Trios Service Manual MK-056
Trios Service Manual MK-056
Trios Service Manual MK-056
AUTHORIZATION
NAME TITLE SIGNATURE DATE
Issued Ofer Adi Service support 12 May 09
by:
Reviewed Omri Kesler COO 12 May 09
By:
Approved Danny Erez CEO 12 May 09
By:
Revision History
Service Manual
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Before using the device, please check local regulations. If any local
legislation is violated, use cannot be authorized.
In the United States, federal law restricts prescription medical devices to
sale by or on the order of a physician, or properly licensed practitioner.
Viora makes no representations regarding federal, state, or local laws or
regulations that might apply to the use and operation of this device.
Corporate Headquarters
Viora, Inc.
30 Montgomery Street
Suite 660
Jersey City, NJ USA 07302
Tel: +1 201 332 4100
Fax: + 1 201 332 4200
Website:www.vioramed.com
E-mail: info@vioramed.com
0344
This device complies with the European Medical Device Directive 93/42/EEC
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Table of Content
1 Background ...................................................................................................................5
2 Scope ............................................................................................................................5
3 Applicable Documents ................................................................................................5
4 Responsibilities: ............................................................................................................5
5 Before You Start ............................................................................................................6
5.1 Conventions Used in this Manual….................................. ............................................6
5.2 Explanation of the Symbols Used in the System…………......................... ..................7
6 Introduction....................................................................................................................8
6.1 System Overview............................. .............................................................................8
6.2 Console.............................. ...........................................................................................8
6.2.1 Display Screen and Keypad…………………........................................... ...... ..............9
6.2.2 System View - Left Side..............................................................................................10
6.2.3 System View - Right Side.............................................................. .............................10
6.2.4 Rear Side............................................................ ........................................................11
6.3 Hand piece.............................. ..................................................................... ..............12
6.4 Technical Specifications.................................... .........................................................13
7 Safety. .........................................................................................................................14
7.1 Introduction……….................. ....................................................................................14
7.2 Installing the System……....................... .....................................................................14
7.3 Operating the System............................. ...................................................................14
7.4 Fire Hazards.............................. .................................................................................15
7.5 System Classifications............................... .................................................................15
7.6 Moving the System within the Facility………......................... .....................................15
7.7 Electrical Requirements................................ ..............................................................15
7.8 Maintaining the System…………......................... .......................................................16
7.9 Environmental Requirements.................................... .................................................16
7.9.1 Air Quality............................................................... ....................................................17
7.9.2 Space Requirements............................................................... ...................................17
8 System Operation……… .............................................................................................17
8.1.1 Language Set Up.............................................................. ..........................................17
8.1.2 Display Brightness Set Up.................................................................... ......................18
8.1.3 Delay for Handle Cooling Set Up…………................................................... ..............19
8.2 System Test Procedures.............................................................................................19
1.2.1 Basic Preparation...................................................................... .................................19
8.2.2 System Fans Test.............................................................. .........................................19
8.2.3 Energy Calibration procedure……........................................................ .....................20
8.3 Replacing the Hand Piece............................... ...........................................................22
8.4 Maintenance............................... ................................................................................24
9 Replacing Parts ...........................................................................................................26
9.1.1 Fuse Replacement......................................................................................................26
9.1.2 Replacing Main Board.............................................................. ..................................30
9.1.3 Replacing Display Board…………………............................................. ......................33
9.1.4 Touch Panel (Lexan) Assembly................................................................. .................34
Appendix....................... ..............................................................................................................35
Troubleshooting Diagram............................................................................................................35
Service Kit ....................................................................................................................................44
Electrical drew of the system:......................................................................................................44
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1 Background
This Service Manual is part of the Service and Maintenance Plan for the Trios™
system.
2 Scope
This document applies to Service and Maintenance. It defines the service
procedures for the Trios™ system.
3 Applicable Documents
N/A
4 Responsibilities:
Service department
Warning
Read this manual to become familiar with all safety requirements
and operating procedures before attempting to operate the system.
Any intense optical energy device can cause injury if used
improperly.
