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

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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.

Safety
Opus Operator's Manual 2-3
2.3.1 Precautions
•Physicians, clinicians and practitioners should read this manual thoroughly
before attempting to operate the system.
•Applicators and applicator tips must be kept clean at all times.
•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 applicator.
•The system needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided in the
accompanying documents.
2.3.2 Cautions
•Only Alma Lasers authorized personnel may service the system. This includes
making internal adjustments to the power supply, applicators, etc.
•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 trigger and/or footswitch unless the applicator is safely
oriented at a specific and intended target.
•The applicators and tips must always be visually inspected before treating the
patient. If any wear or damage is apparent, do not use the applicator.
•Never leave the system turned on, open or unattended during system
maintenance.
2.3.3 Burn Hazards
The system emits RF energy that can damage the skin in cases of using excessive
power levels.
2.3.4 Explosion and Fire Hazards
•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 system, allow it to dry
thoroughly before operating the system.
•Flammable materials must be kept at a safe distance from the system.

Safety
2-4 Opus Operator's Manual
2.3.5 High Voltage Hazards
The system utilizes high-voltage electrical supply. 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 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.
2.3.6 Radiofrequency Operation Safety
•Never use the applicator which damaged or has a damaged tip. Always check
the tip condition before starting the treatment for any defects.
•Always clean the tip properly before treatment.
•Allow access to the treatment room only to personnel who are well trained in
the required safety procedures.
•Make sure that all operators are familiar with the system's controls and know
to shut down the system instantly.
•Never press the applicator trigger or the footswitch without direct and firm
contact of the applicator tip with the treatment area.
•Never place the applicator in contact with or direct it at anything other than the
treatment area.
•Patient shall never come into contact with grounded metal parts or parts with
appreciable capacitance to ground.
•During system operation, the generated electromagnetic field may interfere
with other devices and computers. Always place the system at least two meters
away from computers and other electrical devices.
This equipment has been tested and it conforms to the restrictions for medical
devices. Those restrictions were designed to bring reasonable protection against
harmful interferences in the typical medical installation. This equipment generates,
utilizes and can emit radio signals and may produce nuisance interference to other
nearby devices, if it is not installed and utilized in accordance with the instructions.
However, there is no warranty that it will not cause interference in a particular
installation. If this equipment causes harmful interferences with others devices,
which can be determined by turning the equipment off and on, it is recommended
that the user try to correct the interference by one or more of the following
measures:
•Redirect or relocate the receptor device.
•Increase the distance between the devices.
•Plug the system into a wall socket on a different circuit than the other
equipment.
•Consult with Alma Lasers technical service personal for assistance.
•Avoid placing the applicator's umbilical cable in contact with the patient.

Safety
Opus Operator's Manual 2-5
2.4 System Labels and Icons
The following labels are adhered to the system:
Figure 2-1. System Identification Label
UDI Label
Fuse rating label –located near the fuse compartment and
identifies type of fuses that shall be used for replacement:
Grounded power cable warning label –located on the
bottom of the rear panel.
Electrical Requirement and Hazard label –located next
to the power cable connection port
WEEE separate collection and disposal symbol, located
near the identification label: at the end of useful life the
applicators are to be returned to the manufacturer for
appropriate processing and disposal.
Non-ionizing radiation
Type BF applied part
Follow instructions for use
Caution
Warning
Date of Manufacture

Safety
2-6 Opus Operator's Manual
Manufacturer
Serial Number
Footswitch label; located on the service
panel to identify the footswitch connection port
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.

Opus Operator's Manual 3-1
Installation
3.1 Introduction
The system is designed for installation in an office or a clinic and requires minimal
site preparation. When the 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 and position it in its pre-selected location
•Verify the integrity of the system and its components
•Connect system components (applicators, footswitch)
•Plug the system into a designated electrical outlet
•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 system includes the following:
•System Console
•Opus Plasma Applicator
•Operator' s Manual
•System Trolley
•Power cable
•Infrared thermometer
•Footswitch
•Cradle
•Set of keys
•Dummy connector
3.3 Facility Requirements
Before unpacking the system, ensure that the site meets the requirements described
in the following sections.

