InMode MD InMode LUMECCA 515 User manual

Operator Manual
InMode™ System
with LUMECCA™ 515 & 580
Handpiece
DO6022531B

InMode LUMECCA Operator Manual 0344 2

InMode LUMECCA Operator Manual 0344 3
InMode™ System with LUMECCA™ 515 & 580 Handpieces
Operator Manual
DO6022531B
Copyright © InMODE MD Ltd,
Date: July 2012
All rights reserved. Contents of this publication may not be reproduced in any form
without the written permission of InMode MD Ltd.
M InMODE MD Ltd
Tabor House, Industrial Park South
POB 44, Yokneam 2069201, Israel
For information call: [phone]

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Table of Contents
SECTION 1 - INTRODUCTION ................................................................................................................. 6
B EFORE Y OU S TART ................................................................................................................................... 6
S YSTEM O VERVIEW .................................................................................................................................... 6
C ONVENTIONS U SED IN THE M ANUAL ........................................................................................................ 6
E XPLANATION OF THE S YMBOLS USED ON THE S YSTEM ............................................................................. 7
SECTION 2 - SAFETY ................................................................................................................................. 8
T HE P ATIENT .............................................................................................................................................. 8
T REATING A TTENDANT .............................................................................................................................. 8
C AUTIONS ................................................................................................................................................... 9
O CULAR HAZARDS ...................................................................................................................................... 9
O CULAR SAFETY CONSIDERATIONS ............................................................................................................ 9
E LECTRICAL AND M ECHANICAL S AFETY ...................................................................................................10
F IRE H AZARDS ..........................................................................................................................................10
S AFETY F EATURES OF THE S YSTEM ...........................................................................................................10
A CTIVE ACCESSORY ..................................................................................................................................11
W ARNINGS ................................................................................................................................................12
D EVICE L ABELS .........................................................................................................................................13
H AND PIECES LABELS ................................................................................................................................15
E QUIPMENT C LASSIFICATION ....................................................................................................................16
SECTION 3 - SYSTEM INSTALLATION............................................................................................... 17
E LECTRICAL R EQUIREMENTS ....................................................................................................................17
E NVIRONMENTAL R EQUIREMENTS ............................................................................................................17
E QUIPMENT L IST .......................................................................................................................................17
U NPACKING ...............................................................................................................................................18
I NSTALLATION ...........................................................................................................................................19
F ILLING W ATER ........................................................................................................................................19
M OVING THE S YSTEM ................................................................................................................................20
D ISPOSAL OF S YSTEM ................................................................................................................................20
SECTION 4 – DEVICE DESCRIPTION .................................................................................................. 21
R EAR P ANEL ..............................................................................................................................................21
F RONT P ANEL AND O PERATOR C ONTROL P ANEL ......................................................................................22
S OFTWARE S CREENS .................................................................................................................................23
F UNCTIONAL K EYS ....................................................................................................................................26
S OUND I NDICATOR ....................................................................................................................................26
H ANDPIECES ..............................................................................................................................................27
SECTION 5 - SYSTEM OPERATION ..................................................................................................... 28
D EVICE S TART -U P .....................................................................................................................................28

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S YSTEM S HUTDOWN ..................................................................................................................................28
SECTION 6 - TREATMENT INFORMATION....................................................................................... 29
I NDICATIONS FOR U SE ...............................................................................................................................29
W ARNINGS ................................................................................................................................................29
P OSSIBLE S IDE E FFECTS ............................................................................................................................30
P RE - TREATMENT R ECOMMENDATIONS ......................................................................................................30
T IP C LEANING I NSTRUCTIONS P RIOR TO U SE ............................................................................................31
T REATMENT R ECOMMENDATIONS .............................................................................................................31
T REATMENT SCHEDULE .............................................................................................................................32
P OST TREATMENT RECOMMENDATIONS .....................................................................................................32
SECTION 7 – SYSTEM MAINTENANCE .............................................................................................. 33
E XTERNAL V ALIDATION M ODULE .............................................................................................................33
F ILLING W ATER ........................................................................................................................................33
D RAINING W ATER .....................................................................................................................................35
C LEANING THE D EVICE .............................................................................................................................36
SECTION 8 - TROUBLESHOOTING...................................................................................................... 37
D ESCRIPTION OF F AULTS ...........................................................................................................................37
SECTION 9 - SYSTEM SPECIFICATIONS............................................................................................ 39
EMC S AFETY FOR THE I N M ODE D EVICE ...................................................................................................40
T ABLE FROM IEC60601-1-2, / 5.2.2.1 C & F ................................................................................................44

