DO606737A Rev B InMode System Service Manual
DO606737A Rev B InMode System Service Manual
Optimas (AG606991A)
Triton (AG606992A)
DO606737A, Rev. B 2
InMode™ Service Manual Table of Contents
TABLE OF CONTENTS
1. Introduction ................................................................................................................................. 1-1
Before You Start ............................................................................................................................... 1-1
System Overview .............................................................................................................................. 1-1
Conventions Used in this Manual..................................................................................................... 1-1
Explanation of the Symbols Used in the System and Accessories ................................................... 1-2
2. Safety and Regulatory .................................................................................................................. 2-1
The Patient ....................................................................................................................................... 2-1
Treating Attendant ........................................................................................................................... 2-1
Cautions ............................................................................................................................................ 2-2
Ocular Hazards ................................................................................................................................. 2-2
Ocular Safety Considerations ........................................................................................................... 2-3
Electrical and Mechanical Safety ...................................................................................................... 2-3
Fire Hazards ...................................................................................................................................... 2-4
Safety Features of the System .......................................................................................................... 2-4
Safe Use of the Active Accessories ................................................................................................... 2-5
Device Labels .................................................................................................................................... 2-7
Handpiece Labels.............................................................................................................................. 2-9
Equipment Classification ................................................................................................................ 2-12
System Specifications ..................................................................................................................... 2-13
Output Power Curves ................................................................................................................. 2-16
EMC Safety Compliance ................................................................................................................. 2-19
3. System Description ...................................................................................................................... 3-1
Front Panel and Operator Control Panel .......................................................................................... 3-1
Rear Panel......................................................................................................................................... 3-2
Service Cabinet ................................................................................................................................. 3-4
Graphic User Interface Screens ........................................................................................................ 3-5
System and Handpiece Information Available on User Interface Screens ..................................... 3-18
Diolaze Handpieces Information................................................................................................ 3-19
Lumecca Handpieces Information ............................................................................................. 3-20
BodyFX/MiniFX Handpiece Information .................................................................................... 3-21
Forma & Plus Handpiece Information ....................................................................................... 3-22
FormaV Handpiece Information ................................................................................................ 3-23
Vasculaze System Information ................................................................................................... 3-24
Fractora System Information ..................................................................................................... 3-25
Morpheus8 System Information ................................................................................................ 3-26
Sound Indicator .............................................................................................................................. 3-27
Cut-Off Temperature Control ......................................................................................................... 3-27
Cooling System ............................................................................................................................... 3-27
Handpieces ..................................................................................................................................... 3-28
Diolaze XL ................................................................................................................................... 3-28
Vasculaze ................................................................................................................................... 3-29
Lumecca 515 and 580 ................................................................................................................ 3-30
DO606737A, Rev. B 3
InMode™ Service Manual Table of Contents
DO606737A, Rev. B 4
InMode™ Service Manual Table of Contents
LIST OF FIGURES
Figure 2-1: System Certification and Identification Label ......................................................................... 2-7
Figure 2-2: Laser Emission Warning Label ................................................................................................ 2-7
Figure 2-3: Laser Interlock Label ............................................................................................................... 2-8
Figure 2-4: IPL Warning Label ................................................................................................................... 2-8
Figure 2-5: IPL Emission Warning Label .................................................................................................... 2-8
Figure 2-6: Emergency Stop Label on the Emergency Red Button ........................................................... 2-9
Figure 2-7: Footswitch Connection Port Label .......................................................................................... 2-9
Figure 2-8: Handpieces Identification Labels .......................................................................................... 2-10
Figure 2-9: Diolaze XL Handpieces Connector Labels ............................................................................. 2-11
Figure 2-10: Vasculaze Handpiece Connector Labels ............................................................................. 2-11
Figure 2-11: Diolaze XL and Vasculaze Handpiece Label for Laser Aperture ............................. 2-11
Figure 2-12: Lumecca Handpiece Label for IPL Aperture ................................................................ 2-11
Figure 2-13: Fractora 60-Pin Output Power Versus Impedance ............................................................. 2-16
Figure 2-14: Fractora 24-Pin Output Power Versus Impedance ............................................................. 2-16
Figure 2-15: Forma Output Power Versus Impedance ........................................................................... 2-17
Figure 2-16: Plus Output Power Versus Impedance ............................................................................... 2-17
Figure 2-17: BodyFX Output Power Versus Impedance .......................................................................... 2-18
Figure 2-18: MiniFX Output Power Versus Impedance........................................................................... 2-18
Figure 2-19: Morpheus8 Output Power Versus Impedance ................................................................... 2-18
Figure 3-1: Front Panel Components and Connections ............................................................................ 3-1
Figure 3-2: Rear Panel Connections .......................................................................................................... 3-3
Figure 3-3: Service Cabinet ....................................................................................................................... 3-4
Figure 3-4: Splash Screen .......................................................................................................................... 3-5
Figure 3-5: Login Screen ............................................................................................................................ 3-5
DO606737A, Rev. B 5
InMode™ Service Manual Table of Contents
DO606737A, Rev. B 6
InMode™ Service Manual Table of Contents
DO606737A, Rev. B 7
InMode™ Service Manual Table of Contents
DO606737A, Rev. B 8
InMode™ Service Manual Before You Start
1. INTRODUCTION
Before You Start
Pay special attention to the Clinical Guides to become familiar with all clinical
aspects and operating procedures of the handpieces you will be using, before
connecting them and attempting to operate the system.
The manual and the equipment it describes are for use only by qualified medical
professionals trained in the particular technique to be performed.
Federal (USA) law restricts sale of this device to, or on the order of a physician.
System Overview
The InMode system is employs three different technologies for various aesthetic
applications – Intense Pulsed Light (IPL) and Radiofrequency (RF). The system
operates while in contact with any of the following handpieces: Lumecca IPL for
skin rejuvenation, Diolaze for hair removal, Fractora RF for fractional
resurfacing, Forma/Plus RF for facial and body wrinkle treatment and
BodyFX/MiniFX RF for body contouring, fat and cellulite treatment.
