0% found this document useful (0 votes)
635 views19 pages

Exilite User's Manual Overview

Exilis IPL

Uploaded by

Sulay
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
635 views19 pages

Exilite User's Manual Overview

Exilis IPL

Uploaded by

Sulay
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

EXILITE

USER´S MANUAL
BEFORE YOU START

Dear Customer,

Thank you for purchasing the Exilite system. All of us at


BTL wish you every success with your new device. We
pride ourselves on being as responsive as possible to our
customer’s needs. Your suggestions and comments are
always welcome since we believe an ongoing
relationship with our customers is critically important to
our future product line.

While we would like you to start using your new


equipment right away, we encourage a thorough reading
of this manual in order to fully understand the
operational features of the system.

BTL Industries Ltd.

2
CONTENTS
1 GENERAL CHARACTERISTICS OF THE EXILITE SYSTEM 4
2 SAFETY PRECAUTIONS 5
3 TREATMENT SAFETY 8
4 CONTRAINDICATIONS 9
5 ASSEMBLY AND PUTTING INTO OPERATION 10
6 LIST OF STANDARD AND OPTIONAL PARAMETERS 12
7 TECHNICAL PARAMETERS 13

3
1 GENERAL CHARACTERISTICS OF THE EXILITE SYSTEM

1.1 INTENDED USE


The Exilite is intended to be used in dermatology and general surgical procedures such as treatment of
vascular lesions, pigmented lesions, acne, skin rejuvenation, pain relief and hair removal. The Exilite is a
system utilizing intense pulsed light (IPL) The device is using a high intensity pulsed light emission.

1.2 USER PROFILE


The Exilite is designed to be operated only by personnel properly trained in its handling and use by BTL.
All personnel who operate the system must read the user’s manual. This includes physicians, nurses,
technical staff or other professional staff members.

1.3 OPERATING ENVIRONMENT


The device is intended solely for professional use. The device is designed for indoor use only, not for use
in a location where explosion or water intrusion hazards are present and in dusty or humid
environment.

1.4 PATIENT PROFILE


The use of the device is not limited by age or weight of the patient. The patient must not show any signs
of the conditions defined in the chapter Contraindications. Before the application it is necessary to take
the patient’s medical history and make a thorough examination to determine whe ther or not the
application of this therapy is suitable for the patient.

4
2 SAFETY PRECAUTIONS

2.1 MAINTENANCE
All maintenance and service must be carried out by BTL authorized technical personnel. BTL bears no
responsibility for repairs or service performed by personnel not directly trained by the company.

Improper installation, operation or maintenance of this system may result in malfunctions of this unit or
other devices.

In case of display failure or other obvious defects switch the device off immediately b y pressing the
power switch. Disconnect the power cord from the power outlet and notify a BTL authorized technical
personnel.

Caution

Applicator cables, power cord and plug: Check for frays and kinks. Ensure that the insulation is not
damaged in any way.

Do not use damaged components. Always route electrical cords and cables away from staff or patient
foot-traffic areas where they could increase the chance of a tripping related accident.

All maintenance by the operator must only take place when the system is shut down and disconnected
from the power source.

Caution

With the exception of surface cleaning of the console and the applicator, replacement of the fuse and of
the applicator and filling the water tank, the Exilite system has no user-serviceable parts or assemblies.
Do not remove the instrument covers under any circumstances. Call your distributor for advice about
any malfunction.

The system prevents the connection of accessories other than those supplied by the manufacturer.

5
2.1.1 CLEANING OF THE APPLICATORS AND EXILITE SYSTEM COMPONENTS
The surfaces of the applicators, the applicators’ cables, and the Exilite system console should be cleaned
immediately after use to prevent debris from becoming affixed.

To clean the surface of applicators, the applicator cables, and the system console:

 In order to prevent electrical shock, unplug the power plug from the power outlet before
cleaning or disinfecting the unit.
 The outer surface of the applicator, the applicator cables, and the system console may be
wiped clean with a soft cotton cloth that has been moistened in 70% alcohol.
 If alcohol is used to clean and disinfect any part of the Exilite system, allow it to dry
thoroughly before operating the equipment.
 After wiping, inspect the surfaces for any debris. If debris is present, repeat the wiping step until
all visible debris is removed.
 Never spray aerosol cleaners directly onto the equipment. Aerosol spray cleaners are permitted
to clean the cabinet, but the cleaner should be sprayed onto a clean cloth which may then
be used to wipe the dirty area.
Care should be given to prevent water or other liquids from getting inside the device.