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Section 1 - Introduction
Before You Start
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.
Read this manual to become familiar with all safety requirements and operating
procedures before attempting to operate the System.
System Overview
The InMode LUMECCA is a computerized system generating Intense Pulsed Light (IPL)
which is applied to the skin for selective treatment superficial vascular and pigmented
lesions. Light energy is selectively absorbed by melanin and hemoglobin creating
coagulation of lesion structure.
The System provides individual adjustment of light fluence and pulse duration to achieve
maximum efficiency and safety for each patient. Two handpieces can be attached to the
system where one Handpiece has a filter of 515 nm and is used on light skin treatment
and a second Handpiece with 580nm filter for use on darker skin.
The System provides enhanced safety and patient comfort while minimizing possible side
effects by cooling skin surface during the treatment.
Conventions Used in the Manual
The following conventions in the form of notes and warnings are used in this manual:
Provides general information that is important to keep in mind.
WARNING: This information is extremely important.

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Explanation of the Symbols used on the System
Symbol Description
Warning!
Attention! Consult Accompanying Document
CSA marking (212603 CSA master contract number)
CE marking
Do not discard in trash. Electronic equipment should
be disposed of in an appropriate manner
Fuse
Type B Equipment.
Follow operating instructions
Note

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Section 2 - Safety
This chapter describes safety issues regarding the use and maintenance of the System,
with a special emphasis on electrical and optical safety.
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.
The primary consideration should be to maximize safety for both treating attendant and
patient.
•Read this chapter to be familiar with all its safety requirements
and operating procedures prior to System operation.
•IPL 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.
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 should be removed to avoid accidental light reflection.
Protective eyewear must be used during the treatment.
Treating Attendant
Only authorized individuals with appropriate training and knowledge should operate,
assist in the operation of, or provide maintenance to the InMode System with the
LUMECCA Handpiece.
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.

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Cautions
The following cautions should be heeded for safe System use:
Do not touch the System’s inner parts.
Service is supplied by company-authorized personnell only.
To avoid damage, do not allow the Handpiece to come in contact with hard
materials.
Ocular hazards
The light emitted by the LUMECCA Handpiece is capable of causing eye irritation or
damage.
All persons potentially subject to exposure must wear protective goggles or eyewear in
accordance with national and international standards. The protective eyewear must have
an optical density (OD) of 5 or greater at the LUMECCA wavelength of –515-1200 nm.
For users outside the U.S., the appropriate standard may be EN 207, in which case the
safety eyewear must have a protection class of L5. The IPL is 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 room must be covered with opaque
material, and measures should be taken to prevent unauthorized access to the room.. In
addition, compliance with IEC 60601-2-57 requires that warning label from IR exposure
be posted at all entrances whenever the IPL is in use. An approved sign is provided with
each system along with protective eyewear. Additional eyewear or safety signs may be
obtained from the manufacturer.
All persons potentially subject to IPL exposure must wear appropriate eye protection
whenever the main power is on.
Never look directly into the light output 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 beam anywhere other than the calibration port or intended treatment
area. Stray light and reflection is always a potential hazard and may cause serious injury.
Do not treat eyelids or other areas within the bony area surrounding the orbit. The light
emitted by the LUMECCA IPL is capable of causing serious eye damage.
Ocular safety considerations
• Identify the treatment room clearly by posting approved safety signs in prominent locations.
• Cover all windows to prevent light from escaping the treatment room.
• Restrict entry to the treatment room when IPL is in use. Allow access to those personnel
both essential to the procedure and well trained in safety issues.
• Never direct the IPL beam at anything other than the calibration port or the intended
treatment site.

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• Never look directly into the IPL light guide at the distal end of the Handpiece.
• All persons in the treatment room must wear approved safety eyewear with an optical
density of 5 or greater at the InMode LUMECCA wavelength of –515-1200 nm. For users
outside the U.S., the appropriate standard may be EN 207, in which case the safety
eyewear must have a protection class of L5. This includes the operator, patient, nurses,
and any other persons in the room.
• Do not attempt to remove the protective covers on the Handpiece, which could allow
exposure to high intensity light.
Electrical and Mechanical Safety
Keep all covers and panels of the System closed. Removing the covers creates a safety
hazard.
Keep hands away from the applicator during the System start-up.
Perform maintenance procedures when the System is shut down and disconnected from
the power.
The System is grounded through the grounding conductor in the power cable. This
protective grounding is essential for safe operation.
Move the System slowly and carefully. The System weighs approximately 25kg (55lb.)
and may cause injury if proper care is not used when moving it.
Fire Hazards
The absorption of the IPL energy raises the temperature of the 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. 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.
Safety Features of the System
The System incorporates the following safety features. All personnel operating the
System should be familiar with these features.
System has unique password to avoid device operation by not authorized personnel.
An audible tone indicates energy activation.
The power electronics cannot be activated unless the applicator has been connected to
the System.
During activation, the System performs a self-test of the hardware.
Hardware is tested every 10ms to ensure proper operation of electrical circuit.