The system provides individual adjustment of treatment parameters to achieve
maximum efficiency and safety for each patient.
The system provides enhanced safety while minimizing possible side effects by
monitoring RF parameters.
Caution
A Caution alerts the user to the possibility of a potentially hazardous
situation which, if not avoided, may result in damage to the
equipment.
Warning
A Warning alerts the user to the possibility of serious injury, death,
or serious adverse reactions associated with the use or misuse of
the system.
Symbol Description
Caution!
CE Compliance Symbol
Fuse
Type B Equipment
Type BF Equipment
Date of Manufacture
Catalog Number
Serial Number
Footswitch Connection
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 Section.
Warning
● Read this chapter to be familiar with all its safety requirements
and operating procedures prior to system operation.
● The IPL or RF 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 the manual.
The Patient
Well-trained staff is a key for assuring patient safety. 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.
Jewelry and metal accessories that are within the activation range of the
handpiece should be removed to avoid accidental light reflection or RF
conduction, as applicable.
Protective eyewear must be used by patient during Lumecca IPL and Diolaze
laser treatments.
Treating Attendant
Only authorized individuals with appropriate training and knowledge should
operate, assist in the operation of, or provide maintenance to the InMode
system.
Personnel should not operate the system until they have been fully educated in
its use. Make sure that all treatment personnel are familiar with the system
controls and know how to shut down the system instantly.
There are no user-serviceable parts in the system, and all service and repair
must be performed only by the factory or authorized field service technicians.
Protective goggles must be used by all treatment attendants when using the
Lumecca IPL and Diolaze laser handpieces.
Cautions
The following safety cautions should be heeded:
● Service is supplied by company-authorized personnel only.
● To avoid damage, do not allow the handpieces to come in contact with hard
materials.
Ocular Hazards
The light emitted by the Diolaze laser Handpiece is capable of causing serious
eye damage or blindness. The light emitted by the Lumecca IPL Handpiece is
capable of causing eye irritation or damage.
The laser and the IPL are to be operated only in an enclosed room with
protective eyewear for all persons; direct eye exposure is not safe at any
distance within the room. All windows in the laser room must be covered with
opaque material, and measures should be taken to prevent unauthorized access
to the room. For the laser, remote interlock is provided, which can be connected
to the treatment room doors, disabling laser output if the door is opened during
a procedure. In addition, compliance with ANSI Z1 36.3 and EN 60825-l requires
that laser safety signs be posted at all entrances whenever the laser is in use.
Compliance with IEC 60601-2-57 requires that warning label from IR exposure
be posted at all entrances whenever the IPL is in use. Approved sign is provided
with each system along with protective eyewear. Additional eyewear or safety
signs may be obtained from the manufacturer.
Never look directly into the laser aperture at the distal end of the Handpiece,
even if you are wearing safety glasses. Serious eye injury or blindness could
result.
Avoid directing the laser beam anywhere other than the calibration port or
intended treatment area. Stray laser light and reflection is always a potential
hazard and may cause serious injury.
Do not treat eyebrows, eyelashes, or other areas within the bony area
surrounding the orbit. The light emitted by the laser or the IPL is capable of
causing serious eye damage or blindness. For maximum safety, metal eye
goggles must be worn by the patient for all facial treatments when laser is used.
Fire Hazards
● The absorption of diode IPL energy raises the temperature of the absorbing
material. Do not use the system in the presence of explosive or flammable
materials.
● Materials conducting RF energy cause temperature rise of the absorbing
material. Do not use the system in the presence of explosive or flammable
materials conductive to RF.
● 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. Be
especially careful with the use of oxygen.
● If alcohol is used for cleaning and disinfecting, it must be allowed to dry
thoroughly before the system is used.
Caution
● Do not connect a wet accessory to the system.
● Do not immerse the handpiece under water at any time.
Warning
● This equipment is for use only by trained, licensed physicians.
● Only handpieces manufactured or approved by InMode Ltd.
should be used with InMode system.
● Connect the power cable to a properly polarized and grounded
power source with the frequency and voltage characteristics that
match those listed on the back of the unit.
● Connect the system power cord to a properly grounded
receptacle. Do not use power plug adapters.
● Always turn OFF and unplug the device before cleaning.
● The patient and treatment attendants must use protective
eyewear during the use of the IPL.
● The patient should not come into contact with metal parts which
are earthed, or which have an appreciable capacitance to earth.
The use of antistatic sheeting is recommended for this purpose
Treatment bed or chair should not be electric!
● Use the lowest output setting necessary to achieve the desired
treatment effect. The higher optical or RF energy is applied, the
greater the possibility of unintended thermal damage of skin.
Warning
● Failure of the equipment could result in an unintended increase
of output power.
● The cables of the handpieces should be positioned in such a way
that contact with the patient or other leads is avoided.
● Fire/Explosion Hazard - The following substances will contribute
to increased fire and explosion hazards in the operating room:
Flammable substances (such as alcohol-based skin prepping
agents and tinctures).
Oxygen enriched atmospheres.
Oxidizing agents (such as nitrous oxide [N2O] atmospheres).
Endogenous gases.
● The optical or RF energy and heating associated with the system
can provide an ignition source. Observe fire precautions at all
times. When using InMode in the same room with any of these
substances or gases, prevent their accumulation or pooling
within the area where InMode procedures are performed.
● The operation of the InMode may adversely influence the
operation of other electronic equipment.
● To avoid the RISK of electric shock, this equipment must only be
connected to a supply mains with protective earth.
Device Labels
As required by national and international regulatory agencies, appropriate
Warning and information labels have been attached in specific locations on the
instrument as identified below.