2.1.2 CARING FOR THE APPLICATORS


 The IPL and LED applicators contain electro-optical components that may be damaged if the
applicator is dropped. There is the potential of residual high voltages within the applicator which
may pose a serious risk if the applicator is damaged. Do not drop the applicator. Except during
treatment, the applicator should be always kept in its holder.
 Do not allow sunblock or sunscreen products to come in contact with the applicator. The
ingredients found in these products may cause deterioration or damage to the applicator
material. If sunblock or sunscreen does contact the applicator, clean it immedi ately to prevent
possible damage.
 Never immerse the applicator in any liquid, nor hold it under running water to prevent any
penetration of water into the applicator.
 Clean the sapphire crystal after each patient and application in order to keep it free from dirt
and gel.
 When inserting the filter for the first time, remove the protective foil from the IPL applicator.

2.1.3 FILTERS MAINTENANCE


Optical filters, which control the spectral output of the system, are under warranty to be in perfect
working condition upon receipt. No additional warranty applies.

Under normal working conditions, the performance of these filters is likely to deteriorate with time and
they will require replacing. Defects such as stains on the coated surface and spots where the coating
chips or lifts off the substrate can adversely affect the treatment outcome. Chipped substrates can also
affect the consistency of treatments, and may in some cases present a hazard to the operator or patient.
Although filters are consumables, their life span may be extended considerably if the proper care and
maintenance is given.

6
Do not insert dirty filter. It is very important to keep the filter clean at all times,
otherwise it can harm the patient and cause damage to the applicator. Replace the filter if it is broken or
if the coating is damaged (i.e., spots cover more than 15% of coating surface).

To clean the filter:

 Remove it by grasping the finger grip and then sliding out the filter as shown below.
 Gently dust the surface of the filter with a lint-free cloth.
 Gently wipe off gel and fingerprints from the filter surface with ethyl alcohol or isopropyl
alcohol.
 Wipe the surface of the filter (both sides) with a lint-free cloth.
 After cleaning, reinsert the filter by sliding it in the head while holding the finger grip.
 Make sure you insert the filter facing the flash lamp from the correct side showing the number
of wavelength (see picture below).
 Store the filters in the case.

1 2)
)

Please note the orientation of the filter. See the indication of wavelength.

7
3 TREATMENT SAFETY
The primary considerations should be for the safety of the patient, the operator and other personnel.
Patient safety is primarily assured by a well trained staff and a well laid out treatment room. Patient
education is also important, including information about the nature of the treatment.

During the design phase of the Exilite system, considerable thought was given to maximize safety for
both the patient and personnel.

 If no pulse is triggered for 30 seconds, the Exilite will switch to standby mode (refer to the
chapter Ошибка! Источник ссылки не найден.), thus preventing accidental light emission.
 An emergency shutoff button expedites shutdown when necessary.
 The user accesses the system via the login screen after entering a password. This prevents
unauthorized use of the system.
 A beeper sounds whenever the system triggers a pulse.

3.1 PATIENT AND OPERATOR SAFETY

 Never look directly at beam coming from the applicator, even when wearing Exilite protective
eyewear.
 Always wear protective eyewear.
 Observe the precautionary and operational decals placed on the unit.
 Use of a unit that indicates an Error may pose a risk of injury to the patient, user, or extensive
internal damage to the system.
 Inspect cables, associated connectors, and applicators before each use.
 The Exilite emits intense pulsed light pulses. Make sure that the patient and all those present in
the treatment room guard against accidental exposure to these emissions either directly from
the treatment head or indirectly from a reflecting surface. Do not allow reflective objects such
as jewelry, watches, surgical instruments or mirrors to reflect the pulsed light.
 Allow access to the treatment room only to personnel who have been well trained in th e
required safety procedures.
 Keep hands away from the applicators during system start-up.
 Do not press the IPL applicator trigger button without first verifying that the sapphire crystal is
safely positioned. Make sure the applicator is mounted on its cradle, or, during actual
treatment, pointed at the target area.
 Do not expose the skin to the light pulse except the test patch and the treatment area.
 Make sure to remove the gel from treated areas after treatment. Do not reuse gel!

