Professional Documents
Culture Documents
Alma Lasers Accent Prime Service Manual
Alma Lasers Accent Prime Service Manual
Chapter Contents:
Section Title Page
1.1. Use of this Manual ............................................................................. 1-2
1.2. User Profiler / Intended User ............................................................. 1-2
1.3. Physician Responsibility .................................................................... 1-2
1.4. Maintenance....................................................................................... 1-3
1.5. Modification of the System ............................................................... 1-3
1.6. Resale Inspection ............................................................................... 1-3
1.7. Abbreviations and Acronyms ............................................................ 1-3
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 Accent Prime
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.alma-lasers.de
1.4. Maintenance
The Accent Prime system is a precision, precision device 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.
IR Infrared
J Joule(s)
Kg. Kilogram(s)
kHz Kilohertz
lb. Pound(s)
LCD Liquid crystal display
LED Light emitting diode
m Meter(s)
mm Millimeter(s)
MHz Megahertz
PWM Pulse width modulation
RF Radiofrequency
Sec Second(s)
TEC Thermoelectric cooling
V Volt(s)
VAC Volt(s) alternating current
VDC Volt(s) direct current
W Watt(s)
Chapter Contents:
Section Title Page
2.1. Introduction ........................................................................................ 2-3
2.2. System Safety Features ...................................................................... 2-3
2.2.1. Software ............................................................................................. 2-3
2.2.2. Keyswitch........................................................................................... 2-4
2.2.3. Footswitch .......................................................................................... 2-4
2.2.4. Appliance coupler .............................................................................. 2-4
2.2.5. Emergency Shut-Off Knob ................................................................ 2-4
2.2.6. Input Power ........................................................................................ 2-4
2.2.7. Energy Emission Safety ..................................................................... 2-4
2.2.8. Energy Emission Indicators ............................................................... 2-5
2.2.9. Grounding the System ........................................................................ 2-5
2.2.10. Fuse Protection ................................................................................... 2-5
2.2.11. Cooling System .................................................................................. 2-5
2.3. General Precautions and Cautions...................................................... 2-6
2.3.1. Precautions ......................................................................................... 2-6
2.3.2. Cautions ............................................................................................. 2-6
2.3.3. Burn Hazards...................................................................................... 2-7
2.3.4. Explosion and Fire Hazards ............................................................... 2-7
2.3.5. High Voltage Hazards ........................................................................ 2-7
2.3.6. Radiofrequency Operation Safety ...................................................... 2-7
2.3.7. Ultrasound Operation Safety .............................................................. 2-8
2.4. Equipment Classification and Compliance ........................................ 2-9
2.5. Device Labels ................................................................................... 2-12
2.1. Introduction
This chapter describes general safety issues regarding the use of the Accent Prime system, with
special emphasis on ultrasound, radiofrequency and electrical safety.
Warning
Hazardous voltages are energized when the emergency shut-off knob is engaged.
Note
Federal law (USA) restricts this device to sale by, or on the order of a
physician or any practitioner licensed by the law of the state in which he or
she practices or intends to use or order the use of the device.
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
Accent Prime 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 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.
2.2.1. 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. Keyswitch
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.
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.
The system does not allow simultaneously activation of any two modules.
The system does not allow energy emissions in any other condition.
Warning
To avoid the risk of electric shock, this equipment must only be connected to a supply mains
with protective earth.
2.3.1. Precautions
Physicians, clinicians and practitioners should read this manual thoroughly before attempting
to operate the Accent Prime system.
Modules and module 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 modules or umbilical cables.
Accent Prime 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 Accent Prime system. This includes
making internal adjustments to the power supply, cooling system, modules, 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 module is safely oriented at a specific
and intended target.
The modules and tips must always be visually inspected before treating the patient. If any
wear or damage is apparent, do not use the module.
Never leave the system turned on, open or unattended during system maintenance.
When monitoring skin temperature with the infrared thermometer, AVOID direct beam
contact into the patient's eyes by requesting him/her to close the eyes during treatment!
UniBody and UniFace Modules – these two modules employ a rotating massage ring with
individually spinning balls. Take care not to allow any loose clothing, long hair, jewelry or
other loose item to be caught in the rotating mechanism; this could potentially harm the
patient and damage the module.
Never place the module in contact with or direct it at anything other than the target area. The
cables to the RF applicator should be positioned in such a way that contact with the patient
shall be avoided.
During system operation, the generated electromagnetic field may interfere with other
medical 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.
The RF applicator is not for use with Neutral electrode.
