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.