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COMET

Service Manual
DC23071
Revision Control
Revision Page Description Made By Date
1 Release Zvika kuperman 3 May 3, 2005
Copyright © 2002 Syneron Medical Ltd. All rights reserved.

Print date: May 3, 2005

Syneron Medical Ltd. reserves the right to make changes to its products or
specifications to improve performance, reliability, or manufacturability.
Information provided by Syneron Medical Ltd. is believed to be accurate and
reliable. However, Syneron Medical Ltd. assumes no responsibility for its use. No
license is granted by its implication or otherwise under any patent or patent rights
of Syneron Medical Ltd.

No part of this document may be produced or transmitted in any form or by any means,
electronic or mechanical, for any purpose, without the express written permission of
Syneron Medical Ltd.

Data is subject to change without notification.

Syneron Medical Ltd. has patents and pending patent applications, trademarks,
copyrights, or other intellectual property rights covering subject matter in this
document. The furnishing of this document does not give you any license to these
patents, trademarks, copyrights, or other intellectual property rights except as expressly
provided in any written agreement from Syneron Medical Ltd.

Specifications are subject to change without notice.

Syneron Inc. Tel:+1-905-886-9235


111 Granton Drive Fax: +1-905-886-7046
Unit 110
Richmond Hill, Ontario Canada L4B 1L5
Syneron GmbH Tel:+49-89-6424810
7 Ludwig Ganghofer Str. Fax:+49-89-64248170
D-82031 Grünwald,
Germany
P
Syneron Medical Ltd. Tel:+972-4-9096200
Industrial Zone Fax:+972-4-9096202
P. O. Box 550, Yokneam Illit
Israel 20692
M
Web site: www.syneron.com
E-mail: info@syneron.com
Table Of Contents

1. INTRODUCTION........................................................................................................ 1-1
SYSTEM OVERVIEW ............................................................................................................ 1-1
SYSTEM COMPONENTS ........................................................................................................ 1-1
EQUIPMENT CLASSIFICATION .............................................................................................. 1-3
Explanation of the Symbols used on the Comet System................................................. 1-3
2. SAFETY GUIDELINES.............................................................................................. 2-1
SYSTEM SAFETY FEATURES ................................................................................................ 2-1
GENERAL PRECAUTIONS ..................................................................................................... 2-1
PERSONAL SAFETY ............................................................................................................. 2-2
A SAFE ENVIRONMENT ....................................................................................................... 2-2
OPTICAL SAFETY ................................................................................................................ 2-2
ELECTRICAL AND MECHANICAL SAFETY ............................................................................ 2-3
FIRE HAZARDS .................................................................................................................... 2-3
SAFETY LABELS .................................................................................................................. 2-4
3. INSTALLING THE SYSTEM ................................................................................... 3-1
PRE-INSTALLATION CONSIDERATIONS ................................................................................ 3-1
SYSTEM INSTALLATION ...................................................................................................... 3-2
POST-INSTALLATION PROCEDURES ..................................................................................... 3-2
Moving the System ......................................................................................................... 3-3
4. SERVICING THE SYSTEM ...................................................................................... 4-1
SAFETY CONSIDERATIONS .................................................................................................. 4-1
SERVICING TOOLS ............................................................................................................... 4-2
ACTIVATING THE SYSTEM ................................................................................................... 4-3
TESTING INPUT/OUTPUT ..................................................................................................... 4-5
Testing the Pump and water cooling system.................................................................. 4-5
Testing the Thermoelectric Cooler ................................................................................ 4-6
Testing the Interlock ...................................................................................................... 4-6
VIEWING SYSTEM INFORMATION ........................................................................................ 4-6
CALIBRATING THE SYSTEM ................................................................................................. 4-7
TREATMENT MODE ........................................................................................................... 4-10
Adjusting the Treatment Parameters ........................................................................... 4-12
5. PREVENTIVE MAINTENANCE.............................................................................. 5-1
SAFETY CONSIDERATIONS .................................................................................................. 5-1
MAINTENANCE FREQUENCY ............................................................................................... 5-1
BEFORE AND AFTER EACH TREATMENT ............................................................................... 5-1
ONCE A WEEK (BY OPERATORE) ......................................................................................... 5-1
ONCE A MONTH .................................................................................................................. 5-1
ONCE A YEAR ..................................................................................................................... 5-2
REPLACING THE APPLICATOR ............................................................................................. 5-2
CLEANING THE AIR FILTERS ............................................................................................... 5-3
REPLACING THE DEIONIZER CARTRIDGE ............................................................................ 5-3
REMOVING WATER FROM THE SYSTEM............................................................................... 5-4
DRAINING THE COOLING WATER FROM APPLICATOR .......................................................... 5-5
DC23071 i
6. DISMANTLING THE SYSTEM................................................................................ 6-1
DISMANTLING SYSTEM PANELS .......................................................................................... 6-1
Dismantling the Front Panel ......................................................................................... 6-2
Dismantling the Side Panels .......................................................................................... 6-2
Dismantling the Top Panel ............................................................................................ 6-3
DISMANTLING ELECTRONIC COMPONENTS ......................................................................... 6-4
Dismantling the 42V Resonance Power Supply Card.................................................... 6-7
Dismantling the P.F.C Card .......................................................................................... 6-8
Dismantling the AC Filter Card .................................................................................... 6-9
Dismantling the 12V – 8.3V Power supply Card......................................................... 6-10
Dismantling the RF Generator Card ........................................................................... 6-11
Dismantling the Laser Power Supply Card ................................................................. 6-12
Dismantling the CPU card........................................................................................... 6-13
7. TROUBLESHOOTING .............................................................................................. 7-1
8. SPECIFICATIONS...................................................................................................... 8-1
APPENDIX A: SYSTEM INSTALLATION REPORT................................................... A-I
APPENDIX B: NON-CONFORMANCE REPORT......................................................... B-I
APPENDIX C: GLOSSARY............................................................................................... C-I

ii DC23071
Introduction

1. Introduction
This chapter includes an overview of the Comet system, the main system components and
classification.

System Overview
The Comet System is intended for hair removal treatment. The system technology is a
combination of optical (laser) energy and conducted radio frequency (RF). Both of these
energies supplement each other to provide epidermal and dermal thermolysis at
controlled depth.

The System provides individual adjustment of RF energy and Laser energy to achieve
maximum efficiency and safety for each patient.

The System provides enhanced safety and comfort while minimizing possible side
effects, using a contact cooling mechanism in the applicator and “on-line” energy
monitoring of the tissue during treatment

System components

Applicator Carrier Applicator

System Handles Information Screen

Operator Panel

Figure 1-1: Comet System

DC23071 1-1
Introduction

Applicator
This system can be used with one type Laser Applicators. Applicator that is not connected to
the system should be kept in its carrier case.