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 module's umbilical cable in contact with the patient.
GENERAL
EN ISO 13485 ISO Medical devices - Quality management systems - Requirements - 2012
1.
for regulatory purposes.
3. EN ISO 14155-1 ISO Clinical investigation of medical devices for human subjects. - 2011
RISK MANAGEMENT
SAFETY
SOFTWARE
9. IEC 62304 IEC Medical Device Software: Software Life Cycle Process 1.0 2006
10. IEEE 830 IEEE Recommended Practice for Software Requirements Specifications - 1998
11. IEEE 829 IEEE Standard for Software Test Documentation - 2008
12. IEEE 1016 IEEE Recommended Practice for Software Design Descriptions - 1998
14. IEEE 1012 IEEE Standard for Software Verification and Validation - 2004
ELECTROMAGNETIC COMPATIBILITY
IEC 61000-4-5 IEC Electromagnetic Compatibility (EMC). Part 4: Testing and 2.0 2005
21.
Measurement Techniques. Section 5; Surge Immunity Tests
LABELING
26. EN 980 ECS Symbols for use in the labeling of medical devices - 2008
27. EN 1041 ECS Information supplied by the manufacturer with medical devices - 2008
BIOCOMPATIBILITY
STERILIZATION
Grounded power cable warning label, located next to the power cable connection port:
The WEEE label indicating separate collection and disposal symbol, located near the
identification label: at the end of useful life the system module is to be returned to the
manufacturer for appropriate processing and disposal:
List of icons:
Non-ionizing radiation
Caution
Warning
Date of Manufacture
Manufacturer
Serial Number
Temperature Limitation
Humidity Limitation
Keep Dry
This side up
3.1. Introduction
The Accent Prime system is designed for installation in an office or a clinic and
requires minimal site preparation. When the Accent Prime 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 (modules, footswitch)
Plug the system into a designated electrical outlet
Fill the cooling system reservoir with 50% distilled water and 50% propylene
glycol
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.
Caution
Do not turn the system on before circulating the coolant in the cooling system.
Refer to Section 3.7 and to the label adhered to the system's LCD control panel.
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 Accent Prime system; it incorporates
built-in electronic noise filters.
2. Refer to Figure 3-8: pull open the cover (A) of the modules connection ports (B).
A
B
C
B
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 levers to lock the module connectors in position and ensure
that they are closed all the way, as shown by the arrows in Figure 3-10.
6. Close the cover of the module connection ports (see view A in Figure 3-8).
Caution
Never use the control panel, modules or umbilical cables to move the system.
4.1. Introduction
This chapter provides a detailed description of the Accent Prime system. The
description covers the system's main components, controls and functional sub-
systems, the modules and system & module specifications.
The Accent Prime system combines three state-of-the-art technologies. All
procedures deliver safe and virtually painless treatments that combine the most
advanced and effective technologies for medical aesthetic and dermatology
procedures. The treatments involve no down- time, recuperative period or
uncomfortable side effects.
The RF modules use heating (UniLarge, Coaxipolar, UniBody, UniFace, Tune
Body, Tune Face and Accentuate) and fractional technologies (RF Pixel) to treat
cellulite, skin laxity and body & face contouring, using Alma Lasers' proprietary
radiofrequency technology. In addition the UniBody and UniFace modules offer a
rotating massage ring.
The Tune Body and Tune Face modules integrate vacuum and radiofrequency
energy. The vacuum provides coupling between the tissue and the RF electrodes
during the treatment, to maximize radiofrequency energy transfer to the treated
area.
Treatment with the UniLarge, Coaxipolar, UniBody, UniFace, Tune Body, Tune
Face and Accentuate modules penetrates three layers of the skin: the epidermis,
dermis and subcutaneous fat, enabling treatment to be effective and to meet the
patient's and practitioner's clinical needs. Treatment with the RF modules affects
the epidermis and dermis and the selective ultrasound modules penetrate the
subcutaneous fat layer. All modules offer safe and long-lasting treatment with no
damage to nerves, vessels or connective tissue.
The UltraFace and UltraSpeed modules target fat reduction, deliver body & face
contouring and employ Alma Lasers' unique selective ultrasound technology. The
ultrasound treatment safely and effectively targets localized fat deposits and
reduces body circumference as well as successful body contouring.
The Tango module integrates both ultrasound and radiofrequency technologies.
This combination enables active heating of the treatment area and therefore
increased treatment effectiveness and decreased treatment duration.
A technical discussion of the modules and technical specifications may be found
later in this chapter.