High voltage is present inside the system. Always be aware of the
possible dangers and take proper safeguards as described in this
manual.
The Trios™ system must be serviced only by qualified personnel.
The following conventions in the form of notes, cautions and warnings are
used in this manual:
Note
The content of this Note offers general information that is important to
keep in mind.
Caution
A Caution alerts the user to the possibility of a problem with the device
associated with its use or misuse. Such problems include system
malfunction, failure, and damage to the system or other property. The
caution statement includes a precautionary action that should be taken to
avoid the hazard.
Warning
A Warning alerts the user to the possibility of injury, death, or serious
adverse Trios associated with the use or misuse of the system.
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Symbol Description
CE Compliance Symbol
0344
Fuse
Type BF Equipment
Manufacturer
6 Introduction
The use of TriosTM in aesthetic applications is based on the principle of Selective
Photothermolysis. According to this principle, pulsed light parameters (wavelength,
pulse duration and energy fluency) are chosen to selectively target light sensitive
cells while minimizing damage to surrounding tissues.
The system features three specially designed hand pieces for the top three
phototherapy applications; hair removal, acne treatments and the treatment of
vascular and pigmented lesions (skin rejuvenation).
The Trios™ system is CE certified; FDA approved, and complies with CSA
Canadian regulations. While this system is considered safe for both the operator
and the patient, it should be operated only by trained, qualified treating attendants.
The system includes four core modules: the Console, the Hair Removal (HR) hand
piece, Acne Clearance (AC) hand piece and Skin Rejuvenation (SR) hand piece.
6.2 Console
Software
p lu g
On/Off buzzer
switch
The spot size of the light on the skin is 15mm x 50mm which defines the footprint
of each treatment pulse. The light pulse is activated by pressing the activation
button on the hand piece.
Activation button
When not in operation, place the hand piece in its cradle on the side of the
system.
The system is supplied with one hand piece, optimized for photoepilation. Two
additional hand pieces are available for purchase, depending on the clinic's
needs.
The hand pieces are equipped with optimal filters for the following applications
(specified in nano meter):
Note
The system automatically recognizes the hand piece and filter connected.
7 Safety
This chapter describes the safety issues regarding the use and maintenance of the Trios™
system, with special emphasis on optical and electrical safety.
7.1 Introduction
The system is designed for safe and reliable treatment, when used in accordance with
proper operation and maintenance procedures. Only trained practitioners are qualified to
operate the system. The user and all other personnel operating or maintaining the system
should be familiar with the safety information provided in this chapter. Viora Ltd. assumes
no liability whatsoever for any damage or injury as a result of an application of a product
which is not in strict accordance with the instructions provided with the product. The
primary consideration should be to maximize safety for both treating attendant and the
patient.
Warning
Read this chapter to be familiar with all of its safety requirements and
operating procedures prior to operating the system.
Any intense optical energy can cause injury if used improperly.
High voltage is present inside the system.
Always be aware of the possible dangers and take proper safeguards
as described in this manual.
For complete contact information please refer to page 3 of this
manual.
Warning
Always turn the system off before connecting or disconnecting the
applicator!
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Keep your hands away from the hand piece during system start-up.
Do not allow the hand piece to come in contact with hard materials, excessive heat
or humidity; these may damage the hand piece.
Make sure that all treatment personnel are familiar with the system's controls and
know how to shut down the system instantly.
Do not use flammable substances when preparing the skin for treatment.
If alcohol is used for disinfecting, it must be allowed to dry thoroughly before the
system is used.
The Trios™ system and applicators comply with U.S. Federal Regulations.
The system is classified as a Class IIb device, in accordance with the standards set
by the European Medical Device Directive (93/42/EEC) for CE marking.
If the TriosTM has to be moved to another location, it is advised to pack it in its original
package.
Warning
For continued protection against fire, replace the fuse only with one of
the same type and rating.
Proper grounding is essential for safe operation.
The system is grounded through the grounding conductor (yellow/green) in the power
cable which is plugged into the network electricity outlet. Suitable and appropriate
grounding is essential for safe operation.
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. Viora
strongly recommends that the system be connected to a separate power line with
separate circuit breakers.