Operator Panel
The operator panel is located on top of the system. This panel has 4 function buttons,
information screen, and power-meter for Laser and RF calibration, as shown in the
following diagram.

Power Meter

Information
Screen

Function Buttons

Figure 1-2 Control Panel

Function Buttons

Button Description
Toggle button Use this button to move between the lines and switch
between screen options.
Pressing this button does not cause any hardware reactions.
OK button Use this button to activate the selected function.
Down button Use this button to deactivate the selected function and
decrease the value of the selected function.
Up button Use this button to activate the selected function and increase
the value of the selected function.

In Treatment mode, the Up and Down buttons are only used to increase/decrease
values, respectively.

1-2 DC23071
Introduction

Equipment Classification
The following is a list of the different equipment used and their classifications.

• Laser System Class IV


• Electric shock protection: Class I, Type BF
• Protection against ingress of liquids: Ordinary equipment
• Not suitable for use in presence of flammable substance
• Mode of operation: Continuous
Comet System and DS Applicator comply with the U.S. Federal Regulations and
performance standards 21CFR1041.10 and 1041.11 for medical laser Systems.
Additionally the device is classified as a IIa device defined by the Medical Device
Directive (93/42/EEC) for CE marking.

Explanation of the Symbols used on the Comet System

Symbol Description

Attention Consult Accompanying Document

CSA marking

CE marking

Fuse

Type BF Equipment

M Manufacturer

P Authorized representative in the European


Community

DC23071 1-3
Safety Guidelines

2. Safety Guidelines
The system is designed for safe and reliable treatment when used in accordance with proper
operation and maintenance procedures. Only trained, qualified practitioners can use the
system. The operator and all other personnel operating or maintaining the system should be
familiar with the safety information provided in this chapter.
This chapter provides safety guidelines for use and maintenance of the system, with special
emphasis on optical and electrical safety.

Read this chapter to be familiar with all its safety requirements and operating procedures
prior to System operation. Laser or RF devices 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 the manual

System Safety Features


The Comet system incorporates the following safety features. All personnel operating the
system should be familiar with these features:
• You can only turn the system on using the key provided, and you can only remove
this key when the system is turned off.
• If you need to deactivate the system suddenly, you can press the Emergency Stop
button, regardless of the current state of the system.
• The power electronics cannot be activated unless the Applicator has been
connected to the system.
• An audible tone indicates the emission of laser radiation.
• During activation, the system performs a self-test of the hardware.
• The system hardware is tested every 50 ms to ensure proper operation of the
electrical circuit.
• Skin impedance monitoring prevents accidental energy emission to the patient.

General Precautions
The following general precautions should be taken when using this system:
• Do not touch the inner parts of the system, except for the reservoir (see the
Maintenance chapter for refilling instructions).
• Only company-authorized personnel should service this system.
• Keep the applicator output window clean.
• Do not turn the system on if you detect water leaking from it, or from the
applicator. If the system is on when a water leak is detected, turn it off
immediately.
• Do not allow the applicator to come in contact with hard materials such as metal
that could damage the RF electrodes, Electronics and output window.
• Never use the System in the presence of explosive or flammable materials.

DC23071 2-1
Safety Guidelines

• Make sure that all treatment personnel are familiar with the system controls and
know how to shut down the system instantly in case of an emergency.

Personal Safety
The primary consideration should be to maximize safety for both treating attendants.
The following guidelines will help to ensure personal safety:
• Personnel operating the system should be fully trained to do so.
• A patient history should be completed prior to scheduling.
• Patients should be fully informed of the treatment protocol, the likely results and
any risks associated with the treatment.
• Patients and treating attendants should wear the provided Syneron protective
eyewear during the treatment.

A Safe Environment
The following danger sign is provided with the system. It should be placed outside the
treatment room where the System is being used, where it can be seen clearly.

Figure 2-1: Caution sign for Treatment Room (Europe, USA)

Optical Safety
Follow these guidelines to ensure optical safety:
• Laser radiation present a potential eye hazard and a potential fire or burn hazard.
Take all necessary precautions in the area where the system is being used.
• Follow treatment guidelines, excessive energy can result in thermal damage to the
treated skin.
• Everyone present in the room must wear protective eyewear whenever the system is
in use.
• Never look directly at the output window of the applicator, even when wearing
protective eyewear.
• Remove reflective objects such as jewelry or mirrors, which reflect the light of the
laser.

2-2 DC23071
Safety Guidelines

• When the applicator is not connected to the system, keep it in its case. When it is
connected, and not in use, keep it inserted in the carrier. During the procedure
apply the applicator output window directly to the treatment area.

Electrical and Mechanical Safety


Follow these guidelines to ensure electrical and mechanical safety:
• Keep all covers and panels of the system closed. Removing the covers creates a
safety hazard.
• Keep your hands away from the Applicator during system start-up.
• Perform maintenance procedures only when the system is shut down and the power
is disconnected.
• The system weighs approximately 30kg (66lb.). It should be moved slowly and
carefully.
• The system is grounded through the grounding conductor in the power cable. This
protective grounding is essential for safe operation.

Fire Hazards
Follow these guidelines to avoid fire hazards:
• The absorption of optical energy raises the temperature of absorbing material. Do
not use the system in the presence of explosive or flammable materials.
• Keep drapes and towels moist to prevent them from igniting and burning. Use non-
flammable prepping solutions.
• Do not use flammable substances when preparing the skin for treatment.
• If alcohol is used for cleaning and disinfecting, it must be allowed to dry
thoroughly before the system is used.

DC23071 2-3
Safety Guidelines

Safety Labels
The following labels are affixed to the backside of the System.

