Alma Opus Operator's Manual

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Summary of Contents for Alma Opus

Page 1 Operator’s Manual...
Page 2 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, Inc.
Page 3 Conditions under which the system should be operated. Appendix A EMC Compatibility Intended Use and Indications. Appendix B Clinical General Applicator information and Clinical Guide. Appendix C Opus Colibri applicator Applicator information and Clinical Guide. Appendix D Opus Plasma applicator Opus Operator's Manual...
Page 4: Table Of Contents
Radiofrequency Operation Safety ........... 2-4 System Labels and Icons ................2-5 Installation Introduction ....................3-1 Equipment List ....................3-1 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 Opus Operator's Manual...
Page 5 Prepare the System for Operation ..............6-1 Operation Summary ..................6-1 Operate the System ..................6-2 6.4.1 Turn on the System ................. 6-2 Emitting Radiofrequency Energy ..............6-3 Ready and Standby Modes – Idling Limits ............ 6-3 Opus Operator's Manual...
Page 6 Fuse Replacement ..................7-3 Troubleshooting Introduction ....................8-1 Troubleshooting Guides ................. 8-1 Ordering Information Ordering Information Parts List ..............A-1 Electromagnetic Compatibility A.1. Electromagnetic Emission ................A-1 A.2. Electromagnetic Immunity ................A-2 A.3. Recommended Separation Distances ............A-4 Opus Operator's Manual...
Page 7: System Overview
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.
Page 8: Maintenance
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.
Page 9: Safety
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. Opus Operator's Manual...
Page 10: Emergency Shut-Off Knob
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. General Precautions and Cautions The following precautions cautions, and warnings must be observed for the safe use of the system. Opus Operator's Manual...
Page 11: Precautions
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.
Page 12: High Voltage Hazards
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 •...
Page 13: System Labels And Icons
Non-ionizing radiation Type BF applied part Follow instructions for use Caution Warning Date of Manufacture Opus Operator's Manual...
Page 14 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...
Page 15: Installation
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. Equipment List The system includes the following: •...
Page 16: Space And Positioning
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%. Opus Operator's Manual...
Page 17: Connecting The Applicator
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) Reinstall the front cover by pressing the same two points to latch in into place. Opus Operator's Manual...
Page 18: Aconnecting The Footswitch
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...
Page 19: System Description
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. Keyswitch Figure 4-1. Major System Components Opus Operator's Manual...
Page 20: System Controls
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. Opus Operator's Manual...
Page 21: Technician Mode
Tampering with the settings in the technician mode may adversely affect the safety and efficacy of the system. The technician mode is password-protected and its access is restricted to Alma Lasers authorized service personnel only. System Specifications 4.3.1...
Page 22: Controls And Indicators
In an emergency situation, press the emergency shut-off knob to shut down the system immediately (see section 5.2.2). Warning To avoid misuse of the system, do not leave the key in the key switch while the system is unattended. Opus Operator's Manual...
Page 23: Emergency Shut-Off Knob
Main switch Fuse housing • • Footswitch air tube connection port Power cable connection port (appliance coupler) Figure 5-2. Service Panel Components Footswitch The pneumatic footswitch (see Figure 5-3), supplied with the system activates the radiofrequency emission. Opus Operator's Manual...
Page 24 Connecting the footswitch is necessary only if you prefer to use the footswitch for RF emission. It is possible to emit RF pulses using only the applicator's trigger, in which case you may leave the footswitch unconnected. Opus Operator's Manual...
Page 25: Operating Instructions
This system may only be operated by a licensed practitioner. Improper use or adjustment of this system may invalidate the service warranty agreement. Please contact your authorized Alma Lasers distributor before attempting to use the system in any manner other than those specified in this manual.
Page 26: Operate The System
Keyswitch Off • The speaker button toggles the system's buzzer to On or Off modes. Turn on the keyswitch; • The system powers up. Refer to applicator chapter for further instruction and applicator operation. Opus Operator's Manual...
Page 27: Emitting Radiofrequency Energy
As a standard safety measure, whenever RF energy emission is not immediately required, the system should be set to mode. If the operator should leave Standby the room, the system should be turned off as described in Section 6.8 and the key removed from the keyswitch. Opus Operator's Manual...
Page 28: System Shut-Down
The audible indicator sounds an alert which is longer than the normal emission signal. In such a case you should shut the system down and restart it. If the problem still persists, refer to Chapter 8 – Troubleshooting Opus Operator's Manual...