The following device labels are located on the InMode device console:
Handpiece Labels
The handpieces certification and identification labels are attached to connectors
on the handpieces. They state that the product conforms to the performance
standards, and indicates the manufacturer’s name, date of manufacturing,
model and serial number of the handpiece.
The following labels are located on the handpieces (see Figure 2-8):
● Optical radiation aperture label placed on handpiece connector.
● Manufacturer identification labeling placed on the handpiece connector.
inmode
Vasculaze
1064
LASER APERTURE AT DIS TAL END
Figure 2-11: Diolaze XL and Vasculaze Handpiece Label for Laser Aperture
Equipment Classification
The following is a list of the different equipment used and their classifications.
• Electric shock protection: Class I, Defibrillation-proof Type B for the
optical Handpieces – Diolaze XL, Vasculaze and Lumecca, and Type BF for
the RF Handpieces Fractora, Forma/Plus, and BodyFX/MiniFX.
• Protection against ingress of liquids: Ordinary equipment.
• Not suitable for use in presence of flammable substance.
• Power receptacle must include protective earth and must be checked
before connecting the system.
The InMode System with Diolaze XL and Vasculaze Handpieces complies with 21
CFR, Chapter L Subchapter J, as administered by the Center for Devices and
Radiological Health (CDRH) of the Food and Drug Administration (FDA). CE-
labeled devices comply with all appropriate performance standards as specified
in Annex II of the Medical Device Directive MDD 93/42/EEC. The InMode System
with Diolaze XL and Vasculaze Handpieces is classified as a Class IV laser by the
CDRH and as a Class 4 laser by the European Standard EN 60825-l.
The InMode System with IPL Handpiece is classified as IIb device defined by the
Medical Device Directive (93/42/EEC) for CE marking.
The InMode System with the Fractora, Forma, Plus, and BodyFX/MiniFX
Handpieces is classified as IIb device defined by the Medical Device Directive
(93/42/EEC) for CE marking.
System Specifications
Input Power
Operating Parameters
Dimensions
Weights
RF Power 10 – 50 W
Frequency 1 MHz
Vacuum Automatically controlled
RF Power 10 – 25 W
Frequency 1 MHz
Vacuum Automatically controlled
The curves that follow depict the changes for each RF mode at specific power
settings.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
(a)
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the InMode is used exceeds
the applicable RF compliance level above, the InMode should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such
as re-orienting or relocating the InMode.
(b)
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
3. SYSTEM DESCRIPTION
Front Panel and Operator Control Panel
The operator control panel is located on the upper side of the system. The
operator control panel consists of an LCD touch-screen.
On the front panel there is a gray ON/OFF switch on your left, a red Emergency
Stop Button on the right, and optical handpiece (Lumecca or Diolaze) connector
in the center.
The system recognizes the connected handpiece and enables opening the
relevant screen.
Rear Panel
Refer to Figure 3-2:
Service Cabinet
Refer to Figure 3-3: the service cabinet is accessible by pressing down on the
latch button of the rear grill (shown in view A) and pulling the grill out.
The rear grill is connected to the interior of the system by a grounding wire that
can be disconnected from the grill by pulling off the slip-on connector fitting.
1234
1
Master Password: if you ever lose your private password, you can always log into the system
using the Master Password – 2 2 8 1
● When the currently used activation code expires, you or the customer
may press the Activation button in the Utilities screen; the Activation
screen appears (see Figure 3-8).
● Using the virtual keypad, key in the new alphanumeric activation code
received from directly from InMode and press the ENTER button; the
system will accept the new code and display it in the screen's top bar.
After returning to the Menu screen and choosing the desired application, the
corresponding treatment screen appears.
Selection The frame selects parameters that can be changed by functional keys.
Frame
Fluence: Fluence (light energy density) is changed within the limits from 5 to
40J/cm² and the System starts up at the minimal setting.
Cooling Normal and Strong cooling, 12 and 7oC, respectively.
Pulse Width Short or Long pulse can be selected.
OFF – Single 5-40 J/cm2
Pulse Mode 1 PPS 5-40 J/cm2
2 PPS 5-25 J/cm2
Counter PPS = Pulse Per Second.
Reset The Pulse Counter can be reset.
Pulse Shows the number of pulses delivered from the beginning of the
Counter treatment.
System Mode The System has four treatment modes:
• STANDBY mode: allows the user to set treatment parameters.
Activation of energy is not allowed in STANDBY mode.
• Armed mode: when the Footswitch is pressed, before the Hand Trigger.
• READY mode: when the System is waiting for a signal from the Trigger
Switch to activate the energy. Any attempt to change the treatment
settings switches the System to STANDBY mode.
• Active mode: when the laser is pulsed by pressing the Hand Trigger.
Main Menu Return to the Main Menu to select another Handpiece and change the
Handpiece if needed.
Figure 3-10: Lumecca 580 Treatment Screen (same screen for 515)
Selection Frame The frame selects parameters that can be changed by functional keys.
Fluence Fluence (light energy density) is changed within the limits from 5 to
30 J/cm² and the System starts up at the minimal setting.
Cooling Normal and Strong cooling modes may be selected.
Pulse Width Short or Long pulse can be selected.
Pulse Mode Repeat mode in Normal or Fast repetition rate or in OFF as a single
pulse mode.
Counter Reset Counter can be reset.
Pulse Counter Shows number of pulses delivered from beginning of the
treatment.
System Mode The interfaces have three treatment modes: STANDBY, READY and
Active. STANDBY mode allows the user to set treatment parameters.
Activation of energy is not allowed in STANDBY mode.
In READY mode, the system is waiting for a signal from the trigger
switch to activate the energy. Any attempt to change the treatment
settings switches the system to STANDBY mode.
When the signal from the trigger is indicated, the system switches to
Active mode. Any attempt to change the treatment settings switches
the system to STANDBY mode.