LASER RADIATION
AVOID EYE OR SKIN EXPOSURE TO
DIRECT OR SCATTERED RADIATION
CLASS 4 LASER PRODUCT

DIODE LASER
OUTPUT POWER: 320W max
DIODE LASER WAVELENGHT: 780-980 nm
OUTPUT POWER: 320W max PULSE DURATION: 350msec max
WAVELENGHT: 780-980mm
PULSE DURATION: 350:msec max
CLASS IV LASER PRODUCT

Item 1 Item 2

Item 3 Item 4

DANGER
RISK OF EXPLOSING IF
USED IN THE PRESENCE OF
FLAMMABLE ANESTHETICS

CAUTION
TO REDUCE RISK OF
ELECTRICAL SHOCK
REFER SERVICE TO QUALIFIED
SERVICE PERSONNEL

CAUTION
GROUNDING RELIABILITY CAN
CAN BY ACHIEVED WHEN THE
MACHINE IS CONNECTED TO
AN RECEPTACLE MARKED:
REMOTE INTERLOCK
"HOSPITAL GRADE"
CONNECTOR

Item 5 Item 6 Item 7

2-4 DC23071
Safety Guidelines

Industrial Zone
Yokneam Illit
Medical Ltd. 20692, Israel

MODEL : Comet
PART No. : AS3357A
MANUFACTURED : Oct 2004
SERIAL No. : 1001
POWER : 100-240V~ 10A
50-60 Hz
MADE IN ISRAEL
THIS DEVICE COMPLIES WITH:
a (IEC ; 60601-2-22SECOND EDITION ;NOV 1995
b21 (CFR 1040.10 AND ; 1040.11APRIL 1997
c (PART 18 OF THE FCC RULES .
OPERATION IS SUBJECT TO THE FOLLOWING TWO
CONDITIONS (1) :THIS DEVICE MAY NOT CAUSE HARMFUL
INTERFERENCE ,AND (2) THIS DEVICE MUST ACCEPT ANY
INTERFERENCE RECEIVED ,INCLUDING INTERFERENCE
CAUTION: Neutral 100-240V~; 10A
THAT MAY CAUSE UNDESIRED OPERATION .CONNECT ONLY Fusing T 12.5A; 250V
TO GROUNDED OUTLET .

CAUTION: For
continued protection
against risk type of fire
replace only with same
type and rating fuse

Item 8 Item 9

The following label is glued to the front of the system:

LASER APERTURE
AT END OF
APPLICATOR

Item 10

The following labels are affixed to the connector of the Applicator:

Industrial Zone
Yokneam Illit
Medical Ltd. ,20692Israel

MODEL : DS Comet App.


PART No. : AS34351
MANUFACTURED : Oct 2004
SERIAL No. : 1002 DS
MADE IN ISRAEL

Item 11 Item 12

DC23071 2-5
Safety Guidelines

ITEM 7
ITEM 1
DIODE LASER
OUTPUT POWER: 320W max LASER APERTURE AT
WAVELENGHT: 780-980mm END OF APPLICATOR
PULSE DURATION: 350 :msec max
CLASS IV LASER PRODUCT

DANGER
RISK OF EXPLOSING IF
Medical Ltd.
MODEL : Comet
Industrial Zone
Yokneam Illit
20692, Israel ITEM 8
USED IN THE PRESENCE OF PART No. : AS34331
FLAMMABLE ANESTHETICS MANUFACTURED : Oct 2004
SERIAL No. : 1001
POWER : 90-254V~ 10A

ITEM 5 CAUTION
TO REDUCE RISK OF
ELECTRICAL SHOCK
50-60 Hz

THIS DEVICE COMPLIES WITH:


MADE IN ISRAEL

a (IEC ; 60601-2-22 SECOND EDITION ;NOV 1995


b21 (CFR 1040.10 AND ; 1040.11APRIL 1997
c (PART 18 OF THE FCC RULES .
REFER SERVICE TO QUALIFIED OPERATION IS SUBJECT TO THE FOLLOWING TWO
SERVICE PERSONNEL CONDITIONS (1) :THIS DEVICE MAY NOT CAUSE HARMFUL
INTERFERENCE ,AND (2) THIS DEVICE MUST ACCEPT ANY
INTERFERENCE RECEIVED , INCLUDING INTERFERENCE
THAT MAY CAUSE UNDESIRED OPERATION .CONNECT ONLY
TO GROUNDED OUTLET .
CAUTION
GROUNDING RELIABILITY CAN
CAN BY ACHIEVED WHEN THE
MACHINE IS CONNECTED TO
AN RECEPTACLE MARKED:
" HOSPITAL GRADE "

ITEM 6

ITEM 4

ITEM 9
CAUTION: Neutral 90-254V~; 10A
Fusing T 12A; 250V

CAUTION: For
continued protection
against risk type of fire
replace only with same
type and rating fuse
LASER RADIATION
AVOID EYE OR SKIN EXPOSURE TO
DIRECT OR SCATTERED RADIATION

TEM 2 CLASS 4 LASER PRODUCT

DIODE LASER
OUTPUT POWER: 320W max
WAVELENGHT: 780-980 nm
PULSE DURATION: 350msec max

ITEM 3

Figure 3-2: System Labling

2-6 DC23071
Safety Guidelines

ITEM 10

ITEM 11

LASER APERTURE
AT END OF
APPLICATOR

DS

ITEM 12

Figure 2-2 System and Applicator Labeling

DC23071 2-7
Installing the System

3. Installing the System


This chapter provides the information needed to install the Comet system, including pre-
installation considerations, installation procedures and post installation procedures.

Pre-installation Considerations

Hardware Requirements

The following equipment required for installation, is supplied with the system:
• System platform
• COMET Applicator
• Two pairs of protective goggles
• Two pair of eye-shields
• User Manual
• Room caution sign
• Installation instructions

Electrical Requirements
The System will require separate line supply of:

• Single phase 90-254 Vac; 15A; 50-60Hz.

For continued protection against fire, replace the system fuse only with one of the
same type and rating.
Proper grounding is essential for safe operation.

Environmental Requirements
Corrosive materials can damage electronic parts therefore; the System should operate
in a non-corrosive atmosphere.

Metallic dust can damage electrical equipment. Particle dust absorbs light and heats
up. Hot particles located on the optical light guide can damage it; therefore, particle
dust should be kept to minimum.

For optimal operation of the System, maintain room temperature between 20º-25ºC
(68º-77ºF) and relative humidity of less than 80%.

DC23071 3-1
Installing the System

System Installation
The System is designed for installation in a clinic environment. To install the System
perform the following tasks:

1. Unpack the System.

2. Check the System and all its components for damage.

3. Push the slide latch of the bottle door down and remove the door from the back
of the machine.

4. Fill the System with fresh distillated water. For detailed instructions, refer to
replacing the Cooling Water in Chapter 7.

5. Connect the Applicator to the System platform by aligning the guiding pins in
the Applicator with those in the base; then slide the Applicator connector along
the guiding pins into place and lock it. For complete instructions, refer to
replacing the Applicator in chapter 7).

6. Connect the Power Cord to the System inlet.

7. Plug the System Power Cord into an appropriate electrical outlet.

Post-installation Procedures

Filling the System with Water

The water tank, filter and pump provide the system with a cooling mechanism.
To fill the system with fresh distilled water:
1 Push the slide latch of the bottle door down and remove the door from the back
of the machine.
2 Remove the bottle from the compartment and Fill ½ liter of fresh distillated
water
3 Remount the bottle in the compartment by turning it clockwise. Activate the
pump for 2 minutes using the I/O Test function.
4 Refill bottle with additional water between the Min and Max markings.
5 Reassemble and lock the door.