8
4 CONTRAINDICATIONS
Do not treat (or expose) patients if the following conditions are present:

 Current or history of cancer, especially malignant melanoma or recurrent non-melanoma


skin cancer, or pre-cancerous lesions such as multiple dysplastic nevi.
 Epilepsy and similar chronic neurological disorders.
 Any active infection.
 Diseases which may be stimulated by light at 480 nm to 1200 nm, such as history of
recurrent Herpes Simplex, Systemic Lupus Erythematosus, or Porphyria.
 Use of photosensitive medication and/or herbs that may cause sensitivity to 480 nm to
1200 nm light exposure, such as Isotretinoin, Tetracycline, or St. John's Wort.
 Immunosuppressive diseases, including AIDS and HIV infection, or use of immuno-
suppressive medications.
 Medical conditions that may affect wound healing.
 Patient history of hormonal or endocrine disorders, such as polycystic ovary syndrome
or diabetes, unless under control.
 History of abnormal response to sunlight.
 History of bleeding coagulopathies, use of anticoagulants or heavy aspirin use.
 History of keloid scarring.
 Very dry skin.
 Exposure to sun or artificial tanning during the 3-4 weeks prior / after to treatment.
 Skin type VI.
 Pregnancy and nursing.

9
5 ASSEMBLY AND PUTTING INTO OPERATION

A UNPACKING THE SYSTEM


 Inspect the box for damage and report any damage to the carrier and your dealer. Do not
proceed with installation and assembly if the box is damaged.
 Unpack the system and place it on a stable horizontal surface.

B SAFETY PRECAUTIONS REGARDING THE SYSTEM ASSEMBLY

Warnings

 When bringing the Exilite console from a cold to a warm environment, allow it to adjust to the
new temperature for approximately 2 hours before use. Do not expose the device to very hot or
very cold climatic conditions.
 Always position the device out of direct sunlight.
 If the system cannot be installed immediately after delivery, the unit and its external
components or accessory elements must be stored in their original packaging in a dry place.
 Do not store or operate the unit in a dusty environment. Do not immerse it in any liquid. Do not
place it near running water.
 Do not place the Exilite console close to appliances producing strong electromagnetic, electric or
magnetic field (such as diathermy or X-rays).
 Do not expose the device to direct heat.
 Do not cover the cooling vents located on the rear panel and at the bottom of the device.
The control unit is self-cooled by forced air circulation.
 Leave at least 10 cm (4 inches) between the rear panel of the Exilite console and the wall.
 Do not position the device on a soft surface as this may obstruct air flow to the bottom cooling
vents.
 Do not put any heat-producing devices or objects containing water or other liquid on the Exilite
console.
 The Exilite is not designed to be operated in environments with a danger of explosion. Do not
use in surgical rooms, where inflammable anaesthesia may be used.
 Retain original packaging for future transport.
 The Exilite must operate in a non-corrosive atmosphere. Corrosive materials such as acids can
damage electrical wiring, electronic components and the surfaces of optical components.
 Air-borne dust particles must be kept to a minimum. Dust particles absorb light and heat up. Hot
particles located on the optical filters can damage them. Metallic dust is destructive to electrical
equipment.
 Please refer to the chapter 7 to see operating, transport and storage conditions.

10
The device contains a water based cooling system. The liquid can potentially freeze and a part of the
cooling circuit can break.

The Exilite should not be placed in household waste bins. Please check applicable local, state
and federal laws and regulations for information about the disposal of electronic products in
your area. Prior to device disposal, the lithium battery should be removed and handled as
hazardous waste.

The device must be safely installed to avoid any danger to the patient, the operator, or other persons.
The operator must be able to access the unit from the front.