Main Menu Return to Main Menu to select another handpiece and change the
handpiece if needed.
Figure 3-11: Lumecca HR/SR – HR (Left) and Lumecca HR/SR – SR Treatment Screens
Selection The frame selects parameters that can be changed by functional keys.
Frame
Fluence Fluence (light energy density) is changed within the limits from 5 to 30 J/cm²
for Lumecca, from 3 to 20 J/cm² for Lumecca HR, and from 5 to 20 J/cm² for
Lumecca SR, and the system defaults to the minimal setting at start-up.
Cooling Normal (22oC) and Strong cooling (15oC) can be selected for Lumecca and for
Lumecca HR/SR in SR mode. Strong cooling (5oC) is the only option when using
Lumecca HR/SR in HR mode.
Pulse Width Short (2-11 ms) or Long pulse (3-17 ms) may be selected in SR mode and Short
(3-17 ms), Medium (4-27 ms) or Long Pulse Width (triple medium pulses) may
be selected in HR mode.
Repeat mode in Normal (0.5 PPS), Fast (1 PPS) repetition rate or in OFF as a
single pulse mode in SR mode.
Repeat mode in Normal (0.5 PPS), Fast (1 PPS), Glide (5 PPS) repetition rate or
in OFF as a single pulse mode in HR mode.
Counter Reset Counter can be reset.
Pulse Counter Shows number of pulses delivered from beginning of the treatment.
Continued on next page
System Mode The interfaces have four treatment modes. STANDBY, cooling down, READY,
and active. STANDBY mode allows the user to set treatment parameters.
Activation of energy is not allowed in STANDBY mode.
In cooling down, the system cools the sapphire and its enclosure. The TEC
should be strong enough to maintain sapphire temperature at 8°C. to cool the
sapphire switches the system to STANDBY mode.
In READY mode, the system is waiting for a signal from the trigger switch to
activate the energy. Any attempt to change the treatment settings switches the
system to STANDBY mode. If the sapphire temperature is above 15°C it
switches the system to Cooling Down mode.
When the signal from the trigger is indicated, the system switches to Active
mode. Any attempt to change the treatment settings switches the system to
STANDBY mode.
24 Pin
5
Zone: 0
Single Total: 0
Selection Frame The frame selects parameters that can be changed by functional keys.
Energy Delivered energy is changed from level 20 to 40 and the system starts
up at the minimal energy setting.
Cut-Off Cut-off temperature settings are changed in the range of 35-43°C.
When measured skin surface temperature reaches the preset limit the
RF energy is cut OFF.
Pulse Mode Allows selecting between single RF pulses of 30 sec in Single mode and
continuous RF in Repeat mode, as long as the footswitch is pressed.
Counter Reset Effective time along with energy can be reset.
Temperature This indicator shows the skin surface temperature, as measured by an
Measure integral temperature sensor.
Effective Time This function shows the treatment time, starting from time-point of
2oC below the cut-off temperature.
Main Menu Return to Main Menu to select another handpiece and change the
handpiece if needed.
Selection The frame selects parameters that can be changed by the function
Frame keys.
Fluence Fluence (laser energy density) is changed within the limits from 100 to
300 J/cm², and the system starts up at the minimal setting.
Cooling Select between Strong and Normal cooling of the handpiece tip.
Pulse Mode Select between OFF (Single pulse) or 1 PPS (Pulse Per Second).
Pulse Width Short or Long pulse can be selected.
Tap the top-right corner of the screen (there is no 'button'); the information
values will appear across the top of the screen (see Figure 3-18).
Note
The information values in the following table and figure are for
illustration purposes only. These values are not necessarily correct
for any condition.
Note
The information values in the following table and figure are for
illustration purposes only. These values are not necessarily correct
for any condition.
Note
The information values in the following table and figure are for
illustration purposes only. These values are not necessarily correct
for any condition.
10.95V 0.05A 18.84O 243Ω 0.48W 2005V 1682V 25mS 49V 1000mS 6
10.0
35.0 C 23.7 C
O O
16.8mB
2.0 S
0:00:03
Note
The information values in the following table and figure are for
illustration purposes only. These values are not necessarily correct
for any condition.
Figure 3-22: System and Handpiece Information on the Forma & Plus Screen
Note
The information values in the following table and figure are for
illustration purposes only. These values are not necessarily correct
for any condition.
Note
The information values in the following table and figure are for
illustration purposes only. These values are not necessarily correct
for any condition.
Note
The information values in the following table and figure are for
illustration purposes only. These values are not necessarily correct
for any condition.
24 Pin
5
Zone: 0
Single Total: 0
Note
The information values in the following table and figure are for
illustration purposes only. These values are not necessarily correct
for any condition.
Sound Indicator
● Periodic beeping signal is emitted when optical or RF energy is delivered.
● Warning sound tone indicates inadequate coupling.
Cooling System
The light-emitting elements in the IPL handpieces are cooled by an internal
closed-loop liquid-to-air cooling system. The coolant used is distilled water, an
inert liquid that does not conduct electricity.
Water
Reservoir
Water Pump
Par cle
Filter 5µm
Heat Exchanger
Handpiece with Fan
Deionizer Filter
Flow Meter
Handpieces
Diolaze XL
Vasculaze
Lumecca HR/SR
Fractora
The Forma and Forma Plus handpieces are comprised of a handpiece, cable,
connector and an integral temperature sensor.
FormaV
BodyFX/MiniFX
The BodyFX and MiniFX handpieces are comprised of a vacuum chamber, two RF
electrodes, temperature sensor, 8-character screen, handle, cable and
connector.
Morpheus8
Note
The insulated coating of the needles leaves only 0.5mm of the
needle’s tip exposed.
4. SYSTEM INSTALLATION
Unpack the System
1. The InMode system will be delivered by commercial trucking in a shipping
box with or without banding straps around it (see Figure 4-1).
