Almaco Opus User manual

Operator’s Manual

© 2021, Alma Lasers Ltd. 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 Ltd.
System specifications and the information contained in this document are subject to change without
notice.
Alma Lasers, its logo, Opus, Opus Plasma are either registered trademarks or trademarks of
Alma Lasers Ltd.
Manufacturer:
Alma Lasers Ltd.
18 Haharash St.,
Caesarea North Industrial Park,
3079895 Caesarea, Israel
Tel: [phone]
Fax: [phone]
Email: [e-mail]
Alma Lasers, Inc.
485 Half Day Road
Suite # 100
Buffalo Grove, IL 60089
Tel: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.almalasers.com
Catalog No. OMRF25091701
Revision 4, February 2021

Table of Contents
Opus Operator's Manual 1-3
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, international
standard compliance, classifications and labels.
Chapter 3
Installation
Lists electrical, space and environmental requirements
for installation of the system.
Chapter 4
System Description
Contains a detailed overview of the system and its
various sub-systems, including technical specifications
for the system and each of the applicators.
Chapter 5
Controls and Indicators
Describes the control and service panels, footswitch and
various connections to the system, and functional
indicators.
Chapter 6
Operating Instructions
Explains how to operate the system, offering basic
information and common instructions for operation.
Specific operating instructions for each of the
applicators may be found in the appropriate chapter.
Chapter 7
Maintenance
Provides a detailed review of how to maintain the
system.
Chapter 8
Troubleshooting
Lists the system error messages that might appear
during operation, their probable causes and what
corrective actions to perform.
Chapter 9
Ordering Information
Provides information on how to order the system's
accessories.
Appendix A
EMC Compatibility
Conditions under which the system should be operated.
Appendix B
Clinical General
Intended Use and Indications.
Appendix C
Opus Colibri applicator
Applicator information and Clinical Guide.
Appendix D
Opus Plasma applicator
Applicator information and Clinical Guide.

Table of Contents
1-4 Opus Operator's Manual
Table of Contents
System Overview 1-1
1.1 Use of this Manual .........................................................................................1-1
1.2 Physician Responsibility ................................................................................1-1
1.3 Maintenance ...................................................................................................1-2
1.4 Modification of the System............................................................................1-2
1.5 Resale Inspection ...........................................................................................1-2
1.6 Abbreviations and Acronyms.........................................................................1-2
Safety 2-1
2.1 Introduction....................................................................................................2-1
2.2 System Safety Features ..................................................................................2-1
2.2.1 Software..........................................................................................2-1
2.2.2 Key Switch......................................................................................2-1
2.2.3 Footswitch.......................................................................................2-1
2.2.4 Emergency Shut-Off Knob .............................................................2-2
2.2.5 Appliance Coupler ..........................................................................2-2
2.2.6 Radiofrequency Emission...............................................................2-2
2.2.7 Output Power Control.....................................................................2-2
2.2.8 Grounding the System ....................................................................2-2
2.2.9 Fuse Protection ...............................................................................2-2
2.3 General Precautions and Cautions .................................................................2-2
2.3.1 Precautions......................................................................................2-3
2.3.2 Cautions ..........................................................................................2-3
2.3.3 Burn Hazards ..................................................................................2-3
2.3.4 Explosion and Fire Hazards............................................................2-3
2.3.5 High Voltage Hazards.....................................................................2-4
2.3.6 Radiofrequency Operation Safety...................................................2-4
2.4 System Labels and Icons................................................................................2-5
Installation 3-1
3.1 Introduction....................................................................................................3-1
3.2 Equipment List...............................................................................................3-1
3.3 Facility Requirements ....................................................................................3-1
3.3.1 Space and Positioning.....................................................................3-2
3.3.2 Electrical Requirements..................................................................3-2
3.3.3 Environmental Requirements .........................................................3-2

Table of Contents
Opus Operator's Manual 1-5
3.4 Connecting the Applicator..............................................................................3-3
3.5 aConnecting the Footswitch ...........................................................................3-4
3.6 Storage and Transportation.............................................................................3-4
3.6.1 Moving the System .........................................................................3-4
3.6.2 Environmental Conditions during Transportation ..........................3-4
System Description 4-1
4.1 Introduction ....................................................................................................4-1
4.2 System Components and Controls..................................................................4-1
4.2.1 System Controls..............................................................................4-2
4.2.2 Service Panel...................................................................................4-2
4.2.3 System Software .............................................................................4-2
4.2.4 Fans.................................................................................................4-2
4.2.5 Technician Mode.............................................................................4-3
4.3 System Specifications.....................................................................................4-3
4.3.1 Operation and Control.....................................................................4-3
4.3.2 Electrical Requirements ..................................................................4-3
4.3.3 Physical ...........................................................................................4-3
4.3.4 Classifications .................................................................................4-3
Controls and Indicators 5-1
5.1 Introduction ....................................................................................................5-1
5.2 Control Panel Components.............................................................................5-1
5.2.1 Key switch ......................................................................................5-1
5.2.2 Emergency Shut-Off Knob .............................................................5-2
5.2.3 Touch-Screen Panel ........................................................................5-2
5.3 Service Panel Components .............................................................................5-2
5.4 Footswitch ......................................................................................................5-2
Operating Instructions 6-1
6.1 Introduction ....................................................................................................6-1
6.2 Prepare the System for Operation...................................................................6-1
6.3 Operation Summary .......................................................................................6-1
6.4 Operate the System.........................................................................................6-2
6.4.1 Turn on the System .........................................................................6-2
6.5 Emitting Radiofrequency Energy ...................................................................6-3
6.6 Ready and Standby Modes – Idling Limits ....................................................6-3