Power Supplies
Footswitch
A/C Indicator
Connection
Port
Fuses
Housing
Main Switch
4.2.4. Modules
The modules are used to deliver radiofrequency and ultrasound energy to the
treatment site.
For a treatment session, only one module can be selected. The non-selected module
remains inactive during the treatment.
The following images display the various types of modules and module tips used
with the Accent Prime system.
Figure 4-2 displays the UniLarge and Coaxipolar modules:
Figure 4-4 displays the Accentuate module from its top and bottom:
Thermometer
Figure 4-4 displays the UniBody and UniFace modules with the RF heating tips and
detachable massage rings:
Figure 4-5 displays the RF Pixel module with the pixelated tips for the fractionated
treatment modality:
Figure 4-6 displays the Tune Body and Tune Face modules:
To cease operation of the massaging mechanism, set the Accent Prime system to
Standby mode.
Caution
Take care not to allow any loose clothing, long hair, jewelry or other loose item to
be caught in the rotating mechanism; this could potentially harm the patient and
damage the module.
Caution
Saving the settings overwrites the current default parameters.
Note
Saving the settings for one module type does not affect the
default settings for the other modules.
Warning
Only Alma Lasers authorized service personnel are qualified to access the
technician mode.
Tampering with the settings in the technician mode may adversely affect the
safety and efficacy of the Accent Prime system.
Output Frequency
40.68 MHz ± 20 kHz
Cooling
Thermoelectric cooling, excluding the RF Pixel module
Active Air Cooling for Accentuate module
Up to 150 RPM
Vacuum Pump (for Tune Body/Tune Face modules only connected to the upper
connection only)
Up to 0.045 MPa
Operating Frequencies
2
70 kHz and 160 kHz
Control
Adaptive digital frequency control
Continuous ultrasound output
Cooling
Water cooling
1
The Tango module integrates both ultrasound and radiofrequency technologies.
The RF Output Power of the Tango module is up to 300W.
It is cooled both by water and TEC.
2
Depends on Module type and automatically detected by system.
4.4.4. Physical
Dimensions
46 cm wide x 47 cm deep x 121 cm high
Weights
60 Kg
Protection Fuses
120 VAC, 10 Amp
220/230 VAC, 5 Amp
4.4.6. Classifications
Mode of Protection against Electric Shock
Class I Equipment
Chapter Contents:
Section Title Page
5.1. Introduction........................................................................................ 5-2
5.2. Control Panel Components ................................................................ 5-2
5.2.1. Keyswitch .......................................................................................... 5-3
5.2.2. Emergency Shut-Off Knob ................................................................ 5-3
5.2.3. RF and Ultrasound Emission Indicator .............................................. 5-3
5.2.4. Touch-Screen Panel ........................................................................... 5-4
5.3. Service Panel Components ................................................................ 5-4
5.4. Module Trigger .................................................................................. 5-5
5.5. Footswitch.......................................................................................... 5-7
5.6. Module Connection Ports .................................................................. 5-8
5.1. Introduction
This chapter describes in detail the controls, indicators and connections of the
Accent Prime system. They include:
Control panel components
Service panel components
Module connection ports
Emission control devices
Touch-Screen
Control Panel
Emission
Indicator Keyswitch
Emergency
Shut-off
Knob
5.2.1. Keyswitch
The keyswitch is located on the front panel of the system (see Figure 5-1).
The keyswitch is used to turn the system on and off:
Turning the keyswitch clockwise turns the system on
Turning the key switch counterclockwise starts the shut-down sequence and
turns off the system
Note
Once the keyswitch is turned to the Off position the key should be removed to
prevent unauthorized use of the system. The key cannot be removed when the
keyswitch is in the On position.
Caution
Use the emergency shut-off knob only in case of an emergency.
Note
Only the module that is currently selected can be activated
in Ready mode. Pressing the trigger of the other (non-
selected) module will not have any effect.
The selected module is indicated on the screen.
The UniBody and UniFace modules have no trigger; the
massaging mechanism rotates continuously while the
system is in Ready mode, and RF energy is delivered when
the footswitch is pressed.
Warning
If the system is in Ready mode, energy emission occurs when the module
trigger is activated.
5.5. Footswitch
The pneumatic footswitch (see Figure 5-4), supplied with the Accent Prime system
provides an additional means for starting radiofrequency emission.
Radiofrequency emission starts by pressing the footswitch only when the system is
in Ready mode.
The footswitch's pneumatic tube is connected to its connector on the service panel
(see Figure 5-2).