Installation
3-2 Opus Operator's Manual
3.3.1 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 4.3.3. In order to guarantee proper ventilation, always keep the sides
of the system at least 0.5 meters from the wall or from other obstructions to air
flow.
The system can interfere with computers and other electrical and medical systems.
It should be placed at least two meters away from any such systems.
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.
3.3.2 Electrical Requirements
The power supply allows the system to be plugged into any wall outlet that
supplies: 120VAC, 50/60Hz, 6.3A
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.
Only use the power cable supplied with the system.
Caution
Verify that the system is wired for the appropriate line voltage of your country.
3.3.3 Environmental Requirements
Air Quality:
The system should operate in a non-corrosive atmosphere. Corrosive materials such
as acids can damage electrical wiring, electronic components and the surfaces of
RF delivery components.
Temperature:
To ensure that the system performs optimally, maintain room temperature between
20°C and 25°C and a relative humidity of less than 80%.

Installation
Opus Operator's Manual 3-3
3.4 Connecting the Applicator
The applicators are normally placed in the cradle on the right side of the system.
The connector is attached to the system's connection port under the front cover.
1. Place the applicator in its cradle (A).
2. Remove the front cover: press both spots indicated by the red dots (B) to
unlatch the cover, and pull it off.
Figure 3-1: Applicator Connection Procedure (1)
3. Pull the locking lever out to the unlatched position (A).
4. Insert the applicator connector (B) into the port (C).
Figure 3-2: Applicator Connection Procedure (2)
Caution
Insert the connector so that the guiding pin (D) is facing up. Inserting the connector in the
wrong orientation will damage the system!
5. Close the locking lever to lock the applicator connector in position and
ensure that it is closed all the way, as shown by the arrow:
Figure 3-3: Applicator Connection Procedure (3)
6. Reinstall the front cover by pressing the same two points to latch in into place.

Installation
3-4 Opus Operator's Manual
3.5 Connecting the Footswitch
The footswitch supplied with the system is pneumatically operated.
To connect the footswitch, connect the footswitch's black tube to the connection
port on the system's service panel.
Figure 3-4: Footswitch Connection Port
3.6 Storage and Transportation
3.6.1 Moving the System
To move the system around the floor, ensure that the connected applicator is safely
stored in its cradle; then the system can be rolled around the room on the wheeled
cart.
Carrying the system up or down the stairs should be done by two people, one
carrying the system, and the other carrying the cart.
To transport the system to another location:
1. Disconnect the applicator and store it in its dedicated carrying case.
2. Disconnect the power cable.
3. Disconnect the footswitch's air tube.
4. Pack the system and cart in their original shipping boxes and insert the
foam braces to protect them.
At the new location:
5. Reconnect the footswitch and the power cable.
6. Connect the applicator and resume normal operation.
Caution
Never use the applicator or umbilical cable to move the system.
3.6.2 Environmental Conditions during Transportation
Transportation of the system should be under normal environmental conditions
within the following range:
•Ambient temperature: 20 to 25ºC
•Relative air humidity: less than 80%
•Atmospheric pressure: 90 to 110 kPa

Opus Operator's Manual 4-1
System Description
4.1 Introduction
This chapter provides a detailed description of the system. The description covers
the system's main components, controls and functional sub-systems, the applicators
and system specifications.
The is a non-invasive radiofrequency system.
A technical discussion of the applicator and technical specifications may be found
later in this chapter.
4.2 System Components and Controls
The system consists of the following major components (see Figure 4-1):
•System Console
•Touch-screen control panel
•Dedicated trolley
•Applicator with umbilical cable and connector.
•Footswitch.
Figure 4-1. Major System Components
Keyswitch

System Description
4-2 Opus Operator's Manual
4.2.1 System Controls
The control system incorporates the following features:
•Emergency shutoff 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.
•Touch-screen LCD display: the LCD display provides information on the
status and settings of the system, with touch-screen technology for system
operation.
4.2.2 Service Panel
The service panel is located at the bottom of the system's rear panel. It incorporates
all the required controls and connections for the system:
•Main power cable connection port.
•Housing for two surge-protection fuses.
•Main switch (green) used to activate the micro-processor and the LCD
display.
•Footswitch connection port.
•Electrical current indicator; it illuminates when the power cable is
connected to the wall outlet.
All of the service panel's components are described in detail in Controls and
Indicators chapter.
4.2.3 System Software
The system is a computerized system with embedded software that controls its
operation.
The software controls the operating parameters, runs routine tests to ensure proper
and safe operation, and coordinates its various sub-systems.
The software also runs the graphical user interface, which enables user-friendly
4.2.4 Fans
Several fans are located inside the system.