Table of Contents
1-6 Opus Operator's Manual
6.7 Pause in Operation .........................................................................................6-3
6.8 System Shut-Down ........................................................................................6-4
6.9 Error Detection...............................................................................................6-4
Maintenance 7-1
7.1 Introduction....................................................................................................7-1
7.2 Periodic Service .............................................................................................7-1
7.3 Service Information........................................................................................7-2
7.4 Routine and Preventive Maintenance.............................................................7-2
7.4.1 Cleaning the System .......................................................................7-2
7.5 Fuse Replacement ..........................................................................................7-3
Troubleshooting 8-1
8.1 Introduction....................................................................................................8-1
8.2 Troubleshooting Guides .................................................................................8-1
Ordering Information A-1
9.1 Ordering Information Parts List ....................................................................A-1
Electromagnetic Compatibility A-1
A.1. Electromagnetic Emission.............................................................................A-1
A.2. Electromagnetic Immunity............................................................................A-2
A.3. Recommended Separation Distances ............................................................A-4

Opus Operator's Manual 1-1
System Overview
1.1 Use of this Manual
The OPUS system is designed to meet international safety and performance
standards. Personnel operating the system must have thorough understanding of the
proper way to operate and use the system.
This manual has been prepared to aid cosmeticians and technical personnel to
understand and operate the system. Do not operate the system before reading this
manual and gaining a clear understanding of system operation. If any part of this
manual is not clear, please contact your Alma Lasers representative for
clarification.
Warning
Use of controls or adjustments, or performance of procedures other than those
specified herein may put the operator and/or the patient at risk. Therefore,
before attempting to use or operate the system, personnel operating the system
should read this manual and become thoroughly familiar with all its safety
requirements and operating procedures.
The information provided in this manual 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 appendices that include set up guidelines
for each application.
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
1.2 Physician Responsibility
Regulatory code restricts prescription of medical systems for sale by or on the order
of a physician, or properly licensed practitioner. The properly licensed practitioner
will be responsible for the use and operation of the system and for all operator
qualifications. Alma Lasers makes no representations regarding federal, 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
agencies to determine any credential required by law for clinical use and the
operation of the system.

System Overview
1-2 Opus Operator's Manual
1.3 Maintenance
The system is a precision, technical medical system 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.
1.4 Modification of the System
Warning
No modification of this equipment is allowed.
Unauthorized modification of the hardware, software or specifications of the
system voids all warranties, expressed and implied. Alma Lasers takes no
responsibility for the use or operation of such a modified system.
1.5 Resale Inspection
The system is a precision, technical medical system. 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.
1.6 Abbreviations and Acronyms
°C
Degree(s) Centigrade/Celsius
m
Meter(s)
A
Ampere(s)
mm
Millimeter(s)
AC
Alternating current
MHz
Megahertz
cm
Centimeter(s)
PWM
Pulse width modulation
DC
Direct current
RF
Radiofrequency
HAS
Heat appreciation scale
Sec
Second(s)
Hz
Hertz
LED
Light emitting diode
J
Joule(s)
V
Volt(s)
Kg.
Kilogram(s)
VAC
Volt(s) alternating current
kHz
Kilohertz
VDC
Volt(s) direct current
LCD
Liquid crystal display
W
Watt(s)
IEC
International Electrotechnical Commission

Opus Operator's Manual 2-1
Safety
2.1 Introduction
This chapter describes general safety issues regarding the use of the system, with
special emphasis on radiofrequency and electrical safety.
Warning
Hazardous voltages are energized when the emergency shut-off knob is
engaged.
With proper operation and maintenance, trained and qualified trained and qualified
beauty operators can use the system safely. The beauty operator 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 the safety of the patient, the beauty operator
and other personnel. Patient safety is mainly assured with 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 Features
The system was designed to maximize safety for both patient and personnel. The
following are some of the system's preventive safety measures:
2.2.1 Software
•Once the system is turned on, the software checks all safety-related hardware
features.
•A watchdog cycle continuously monitors the safe system operation during the
treatment.
•If an error occurs, the system displays a warning message and, if necessary,
the software shuts down the system.
2.2.2 Key Switch
•The system 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 system.
2.2.3 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.

Safety
2-2 Opus Operator's Manual
2.2.4 Emergency Shut-Off Knob
When pressed, the emergency shut-off knob cuts the power supply to the system,
which results in immediate shut-down of the entire system.
2.2.5 Appliance Coupler
The appliance coupler located at the service panel of the.
Note
The appliance coupler considered as main disconnection device in any case of
hazardous situation. The disconnection of the electrical cable from the
electricity will cause immediate shut down of the system.
2.2.6 Radiofrequency Emission
The system enables RF emission only when the following conditions are met:
1. The system is in READY mode.
2. The applicator trigger or the footswitch is pressed.
The system does not allow RF emission in any other condition.
2.2.7 Output Power Control
The system controls output power using PWM (Pulse Width Modulation). The
maximum power never exceeds the preinstalled RF power limits.
2.2.8 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.
2.2.9 Fuse Protection
The system is protected by two slow blow type fuses. The fuses are located in the
fuse holder on the rear panel.
For detailed instructions on fuse replacement, refer to Maintenance Chapter.
2.3 General Precautions and Cautions
The following precautions cautions, and warnings must be observed for the safe
use of the system.