For detailed instructions on connecting the footswitch, refer to Chapter 3 –
Installation.
Warning
If the system is in Ready mode, energy emission occurs when the footswitch is
activated.
6.1. Introduction
This chapter describes in detail the operating instructions of the Accent Prime
system. Specific treatment parameters and information concerning the therapeutic
applications of the system are provided in the appropriate clinical guide.
Caution
This system may only be operated by a licensed practitioner.
Improper use or adjustment of this system may invalidate the system's
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.
Note
4. Press the Start button; the Module Selection screen appears (see Figure 6-3).
2. Press the Face button to change the illustration of the human body to an
illustration of a human face, for the purpose of selecting a facial area for
treatment.
After the treatment area is selected, the system shows a transient Please wait screen
for a few seconds (as shown in Figure 6-5), until the relevant operating screen
shows.
2 3 1
7 8 9 10 11 6
7. Back – press the Back button to go back to the Select Area screen (see
Figure 6-4).
8. Home – press the Home button to return to the Module Selection screen (see
Figure 6-3).
9. Save – saves the current parameter settings for this particular treatment
modality (RF) in the system's memory (see Section 6.15).
10. Reset – resets the treated areas (grids) in the target site.
11. Standby/Ready Softkey – toggles the system between Standby and Ready
modes:
Press the STANDBY key to switch the system to Ready mode (red).
Press the READY key to switch the system to Standby mode (green).
After making your tip selection, the program will advance to the Stationary
Standby screen if you have selected the Icepick tip, or the In-Motion Standby
screen if you have selected the Spark, Traumatic or Atrophic tip (see Figure 6-8).
8 7 6 5
The Stationary Standby screen provides the controls and displays required to
operate and control of the system when the RF Pixel module is active and the
Icepick stationary tip is connected to the module.
After setting the desired RF power level and transitioning to Ready mode, RF
energy will be emitted for as long as the footswitch or module trigger is pressed.
1. Treatment Tip Identifier – displays which type of RF Pixel tip is currently
selected for operation.
2. Power Selection – select the desired RF power by pressing the ▲ or ▼
buttons to increase or decrease the displayed power value, between 5-110W
(for the Spark tip, the range is between 5 to 25W).
3. Pulse Duration Setting – select the pulse duration, from 0.1 to 1.0 seconds by
pressing the ▲ or ▼ softkeys.
Note
The In-Motion modality operates in the same fashion as the Stationary
modality, only without the Pulse Duration setting factor.
4. Intensity Depth Selector – this control selects which intensity of RF energy
will be delivered to the target site. The intensity level of the treatment is
determined by the operator. At each intensity level the indicator will change
from Ablative to Thermal:
Thermal is the lowest intensity of energy at the preinstalled RF power.
Ablative is the highest intensity at the same RF energy.
Touch the appropriate area of the bar to select the desired intensity of RF
energy application.
5. Standby/Ready Softkey – toggles the system between Standby and Ready
modes:
Press the STANDBY key to switch the system to Ready mode (red).
Press the READY key to switch the system to Standby mode (green).
6. Save – saves the current parameter settings for this particular treatment
modality (RF) in the system's memory (see Section 6.15).
7. Home – press the Home button to return to the Module Selection screen (see
Figure 6-3).
8. Back – press the Back button to go back to the RF Pixel Tip Selection screen
(see Figure 6-7).
6.7.2. Operating with the Tune Body and Tune Face Modules
The main treatment screen for tune mode is the same screen for both RF modules:
Tune Body and Tune Face. (While connected to the upper connection only)
The following is a brief description of the Tune Body Standby screen elements, as
indicated by the numbered arrows in Figure 6-9:
2 3 1
6 5
15 14 13 12 11 10 9 8
7. Timer – this countdown timer is set automatically by the system after the
power and energy selections are made, and will count down to 00:00 (zero
time) as the system emits RF pulses.
8. Intensity Depth Selector – refer to Section 6.7.
9. Mode Selector - toggles the system between Pulse and Stacking modes:
In Pulse mode, the module emits pulses (each pulse lasts between 1-5
seconds).
In Stacking mode, the module emits between 2 to 10 pulses per
session.
10. Vacuum Intensity Selector – toggles the system between High Vac and
Low Vac modes.
11. Standby/Ready Softkey – toggles the system between Standby and
Ready modes:
Press the STANDBY key to switch the system to Ready mode (red).
Press the READY key to switch the system to Standby mode (green).
12. Reset – resets the treated areas (grids) in the target site.
13. Save – saves the current parameter settings for this particular treatment
modality (RF) in the system's memory (see Section 6.15).
