuous Wave
DC
Direct current
OD
Optical Density
1570
1570 nm laser
CO2
Carbon Dioxide
RF
Radio frequency
IEC
International Electrotechnical Commission

Alma Hybrid - Instructions for Use
2-1
Safety
2.1 Introduction
This chapter describes general safety issues regarding the use of the system, with special emphasis
on optical and electrical safety.
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
system 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.
2.2 System Safety Measures
The system was designed to maximize safety for patient and personnel.
The system is equipped with an independent monitoring system, which monitors the output energy
and prevents excessive levels by cutting off the operation, followed by an error message
accordingly. The following are some of the system’s preventive safety measures.
2.3 Electrical Safety
The system is protected by a semi-automatic circuit breaker.
The SW checks all safety related hardware after the system is switched on.
Emission timing is regulated by hardware timers.
If an error occurs, the system displays a warning message to the operator and disables further
operation.
The patient should avoid contact with the ground or with parts that have appreciable
capacitance to earth (e.g., operating table supports, etc.).
Warning
Hazardous voltages are energized when the emergency shut-off knob is engaged.
Note
The appliance coupler is considered as main disconnection device in any case of hazardous
situation. The disconnection of the electrical cable from the electricity will cause to immediate shut
down of the system.

2-2
Alma Hybrid - Instructions for Use
Safety
2.3.1 Laser Safety
•Precise optical engineering is used to transmit laser energy to the treatment site. Laser energy
is emitted only through the output ports of the laser applicators.
•The system incorporates a safety remote interlock connector for connecting an external
interlock on the entrance door to the treatment room. It disables the system and prevents
operation when the entrance door is opened.
•An emergency shutoff knob expedites shutdown when necessary. When pressed, it
immediately shuts down system operation.
•The system incorporates two emission indicators: a buzzer and a yellow emission indicator
•Laser emission is enabled only when the operator switches to READY mode and presses the
footswitch.
•Coolant is circulated through the system as soon as the system is turned on. Coolant flow
is monitored and emission is disabled if the water flow stops.
•The temperature of the coolant is monitored by a thermal sensor in order to eliminate the risk
of overheating. The emission is disabled if the coolant temperature becomes higher than the
allowed tolerance.
Warning
Any laser-emitting system can cause injury if used improperly. High voltages are present inside
the system. Personnel who work with lasers must always be aware of the possible dangers and
must take the proper safeguards as described in this manual.
Use carefully. May cause serious burns. Do not use over sensitive skin areas or in the presence of
poor circulation. The unattended use of the system by children or incapacitated persons may be
dangerous.
Caution
Laser fume and/or plume may contain vaporized tissue particles, pathogens, and toxic gases
emanating during CO2 laser procedures is an occupational hazard and may also obscure the
operative fields.

Alma Hybrid - Instructions for Use
2-3
Safety
2.4 The Treatment Room
The treatment room must be clearly labeled with signs indicating that high intensity laser energy is
in use. The treatment room sign that is supplied with the system is shown in figure below:
Figure 2-1. Treatment Room and system Warning Signs
The treatment room should not include any light reflecting objects such as a mirror.
Access to the system 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 the treatment room personnel are familiar with the system controls and know how
to shut down the system instantly.

2-4
Alma Hybrid - Instructions for Use
Safety
2.5 General Precautions and Cautions
The following precautions, cautions and warnings must be observed for the safe use of the system.
2.5.1 Precautions
•Physicians and clinicians should read this manual thoroughly before attempting to operate
the system.
•The optical output lenses of the applicators must be kept clean at all times.
•The system 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 the system by the applicators or articulated arm or display.
•Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
2.5.2 Cautions
•only. Federal law (US) restricts this Device to sale by or on the order of a physician
(applicable for USA only).
•Only Alma Lasers authorized personnel may service the system. This includes making
internal adjustments to the power supply, cooling system, optics, applicators etc.
•The system is not intended for use by persons (including children) with reduced physical,
sensory or mental capabilities, or lack of experience and knowledge.
•Verify that the system is suited for the appropriate electrical voltage of your country.
•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.
•Ensure proper electrical and mechanical connection of the applicator before each treatment.
•Always turn off the system when it is not in use.
•Never leave the system unattended in Ready mode.
•Never allow untrained personnel to operate the system.
•Never press the footswitch unless the applicator is safely oriented at a specific and intended
target.
•Never leave the system turned on, open or unattended during system maintenance. Remove
the key from the system when unattended.