If the system is filled with water, it should be stored at a temperature of over 2ºC (35ºF).
Otherwise the optical glass freezes over, damaging the system completely.
This damage will not be covered by manufacture warranty.

3-2 DC23071
Installing the System

Moving the System

To move the System within the facility:

1. Turn the System off.

2. Disconnect the Power Cord.

3. Place the Applicator into its carrier.

4. Release the wheel brakes.

5. With one hand secure the Applicator and slowly push or pull the System
using the handle.

To move the System to another facility:

1. Turn the System off.

2. Drain water from the System and Applicator. For complete instructions,
refer to chapter 7, Maintenance).

3. Disconnect the Power Cord.

4. Disconnect the Applicator and pack it into its storage case.

5. Release the wheel brakes.

6. Slowly push or pull the System using the handle.

7. Lift the System to the vehicle and lay it carefully on its two rear handles.

Upon arrival at the new location:

1. Release the wheel (if they are lock) brakes and move the System to its new
service area, using the System handle.

2. Reconnect the Applicator.

3. Inspect the water reservoir to ensure that the System has not lost its water
supply. If needed refill the tank with distilled water. Close the cover
securely.

4. Reconnect the Power cord.

Never lift, pull or push the System using the operating panel. Always use the handles when
moving the System.

The system is heavy. Two people are needed to lift it.

DC23071 3-3
Servicing the System

4. Servicing the System


This chapter walks you through the basic information you need to operate and service the
system.

Safety Considerations
Before turning the system on, read and follow these safety guidelines:

The system contains dangerous voltage.

Put the Applicator into its carrier during system start-up.

The Applicator emits intense laser energy. Therefore, everyone present in the treatment
room must wear appropriate safety eyewear, and never look directly at the Applicator
output window, even when wearing safety eyewear.

Never direct the Applicator output window at anything other than the treatment area.

Do not apply excessive energy to the treated area. This can damage the skin, resulting in
abnormal pigmentation, atrophy or hypertrophy.

When calibrating the system, adhere to the procedures specified in this manual, otherwise
hazardous radiation exposure may occur.

In case of an emergency, press the Emergency button. This will turn off the system,
regardless of the current state of the machine.

Release the Emergency button, otherwise the System will remain shut off.

DC23071 4-1
Servicing the System

Servicing Tools

Tools Required for Repair


Tools Used to Repair
T-handle ball driver tool 5mm M6 screws holding top part and bottom handle
to frame
T handle ball driver tool 3mm • M4 screws connecting fans to shield
• All covers and top assy

T handle ball driver tool 5/32 • High current contacts on Laser PS

Ball driver hex screw driver 7/64” • Screw cap socket #6-32NC,
• PCB to shield and to frame chasis

Combination Spanner 11mm • Top assy

Combination spanner 10mm • Releasing the wheels

Slotted screwdriver 3x100 • Screws from SW plug,

Volt meter 0-1000V, AC, DC Check voltage on capacitor banks


Ohm meter To check connectivity in harnesses

Tool Use
Assistance Software Plug For system diagnostics and calibration
Resistor Load For RF diagnostics and calibration

4-2 DC23071
Servicing the System

Activating the System

Before turning the system on:


• Verify that the power cord is connected to the system, and that the
system is properly plugged in.
• Install the Service plug.
• Connect the Applicators.

Activate the system by turning the key clockwise as far as it will go, and then release the key.

Applicator carrier

Emergency button

Key

Figure 4-1 Key and Emergency button location

The System initiates a self-test of controller memory. During this test, the following screen is
displayed.

Self Test

SW Version 1.00
Service Software
Please Wait…

Figure 4-2 Self-Test screen

DC23071 4-3
Servicing the System

When the memory test is over, the following screen might be displayed.

Configuration ID
Wrong Version
Save Parameters? OK
Other Key – No

Figure 4-3 Memory test failure screen

If the system does not have Water flow meter installed press any button but OK, if system has
Water flow meter press OK button. After pressing a button the Main Menu is displayed.

Menu

I/O Test

Information
Calibration

Treatment

BurnIn

Figure 4-4 Service Menu screen

The Service Menu screen allows you to choose from the following options:
• I/O Test
• Information
• Calibration
• Treatment
• Burn-In

4-4 DC23071
Servicing the System

When servicing the system, you will be using the first 3 options. Use the Toggle button to
bring the cursor to the chosen option.

Testing Input/Output
The I/O test mode is used to manually test different modules of the system separately before
calibrating the system.
To activate the I/O Test mode, toggle to select the I/O Test option and click Ok. The
following screen is displayed.

I/O

Pump Off 20°C


Water Flow Off 0:00
TEC Laser Off
Cooling Down Enable
Interlock Off
Fans OK
Figure 4-5 :I/O Test screen

Testing the Pump and water cooling system

1 Open the water compartment door at the back of the system, and verify that the
bottle is full with water between the Min and MAX markings.
2 On the Service screen, move the cursor to Pump, and use the Up button to
activate the pump, Make sure that the “Water Flow” changes to OK
3 Visually check the pump and water hoses while the cooling water is flowing,
to locate any source of leakage.
4 Use the Down button to deactivate the pump, make sure that “Water Flow”
changes to Off.
5 Press the OK button to return to the main Test Screen.

DC23071 4-5
Servicing the System

Testing the Thermoelectric Cooler

I/O

Pump Off 20°C


Water Flow Off 0:00
TEC Laser Off
Cooling Down Enable
Interlock Off
Fans OK
Figure 4-6: I/O Test screen contd.

1 On the service screen Toggle to TEC Laser, and use the Up button to activate
the cooling mechanism.
2 For approx. 1 minute, monitor the decrease in the temperature of the applicator
(Temp=xx), and verify that this stabilizes at approx. 5+/- 2°C. Record this
temperature in the test form. Deactivate this function using the Down button.

Testing the Interlock

1 Disconnect the Interlock Jack Located on the upper backside of the system,
and verify that the Interlock is “On” on the LCD screen.
2 Reconnect the Interlock Jack, and verify that the Interlock is “Off” on the LCD
screen.

Viewing System Information


The Information screen shows the software version, Applicator type connected, the number
of pulses triggered by each Applicator and the information stored in the applicator and system
memory.
To view system Information:
1 From the Menu, toggle to Information and click OK. Then the Information
screen appears.