14. Home – press the Home button to return to the Module Selection screen
(see Figure 6-3).
15. Back – press the Back button to go back to the Select Area screen (see
Figure 6-4).
2 3 1
6
5
9
13 12 11 10 8
This procedure also takes place during ultrasound treatments after every three to
five minutes (depends on the operating module), of ultrasound energy emission and
takes approximately 3 seconds. This process does not interfere with the operation of
the system and the treatment may continue uninterrupted.
Note
During a resonance-tuning while in procedure, no Ultrasound
emission will be delivered and the “BIP” sound would be single
“BIP”. The timer clock will be hold during the test.
If the system is switched to Standby mode for more than
5 minutes, it will automatically perform a resonance tuning
routine when switched back to Ready mode.
2 1
10 9 8 7 6 5
2 3 1
12 11 10 9 8
that will count down to 00:00 (zero time), at which point the screen will
display the next grid to be treated.
5. RF Power Setting – set the desired power by pressing the ▲ or ▼ button to
increase or decrease the displayed power value.
6. Power Selection – select the desired ultrasound and RF energy level; Low
(button with single wavy line), Medium (button with double wavy line) or
High (button with triple wavy line).
7. Invested Energy – the level of energy to be invested per grid is set
automatically by the system after the power and hot/cold energy selections are
made.
8. Standby/Ready Softkey – toggles the system between Standby and Ready
modes:
Press the STANDBY key to switch the system to Ready mode (red).
Press the READY key to switch the system to Standby mode (green).
9. Reset – resets the treated areas (grids) in the target site.
10. Save – saves the current parameter settings for this particular treatment
modality (Ultrasound) in the system's memory (see Section 6.15).
11. Home – press the Home button to return to the Module Selection screen (see
Figure 6-3).
12. Back – press the Back button to go back to the Select Area screen (see
Figure 6-4).
After the STBY button is pressed, the system transitions to READY mode (refer to
Figure 6-13):
To activate energy emission – press the START button (it will change to
STOP button). Ultrasound energy is now emitted.
To activate the Radiofrequency emission – press continuously on the
module’s trigger. Once you leave the trigger, RF emission is stopped, and
only US energy is emitted.
To stop energy emission, press the STOP button (it will change back to
START button).
Figure 6-13: START and STOP buttons on Tango Module READY Screen
Note
While the Tango module emits US energy, the READY button
changes alternately to red and blue circles, reflecting the hot
and cold times of the cycle.
Note
Blinking emission indicators after releasing the trigger or
the footswitch indicates that radiofrequency emission has
stopped and that the system is in Ready mode.
To cease radiofrequency emission at, any time, release the
trigger/footswitch.
Caution
Saving the settings deletes and overwrites the current default parameters (or any
previously-saved settings) for the selected treatment modality.
Note
Saving the settings for treatment modality does not affect the
default settings for the other modalities.
Note
Warning
Do not leave the key in the keyswitch unattended. It may lead to unauthorized
use of the system.
Chapter Contents:
Section Title Page
Introduction
This chapter contains maintenance instructions for the Accent Prime system.
Routine maintenance may be performed by clinic staff unless otherwise specified.
Any maintenance procedure not mentioned in this chapter must be performed only
by Alma Lasers authorized technical personnel.
The system is designed to operate reliably without any need for operator
maintenance. However, the outer surfaces of the system should be kept clean for
hygienic reasons and the applicator tips should be cleaned between sessions to
enable effective treatment.
Warning
Maintenance by the operator should be performed only when the system is shut
down and disconnected from the mains power source. Performing maintenance
procedures with the system turned on may be hazardous to the operator and/or
destructive to the system.
Periodic Service
The system should be periodically inspected and maintained to keep it in peak
operating condition.
The following routine service operations should be performed by Alma Lasers
authorized technical personnel every 12 months:
General system check
Interior inspection, including cleaning accumulated layers of dust
Check the radiofrequency output energy
Cooling system:
Check the water level in the cooling system; refill if necessary
Replace the filter
Clean the radiator
Check the water quick-connector O-rings on the modules
If periodic service is not performed according to schedule (every 12 months) by an
Alma Lasers-authorized service provider, any warranty agreement of the system
and its associated modules and/or accessories will be invalidated.
Warning
The Accent Prime system generates hazardous voltages within the main
console.
The interior of the system may be serviced only by Alma Lasers authorized
technical personnel.
Service Information
In communications with Alma Lasers authorized representatives regarding the
system, always include the part number and serial number indicated
on the identification label located on the system service panel.