Alma Hybrid - Instructions for Use
2-5
Safety
•The system, applicators and tips must always be visually inspected before treating the
patient. If any wear or damage is apparent, do not use the applicator or tip.
•The system can be turned ON only when the key is inserted in the key switch. When not in
operation, the key should be removed to prevent unauthorized use of the system.
2.6 Warnings Related to Laser Emission
2.6.1 Burn Hazards
The system radiation is invisible to the human eye and can cause third-degree burns, even when
unfocused.
2.6.2 Direct and Reflected Eye Exposure Hazards
•It is essential that all people present in the treatment room during the treatment protect their
eyes by wearing Alma Lasers recommended protective eyewear.
•The protective eyewear must be labeled according to the wavelength and optical density for
which they offer protection.
•It isgood practice toinstruct the patient (if not anesthetized) to close their eyes during treatment
even when wearing protective eye glasses.
•If the patient cannot wear the protective eyewear, fit the patient with opaque eye protection
that completely blocks light from the eyes.
•If thetreatmentareaisvery close tothe eyes (e.g. eyelids), protect the eyes withcorneal shields.
2.6.3 Laser Safety Eyewear
•All personnel have to use safety eyewear and should verify that the eyewear provides adequate
protection. Refer to the appropriate applicator manuals to determine which safety eyewear
should be used per appropriate wavelength.
•The safety eyewear and opaque eye protectors are supplied with the system and offer an
adequate protection. For additional safety eyewear ordering please contact your Alma Lasers
representative.
Warning
Never substitute prescription eyewear for the appropriate laser safety eyewear, as severe eye
damage could occur. Prescription eyewear can concentrate the laser light to the eye and/or can be
shattered by a high-power density beam, possibly causing severe eye damage.
Use extreme caution when performing procedures around the eyes. Severe and permanent eye
damage may occur from direct or indirect exposure to the laser beam.

2-6
Alma Hybrid - Instructions for Use
Safety
•All personnel within the operating area of the laser must wear eye protection with protection
level 10600nm D LB 4 +1570nm D LB3 according to EN 207, and with a minimum optical
density (OD) of 3.0, for wavelength of 10600nm+1570nm, according to ANSI Z 136.3.
•The Ocular Hazard Distance (OHD) is 3 m.
2.6.4 Explosion and Fire Hazards
•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.
•Have water available to extinguish small fires.
•Ensure that a carbon dioxide fire extinguisher is available.
•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 any part of the system, allow it to dry thoroughly before operating
the system.
•Flammable substances must be kept at a safe distance from the system.
2.6.5 High Voltage Hazards
•The system utilizes high-voltage electricity. To avoid personnel injury, do not operate the
system before ensuring that the exterior panels are undamaged and properly closed. Do not
attempt to remove or disassemble the exterior panels.
•The system produces very high voltages in various components. Some components may retain
a charge after the power supply has been turned OFF. No part of the exterior housing should
be removed, except by Alma Lasers authorized personnel.
•Never leave the system turned ON, open or unattended during system maintenance.
Warning
The electrical cable should be removed from mains before any service or in case of any detected
malfunction.

Alma Hybrid - Instructions for Use
2-7
Safety
2.6.6 Grounding the System
The system is grounded through the grounding conductor in the power cable and internal grounding
pin.
2.7 System Safety Features
The 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. The detailed information provided
in CHAPTER 3 –System Description.
➢Emergency Shut-Off Knob
➢Circuit Breaker
➢Emission Indicators
➢Remote Interlock
➢Footswitch
2.7.1 Laser Safety Shutter
The system is equipped with an electronic safety shutter that –when closed –prevents laser beam
emission from the articulated arm's end joint.
In any case of system failure or / and electrical disconnection, the shutter will close automatically
in order to prevent impromptu laser emission.
2.8 System and Equipment Classifications and Compliance
CDRH Laser Classification according to 21CFR 1040.10:
Class IV
Laser Classification according to EN 60825-1:
Class 4
Mode of Protection against Electric Shock:
Class I Equipment
Degree of Protection against Electric Shock:
Type BF Applied Part
Protection against ingress of liquids:
Ordinary equipment
Not suitable for use in presence of flammable anesthetic mixture with air or nitrous oxide.
Warning
To avoid the risk of electric shock, this equipment must only be connected to supply mains with
protective earth.