Page 29: Maintenance
Alma Lasers-authorized service provider, any warranty agreement of the system and its associated applicators and/or accessories will be invalidated. Warning The system generates hazardous voltages within the main console. The interior of the system may be serviced only by Alma Lasers authorized technical personnel. Opus Operator's Manual...
Page 30: Service Information
The system generates high voltages when powered up. Always turn the system off and unplug the power cable before performing maintenance procedures. The interior of the system or its components may be serviced only by Alma Lasers authorized technical personnel. 7.4.1...
Page 31: Fuse Replacement
Turn on the system and verify that it is functioning properly. Caution • Make sure that the type and rating of the new and the replaced fuses match. • Always replace both fuses at the same time. Opus Operator's Manual...
Page 32: Troubleshooting
Table 8-1 provides a list of alarms and error messages that may appear on the screen, their possible causes and corrective actions to be performed. If the corrective actions listed in the table do not solve the problem, contact your Alma Lasers Service representative.
Page 33 Shutting Down Timeout system left idle for 7 minutes. If problem persists, call Alma Lasers Service. Shut the system down and contact Alma Lasers Phase Shifter Error Hardware malfunction. Service. Shut the system down and contact Alma Lasers RS232 Header is missing Software malfunction.
Page 34: Ordering Information
Ordering Information Parts List This chapter offers information necessary for ordering system accessories. The following table displays the names of the items by which you should place your orders with your Alma Lasers distributor. Description Opus Plasma Applicator Applicator Tips:...
Page 35: Electromagnetic Compatibility
The EUT in operating mode belongs to equipment Group 2 - as per classification of standards IEC 60601-1-2 / CISPR 11. The EUT in standby mode was tested according to equipment Group 1 limits- as per classification of standards IEC 60601-1-2 / CISPR 11 Opus Operator's Manual...
Page 36: Electromagnetic Immunity
30 A/m 30 A/m typical location in a typical commercial IEC 61000-4-8 or hospital environment. NOTE: U is the AC mains voltage prior to application of the test level. Opus Operator's Manual...
Page 37 780 MHz 810 MHz Proximity fields 870 MHz 28 V/m from RF wireless 930 MHz communications 1720 MHz equipment 1845 MHz 28 V/m 1970 MHz 2450 MHz 28 V/m 5240 MHz 5500 MHz 9 V/m 5785 MHz Opus Operator's Manual...
Page 38: Recommended Separation Distances
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Opus Operator's Manual...
Page 39 ALL FIELDS B.1 Overview This chapter is provided to aid professionals in the use of the Opus System. Personnel operating the system must have a thorough understanding of its proper operation. This chapter has been prepared to aid medical personnel to understand the intended use, indications, contraindications and adverse events relating to use.
Page 40 • Ablative/non-ablative cosmetic intervention (deep peeling) in the past 3 months B.3.2 Adverse Events and Side Effects (Opus Plasma Applicator and Tips) The use of the system may cause: • Heating sensation or pain – patient may experience a heating sensation during or just following the treatment, however, such pain is expected to be mild and to resolve within few minutes.
Page 41 History of Keloid formation or wound healing process abnormalities in the treatment area • Ablative/non-ablative cosmetic intervention (deep peeling) in the past 3 months B.3.5 Adverse Events and Side Effects (Opus Colibri Applicator and Tips) The use of the system may cause: •...
Page 42 Opus Colibri applicator C.1 Introduction This clinical guide is provided to aid professionals in the use of the Opus system. This appendix specifically addresses the Opus Colibri applicator. The information provided in this appendix adds to or reinforces information presented in the system operator manuals concerning instructions for use, precautions and warnings necessary to reduce the risk of injury.
Page 43 A P P L I C A T O R – O p u s C o l i b r i Figure C-3 - Tip Labels Table C-1 - Opus Colibri Applicator and Tips Specifications Applicator tip Colibri RF Output Power [W]:...
Page 44 A P P L I C A T O R – O p u s C o l i b r i C.3 Opus Colibri Applicator and Tips Screens Turn key switch ON and press Start button on the following screen:...
Page 45 A P P L I C A T O R – O p u s C o l i b r i Note Timer pulse duration selection refers to treatment in Stationary mode only. In-Motion mode selection will disable Timer option. Plasma Intensity –...
Page 46 This includes beauty operators, physicians, nurses, technical staff or other professional staff members. Alma Lasers provides in-service training for the system. At the end of this in-service training, personnel are considered trained for the operation of the system.