Warning
Unauthorized servicing or modification of this system not described in this
manual may expose the operator or patient to potential high voltage hazards.
Improper use or adjustment of this system may invalidate the service
warranty agreement.
Warning
The Accent Prime 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.
The Accent Prime modules, in particularly the applicator tips, are cooled
intensively when the system is in Ready mode. Water may condense on the
applicator tip's surface which could affect the treatment process and, under certain
conditions, may produce sparks. Avoid water condensation on the applicator tip's
surface. Wipe the surface of the applicator tip clean immediately before a treatment.
In addition, pay attention to cleaning the thermometer display on the UniLarge and
Bipolar modules.
Following every treatment wipe the module with a soft cotton swab dipped in 70%
alcohol.
On a weekly basis check the module tips for cleanliness. If necessary clean the
module tips with a soft cotton swab dipped in 70% alcohol.
Caution
Do not wet the module with water or immerse the module in any liquid.
During treatment use only the treatment oil recommended by Alma Lasers.
Warning
Do not treat a patient with not disinfected tip; this can lead to cross-
contamination!
Ensure that the tip is absolutely dry before inserting it back into the module and
before treating a patient.
Read the disinfectant manufacturer's instructions carefully before use.
Use appropriate personal protective equipment during cleaning.
1
Enzol® is a Johnson & Johnson product
2
Endozime® AW Triple Plus with APA is a product of the Ruhof company
13. Shake the tip dry, and dry it using a clean lint-free cloth. Pressurized air can be
used to dry the tip if applicable (< 20 PSI / < 1.4 Bar).
Figure 7-1: UniBody Module's Massage Ring (for illustration purposes only)
Caution
Never fill the coolant reservoir with regular tap water. Use only 50% distilled water
and 50% propylene glycol.
VENT Coolant
Port FILL Port
Fuse Replacement
To replace burnt fuses:
1. Turn off the system and disconnect the power cable from
the outlet.
2. Unplug the power cable from the power cable
connection port on the service panel.
3. Remove the fuse housing as shown in Figure 7-8.
4. Remove the burnt fuses from the housing and replace
them with the new ones.
5. Make sure that the fuses fit snugly within the fuse
housing.
6. Insert the fuse housing into its receptacle and push it in
until it snaps into place.
7. Connect the power cable to the system and to the mains
outlet.
Figure 7-4: Fuse Housing
8. Turn on the system and verify that it is functioning
Removal
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.
Warning
To protect the RF module and Ultrasound module from possible damage,
disconnect and store it prior to system disassembly.
Once you have removed the printed-circuit boards from their protective
antistatic bags, handle them only by their edges.
Replacing/Accessing RF Controller
The PWM (Pulse Width Modulation) controller (inserted inside the RF Controller)
governs the RF output power from the RF amplifier to the handpiece module.
Proceed as follows (refer to Figure 7-5):
1. Disconnect the PWM-to-amplifier SMA Cable (1) from the board; use an
adjustable wrench to loosen the connector's nut.
2. Remove the four Phillips screws (2) that secure the board to its mounting plate.
3. Disconnect the input control harness's connector (3) by releasing 2 screws and
pulling it out of its counterpart on the board.
4. Disconnect the control communication harness’s connector (4) by releasing 2
screws and pulling it out of its counterpart on the board.
5. Unpack and install the new RF controller by reversing steps 1 through 4 above.
2. Disconnect the two D-type harness connectors (1, 2) from the module using a
flat screwdriver Refer to Figure 7-7.
3. Disconnect the Molex connector (3) from the module Refer to Figure 7-7.
4. Open the RF cable from the RF Controller board (4) Refer to Figure 7-7.
5. Flip up the cover to access the interface control board, Refer to Figure 7-8.
7. Removing the four Philips screws that that secure the board to its mounting
plate. (Marked 4,5,6,7), and release the board Refer to Figure 7-9.
8. Unpack and install the new Interface controller by reversing steps 1 -7 above.
2. Disconnect the RF N-Type cable connector (3) from the Ultrasound generator;
unscrew counter-clockwise and remove.
5. Refer to Figure 7-13, carefully, slide the Ultrasound Generator on its base
bracket, out via the backside of the system.
3. Slide out and remove the Lambda Power Supply as shown in Figure 7-22
Figure 7-27: Water system accessing the pump and the radiator.
3. Remove both brackets (steps 1-2) to gain access to the cooling system interior
for access the pump, the radiator, the water reservoir, the practical filter, the
level switch and the flow switch, as shown on Figure 7-28, Figure 7-29 and
Figure 7-30.