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System starts at a low power setting.
Active accessory
Examine the Handpiece and connectors to the System before using. Ensure that the
accessory functions as intended. Improper connection may result in arcs and
sparks, accessory malfunction, or unintended treatment effects.
Do not wrap the Handpiece cords around metal objects. It may induce current that
could lead to electrical shocks, fire or injury to the patient or personnel.
Don’t direct Handpiece output window on other treatment attendants or on are that
intended to be treated.
•Do not connect a wet accessory to the System.
•Do not immerse the applicator under water at any time.

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Warnings
This equipment is for use only by trained, licensed physicians.
Only handpieces manufactured or approved by InMODE MD Ltd. should be used with
InMode System.
Connect the power cord 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 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 system use.
Use the lowest output setting necessary to achieve the desired treatment effect. The higher
optical energy is applied, the greater the possibility of unintended thermal damage of skin.
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).
• Naturally occurring flammable gases which may accumulate in body cavities such as
the bowel.
• Oxygen enriched atmospheres.
• Oxidizing agents (such as nitrous oxide [N
2
O] atmospheres).
• Endogenous gases.
The IPL 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 IPL 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.

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Device Labels
The following device labels are located on the back panel of the InMode device
Figure 2.1 System Certification and identification label
Figure 2.2 Emergency STOP label

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Figure 2.3 IPL warning label
Figure 2.4 IPL emission warning label
Figure 2.5 IPL footswitch label

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Hand pieces labels
Figure s 2.5 and 2.6 shows the labels affixed to the IPL handpieces
Figure 2.6 LUMECCA 515 Handpiece identification label

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Figure 2.7 LUMECCA 580 Handpiece identification label
These certification and identification labels are attached to connectors on the Handpiece.
It states that the product conforms to the performance standards, and indicates the
manufacturer’s name, date of manufacturing, model and serial number of the Handpiece.
There are two models of Handpiece: LUMECCA515 with 515nm filer for light skin
treatment and LUMECCA580 with 580nm filer for darker skin.
Equipment Classification
The following is a list of the different equipment used and their classifications.
Electric shock protection: Class I, Defibrillation-proof Type B.
Protection against ingress of liquids: Ordinary equipment.
Not suitable for use in presence of flammable substance.
The InMode System with LUMECCA handpieces is classified as IIa device defined
by the Medical Device Directive (93/42/EEC) for CE marking.

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Section 3 - System Installation
Electrical Requirements
The System will require a separate line supply of single phase (100Vac; 15A) or
(115Vac; 15A) or (230Vac; 15A) or (240Vac; 15A) 50-60Hz.
Power receptacles must be within 15 feet of the System site.
The System should not share a power line with other equipment.
For continued protection against fire, replace the 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.
For optimal operation of the System, maintain room temperature between
20º-27ºC (68º-79ºF) and relative humidity of less than 80%.
Equipment List
The System includes the following:
System platform.
LUMECCA 515 & 580 Handpieces.
LUMECCA Handpiece cradle.
Operator manual.
Power cord.
User protective goggles.
Patient eyewear.
Power meter.

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Unpacking
In order to unpack the device:
1. Remove the paper strip and open the box.
2. Remove accessories and foams around the device.
3. Take device out of the box using top and bottom handles.

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Installation
The System is designed for installation in a clinic environment. To install the System
perform the following tasks:
Check the System and all its components for damage.
Connect cradle to the deice (Fig. 3.1).
Connect Handpiece to the connector on front panel (Fig 4.1).
Place Handpiece into the cradle.
Connect the footswitch.
Connect the Power Cord to the System inlet.
Plug the System Power Cord into an appropriate electrical outlet.
Figure 3.1 Cradle connections to the device
Filling Water
InMode system and LUMECCA handpieces are shipped without water. Distilled water
must be used and failure to do so will void the service warranty.
For detailed instructions refer to Section 7 – System Maintenance.

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Moving the System
To move the System:
Turn the System off.
Disconnect the Power Cord.
Disconnect the Handpieces.
Disconnect the footswitch.
Release the wheel brakes.
Slowly push or pull the System using the handle.
When moving to another facility, lift the System to the vehicle and lay it carefully on
its side.
For shipment, drain the water from the system and the hanspieces, as described in
Section 7- System Maintenance.
Never lift, pull or push the System using the operating panel.
Always use the handles when moving the System.
Upon unpacking check the System for mechanical damage (e.g.,
cracks in the cable insulation).
Never leave the system or/and handpieces with water in, exposed
to freezing temperatures (< 4°C).
Disposal of System
To comply with European Commission Directive 2002/96/EC on Waste Electrical and
Electronic Equipment (WEEE) and other country and state regulations, please DO NOT
dispose of this equipment in any location other than designated locations.