4-6 DC23071
Servicing the System

Version 1.00 Information

System Comet 1.1


Laser App. DS 320W 45A
Laser #Pulse 10350
NV Memory Dump

Figure 4-7 Information Screen

2 To change applicator type, toggle to the Laser App. and change applicator type
using the Up or Down buttons.
3 Before exiting the Information screen, you will be prompted to save the
changes you have made.
4 To view stored information in applicator and system memory toggle to the NV
Memory Dump and press OK, the next screen appears.

ID RFCF URFC SVER


NV1 96 1.40 1.40 2.20
NV2 96 1.40 1.40

ID TYPE LACF ULCF PULSES


NV1 96 12 0.91 0.91 300
NV2 96 12 0.91 0.91
BK1: 300 BK2: 300

Figure 4-8 NV Memory Screen

5 The upper section displays the system memory, and the lower part displays the
applicator memory (NV1, NV2).
Calibrating the System
There are two calibration modes:
• Calibration of Laser energy
• Calibration of RF energy
To calibrate the system, you need to go back to the Main Service Menu, toggle to Calibration
and click OK.

DC23071 4-7
Servicing the System

After Initialization the Calibration screen is displayed.

Standby Calibration

Laser

RF

Save and Exit

Figure 4-9 Calibration screen

Laser Calibration

Before performing laser calibration make sure applicator tips and lightguide are clean,
with no Gel or other materilas that might damage the power meter or cause wrong
calibration
After calibration screen is displayed press OK key to go into the Laser calibration screen
shown below

Standby Laser Calibration

Laser App. DS 320W 45A


LACF 0.86
Light Energy 6.17 J
PM Energy 6.16 J

Figure 4-10 Laser Calibration screen

1 To move from Standby mode to Ready mode, toggle to LACF and click OK.
2 Apply the applicator output window to the power meter on the upper right side
of the top assembly, (Compare reading with Ophir power-meter).
3 Apply 3 pulses into the Built-in power meter with 5 sec delay between the
pulses.

4-8 DC23071
Servicing the System

4 Adjust the LACF with the Up or Down Buttons so it will display Light Energy
as close as possible to the reading of the PM Energy.
5 Press OK button to go back to main calibration screen.
6 Toggle to Save & Exit and click OK to save the changes and return to the main
service menu.

RF Calibration

Before performing RF calibration make sure applicator tips and lightguide are clean,
with no Gel or other materilas that might damage the power meter or cause wrong
calibration
After calibration screen is displayed press OK key to go into the RF calibration screen as
shown below

Standby RF Calibration

Laser App. DS 320W 45A


RFCF 0.73
V (RF) 107
I (RF) 69
RF Energy 17.0 J
PM Energy 16.9 J
Figure 4-11 RF Calibration screen

1 To move from Standby mode to Ready mode, toggle to RFCF and click OK.
2 Shoot one pulse into the air.
3 On the display “V“ should read >200 (typical 248) otherwise adjust POT1 (See
Figure 4.10).
4 Apply the applicator output window to the built-in power meter on the upper
right side of the top assembly and apply one pulse
5 On the display, “I” should read 68 ÷ 72 and correspondingly “V” should read
80 ÷ 140 (typical 120), otherwise adjust POT2 (See Figure 4.10).
6 Shoot one pulse in the air, and verify that “V” is >200 (typical 248).
7 After “V” and “I” are adjusted correctly, Apply 3 pulses into the Built-in
power meter with 5 sec delay between the pulses.
8 Using the Up and Down buttons adjust the RF Energy as close as possible to
the PM Energy (See Figure 4-9).
9 Press OK button to go back to main calibration screen.
10 Toggle to Save & Exit and click OK to save the changes and return to the
Calibration screen.

DC23071 4-9
Servicing the System

POT2
Trimmer for I calibration

POT1
Trimmer for V calibration

Figure 4-10 RF Generator Card Layout

Treatment Mode
To activate the Treatment mode, choose Treatment and click OK. Before the Treatment
screen appears, the system performs a hardware initialization, and a message appears on the
screen to indicate that testing is in process. The following diagram shows the message.

Initiate

Please Wait…
30%

Figure 4-12 Initializing Hardware Process message

When initiation is complete, the system is in Standby mode. To start treatment, you need to
click OK, to switch the system from Standby mode to Ready mode.

4-10 DC23071
Servicing the System

Cooling DS

Light J/cm2 10 20°C


RF J/cm3 10
Counter 0
Auto Repeat Disabled
ISL/ISM [%] 30/0
Pulse Short
Figure 4-13 Treatment screen in Standby mode

The Cooling message may appear in the left-top corner of the screen indicating that the
Applicator is overheated, so the electrode cooling process has been initiated. When the
electrodes are cold Cooling message changes to Standby.

Standby DS

Light J/cm2 10 20°C


RF J/cm3 10
Counter 0
Auto Repeat Disabled
ISL/ISM [%] 30/0
Pulse Short
Figure 4-14 Treatment screen in Cooling Down mode

When this happens during treatment, treatment stops. Wait until the Cooling message
changes to Standby on the screen, then click OK to resume treatment.

DC23071 4-11
Servicing the System

Adjusting the Treatment Parameters

The treatment parameters appear on the Treatment screen. You can adjust the following
parameters using the buttons on the Operator panel.

Parameter Description
Light The optical energy level applied to the treatment area. The
light energy range depends on the treatment type.

RF RF is the amount of energy level generated by the RF current


inside the tissue; its value can be varied depending on the type
of treatment.

Counter Total number of pulses triggered.

Auto Repeat Disabled by default for safety, to enable the option toggle to
Auto Repeat and use the Up button to change it to the desired
repeat speed, 1 PPS, 1.5 PPS, 2 PPS. Use the Down Button to
go back.

ISL/ISM Impedance Safety Limits/ Impedance Safety Measurement


(relative decrease of skin impedance)

After each pulse is triggered, the system switches back to Standby mode to recharge the
system with energy. Then the system switches back to Ready mode automatically, enabling
you to trigger additional pulses.

4-12 DC23071
Preventive Maintenance

5. Preventive Maintenance
This chapter describes the maintenance procedures that need to be carried out when the
system is serviced, and instructions for preventive maintenance.

Safety Considerations
Before proceeding with preventive maintenance procedures, read and follow these safety
guidelines:
The Warning sign located near the power inlet indicates that the power supply cord
should be disconnected before servicing the system, to prevent electric shock.

For continued protection against fire, replace the fuse with one of the same type and
rating only.

For optimal system performance, clean the system output window using a dedicated
cleaner and non-abrasive cloth.