2. If the box is strapped, carefully cut the straps and the strapping tape with a
blade and open the box's top panels (see Figure 4-2).
4. Remove the accessories box (see Figure 4-4) and set it aside.
5. Remove all of the foam braces and board plates from around the system
console, except for the one under the wheels (see Figure 4-5).
Figure 4-5: Removing the System Console from the Box (1)
6. Remove the system console from the box in the following sequence (see
Figure 4-6):
● Lift the box to a standing position, as shown in view A.
● Grab the handle and roll the system console out of the box (B).
● Position the system console on the floor and remove the bottom foam
brace from under the wheels (C).
Figure 4-6: Removing the System Console from the Box (2)
7. Remove the nylon sheet wrapping from around the system console (see
Figure 4-7).
8. Remove the plastic sheet wrapping from around the touch-screen control
panel.
Note
InMode recommends that the customer save the shipping box and
packing material in case the need arises to move the system to a
different location.
Accessories Kit
The accessories kit (see Figure 4-8) contains the following equipment; compare
the content to the following list and the shipping list packed with the system. If
any component is missing or damaged report this as soon as possible to InMode
Customer Service.
4. Footswitch.
Electrical Requirements
The system is equipped with a universal power supply and requires a separate
line supply of one of the following configurations:
● 100 VAC; 15A; 50-60Hz; ZMAX = 0.03Ω; Single Phase
● 115 VAC; 15A; 50-60Hz; ZMAX = 0.03Ω; Single Phase
● 240 VAC; 15A; 50-60Hz; ZMAX = 0.03Ω; Single Phase
The system should not share a power line with other equipment.
Power receptacle must include protective earth and must be checked before
connecting the system.
Warning
● For continued protection against fire, replace the fuses only with
those 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.
1. Connect the power cable to the system's power inlet (see Figure 4-9).
Connect the other side of the cable to a hospital-grade power wall
receptacle.
Note
The power cable is not supplied with the InMode system.
3. Refer to Figure 4-10: install the four handpiece cradles by screwing the
center-pivot wheel into the threaded hole, hand-tight only, no tools.
5. Initial setup should be done with the Lumecca IPL handpiece, or with the
handpiece bypass module. Insert the handpiece's connector with the label at
a 90° counter-clockwise angle (as shown in the inset), and twist it 90° to the
right, such that the label is straight. Insert the handpiece into an appropriate
cradle.
Note
If the system is meant by the customer to be operated only with RF
handpieces, then filling the cooling system is not required.
Caution
● InMode systems and handpieces are shipped without water.
Distilled water must be used; failure to do so will void the service
warranty.
● During water filling, air bubbles can form inside the hoses which
may cause water flow issues.
2. Remove the grill from the service cabinet (see page 3-4) and pull the
reservoir out of its bracket clips.
3. Refer to Figure 4-12: unscrew the water reservoir from its cap. Pour distilled
water into it up to the top-level line, while the water filter and tube are
inside the reservoir to prevent spillage (as shown in view A).
4. Screw the reservoir back into its cap and insert the reservoir back into its
bracket clips (B).
5. Turn the system ON and press the main Start button (see Figure 4-11); the
system will initialize its software operating system (up to 30 seconds), and
will finally present the Login screen (see Figure 4-13).
166 Sec
0.86A
9. Refer to Figure 4-16: when there are about 300 seconds left of the 600
second count-down, open the air-bleed valve on top of the particle filter by
turning it counter-clockwise; the air trapped in the cooling system will
escape through the valve.
10. When the first few drops of water start to come out of the valve, close it
tight. Ensure that no water is leaking from the system.
12. Turn OFF the system and check the level of water in the water reservoir; it
the water level is below the maximum line, refill the bottle and perform
steps 4 through 8 above again.
14. The water filling process described above should now be repeated with all
the water-cooled handpieces the customer has purchased, in order to fill the
cooling path of each handpiece.
The remote interlock connection on both sides – the system's connector and the
treatment room's door – should be performed by a qualified electrician.
2. Connect the cable from the remote interlock switch (on the treatment room
door) to the system's plug and reinsert the plug into the connection port.
Footswitch Connection
To connect the footswitch, place it on the floor and plug its power cable into the
footswitch connection port located in the service panel (see Figure 4-17). Screw
the cable's threaded studs into the connection terminal securely.
Installation of the InMode system is now complete; the system may be signed-
off to the customer.
5. MODULES REPLACEMENT
Warning
WARNING! DISCONNECT POWER SUPPLY CABLE BEFORE
SERVICING TO AVOID ELECTRIC SHOCK.
For continued protection against fire, replace the surge-protection
fuses only with those of the same type and rating.
1. Remove the grill from the service cabinet (see page 3-4).
2. Remove the water reservoir from the service cabinet and disconnect it from
its cap. Pour the water into a sink.
3. Hold the reservoir bottle with the deionizer filter about half-way in the
bottle (see Figure 5-1).
5. When water stops draining, the cooling system is empty; turn OFF the
InMode system and disconnect it from the electrical supply.
1. Using a standard Phillips screwdriver loosen and remove the four (4) sets of
Phillips screws and washers from the rear side of the side panel you wish to
remove, as shown in view A.
2. The panel connected to the interior of the system by a grounding wire that
can be disconnected by pulling off the slip-on connector fitting, shown by
the arrow in view B.
3. Set the panel aside in a safe place such that it will not get scratched.
3. Disconnect the main ON/OFF switch (see Figure 5-5): swing the front panel
out part-way (view A); grab the switch's connection block and twist it 1/4
turn to the left to disconnect it from the front part of the switch (view B).
4. Set the panel aside in a safe place such that it will not get scratched.
Prior to replacing the flow meter, drain the InMode’s cooling system of all
coolant; refer to Figure 5-7:
1. The flow meter is secured to the system’s chassis, in front of the set of
capacitors, shown in the box in view A.