Figure 7-28: Water system accessing the pump and the radiator.
Figure 7-29: Water system accessing the pump and the radiator.
Figure 7-30 Water system accessing the pump and the radiator.
2. Remove the four Phillips screws on the bottom left (1,2), and on the bottom
right (3,4) that locked the screen to the chassis shown on Figure 7-31B.
3. Flip the screen upside down, and disconnect both the D-type connector (1) and
the DC power cables (2) shown on Figure 7-32.
4. Remove the screen bracket by releasing eight locking on the back pf the screen
bracket as shown on Figure 7-33.
3. Remove two Philips screws (1,2) that locked the power wires and five (1-5)
Screws that holds the TEC controller to the chassis Figure 7-36.
2. Open three BNC connectors (1,2,3) and disconnect D-Type connector (4) and
the fan power connector (5) as shown on Figure 7-38.
3. Open two Philips screws (1,2) that locked the Phase Shifter to the chassis
Figure 7-39.
4. Open BNC connector (1) connected to the RF Sensor and gently slide the Phase
Shifter unit to the right as shown in Figure 7-40.
6. Releasing the Phase Shifter bracket by opening one Philips screw (1) that
located in the front of the Phase Shifter and two screws (2,3) located in the
back of the Phase Shifter Figure 7-42.
5. Unpack and install the new Phase Shifter or RE sensor by reversing steps 1-4
Chapter Contents:
Section Title Page
8.1. Introduction
The Accent Prime system is equipped with a self-testing software routine that
continuously monitors the system operation. If a system malfunction is detected, an
error message will appear on the LCD display.
An error will disable system operation and the operator should turn the system off
using the keyswitch and the main switch.
The following troubleshooting tables do not attempt to list all possible system
failures. Any fault not listed should be referred to Alma Lasers Service personnel.
Warning
Do not attempt to open or disassemble the system covers.
The software of
Ultrasound 1. Restart the system.
US Gen Version
generator not
Error 2. Install the correct System software.
compatible with the
system software
System cannot 1. Restart the system.
Unrecognized recognize the
Handpiece connected 2. Check that connecting handpiece intended for
handpiece this system.
Fail to load data Fail to load data 1 .Reinstall software and check wiring.
from flash from Rabbit flash 2. Replace IPL controller.
Wrong Phase
RfCtrl Ver Error Shifter PIC 1. Replace Phase Shifter.
software
2. Run the RFU.exe file (Rabbit Field Utility) on your computer from its
location; The main screen appears and choose Processor Type Rabbit
4000 (see Figure 8-2).
4. In the Communication Options dialog box, select the correct COM port from
the drop down list.
7. Connect the D-Type connector of the flat cable to your computer's serial port,
or USB to Serial Converter.
9. Connect the cable connector marked PROG on the other end of the cable to the
Rabbit processor. Make sure that the cable's red lead is facing toward the hole
(see Figure 8-4).
10. Connect the power cable to the system and turn the system on.
11. From the opening screen menu of the RFU program (see Figure 8-2), select
File and Load Flash Image; the Choose Flash Image dialog box appears (see
Figure 8-1).
12. In the dialog box select the bin file to load and click OK.
13. A progress bar appears; wait until it disappears, switch off the system,
disconnect the flat cable and turn system back ON.
14. Go to the Password screen and check on the LCD display that the software
version installed is the same as the one expected (circled in Figure 8-6).
If the flat cable is not connected properly, an error message will appear when trying
to load the software, notifying No Rabbit Processor Connected. Reconnect the
cable and retry to load the software package again.
6. Make sure "Memory card transfer" is selected and click on the "Start" button
(in red). Language selection screen appears (see Figure 8-10)
7. Open the system control panel and insert the memory card Figure 8-11.
11. Transmit confirmation screen appears Figure 8-3. Press OK [Transmit] button
twice.
12. When transmission ends, the restart screen appears Figure 8-5.
15. Wait for the system to restart and turn system power off.
16. To verify that LCD software upgrade was successful turn the system power on.
17. In the tech3 screen, verify that the software version marked with “L” is similar
on both lines (Figure 8-6).
Press the “Return” button; the system backs to Language selections screen Figure
8-10.
Check that memory card inserted properly
Press “English” button Figure 8-10.
1. FlowSw: this indicator is for testing the coolant flow; in normal conditions this
indicator should be yellow.
2. RightSw: when pressing the RF handpiece's trigger, the grey indicator turns
yellow.