For optimal system performance, preventative maintenance is recommended.

Maintenance Frequency
The following table suggests how often each of the maintenance procedures should be
performed.

Before and after each treatment


Clean the entire hand-piece surface with a medical disinfectant such as Baby-wipes. Wipe the
tip (light guide and electrode rails) with isopropyl alcohol. Let the tip dry completely before
pulsing the System. Cleaning of the hand-piece should always be done while System is in
Stand-By mode or turned off. Be careful not to spill any liquids on the system.

Once a Week (by operatore)


Calibrate each of the applicators. Follow calibration protocol as per Calibration mode
instruction (page 5-9)
Clean the System at least once a week. Turn the System off and wipe all surfaces. Be careful
not to spill any liquids on the system.

Once a Month
Replace the cooling water at last once a month. Follow the “Draining and Replacing the
Deionizer Cartridge & Cooling Water” instruction (page 7-4).
Clean the tow filter screens at least once a month. Follow the “Cleaning the Air Filters”
instruction (page 7-2).

DC23071 5-1
Preventive Maintenance

Once a Year
Replace the Deionizer Cartridge at last once a year. Follow the “Draining and Replacing the
Deionizer Cartridge & Cooling Water” instruction (page 7-5).
Send the Power Meter to Syneron service center for calibration.

Replacing the Applicator


Each Applicator contains an ID chip with a distinctive serial number and calibration data.
If the Applicator becomes unusable, replace it as follows:
1 Drain the water from the Applicator. (See “Removing Water from the System
and Applicator” in this chapter).
2 Turn the system off.
3 Lift up the lever, and pull the Applicator connector out.
4 Hold the new Applicator connector in front of the system connector, lining it
up so that the guiding pins fit.
5 Slide the Applicator connector along the guiding pins.
6 Press down the lever to lock the Applicator into place.

Latch Up

Latch Down

5-2 DC23071
Preventive Maintenance

Cleaning the Air Filters


The air filters should be cleaned at least once a months.

Air Filters

Figure 5-1 Air Filtrer Location

To clean the air filters:


1 Turn the system off.
2 Remove the filters and carefully brush the outside surfaces with a soft brush.
3 Reassemble back the filter and secure it with the 4 black ball nuts.

Replacing the Deionizer Cartridge


For safety, and proper system performance, replace the cooling water with fresh distilled
water only.

To remove the Deionizer Cartridge:


1 Turn the system off.
2 Push the slide latch of the bottle door down, and remove the door.
3 Disconnect the Deionizer Cartridge from the water hoses by pressing the two
release buttons on the upper and lower part of the Deionizer.
4 Pull out the Deionizer Cartridge from its holder.

To install a new Deionizer Cartridge:


1 Push in the new Deionizer Cartridge until it locks into its holder.
2 Connect the water hoses into the Deionizer filter until they are securely locked.
3 Remove the water bottle from the compartment, pour out the distilled water
from the bottle and wash it with new fresh water.
4 Fill 1 liter of distilled water into the bottle and install it back into the
compartment
5 Turn the system on and in the I/O Test option activate the pump for few
minutes, then turn it off and shut down the system.
6 Remove the water bottle and fill in additional distilled water all the way to the
MAX marking on the bottle.
7 Place the bottle in the compartment and lock the bottle door.

DC23071 5-3
Preventive Maintenance

Hose1 release
Deionizer Holder

Deionizer Filter

Hose2 Release

Removing Water from the System


To protect the optical glass from freezing, remove the water from the applicator and/or the
system before transportation.

To remove water:
1 From the Service Menu, toggle to I/O Test.
2 Push the slide latch of the bottle door down. The latch is located at the back of
the System. Remove the door.
3 Remove the bottle from its compartment
4 Holding the bottle cover with one hand, loosen the bottle by turning it
clockwise.
5 Hold the bottle cover far above the bottle so that the water can flow freely
through the water pipe.
6 Activate the Pump by clicking the Up button and wait until all the water is
poured from the System to the bottle.
7 Turn the system off.
8 Pour out the water from the bottle.
9 Hold the bottle cover with one hand and with the other hand mount the bottle
and lock it by turning the bottle counterclockwise.
10 Place the bottle in the compartment and lock the bottle door.

Before transporting the machine and/or applicator , drain all water from the Applicator
and the System, otherwise the system will be permanently damaged.
This damage will not be covered by manufacture warranty.

5-4 DC23071
Preventive Maintenance

Water Bottle

Slide Latch

Door

Draining the Cooling Water from applicator

NOT COVERED BY WARRANTY


If water is not drained from the Applicator and the System before transporting the
machine, the optical glass will freeze and crack, causing severe damage to the
machine and applicator. Such damage is not covered by your warranty, and you may
be charged for replacing damaged parts of the system.

Read the instructions provided for “Draining the Cooling Water”.

Follow these instructions to drain the cooling water from the Applicator with a mechanical
hand pump.
1 Disconnect the Applicator from the system.
2 Mount 2 Quick Connection Valves to the Applicator adaptors.
3 Place a draining bottle under the open end of tube 2.
4 Pump the water out of the applicator with until no more water flows out.
5 Disconnect the Quick Connection Valves by pressing the metal release button
on the valves.

Mechanical draining kit can be purchased from manufacture (Syneron).

DC23071 5-5
Preventive Maintenance

Mechanical
Air Pump Release
Button

Tube 1

Quick Connection
Valves

Tube 2

Bottle

Figure 5-2: Draining the cooling water

5-6 DC23071
Dismantling the System

6. Dismantling the System


This chapter provides instructions for dismantling the system panels and the electronic
components of the system. For a list of electronic components, see “Appendix B”.
To reassemble system parts and electronic components, perform the dismantling procedure,
backwards.

Disconnect the system power before dismantling/assembling electronic components.

When dismantling/assembling this system, do not use any tools that are not specified
in the “Servicing the System” section of this manual.

Do not replace any of the original screws, jumpers or connectors provided with this
system, unless Syneron supplies them for this purpose.

Dismantling System Panels


You will need to dismantle the front, side, and top panels to access the electronic parts of the
system.

Top Assy

Left Panel

Right Panel
Front Panel

Figure 6-1: Dismantling the front panel

DC23071 6-1
Dismantling the System

Dismantling the Front Panel

No. Part Number Description


1 MP26121 Front Panel
2 SC05300 3 x Screws

Dismantling the front panel:


1 Loosen and remove the 3 screws securing the panel to the system.
2 Tilt the front panel slightly and disconnect grounding wire “Quick-Connect”
connector.
3 Remove the front panel completely.