The main fuse, located within the unit, is a 3.15A circuit breaker (for 230V) or 6.3A (for
115V).
Power supply to the system will cease when the circuit breaker trips.
Caution
Verify that the Trios TM is wired to the appropriate line voltage of your
country (115 V or 230V).
Shut down the system and disconnect the power cable before performing any
maintenance procedures.
Metallic dust can damage electrical equipment. Dust particles absorb light and heat
up. Hot particles located on the optical light guide can damage it; therefore dust
particles should be kept to a minimum.
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For optimal operation of the system, maintain room temperature between 10º - 30ºC
(50º-86ºF) and relative humidity of less than 80%.
If the system has been stored in an environment cooler than the above mentioned
temperatures, allow it time to warm up to room temperature before first activation.
Place the Trios™ system away from heating ducts or other outlets.
Trios TM is designed for installation in a clinical environment and requires minimal site
preparation. The base dimensions of the system are 45 cm (L) X 38 cm (W) X 27 cm (H).
A sufficient space of 10cm should be cleared at the back of the device to permit
appropriate ventilation.
8 System Operation
In this section you will find set up and operational instructions for the Trios™ system as well as
test procedures and maintenance requirements.
Use of controls, adjustments or performance of procedures other than those specified herein
may result in hazardous light exposure
• Simultaneously press the left and right arrows for approximately 5 seconds for the
language options to appear on the screen (Figure 8).
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• Press OK.
• Press OK for approximately 10 second for the brightness options to appear on the
screen (Figure 9)
• Make your selection using the Left and right navigation arrows.
• Make your selection using the Left and right navigation arrows.
• Press OK.
• Turn the system Off before reconnecting the hand piece.
• When the system is turned on, the fans will start to operate automatically, Proper
air flow is conducted from the outside into the system to both fans.
Warning
Check for dust or any obstacle on the finger guard of the fan and
carefully clean, if required.
Proper air flow is essential for safe operation.
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Note
Energy calibration procedure is essential for an appropriate functionality
of the system.
Calibration procedure should be made with HR applicator.
This procedure must be executed annually.
The calibration procedure can be divided into 3 phases:
1. System Set Up
2. Measurement Equipment Set Up
3. Calibration Measurements and Adjustments
Below you will find detailed instructions to all 3 phases.
System Set Up
Define the treatment intensity to level 15 by pressing the right arrow key, and then press
the Press Operate key.
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In case the output is not 165 Joules, either reduce or increase the system
capacitors' charging, by means of the potentiometer VR1 (installed on the main
board card) (Figure 15).
Make sure not to release more than 8 consecutive pulses before letting the system to
cool down to avoid inaccuracies in the read.
The TriosTM system is equipped with an internal computer and counter which constantly
test the hand piece attached to ensure its efficacy and helps maintain Viora's high
standards of treatment and treatment's safety.
When the hand piece has completed its designated number of pulses, the system will
alert the operator to replace the hand piece.
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To utilize a different application (each application has its own unique hand
piece).
When the system detects a significant drop in energy level.
When significant contamination has been accumulated on the surface of
the light guide. (You may avoid this situation by simply cleaning the hand
piece after each treatment using humid duster).
When physical damage has been inflicted on the light guide or the hand
piece casing.
When the hand piece achieved 100,000 pulses.
• Disconnect the hand piece from the back of the main console by pulling the
connector's bridge until the safety pin enters the designed niche (Figures 16)
Safety pin
Figures 16. releasing the hand piece from the system's connector.
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• When the connector's bridge stops on the improved safety pin push the safety
pin with any object that has diameter smaller than 3 mm.(Figure 17)
• While holding the safety pin down keep pushing the connector's bridge forward
until the outlet is released.
• Connect the new selected hand piece to its port on the rear panel.
8.4 Maintenance
While the Trios™ system should not be serviced by anyone other than an authorized agent or
technician, the system requires minimal preventative maintenance and cleaning to ensure
optimal system performance.