11
6 LIST OF STANDARD AND OPTIONAL ACCESSORIES
The system consists of the following accessories:

Standard accessories:

 1x applicator with crystal 11 x 40 mm


 1x holder for IPL applicator
 5x optical filters with different wavelengths (480 nm, 530 nm, 560 nm, 640 nm, 690 nm)
 1x calibration filter
 1x IPL eyewear for operators
 1x protective eye caps for patients
 1x power cable
 1x filling kit
 2x spare fuses T16AL/250 V
 2x spare fuses FF5AH/250 V
 1x screw driver
 4x screws
 2x plugs
 1x portable case
 1x gel 300 ml
 1x touch screen pen
 1x user’s manual

Optional accessories:

 IPL applicator with crystal 11 x 40 mm


 optical filters with different wavelengths (480 nm, 530 nm, 560 nm, 640 nm, 690 nm)
 calibration filter
 yellow LED Postlight applicator
 holder for LED Postlight applicator
 footswitch
 IPL eyewear for operators
 protective eye caps for patients
 spare fuses T16AL/250 V, FF5AH/250 V
 screw driver
 screws
 plugs
 portable case
 gel 300 ml
 gel 1000 ml

Accessories not manufactured by BTL for use with the Exilite system must not be attached to
the system to prevent potential harm to the patient and/or damage the unit. BTL Industries
is not responsible for any consequence resulting from using products manufactured by other
companies.

12
7 TECHNICAL PARAMETERS

Name Exilite
Operating conditions
Ambient temperature +15 °C to +30 °C
Relative humidity 30 % to 75 %
Atmospheric pressure 800 hPA to 1060 hPA
Position On castors
Transport and storage conditions
Ambient temperature +10 °C to +40 °C
Relative humidity 10 % to 85 %
Atmospheric pressure 650 hPA to 1100 hPa
Position According to marking on the package
Additional conditions Transport only in supplied packaging, drain
cooling water
Power supply
Maximum power input 1500 VA
Mains voltage ~100-240 V
Frequency 50-60 Hz
Electrical protection class Class I
External exchangeable fuse - device 2x T16AL/250 V, tube safety fuse 5.2 x 20 mm
External exchangeable fuse - applicator 2x FF5AH/250 V, tube safety fuse 5 x 20 mm
Mains switch On the rear side of the device,
positions 0 (off) and I (on)
Design
Weight - unit 42.7 kg (95.46 lb)
Weight - IPL applicator 2.25 kg (4.96 lb)
Weight - Postlight LED applicator 0.510 kg (1.12 lb)
Dimensions - system console (W x H x D) 580 x 980 x 580 mm (22.8 x 38.6 x 22.8 in)
Dimensions - IPL applicator (W x H x D) 60 x 85 x 240 mm (2.36 x 3.35 x 9.45 in)
Dimensions - Postlight LED applicator 65 x 100 x 160 mm (2.56 x 3.94 x 6.30 in)
(W x H x D)
IP classification IP20
Class according to MDD 93/42EEC IIb
Display elements
Graphic color touch screen Diagonal 8.4“ / 21.5 cm, 640 x 480 pixels
Exilite treatment
Fluence adjustment range 5 to 40 J/cm2
Fluence adjustment accuracy ± 20 % of range
Cooling 0 to 100 %
IPL applicator classification Type B applied part
Postligh LED treatment (optional)
13
Power adjustment range 50-400 mW
Power adjustment accuracy ± 30 of value set
Postlight LED applicator classification Type BF applied part

ELECTROMAGNETIC COMPATIBILITY (EMC)


The Exilite needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided in this document. Portable and mobile RF communications
equipment can affect the Exilite.

Guidance and manufacturer’s declaration – electromagnetic emissions


The Exilite is intended for use in the electromagnetic environment specified below.
The customer or the user of the Exilite should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
The Exilite uses RF energy only for its internal function.
RF emissions
Group 1 Therefore, its RF emissions are very low and are not likely to
CISPR 11
cause any interference in nearby electronic equipment.
RF emissions
Class A
CISPR 11
Harmonic
The Exilite is suitable for use in all establishments other than
emissions
domestic and those directly connected to the public low-voltage
IEC 61000-3-2
power supply network that supplies buildings used for domestic
Voltage Non applicable
purposes.
fluctuations/
flicker emissions
IEC 61000-3-3

The Exilite should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is
necessary, the Exilite should be observed to verify normal operation in such configuration.