Page 47 A P P L I C A T O R – O p u s C o l i b r i Steam Gravity sterilization procedure: • Temperature: 121°C (250°F) • Time of exposure: 30 minutes • Drying Time: 30 minutes C.7 Pre-Treatment Information General During the first visit the professional (or an authorized staff member) should:...
Page 48 A P P L I C A T O R – O p u s C o l i b r i C.8 Treatment Practical Considerations of Operation and Technique The treatment technique with the Colibri tip can only be carried out by "stationery" mode. This treatment option includes plasma intensity selection.
Page 49 A P P L I C A T O R – O p u s C o l i b r i C.9 Treatment Protocol Pre-Treatment 1. Perform a thorough medical history and screen for contraindications. 2. Photo-document the treatment area. 3.
Page 50 Results are visible from 1-month post-treatment. All adverse side effects should be reported to the treating physician with a follow-up report sent to the Director of Clinical Operations at Alma Lasers at: Alma Lasers, Inc. 485 Half Day Road, Suite # 100...
Page 51 Opus Plasma Applicator D.1 Introduction This clinical guide is provided to aid professionals in the use of the Opus system. This appendix specifically addresses the Opus Plasma applicator. The information provided in this appendix adds to or reinforces information presented in the system operator manuals concerning instructions for use, precautions and warnings necessary to reduce the risk of injury.
Page 52 A P P L I C A T O R – O p u s P l a s m a GLIDE (Roller) FOCUS:IN FOCUS Tips label In-motion Tip label Figure D.2-3 – Applicator Tips Table D-1 - Applicator and Tips Specifications GLIDE FOCUS Applicator tip...
Page 53 A P P L I C A T O R – O p u s P l a s m a Applicator Trigger and footswitch Warning If the system is in Ready mode, energy emission occurs when the applicator trigger or footswitch is activated. RF emission is controlled by the applicator trigger or footswitch: Figure D.2-4 –...
Page 54 A P P L I C A T O R – O p u s P l a s m a After making your tip selection, the program will advance to the screen depends on the selected tip. Figure D-7: FOCUS & FOCUS:IN Tips Screen Figure D-8: GLIDE Tip Screen The following is a description of the screen's elements, as indicated by the numbered arrows: Treatment Tip Identifier –...
Page 55 This includes physicians, nurses, technical staff or other professional staff members. Alma Lasers provides in-service training for the system. At the end of this in-service training, personnel are considered trained for the operation of the system.
Page 56 A P P L I C A T O R – O p u s P l a s m a Warning The use of any water-based (ultrasonic) gel on the skin is prohibited! D.5 Tips Connection When using the applicator, either the Focus & Focus IN or Glide tips must be selected and connected to the applicator.
Page 57 A P P L I C A T O R – O p u s P l a s m a ® Prepare Endozime AW Triple Plus with APA (Endozime AW) detergent solution according to the manufacturer's recommendations (½ oz. per gal. / 4 ml. per liter) in the supplied digital ultrasound cleaner.
Page 58 A P P L I C A T O R – O p u s P l a s m a D.7 Pre-Treatment Information General During the first visit the physician (or an authorized staff member) should: • Perform a thorough patient medical history, including previous treatment modalities, and examine the dermatology condition for suitability of treatment with the system.
Page 59 A P P L I C A T O R – O p u s P l a s m a D.9 Skin Test The purpose of the skin test is to monitor the patient's skin reaction and to rule out unexpected adverse side effects. Always perform a skin test on the intended treatment area during the first session according to the following recommendations: Table D-2: FOCUS:IN and FOCUS Skin Test Parameters...
Page 60 A P P L I C A T O R – O p u s P l a s m a It is recommended that treating physicians familiarize themselves with RF and ablative treatments based on clinical literature. These general guidelines are not intended to be a substitute for clinical education, judgment, and/or experience of the physician.
Page 61 If adverse skin effects occur (such as excessive reddening or swelling), you may change the exposure time or reduce the energy. Meticulous wound care (open or closed techniques) is crucial after skin resurfacing; below are Alma Lasers recommendations for follow-up. Physicians may refer to them, and then determine their own suitable regimen.
Page 62 All adverse side effects should be reported to the treating physician with a follow-up report sent to the Director of Clinical Operations at Alma Lasers at: Alma Lasers, Inc. 485 Half Day Road, Suite # 100...