Dismantling the Side Panels

Dismantle the front panel before attempting to dismantle the side panels.
Disconnect the grounding wires “Quick-Connect” Connector before dismantling the side
panels.

No. Part Number Description


1. AS33361 Left panel Assy
2. AS33351 Right Panel Assy
3. SC05230 Front Screws x 3
4. SC05230 Backside Screws x 4

Dismantling each of the side panels:


1 Loosen and release the screws in the front and backsides of the system.
2 Tilt the side panels slightly and disconnect grounding wire “Quick-Connect”
connector.
3 Remove the side panels completely.

6-2 DC23071
Dismantling the System

Dismantling the Top Panel

Figure 6-2: Dismantling the top panel

No. Part Number Description


1 AS26021 Control Panel Assy
2 SC05230 4xScrews

Dismantle the front and side panels before attempting to dismantle the top panel.
Dismantling the top panel:
1 Release the 4 screws securing the panel to the system.
2 Lift the top panel slightly, and carefully disconnect the flat cable and power
meter cable underneath it.
3 Remove the top panel completely.

DC23071 6-3
Dismantling the System

Dismantling Electronic Components

Figure 6-3: Right Side -Electronic Component Location

Code Component Part Number


A 12V – 8.3V Power Supply card AS24072
B RF Generator card AS20731
C Laser PS AS20751
D Pump AS26151
E Bottom Fan AS03132

6-4 DC23071
Dismantling the System

F
G

H
J

K
L

Figure 6-4: Left Side -Electronic Component Location

Code Component Part Number


F 42V Resonance Power Supply AS20741
G Emergency Switch EE13210
H Key Switch EE16030
I Closing part assembly AS09222
J P.F.C card assy AS19552
K Line Filter EE20690
L AC Filter Assy AS26361
M Power entry EE01960

DC23071 6-5
Dismantling the System

N CPU card AS26651


O Buzzer AS24231
P Castor BM11400
Q Castor with break BM11410

6-6 DC23071
Dismantling the System

Dismantling the 42V Resonance Power Supply Card

Figure 6-5: 42V Resonance Power Supply card

Part Number Description


1 AS20741 42V Resonance Power Supply card
2 AS26691 Screws x 6

Dismantling the 42V Resonance Power Supply card:


1 Disconnect all connectors.
2 Loosen and release the 6 screws attaching the card to the system.
3 Remove the card by drawing it towards you carefully.

Reassembling the 42V Resonance Power Supply card:


1 Mount the card in position.
2 Secure the card with the 6 screws to the system.
3 Reconnect all connectors.

DC23071 6-7
Dismantling the System

Dismantling the P.F.C Card

Figure 6-6: P.F.C Card

No. Part Number Description


1 AS19554 PFC card
2 AS26691 5 x Screws

Dismantling the P.F.C card:


1 Dismantle the all connectors from the card.
2 Loosen and release the 5 screws.
3 Remove the card carefully.

Reassembling the P.F.C card:


1 Mount the card in position.
2 Secure the card with the 5 screws to the system.
3 Reconnect all connectors.

6-8 DC23071
Dismantling the System

Dismantling the AC Filter Card

Figure 6-7: AC Filter Card

No. Part Number Description


1 AS26361 AC Filter Card
2 AS26691 4 x Screws

Dismantling the AC Filter Card:


1 Loosen and remove the all connectors from the card.
2 Loosen and remove all 4 screws.
3 Remove the card carefully.

Reassembling the AC Filter card:


1 Mount the card in position.
2 Secure the card with the 4 screws to the system.
3 Reconnect all connectors.

DC23071 6-9
Dismantling the System

Dismantling the 12V – 8.3V Power supply Card

Figure 6-8: 12V-8.3V Power supply card

No. Part Number Description


1 AS24072 12V-8.3V Power supply card
2 AS26691 6x Screws

Dismentling the 12V-8.3V Power supply card:


1 Remove all connectors from card.
2 Loosen and remove the 6 screws from the card.
3 Remove the card carefully.

Reassembling the 12V-8.3V Power supply card:


1 Mount the card in position.
2 Secure the card with the 6 screws to the system.
3 Reconnect all connectors.

6-10 DC23071
Dismantling the System

Dismantling the RF Generator Card

Figure 6-9: RF Generator card

No. Part Number Description


1 AS20732 RF Generator card
2 SC26691 6x Screws

Dismantling the RF Generator card:


1 Dismantle all connectors from the card.
2 Loosen and release the 6 screws attaching the card to the system.
3 Remove the card by drawing it towards you carefully.

Assembling the RF Generator cadr:


1 Mount the card in position.
2 Secure the card with the 6 screws to the system.
3 Reconnect all connectors.

DC23071 6-11
Dismantling the System

Dismantling the Laser Power Supply Card

Figure 6-10: Laser Power Supply card

No. Part Number Description


1 AS20753 Laser Power Supply card
2 SC26691 6 x Screws

Dismantling the Laser Power Supply card:


1 Remove the 3 connectors from the card.
2 Unscrew the 2 wires connected to the LaserAnode, LaserCathode terminals.
3 Loosen and release the 6 screws attaching this card to the system, and carefully
remove the card.

Assembling the Laser Power Supply cadr:


1 Reassembling the Laser Power Supply:
2 Remount the card back in place and secure it with the 6 screws.
3 Screw back the White wire to the LaserAnode terminal and the Black wire to
the LaserCathode terminal.
4 Reconnect all connectors back to the card.

6-12 DC23071
Dismantling the System

Dismantling the CPU card

Figure 6-11: CPU card

No. Part Number Description


1 AS26651 CPU card
2 SC26691 4 x Screws

Dismantling the CPU card, you need to remove the top system panel.
1 Release the 2 screws located on the memory plug and remove it.
2 Dismantle all the connectors attached to the CPU card.
3 Loosen and release the 4 screws, and carefully remove the CPU card.

Reassembling the CPU card:


1 Mount the card in position.
2 Secure the card with the 6 screws to the system.
3 Reconnect all connectors.

After installing a new CPU card, you need to activate the system and perform RF Calibration

DC23071 6-13
Troubleshooting

7. Troubleshooting
If you encounter an Error message, turn off the machine and wait 30 seconds before restarting
it. If the Error message reappears, call the nearest Syneron service center. Record the contents
of the Error message for the service technician.
Several of the system faults do not require company service and you can fix them yourself,
by following the procedures in the Maintenance chapter. The following system diagram will
help you to locate the fault.