Recommended separation distances between portable and mobile RF communications equipment and
the Exilite

The Exilite is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the Exilite can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the Exilite as recommended below, according to the maximum output power of the
communications equipment.

Rated maximum Separation distance according to frequency of transmitter


output power of
(m)
transmitter

(W) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

14
d = 1.2 P d = 1.2 P d = 2.3 P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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.
Guidance and manufacturer’s declaration – electromagnetic immunity

The Exilite is intended for use in the electromagnetic environment specified below. The customer or the
user of the Exilite should assure that it is used in such an environment.

IEC 60601 Electromagnetic environment


Immunity test Compliance level
test level – guidance

Floors should be wood,


Electrostatic ±6 kV contact ±6 kV contact concrete or ceramic tile. If
discharge (ESD) floors are covered with
synthetic material, the
IEC 61000-4-2 ±8 kV air ±8 kV air relative humidity should be at
least 30%.

±2 kV for power ±2 kV for power supply Mains power quality should


Electrical fast
supply lines lines be that of a typical
transient/burst
commercial or hospital
±1 kV for ±1 kV for input/output environment.
IEC 61000-4-4
input/output lines lines

±1 kV line(s) Mains power quality should


±1 kV line to line be that of a typical
Surge to line(s)
commercial or hospital
IEC 61000-4-5 ±2 kV line(s) environment.
±2 kV line to earth
to earth

Voltage dips, short <5 % UT <5 % UT Mains power quality should

15
interruptions and (>95 % dip in UT) (>95 % dip in UT) be that of a typical
voltage variations commercial or hospital
for 0.5 cycle for 0.5 cycle
on power supply environment. If the user of
input lines the Exilite requires continued
operation during power mains
IEC 61000-4-11 40 % UT 40 % UT
interruptions, it is
(60 % dip in UT) (60 % dip in UT) recommended that the Exilite
be powered from an
for 5 cycles for 5 cycles uninterruptible power supply
or a battery.

70 % UT 70 % UT

(30 % dip in UT) (30 % dip in UT)

for 25 cycles for 25 cycles

<5 % UT <5 % UT

(>95 % dip in UT) (>95 % dip in UT)

for 5 s for 5 s

Power frequency magnetic


Power frequency fields should be at levels
(50/60 Hz) characteristic of a typical
magnetic field 3 A/m 3 A/m
location in a typical
IEC 61000-4-8 commercial or hospital
environment.

NOTE: UT is the a.c. mains voltage prior to application of the test level.

16
Guidance and manufacturer’s declaration – electromagnetic immunity
The Exilite is intended for use in the electromagnetic environment specified below. The customer or the
user of the Exilite should assure that it is used in such an environment.
IEC 60601 Compliance
Immunity test Electromagnetic environment – guidance
test level level
Portable and mobile RF communications
equipment should be used no closer to any part
of the Exilite, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
Recommended separation distance
d = 1.17P
Conducted RF 3 Vrms 3 Vrms
d = 1.17P 80 MHz to 800 MHz
IEC 61000-4-6 150 kHz to
Radiated RF 80 MHz 3 V/m d = 2.33P 800 MHz to 2.5 GHz
IEC 61000-4-3
3 V/m
80 MHz to where P is the maximum output power rating of
2.5 GHz the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in metres
(m).
Field strengths from fixed RF transmitters, as
deter-mined by an electromagnetic site survey,a
should be less than the compliance level in each
frequency range. b
Interference may occur in the vicinity of
equipment marked with the following symbol

17
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 Exilite is used exceeds the applicable RF compliance level above, the Exilite should
be observed to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as re-orienting or relocating the Exilite.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

18
MANUFACTURER
BTL Industries Ltd.
161 Cleveland Way
Stevenage
Hertfordshire
SG1 6BU
United Kingdom

For service, please contact our service department at service@btlnet.com.

Date of last revision: 25th September, 2017

ID: 716-80MANEN02100

© All rights reserved. No part of this manual may be reproduced, saved or transferred by any means
including electronic, mechanical, and photographic without the prior written approval from BTL
Industries Limi

19

You might also like