2. Use a Philips screwdriver to disconnect the flow (view B), and gently pull the
harness’s connector out of the flow meter’s socket.
Note
Take care not to lose the square rubber gasket at the point of
connection.
3. Release the flow meter from the chassis by cutting off the two tie-wraps,
shown by the yellow arrows in view C.
4. Disconnect the flow meter from the inlet and outlet tubes by pressing on the
quick-release rings, shown by the blue arrows in view C.
5. Unpack and install the new flow meter by reversing steps 2 – 4 above.
6. After completing the installations, refill the InMode’s cooling system with
fresh, distilled water, start the system and ensure that there are no leaks
from the top or bottom side of the flow meter.
1. Refer to Figure 5-8: to replace the harness, first disconnect it from the
flow meter (view A), and then disconnect its other side from the
controller board (view B).
1. AC Filter
2. Surge-Protection Fuse Housings
3. Water Pump
4. Power Supply Module
5. Laser Driver Board (with cooling fan)
6. RF Board
Note
The wire leads should be tagged before disconnection to avoid
confusion when reconnecting them to the new mini-IPL board.
2. Loosen and disconnect the five high voltage wire leads (shown by the arrows
numbered B, C & D) from the board.
3. Loosen and remove the four sets of Phillips screw and washer sets (shown
by the arrows in Figure 5-13) from the board.
4. Unpack and install the new Mini-IPL board by reversing steps 1 – 3 above.
2. Loosen and remove the four sets of Phillips screw and washer sets (shown
by the arrows numbered B) from the board. The screw in the top-right
corner also connects a grounding wire lead.
Note
RF calibration must be performed after board replacement.
2. Loosen and remove the four sets of Phillips screw and washer sets from the
board.
3. Unpack and install the new DC-to-DC board by reversing steps 1 – 2 above.
1. Loosen and remove the four sets of Phillips screw and washer sets shown in
area A and the two sets shown in area B that secure the double-connector
assembly to the chassis.
Note
The double-connector's wiring harness is secured to other harnesses
by means of tie-wraps. Make sure you re-secure the harness with tie-
wraps after replacement is complete.
Replacing the laser driver board assembly requires the prior removal of the
right-side exterior panel; proceed as follows (refer to Figure 5-18):
1. Disconnect the three harness connectors (shown by the arrows in view A)
from the board.
2. Loosen and remove the six wire terminals (shown by the arrows marked T in
view B) from the board.
3. Loosen and remove the four sets of Allen screw and washer sets (shown by
the arrows marked S in view B) from the board.
4. Unpack and install the new laser driver board assembly by reversing steps
1 – 3 above.
Replacing the cooling system pump requires the prior removal of the left-side
exterior panel; proceed as follows (refer to Figure 5-19):
1. Disconnect the pump's wiring harness from its mid-wire connector (A).
2. Disconnect the two water tubes by pressing in on the gray pressure rings (B).
3. Cut and remove the tie-wrap from behind the pump assembly.
4. Loosen and remove the four sets of 3 mm Allen screws and washer sets that
secure the pump assembly to the chassis from underneath the system
(shown by the arrows in Figure 5-20).
8. Wipe up any water that may have leaked on to the chassis when you
disconnected the tubes.
1. Tag to five wire leads leading to the AC filter (two on the top and three on
the bottom) to help you reconnect them properly to the new filter.
2. Remove the two slip-on wire leads from the top side of the filter (view A).
3. Remove the three slip-on wire leads from the bottom side of the filter
(view B).
4. Loosen and remove the two Philips screw & washer sets, one from the top
and one from the bottom of the filter.
3. Remove the grill from the service cabinet (see page 3-4).
4. Holding the particle filter with one hand, loosen the filter by pressing the
upper black quick connector and pulling the fitting's ring out of the water
tube (see Figure 5-23, arrows # A).
5. Repeat the above step # 4 with lower black quick connector. Discard the old
filter.
1. Hold the particle filter when the arrow on the filter body pointing upwards
(see Figure 5-23, arrow # B).
2. Push the lower system water tube into lower filter’s quick black connector as
far as possible.
3. Push the upper system water tube into upper filter’s quick black connector
as much as possible.
4. Remove the water bottle from the compartment, pour out the distilled
water from the bottle and wash it with new fresh water.
5. Refill the water from the system (see page 6-6).
3. Refer to Figure 5-26: disconnect the following harnesses from the control
panel:
A. Ground wire lead
B. Adapter board*
C. Touch-screen controller
D. LCD data
(*) Note
The adapter board connector (B) is attached to the rear of the control
panel with double-sided adhesive tape, which may not be serviceable
after removal of the connector; if necessary, replace with new tape.
6. MAINTENANCE
This chapter describes the routine maintenance procedures that users may
perform:
● Cleaning the InMode system and handpieces.
● Replacing the cooling water
Warning
WARNING! DISCONNECT POWER SUPPLY CABLE BEFORE
SERVICING TO AVOID ELECTRIC SHOCK.
For continued protection against fire, replace the surge-protection
fuses only with those of the same type and rating.
Note
● For optimal system performance, clean the handpiece tips using
an alcohol-free cleaner and non-abrasive cloth.
● For optimal system performance, preventative maintenance is
recommended.
Wipe the entire handpiece, especially the tip (light guide and electrode rails)
with alcohol/chloride/acetone-free disinfectant after each treatment session.
Caution
Failure to replace your filters can lead to serious malfunctions of the
IPL, Vasculaze and Diolaze XL handpieces.
2
If you have purchased an extended service warranty you are covered for a Water Filter Kit. If
you are not covered in your service warranty, contact InMode Service Department to order.
Maintenance
Cleaning Method
• Remove the rear cover door and wash it under tap water until the filter net
is clean. Air pressure (if available) can be used carefully.
Caution
Never install a dust filter that is not completely dry!