C o m e t S y s te m
A p p lic a to r

42V R .F G e n e ra to r RF
A C L in e P o w e r F a c to r R esonant Pow er E le c tro d e
4 0 0 V /1 6 0 0 W
F ilte r M o d u le C o rre c tio n S u p p ly
AS20731
AS2636x
AS19551 A S2074B

L a s e r D io d e

Laser Pow er
42V
M a in E m e rg e n cy S u p p ly
S w itc h S to p
AS2075C

C o n tro l & S ta tu s
TE K
8 .3 V
42V D C /D C 1 2 V -8 .3 V

AS24071

W a te r
Pump
D is p la y
T e m p e ra tu re se n so r

12V

P o w e r M e te r
CPU 8 .3 V

AS1430x

AS2371x

12V Fans

K eyP ad

Figure 7-1: System Block Diagram

No Display

If there is no display showing:


• Check the power cable. Make sure that the Plug cable is inserted into both the wall
socket and the System inlet.
• Adjust contrast potentiometer on CPU card or, Replace LCD or, LCD addaptor or,
CPU card.

DC23071 7-1
Troubleshooting

SW Memory Fault ChkSum = [XXXX] h

If the SW Memory fault ChkSum = [XXXX] h message appears:


• Verify that the memory plug is tight. Turn the System on.
• If massage reappears replace Memory plug or CPU card.

Fan Fault

If the Fan Fault message appears:


• Verify that the fan is not blocked by an external object. If the fan is blocked,
remove the object.
• Make sure fan is rotating.
• Check wiring and connectors or, Replace CPU card or, Fan Rework assy.

Applicator Connection Fault

If the Applicator Connection Fault message appears:


• Check Temp using Maintenance plug if “xx” Dallas needs to be replaced or
Thermal Switch or, CPU card.
• Check main Molex interface connector or, wiring.

Laser Applicator Mem Read Fault

If the Laser Applicator Mem Read Fault message appears:


• Replace applicator or, CPU card.

Laser Applicator Mem Write Fault

If the Laser Applicator Mem Write Fault message appears:


• Replace applicator or, CPU card.

Laser Applicator Temp Sensor Fault

If the Laser Applicator Temp Sensor Fault message appears:


• Replace applicator or, CPU card.

7-2 DC23071
Troubleshooting

Laser Applicator Over Heating

If the Laser Applicator Over Heating message appears:


• Make sure pump is working and Check water flow or, Check TEC cooling with
Maintenance software plug.

Wrong Applicator Type Fault

If the Wrong Applicator Type Fault message appears:


• Check NV RAM for ubnormal parameters and correct it using Maintenance
software plug.

System Setup Needed

If the System Setup Needed message appears:


• If massage reappears, Check NV RAM for ubnormal parameters and correct it
using Maintenance software plug.

Laser Applicator Setup Needed

If the Laser Applicator Setup needed message appears:


• If massage reappears, Check NV RAM for ubnormal parameters and correct it
using Maintenance software plug..

RF Energy Card Fault [XXX]

If the RF Energy Card Fault [XXX] message appears:


• Check fuse on RF card.
• If Fuse is OK replace RF card.
• If message reapears check wiring.

Laser Fault

If the Laser Fault message appears:


• Replace applicator or, Laser P.S or, CPU card.

DC23071 7-3
Troubleshooting

Laser Over Current

If the Laser Over Current message appears:


• Replace applicator or, Laser P.S or check wiring.

Bad Coupling

If the Bad Coupling message appears:


• Check RF fuse that it is not burnt.
• Check RF signal.
• Check RF calibration of “V” in the air and with load.

7-4 DC23071
Specifications

8. Specifications
Environment

• Operating 20º - 25ºC [68º-77ºF]; Relative Humidity of less than


80%.
• Storage - Water full 2° - 55°C [35° - 131°F]; Relative Humidity 80%
System

• Storage - Water empty -20° - 55°C [-4° - 131°F]; Relative Humidity 80%
System
Input Voltage (Factory setup)

• Single phase 90-254 Vac; 15A; 50-60Hz.

Output Parameters

• RF energy 10 – 50 [J/cm3]

• Laser energy 10 - 50 [J/cm2]

• Light spectrum 780- 980nm

• Cooling temperature 5°C

• Treated area 15mmx10mm


Dimensions

• System 36 cm W x 38 cm D x 97 cm H [14.2`` W x 15`` D x 38.2`` H]

• Applicator 170 cm L [67`` L]


cable
Weight

• System 30 Kg [66 lbs.]

• Applicator 3 Kg [6.6 lbs.]

DC23071 8-1
Specifications

Appendix A: System
Installation Report
The following report is filled out every time the Comet system is installed, and sent to the
nearest Syneron Medical Ltd service center.

DC23071 A-i
System Installation Report

Clinic: :

Name: :

Address: :

Zip Code:

Site Tel. : :

Site Fax. : :

Contact Person:

Installation Date:

Comet S/N:

SR DS WR LV AC

Applicator Type S/N:

Software Memory Plug S.N. & Version:

Special Requirements:

Remarks:

Installed By: Signature:

System Installation Report Page ___ of ___


Appendix B: Non-Conformance
Report
Notify Syneron Medical Ltd. within 24 hours as to any problems related to the safety of the
user or patients following the use of this system.
Document each system fault in the Non-Conformance Report form (on the next page), and
send this to the manufacturer. Syneron also welcomes feedback regarding possible ways to
improve the system, user and patient complications during the treatment, maintenance or
storage of the system.

DC23071 B-i
Safety Related Problems Yes No
Source Non Conformance Report No:____________
1 Customer Complaint From Supplier
2 Internal Audit

3 Management Review Opening Date:


4 Internal Non-Conformance Item/Assembly
Part number Serial
5 Corrective Action
number
6 Preventive Action
7 Other Description
Description:
------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------

Cause:
------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------

Repair Action:
----------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------

Decision: UAI Repair Rework RTV Scrap


Performed By: _______________ Date: _____________ Signature:______________
Product meets all regulatory requirements after the tests.
Corrective/Preventive Action:
------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------
Performed By: _______________ Date: _________________

Verifying Corrective Action


Approved By: ________________ Date: _________________
According to: _____________________________________________

Form No. 1311, Rev. 02

Non-Cnformance Reportt Page ___ of ___


Appendix C: Glossary
DS Applicator for Hair Removal
Treatment
Interlock Interlock Remote Control
ISL Impedance Safety Limit User defined
ISM Impedance Safety Measurement
LACF Laser energy Calibration Factor
LCD Liquid Crystal Display
POT Variable Resistor
TCF Temperature Calibration Factor Sets the temperature of the RF
Laser/Lamp electrode.
TEC Thermo Electric Cooler Cooling mechanism
Laser/Lamp

DC23071 C-i

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