2-8
Alma Hybrid - Instructions for Use
Safety
2.9 Labeling and Signs
2.9.1 System Labels
The following labels are adhered to the system:
Identification Label located on the service panel:
•Manufacturer's details
•System model
•System weight
•System's electrical requirements
•Serial number and date of manufacture
•Caution: Consult Operating Instructions
•*Unique Device Identification [GTIN-Global Trade Item Number]is to be add following
clearance.
•Degree and type of protection against electric shock
Figure 2-2. The Alma Hybrid Laser System (30W and 70W) Identification Labels
Laser Class 4 label –located on the rear panel of the system.

Alma Hybrid - Instructions for Use
2-9
Safety
Figure 2-3. The Alma Hybrid Laser System (30W and 70W) Laser Class 4 Label

2-10
Alma Hybrid - Instructions for Use
Safety
Emergency stop label –label located above the
emergency shut-off knob.
Grounded power cable warning label –located on the
rear panel.
Electrical Requirement and Hazard label –located
next to the power cable connection port.
Laser aperture warning label –located near the
applicator.
Laser radiation warning label –located on the rear
panel of the system and articulated arm.
Interlocklabel –located on the service panel toidentify
the interlock connection port.
Coolant Full Notification Tag.
Footswitch label –located on the service panel to
identify the footswitch connection port.
Vent label –identifies the connection port for the air
vent of the cooling system's water reservoir.
Fill label –identifies the connection port for the
accessory used by the service technician to fill the
cooling system's water reservoir.
WEEE label –indicating separate collection and
disposal symbol, located near the identification label: at
the end of useful life the system Applicators are to be
returned to the manufacturer for appropriate processing
and disposal.
Follow instructions for use
Federal (US) law restricts this device to sale by the
order of a physician licensed by the law of the state
in which he practiced to use or order the use of the
device

Alma Hybrid - Instructions for Use
2-11
Safety
Caution
Warning
Date of Manufacture
Manufacturer
Serial Number
Type BF Applied Part
No Pushing label; located on the rear panel of the system
Packaging Label - attached to the system's shipping
crate
Keep Dry - This symbol indicates that the crate must be
protected from excessive humidity and accordingly
must be stored under cover. If particularly large or bulky
packages cannot be stored in a warehouse or shed, they
must be carefully covered with tarpaulins
Fragile - Cargo marked with this symbol should be
handled carefully and should never be tipped over or
slung
Top - The package must be always transported, handled
and stored in such way that the arrows always point
upwards. Rolling, Swinging, severe tipping or tumbling,
or other such handling must be avoided.
The cargo need not, however, be stored “on top”.
Temperature Limitations - The symbol provides the
storage and transport temperature range. In this case, the
temperature limit is between high +50 °C and low 0 °C.
Humidity Limitations - The symbol provides the
storage and transport humidity range. In this case, the
humidity limit is between 60% high and 10% low.
Air Pressure Limitations - The symbol provides the
storage and transport air pressure limit. In this case,
indicating a low 90 kPa and a high 110 kPa.

Alma Hybrid - Instructions for Use
3-1
System Description
3.1 Introduction
This chapter provides a detailed description of the system. The description covers the system's main
components, controls, functional sub-systems and system specifications.
The system offers a state-of-the-art platform utilizing a 10600nm laser and1570nm fiber laser
technologies.
10600nm Laser Technology
The active medium used is a carbon dioxide gas mixture enclosed within a quartz laser resonator
equipped with electrodes. The sealed-off, RF-exited 10600nm laser resonator is positioned between
the two mirrors in the optical cavity. The rear mirror is totally reflective, whereas the front mirror
is partially reflective and transmits the 10600nm laser beam into the system's articulated arm.
The DC power supply (pumping source) provides voltage to the electrodes which produces an
electrical discharge along the resonator. The discharged electrons collide with the 10600nm
molecules in the gas mixture and excite them to a vibrationally excited level (an asymmetric
stretching mode). The stimulated emission takes place between this level and a lower vibrationally
excited level (a symmetric stretching mode), resulting in laser emission in the far-infrared range at
a wavelength of 10.6 microns.
1570nm Fiber Laser Technology
The fiber laser applicator comprises laser diodes, WDMs and taps, erbium ytterbium- doped fiber
and the micro-processor-based controller for standalone operation. Communication is provided by
a serial RS-232 link in the electrical interface.