Caution
For safety and proper system performance, replace the cooling
water with fresh distilled water only.
InMode systems and handpieces are shipped without water. Distilled
water must be used and failure to do so will void the service
warranty.
During water filling air bubbles can form inside the hoses which may
cause water flow issues. These instructions will assist in preventing
this from occurring.
1. Remove the grill from the service cabinet (see page 3-4).
2. Unscrew the water reservoir from its cap and discard the water in the
reservoir. Re-screw the reservoir onto its cap.
3. Press the main Start button; the system will initialize its software operating
system (up to 30 seconds) and will finally present the Login screen (see
Figure 6-2).
5. Enter the factory-default password (1 2 3 4); the software is loaded from the
plug and a self-test of the system modules is performed. After the end of the
self-test, the Menu screen appears (see Figure 6-3).
7. Press the ▼ icon on the DRAIN/Fill WATER option bar; the cooling pump
will start and force all the water from the system's tubing and connected
handpiece into the empty reservoir.
9. If you have more handpieces filled with water, connect them in turn to the
system and repeat the above procedure to drain them.
Note
If the system is meant by the customer to be operated only with RF
handpieces, then filling the cooling system is not required.
Caution
● InMode systems and handpieces are shipped without water.
Distilled water must be used; failure to do so will void the service
warranty.
● During water filling, air bubbles can form inside the hoses which
may cause water flow issues.
2. Remove the grill from the service cabinet (see page 3-4) and pull the
reservoir out of its bracket clips.
3. Refer to Figure 4-12: unscrew the water reservoir from its cap. Pour distilled
water into it up to the top-level line, while the water filter and tube are
inside the reservoir to prevent spillage (as shown in view A).
4. Screw the reservoir back into its cap and insert the reservoir back into its
bracket clips (B).
5. Turn the system ON and press the main Start button (see Figure 4-11); the
system will initialize its software operating system (up to 30 seconds), and
will finally present the Login screen (see Figure 4-13).
9. Refer to Figure 4-16: when there are about 300 seconds left of the 600
second count-down, open the air-bleed valve on top of the particle filter by
turning it counter-clockwise; the air trapped in the cooling system will
escape through the valve.
10. When the first few drops of water start to come out of the valve, close it
tight. Ensure that no water is leaking from the system.
12. Turn OFF the system and check the level of water in the water reservoir; it
the water level is below the maximum line, refill the bottle and perform
steps
4 through 8 above again.
14. The water filling process described above should now be repeated with all
the water-cooled handpieces the customer has purchased, in order to fill the
cooling path of each handpiece.
The Diolaze XL, Vasculaze and Lumecca handpieces may be damaged in cold
(freezing) temperatures that occur during
transportation or the local storage
environment. In cold climates, especially
during the winter, systems and handpieces
may be damaged during transportation or
storage when exposed to freezing
temperature.
1. Hold the water draining tool's connector and insert the handpiece's
connector with the label at a 90° counter-clockwise angle (as shown in
Figure 6-11), and twist it 90° to the right, such that the label is straight.
2. Hold the handpiece and draining tool over a sink and start pumping air
through the handpiece until no more water drains out.
Caution
● When manually draining the handpiece, use only the water
draining tool supplied by InMode [P/N # TL605952(x)].
● Damage caused to the system or handpieces by frozen water will
not be covered under the system's warranty.
RF Calibration
RF calibration of the InMode system requires the following tools (see Figure
6-12):
● RF calibration software plug (All RF ATP, ver. 1.20-2 or higher).
● Load resistor jig (200Ω, P/N # AT606086A).
● 100 MHz floating oscilloscope.
2. Remove the User software plug from the system and connect the RF
calibration software plug (InMode ATP).
3. Connect the load resistor jig to the system's upper RF connection port.
4. Connect both probes of the oscilloscope to the load resistor jig and ensure
that all 200Ω are seen on the scope (see Figure 6-14).
Scope settings:
A channel V/div – 50v/div
Set trigger to Channel A
Set trigger type to positive edge, Normal
Set trigger level to 20V
Set time division to 1 µs.
5. Turn the system ON and wait until the Keypad Test screen is shown (see
Figure 6-15).
7. Press the Scroll button; the Footswitch, Handpiece and Fan Test screen
appears (see Figure 6-16).
9. Follow the on-screen instructions and press the footswitch three times in
succession to test it; a successful test will transition the display on to the
next test screen.
10. The Speaker and Screen Test screen (see Figure 6-17) offers two options:
● Press the Speaker icon; if the system emits a tone you may adjust the
volume by pressing the button again repeatedly until you are satisfied.
● Observe the color bars; if they appear as they do in Figure 6-17 the
system's display screen is functioning normally.
11. Press the button to transition to the RF Calibration screen; on this screen
you will calibrate the RF V1rms, I1rms, V2rms and I2rms levels and insert them in
the system:
16. Press the footswitch again and release; the automated phase of RF
calibration begins. Upon successful completion (~2 minutes) the system will
display a confirmation pop-up to save the new calibration tables; press the
Down button to Save or the Scroll button to cancel. Observe the average
error percentage value and record it in the test form.
18. Use the Up button to raise the Setup Power value to 40.0W; press the
footswitch once and observe the Avg. Error value for the test form. Release
the footswitch now.
19. Use the Up button to raise the Setup Power value to 75.0W; press the
footswitch once and observe the Avg. Error value for the test form. Release
the footswitch now.
20. Turn OFF the InMode system; the RF calibration is now complete; make a
copy of the RF Calibration Test Form on the next page and fill in all the
necessary data from the system you have just tested.