Warning
Shut down the system and disconnect the power cable before performing any maintenance
procedures.
o Remove the air filter's cover and expose the air filter (fig18- 20)
o Reverse the above steps, and continue working with the system
Figure 21
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9 Replacing Parts
9.1.1 Triac Replacing
Disconnect the air pipe from the fast connection (figure 24).
Disconnect the
40A wires from
the RF Chock and
from the main
capacitors(figure
25)
Unscrew the nuts, tighten the diodes to the system body (Figure 26)
Unscrew two nut, holding the connector to the system body, from the internal side of the
system and another Allen bolt from the external side (use 12mm key and Allen 4mm key
see figure 27 ,28).
Gently press on the two clips on both side of the fuse hose, and pull (Figure 29).
The Trios system contain 4 protection fuses except to the main one (that locate on the
rear side of the system) in order to replace the fuses please follow the below steps.
Locket the blown fuse according to the type of the malfunction (Figure 31).
- Fuse F1 @ 4A.
- Fuse F2 @ 0.032A.
Disconnect the transformer from the machine's base by unscrewing four M4 bolts.
Moving the transformer will create a working space and access to the main board
(Figure 32).
Four M4 bolts
Disconnect the relevant harnesses from the main board (Figures 33-37).
Note
You may want to consider marking the harnesses before you disconnect
the main board. It will make the reconnection of the harness easier.
Connectors J1, J2
Fans' Harnesses
Display Harness
Connector J 4
High voltage connection
Disconnect the main board from the machine's body by unscrewing five of
the Allen M4 bolts (use Ball End T-Handle - Inch).
Caution
Always check for the QC sticker on the board! This sticker approves that
the board has past a successful calibration (Figure 37).
QC Sticker
Make sure that all of the harnesses are properly connected (Figure 26 ).
HRVio-1000
PLC OUT PUT
Display board
Lexan's harness
Designated notch
Jp1 connection
Appendix
Appendix A
Troubleshooting
Note
The Troubleshooting chapter is presented as a process. The colored
block diagram represents symptom (Blue), possible cause (Yellow) and
solution (Green).
All of Viora's products are based on replacing sub-system principals.
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Appendix B
Service Kit
AssVIO-3000
2 IPL Main board 2
AssVIO-2023
3 Fuses 5X20 3.15A /6.3 VIO- 2019-3.15 10
S-B
8 Lexan VIO-2025 2
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9 Vio-2007 2
Triac 600 V 40 A
NTE5679
10 Rectifier bridge 800V Vio2008 2
25A
11 Vio-1014 2
Capacitor 27,000mF
,250 V
12 Fan 12V VIO-2012 2
14 Vio-2014 2
Diode D2
15 Pump 220V/110 AC0602-220/ 2
AC0602-110
16 Vio-2013-2 2
Buzzer Switch
17 VIO-7010-1 2
19 PLC VIO-2028 1
Appendix B
Electrical drew of the system:
Appendix C
IPL Pulse Test Of the Trios™
Dear colleague, in order to verify proper pulse of the Trios™, please follow the below procedure
step by step test.
1. Overview
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This procedure is indicated to verify proper IPL pulse of the Trios™ , and proper
indication by 'ready light' and sound.
2. Required tools
Warning!
During the test procedure you will be asked to measure high voltage, if you not an authoritative
technician, that train by Viora Ltd, and used with the proper tools, you not allowed to perform
this test!
3. Procedure
3.1. Internal part access
3.1.1. Open the system's cover by unscrewing the two M4 bolts located in the rear side
of the system and the other 6 M4 bolts located in the bottom of the system (Figure
1 & 2).
Figure 1 & 2. M4 bolts location
If the voltage values are correct, continue with the test procedure.
4.4. Verify minimum 350V between the capacitors cathode to the anode on the D2 diode
(Figure 6 & 7).
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Please note the measurement should be performed exactly on the indicated locations.
If the voltage value is below 350V (~180V), check for short circuit in diode D2 (Figure 8).
Replace the diode is necessary.
If the voltage value is 0V, check Fuse F1, and the proper connection of the system's
harnesses as follows:
o Power board to Display board (Figure 9 &10)
o Display board to PLC, in and out connections (Figure 11)