3. LeftSw: when pressing the RF handpiece's trigger, the grey indicator turns
yellow.
4. LevelSw: displays the coolant level in the reservoir; in normal conditions this
indicator should be yellow.
5. FootSw: when pressing the footswitch, the grey indicator turns yellow.
Use the RF measurement tool to measure the output power of the RF Amplifier
(refer to the RF measurement tool's operation manual).
1. Hot: notes the Hot mode parameters of the Accent Prime system. It is strongly
recommended not to change this setting.
2. Cold: notes the Cold mode parameters of the Accent Prime system. It is
strongly recommended not to change this setting.
3. Resonance: activates the procedure of resonance point seeking for each mode.
4. Stop: this button activates or ceases ultrasound emission for selected frequency.
1. Wipe the tip dry; condensation on the tip can cause sparks.
2. Check that the tip's alumina coating is intact.
3. Replace the RF module.
8.7.2. RF Controller PWM Output Measurement
On occasion you may be requested by the Technical Support Department at Alma
Lasers to measure the RF controller's power output.
To do so, use a DVM (Digital Volt Meter) to measure the voltage between the
control cable connector's central pin and a ground source (see Figure 8-22).
Disconnect the SMA Cable from the RF controller.
Go to RF TECH3 and press the zero (0%) on the bottom left side of the screen, a
keypad will open, enter the different Duty Cycle values and press D/A OFF button
to apply, check with DVM on the SMA connector the output voltage accordingly:
2. 10% -> 0.46±5%
3. 50% -> 2.3±5%
4. 100% -> 4.62V±5%
3. In StBy mode measure the output voltage of the Ultrasound power supply (see
Figure 8-25).
4. Unscrew N-type coaxial connector from Ultrasound generator and measure the
voltage between central pin of the N-type connector and ground source (see
Figure 8-26). The voltage reading should be a same with output voltage of the
power supply.
Warning
Do not short the central pin of the N-type coaxial connector with
ground ring by the DMV probe. It can cause Ultrasound generator
damage.
Warning
This testing should be provided in StandBy mode only.
5. Disconnect the Red wire from the Ultrasound generator power supply and
connect DVM for current measurement (series) (see Figure 8-27).
After connecting the DVM proceed to the following table to continue the test
On right side of the
Hot row press
Resonance The
system will find the
resonance frequency
and show in
Resonance column.
On the appearing
keyboard type the 4
digits of the
resonance value and
press Enter.
On the appearing
keyboard type the 4
digits of the
resonance value and
press Enter.
6. Compare the current reading result (see Figure 8-28) from the DVM and Tech4
Ultrasound screen. The acceptable difference should be ±10%. The current
reading at the resonance point should be not less than 500mA.
In the power measured we have taken into account the modulation frequency. The
measured RF-power must be lower than setting value due to the point that RF-
signal is modulated with a frequency of 15 kHz.
Bird power meters are calibrated for continuous wave signals and measures the
power value with accuracy ±5%. To understand the correlation between the power
measured on the Bird and the power output on the tip of the handpiece it is
necessary to use the calibration table below.
RF Amplifier of 320W
Duty Cycle set in tech Handpiece real RF Measured RF POWER
mode, % POWER,W on Bird model 43, W
0 0 0
10 36 17.77
15 54 26.66
20 72 37.33
25 90 46.22
30 108 60.44
35 126 73.77
40 144 87.11
Due to the said above, it should be noted that at duty cycles above 90% the real
power and the Bird measurement coincide.
Connect the system to power and turn ON the system, enter into technician mode.
In Tech3 Set the PWM % output, set D/A ON and activate the emission by pressing
the trigger or Foot Pedal. Releasing the foot Pedal will stop emitting power
Perform the test as follows:
1. Uniform / Unilarge / Unipolar Uniface – PWM should be set to 20%, 25%,
30%
2. Bipolar – PWM should be set to 15%.
Attach the handpiece to your hand or body and check the values on the Bird power
meter to match the table above.
Chapter Contents:
Section Title Page
9.1. Introduction
The following spare parts catalog lists all of the Accent Prime modules and parts
that should be stored by the Alma Lasers depot or distributorship for the use of the
field service engineers.
The Item # column of the table indicates the item number as shown in the
illustration on the pages following the table.
The Figure # column notes in which illustration (following the table) the particular
item can be found.
The Description column of the table provides the item name and/or its brief
description.
The Part # column of the table shows the item part number, by which it should be
ordered from Alma Lasers
Front Back
Left Right
Front Back
Left Right