Actual
Test # Test Description Expected Results Comments
Results
1 Visual Inspection
2 Keypad Test Pass/Fail
Fan: Pass/Fail
Hand-Piece:
3 Footswitch test
Pass/Fail
Footswitch: Pass/Fail
RF Test:
Set to: 15 W Setup energy +/-15%
6
Set to: 40 W Setup energy +/-10%
Set to: 75 W Setup energy +/-10%
Comments:
Tester:
Date:
Signature:
Note
Before using the Ophir power meter, ensure that both the Nova meter
and the sensor are calibrated and validated.
3. Set up the external power meter and the thermopile jig as shown in view A
of Figure 6-23 below. Adjust the external power meter's test mode to Joules.
1. Turn ON the system (User software plug) and select the desired handpiece’s
portal from the Menu screen (see Figure 3-6); the relevant handpiece
screen will appear (a sample Lumecca screen is shown in Figure 6-24).
Ensure that cooling is set to Strong.
2. Tap the top-right corner of the screen (there is no 'button'); the information
values will appear across the top of the screen.
4. Check and ensure that the displayed temperature drops by 5°C within the
time frame relevant to the specific handpiece type.
5. Make a copy of the form and fill in all the necessary data from the handpiece
you have just tested.
Comments:
Tester:
Date:
Signature:
3
Circle the applicable wavelength
Comments:
Tester:
Date:
Signature:
4
Circle the applicable wavelength
Comments:
Tester:
Date:
Signature:
7. TROUBLESHOOTING
The InMode system is equipped with a self-testing software routine that
continuously monitors system operation. If a system malfunction is detected, an
error message will appear on the LCD screen.
The following troubleshooting tables do not attempt to list all possible system
failures. Any fault not listed should be referred to the InMode Service Center.
Table 7-1 through Table 7-6 provide lists of error messages or symptoms that
may appear on the LCD screen or affect the system, their possible causes and
corrective actions to be performed. If the corrective actions listed in the table do
not solve the problem, contact the InMode Service Center.
The order in which the corrective actions appear is indicative of their relative
probability of solving the problem. Therefore, the probable causes should be
checked, and the actions should be performed, in the order in which they
appear.
Table 7-7 lists some probable system malfunctions for which no messages are
displayed. If the corrective actions listed in the table do not solve the problem,
contact the InMode Service Center.
The following pages contain tables describing the part, followed by the
illustration that displays the part.
● The Item # column of the table indicates the item number as shown in
the appropriate illustration.
● 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
can be ordered.
P3 TF1 J2 J18 J8 J7
Interlock
RF J
RF J17
P Connector
2
Connector
1
Controller card
RF Card
Speaker J5 J12 J3/J10 J6
Footswitch
P2
P3 P1
CAP+ Vlam p
+
+
-
CAP-
Main Connector
IPL Card Capacitors
Bank
Laser Driver
+48V GND
48V PS - INT
+
- +
+
Fan -
P?
1
2
3
4
R
5
R
6
R F+
7
R F-
1
2
P? R
2.5V ref
17
16
8
TH2-A
TH2-B
Speaker R
V TR
RF+
9
RF-
J?
10
Me yP J17 R
11
1
2
Speaker R
12
13
1
9
2
10
3
11
4
12
5
13
6
14
7
15
8
P? P? RxC
14
BodyT BodyFX 1
2
1
2
J18
1 2
RxC
15
16
3 3 3 4 17
4 4 5 6 18
5 5 7 8 19
-
6 6 9 10 20
B X B 11 12
X Header 20
13 14
P? 15 16
P? P?
17 18
T EC+
1 1 19 20 1
T EC-
2 2 2
LCD EN 3.3V
3
T EC TEC PWM 3.3V
4
5
Header 5
J11 P 11 P?
RST
1 1 RS T Int 1
2 2 2
SCL
3 3 3
S DA
4 4 4
Int S CL
5 5 5
SDA
6 6 6
7
T h T h
ID card
1
2
1
2
3
4
1
2
3
4
8
7
6
5
4
3
2
1
1
2
3
4
1
2
3
4
1
2
3
4
F h
C C
J9 J7 J1 J8 J3 J10 J6
P r IN P F Laser DRV
P9 P7 P1 P8 P3 P6
P r IN P F Laser DRV C
F h
1
2
1
2
3
4
1
2
3
4
8
7
6
5
4
3
2
1
1
2
3
4
1
2
3
4
LD_PU LSE_G ND
Comm GN D
LD_PU LSE
LD E N
+48V
GND
GND
GND
+485
Flow
Vdd
Vdd
-485
0V
P? P? P4 P?
- RF-
3 3 1 1
RF+
2 2 2 2
C
1 1
B X B X
Header 3Header 3 P3 P?
T A
1 1
T B
2 2
P? P? RF-
3 3
- VTR
3 3 4 4
2. ef
2 2 5 5
C RF+
1 1 6 6
Header 3Header 3 B B
P? P3
C CAP + CAP +
1 1
2 2
- VL amp
+48V
G ND
3 3
C
4 4
P? P?
5 5
-
6 6 1 1
2 2
T h T h ISO
3 3
Trig
LD_PU LSE_G N D
4 4
Header 4 Header 4
LD_PU LSE
In lock C
P?
1
J3
1 CAP+
2 2
1
2
3
3 3
P? PJP e
4 4
P? PJP e L aser EN P C
5 5
L aser EN P
6 6
1
2
3
-
7 7
L AS Master E N
8 8
9 9
P? P? L D EN
10 10
-
LD_PU LS E_G ND
3 3 11 11
2 2 12 12
+ 48V
G ND
1 1
LD_PU LS E
Header 12
Header 12
Comm GN D
JPc JPc P? J2
1
2
3
4
1 1
3.3V
+485
-485
2 2
P?
3 3
P?
4 4
5 5
1
6 6
1
2
3
4
7 7
2
8 8
9 9
Ca 1
10 10
P? P? Ca 2 Header 10
Header 10
1 1
2 2
Cathode1
Cathode2
Anode1
Anode2
T EC+ IS O
T EC- Trig
VLamp